Existing law, the Pharmacy Law, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances. A knowing violation of the Pharmacy Law is a crime.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the patient under specified circumstances. The bill would authorize an intern pharmacist or a pharmacy technician to perform the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to establish criteria regarding who is a high-risk patient for purposes of the bills provisions, and determine a timeframe for completion of the medication profile or list, based on the populations served by the hospital. The bill would exclude the State Department of State Hospitals from the bills provisions.

By placing new requirements on a pharmacist, this bill would expand the scope of an existing crime and would, therefore, impose 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, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances. A knowing violation of the Pharmacy Law is a crime.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the patient under specified circumstances. The bill would authorize an intern pharmacist or a pharmacy technician to perform the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to establish criteria regarding who is a high-risk patient for purposes of the bills provisions, and determine a timeframe for completion of the medication profile or list, based on the populations served by the hospital. The bill would exclude the State Department of State Hospitals from the bills provisions.

By placing new requirements on a pharmacist, this bill would expand the scope of an existing crime and would, therefore, impose 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, a willful violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the patient under specified circumstances. The bill would authorize an intern pharmacist or a pharmacy technician to perform the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to establish criteria regarding who is a high-risk patient for purposes of the bills provisions, and determine a timeframe for completion of the medication profile or list, based on the populations served by the hospital. The bill would exclude the State Department of State Hospitals from the bills provisions.

By placing new requirements on a pharmacist, this bill would expand the scope of an existing crime and would, therefore, impose 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, a willful violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the patient under specified circumstances. The bill would authorize an intern pharmacist or a pharmacy technician to perform the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to determine what constitutes establish criteria regarding who is a high-risk patient for purposes of the bills provisions provisions, and determine a timeframe for completion of the medication profile or list, based on the populations served by the hospital. The bill would exclude the State Department of State Hospitals from the bills provisions.

By placing new requirements on a pharmacist, this bill would expand the scope of an existing crime and would, therefore, impose 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, a willful violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the patient under specified circumstances. The bill would authorize an intern pharmacist or a pharmacy technician to perform the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to determine what constitutes a high-risk patient for purposes of the bills provisions based on the populations served by the hospital.

By placing new requirements on a pharmacist, this bill would expand the scope of an existing crime and would, therefore, impose 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, a willful violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the patient under specified circumstances. The bill would authorize an intern pharmacist or a pharmacy technician to perform the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to determine what constitutes a high-risk patient for purposes of the bills provisions based on the populations served by the hospital.

By placing new requirements on a pharmacist, this bill would expand the scope of an existing crime and would, therefore, impose 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, a willful violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission and discharge of the patient. patient under specified circumstances. The bill would authorize an intern pharmacist or a pharmacy technician to perform the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to determine what constitutes a high-risk patient for purposes of the bills provisions based on the populations served by the hospital.

By placing new requirements on a pharmacist, this bill would expand the scope of an existing crime and would, therefore, impose 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, a willful violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission and discharge of the patient. The bill would authorize an intern pharmacist or a pharmacy technician to perform that function if the intern pharmacist or pharmacy technician has successfully completed training and proctoring by a pharmacist and where a quality assurance program is used to monitor competency. The bill would require the board to adopt regulations specifying the training and proctoring required to be completed. the task of obtaining an accurate medication profile or list for a high-risk patient if certain conditions are satisfied. The bill would require the hospital to determine what constitutes a high-risk patient for purposes of the bills provisions based on the populations served by the hospital.

By expanding placing new requirements on a pharmacist, this bill would expand the scope of a crime, the bill would an existing crime and would, therefore, impose 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, a willful violation of which is a misdemeanor, provides for the licensure and regulation of pharmacists, intern pharmacists, pharmacy technicians, and pharmacies by the California State Board of Pharmacy. Existing regulatory law requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled at that pharmacy, except under specified circumstances.

This bill would require a pharmacist at a hospital pharmacy to obtain an accurate medication profile for each high-risk patient upon admission and discharge of the patient. The bill would authorize an intern pharmacist or a pharmacy technician to perform that function if the intern pharmacist or pharmacy technician has successfully completed training and proctoring by a pharmacist and where a quality assurance program is used to monitor competency. The bill would require the board to adopt regulations specifying the training and proctoring required to be completed.

By expanding the scope of a crime, the bill would impose 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.

 UNFINISHED BUSINESS  

Bill No: SB 1254

Author:

:

Vote:

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/23/18

AYES: Hill, Fuller, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/22/18

AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener

SENATE FLOOR: 38-0, 5/29/18

AYES: Allen, Anderson, Atkins, Bates, Beall, Bradford, Cannella, De León, Dodd, Fuller, Gaines, Galgiani, Glazer, Hernandez, Hertzberg, Hill, Hueso, Jackson, Lara, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Newman, Nguyen, Nielsen, Pan, Portantino, Roth, Skinner, Stern, Stone, Vidak, Wieckowski, Wiener, Wilk

NO VOTE RECORDED: Berryhill

ASSEMBLY FLOOR: 75-0, 8/23/18 (Consent) - See last page for vote

SUBJECT:

SOURCE: Author

DIGEST:

This bill requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient.

Assembly Amendments

clarify the participation and responsibility of pharmacy technicians in obtaining accurate medication profiles or lists as specified; allow hospitals to determine the timeframe for completion of the medication profile or list; exempts the State Department of State Hospitals from the requirements of this measure; and clarify that the requirements under this measure shall not be construed to prohibit other healing arts licensees as specified from obtaining an accurate medication profile or list.

