AB 401: Pharmacy: remote dispensing site pharmacy: telepharmacy: shared clinic office space.
- Session Year: 2017-2018
- House: Assembly
- Latest Version Date: 2017-10-07
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would require the board to issue a remote dispensing site pharmacy license to a supervising pharmacy, as defined, of a remote dispensing site pharmacy, as defined, if all the requirements for licensure are met for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is located. The bill would require a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would prohibit pharmacy services from being provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for one remote dispensing site pharmacy. The bill would require a remote dispensing site pharmacy to utilize specified secure communications systems and security systems. The bill would prohibit a remote dispensing site pharmacy from being located in any state facility and would prohibit a remote dispensing site pharmacy from being located or operated for the purpose of displacing state employees. The bill would require a remote dispensing site pharmacy that dispenses more than 225 prescriptions per day, calculated each calendar year, to cease being a remote dispensing site pharmacy and authorizes the remote dispensing site pharmacy to become a full-service pharmacy if it meets all the requirements for licensure as a pharmacy.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of a pharmacy in addition to serving as a pharmacist-in-charge of a supervising pharmacy and would require the designated pharmacist-in-charge of the supervising pharmacy to also serve as the designated pharmacist-in-charge of the remote dispensing site pharmacy. The bill would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law prohibits a person from acting as a wholesaler of any dangerous drug or dangerous device unless the wholesaler has obtained a license from the board. Subject to certain exceptions, existing federal law requires a person, who manufactures, distributes, dispenses, imports, or exports any controlled substance to obtain a registration and requires a registrant to inform the United States Drug Enforcement Administration of any suspicious orders.
This bill would require a wholesaler to notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration.
Existing law prohibits the board from issuing more than one site license to a single premises, except as specified.
This bill, until January 1, 2021, would authorize the board to issue specified licenses to 2 independently owned clinics that share a clinic office space, as specified. The bill would make each clinic jointly and severally responsible for drug losses. The bill would require the applicants to provide the board with a copy of the co-location agreement and a one-time application fee of $750 for the licenses. The bill would require a new application and specified fees for any change in ownership in either clinic. The bill would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi-Cal financing issues have been sufficiently addressed, as specified. The bill would authorize the Department of Health Care Services to seek any federal approvals it deems necessary to implement this provision. The bill also would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed, as specified.
Under existing law, the State Department of Public Health is responsible for the licensing and regulation of clinics, as defined. Existing law exempts from the licensing and regulation provisions any clinic directly conducted, maintained, or operated by the United States or by any of its departments, offices, or agencies, and specified primary care clinics directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city.
This bill, until January 1, 2021, would authorize primary care clinics and specialty clinics to operate, as specified, in shared clinic space with the government clinics specified above. The bill would authorize the department to enter and inspect the shared space at any time, as specified. The bill would make the licensed primacy care clinic or specialty clinic responsible for any statutory or regulatory violations occurring on the premises. The bill would authorize the department to implement, interpret, or make specific these provisions by means of all-facility letters, or similar instructions, without taking regulatory action.
Existing law makes a violation of any provision of the Pharmacy Law punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by SB 752 to be operative only if this bill and SB 752 are enacted and this bill is enacted last.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would require the board to issue a remote dispensing site pharmacy license to a supervising pharmacy, as defined, of a remote dispensing site pharmacy, as defined, if all the requirements for licensure are met for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is located. The bill would require a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would prohibit pharmacy services from being provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for one remote dispensing site pharmacy. The bill would require a remote dispensing site pharmacy to utilize specified secure communications systems and security systems. The bill would prohibit a remote dispensing site pharmacy from being located in any state facility and would prohibit a remote dispensing site pharmacy from being located or operated for the purpose of displacing state employees. The bill would require a remote dispensing site pharmacy that dispenses more than 225 prescriptions per day, calculated each calendar year, to cease being a remote dispensing site pharmacy and authorizes the remote dispensing site pharmacy to become a full-service pharmacy if it meets all the requirements for licensure as a pharmacy.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of a pharmacy in addition to serving as a pharmacist-in-charge of a supervising pharmacy and would require the designated pharmacist-in-charge of the supervising pharmacy to also serve as the designated pharmacist-in-charge of the remote dispensing site pharmacy. The bill would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law prohibits a person from acting as a wholesaler of any dangerous drug or dangerous device unless the wholesaler has obtained a license from the board. Subject to certain exceptions, existing federal law requires a person, who manufactures, distributes, dispenses, imports, or exports any controlled substance to obtain a registration and requires a registrant to inform the United States Drug Enforcement Administration of any suspicious orders.
This bill would require a wholesaler to notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration.
Existing law prohibits the board from issuing more than one site license to a single premises, except as specified.
This bill, until January 1, 2021, would authorize the board to issue specified licenses to 2 independently owned clinics that share a clinic office space, as specified. The bill would make each clinic jointly and severally responsible for drug losses. The bill would require the applicants to provide the board with a copy of the co-location agreement and a one-time application fee of $750 for the licenses. The bill would require a new application and specified fees for any change in ownership in either clinic. The bill would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi-Cal financing issues have been sufficiently addressed, as specified. The bill would authorize the Department of Health Care Services to seek any federal approvals it deems necessary to implement this provision. The bill also would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed, as specified.
Under existing law, the State Department of Public Health is responsible for the licensing and regulation of clinics, as defined. Existing law exempts from the licensing and regulation provisions any clinic directly conducted, maintained, or operated by the United States or by any of its departments, offices, or agencies, and specified primary care clinics directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city.
This bill, until January 1, 2021, would authorize primary care clinics and specialty clinics to operate, as specified, in shared clinic space with the government clinics specified above. The bill would authorize the department to enter and inspect the shared space at any time, as specified. The bill would make the licensed primacy care clinic or specialty clinic responsible for any statutory or regulatory violations occurring on the premises. The bill would authorize the department to implement, interpret, or make specific these provisions by means of all-facility letters, or similar instructions, without taking regulatory action.
Existing law makes a violation of any provision of the Pharmacy Law punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by SB 752 to be operative only if this bill and SB 752 are enacted and this bill is enacted last.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would require the board to issue a remote dispensing site pharmacy license to a supervising pharmacy, as defined, of a remote dispensing site pharmacy, as defined, if all the requirements for licensure are met for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is located. The bill would require a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would prohibit pharmacy services from being provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for one remote dispensing site pharmacy. The bill would require a remote dispensing site pharmacy to utilize specified secure communications systems and security systems. The bill would prohibit a remote dispensing site pharmacy from being located in any state facility and would prohibit a remote dispensing site pharmacy from being located or operated for the purpose of displacing state employees. The bill would require a remote dispensing site pharmacy that dispenses more than 225 prescriptions per day, calculated each calendar year, to cease being a remote dispensing site pharmacy and authorizes the remote dispensing site pharmacy to become a full-service pharmacy if it meets all the requirements for licensure as a pharmacy.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of a pharmacy in addition to serving as a pharmacist-in-charge of a supervising pharmacy and would require the designated pharmacist-in-charge of the supervising pharmacy to also serve as the designated pharmacist-in-charge of the remote dispensing site pharmacy. The bill would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law prohibits a person from acting as a wholesaler of any dangerous drug or dangerous device unless the wholesaler has obtained a license from the board. Subject to certain exceptions, existing federal law requires a person, who manufactures, distributes, dispenses, imports, or exports any controlled substance to obtain a registration and requires a registrant to inform the United States Drug Enforcement Administration of any suspicious orders.
This bill would require a wholesaler to notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration.
Existing law prohibits the board from issuing more than one site license to a single premises, except as specified.
This bill, until January 1, 2021, would authorize the board to issue specified licenses to 2 independently owned clinics that share a clinic office space, as specified. The bill would make each clinic jointly and severally responsible for drug losses. The bill would require the applicants to provide the board with a copy of the co-location agreement and a one-time application fee of $750 for the licenses. The bill would require a new application and specified fees for any change in ownership in either clinic. The bill would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi-Cal financing issues have been sufficiently addressed, as specified. The bill would authorize the Department of Health Care Services to seek any federal approvals it deems necessary to implement this provision. The bill also would prohibit the board from issuing these licenses to clinics that share a clinic office space until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed, as specified.
Under existing law, the State Department of Public Health is responsible for the licensing and regulation of clinics, as defined. Existing law exempts from the licensing and regulation provisions any clinic directly conducted, maintained, or operated by the United States or by any of its departments, offices, or agencies, and specified primary care clinics directly conducted, maintained, or operated by this state or by any of its political subdivisions or districts, or by any city.
This bill, until January 1, 2021, would authorize primary care clinics and specialty clinics to operate, as specified, in shared clinic space with the government clinics specified above. The bill would authorize the department to enter and inspect the shared space at any time, as specified. The bill would make the licensed primacy care clinic or specialty clinic responsible for any statutory or regulatory violations occurring on the premises. The bill would authorize the department to implement, interpret, or make specific these provisions by means of all-facility letters, or similar instructions, without taking regulatory action.
Existing law makes a violation of any provision of the Pharmacy Law punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by SB 752 to be operative only if this bill and SB 752 are enacted and this bill is enacted last.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would require the board to issue a remote dispensing site pharmacy license to a supervising pharmacy, as defined, of a remote dispensing site pharmacy, as defined, if all the requirements for licensure are met for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is located. The bill would require a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would prohibit pharmacy services from being provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for one remote dispensing site pharmacy. The bill would require a remote dispensing site pharmacy to utilize specified security secure communications systems and security systems. The bill would prohibit a remote dispensing site pharmacy from being located in any state facility and would prohibit a remote dispensing site pharmacy from being located or operated for the purpose of displacing state employees. The bill would require a remote dispensing site pharmacy that dispenses more than 300 225 prescriptions per day, calculated each calendar year, to cease being a remote dispensing site pharmacy and authorizes the remote dispensing site pharmacy to become a full-service pharmacy if it meets all the requirements for licensure as a pharmacy.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of a pharmacy in addition to serving as a pharmacist-in-charge of a supervising pharmacy and would require the designated pharmacist-in-charge of the supervising pharmacy to also serve as the designated pharmacist-in-charge of the remote dispensing site pharmacy. The bill would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law prohibits a person from acting as a wholesaler of any dangerous drug or dangerous device unless the wholesaler has obtained a license from the board. Subject to certain exceptions, existing federal law requires a person, who manufactures, distributes, dispenses, imports, or exports any controlled substance to obtain a registration and requires a registrant to inform the United States Drug Enforcement Administration of any suspicious orders.
This bill would require a wholesaler to notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration.
Existing law prohibits the board from issuing more than one site license to a single premises, except as specified.
This bill, until January 1, 2021, would authorize the board to issue specified licenses to 2 independently owned clinics that share a clinic office space, as specified. The bill would make each clinic jointly and severally responsible for drug losses. The bill would require the applicants to provide the board with a copy of the co-location agreement and a one-time application fee of $750 for the licenses. The bill would require a new application and specified fees for any change in ownership in either clinic.
Existing law makes a violation of any provision of the Pharmacy Law punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
This bill would incorporate additional changes to Section 4059.5 of the Business and Professions Code proposed by SB 752 to be operative only if this bill and SB 752 are enacted and this bill is enacted last.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would require the board to issue a remote dispensing site pharmacy license to a supervising pharmacy, as defined, of a remote dispensing site pharmacy, as defined, if all the requirements for licensure are met for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is located. The bill would authorize require a remote dispensing site pharmacy to use a telepharmacy system, as specified. specified, and would prohibit pharmacy services from being provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for one remote dispensing site pharmacy. The bill would require a remote dispensing site pharmacy to utilize specified security communications systems and security systems. The bill would prohibit a remote dispensing site pharmacy from being located in any state facility and would prohibit a remote dispensing site pharmacy from being located or operated for the purpose of displacing state employees. The bill would require a remote dispensing site pharmacy that dispenses more than 300 prescriptions per day, calculated each calendar year, to cease being a remote dispensing site pharmacy and authorizes the remote dispensing site pharmacy to become a full-service pharmacy if it meets all the requirements for licensure as a pharmacy.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of no more than 2 remote dispensing site pharmacies, a pharmacy in addition to serving as a pharmacist-in-charge of a supervising pharmacy, pharmacy and would require the designated pharmacist-in-charge of the supervising pharmacy to also serve as the designated pharmacist-in-charge of the remote dispensing site pharmacy. The bill would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law makes a violation of any provision of the Pharmacy Law punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would authorize a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would require the board to issue a remote dispensing site pharmacy license to a remote dispensing site pharmacy that meets a supervising pharmacy, as defined, of a remote dispensing site pharmacy, as defined, if all the requirements for licensure. licensure are met for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is located. The bill would authorize a remote dispensing site pharmacy to use a telepharmacy system, as specified. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for up to 2 one remote dispensing site pharmacies. pharmacy. The bill would require a remote dispensing site pharmacy to utilize specified security communications systems and security systems. The bill would prohibit a remote dispensing site pharmacy from being located in any state facility and would prohibit a remote dispensing site pharmacy from being located or operated for the purpose of displacing state employees.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of no more than 2 remote dispensing site pharmacies, in addition to serving as a pharmacist-in-charge of a supervising pharmacy, and would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law makes a violation of any of its provisions provision of the Pharmacy Law punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the department Department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would authorize a remote dispensing site pharmacy to use a telepharmacy system, as specified, and would require the board to issue a remote dispensing site pharmacy license for certain purposes and authorizes the board to establish, by regulation, locations eligible for a remote dispensing site pharmacy, as specified. to a remote dispensing site pharmacy that meets all the requirements for licensure. The bill would require a remote dispensing site pharmacy to be located in a medically underserved area, as defined, unless otherwise approved by the board. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for up to 3 2 remote dispensing site pharmacies and requires a pharmacist from the supervising pharmacy to, among other things, be capable of being on site at the remote dispensing pharmacy within 6 hours. pharmacies. The bill would require a remote dispensing site pharmacy to utilize specified security communications systems and security systems.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order. The bill would require any controlled substances signed for by a pharmacy technician to be stored separately from existing inventory until they are reviewed and countersigned by a pharmacist.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of no more than 3 2 remote dispensing site pharmacies, in addition to serving as a pharmacist-in-charge of a supervising pharmacy, and would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would prohibit a pharmacy technician working at a remote dispensing site pharmacy from performing certain tasks, including receiving a new prescription order orally. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law makes a violation of any of its provisions punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law, the Pharmacy Law, requires the California State Board of Pharmacy, which is within the department of Consumer Affairs, to license and regulate the practice of pharmacy, including pharmacists, pharmacy technicians, and pharmacies.
This bill would require the board to issue a remote dispensing site pharmacy license for certain purposes and authorizes the board to establish, by regulation, locations eligible for a remote dispensing site pharmacy, as specified. The bill would authorize a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for up to 3 remote dispensing site pharmacies and requires a pharmacist from the supervising pharmacy to, among other things, be capable of being on site at the remote dispensing pharmacy within 6 hours. The bill would require a remote dispensing site pharmacy to utilize specified security communications systems and security systems.
Existing law prohibits the ordering of dangerous drugs and devices by an entity not licensed by the board, except as otherwise provided, and requires the order to be delivered to the licensed premises and signed for by a pharmacist.
This bill would authorize a licensed remote dispensing site pharmacy, as defined, to order dangerous drugs and devices and authorizes a registered pharmacy technician meeting specified requirements to receive and sign for the delivered order.
Existing law requires every pharmacy to designate a pharmacist-in-charge, as specified, and requires the pharmacist-in-charge to be responsible for the pharmacys compliance with all state and federal laws pertaining to the practice of pharmacy.
This bill would authorize a pharmacist to serve as a pharmacist-in-charge of no more than 3 remote dispensing site pharmacies, in addition to serving as a pharmacist-in-charge of a supervising pharmacy, and would require the pharmacist-in-charge and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring sufficient staffing, as specified.
Existing law authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist and prohibits the ratio of pharmacy technicians performing these tasks to any additional pharmacists from exceeding 2 to 1, except as specified.
This bill would instead authorize a registered pharmacy technician, who meets certain requirements, to work at a remote dispensing site pharmacy and to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system. The bill would authorize a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
Existing law makes a violation of any of its provisions punishable as a crime.
By expanding the scope of an existing crime, this bill would result in a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
(a)The Legislature hereby finds and declares all of the following:
(1)Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.
(2)Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.
(3)Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.
(4)Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.
(5)In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.
(b)The Legislature further finds and declares both of the following:
(1)Section 4001.1 of the Business and Professions Code establishes public protection as the highest priority of the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. That section further provides that whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.
(2)Public protection requires the California State Board of Pharmacy to enforce the laws related to a supervising pharmacy, as defined by Section 4044.6 of the Business and Professions Code, and a remote dispensing site pharmacy, as defined in Section 4044.3 of the Business and Professions Code, through licensure.
(c)It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.