ANALYSIS:

Existing law:

1. Establishes the Board of Pharmacy (Board) to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001
2. Authorizes the Board to adopt rules and regulations as may be necessary for the protection of the public. (BPC § 4005)
3. Defines “hospital pharmacy” as a pharmacy, licensed by the Board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay. (BPC § 4029)
4. Defines “pharmacist” as a natural person to whom a license has been issued by the Board which is required for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription. (BPC § 4036; BPC § 4051)
5. Establishes a corresponding responsibility for licensed pharmacists to protect their patients when dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices, or the provision of services. (BPC § 4306.5)
6. Defines “Pharmacy technician” as an individual who assists a pharmacist in a pharmacy in the performance of his or her pharmacy related duties. (BPC § 4038)
7. 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; holds the pharmacist responsible for the duties performed under his or her supervision by a technician. (BPC § 4115(a))
8. Authorizes an intern pharmacist to perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the Board.
9. Limits a pharmacy with only one pharmacist to no more than one pharmacy technician, and states that the total ratio of pharmacy technicians to any additional pharmacist shall not exceed 2:1. (BPC § 4115(f))
10. Requires every pharmacy to establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. (BPC § 4125)
11. Requires a health facility to establish and implement a written policy to ensure that each patient receives information regarding each drug given at the time of discharge, including the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions.
    (BPC § 4074)
12. Requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy. (California Code of Regulations (CCR) Title 16 Section 1707.1(a))

This bill:

1. Requires a hospital pharmacist to obtain an accurate medication profile or list, upon admittance of a high-risk patient, under the following conditions:
   1. The hospital has more than 100 beds; and,
   2. The accurate medication profile or list can be acquired by the pharmacist during the hospital pharmacy's hours of operation.
2. Allows a pharmacy technician or an intern pharmacist to perform the task of obtaining an accurate medication profile or list for a high-risk patient if both of the following conditions are satisfied:
   1. The hospital pharmacy has a quality assurance program to monitor competency; and,
   2. The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed that training and proctoring.
3. Requires the hospital to establish criteria regarding who is a high-risk patient for purposes of this bill, and to determine the timeframe for completion of the medication profile or list, based on the patient populations served by the hospital.
4. Authorizes the Board of Pharmacy (Board) to adopt rules and regulations to carry out the purposes of this bill.
5. Specifies that the provisions of this bill do not apply to the Department of State Hospitals.
6. Provides that the requirements under this measure shall not be construed to prohibit a healing arts licensee as specified from obtaining an accurate medication profile or list.

Background

According to the author, it is startling that up to 70% of patients have errors on their medication lists upon admission to a hospital and up to 59% of these errors have the potential to cause moderate to severe harm. The Author states that currently, there is a lack of oversight for ensuring that such medical lists are accurate upon hospital admission. This lack of defined responsibility results in errors in the list and errors in medication orders when patients are in the hospital and ultimately when they are discharged. This leads to significant harm to the patient and studies have shown that this problem also costs billions of dollars due to medication-related readmissions and adverse drug events. The author contends that high risk patients such as those that are elderly, those with multiple chronic diseases and/or receiving multiple medications are at a higher probability of having errors on their admission medication lists at an average of eight errors per patient. The author points to one study that shows that only 5.3% of patients 65 years or older that are on five or more mediations had an accurate list. The author concludes that this bill will better ensure the accuracy of a patient medication profile is at admission, thereby potentially stopping any errors, which will enhance patient safety and reduce physician and hospital liability, including after the patient’s discharge.

Existing law and current Board regulations require pharmacies to maintain medication profiles for all patients who have prescriptions filled in that pharmacy. Current medication profile information to be listed includes the patient's full name and address, telephone number, date of birth or age and gender. For each prescription dispensed by the pharmacy, information includes the name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed; the prescriber's name and where appropriate, license number, federal Drug Enforcement Agency registration number or other unique identifier, the date on which a drug was dispensed or refilled, the prescription number for each prescription, and other information as specified pursuant to regulations of the Board.

Medication profiles must include any of the following which may relate to drug therapy: patient allergies; idiosyncrasies; current medications and relevant prior medications including nonprescription medications and relevant devices; or, medical conditions which are communicated by the patient or the patient's agent; as well as any other information which the pharmacist, their professional judgment, deems appropriate.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

According to the Assembly Appropriations Committee:

1. Minor and absorbable costs to the Board of Pharmacy for compliance inspections and addressing violations (Pharmacy Board Contingent Fund).
2. One-time minor and absorbable information technology costs to the Department of Consumer Affairs for the creation of new enforcement codes (Pharmacy Board Contingent Fund).

SUPPORT: (Verified 8/23/18)

California Hospital Association

California State Board of Pharmacy

Cedars-Sinai

The Pharmacy Group

OPPOSITION: (Verified 8/23/18)

None received

ARGUMENTS IN SUPPORT: The California Hospital Association states that pharmacists presently maintain and monitor inpatient medication profiles, and that research shows that patients who the hospital determines to be high-risk can benefit from a pharmacist or pharmacists technician compiling a list of mediations the patient is taking upon admission, because it will assist in decreasing adverse drug events upon hospital admission and during hospitalization. Cedars-Sinai states that 20% of admissions are medication related and medication errors can lead to significant morbidity and mortality. Cedars-Sinai concludes that having an accurate medication list is essential.

The California State Board of Pharmacy (BOP) indicates that currently the task of obtaining a medication profile for patients can be performed by a variety of staff, many of whom may not have the foundational pharmacy knowledge to adequately collect such information. The BOP asserts that this bill will ensure more accurate medication information is available to health care providers providing treatment to patients. The BOP believes that pharmacy staff are the most suitable to perform this task and as such supports efforts to implement this important measure.

ASSEMBLY FLOOR: 75-0, 8/23/18

AYES: Acosta, Aguiar-Curry, Arambula, Baker, Berman, Bigelow, Bloom, Bonta, Brough, Burke, Caballero, Calderon, Carrillo, Cervantes, Chau, Chávez, Chen, Chiu, Choi, Chu, Cooley, Cooper, Dahle, Daly, Eggman, Flora, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo Garcia, Gipson, Gloria, Gonzalez Fletcher, Gray, Grayson, Harper, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Maienschein, Mathis, Mayes, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Quirk, Quirk-Silva, Reyes, Rivas, Rodriguez, Rubio, Salas, Santiago, Steinorth, Mark Stone, Ting, Voepel, Waldron, Weber, Wood, Rendon

NO VOTE RECORDED: Travis Allen, Cunningham, Low, McCarty, Thurmond

Prepared by:

8/23/18 17:08:41

**** END ****

Date of Hearing: August 15, 2018

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez Fletcher, Chair

SBPCA Bill Id:SB 1254

Author:(Stone) – As Amended Ver:June 28, 2018

Urgency: No State Mandated Local Program: Yes Reimbursable: No

SUMMARY:

This bill requires a hospital pharmacist to obtain an accurate medication profile or list for each high-risk patient. Specifically, this bill:

1. Requires a hospital pharmacist to obtain an accurate medication profile or list, upon admittance of a high-risk patient, if the hospital has more than 100 beds and the medication profile or list can be acquired by the pharmacist during the hospital pharmacy's hours of operation.
2. Allows a pharmacy technician or an intern pharmacist to obtain an accurate medication profile or list for a high-risk patient if both of the following conditions are satisfied:
   1. The hospital pharmacy has a quality assurance program to monitor competency.
   2. The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed that training and proctoring.
3. Requires a hospital to establish criteria regarding who is a high-risk patient for purposes of this section based on the patient populations served by the hospital.

FISCAL EFFECT:

1. Minor and absorbable costs to the Board of Pharmacy for compliance inspections and addressing violations (Pharmacy Board Contingent Fund).
2. One-time minor and absorbable information technology costs to the Department of Consumer Affairs for the creation of new enforcement codes (Pharmacy Board Contingent Fund).

COMMENTS:

1. Purpose. This bill seeks to improve hospital patient safety for high-risk patients by reducing adverse drug events. According to the author, high-risk patients such as those that are elderly, those with multiple chronic diseases and/or receiving multiple medications are at a higher probability of having errors on their admission medication lists at an average of eight errors per patient. This bill will better ensure the accuracy of what a patient medication profile is at admission, thereby potentially stopping any errors, which will enhance patient safety and reduce physician and hospital liability, including after the patient’s discharge.
2. Background. Existing law and regulations requires all pharmacies to maintain medication profiles for all patients who have prescriptions filled in that pharmacy. The information listed on a medication profile includes all of the following that apply:
3. The patient’s full name and address, telephone number, date of birth or age, and gender.
4. The name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed.
5. The prescriber’s name and license number and Drug Enforcement Agency registration number or other unique identifier.
6. The date on which a drug was dispensed or refilled.
7. The prescription number for each prescription.
8. Patient allergies, idiosyncrasies, current medications, and relevant prior medications including nonprescription medications and relevant devices, or medical conditions which are communicated by the patient or the patient's agent.
9. Any other information which the pharmacist, their professional judgment, deems appropriate.

This bill seeks to help avoid medical errors by requiring a pharmacist at a hospital to obtain the medication profile for their high-risk patients.

1. Support. The California Hospital Association states research shows patients who the hospital determines to be high-risk can benefit from a pharmacist or pharmacists technician compiling a list of mediations the patient is taking upon admission, because it will assist in decreasing adverse drug events upon hospital admission and during hospitalization.
2. Opposition. The California Chapter of the American College of Emergency Physicians states that requiring a pharmacist to obtain a medication profile when a patient is admitted will slow hospital throughput and delay patients from receiving necessary treatment. The United Nurses Associations of California/Union of Health Care Professionals states that this bill does not define "high-risk" patient and fails to define "accurate medication profile."

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: June 26, 2018

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SB 1254

Author:(Stone) – As Amended Ver:June 21, 2018

SENATE VOTE: 38-0

SUBJECT: Hospital pharmacies: medication profiles or lists for high-risk patients.

SUMMARY: Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient. Specifically, this bill:

1. Requires a hospital pharmacist to obtain an accurate medication profile or list, upon admittance of a high-risk patient, under the following conditions:
   1. The hospital has more than 100 beds; and,
   2. The accurate medication profile or list can be acquired by the pharmacist during the hospital pharmacy's hours of operation.
2. Allows a pharmacy technician or an intern pharmacist to perform the task of obtaining an accurate medication profile or list for a high-risk patient if both of the following conditions are satisfied:
   1. The hospital pharmacy has a quality assurance program to monitor competency; and,
   2. The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed that training and proctoring.
3. Requires the hospital to establish criteria regarding who is a high-risk patient for purposes of this bill, and to determine the timeframe for completion of the medication profile or list, based on the patient populations served by the hospital.
4. Authorizes the Board of Pharmacy (Board) to adopt rules and regulations to carry out the purposes of this bill.
5. Specifies that the provisions of this bill do not apply to the Department of State Hospitals.

EXISTING LAW:

1. Establishes the Board to license pharmacists and administer and regulate the Pharmacy Law, and authorizes the Board to adopt rules and regulations as may be necessary for the protection of the public.
2. Defines “hospital pharmacy” as a pharmacy, licensed by the Board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay.
3. Defines “pharmacist” as a natural person to whom a license has been issued by the Board which is required for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription. Requires licensed pharmacists to protect their patients when dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices, or the provision of services.
4. Defines “pharmacy technician” as an individual who assists a pharmacist in a pharmacy in the performance of his or her pharmacy related duties, and authorizes a pharmacy technician to perform packaging, manipulative, repetitive, or other nondiscretionary tasks only while assisting, and under the direct supervision and control of, a pharmacist
5. Authorizes an intern pharmacist to perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the Board.
6. Limits a pharmacy with only one pharmacist to no more than one pharmacy technician (1:1), and states that the total ratio of pharmacy technicians to any additional pharmacist cannot exceed 2:1.
7. Requires every pharmacy to establish a quality assurance program to, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel.
8. Requires a health facility to establish and implement a written policy to ensure that each patient receives information regarding each drug given at the time of discharge, including the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions.
9. Requires pharmacies, through regulations, to maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy.