SEC. 2.Section 4044.3 is added to the Business and Professions Code, to read:4044.3.(a)Remote dispensing site pharmacy means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians, as defined in Section 4132, where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
(b)Unless otherwise specified in this chapter, a remote dispensing site pharmacy shall comply with all state and federal laws regulating the practice of pharmacy.
SEC. 3.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.(a)Supervising pharmacy means a licensed pharmacy located in this state that is owned and operated by a person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one board-licensed pharmacist, as defined in Section 4036, that exclusively oversees the operations of a remote dispensing site pharmacy.
(b)A supervising pharmacy shall be exclusively responsible for the operation of the remote dispensing site pharmacy and its employees pursuant to Section 4131.
SEC. 4.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a remote dispensing site pharmacy and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 5.5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Section 4107 of the Business and Professions Code is amended to read:4107.(a)The board shall not issue more than one site license to a single premises except as follows:
(1)To issue a veterinary food-animal drug retailer license to a wholesaler pursuant to Section 4196.
(2)To issue a license to compound sterile drugs to a pharmacy pursuant to Section 4127.1 or 4127.2.
(3)To issue a centralized hospital packaging license pursuant to Section 4128.
(4)To issue licenses to two independently owned clinics that share a clinic office space pursuant to Section 4180.5.
(b)For the purposes of this subdivision, premises means a location with its own address and an independent means of ingress and egress.
SEC. 7.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy Systems and Remote Dispensing Site Pharmacies4130.(a)A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.
(c)(1)A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a medically underserved area means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
(e)A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license.
(f)A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.
(g)A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.
(h)If a remote dispensing site pharmacy dispenses more than 225 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy.
4131.(a)A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.
(b)A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(d)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
(e)Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy.
(f)Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
4132.(a)In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall meet the qualifications promulgated by the board. The regulations developed by the board shall only apply to pharmacy technicians working at remote dispensing sites.
(b)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(c)A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)Identify, evaluate, or interpret a prescription.
(4)Interpret the clinical data in a patient medication record system or patient chart.
(5)Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)Perform any function that requires the professional judgment of a licensed pharmacist.
(8)Compound drug preparations.
(d)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy.
(d)A telepharmacy system shall be able to do all of the following:
(1)Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(e)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(f)All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board.
(h)Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable.
(c)The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.
SEC. 8.Section 4169.1 is added to the Business and Professions Code, immediately following Section 4169, to read:4169.1.A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
SEC. 9.Section 4180.5 is added to the Business and Professions Code, to read:4180.5.(a)The board may issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space, provided that the clinics comply with the following:
(1)Each clinic maintains a separate clinic license with the board with its own professional directors, administrators, owners, and officers.
(2)Each clinic maintains physically separate and locked drug stocks.
(3)Each clinic separately maintains all records required by this article, including acquisition and disposition records.
(4)Dangerous drugs and dangerous devices shall not be loaned between the two licensed clinics.
(b)Dangerous drugs and dangerous device losses at the shared clinic office shall be reported to the board as required by law. Each clinic may be jointly and severally responsible for the drug losses.
(c)The applicants shall also provide the board with a copy of the co-location agreement and a one-time application fee of seven hundred fifty dollars ($750) for the licenses.
(d)Any change in ownership in either clinic shall require a new application under this section and fees as required by subdivision (q) of Section 4400 and subdivision (c) of this section.
(e)The board shall not issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to this section until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi-Cal financing issues, including the ability to claim associated federal financial participation or 340(b) program participation, have been sufficiently addressed to the directors satisfaction. The Department of Health Care Services may seek any federal approvals it deems necessary to implement this section.
(f)The board shall not issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to the section until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed to the directors satisfaction.
(g)This section shall become inoperative on January 1, 2021, and as of that date is repealed.
SEC. 10.Section 1211 is added to the Health and Safety Code, to read:1211.(a)Notwithstanding any other law, a clinic licensed pursuant to Section 1204 may operate in shared clinic space with a clinic exempt from licensure pursuant to subdivision (b) of Section 1206 under the following conditions:
(1)Each clinic uses signage that clearly identifies which clinic is operating during the hours of operation.
(2)The licensed clinic reports the operating hours of both clinics.
(3)Each clinic maintains separate medical records.
(4)Each clinic maintains separate drug storage.
(5)Both clinics are licensed by the California State Board of Pharmacy pursuant to Section 4180.5 of the Business and Professions Code.
(b)The department may enter and inspect the shared space at any time pursuant to Section 1227 of the Health and Safety Code, including accessing records. The exempt clinic shall allow the department to access and inspect its records.
(c)The licensed clinic shall be responsible for any statutory or regulatory violations occurring on the premises.
(d)Notwithstanding the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code), the department may implement, interpret, or make specific this section by means of all-facility letters, or similar instructions, without taking regulatory action.
(e)This section shall become inoperative on January 1, 2021, and as of that date is repealed.
SEC. 11.Section 5.5 of this bill incorporates amendments to Section 4059.5 of the Business and Professions Code proposed by both this bill and Senate Bill 752. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4059.5 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 752, in which case Section 5 of this bill shall not become operative.
SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)The Legislature hereby finds and declares all of the following:
(1)Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.
(2)Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.
(3)Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.
(4)Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.
(5)In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.
(b)The Legislature further finds and declares both of the following:
(1)Section 4001.1 of the Business and Professions Code establishes public protection as the highest priority of the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. That section further provides that whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.
(2)Public protection requires the California State Board of Pharmacy to enforce the laws related to a supervising pharmacy, as defined by Section 4044.6 of the Business and Professions Code, and a remote dispensing site pharmacy, as defined in Section 4044.3 of the Business and Professions Code, through licensure.
(c)It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.
SEC. 2.Section 4044.3 is added to the Business and Professions Code, to read:4044.3.(a)Remote dispensing site pharmacy means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians, as defined in Section 4132, where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
(b)Unless otherwise specified in this chapter, a remote dispensing site pharmacy shall comply with all state and federal laws regulating the practice of pharmacy.
SEC. 3.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.(a)Supervising pharmacy means a licensed pharmacy located in this state that is owned and operated by a person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one board-licensed pharmacist, as defined in Section 4036, that exclusively oversees the operations of a remote dispensing site pharmacy.
(b)A supervising pharmacy shall be exclusively responsible for the operation of the remote dispensing site pharmacy and its employees pursuant to Section 4131.
SEC. 4.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a remote dispensing site pharmacy and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 5.5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Section 4107 of the Business and Professions Code is amended to read:4107.(a)The board shall not issue more than one site license to a single premises except as follows:
(1)To issue a veterinary food-animal drug retailer license to a wholesaler pursuant to Section 4196.
(2)To issue a license to compound sterile drugs to a pharmacy pursuant to Section 4127.1 or 4127.2.
(3)To issue a centralized hospital packaging license pursuant to Section 4128.
(4)To issue licenses to two independently owned clinics that share a clinic office space pursuant to Section 4180.5.
(b)For the purposes of this subdivision, premises means a location with its own address and an independent means of ingress and egress.
SEC. 7.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy Systems and Remote Dispensing Site Pharmacies4130.(a)A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.
(c)(1)A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a medically underserved area means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
(e)A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license.
(f)A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.
(g)A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.
(h)If a remote dispensing site pharmacy dispenses more than 225 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy.
4131.(a)A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.
(b)A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(d)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
(e)Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy.
(f)Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
4132.(a)In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall meet the qualifications promulgated by the board. The regulations developed by the board shall only apply to pharmacy technicians working at remote dispensing sites.
(b)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(c)A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)Identify, evaluate, or interpret a prescription.
(4)Interpret the clinical data in a patient medication record system or patient chart.
(5)Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)Perform any function that requires the professional judgment of a licensed pharmacist.
(8)Compound drug preparations.
(d)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy.
(d)A telepharmacy system shall be able to do all of the following:
(1)Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(e)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(f)All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board.
(h)Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable.
(c)The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.
SEC. 8.Section 4169.1 is added to the Business and Professions Code, immediately following Section 4169, to read:4169.1.A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
SEC. 9.Section 4180.5 is added to the Business and Professions Code, to read:4180.5.(a)The board may issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space, provided that the clinics comply with the following:
(1)Each clinic maintains a separate clinic license with the board with its own professional directors, administrators, owners, and officers.
(2)Each clinic maintains physically separate and locked drug stocks.
(3)Each clinic separately maintains all records required by this article, including acquisition and disposition records.
(4)Dangerous drugs and dangerous devices shall not be loaned between the two licensed clinics.
(b)Dangerous drugs and dangerous device losses at the shared clinic office shall be reported to the board as required by law. Each clinic may be jointly and severally responsible for the drug losses.
(c)The applicants shall also provide the board with a copy of the co-location agreement and a one-time application fee of seven hundred fifty dollars ($750) for the licenses.
(d)Any change in ownership in either clinic shall require a new application under this section and fees as required by subdivision (q) of Section 4400 and subdivision (c) of this section.
(e)The board shall not issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to this section until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi-Cal financing issues, including the ability to claim associated federal financial participation or 340(b) program participation, have been sufficiently addressed to the directors satisfaction. The Department of Health Care Services may seek any federal approvals it deems necessary to implement this section.
(f)The board shall not issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to the section until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed to the directors satisfaction.
(g)This section shall become inoperative on January 1, 2021, and as of that date is repealed.
SEC. 10.Section 1211 is added to the Health and Safety Code, to read:1211.(a)Notwithstanding any other law, a clinic licensed pursuant to Section 1204 may operate in shared clinic space with a clinic exempt from licensure pursuant to subdivision (b) of Section 1206 under the following conditions:
(1)Each clinic uses signage that clearly identifies which clinic is operating during the hours of operation.
(2)The licensed clinic reports the operating hours of both clinics.
(3)Each clinic maintains separate medical records.
(4)Each clinic maintains separate drug storage.
(5)Both clinics are licensed by the California State Board of Pharmacy pursuant to Section 4180.5 of the Business and Professions Code.
(b)The department may enter and inspect the shared space at any time pursuant to Section 1227 of the Health and Safety Code, including accessing records. The exempt clinic shall allow the department to access and inspect its records.
(c)The licensed clinic shall be responsible for any statutory or regulatory violations occurring on the premises.
(d)Notwithstanding the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code), the department may implement, interpret, or make specific this section by means of all-facility letters, or similar instructions, without taking regulatory action.
(e)This section shall become inoperative on January 1, 2021, and as of that date is repealed.
SEC. 11.Section 5.5 of this bill incorporates amendments to Section 4059.5 of the Business and Professions Code proposed by both this bill and Senate Bill 752. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4059.5 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 752, in which case Section 5 of this bill shall not become operative.
SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)The Legislature hereby finds and declares all of the following:
(1)Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.
(2)Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.
(3)Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.
(4)Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.
(5)In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.
(b)The Legislature further finds and declares both of the following:
(1)Section 4001.1 of the Business and Professions Code establishes public protection as the highest priority of the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. That section further provides that whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.
(2)Public protection requires the California State Board of Pharmacy to enforce the laws related to a supervising pharmacy, as defined by Section 4044.6 of the Business and Professions Code, and a remote dispensing site pharmacy, as defined in Section 4044.3 of the Business and Professions Code, through licensure.
(c)It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.
SEC. 2.Section 4044.3 is added to the Business and Professions Code, to read:4044.3.(a)Remote dispensing site pharmacy means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians, as defined in Section 4132, where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
(b)Unless otherwise specified in this chapter, a remote dispensing site pharmacy shall comply with all state and federal laws regulating the practice of pharmacy.
SEC. 3.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.(a)Supervising pharmacy means a licensed pharmacy located in this state that is owned and operated by a person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one board-licensed pharmacist, as defined in Section 4036, that exclusively oversees the operations of a remote dispensing site pharmacy.
(b)A supervising pharmacy shall be exclusively responsible for the operation of the remote dispensing site pharmacy and its employees pursuant to Section 4131.
SEC. 4.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a remote dispensing site pharmacy and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 5.5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Section 4107 of the Business and Professions Code is amended to read:4107.(a)The board shall not issue more than one site license to a single premises except as follows:
(1)To issue a veterinary food-animal drug retailer license to a wholesaler pursuant to Section 4196.
(2)To issue a license to compound sterile drugs to a pharmacy pursuant to Section 4127.1 or 4127.2.
(3)To issue a centralized hospital packaging license pursuant to Section 4128.
(4)To issue licenses to two independently owned clinics that share a clinic office space pursuant to Section 4180.5.
(b)For the purposes of this subdivision, premises means a location with its own address and an independent means of ingress and egress.
SEC. 7.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy Systems and Remote Dispensing Site Pharmacies4130.(a)A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.
(c)(1)A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a medically underserved area means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
(e)A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license.
(f)A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.
(g)A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.
(h)If a remote dispensing site pharmacy dispenses more than 225 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy.
4131.(a)A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.
(b)A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(d)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
(e)Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy.
(f)Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
4132.(a)In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall meet the qualifications promulgated by the board. The regulations developed by the board shall only apply to pharmacy technicians working at remote dispensing sites.
(b)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(c)A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)Identify, evaluate, or interpret a prescription.
(4)Interpret the clinical data in a patient medication record system or patient chart.
(5)Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)Perform any function that requires the professional judgment of a licensed pharmacist.
(8)Compound drug preparations.
(d)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy.
(d)A telepharmacy system shall be able to do all of the following:
(1)Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(e)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(f)All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board.
(h)Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable.
(c)The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.
SEC. 8.Section 4169.1 is added to the Business and Professions Code, immediately following Section 4169, to read:4169.1.A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
SEC. 9.Section 4180.5 is added to the Business and Professions Code, to read:4180.5.(a)The board may issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space, provided that the clinics comply with the following:
(1)Each clinic maintains a separate clinic license with the board with its own professional directors, administrators, owners, and officers.
(2)Each clinic maintains physically separate and locked drug stocks.
(3)Each clinic separately maintains all records required by this article, including acquisition and disposition records.
(4)Dangerous drugs and dangerous devices shall not be loaned between the two licensed clinics.
(b)Dangerous drugs and dangerous device losses at the shared clinic office shall be reported to the board as required by law. Each clinic may be jointly and severally responsible for the drug losses.
(c)The applicants shall also provide the board with a copy of the co-location agreement and a one-time application fee of seven hundred fifty dollars ($750) for the licenses.
(d)Any change in ownership in either clinic shall require a new application under this section and fees as required by subdivision (q) of Section 4400 and subdivision (c) of this section.
(e)The board shall not issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to this section until the board is provided with documentation from the Director of the Department of Health Care Services that any Medi-Cal financing issues, including the ability to claim associated federal financial participation or 340(b) program participation, have been sufficiently addressed to the directors satisfaction. The Department of Health Care Services may seek any federal approvals it deems necessary to implement this section.
(f)The board shall not issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space pursuant to the section until the board is provided with documentation from the Director of the Department of Public Health that any licensing and regulatory issues have been sufficiently addressed to the directors satisfaction.
(e)(g)This section shall become inoperative on January 1, 2021, and as of that date is repealed.
SEC. 10.Section 1211 is added to the Health and Safety Code, to read:1211.(a)Notwithstanding any other law, a clinic licensed pursuant to Section 1204 may operate in shared clinic space with a clinic exempt from licensure pursuant to subdivision (b) of Section 1206 under the following conditions:
(1)Each clinic uses signage that clearly identifies which clinic is operating during the hours of operation.
(2)The licensed clinic reports the operating hours of both clinics.
(3)Each clinic maintains separate medical records.
(4)Each clinic maintains separate drug storage.
(5)Both clinics are licensed by the California State Board of Pharmacy pursuant to Section 4180.5 of the Business and Professions Code.
(b)The department may enter and inspect the shared space at any time pursuant to Section 1227 of the Health and Safety Code, including accessing records. The exempt clinic shall allow the department to access and inspect its records.
(c)The licensed clinic shall be responsible for any statutory or regulatory violations occurring on the premises.
(d)Notwithstanding the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code), the department may implement, interpret, or make specific this section by means of all-facility letters, or similar instructions, without taking regulatory action.
(e)This section shall become inoperative on January 1, 2021, and as of that date is repealed.
SEC. 10.SEC. 11.Section 5.5 of this bill incorporates amendments to Section 4059.5 of the Business and Professions Code proposed by both this bill and Senate Bill 752. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4059.5 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 752, in which case Section 5 of this bill shall not become operative.
SEC. 11.SEC. 12.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)The Legislature hereby finds and declares all of the following:
(1)Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.
(2)Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.
(3)Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.
(4)Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.
(5)In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.
(b)The Legislature further finds and declares both of the following:
(1)Section 4001.1 of the Business and Professions Code establishes public protection as the highest priority of the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. That section further provides that whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.
(2)Public protection requires the California State Board of Pharmacy to enforce the laws related to a supervising pharmacy, as defined by Section 4044.6 of the Business and Professions Code, and a remote dispensing site pharmacy, as defined in Section 4044.3 of the Business and Professions Code, through licensure.
(c)It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.
SEC. 2.Section 4044.3 is added to the Business and Professions Code, to read:4044.3.(a)Remote dispensing site pharmacy means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians technicians, as defined in Section 4132, where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
(b)Unless otherwise specified in this chapter, a remote dispensing site pharmacy shall comply with all state and federal laws regulating the practice of pharmacy.
SEC. 3.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.(a)Supervising pharmacy means a licensed pharmacy located in this state that is owned and operated by a person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one board-licensed pharmacist, as defined in Section 4036, that exclusively oversees the operations of a remote dispensing site pharmacy.
(b)A supervising pharmacy shall be exclusively responsible for the operation of the remote dispensing site pharmacy and its employees pursuant to Section 4131.
SEC. 4.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a remote dispensing site pharmacy and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 5.5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative or in the case of a reverse distributor a designated representative-reverse distributor, that individual shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other provision of law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a pharmacy technician pursuant to this section shall be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Section 4107 of the Business and Professions Code is amended to read:4107.(a)The board shall not issue more than one site license to a single premises except as follows:
(1)To issue a veterinary food-animal drug retailer license to a wholesaler pursuant to Section 4196.
(2)To issue a license to compound sterile drugs to a pharmacy pursuant to Section 4127.1 or 4127.2.
(3)To issue a centralized hospital packaging license pursuant to Section 4128.
(4)To issue licenses to two independently owned clinics that share a clinic office space pursuant to Section 4180.5.
(b)For the purposes of this subdivision, premises means a location with its own address and an independent means of ingress and egress.
SEC. 6.SEC. 7.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy Systems and Remote Dispensing Site Pharmacies4130.(a)A telepharmacy system shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.
(c)(1)A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a medically underserved area means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
(e)A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license.
(f)A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.
(g)A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.
(h)If a remote dispensing site pharmacy dispenses more than 300 225 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy.
4131.(a)A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.
(b)A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(d)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
(e)Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy.
(f)Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
4132.(a)In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall meet the qualifications promulgated by the board. The regulations developed by the board shall only apply to pharmacy technicians working at remote dispensing sites.
(b)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(c)A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)Identify, evaluate, or interpret a prescription.
(4)Interpret the clinical data in a patient medication record system or patient chart.
(5)Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)Perform any function that requires the professional judgment of a licensed pharmacist.
(8)Compound drug preparations.
(d)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)Patient counseling shall be provided using audio-visual communication prior to all prescriptions being dispensed from a remote dispensing site pharmacy.
(d)A telepharmacy system shall be able to do all of the following:
(1)Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(e)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(f)All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board.
(h)Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable.
(c)The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.
SEC. 8.Section 4169.1 is added to the Business and Professions Code, immediately following Section 4169, to read:4169.1.A wholesaler, upon discovery, shall notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration. Suspicious orders include, but are not limited to, orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.
SEC. 9.Section 4180.5 is added to the Business and Professions Code, to read:4180.5.(a)The board may issue licenses authorized under Section 4180 to two independently owned clinics that share a clinic office space, provided that the clinics comply with the following:
(1)Each clinic maintains a separate clinic license with the board with its own professional directors, administrators, owners, and officers.
(2)Each clinic maintains physically separate and locked drug stocks.
(3)Each clinic separately maintains all records required by this article, including acquisition and disposition records.
(4)Dangerous drugs and dangerous devices shall not be loaned between the two licensed clinics.
(b)Dangerous drugs and dangerous device losses at the shared clinic office shall be reported to the board as required by law. Each clinic may be jointly and severally responsible for the drug losses.
(c)The applicants shall also provide the board with a copy of the co-location agreement and a one-time application fee of seven hundred fifty dollars ($750) for the licenses.
(d)Any change in ownership in either clinic shall require a new application under this section and fees as required by subdivision (q) of Section 4400 and subdivision (c) of this section.
(e)This section shall become inoperative on January 1, 2021, and as of that date is repealed.
SEC. 10.Section 5.5 of this bill incorporates amendments to Section 4059.5 of the Business and Professions Code proposed by both this bill and Senate Bill 752. That section shall only become operative if (1) both bills are enacted and become effective on or before January 1, 2018, (2) each bill amends Section 4059.5 of the Business and Professions Code, and (3) this bill is enacted after Senate Bill 752, in which case Section 5 of this bill shall not become operative.
SEC. 7.SEC. 11.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)The Legislature hereby finds and declares all of the following:
(1)Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.
(2)Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.
(3)Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.
(4)Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.
(5)In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.
(b)The Legislature further finds and declares both of the following:
(1)Section 4001.1 of the Business and Professions Code establishes public protection as the highest priority of the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. That section further provides that whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.
(2)Public protection requires the California State Board of Pharmacy to enforce the laws related to a supervising pharmacy, as defined by Section 4044.6 of the Business and Professions Code, and a remote dispensing site pharmacy, as defined in Section 4044.3 of the Business and Professions Code, through licensure.
(c)It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.
SEC. 2.Section 4044.3 is added to the Business and Professions Code, to read:4044.3.(a)Remote dispensing site pharmacy means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
(b)Unless otherwise specified in this chapter, a remote dispensing site pharmacy shall comply with all state and federal laws regulating the practice of pharmacy.
SEC. 3.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.(a)Supervising pharmacy means a licensed pharmacy located in this state that is owned and operated by a pharmacist or more than one person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one board-licensed pharmacist, as defined in Section 4036, that exclusively oversees the operations of a remote dispensing site pharmacy.
(b)A supervising pharmacy shall be exclusively responsible for the operation of the remote dispensing site pharmacy and its employees pursuant to Section 4131.
SEC. 4.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a remote dispensing site pharmacy and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. The Any receipt and storage of a controlled substance by a pharmacy technician under pursuant to this section shall be maintained on video that is accessible to the supervising pharmacy and shall be maintained for 90 days. captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the remote dispensing site pharmacy for 120 days.
SEC. 6.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy Systems and Remote Dispensing Site Pharmacies4130.(a)A telepharmacy system may shall be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.
(c)(1)A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a medically underserved area means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
(e)A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy. A supervising pharmacy shall not obtain more than one remote dispensing site pharmacy license.
(f)A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.
(g)A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.
(h)If a remote dispensing site pharmacy dispenses more than 300 prescriptions per day, calculated each calendar year, it shall cease to be a remote dispensing site pharmacy and may become a full-service pharmacy licensed under Section 4110 with a pharmacist onsite if it meets all the requirements for licensure for a pharmacy.
4131.(a)A supervising pharmacy shall provide telepharmacy services for only one remote dispensing site pharmacy.
(b)A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)(1)Except as otherwise provided in paragraph (2), a A supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(2)If a supervising pharmacy and a remote dispensing site pharmacy are not under common ownership, the supervising pharmacy and remote dispensing site pharmacy shall enter into a written contract or agreement that specifies the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement, consistent with all federal and state laws.(d)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
(e)Notwithstanding any other law, a pharmacist may serve as the pharmacist-in-charge for no more than two remote dispensing site pharmacies a pharmacy in addition to serving as pharmacist-in-charge of a supervising pharmacy. The designated pharmacist-in-charge of the supervising pharmacy shall also serve as the designated pharmacist-in-charge at the remote dispensing site pharmacy.
(f)Notwithstanding any other law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
4132.(a)In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall have both of the following: meet the qualifications promulgated by the board.
(1)At least one year of experience in the past three years working in retail pharmacy practice.(2)Completed a documented training program on proper use of the telepharmacy system at the remote dispensing site pharmacy.(b)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(c)A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)Identify, evaluate, or interpret a prescription.
(4)Interpret the clinical data in a patient medication record system or patient chart.
(5)Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)Perform any function that requires the professional judgment of a licensed pharmacist.
(8)Compound drug preparations.
(d)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)Patient counseling shall be provided using audio-visual communication for prior to all prescriptions being dispensed from a remote dispensing site pharmacy.
(d)A telepharmacy system shall be able to do all of the following:
(1)Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(e)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(f)All records of prescriptions dispensed including the records of the actions performed through the telepharmacy system shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist-in-charge shall be responsible for submitting the report to the board.
(h)Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a remote dispensing site pharmacy if the telepharmacy system is unavailable.
(c)The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 90 120 days.
SEC. 7.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)The Legislature hereby finds and declares all of the following:
(1)Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.
(2)Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.
(3)Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.
(4)Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.
(5)In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.
(b)The Legislature further finds and declares both of the following:
(1)Section 4001.1 of the Business and Professions Code establishes public protection as the highest priority of the California State Board of Pharmacy in exercising its licensing, regulatory, and disciplinary functions. That section further provides that whenever the protection of the public is inconsistent with other interests sought to be promoted, the protection of the public shall be paramount.
(2)Public protection requires the California State Board of Pharmacy to enforce the laws related to a supervising pharmacy, as defined by Section 4044.6 of the Business and Professions Code, and a remote dispensing site pharmacy, as defined in Section 4044.3 of the Business and Professions Code, through licensure.
(b)(c)It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.
SEC. 2.Section 4044.3 is added to the Business and Professions Code, to read:4044.3.Remote dispensing site pharmacy means a licensed pharmacy located in this state that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
SEC. 3.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.Supervising pharmacy means a licensed pharmacy located in this state that is owned and operated by a pharmacist or more than one pharmacist, as defined in Section 4036, that exclusively oversees the activities operations of a remote dispensing site pharmacy.
SEC. 4.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. The receipt and storage of a controlled substance by a pharmacy technician under this section shall be maintained on video that is accessible to the supervising pharmacy and shall be maintained for 90 days.
SEC. 6.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy Systems and Remote Dispensing Site Pharmacies4130.(a)A telepharmacy system may be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located.
(c)(1)A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a medically underserved area means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
(e)A remote dispensing site pharmacy license shall be issued only to the supervising pharmacy.
(f)A remote dispensing site pharmacy shall not be operated by the state and shall not be located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers. This section shall not be construed to preclude a pharmacist who is otherwise eligible to operate a remote dispensing site pharmacy pursuant to this section from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and pharmacy technicians employed by the state.
(g)A remote dispensing site pharmacy shall not be located or operated for the purpose of displacing state employees.
4131.(a)A pharmacy located in this state may serve as a supervising pharmacy to shall provide telepharmacy services for up to two only one remote dispensing site pharmacies. pharmacy.
(b)A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)(1)Except as otherwise provided in paragraph (2), a supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(2)If a supervising pharmacy and a remote dispensing site pharmacy are not under common ownership, the supervising pharmacy and remote dispensing site pharmacy shall enter into a written contract or agreement that specifies the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement, consistent with all federal and state laws.
(d)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
(e)Notwithstanding any law, a pharmacist may serve as the pharmacist-in-charge for no more than two remote dispensing site pharmacies in addition to serving as pharmacist-in-charge of a supervising pharmacy.
(f)Notwithstanding any law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
4132.(a)In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall have both of the following:
(1)At least one year of experience in the past three years working in retail pharmacy practice.
(2)Completed a documented training program on proper use of the telepharmacy system at the remote dispensing site pharmacy.
(b)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(c)A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)Identify, evaluate, or interpret a prescription.
(4)Interpret the clinical data in a patient medication record system or patient chart.
(5)Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)Perform any function that requires the professional judgment of a licensed pharmacist.
(d)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)Patient counseling shall be provided using audio-visual communication for all prescriptions dispensed from a remote dispensing site pharmacy.
(d)A telepharmacy system shall be able to do all of the following:
(1)Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(e)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(f)All records of prescriptions dispensed shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances.
(h)Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries.
(c)The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 90 days.
SEC. 7.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
(a)The Legislature hereby finds and declares all of the following:
(1)Greater access to health care professionals improves patient outcomes. Patients see their pharmacist more often than any other health care professional. Making pharmacists readily available should be a top priority of the state.
(2)Health care delivery and technology are evolving. Utilizing technology to connect patients to pharmacists in areas where there is no access will improve medication adherence and outcomes.
(3)Over 30 percent of patients never fill their prescriptions. According to a study by Kaiser, this number drops to 5 percent when patients have more convenient access to a pharmacy. Lack of convenient access to a pharmacy leads to lower rates of medication adherence and, according to the New England Healthcare Institute, nonadherence leads to over $290 billion in avoidable medial spending each year.
(4)Seventy-seven percent of rural counties are designated as health professional shortage areas. In California there are 115 identified areas located in 47 counties where the closest pharmacy is more than 10 miles away.
(5)In rural communities, the geographic and economic realities make it difficult to maintain a pharmacy. Between 2003 and 2013, there was a 12.1-percent decrease in rural pharmacies. Remote dispensing site pharmacies create an economically feasible way to bring pharmacy access to these underserved areas through the use of technology.
(b)It is the intent of the Legislature to enact legislation that will promote policies to allow all California patients, regardless of location, to have access to a pharmacist, thereby increasing medication adherence.
SECTION 1.SEC. 2.Section 4044.3 is added to the Business and Professions Code, to read:4044.3.Remote Dispensing Site Pharmacy dispensing site pharmacy means a licensed pharmacy located in this state that is operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
SEC. 2.SEC. 3.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.Supervising pharmacy means a licensed pharmacy located in this state that oversees the activities of a remote dispensing site pharmacy.
SEC. 3.SEC. 4.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 4.SEC. 5.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site. A controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist. The receipt and storage of a controlled substance by a pharmacy technician under this section shall be maintained on video that is accessible to the supervising pharmacy and shall be maintained for 90 days.
SEC. 5.SEC. 6.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy Systems and Remote Dispensing Site Pharmacies4130.(a)If A telepharmacy system may be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
(b)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the site is to be located.
(b)In order to further the goal of increasing access to dispensing and pharmaceutical care services, the board may establish, by regulation, locations eligible for a remote dispensing site pharmacy license that shall include medically underserved areas and populations and health profession shortage areas, as determined by the federal Department of Health and Human Services, the federal Health Resources and Services Administration, and health care facilities and clinics regulated by the state.(c)(1)A remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a medically underserved area means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
(2)Notwithstanding paragraph (1), if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
(d)A remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
4131.(a)A pharmacy located in this state may serve as a supervising pharmacy to provide telepharmacy services for up to three two remote dispensing site pharmacies.
(b)A supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
(c)(1)Except as otherwise provided in paragraph (2), a supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
(2)If a supervising pharmacy and a remote dispensing site pharmacy are not under common ownership, the supervising pharmacy and remote dispensing site pharmacy shall enter into a written contract or agreement that specifies the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement, consistent with all federal and state laws.
(b)(d)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations electronically through audio and visual technology from the supervising pharmacy.
(c)(e)Notwithstanding any law, a pharmacist may serve as the pharmacist-in-charge for no more than three two remote dispensing site pharmacies in addition to serving as pharmacist-in-charge of a supervising pharmacy.
(d)(f)Notwithstanding any law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
(e)A pharmacist from the supervising pharmacy shall be capable of being on site at the remote dispensing pharmacy within six hours of notice that his or her presence is required.4132.(a)Notwithstanding In addition to the requirements of Section 4202, a pharmacy technician working at a remote dispensing site pharmacy shall have both of the following:(1)At least one year of experience in the past three years working in retail pharmacy practice.
(2)Completed a documented training program on proper use of the telepharmacy system at the remote dispensing site pharmacy.
(b)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(b)In order to qualify to work at a remote dispensing site pharmacy, a registered pharmacy technician shall meet all additional qualifications as established by the board through regulation.(c)A pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
(1)Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
(2)Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
(3)Identify, evaluate, or interpret a prescription.
(4)Interpret the clinical data in a patient medication record system or patient chart.
(5)Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
(6)Supervise the packaging of drugs and check the packaging procedure and product upon completion.
(7)Perform any function that requires the professional judgment of a licensed pharmacist.
(c)(d)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)The A telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)The remote dispensing site shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 30 days.(c)Patient counseling shall be provided using audio-visual communication for all prescriptions dispensed from a remote dispensing site pharmacy.
(d)A telepharmacy system shall be able to do all of the following:
(1)Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
(2)Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
(3)Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
(4)Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
(5)Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
(d)(e)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(e)The board shall certify acceptable video and audio communication systems for use in remote dispensing sites.(f)All records of prescriptions dispensed shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)An audit of at least three controlled substances at the remote dispensing site pharmacy shall be completed and documented quarterly by a pharmacist from the supervising pharmacy.(c)All controlled substances at a remote dispensing site pharmacy shall be stored in a secure cabinet or safe that is locked.
(d)A pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
(e)The pharmacist-in-charge of a remote dispensing site pharmacy shall review all inventory and inventory reconciliation reports taken and shall establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
(f)A pharmacist from the supervising pharmacy shall compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
(1)A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
(2)A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
(3)A comparison of paragraphs (1) and (2) in order to determine if there are any variances.
(4)All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
(g)A remote dispensing site pharmacy shall report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances.
(h)Possible causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
(i)The inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries.
(c)If controlled substances are maintained or dispensed from the remote dispensing site pharmacy, the remote dispensing site pharmacy shall comply with all applicable state and federal requirements for the security and recordkeeping requirements of controlled substances.(c)The remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 90 days.