FISCAL EFFECT: According to the Senate Appropriations Committee:

1. The Board notes minor and absorbable costs as they would inspect facilities for compliance during existing inspections. Any additional workload created by violations of the provisions in this bill would also be considered minor and absorbable.
2. Potential cost pressures related to information technology (IT) development and programming. The Department of Consumer Affairs’ Office of Information Services has identified a one-time cost of $2,500 for the creation of new enforcement codes which can be absorbed through the redirection of existing maintenance resources. The projected cost assumes five new codes without programming logic. If additional programming logic is required, the cost would increase.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, it is startling that up to 70% of patients have errors on their medication lists upon admission to a hospital and up to 59% of these errors have the potential to cause moderate to severe harm. The author states that currently, there is a lack of oversight for ensuring that such medical lists are accurate upon hospital admission. This lack of defined responsibility results in errors in the list and errors in medication orders when patients are in the hospital and ultimately when they are discharged. This leads to significant harm to the patient and studies have shown that this problem also costs billions of dollars due to medication-related readmissions and adverse drug events. The author contends that high risk patients such as those that are elderly, those with multiple chronic diseases and/or receiving multiple medications are at a higher probability of having errors on their admission medication lists at an average of eight errors per patient. The author points to one study that shows that only 5.3% of patients 65 years or older that are on five or more mediations had an accurate list. The author concludes that this bill will better ensure the accuracy of a patient medication profile is at admission, thereby potentially stopping any errors, which will enhance patient safety and reduce physician and hospital liability, including after the patient’s discharge.
2. BACKGROUND. Existing law and current Board regulations require pharmacies to maintain medication profiles for all patients who have prescriptions filled in that pharmacy. Current medication profile information to be listed includes the patient's full name and address, telephone number, date of birth or age and gender. For each prescription dispensed by the pharmacy, information includes the name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed; the prescriber's name and where appropriate, license number, federal Drug Enforcement Agency registration number or other unique identifier, the date on which a drug was dispensed or refilled, the prescription number for each prescription, and other information as specified pursuant to regulations of the Board.
   
   Medication profiles must include any of the following which may relate to drug therapy: patient allergies; idiosyncrasies; current medications and relevant prior medications including nonprescription medications and relevant devices; or, medical conditions which are communicated by the patient or the patient's agent; as well as any other information which the pharmacist, their professional judgment, deems appropriate.
3. SUPPORT. The California Hospital Association states that pharmacists presently maintain and monitor inpatient medication profiles, and that research shows that patients who the hospital determines to be high-risk can benefit from a pharmacist or pharmacists technician compiling a list of mediations the patient is taking upon admission, because it will assist in decreasing adverse drug events upon hospital admission and during hospitalization. Cedars-Sinai states that 20% of admissions are medication related and medication errors can lead to significant morbidity and mortality. Cedars-Sinai concludes that having an accurate medication list is essential.
4. OPPOSITION. The California Chapter of the American College of Emergency Physicians (California ACEP) notes that emergency physicians understand the complex issues that can arise when a provider is not properly informed of a patient's complete medication profile. California ACEP states that requiring a pharmacist to obtain a medication profile when a patient is admitted will slow hospital through-put and delay patients from receiving necessary treatment. The United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP) states that this bill does not define "high-risk" patient and fails to define "accurate medication profile." UNAC/UHCP concludes that as a result, the medication profile will likely not be accurate at all and thus will not result in any appreciable improvement in patient care.
5. RELATED LEGISLATION.
   1. AB 2859 (Caballero) would require community pharmacies to display safe storage products for sale in a place close to the pharmacy. AB 2859 is pending in the Senate Business, Professions and Economic Development Committee.
      
   2. AB 2789 (Wood) would require that prescriptions be submitted electronically, with exceptions. AB 2789 is pending in the Senate Appropriations Committee.
      
   3. SB 1286 (Pan) of 2018 would have increased the pharmacist/pharmacy technician ratio from 1:1 to 1:4. SB 1286 did not receive a hearing in the Senate Business, Professions and Economic Development Committee.
   4. SB 1264 (Stone) requires Medi-Cal to cover hypertension medication management services provided by a pharmacist or advanced practice pharmacist. SB 1264 is pending in the Assembly Appropriations Committee.
6. PREVIOUS LEGISLATION. AB 1859 (Bocanegra) of 2017 would have increased the pharmacist/pharmacy technician ratio from 1:1 to 1:4. AB 1859 did not receive a hearing in the Assembly Appropriations Committee.
7. DOUBLE REFERRAL. This bill is double referred; it passed the Assembly Committee on Business and Professions on June 19, 2018 on a vote of 17-0.
8. SUGGESTED AMENDMENT. As currently drafted this bill appears to limit the task of obtaining medication profiles to pharmacists. The Committee may wish to amend this bill to clarify that nothing in this section shall prohibit a qualified health care professional from obtaining an accurate medication profile as described in subdivision (a).

REGISTERED SUPPORT / OPPOSITION:

Support

California Hospital Association
Cedars-Sinai
The Pharmacy Group

Opposition

California Chapter of the American College of Emergency Physicians
United Nurses Associations of California/Union of Health Care Professionals

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097

Date of Hearing:

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

SBPCA Bill Id:

Author:() – As Ver:

SENATE VOTE:

SUBJECT:

SUMMARY: Requires a hospital pharmacist to obtain an accurate medication profile or list for each high-risk patient upon admission of the high-risk patient, under certain conditions.