SEC. 6.Section 4181 of the Business and Professions Code is amended to read:4181.(a)Prior to the issuance of a clinic license authorized under Section 4180, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health relating to the drug distribution service to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation occur in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator.(b)The dispensing of drugs in a clinic shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations, including, but not limited to, Article 8 (Commencing with Section 4130).SEC. 7.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
Remote Dispensing Site Pharmacy means a licensed pharmacy that is operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
SEC. 2.Section 4044.6 is added to the Business and Professions Code, to read:4044.6.Supervising pharmacy means a licensed pharmacy that oversees the activities of a remote dispensing site pharmacy.
SEC. 3.Section 4044.7 is added to the Business and Professions Code, to read:4044.7.Telepharmacy means a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
SEC. 4.Section 4059.5 of the Business and Professions Code is amended to read:4059.5.(a)Except as otherwise provided in this chapter, dangerous drugs or dangerous devices may only be ordered by an entity licensed by the board and shall be delivered to the licensed premises and signed for and received by a pharmacist. Where a licensee is permitted to operate through a designated representative, the designated representative shall sign for and receive the delivery.
(b)A dangerous drug or dangerous device transferred, sold, or delivered to a person within this state shall be transferred, sold, or delivered only to an entity licensed by the board, to a manufacturer, or to an ultimate user or the ultimate users agent.
(c)Notwithstanding subdivisions (a) and (b), deliveries to a hospital pharmacy may be made to a central receiving location within the hospital. However, the dangerous drugs or dangerous devices shall be delivered to the licensed pharmacy premises within one working day following receipt by the hospital, and the pharmacist on duty at that time shall immediately inventory the dangerous drugs or dangerous devices.
(d)Notwithstanding any other provision of law, a dangerous drug or dangerous device may be ordered by and provided to a manufacturer, physician, dentist, podiatrist, optometrist, veterinarian, naturopathic doctor pursuant to Section 3640.7, or laboratory, or a physical therapist acting within the scope of his or her license. A person or entity receiving delivery of a dangerous drug or dangerous device, or a duly authorized representative of the person or entity, shall sign for the receipt of the dangerous drug or dangerous device.
(e)A dangerous drug or dangerous device shall not be transferred, sold, or delivered to a person outside this state, whether foreign or domestic, unless the transferor, seller, or deliverer does so in compliance with the laws of this state and of the United States and of the state or country to which the dangerous drugs or dangerous devices are to be transferred, sold, or delivered. Compliance with the laws of this state and the United States and of the state or country to which the dangerous drugs or dangerous devices are to be delivered shall include, but not be limited to, determining that the recipient of the dangerous drugs or dangerous devices is authorized by law to receive the dangerous drugs or dangerous devices.
(f)Notwithstanding subdivision (a), a pharmacy may take delivery of dangerous drugs and dangerous devices when the pharmacy is closed and no pharmacist is on duty if all of the following requirements are met:
(1)The drugs are placed in a secure storage facility in the same building as the pharmacy.
(2)Only the pharmacist-in-charge or a pharmacist designated by the pharmacist-in-charge has access to the secure storage facility after dangerous drugs or dangerous devices have been delivered.
(3)The secure storage facility has a means of indicating whether it has been entered after dangerous drugs or dangerous devices have been delivered.
(4)The pharmacy maintains written policies and procedures for the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(5)The agent delivering dangerous drugs and dangerous devices pursuant to this subdivision leaves documents indicating the name and amount of each dangerous drug or dangerous device delivered in the secure storage facility.
The pharmacy shall be responsible for the dangerous drugs and dangerous devices delivered to the secure storage facility. The pharmacy shall also be responsible for obtaining and maintaining records relating to the delivery of dangerous drugs and dangerous devices to a secure storage facility.
(g)Notwithstanding subdivision (a), dangerous drugs and devices may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician, who meets the qualifications of Section 4132, at the remote site.
SEC. 5.Article 8 (commencing with Section 4130) is added to Chapter 9 of Division 2 of the Business and Professions Code, to read:8.Telepharmacy and Remote Dispensing Site Pharmacies4130.(a)If all of the requirements of this article and other relevant provisions of this chapter are met, the board shall issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the site is to be located.
(b)In order to further the goal of increasing access to dispensing and pharmaceutical care services, the board may establish, by regulation, locations eligible for a remote dispensing site pharmacy license that shall include medically underserved areas and populations and health profession shortage areas, as determined by the federal Department of Health and Human Services, the federal Health Resources and Services Administration, and health care facilities and clinics regulated by the state.
4131.(a)A pharmacy located in this state may serve as a supervising pharmacy to provide telepharmacy services for up to three remote dispensing site pharmacies.
(b)Unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician meeting the qualifications of Section 4132. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. For the purposes of this article, direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations electronically from the supervising pharmacy.
(c)Notwithstanding any law, a pharmacist may serve as the pharmacist-in-charge for no more than three remote dispensing site pharmacies in addition to serving as pharmacist-in-charge of a supervising pharmacy.
(d)Notwithstanding any law, the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
(e)A pharmacist from the supervising pharmacy shall be capable of being on site at the remote dispensing pharmacy within six hours of notice that his or her presence is required.
4132.(a)Notwithstanding Section 4115, a registered pharmacy technician may perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
(b)In order to qualify to work at a remote dispensing site pharmacy, a registered pharmacy technician shall meet all additional qualifications as established by the board through regulation.
(c)Notwithstanding Section 4115, a pharmacist at a supervising pharmacy may supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This subdivision shall not be construed to alter a pharmacists ability to also supervise pharmacy technicians at the supervising pharmacy.
4133.(a)A telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacys personnel and patients.
(b)The system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
(c)The remote dispensing site shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 30 days.
(d)The video and audio communication system used to counsel and interact with each patient or patients caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
(e)The board shall certify acceptable video and audio communication systems for use in remote dispensing sites.
4134.(a)A pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
(b)A perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
(c)An audit of at least three controlled substances at the remote dispensing site pharmacy shall be completed and documented quarterly by a pharmacist from the supervising pharmacy.
4135.(a)While closed, a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
(b)Unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries.
(c)If controlled substances are maintained or dispensed from the remote dispensing site pharmacy, the remote dispensing site pharmacy shall comply with all applicable state and federal requirements for the security and recordkeeping requirements of controlled substances.
SEC. 6.Section 4181 of the Business and Professions Code is amended to read:4181.(a)Prior to the issuance of a clinic license authorized under Section 4180, the clinic shall comply with all applicable laws and regulations of the State Department of Public Health relating to the drug distribution service to ensure that inventories, security procedures, training, protocol development, recordkeeping, packaging, labeling, dispensing, and patient consultation occur in a manner that is consistent with the promotion and protection of the health and safety of the public. The policies and procedures to implement the laws and regulations shall be developed and approved by the consulting pharmacist, the professional director, and the clinic administrator.
(b)The dispensing of drugs in a clinic shall be performed only by a physician, a pharmacist, or other person lawfully authorized to dispense drugs, and only in compliance with all applicable laws and regulations. regulations, including, but not limited to, Article 8 (Commencing with Section 4130).
SEC. 7.No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
|
Date
|
Status
|
|---|---|
| Oct 7, 2017 | Chaptered by Secretary of State - Chapter 548, Statutes of 2017. |
| Oct 7, 2017 | Approved by the Governor. |
| Sep 20, 2017 | Enrolled and presented to the Governor at 4:30 p.m. |
| Sep 13, 2017 | Assembly Rule 77(a) suspended. |
| Sep 13, 2017 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after September 15 pursuant to Assembly Rule 77. |
| Sep 12, 2017 | Read third time. Passed. Ordered to the Assembly. |
| Sep 11, 2017 | Read second time. Ordered to third reading. |
| Sep 7, 2017 | Read third time and amended. Ordered to second reading. |
| Sep 5, 2017 | Read second time. Ordered to third reading. |
| Sep 1, 2017 | Read second time and amended. Ordered returned to second reading. |
| Aug 21, 2017 | In committee: Referred to APPR. suspense file. |
| Jul 11, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 9. Noes 0.) (July 10). Re-referred to Com. on APPR. |
| Jul 6, 2017 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on B., P. & E.D. |
| Jun 19, 2017 | In committee: Hearing postponed by committee. |
| Jun 14, 2017 | Referred to Com. on B., P. & E.D. |
| Jun 1, 2017 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 31, 2017 | Read third time. Passed. Ordered to the Senate. (Ayes 76. Noes 0. Page 1893.) |
| May 26, 2017 | From committee: Do pass. (Ayes 17. Noes 0.) (May 26). |
| May 11, 2017 | Re-referred to Com. on APPR. |
| May 10, 2017 | From committee chair, with author's amendments: Amend, and re-refer to Com. on APPR. Read second time and amended. |
| May 3, 2017 | In committee: Set, first hearing. Referred to APPR. suspense file. |
| Apr 4, 2017 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 15. Noes 0.) (April 4). Re-referred to Com. on APPR. |
| Mar 22, 2017 | Re-referred to Com. on B. & P. |
| Mar 21, 2017 | From committee chair, with author's amendments: Amend, and re-refer to Com. on B. & P. Read second time and amended. |
| Feb 21, 2017 | Referred to Com. on B. & P. |
| Feb 10, 2017 | From printer. May be heard in committee March 12. |
| Feb 9, 2017 | Read first time. To print. |
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Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Sep 13, 2017 | AB 401 Aguiar-Curry Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Sep 12, 2017 | Assembly 3rd Reading AB401 Aguiar-Curry By Pan | Senate Floor |
Passed |
|
| Sep 1, 2017 | Do pass as amended | Senate Standing Committee on Appropriations |
Passed |
|
| Aug 21, 2017 | Placed on suspense file | Senate Standing Committee on Appropriations |
Passed |
|
| Jul 10, 2017 | Do pass, but first be re-referred to the Committee on [Appropriations] | Senate Standing Committee on Business, Professions and Economic Development |
Passed |
|
| May 31, 2017 | AB 401 AGUIAR-CURRY Assembly Third Reading | Assembly Floor |
Passed |
|
| May 26, 2017 | Do pass. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 4, 2017 | Do pass and be re-referred to the Committee on [Appropriations] | Assembly Standing Committee on Business and Professions |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| Association Of California State Supervisors | ** Support | Sep 9, 2017 |
| California Pharmacists Association | ** Support | Sep 9, 2017 |
| California Society Of Health-System Pharmacists | ** Against | Sep 9, 2017 |
| California State Retirees | ** Support | Sep 9, 2017 |
| CaliforniaHealth+ Advocates | ** Support | Sep 9, 2017 |
| Cardinal Health | ** Support | Sep 9, 2017 |
| Planned Parenthood Affiliates Of California | ** Support | Sep 9, 2017 |
| Planned Parenthood Mar Monte | ** Support | Sep 9, 2017 |
| Planned Parenthood Northern California Action Fund | ** Support | Sep 9, 2017 |
| Pucci's Pharmacy | * Support | Jul 10, 2017 |
CONCURRENCE IN SENATE AMENDMENTS
CSA1 Bill Id:AB 401
Author:(Aguiar-Curry)
As Amended Ver:September 7, 2017
Majority vote
ASSEMBLY: | 76-0 | (May 31, 2017) | SENATE: | 40-0 | (September 12, 2017) |
Original Committee Reference: B. & P.
SUMMARY: This measure authorizes a remote dispensing site pharmacy to use a telepharmacy system, and would require the Board of Pharmacy (Board) to issue a remote dispensing site pharmacy license; requires a remote dispensing site pharmacy to be located in a medically underserved area; authorizes a pharmacist to serve as a supervising pharmacist to provide telepharmacy services for up to two remote dispensing site pharmacies; authorizes a licensed remote dispensing site pharmacy to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician to receive and sign for the delivered order; authorizes a registered pharmacy technician to work at a remote dispensing site pharmacy and to perform tasks under the supervision of a pharmacist using a telepharmacy system; and, authorizes a pharmacist at a supervising pharmacy to supervise up to two pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
The Senate amendments:
- Require a wholesaler to notify the board in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler by providing the board a copy of the information that the wholesaler provides to the United States Drug Enforcement Administration.
- Until January 1, 2021, would authorize the board to issue specified licenses to two independently owned clinics that share a clinic office space; make each clinic jointly and severally responsible for drug losses; require the applicants to provide the board with a copy of the co-location agreement and a one-time application fee of $750 for the licenses; and, require a new application and specified fees for any change in ownership in either clinic.
EXISTING LAW:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) Section 4001.)
- Defines a "pharmacy" as an area, place, or premises licensed by the BOP in which the profession of pharmacy is practiced and where prescriptions are compounded. "Pharmacy" includes, but is not limited to, any area, place, or premises described in a license issued by BOP wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, or repackaged, and from which the controlled substances, dangerous drugs, or dangerous devices are furnished, sold, or dispensed at retail. (BPC Section 4037)
- Requires a pharmacy with only one pharmacist to have no more than one pharmacy technician (PT). Limits the ratio of pharmacists to PTs to 1:2, except with regards to personnel performing clerical functions, as specified, and in certain other limited settings. (BPC Section 4115 (f)(1))
- Authorizes the use of automated drug delivery systems. (BPC Section 4119.1)
FISCAL EFFECT: According to the Senate Committee on Appropriations, this bill will result in:
- One-time costs of $250,000 in 2018-19 and ongoing costs of $235,000 per year for the Board to issue licenses, conduct inspections, and take any necessary enforcement actions.
- One-time costs of about $60,000 and ongoing costs of about $10,000 per year for the development and maintenance of the information technology requirements to issue the new license type by the Board.
- Minor costs for the Board to accept reports from drug wholesalers regarding suspicious orders of controlled substances and to take enforcement action, as needed.
- Minor costs for the Board to issue additional pharmacy licenses to independently owned clinics that share office space.
COMMENTS:
Purpose. This bill is sponsored by the author. According to the author, "A pharmacist is a critical member of a comprehensive healthcare team. However, there are approximately 115 designated communities in 47 California counties that do not have access to a pharmacist within 10 miles. For people living in these communities, visiting a pharmacist can mean up to a 90 mile drive. This is a significant barrier to accessing quality healthcare services. Authorizing remote dispensing pharmacies to operate throughout the state in these medically underserved communities provides opportunities for better patient education, increased medication adherence, and better health outcomes."
Background. Pharmacist Practice and Regulation. Pharmacists are healthcare professionals who understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. Pharmacists provide counseling on the appropriate use and effects of prescribed drugs. Pharmacists must obtain the Doctor of Pharmacy degree before they are eligible to sit for the North American Pharmacist Licensure Examination (NAPLEX) to enter into pharmacy practice (Accreditation Council for Pharmacy Education, Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree, 2011).
In 2014, the United States Bureau of Labor Statistics reported that there were 297,100 pharmacist jobs. The majority (65%) of those pharmacists work in retail settings, about 22% work in hospitals, and the remainder work in mail-order or Internet pharmacies, pharmaceutical wholesalers, physicians' offices, and for the Federal Government (United States Bureau of Labor Statistics. Occupational Outlook Handbook, 2010–11). In California, pharmacists are regulated by the State Board of Pharmacy. There are 42,691 pharmacists and 70,624 pharmacy technicians with active licenses in the state.
Regulation of Pharmacies. There are 7081 pharmacies regulated by the Board. Of these, 513 are hospital pharmacies. The Board reported it also regulates 506 non-resident pharmacies which are generally including mail order pharmacies. The board has additional licenses for those pharmacies that perform sterile compounding and are located in California (890) and ship into CA from another state (91). The Board does not currently regulate remote dispensing pharmacies.
Telehealth and Telepharmacy. In 2011, California passed the Telehealth Advancement Act. This Act updated the state's definition of telehealth, simplified approval processes for telehealth services, and expanded the range of medical services that may be provided via telehealth. The law establishes legal parity between the direct and remote delivery of pharmacy care.
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. Services may include drug therapy monitoring, patient counseling, authorization for prescription drugs, and monitoring of formulary compliance utilizing teleconferencing or videoconferencing. Telepharmacy may also include remote dispensing of medications by automated packaging and labeling systems.
Other States and Jurisdictions. Implementation of telepharmacy began in the 2000s in response to myriad factors including changes in Medicare reimbursement rates and the recession. The impact of these changes was a significant decline in independent pharmacies in rural areas. To date, 20 states have passed legislation to permit telepharmacy. North Dakota was the first state to implement telepharmacy regulations, and the United States Navy operates the largest telepharmacy program.
This measure would authorize the Board to issue remote dispensing pharmacy licenses for facilities that connect a licensed pharmacist to patients using a telepharmacy system. Approximately 115 underserved communities, as defined as having no pharmacist within a 10 mile radius, across 47 different counties would be eligible to receive services via this measure. The remote dispensing pharmacy would be staffed by a registered pharmacy technician, who meets additional training criteria, and would be supervised virtually by a licensed pharmacist at a separate location. The pharmacist-in-charge is required to be located at a traditional pharmacy within 150 miles and four hours of the remote dispensing pharmacy. This measure also establishes minimum standards for the remote dispensing location in order to ensure safety and quality control. These include standards for the telepharmacy technology, security requirements, and processes for ordering, stocking, and recording different types of drugs.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 FN: 0002093
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 401
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 7/10/17
AYES: Hill, Fuller, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 9/1/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
ASSEMBLY FLOOR: 76-0, 5/31/17 - See last page for vote
DIGEST:
This bill establishes a remote dispensing site pharmacy license to increase access to pharmaceutical care services, adds reporting requirements for wholesalers regarding suspicious orders, and authorizes licensure of shared clinic office space.
Senate Floor Amendments of 9/7/17 incorporate additional provisions at the request of the Department of Health Care Services (DHCS) and the Department of Public Health (DPH) to ensure appropriate safeguards for clinics sharing office space.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001.)
- Defines a “pharmacy” as an area, place, or premises licensed by the BOP in which the profession of pharmacy is practiced and where prescriptions are compounded. “Pharmacy” includes, but is not limited to, any area, place, or premises described in a license issued by BOP wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, or repackaged, and from which the controlled substances, dangerous drugs, or dangerous devices are furnished, sold, or dispensed at retail. (BPC § 4037)
- Requires a pharmacy with only one pharmacist to have no more than one pharmacy technician (PT). Limits the ratio of pharmacists to PTs to 1:2, except with regards to personnel performing clerical functions, as specified, and in certain other limited settings. (BPC § 4115 (f)(1))
- Authorizes the use of automated drug delivery systems. (BPC § 4119.1)
This bill:
- Defines a “remote dispensing site pharmacy” (RDSP) to mean a licensed pharmacy located in California that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered PTs where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
- States that, unless otherwise specified in this bill, a RDSP shall comply with all state and federal laws regulating the practice of pharmacy.
- Defines a “supervising pharmacy” as a licensed pharmacy located in California that is owned and operated by person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one pharmacist that exclusively oversees the operations of a RDSP.
- Requires a supervising pharmacy to be exclusively responsible for the operation of the RDSP and its employees.
- Defines “telepharmacy” as a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a RDSP, drug regimen review, and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
- Authorizes dangerous drugs and devices and controlled substances to be ordered by a RDSP licensed by the BOP and may be signed for and received by a registered PT, who meets specified qualifications, at the remote site. Requires a controlled substance signed for by a PT to be stored separately from the existing inventory until the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a PT is required to be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the RDSP for 120 days.
- Authorizes the BOP to issue licenses to two independently owned clinics that share a clinic office space, as specified.
- Requires a telepharmacy system to be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a RDSP.
- Requires the BOP to issue a RDSP license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located, if all the requirements for a license are met.
- Requires that a RDSP to be located in a medically underserved area (MUA) unless otherwise approved by the BOP.
- Defines a “MUA” as a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site. However, if a pharmacy serving the general public is later established within 10 road miles of a RDSP, the RDSP may continue to operate.
- Limits the staffing of a RDSP to pharmacists or PTs, or both, and prohibits employment of any unlicensed personnel.
- Prohibits a remote dispensing site pharmacy license from being issued to anyone other than the supervising pharmacy, and limits the supervising pharmacy to one RDSP license.
- Prohibits a RDSP from being operated by the state or being located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers.
- Clarifies that a pharmacist who is otherwise eligible to operate a RDSP is not precluded from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and PTs employed by the state.
- Prohibits a RDSP from being located or operated for the purpose of displacing state employees.
- States that if a RDSP dispenses more than 300 prescriptions per day, calculated each calendar year, it shall cease to be a RDSP and may become a regular pharmacy if it meets the licensing requirements.
- Authorizes a supervising pharmacy to provide telepharmacy services for only one RDSP.
- Requires a supervising pharmacy to be located within 150 road miles from a RDSP, unless otherwise approved by the BOP.
- Requires a supervising pharmacy and remote dispensing site pharmacy to be under common ownership.
- Requires, unless staffed by a pharmacist, a RDSP to be staffed by at least one registered and PT, as specified. Requires the PT to remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the RDSP is operational. Specifies that direct supervision and control does not require the pharmacist to be physically present at the RDSP, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
- Limits a pharmacist to serving as the pharmacist-in-charge for a pharmacy in addition to serving as the pharmacist in charge of a supervising pharmacy. States that the pharmacist in charge of the supervising pharmacy shall also serve as the designated pharmacist in charge at the RDSP.
- Requires the pharmacist-in-charge of the RDSP and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring that both the supervising pharmacy and the RDSP are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
- Requires a PT at a RDSP to meet requirements specified by the BOP in regulations, and specifies that the regulations developed shall only apply to PTs working at RDSP.
- Authorizes a registered PT to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a RDSP under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
- Prohibits a PT at a RDSP from doing certain tasks.
- Authorizes a pharmacist at a supervising pharmacy to supervise up to two PTs at each RDSP. Clarifies that this does not alter a pharmacist’s ability to also supervise PTs at the supervising pharmacy.
- Requires a telepharmacy system to maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the RDSP’s personnel and patients.
- Requires a telepharmacy system to facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
- Requires patient counseling to be provided using audio-visual communication prior to all prescriptions dispensed from a RDSP.
- Requires a telepharmacy system to be able to do all of the following:
- Identify and record the PT preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
- Require a pharmacist to review and compare the electronic image of any new prescription presented at the RDSP with the data entry record of the prescription.
- Require the PT to use barcode technology to verify the accuracy of the drug to be dispensed.
- Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
- Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
- Requires the video and audio communication system used to counsel and interact with each patient or patient’s caregiver to be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
- Requires all records of prescriptions dispensed, including the records of the actions performed through the telepharmacy system, to be maintained at the RDSP and be maintained for three years after the filling of the prescription.
- Requires a pharmacist from the supervising pharmacy to complete a monthly in-person, self-inspection of each RDSP using a form designated by the BOP and shall retain all inspection reports.
- Requires a perpetual inventory to be kept for all controlled substances stored at a RDSP.
- Requires all controlled substances at a RDSP to be stored in a secure cabinet or safe that is locked.
- Requires a pharmacist from the supervising pharmacy to perform inventory and inventory reconciliation functions at a RDSP to detect and prevent the loss of any controlled substance.
- Requires the pharmacist-in-charge of a RDSP to review all inventory and inventory reconciliation reports taken and establish and maintain secure methods to prevent losses of any controlled substance. Requires the BOP to develop written policies and procedures for performing the inventory reconciliation reports required.
- Requires a pharmacist from the supervising pharmacy to compile an inventory reconciliation report of all Schedule II controlled substances at a RDSP at least once every three months.
- Requires a remote dispensing site pharmacy to report to the BOP, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use, in which case the report shall be made within 14 days of discovering the loss. Requires, if the RDSP is unable to identify the cause of the loss, the RDSP to undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist in charge shall be responsible for submitting this report to the BOP.
- Requires possible causes of overages to be identified in writing and incorporated into the inventory reconciliation report.
- Requires the inventory reconciliation report to be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the RDSP. Specifies that a countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. Requires the inventory reconciliation report to be maintained in the RDSP for at least three years in a readily retrievable form.
- Requires a RDSP to, when closed, utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
- Prohibits a RDSP from being open or its employees being allowed access during times the supervising pharmacy is closed, unless a pharmacist is present at the RDSP. Requires the security system to allow for tracking of entries into the RDSP and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a RDSP if the telepharmacy system is unavailable.
- Requires the RDSP to retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.
- Requires a wholesaler, upon discovery, to notify the BOP in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler, as specified.
- Authorizes the BOP to issue licenses to two independently owned nonprofit or free clinics that share a clinic office space, provided that the clinics comply with restrictions on ownership, drug stocks, records, and loss agreements.
- Prohibits BOP from issuing a license to purchase drugs to a clinic to two independently owned clinics that share a clinic office space until BOP is provided with documentation from DHCS and DPH that any Medi-Cal financing issues, licensing, and regulatory issues have been sufficiently addressed to the directors of DHCS and DPH’s satisfaction. Authorizes DHCS to seek any federal approvals necessary.
- Authorizes a licensed clinic to share space with a clinic exempt from licensure under specified conditions.
- Authorizes DPH to enter and inspect the shared space at any time, including accessing records.
- States that the licensed clinic shall be responsible for any statutory or regulatory violations occurring on the premises.
- Sunsets provisions of law relating to shared clinic space between a licensed and exempt clinic on January 1, 2021.
- Contains contingent enactment amendments related to SB 752 (Stone, 2017).
- Makes legislative findings and declarations relating to the necessity of this bill.
Background
BOP regulates the practice of pharmacists, interns, PTs, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license).
The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.
California passed laws supporting telemedicine in 1996, establishing it as a legitimate means of receiving health care services. The telemedicine statutes were updated in 2011 with the Telehealth Advancement Act, which updated the state's definition of telehealth, simplified approval processes for telehealth services, and expanded the range of medical services that may be provided via telehealth. The law also establishes legal parity between the direct and remote delivery of pharmacy care.
Telemedicine has evolved across healthcare industries, and is currently used in the pharmacy world to facilitate the use of automated drug delivery systems (ADDS). An ADDS is a mechanical system controlled remotely by a pharmacist that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of prepackaged dangerous drugs or dangerous devices. It is essentially an exceptionally sophisticated vending machine controlled by a pharmacist, with the security and patient safety controls of a pharmacy. Current law requires an ADDS to link to a pharmacist with two-way audio and video.
This bill defines “telepharmacy” as a means to establish a whole pharmacy, not just a drug dispensing machine, in medically underserved areas. This bill creates a license and regulatory system to enable the remote, direct supervision of PTs working in a RDSP under the control of a supervising pharmacy and pharmacist. This bill contains sufficient safety and security provisions to create equivalency with traditional pharmacies.
This bill also allows BOP to issue licenses to two independently owned nonprofit or free clinics that share a clinic office space, provided that the clinics comply with restrictions on ownership, drug stocks, records, and loss agreements.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Senate Appropriations Committee:
- One-time costs of $250,000 in 2018-19 and ongoing costs of $235,000 per year for the BOP to issue licenses, conduct inspections, and take any necessary enforcement actions (Pharmacy Board Contingent Fund).
- One-time costs of about $60,000 and ongoing costs of about $10,000 per year for the development and maintenance of the information technology requirements to issue the new license type by the BOP (Pharmacy Board Contingent Fund).
- Minor costs for the BOP to accept reports from drug wholesalers regarding suspicious orders of controlled substances and to take enforcement action, as needed (Pharmacy Board Contingent Fund).
- Minor costs for the BOP to issue additional pharmacy licenses to independently owned clinics that share office space (Pharmacy Board Contingent Fund).
Association of California State Supervisors
California Pharmacists Association
California State Retirees
CaliforniaHealth+ Advocates
Cardinal Health
Planned Parenthood Affiliates of California
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
The Community Action Fund of Planned Parenthood of Orange and San Bernardino Counties
California Society of Health-System Pharmacists
ARGUMENTS IN SUPPORT: Planned Parenthood Affiliates of California (PPAC) write, “PPAC recognizes the evolving nature of delivery of health care services and often times, those who are rural and disadvantaged are often the last beneficiary of these advances. As a result, we support the utilization and expansion of telehealth and telemedicine in order to serve a growing and diverse patient population, help alleviate provider shortages, and to meet increased demand for services. It helps eliminate distance barriers and can improve access to medical services that would often not be consistently available in distant rural communities.”
ARGUMENTS IN OPPOSITION: The California Society of Health-System Pharmacists are concerned about the definition of a MUA, the potential for RDSPs to become permanent facilities even if a full-fledged pharmacy is established in a previously designated MUA, and requests the establishment of PT training requirements to prepare PTs for this new practice setting.
ASSEMBLY FLOOR: 76-0, 5/31/17
AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bocanegra, Bonta, Brough, Burke, Caballero, Calderon, Cervantes, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Cunningham, Dababneh, Dahle, Daly, Flora, Fong, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gomez, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Ridley-Thomas, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon
NO VOTE RECORDED: Chen, Choi, Eggman, Melendez
9/9/17 14:30:59
**** END ****
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 401
:
SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 7/10/17
AYES: Hill, Fuller, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk
SENATE APPROPRIATIONS COMMITTEE: 7-0, 9/1/17
AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener
ASSEMBLY FLOOR: 76-0, 5/31/17 - See last page for vote
SUBJECT: Pharmacy: remote dispensing site pharmacy: telepharmacy: shared clinic office space
DIGEST:
This bill establishes a remote dispensing site pharmacy license to increase access to pharmaceutical care services, adds reporting requirements for wholesalers regarding suspicious orders, and authorizes licensure of shared clinic office space.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001.)
- Defines a “pharmacy” as an area, place, or premises licensed by the BOP in which the profession of pharmacy is practiced and where prescriptions are compounded. “Pharmacy” includes, but is not limited to, any area, place, or premises described in a license issued by BOP wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, or repackaged, and from which the controlled substances, dangerous drugs, or dangerous devices are furnished, sold, or dispensed at retail. (BPC § 4037)
- Requires a pharmacy with only one pharmacist to have no more than one pharmacy technician (PT). Limits the ratio of pharmacists to PTs to 1:2, except with regards to personnel performing clerical functions, as specified, and in certain other limited settings. (BPC § 4115 (f)(1))
- Authorizes the use of automated drug delivery systems. (BPC § 4119.1)
This bill:
- Defines a “remote dispensing site pharmacy” (RDSP) to mean a licensed pharmacy located in California that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered PTs where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
- States that, unless otherwise specified in this bill, a RDSP shall comply with all state and federal laws regulating the practice of pharmacy.
- Defines a “supervising pharmacy” as a licensed pharmacy located in California that is owned and operated by person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one pharmacist that exclusively oversees the operations of a RDSP.
- Requires a supervising pharmacy to be exclusively responsible for the operation of the RDSP and its employees.
- Defines “telepharmacy” as a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a RDSP, drug regimen review, and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
- Authorizes dangerous drugs and devices and controlled substances to be ordered by a RDSP licensed by the BOP and may be signed for and received by a registered PT, who meets specified qualifications, at the remote site. Requires a controlled substance signed for by a PT to be stored separately from the existing inventory until the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a PT is required to be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the RDSP for 120 days.
- Authorizes the BOP to issue licenses to two independently owned clinics that share a clinic office space, as specified.
- Requires a telepharmacy system to be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a RDSP.
- Requires the BOP to issue a RDSP license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located, if all the requirements for a license are met.
- Requires that a RDSP to be located in a medically underserved area (MUA) unless otherwise approved by the BOP.
- Defines a “MUA” as a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site. However, if a pharmacy serving the general public is later established within 10 road miles of a RDSP, the RDSP may continue to operate.
- Limits the staffing of a RDSP to pharmacists or PTs, or both, and prohibits employment of any unlicensed personnel.
- Prohibits a remote dispensing site pharmacy license from being issued to anyone other than the supervising pharmacy, and limits the supervising pharmacy to one RDSP license.
- Prohibits a RDSP from being operated by the state or being located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers.
- Clarifies that a pharmacist who is otherwise eligible to operate a RDSP is not precluded from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and PTs employed by the state.
- Prohibits a RDSP from being located or operated for the purpose of displacing state employees.
- States that if a RDSP dispenses more than 300 prescriptions per day, calculated each calendar year, it shall cease to be a RDSP and may become a regular pharmacy if it meets the licensing requirements.
- Authorizes a supervising pharmacy to provide telepharmacy services for only one RDSP.
- Requires a supervising pharmacy to be located within 150 road miles from a RDSP, unless otherwise approved by the BOP.
- Requires a supervising pharmacy and remote dispensing site pharmacy to be under common ownership.
- Requires, unless staffed by a pharmacist, a RDSP to be staffed by at least one registered and PT, as specified. Requires the PT to remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the RDSP is operational. Specifies that direct supervision and control does not require the pharmacist to be physically present at the RDSP, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
- Limits a pharmacist to serving as the pharmacist-in-charge for a pharmacy in addition to serving as the pharmacist in charge of a supervising pharmacy. States that the pharmacist in charge of the supervising pharmacy shall also serve as the designated pharmacist in charge at the RDSP.
- Requires the pharmacist-in-charge of the RDSP and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring that both the supervising pharmacy and the RDSP are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
- Requires a PT at a RDSP to meet requirements specified by the BOP in regulations, and specifies that the regulations developed shall only apply to PTs working at RDSP.
- Authorizes a registered PT to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a RDSP under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
- Prohibits a PT at a RDSP from doing certain tasks.
- Authorizes a pharmacist at a supervising pharmacy to supervise up to two PTs at each RDSP. Clarifies that this does not alter a pharmacist’s ability to also supervise PTs at the supervising pharmacy.
- Requires a telepharmacy system to maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the RDSP’s personnel and patients.
- Requires a telepharmacy system to facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
- Requires patient counseling to be provided using audio-visual communication prior to all prescriptions dispensed from a RDSP.
- Requires a telepharmacy system to be able to do all of the following:
- Identify and record the PT preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
- Require a pharmacist to review and compare the electronic image of any new prescription presented at the RDSP with the data entry record of the prescription.