EXISTING LAW:

1. Establishes the Board of Pharmacy (Board) to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Authorizes the Board to adopt rules and regulations as may be necessary for the protection of the public. (BPC § 4005)
3. Defines “hospital pharmacy” as a pharmacy, licensed by the Board, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay. (BPC § 4029)
4. Defines “pharmacist” as a natural person to whom a license has been issued by the Board which is required for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription. (BPC § 4036; BPC § 4051)
5. Establishes a corresponding responsibility for licensed pharmacists to protect their patients when dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices, or the provision of services. (BPC § 4306.5)
6. Defines “Pharmacy technician” as an individual who assists a pharmacist in a pharmacy in the performance of his or her pharmacy related duties. (BPC § 4038)
7. 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; holds the pharmacist responsible for the duties performed under his or her supervision by a technician. (BPC § 4115(a))
8. Authorizes an intern pharmacist to perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the Board.
9. Limits a pharmacy with only one pharmacist to no more than one pharmacy technician, and states that the total ratio of pharmacy technicians to any additional pharmacist shall not exceed 2:1. (BPC § 4115(f))
10. Requires every pharmacy to establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. (BPC § 4125)
11. Requires a health facility to establish and implement a written policy to ensure that each patient receives information regarding each drug given at the time of discharge, including the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. (BPC § 4074)
12. Requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy. (California Code of Regulations (CCR) Title 16 Section 1707.1(a))

THIS BILL:

1. Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the high-risk patient under the following conditions:
   1. The hospital has more than 100 beds.
   2. The accurate medication profile or list may be acquired by the pharmacist during the hospital pharmacy’s hours of operation.
2. Authorizes a pharmacy technician or an intern pharmacist to perform the task of obtaining an accurate medication profile or list for a high-risk patient if both of the following conditions are satisfied:
   1. The hospital pharmacy has a quality assurance program to monitor competency.
   2. The hospital has established policies and procedures for training and proctoring pharmacy technicians or intern pharmacists by the hospital pharmacy department and the pharmacy technician or intern pharmacist has completed that training and proctoring.
3. Requires a hospital to establish criteria regarding who is a high-risk patient for purposes of this section based on the patient populations served by the hospital.
4. Expressly authorizes the Board to adopt rules and regulations to carry out the purposes and objectives of the bill.

FISCAL EFFECT: According to the Senate Committee on Appropriations, minor and absorbable costs to the Board and potential cost pressures to the Department of Consumer Affairs for o information technology development and programming estimated at $2,500.

COMMENTS:

Purpose. This bill is sponsored by the author. According to the author:

It’s startling that up to 70% of patients have errors on their medication lists upon admission to a hospital and up to 59% of these errors have the potential to cause moderate to severe harm.

Currently, there is a lack of oversite for ensuring that such medical lists are accurate upon hospital admission. This lack of defined responsibility results in errors in the list and errors in medication orders when patients are in the hospital and ultimately when they are discharged. This leads to significant harm to the patient and studies have shown that this problem also costs billions of dollars due to medication-related readmissions and adverse drug events.

High risk patients such as those that are elderly, those with multiple chronic diseases and/or receiving multiple medications are at a higher probability of having errors on their admission medication lists at an average of 8 errors per patient. One study shows that only 5.3% of patients 65 years or older that are on five or mediations had an accurate list – that’s 94.7% that were not accurate. This bill will better ensure the accuracy of what a patient medication profile is at admission, thereby potentially stopping any errors, which will enhance patient safety and reduce physician and hospital liability, including after the patient’s discharge.

Background. Under current law, all pharmacies are required to maintain medication profiles for all patients who have prescriptions filled in that pharmacy. The information listed on a medication profile includes all of the following that apply:

1. The patient’s full name and address, telephone number, date of birth or age, and gender;
2. The name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed;
3. The prescriber’s name and license number and Drug Enforcement Agency registration number or other unique identifier;
4. The date on which a drug was dispensed or refilled;
5. The prescription number for each prescription;
6. Patient allergies, idiosyncrasies, current medications and relevant prior medications including nonprescription medications and relevant devices, or medical conditions which are communicated by the patient or the patient's agent;
7. Any other information which the pharmacist, their professional judgment, deems appropriate.

This bill seeks to help avoid medical errors and empower a pharmacist to carry out his or her corresponding responsibility by requiring a pharmacist at a hospital to obtain the medication profile for his or her high-risk patients. This information would improve a pharmacist’s ability to make dispensing decisions for patients who may be at risk for receiving inappropriate medication. The bill aims to narrow which pharmacists must comply with the bill, and would clarify the ability of pharmacy technicians and intern pharmacists to obtain the profile or list on behalf of a pharmacist.

Current Related Legislation. AB 2859 (Caballero) would require community pharmacies to display safe storage products for sale in a place close to the pharmacy. This bill is pending in the Senate Business, Professions and Economic Development Committee.

AB 2789 (Wood) would require that prescriptions be submitted electronically, with exceptions. This bill is pending in the Senate Business, Professions and Economic Development Committee.

SB 1286 (Pan) of 2018 would have increased the pharmacist/pharmacy technician ratio from 1:1 to 1:4. This bill did not receive a hearing in the Senate Business, Professions and Economic Development Committee.

Prior Related Legislation. AB 1859 (Bocanegra) of 2017 would have increased the pharmacist/pharmacy technician ratio from 1:1 to 1:4. This bill did not receive a hearing in the Assembly Appropriations Committee.

ARGUMENTS IN SUPPORT:

The California Hospital Association (CHA) supports this bill. CHA explains that “adverse drug events account for an estimated one in three of all hospital adverse events, affects about 2 million hospital stays each year, and prolong hospital stays by 1.7 to 4.6 days.” While CHA states that hospitals “strive to find ways to reduce these largely preventable events to improve patient quality and safety, reduce health care costs, engage consumers, and improve health care outcomes,” this can be difficult with high-risk patients who are often those “with chronic diseases who take multiple medications.” CHA argues that requiring a pharmacist to obtain a medication profile “would assist in decreasing adverse drug events upon hospital admission and during hospitalization.”