- Require the PT to use barcode technology to verify the accuracy of the drug to be dispensed.
- Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
- Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
- Requires the video and audio communication system used to counsel and interact with each patient or patient’s caregiver to be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
- Requires all records of prescriptions dispensed, including the records of the actions performed through the telepharmacy system, to be maintained at the RDSP and be maintained for three years after the filling of the prescription.
- Requires a pharmacist from the supervising pharmacy to complete a monthly in-person, self-inspection of each RDSP using a form designated by the BOP and shall retain all inspection reports.
- Requires a perpetual inventory to be kept for all controlled substances stored at a RDSP.
- Requires all controlled substances at a RDSP to be stored in a secure cabinet or safe that is locked.
- Requires a pharmacist from the supervising pharmacy to perform inventory and inventory reconciliation functions at a RDSP to detect and prevent the loss of any controlled substance.
- Requires the pharmacist-in-charge of a RDSP to review all inventory and inventory reconciliation reports taken and establish and maintain secure methods to prevent losses of any controlled substance. Requires the BOP to develop written policies and procedures for performing the inventory reconciliation reports required.
- Requires a pharmacist from the supervising pharmacy to compile an inventory reconciliation report of all Schedule II controlled substances at a RDSP at least once every three months.
- Requires a remote dispensing site pharmacy to report to the BOP, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use, in which case the report shall be made within 14 days of discovering the loss. Requires, if the RDSP is unable to identify the cause of the loss, the RDSP to undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist in charge shall be responsible for submitting this report to the BOP.
- Requires possible causes of overages to be identified in writing and incorporated into the inventory reconciliation report.
- Requires the inventory reconciliation report to be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the RDSP. Specifies that a countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. Requires the inventory reconciliation report to be maintained in the RDSP for at least three years in a readily retrievable form.
- Requires a RDSP to, when closed, utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
- Prohibits a RDSP from being open or its employees being allowed access during times the supervising pharmacy is closed, unless a pharmacist is present at the RDSP. Requires the security system to allow for tracking of entries into the RDSP and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a RDSP if the telepharmacy system is unavailable.
- Requires the RDSP to retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.
- Requires a wholesaler, upon discovery, to notify the BOP in writing of any suspicious orders of controlled substances placed by a California-licensed pharmacy or wholesaler, as specified.
- Authorizes the BOP to issue licenses to two independently owned nonprofit or free clinics that share a clinic office space, provided that the clinics comply with restrictions on ownership, drug stocks, records, and loss agreements.
- Contains contingent enactment amendments related to SB 752 (Stone, 2017).
- Makes legislative findings and declarations relating to the necessity of this bill.
Background
BOP regulates the practice of pharmacists, interns, PTs, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license).
The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.
California passed laws supporting telemedicine in 1996, establishing it as a legitimate means of receiving health care services. The telemedicine statutes were updated in 2011 with the Telehealth Advancement Act, which updated the state's definition of telehealth, simplified approval processes for telehealth services, and expanded the range of medical services that may be provided via telehealth. The law also establishes legal parity between the direct and remote delivery of pharmacy care.
Telemedicine has evolved across healthcare industries, and is currently used in the pharmacy world to facilitate the use of automated drug delivery systems (ADDS). An ADDS is a mechanical system controlled remotely by a pharmacist that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of prepackaged dangerous drugs or dangerous devices. It is essentially an exceptionally sophisticated vending machine controlled by a pharmacist, with the security and patient safety controls of a pharmacy. Current law requires an ADDS to link to a pharmacist with two-way audio and video.
This bill defines “telepharmacy” as a means to establish a whole pharmacy, not just a drug dispensing machine, in medically underserved areas. This bill creates a license and regulatory system to enable the remote, direct supervision of PTs working in a RDSP under the control of a supervising pharmacy and pharmacist. This bill contains sufficient safety and security provisions to create equivalency with traditional pharmacies.
This bill also allows BOP to issue licenses to two independently owned nonprofit or free clinics that share a clinic office space, provided that the clinics comply with restrictions on ownership, drug stocks, records, and loss agreements.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Senate Appropriations Committee:
- One-time costs of $250,000 in 2018-19 and ongoing costs of $235,000 per year for the BOP to issue licenses, conduct inspections, and take any necessary enforcement actions (Pharmacy Board Contingent Fund).
- One-time costs of about $60,000 and ongoing costs of about $10,000 per year for the development and maintenance of the information technology requirements to issue the new license type by the BOP (Pharmacy Board Contingent Fund).
- Minor costs for the BOP to accept reports from drug wholesalers regarding suspicious orders of controlled substances and to take enforcement action, as needed (Pharmacy Board Contingent Fund).
- Minor costs for the BOP to issue additional pharmacy licenses to independently owned clinics that share office space (Pharmacy Board Contingent Fund).
Association of California State Supervisors
California Pharmacists Association
California State Retirees
CaliforniaHealth+ Advocates
Cardinal Health
Planned Parenthood Affiliates of California
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
The Community Action Fund of Planned Parenthood of Orange and San Bernardino Counties
California Society of Health-System Pharmacists
ARGUMENTS IN SUPPORT: Planned Parenthood Affiliates of California (PPAC) write, “PPAC recognizes the evolving nature of delivery of health care services and often times, those who are rural and disadvantaged are often the last beneficiary of these advances. As a result, we support the utilization and expansion of telehealth and telemedicine in order to serve a growing and diverse patient population, help alleviate provider shortages, and to meet increased demand for services. It helps eliminate distance barriers and can improve access to medical services that would often not be consistently available in distant rural communities.”
ARGUMENTS IN OPPOSITION: The California Society of Health-System Pharmacists are concerned about the definition of a MUA, the potential for RDSPs to become permanent facilities even if a full-fledged pharmacy is established in a previously designated MUA, and requests the establishment of PT training requirements to prepare PTs for this new practice setting.
ASSEMBLY FLOOR: 76-0, 5/31/17
AYES: Acosta, Aguiar-Curry, Travis Allen, Arambula, Baker, Berman, Bigelow, Bloom, Bocanegra, Bonta, Brough, Burke, Caballero, Calderon, Cervantes, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Cunningham, Dababneh, Dahle, Daly, Flora, Fong, Frazier, Friedman, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gomez, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Ridley-Thomas, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Voepel, Waldron, Weber, Wood, Rendon
NO VOTE RECORDED: Chen, Choi, Eggman, Melendez
9/5/17 9:41:24
**** END ****
SENATE COMMITTEE ON
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
AB 401 (Aguiar-Curry) - Pharmacy: remote dispensing site pharmacy: telepharmacy
Version: | Policy Vote: |
Urgency: | Mandate: |
Hearing Date: | Consultant: |
Bill Summary:
AB 401 would establish a remote dispensing site pharmacy license, under the authority of the Board of Pharmacy.
*********** ANALYSIS ADDENDUM – SUSPENSE FILE ***********
The following information is revised to reflect amendments
adopted by the committee on September 1, 2017
Fiscal Impact:
- One-time costs of $250,000 in 2018-19 and ongoing costs of $235,000 per year for the Board of Pharmacy to issue licenses, conduct inspections, and take any necessary enforcement actions (Pharmacy Board Contingent Fund).
- One-time costs of about $60,000 and ongoing costs of about $10,000 per year for the development and maintenance of the information technology requirements to issue the new license type by the Board of Pharmacy (Pharmacy Board Contingent Fund).
- Minor costs for the Board of Pharmacy to accept reports from drug wholesalers regarding suspicious orders of controlled substances and to take enforcement action, as needed (Pharmacy Board Contingent Fund).
- Minor costs for the Board of Pharmacy to issue additional pharmacy licenses to independently owned clinics that share office space (Pharmacy Board Contingent Fund).
Author Amendments:
Require a drug wholesaler to report to the Board of Pharmacy of any suspicious orders of controlled substances. The amendments would authorize the Board to issue licenses to independently owned clinics that share clinic office space, until 2021.
-- END --
SENATE COMMITTEE ON APPROPRIATIONS
Senator Ricardo Lara, Chair
2017 - 2018 Regular Session
AB 401 (Aguiar-Curry) - Pharmacy: remote dispensing site pharmacy: telepharmacy
Version: July 6, 2017 | Policy Vote: B., P. & E.D. 9 - 0 |
Urgency: No | Mandate: Yes |
Hearing Date: August 21, 2017 | Consultant: Brendan McCarthy |
This bill meets the criteria for referral to the Suspense File.
Bill Summary:
AB 401 would establish a remote dispensing site pharmacy license, under the authority of the Board of Pharmacy.
Fiscal Impact:
- One-time costs of $250,000 in 2018-19 and ongoing costs of $235,000 per year for the Board of Pharmacy to issue licenses, conduct inspections, and take any necessary enforcement actions (Pharmacy Board Contingent Fund).
- One-time costs of about $60,000 and ongoing costs of about $10,000 per year for the development and maintenance of the information technology requirements to issue the new license type by the Board of Pharmacy (Pharmacy Board Contingent Fund).
Background:
Under current law, the Board of Pharmacy licenses pharmacists and pharmacies in the state. Under current law, pharmacists can use automated drug delivery systems to provide pharmacy services at a remote location. Using these systems, a licensed pharmacist can dispense dangerous drugs in specified quantities to licensed health care professionals without being physically present. (Such systems are limited to use in health care facilities such as skilled nursing facilities or clinics.) Current law imposes certain requirements on pharmacists that use such systems. Current law allows clinics to use an automated drug delivery system, if the clinic is licensed by the Board of Pharmacy to do so.
Proposed Law:
AB 401 would establish a remote dispensing site pharmacy license, under the authority of the Board of Pharmacy.
Specific provisions of the bill would:
- Define a remote dispensing site pharmacy as a licensed pharmacy that is exclusively overseen by a supervising pharmacist and staffed by one or more qualified pharmacy technicians, and where pharmacy services are provided through telepharmacy;
- Authorize dangerous drugs and devices and controlled substances to be signed for by a pharmacy technician at a licensed remote dispensing site pharmacy;
- Specify the requirements for licensure as a remote dispensing site pharmacy, including the allowable locations, staffing requirements, and supervision requirements;
- Prohibit the state from operating a remote dispensing site pharmacy;
- Specify the requirements for pharmacy technicians working in a remote dispensing site pharmacy;
- Specify requirements for the use of video and audio communication by the supervising pharmacy, including requirements for patient confidentiality and record retention;
- Specify the requirements for inventory control.
Related Legislation:
SB 528 (Stone) would allow a pharmacy to provide services using an automated drug delivery system to specified health facilities participating in the federal Section 340B Drug Pricing Program. That bill is pending on the Assembly Appropriations Committee’s Suspense File.
Staff Comments:
Operation of the Board of Pharmacy’s licensing program is supported by license application and renewal fees. At this time, the number of remote dispensing site pharmacy licenses that are likely to be issued is unknown. Therefore, it is not clear whether there will be sufficient application and renewal fee revenue to support the fixed licensing and enforcement costs incurred by the Board of Pharmacy. In the long-run, the licensing and enforcement workload at the Board will be driven by the number of licensees and so fee revenues should roughly offset the Board’s workload.
The only costs that may be incurred by a local agency relate to crimes and infractions. Under the California Constitution, such costs are not reimbursable by the state.
-- END --
SENATE COMMITTEE ON
BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT
Senator Jerry Hill, Chair
2017 - 2018 Regular
Bill No: Hearing Date: July 10, 2017
Author: | |||
Version: | July 6, 2017 | ||
Urgency: | No | Fiscal: | Yes |
Consultant: | Sarah Huchel | ||
Subject:
SUMMARY:
Establishes a remote dispensing site pharmacy license for the purpose of increasing access to pharmaceutical care services.
Existing law:
- Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law. (Business and Professions Code (BPC) § 4001.)
- Defines a “pharmacy” as an area, place, or premises licensed by the BOP in which the profession of pharmacy is practiced and where prescriptions are compounded. “Pharmacy” includes, but is not limited to, any area, place, or premises described in a license issued by the board wherein controlled substances, dangerous drugs, or dangerous devices are stored, possessed, prepared, manufactured, derived, compounded, or repackaged, and from which the controlled substances, dangerous drugs, or dangerous devices are furnished, sold, or dispensed at retail.
(BPC § 4037) - Defines a “pharmacy technician (PT)” as an individual who assists a pharmacist in a pharmacy in the performance of his or her related duties, which shall include packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and while under the direct supervision and control of, a pharmacist. The pharmacist shall be responsible for the duties performed his or her supervision by a PT. (BPC §§ 4038, 4115)
- Requires a pharmacy with only one pharmacist to have no more than one PT. Limits the ratio of pharmacists to PTs to 1:2, except with regards to personnel performing clerical functions, as specified, and in certain other limited settings. (BPC § 4115 (f)(1))
- Authorizes the use of automated drug delivery systems. (BPC § 4119.1)
- Requires every pharmacy to designate a pharmacist in charge who is responsible for the pharmacy’s compliance with all state and federal laws. (BPC § 4113)
This bill:
- Defines a “remote dispensing site pharmacy” (RDSP) to mean a licensed pharmacy located in California that is exclusively overseen and operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
- States that, unless otherwise specified in this bill, a RDSP shall comply with all state and federal laws regulating the practice of pharmacy.
- Defines a “supervising pharmacy” as a licensed pharmacy located in California that is owned and operated by person or persons where the majority of the beneficial interest in, as well as the management and control, resides with at least one pharmacist that exclusively oversees the operations of a RDSP.
- Requires a supervising pharmacy to be exclusively responsible for the operation of the RDSP and its employees.
- Defines “telepharmacy” as a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs by a RDSP, drug regimen review, and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
- Authorizes dangerous drugs and devices and controlled substances to be ordered by a RDSP licensed by the BOP and may be signed for and received by a registered PT, who meets specified qualifications, at the remote site. Requires a controlled substance signed for by a PT to be stored separately from the existing inventory until the controlled substance is reviewed and countersigned by a pharmacist. Any receipt and storage of a controlled substance by a PT is required to be captured on video, and that video shall be made accessible to the supervising pharmacy and maintained by the RDSP for 120 days.
- Requires a telepharmacy system to be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a RDSP.
- Requires the BOP to issue a RDSP license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the remote dispensing site pharmacy is to be located, if all the requirements for a license are met.
- Requires that a RDSP to be located in a medically underserved area (MUA) unless otherwise approved by the BOP.
- Defines a “MUA” as a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site. However, if a pharmacy serving the general public is later established within 10 road miles of a RDSP, the RDSP may continue to operate.
- Limits the staffing of a RDSP to pharmacists or PTs, or both, and prohibits employment of any unlicensed personnel.
- Prohibits a remote dispensing site pharmacy license from being issued to anyone other than the supervising pharmacy, and limits the supervising pharmacy to one RDSP license.
- Prohibits a RDSP from being operated by the state or being located in any state facility, including, but not limited to, correctional facilities, state hospitals, or developmental centers.
- Clarifies that a pharmacist who is otherwise eligible to operate a RDSP is not precluded from leasing space in property owned by the state, provided it is not for the purpose of serving individuals otherwise served by pharmacists and PTs employed by the state.
- Prohibits a RDSP from being located or operated for the purpose of displacing state employees.
- States that if a RDSP dispenses more than 300 prescriptions per day, calculated each calendar year, it shall cease to be a RDSP and may become a regular pharmacy if it meets the licensing requirements.
- Authorizes a supervising pharmacy to provide telepharmacy services for only one RDSP.
- Requires a supervising pharmacy to be located within 150 road miles from a RDSP, unless otherwise approved by the BOP.
- Requires a supervising pharmacy and remote dispensing site pharmacy to be under common ownership.
- Requires, unless staffed by a pharmacist, a RDSP to be staffed by at least one registered and PT, as specified. Requires the PT to remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the RDSP is operational. Specifies that direct supervision and control does not require the pharmacist to be physically present at the RDSP, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
- Limits a pharmacist to serving as the pharmacist-in-charge for a pharmacy in addition to serving as the pharmacist in charge of a supervising pharmacy. States that the pharmacist in charge of the supervising pharmacy shall also serve as the designated pharmacist in charge at the RDSP.
- Requires the pharmacist-in-charge of the RDSP and the pharmacist-on-duty at the supervising pharmacy to be responsible for ensuring that both the supervising pharmacy and the RDSP are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
- Requires a PT at a RDSP to meet requirements specified by the BOP in regulations.
- Authorizes a registered PT to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a RDSP under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
- Prohibits a PT at a RDSP from doing any of the following:
- Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
- Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
- Identify, evaluate, or interpret a prescription.
- Interpret the clinical data in a patient medication record system or patient chart.
- Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
- Supervise the packaging of drugs and check the packaging procedure and product upon completion.
- Perform any function that requires the professional judgment of a licensed pharmacist.
- Compound any drug preparations.
- Authorizes a pharmacist at a supervising pharmacy to supervise up to two PTs at each RDSP. Clarifies that this does not alter a pharmacist’s ability to also supervise PTs at the supervising pharmacy.
- Requires a telepharmacy system to maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the RDSP’s personnel and patients.
- Requires a telepharmacy system to facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
- Requires patient counseling to be provided using audio-visual communication prior to all prescriptions dispensed from a RDSP.
- Requires a telepharmacy system to be able to do all of the following:
- Identify and record the PT preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
- Require a pharmacist to review and compare the electronic image of any new prescription presented at the RDSP with the data entry record of the prescription.
- Require the PT to use barcode technology to verify the accuracy of the drug to be dispensed.
- Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
- Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
- Requires the video and audio communication system used to counsel and interact with each patient or patient’s caregiver to be secure and compliant with the federal Health Insurance Portability and Accountability Act (Public Law 104-191).
- Requires all records of prescriptions dispensed, including the records of the actions performed through the telepharmacy system, to be maintained at the RDSP and be maintained for three years after the filling of the prescription.
- Requires a pharmacist from the supervising pharmacy to complete a monthly in-person, self-inspection of each RDSP using a form designated by the BOP and shall retain all inspection reports.
- Requires a perpetual inventory to be kept for all controlled substances stored at a RDSP.
- Requires all controlled substances at a RDSP to be stored in a secure cabinet or safe that is locked.
- Requires a pharmacist from the supervising pharmacy to perform inventory and inventory reconciliation functions at a RDSP to detect and prevent the loss of any controlled substance.
- Requires the pharmacist-in-charge of a RDSP to review all inventory and inventory reconciliation reports taken and establish and maintain secure methods to prevent losses of any controlled substance. Requires the BOP to develop written policies and procedures for performing the inventory reconciliation reports required.
- Requires a pharmacist from the supervising pharmacy to compile an inventory reconciliation report of all Schedule II controlled substances at a RDSP at least once every three months. Requires this compilation to contain:
- A physical count, not an estimate, of all quantities of Schedule II controlled substances at the RDSP. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required.
- A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
- A comparison of paragraphs (a) and (b) in order to determine if there are any variances.
- All records used to compile each inventory reconciliation report shall be maintained in the RDSP for at least three years in a readily retrievable form.
- Requires a remote dispensing site pharmacy to report to the BOP, in writing, any identified losses of controlled substances and possible causes of the loss within
30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use, in which case the report shall be made within 14 days of discovering the loss. Requires, if the RDSP is unable to identify the cause of the loss, the RDSP to undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances. The pharmacist in charge shall be responsible for submitting this report to the BOP. - Requires possible causes of overages to be identified in writing and incorporated into the inventory reconciliation report.
- Requires the inventory reconciliation report to be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the RDSP. Specifies that a countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. Requires the inventory reconciliation report to be maintained in the RDSP for at least three years in a readily retrievable form.
- Requires a RDSP to, when closed, utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
- Prohibits a RDSP from being open or its employees being allowed access during times the supervising pharmacy is closed, unless a pharmacist is present at the RDSP. Requires the security system to allow for tracking of entries into the RDSP and the pharmacist-in-charge shall periodically review the record of entries. Pharmacy services shall not be provided at a RDSP if the telepharmacy system is unavailable.
- Requires the RDSP to retain a recording of facility surveillance, excluding patient communications, for a minimum of 120 days.
- Makes Legislative findings and declarations relating to the necessity of this bill.
FISCAL EFFECT:
This measure has been keyed fiscal by Legislative Counsel. According to the Assembly Appropriations Committee analysis dated May 3, 2017:
- Costs to BOP to develop licensure forms, processes, and regulations, and to perform ongoing inspections in the range of $250,000 in the first year and $150,000-$230,000 annually ongoing (Pharmacy Board Contingent Fund).
- One-time information technology costs of $60,000 to $115,000 (same fund).
- Unknown potential impact on statewide health care costs. To the extent more individuals fill prescriptions they otherwise would not fill, there could be additional health care dollars spent on drugs, including through the Medi-Cal program. However, improving medication adherence is helpful to control chronic conditions such as diabetes, heart disease, and hypertension, which can result in more costly health care interventions when uncontrolled, such as hospital stays.
COMMENTS:
- Purpose. This bill is sponsored by the Author. According to the Author’s office, “Patients often see their pharmacist far more frequently than any other healthcare provider, and a pharmacist is a critical member of a comprehensive healthcare team. Making pharmacists more readily available can result in significant improvements to an individual’s health and the health of entire communities that currently lack a pharmacist. People living in pharmacy-deprived areas face many barriers to obtaining comprehensive medical care. These patients desire more convenient access to their health care services, and remote pharmacy dispensing is a proven model to provide improved care that is both safe and effective.
“This innovative model of pharmacy was first tested and studied in North Dakota from 2002-2008. The study found that remote dispensing pharmacies not only created more convenient opportunities for patients to obtain their medication, but also showed reduced medication error rates in remote dispensing locations when compared with the national average.
“The means to provide better access to a pharmacist and pharmaceutical care throughout California are available today. Many other states have successfully implemented telepharmacy programs, which already have benefitted thousands of underserved patients across the country.”
- BOP. BOP regulates the practice of pharmacists, interns, PTs, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license).
The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.
- Telepharmacy. California passed laws supporting telemedicine in 1996, establishing it as a legitimate means of receiving health care services. The telemedicine statutes were updated in 2011 with the Telehealth Advancement Act, which updated the state's definition of telehealth, simplified approval processes for telehealth services, and expanded the range of medical services that may be provided via telehealth. The law also establishes legal parity between the direct and remote delivery of pharmacy care.
Telemedicine has evolved across healthcare industries, and is currently used in the pharmacy world to facilitate the use of automated drug delivery systems (ADDS). An ADDS is a mechanical system controlled remotely by a pharmacist that performs operations or activities, other than compounding or administration, relative to the storage, dispensing, or distribution of prepackaged dangerous drugs or dangerous devices. It is essentially an exceptionally sophisticated vending machine controlled by a pharmacist, with the security and patient safety controls of a pharmacy. Current law requires an ADDS to link to a pharmacist with two-way audio and video.
This bill defines “telepharmacy” as a means to establish a whole pharmacy, not just a drug dispensing machine, in medically underserved areas. This bill creates a license and regulatory system to enable the remote, direct supervision of PTs working in a RDSP under the control of a supervising pharmacy and pharmacist. This bill contains sufficient safety and security provisions to create equivalency with traditional pharmacies.
- Related Legislation. SB 528 (Stone) authorizes a pharmacy to provide pharmacy services to clinics that qualify as “covered entities” through the use of an ADDS. (Status: This bill is pending in the Assembly Appropriations Committee.)
- Prior Legislation. AB 415 (Logue, Chapter 547, Statutes of 2011) enacted the Telehealth Advancement Act.
- Arguments in Support. Planned Parenthood Affiliates of California (PPAC) write, “PPAC recognizes the evolving nature of delivery of health care services and often times, those who are rural and disadvantaged are often the last beneficiary of these advances. As a result, we support the utilization and expansion of telehealth and telemedicine in order to serve a growing and diverse patient population, help alleviate provider shortages, and to meet increased demand for services. It helps eliminate distance barriers and can improve access to medical services that would often not be consistently available in distant rural communities.”
SUPPORT AND OPPOSITION:
Support:
California Pharmacists Association
California State Retirees
CaliforniaHealth+ Advocates
Cardinal Health
Planned Parenthood Affiliates of California
Planned Parenthood Mar Monte
Planned Parenthood Northern California Action Fund
The Community Action Fund of Planned Parenthood of Orange and San Bernardino Counties
Opposition:
None on file as of July 5, 2017.
-- END --
ASSEMBLY THIRD READING
ATR Bill Id:AB 401
Author:(Aguiar-Curry)
As Amended Ver:May 10, 2017
Majority vote
Committee | Votes | Ayes | Noes |
Business & Professions | 15-0 | Salas, Brough, Arambula, Baker, Bloom, Chiu, Cunningham, Dahle, Eggman, Gipson, Grayson, Holden, Low, Steinorth, Ting | |
Appropriations | 17-0 | Gonzalez Fletcher, Bigelow, Bloom, Bocanegra, Bonta, Brough, Calderon, McCarty, Quirk, Fong, Friedman, Gallagher, Eduardo Garcia, Gray, Muratsuchi, Obernolte, Reyes |
|
SUMMARY: This measure authorizes a remote dispensing site pharmacy to use a telepharmacy system, and would require the Board of Pharmacy (Board) to issue a remote dispensing site pharmacy license; requires a remote dispensing site pharmacy to be located in a medically underserved area; authorizes a pharmacist to serve as a supervising pharmacist to provide telepharmacy services for up to two remote dispensing site pharmacies; authorizes a licensed remote dispensing site pharmacy to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician to receive and sign for the delivered order; authorizes a registered pharmacy technician to work at a remote dispensing site pharmacy and to perform tasks under the supervision of a pharmacist using a telepharmacy system; and, authorizes a pharmacist at a supervising pharmacy to supervise up to two pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy. Specifically, this bill:
- Defines "Remote dispensing site pharmacy" as a licensed pharmacy located in this state that is operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
- Defines "Supervising pharmacy" as a licensed pharmacy located in this state that oversees the activities of a remote dispensing site pharmacy.
- Defines "Telepharmacy" as a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
- Provides that dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician at the remote site.
- Requires that a controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist.
- Specifies that the receipt and storage of a controlled substance by a pharmacy technician under this section shall be maintained on video that is accessible to the supervising pharmacy and shall be maintained for 90 days.
- Provides that a telepharmacy system may be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
- Directs the Board to issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the site is to be located.
- Specifies that a remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a "medically underserved area" means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
- Indicates if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
- Specifies that a remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
- Permits a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for up to two remote dispensing site pharmacies.
- Specifies that a supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
- States that a supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
- Provides that if a supervising pharmacy and a remote dispensing site pharmacy are not under common ownership, the supervising pharmacy and remote dispensing site pharmacy shall enter into a written contract or agreement that specifies the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement, consistent with all federal and state laws.
- Requires, that unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. Direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
- Permits a pharmacist to serve as the pharmacist-in-charge for no more than two remote dispensing site pharmacies in addition to serving as pharmacist-in-charge of a supervising pharmacy.
- Specifies that the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
- Requires that a pharmacy technician working at a remote dispensing site pharmacy shall have both of the following:
- At least one year of experience in the past three years working in retail pharmacy practice.
- Completed a documented training program on proper use of the telepharmacy system at the remote dispensing site pharmacy.
- Permits a registered pharmacy technician to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
- Specifies that a pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
- Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
- Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
- Identify, evaluate, or interpret a prescription.
- Interpret the clinical data in a patient medication record system or patient chart.
- Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
- Supervise the packaging of drugs and check the packaging procedure and product upon completion.
- Perform any function that requires the professional judgment of a licensed pharmacist.
- Allows a pharmacist at a supervising pharmacy to supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This shall not be construed to alter a pharmacist's ability to also supervise pharmacy technicians at the supervising pharmacy.
- Requires that a telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients.
- Requires that a telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
- States that patient counseling shall be provided using audio-visual communication for all prescriptions dispensed from a remote dispensing site pharmacy.
- Requires that a telepharmacy system shall do all of the following:
- Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
- Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
- Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
- Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
- Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
- States that the video and audio communication system used to counsel and interact with each patient or patient’s caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act.
- Requires that all records of prescriptions dispensed shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
- Specifies that a pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
- Requires a perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
- Requires all controlled substances at a remote dispensing site pharmacy to be stored in a secure cabinet or safe that is locked.
- Specifies that a pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
- Requires the pharmacist-in-charge of a remote dispensing site pharmacy to review all inventory and inventory reconciliation reports taken and to establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
- Requires a pharmacist from the supervising pharmacy to compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
- A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
- A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
- A of inventory reports to determine if there are any variances.
- All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
- Requires a remote dispensing site pharmacy to report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances.
- Specifies that causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
- Requires that the inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
- Requires a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
- Specifies that unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries.
- Requires that the remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 90 days.
- Makes findings and declarations.
FISCAL EFFECT: According to Assembly Appropriations Committee:
- Costs to Board of Pharmacy to develop licensure forms, processes, and regulations, and to perform ongoing inspections in the range of $250,000 in the first year and $150,000-$230,000 annually ongoing.
- One-time information technology costs of $60,000 to $115,000.
- Unknown potential impact on statewide health care costs. To the extent more individuals fill prescriptions they otherwise would not fill, there could be additional health care dollars spent on drugs, including through the Medi-Cal program. However, improving medication adherence is helpful to control chronic conditions such as diabetes, heart disease, and hypertension, which can result in more costly health care interventions when uncontrolled, such as hospital stays.
COMMENTS:
Purpose. This bill is sponsored by the author. According to the author, "A pharmacist is a critical member of a comprehensive healthcare team. However, there are approximately 115 designated communities in 47 California counties that do not have access to a pharmacist within 10 miles. For people living in these communities, visiting a pharmacist can mean up to a 90 mile drive. This is a significant barrier to accessing quality healthcare services. Authorizing remote dispensing pharmacies to operate throughout the state in these medically underserved communities provides opportunities for better patient education, increased medication adherence, and better health outcomes."
Background. Pharmacist Practice and Regulation. Pharmacists are healthcare professionals who understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. Pharmacists provide counseling on the appropriate use and effects of prescribed drugs. Pharmacists must obtain the Doctor of Pharmacy degree before they are eligible to sit for the North American Pharmacist Licensure Examination (NAPLEX) to enter into pharmacy practice (Accreditation Council for Pharmacy Education, Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree, 2011).
In 2014, the United States Bureau of Labor Statistics reported that there were 297,100 pharmacist jobs. The majority (65%) of those pharmacists work in retail settings, about 22 percent work in hospitals, and the remainder work in mail-order or Internet pharmacies, pharmaceutical wholesalers, physicians’ offices, and for the Federal Government (US Bureau of Labor Statistics. Occupational Outlook Handbook, 2010–11). In California, pharmacists are regulated by the State Board of Pharmacy. There are 42,691 pharmacists and 70,624 pharmacy technicians with active licenses in the state.
Regulation of Pharmacies. There are 7,081 pharmacies regulated by the Board. Of these, 513 are hospital pharmacies. The Board reported it also regulates 506 non-resident pharmacies which are generally including mail order pharmacies. The board has additional licenses for those pharmacies that perform sterile compounding and are located in California (890) and ship into CA from another state (91). The Board does not currently regulate remote dispensing pharmacies.
Telehealth and Telepharmacy. In 2011, California passed the Telehealth Advancement Act. This Act updated the state's definition of telehealth, simplified approval processes for telehealth services, and expanded the range of medical services that may be provided via telehealth. The law establishes legal parity between the direct and remote delivery of pharmacy care.
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. Services may include drug therapy monitoring, patient counseling, authorization for prescription drugs, and monitoring of formulary compliance utilizing teleconferencing or videoconferencing. Telepharmacy may also include remote dispensing of medications by automated packaging and labeling systems.
Other States and Jurisdictions. Implementation of telepharmacy began in the 2000s in response to myriad factors including changes in Medicare reimbursement rates and the recession. The impact of these changes was a significant decline in independent pharmacies in rural areas. To date, 20 states have passed legislation to permit telepharmacy. North Dakota was the first state to implement telepharmacy regulations, and the United States Navy operates the largest telepharmacy program.
This measure would authorize the Board to issue remote dispensing pharmacy licenses for facilities that connect a licensed pharmacist to patients using a telepharmacy system. Approximately 115 underserved communities, as defined as having no pharmacist within a 10 mile radius, across 47 different counties would be eligible to receive services via this measure. The remote dispensing pharmacy would be staffed by a registered pharmacy technician, who meets additional training criteria, and would be supervised virtually by a licensed pharmacist at a separate location. The pharmacist-in-charge is required to be located at a traditional pharmacy within 150 miles and four hours of the remote dispensing pharmacy. This measure also establishes minimum standards for the remote dispensing location in order to ensure safety and quality control. These include standards for the telepharmacy technology, security requirements, and processes for ordering, stocking, and recording different types of drugs.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301 FN: 0000724
Date of Hearing: May 3, 2017
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez Fletcher, Chair
ABPCA Bill Id:AB 401
Author:(Aguiar-Curry) – As Amended Ver:March 21, 2017
Policy Committee: | Business and Professions | Vote: | 15 - 0 |
|
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Urgency: No State Mandated Local Program: Yes Reimbursable: No
SUMMARY:
This bill allows licensed pharmacies to operate "remote dispensing site pharmacies" and use "telepharmacy systems," as defined, to manage activities at the remote site, and limits establishment of remote sites to geographic areas underserved by pharmacies.
It also establishes additional experience requirements for registered pharmacy technicians who staff remote sites, requires audio and video communication systems between supervising pharmacies and remote sites, requires regular inspections of the remote site by a pharmacist, and establishes related protocols, including particular specifications for controlled substances.
FISCAL EFFECT:
- Costs to Board of Pharmacy to develop licensure forms, processes, and regulations, and to perform ongoing inspections in the range of $250,000 in the first year and $150,000-$230,000 annually ongoing (Pharmacy Board Contingent Fund).