ARGUMENTS IN OPPOSITION:

The California Chapter of the American College of Emergency Physicians (California ACEP) opposes the bill. California ACEP agrees that “medication profiles are a valuable tool to ensuring a safe handoff for patients as they transition between levels of care.” However, California ACEP states that “by limiting the providers who can create a medication profile, the bill will slow down the admissions process and place additional stress on California’s overcrowded emergency departments.” California ACEP plans to work with the author to resolve these concerns in a subsequent committee.

IMPLEMENTATION ISSUES:

Many of the terms used in this bill’s provisions are undefined and could lead to ambiguity and inconsistent interpretation by hospitals. For example, the bill employs use of the term “high-risk” to describe patients whose medication profile must be obtained; however, this term does not have a statutory meaning and is instead expressly left to each hospital to decide what criteria would make a patient “high-risk.” Meanwhile, hospitals do not currently have the ability to determine when a medication profile or list must be completed. There is also uncertainty as to what constitutes an “accurate medication profile” for purposes of the bill. While the Board could potentially promulgate regulations under the bill to clarify this point, until it does, some hospitals may have difficulty complying with the law. The author should work with stakeholders to ensure that while an appropriate level of discretion is provided to hospitals impacted by the bill, further clarity is added to the language in the bill to resolve any unnecessary ambiguities.

In addition, the bill refers broadly to hospital pharmacies, which could be interpreted to fall into a relatively extensive definition. This would include facilities managed by the Department of State Hospitals, who already provide pharmacists with extensive profiles on patients referred by the courts. The bill should be amended to clarify that these entities do not apply under the bill.

AMENDMENTS:

1. To provide hospitals with the authority to determine when a medication profile or list must be completed:

Amend (c) of Section 1 to insert:

… and shall determine the timeframe for completion of the medication profile or list.

1. To exempt facilities operated by the Department of State Hospitals from the bill:

Add a subdivision (e) to Section 1 stating:

This section shall not apply to the Department of State Hospitals.

REGISTERED SUPPORT:

California Hospital Association
California Life Sciences Association

REGISTERED OPPOSITION:

California Chapter of the American College of Emergency Physicians

Analysis Prepared by: Robert Sumner / B. & P. / (916) 319-3301

 THIRD READING  

Bill No: SB 1254

Author:

:

Vote:

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/23/18

AYES: Hill, Fuller, Dodd, Galgiani, Glazer, Hernandez, Newman, Pan, Wilk

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/22/18

AYES: Lara, Bates, Beall, Bradford, Hill, Nielsen, Wiener

SUBJECT:

SOURCE: Author

DIGEST:

This bill requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile, or list, for each high-risk patient upon admission if specific conditions are met and authorizes an intern pharmacist or a pharmacy technician to perform this task if certain conditions are satisfied. Provides that the Board of Pharmacy may adopt rules and regulations to carry out the purposes and objectives of this bill.

ANALYSIS:

Existing law:

1. Establishes the Board of Pharmacy (BOP) to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Grants the BOP the authority to adopt rules and regulations, not inconsistent with the laws of California, as may be necessary for the protection of the public pertaining to the practice of pharmacy; pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed; and providing for standards of minimum equipment for licensed establishments. (BPC § 4005(a))
   
3. Defines a “hospital pharmacy” to mean a pharmacy licensed by the BOP located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illness for which persons may be admitted for overnight stay and that meets all the requirements and rules and regulations of the BOP. (BPC § 4029)
   
4. Defines a “pharmacy technician (PT)” as an individual who assists a pharmacist in a pharmacy in the performance of his or her related duties, as specified. The pharmacist shall be responsible for the duties performed under his or her supervision by a PT. (BPC §§ 4038, 4115)
   
5. Authorizes the BOP to issue an intern pharmacist (IP) license to an individual currently enrolled in a pharmacy school, an individual who has graduated from pharmacy school and who has applied to become a licensed pharmacist, or a foreign graduate pharmacy student, as specified. Provides that an IP may perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist. (BPC §§ 4114, 4030)
6. Authorizes an advanced practice pharmacist (APP), as part of the care provided by a health care facility, in accordance with the policies, procedures, or protocols of that facility, initiate or adjust the drug regimen of a patient pursuant to a specific written order or authorization made by the individual patient’s treating prescriber, and accordance with the policies, procedures, or protocols of the health care facility. (BPC § 4052.2)
   
7. Requires a health facility to establish and implement a written policy to ensure that each patient shall receive information regarding each drug given at the time of discharge. This information shall include the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. This information shall be given by a pharmacist or registered nurse or the prescriber. (BPC § 4074 (e))
   
8. Requires every pharmacy to establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. The purpose of the quality assurance program shall be to assess errors that occur in the pharmacy in dispensing or furnishing prescription medications so that the pharmacy may take appropriate action to prevent a recurrence. (BPC § 4125)
9. Requires that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (Health and Safety Code § 11153)
10. Requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy. (California Code of Regulations (CCR) Title 16 Section 1707.1(a))
11. Requires a patient medication record to be maintained in an automated data processing or manual record mode such that specified information is readily retrievable during the pharmacy's normal operating hours. (CCR Title 16 Section 1707.1(a)(1))
    
12. Requires the patient medication record to be maintained for at least one year from the date when the last prescription was filled. (CCR Title 16 Section 1707.1(a)(2))

This bill:

1. Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the high-risk patient under the following conditions:
   
   1. The hospital has more than 100 beds.
      
   2. The medication profiles are acquired during the hospital pharmacy’s hours of operation.
2. Permits a PT or an intern pharmacist to perform the task of obtaining an accurate medication profile or list for a high-risk patient if the PT or intern pharmacist has been trained by the hospital pharmacy department and if the following conditions are satisfied:
   
   1. The hospital pharmacy has a quality assurance program, which is under the direction of the pharmacist-in-charge, to monitor competency.
      
   2. The hospital has established policies and procedures for training and proctoring PTs or intern pharmacists and the PT or intern pharmacist has completed that training and proctoring.
      
   3. Trained pharmacy technicians responsible for obtaining medications lists would not be included in the hospital required pharmacist to technician ratio.
3. Requires the hospital to establish criteria regarding who is a high-risk patient based on the patient populations served by the hospital.
4. Provides that the BOP may adopt rules and regulations to carry out the purposes and objectives of this measure.

Background

As indicated by the author, “[C]urrently medication lists are obtained by a variety of individuals with varying knowledge about medications including medical assistants in doctors’ offices and busy clinicians in hospitals who are focused on immediate patient care needs. Under current law, there is no requirement specifying what a hospital pharmacy must obtain when high-risk patients are admitted and discharged regarding their medication profile.” The Author states that “There is a lack of defined responsibility to ensure medication lists are accurately obtained at hospital admission and discharge which puts patients at significant risk for harm and readmissions, which this bill aims to remedy.”

Duty to Maintain Medication Profiles (Patient Medication Records). Under current BOP regulations, pharmacies are required to maintain medication profiles for all patients who have prescriptions filled in that pharmacy. The information required to be listed on this medication profile includes the patient's full name and address, telephone number, date of birth or age and gender. For each prescription dispensed by the pharmacy, information includes the name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed; the prescriber's name and where appropriate, license number, Drug Enforcement Agency registration number or other unique identifier; the date on which a drug was dispensed or refilled; the prescription number for each prescription; and other information as specified pursuant to regulations of the BOP.


Medication profiles must include any of the following which may relate to drug therapy: patient allergies, idiosyncrasies, current medications and relevant prior medications including nonprescription medications and relevant devices, or medical conditions which are communicated by the patient or the patient's agent; as well as any other information which the pharmacist, their professional judgment, deems appropriate.

Training and Proctoring of Pharmacy Technicians and Interns. An “intern pharmacist” is authorized to perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the BOP. "Direct supervision and control" means that a pharmacist is on the premises at all times and is fully aware of all activities performed by either a pharmacy technician or intern pharmacist. At the discretion of the BOP, an intern pharmacist license may be issued for a period of one to six years to a person who is currently enrolled in a school of pharmacy recognized by the BOP; two years to a person who is a graduate of a school of pharmacy recognized by the BOP and who has applied to become licensed as a pharmacist in California; two years to a foreign graduate who has met specified educational requirements; one year to a person who has failed the pharmacist licensure examination four times and has reenrolled in a school of pharmacy to satisfy specified requirements. The BOP may issue an intern pharmacist license to an individual for the period of time specified in a decision of reinstatement adopted by the BOP.

Before applying for the pharmacist licensure examination, an intern pharmacist is required to complete 1,500 hours of pharmacy practice experience. This pharmacy practice experience must comply with the Standards of Curriculum established by the Accreditation Council for Pharmacy Education (ACPE) or with regulations adopted by the BOP. This pharmacy practice experience must include 900 hours of pharmacy practice experience in a pharmacy as a pharmacist and shall include pharmacy practice experience in both a community and institutional pharmacy practice setting. Certification of an applicant’s licensure in another state shall be submitted in writing and signed, under oath, by a duly authorized official of the state in which the license is held. An applicant for the examination who has graduated after January 1, 2016, from an ACPE accredited college of pharmacy or school of pharmacy recognized by the board shall be deemed to have satisfied the specified pharmacy practice experience requirements.

A PT is an individual who assists a pharmacist in a pharmacy in the performance of his or her pharmacy related duties. A PT may perform packaging, manipulative, repetitive, or other nondiscretionary tasks, only while assisting, and while under the direct supervision and control of a pharmacist. The BOP may issue a PT license to an individual if he or she is a high school graduate or possesses a general educational development certificate equivalent, and meets any one of the following requirements: (1) Has obtained an associate's degree in pharmacy technology; (2) Has completed a course of training specified by the BOP; (3) Has graduated from a school of pharmacy recognized by the BOP and; (4) Is certified by a PT certifying organization offering a PT certification program accredited by the National Commission for Certifying Agencies that is approved by the BOP.

FISCAL EFFECT: Appropriation: Fiscal Com.: Local:

According to the Senate Committee on Appropriations:

• The BOP notes minor and absorbable costs as they would inspect facilities for compliance during existing inspections. Any additional workload created by violations of the provisions in this bill would also be considered minor and absorbable.
• Potential cost pressures related to information technology development and programming. The Department of Consumer Affairs’ Office of Information Services has identified a one-time cost of $2,500 for the creation of new enforcement codes which can be absorbed through the redirection of existing maintenance resources. The projected cost assumes five new codes without programming logic. If additional programming logic is required, the cost would increase.

SUPPORT: (Verified 5/23/18)

California Hospital Association

Director, Multicampus Program in Geriatric Medicine and Gerontology, University
of California, Los Angeles

Dean of the School of Pharmacy and Professor and Chair of Department of
Medicine, University of California San Francisco

President and CEO of Cedars-Sinai

Numerous Individuals including pharmacists and physicians

OPPOSITION: (Verified 5/23/18)

United Nurses Associations of California/Union of Health Care Professionals

ARGUMENTS IN SUPPORT: The California Hospital Association (CHA) is in support of this measure and indicates that adverse drug events account for an estimated one in three of all hospital adverse events, affecting about 2 million hospital stays each year and prolong hospital stays by 1.7 to 4.6 days. Hospitals and health systems strive to find ways to reduce these largely preventable events to improve patient quality and safety, reduce health care costs, engage consumers and improve health care outcomes. High-risk patients – often those with chronic diseases who take multiple medications – experience higher medication error rates on admission and greater risk of medication errors during their hospital stays. CHA further contends that research shows that patients who the hospital determines to be high-risk can benefit from a pharmacist or pharmacist technician compiling a list of medications the patient is taking upon admission and that this would assist in decreasing adverse drug events upon hospital admission and during hospitalization.