- One-time information technology costs of $60,000 to $115,000 (same fund).
- Unknown potential impact on statewide health care costs. To the extent more individuals fill prescriptions they otherwise would not fill, there could be additional health care dollars spent on drugs, including through the Medi-Cal program. However, improving medication adherence is helpful to control chronic conditions such as diabetes, heart disease, and hypertension, which can result in more costly health care interventions when uncontrolled, such as hospital stays.
COMMENTS:
- Purpose. This bill is intended to expand geographic access to pharmacies and pharmacists, given the decline in independent pharmacies and the availability of modern communication technologies.
- Background. The Board regulates approximately 7,100 pharmacies and 4,300 pharmacists, as well as pharmacy technicians. Though twenty other states authorize telepharmacy, California law does not allow it. It is estimated approximately 115 communities in 47 counties would qualify as medically underserved according to the definition established in this bill, and thus could potentially house a remote dispensing site pharmacy. Other avenues for remote dispensing exist, including mail-order pharmacies, but provision of drugs through the mail does not provide the same access to pharmacist consultation.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing:
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Rudy Salas, Chair
ABPCA Bill Id:AB 401
Author:(Aguiar-Curry) – As Amended Ver:March 21, 2017
SUBJECT: Pharmacy: remote dispensing site pharmacy: telepharmacy.
SUMMARY: This measure authorizes a remote dispensing site pharmacy to use a telepharmacy system, and would require the Board of Pharmacy (Board) to issue a remote dispensing site pharmacy license; requires a remote dispensing site pharmacy to be located in a medically underserved area; authorizes a pharmacist to serve as a supervising pharmacist to provide telepharmacy services for up to 2 remote dispensing site pharmacies; authorizes a licensed remote dispensing site pharmacy to order dangerous drugs and devices and controlled substances and authorizes a registered pharmacy technician to receive and sign for the delivered order; authorizes a registered pharmacy technician to work at a remote dispensing site pharmacy and to perform tasks under the supervision of a pharmacist using a telepharmacy system; and, authorizes a pharmacist at a supervising pharmacy to supervise up to 2 pharmacy technicians at each remote dispensing site pharmacy in addition to any pharmacy technicians being supervised at the supervising pharmacy.
EXISTING LAW:
- Establishes the Board within the Department of Consumer Affairs, to regulate the practice of pharmacy (Business and Professions Code (BPC) § 4000 et seq.)
THIS BILL:
- Defines “Remote dispensing site pharmacy” as a licensed pharmacy located in this state that is operated by a supervising pharmacy and staffed by one or more qualified registered pharmacy technicians where pharmaceutical care services, including, but not limited to, the storage and dispensing of prescription drugs and controlled substances, drug regimen review, and patient counseling, are remotely monitored or provided, or both, by a licensed pharmacist through the use of telepharmacy technology.
- Defines “Supervising pharmacy” as a licensed pharmacy located in this state that oversees the activities of a remote dispensing site pharmacy.
- Defines “Telepharmacy” as a system that is used by a supervising pharmacy for the purpose of monitoring the dispensing of prescription drugs and provides for related drug regimen review and patient counseling by an electronic method, including, but not limited to, the use of audio, visual, still image capture, and store and forward technology.
- Provides that dangerous drugs and devices and controlled substances may be ordered by a remote dispensing site pharmacy licensed by the board and may be signed for and received by a registered pharmacy technician at the remote site.
- Requires that a controlled substance signed for by a pharmacy technician under this section shall be stored separately from existing inventory until the time the controlled substance is reviewed and countersigned by a pharmacist.
- Specifies that the receipt and storage of a controlled substance by a pharmacy technician under this section shall be maintained on video that is accessible to the supervising pharmacy and shall be maintained for 90 days.
- Provides that a telepharmacy system may be used for the dispensing of prescription drugs and providing related drug regimen review and patient counseling services at a remote dispensing site pharmacy.
- Directs the Board to issue a remote dispensing site pharmacy license for the purpose of increasing access to dispensing or pharmaceutical care services in the geographic area in which the site is to be located.
- Specifies that a remote dispensing site pharmacy shall only be located in a medically underserved area unless otherwise approved by the board. For purposes of this section, a “medically underserved area” means a location that does not have a pharmacy that serves the general public within 10 road miles of the remote dispensing site.
- Indicates if a pharmacy serving the general public is later established within 10 road miles of a remote dispensing site pharmacy, the remote dispensing site pharmacy may continue to operate.
- Specifies that a remote dispensing site pharmacy shall only be staffed by pharmacists or pharmacy technicians, or both, and shall not employ any unlicensed personnel.
- Permits a pharmacy located in this state to serve as a supervising pharmacy to provide telepharmacy services for up to two remote dispensing site pharmacies.
- Specifies that a supervising pharmacy shall not be located greater than 150 road miles from a remote dispensing site pharmacy, unless otherwise approved by the board.
- States that a supervising pharmacy and remote dispensing site pharmacy shall be under common ownership.
- Provides that if a supervising pharmacy and a remote dispensing site pharmacy are not under common ownership, the supervising pharmacy and remote dispensing site pharmacy shall enter into a written contract or agreement that specifies the services to be provided and the responsibilities and accountabilities of each party in fulfilling the terms of the contract or agreement, consistent with all federal and state laws.
- Requires, that unless staffed by a pharmacist, a remote dispensing site pharmacy shall be staffed by at least one registered pharmacy technician. A technician shall remain under the direct supervision and control of a pharmacist at the supervising pharmacy at all times that the remote dispensing site pharmacy is operational. Direct supervision and control does not require the pharmacist to be physically present at the remote dispensing site pharmacy, but the pharmacist shall use a telepharmacy system to supervise operations through audio and visual technology from the supervising pharmacy.
- Permits a pharmacist to serve as the pharmacist-in-charge for no more than two remote dispensing site pharmacies in addition to serving as pharmacist-in-charge of a supervising pharmacy.
- Specifies that the pharmacist-in-charge of the remote dispensing site pharmacy and the pharmacist-on-duty at the supervising pharmacy shall be responsible for ensuring that both the supervising pharmacy and remote dispensing site pharmacy are sufficiently staffed to allow for appropriate supervision, which is supervision that would not be reasonably expected to result in an unreasonable risk of harm to public health, safety, or welfare.
- Requires that a pharmacy technician working at a remote dispensing site pharmacy shall have both of the following:
- At least one year of experience in the past three years working in retail pharmacy practice.
- Completed a documented training program on proper use of the telepharmacy system at the remote dispensing site pharmacy.
- Permits a registered pharmacy technician to perform order entry, packaging, manipulative, repetitive, and other nondiscretionary tasks at a remote dispensing site pharmacy under the supervision of a pharmacist at a supervising pharmacy using a telepharmacy system.
- Specifies that a pharmacy technician at a remote dispensing site pharmacy shall not do any of the following:
- Receive a new prescription order orally from a prescriber or other person authorized to prescribe by law.
- Consult with a patient or his or her agent regarding a prescription, either prior to or after dispensing, or regarding any medical information contained in a patient medication record system or patient chart.
- Identify, evaluate, or interpret a prescription.
- Interpret the clinical data in a patient medication record system or patient chart.
- Consult with any prescriber, nurse, or other health care professional or authorized agent thereof.
- Supervise the packaging of drugs and check the packaging procedure and product upon completion.
- Perform any function that requires the professional judgment of a licensed pharmacist.
- Allows a pharmacist at a supervising pharmacy to supervise up to two pharmacy technicians at each remote dispensing site pharmacy. This shall not be construed to alter a pharmacist’s ability to also supervise pharmacy technicians at the supervising pharmacy.
- Requires that a telepharmacy system shall maintain a video and audio communication system that provides for effective communication between the supervising pharmacy and the remote dispensing site pharmacy’s personnel and patients.
- Requires that a telepharmacy system shall facilitate adequate pharmacist supervision and allow the appropriate exchange of visual, verbal, and written communications for patient counseling and other matters involved in the lawful dispensing of drugs.
- States that patient counseling shall be provided using audio-visual communication for all prescriptions dispensed from a remote dispensing site pharmacy.
- Requires that a telepharmacy system shall do all of the following:
- Identify and record the pharmacy technician preparing each prescription and the supervising pharmacist who reviewed and authorized the dispensing of the prescription.
- Require a pharmacist to review and compare the electronic image of any new prescription presented at the remote dispensing site pharmacy with the data entry record of the prescription.
- Require the pharmacy technician to use barcode technology to verify the accuracy of the drug to be dispensed.
- Require remote visual confirmation by a pharmacist at the supervising pharmacy of the drug stock bottle and the drug to be dispensed prior to dispensing.
- Ensure that a prescription is not sold or delivered to a patient prior to a pharmacist performing final verification of the accuracy of the prescription and releasing the prescription for sale and delivery.
- States that the video and audio communication system used to counsel and interact with each patient or patient’s caregiver shall be secure and compliant with the federal Health Insurance Portability and Accountability Act.
- Requires that all records of prescriptions dispensed shall be maintained at the remote dispensing site pharmacy and shall be maintained for three years after the filling of the prescription.
- Specifies that a pharmacist from the supervising pharmacy shall complete a monthly in-person, self-inspection of each remote dispensing site pharmacy using a form designated by the board and shall retain all inspection reports.
- Requires a perpetual inventory shall be kept for all controlled substances stored at a remote dispensing site pharmacy.
- Requires all controlled substances at a remote dispensing site pharmacy to be stored in a secure cabinet or safe that is locked.
- Specifies that a pharmacist from the supervising pharmacy shall perform inventory and inventory reconciliation functions at a remote dispensing site pharmacy to detect and prevent the loss of any controlled substance.
- Requires the pharmacist-in-charge of a remote dispensing site pharmacy to review all inventory and inventory reconciliation reports taken and to establish and maintain secure methods to prevent losses of any controlled substance. The board shall develop written policies and procedures for performing the inventory reconciliation reports required by this section.
- Requires a pharmacist from the supervising pharmacy to compile an inventory reconciliation report of all Schedule II controlled substances at a remote dispensing site pharmacy at least once every three months. This compilation shall require all of the following:
- A physical count, not an estimate, of all quantities of Schedule II controlled substances at the remote dispensing site pharmacy. The biennial inventory of controlled substances as required under federal law may serve as one of the mandated inventories under this section in the year that the federal biennial inventory is performed, provided that the biennial inventory was taken no more than three months from the last inventory required by this section.
- A review of all acquisitions and dispositions of Schedule II controlled substances since the last inventory reconciliation report.
- A of inventory reports to determine if there are any variances.
- All records used to compile each inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
- Requires a remote dispensing site pharmacy to report to the board, in writing, any identified losses of controlled substances and possible causes of the loss within 30 days of discovering the loss unless the cause of loss is theft, diversion, or self-use in which case the report shall be made within 14 days of discovering the loss. If the remote dispensing site pharmacy is unable to identify the cause of the loss, the remote dispensing site pharmacy shall undertake further investigation to identify the cause of the loss and security improvements necessary to prevent any additional losses of controlled substances.
- Specifies that causes of overages shall be identified in writing and incorporated into the inventory reconciliation report.
- Requires that the inventory reconciliation report shall be dated and signed by the individual or individuals performing the inventory and countersigned by the pharmacist-in-charge of the remote dispensing site pharmacy. A countersignature shall not be required if the pharmacist-in-charge personally completed the inventory reconciliation report. The inventory reconciliation report shall be maintained in the remote dispensing site pharmacy for at least three years in a readily retrievable form.
- Requires a remote dispensing site pharmacy shall utilize an alarm or other comparable monitoring system to protect its equipment, records, and supply of drugs, devices, and other restricted sale items from unauthorized access, acquisition, or use.
- Specifies that unless a pharmacist is present at the remote dispensing site pharmacy, a remote dispensing site pharmacy shall not be open or its employees allowed access to it during times the supervising pharmacy is closed. The security system shall allow for tracking of entries into the remote dispensing site pharmacy and the pharmacist-in-charge shall periodically review the record of entries.
- Requires that the remote dispensing site pharmacy shall retain a recording of facility surveillance, excluding patient communications, for a minimum of 90 days.
- Makes findings and declarations.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
Purpose. This bill is sponsored by the author. According to the author, “A pharmacist is a critical member of a comprehensive healthcare team. However, there are approximately 115 designated communities in 47 California counties that do not have access to a pharmacist within 10 miles. For people living in these communities, visiting a pharmacist can mean up to a 90 mile drive. This is a significant barrier to accessing quality healthcare services. Authorizing remote dispensing pharmacies to operate throughout the state in these medically underserved communities provides opportunities for better patient education, increased medication adherence, and better health outcomes.”
Background. Pharmacist Practice and Regulation. Pharmacists are healthcare professionals who understand the biochemical mechanisms and actions of drugs, drug uses, therapeutic roles, side effects, potential drug interactions, and monitoring parameters. Pharmacists provide counseling on the appropriate use and effects of prescribed drugs. Pharmacists must obtain the Doctor of Pharmacy degree before they are eligible to sit for the North American Pharmacist Licensure Examination (NAPLEX) to enter into pharmacy practice (Accreditation Council for Pharmacy Education, Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree, 2011).
In 2014, the United States Bureau of Labor Statistics reported that there were 297,100 pharmacist jobs. The majority (65 percent) of those pharmacists work in retail settings, about 22 percent work in hospitals, and the remainder work in mail-order or Internet pharmacies, pharmaceutical wholesalers, physicians’ offices, and for the Federal Government (US Bureau of Labor Statistics. Occupational Outlook Handbook, 2010–11). In California, pharmacists are regulated by the State Board of Pharmacy. There are 42,691 pharmacists and 70,624 pharmacy technicians with active licenses in the state.
Regulation of Pharmacies. There are 7081 pharmacies regulated by the Board. Of these, 513 are hospital pharmacies. The Board reported it also regulates 506 non-resident pharmacies which are generally including mail order pharmacies. The board has additional licenses for those pharmacies that perform sterile compounding and are located in California (890) and ship into CA from another state (91). The Board does not currently regulate remote dispensing pharmacies.
Telehealth and Telepharmacy. In 2011, California passed the Telehealth Advancement Act. This Act updated the state's definition of telehealth, simplified approval processes for telehealth services, and expanded the range of medical services that may be provided via telehealth. The law establishes legal parity between the direct and remote delivery of pharmacy care.
Telepharmacy is the delivery of pharmaceutical care via telecommunications to patients in locations where they may not have direct contact with a pharmacist. Services may include drug therapy monitoring, patient counseling, authorization for prescription drugs, and monitoring of formulary compliance utilizing teleconferencing or videoconferencing. Telepharmacy may also include remote dispensing of medications by automated packaging and labeling systems.
Other States and Jurisdictions. Implementation of telepharmacy began in the 2000s in response to myriad factors including changes in Medicare reimbursement rates and the recession. The impact of these changes was a significant decline in independent pharmacies in rural areas. To date, 20 states have passed legislation to permit telepharmacy. North Dakota was the first state to implement telepharmacy regulations, and the United States Navy operates the largest telepharmacy program.
This measure would authorize the Board to issue remote dispensing pharmacy licenses for facilities that connect a licensed pharmacist to patients using a telepharmacy system. Approximately 115 underserved communities, as defined as having no pharmacist within a 10 mile radius, across 47 different counties would be eligible to receive services via this measure. The remote dispensing pharmacy would be staffed by a registered pharmacy technician, who meets additional training criteria, and would be supervised virtually by a licensed pharmacist at a separate location. The pharmacist-in-charge is required to be located at a traditional pharmacy within 150 miles and four hours of the remote dispensing pharmacy. This measure also establishes minimum standards for the remote dispensing location in order to ensure safety and quality control. These include standards for the telepharmacy technology, security requirements, and processes for ordering, stocking, and recording different types of drugs.
ARGUMENTS IN SUPPORT:
The California Pharmacists Association supports the bill and writes, “Through utilizing telepharmacy technology, pharmacists will be able to provide counseling to patients when they pick up their prescriptions at the remote dispensing pharmacy in medically underserved areas. The ability for patients to access the services of a community pharmacy is essential in ensuring continuity of care and adherence to directions given by prescribing physicians.”
Cardinal Health writes in their letter of support, “Access to prescription medications and pharmacist consultations in settings that are convenient to California citizens will improve healthcare for your constituents. Cardinal Health is committed to supporting thoughtful land effective legislation that aligns with our mission of making healthcare safer and more cost effective.”
REGISTERED SUPPORT:
California Pharmacists Association
Cardinal Health
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Le Ondra Clark Harvey, Ph.D. / B. & P. / (916) 319-3301
Discussed in Hearing
1MIN
Assembly Floor
4MIN
Senate Floor
1H
Senate Standing Committee on Appropriations
11MIN
Senate Standing Committee on Business, Professions and Economic Development
1MIN
Assembly Floor
1H
Assembly Standing Committee on Appropriations
6MIN
Assembly Standing Committee on Business and Professions
Bill Author
Bill Co-Author(s):