The Dean of the School of Pharmacy and Professor and Chair of Department of
Medicine, University of California San Francisco, the Director, Multicampus Program in Geriatric Medicine and Gerontology University of California, Los Angeles, President and CEO of Cedars-Sinai and other numerous individuals, including physicians and pharmacists, write in support, noting that “The safe, effective use of medications is critically important, particularly in patients receiving multiple medications and those with concomitant co-morbidities. We strongly support a collaborative approach between pharmacists and physicians and other health care providers in ensuring medication safety. However, these efforts are often limited by the quality of the medication list. In our opinion, the proposed legislation will serve as a key first step toward maximizing medication safety in our hospitalized patients.”

Supporters state that up to 20 percent of readmissions are medication-related, especially in patients who are considered high risk as a result of chronic diseases, the number of medications they are taking, and other factors such as age and literacy. To illustrate, geriatric patients on average are prescribed 15 different medications simultaneously. Up to 70 percent of patients have errors on their medication lists and up to 59 percent of these have the potential to cause moderate to severe harm. A recent study in high risk patients demonstrated that patients have an average of eight errors on their medication lists, which resulted in an average of three errors per patient when they were admitted to the hospital. There was an 80 percent reduction in medication errors when pharmacists and trained technicians obtained medication lists in comparison to standard care and the risk of patient harm was also significantly reduced.

According to supporters, having pharmacy staff involved in making sure lists are accurate allows physicians and nurses to spend more time focusing on critical patient needs. Ensuring additional medication safety measures is increasingly important as the number of complex medications available to treat conditions and diseases continues to increase. Supporters believe that this bill would increase patient safety in both the hospital setting and in the post-discharge home setting as well.

ARGUMENTS IN OPPOSITION: The United Nurses Associations of California/Union of Health Care Professionals (UNAC/UHCP) are opposed to this measure and argue that it would erode protections for pharmacists without any justification or benefit to patients. They indicate that by exempting a pharmacy technician from the current ratios between pharmacists and technicians in this measure, ratios which were established to ensure that the pharmacists were not so burdened with supervisorial duties that they could consult with and interact with patients, would dramatically impact the ability of the pharmacist to deliver quality care. UNAC/UHCP are also concerned that the bill does not define “high-risk patient” of “accurate medication profile” and how pharmacists or technicians will obtain a complete list of medications from patients who may obtain medications from multiple sources outside of the hospital. Thus they believe that the medication profile with not be “accurate” at all and thus will not result in any appreciable improvement of patient care. UNAC/UHCP also believes that the pharmacy technician would not be dedicated solely to collecting patient medication profiles and would be assigned other tasks, thus allowing hospitals to circumvent the existing ratio requirements and employ cheaper pharmacy staff without improving patient care.

Prepared by:

5/24/18 11:05:29

**** END ****

SENATE COMMITTEE ON

Senator Ricardo Lara, Chair

2017 - 2018 Regular Session

SB 1254 (Stone) - Hospital pharmacies: medication profiles or lists for high-risk patients

This bill does not meet the criteria for referral to the Suspense File.

Bill Summary:

Senate Bill 1254 requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile, or list, for each high-risk patient upon admission if specific conditions are met and authorizes an intern pharmacist or a pharmacy technician to perform this task if certain conditions are satisfied.

Fiscal Impact:

• The Board of Pharmacy notes minor and absorbable costs as they would inspect facilities for compliance during existing inspections. Any additional workload created by violations of the provisions in this bill would also be considered minor and absorbable.
• Potential cost pressures related to information technology (IT) development and programming. The Department of Consumer Affairs’ Office of Information Services has identified a one-time cost of $2,500 for the creation of new enforcement codes which can be absorbed through the redirection of existing maintenance resources. The projected cost assumes five new codes without programming logic. If additional programming logic is required, the cost would increase.

Background:

1. Existing law and current Board of Pharmacy regulations require pharmacies to maintain medication profiles for all patients who have prescriptions filled in that pharmacy. Current medication profile information to be listed includes: the patient's full name and address, telephone number, date of birth or age and gender. For each prescription dispensed by the pharmacy, information includes the name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed; the prescriber's name and where appropriate, license number, Drug Enforcement Agency registration number or other unique identifier; the date on which a drug was dispensed or refilled; the prescription number for each prescription; and other information as specified pursuant to regulations of the BOP.
   
   Medication profiles must include any of the following which may relate to drug therapy: patient allergies, idiosyncrasies, current medications and relevant prior medications including nonprescription medications and relevant devices, or medical conditions which are communicated by the patient or the patient's agent; as well as any other information which the pharmacist, their professional judgment, deems appropriate.

Proposed Law:

The bill requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission if the hospital has more than 100 beds and the pharmacist may acquire the accurate medication profile or list during the hospital pharmacy’s hours of operation.

The bill authorizes an intern pharmacist to obtain the medication profile or list if the hospital pharmacy has a quality assurance program, as specified; if the intern pharmacist has completed specified training and proctoring; and if the pharmacy technician’s only function.

The bill requires the Board of Pharmacy to establish criteria of who is a high-risk patient for purposes of implementing the bill.

Staff Comments:

The bill provides that no reimbursement is required under Article XIIIB of the California Constitution.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: Hearing Date: April 23, 2018

Subject:

SUMMARY:

Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile, or list, for each high-risk patient upon admission if specific conditions are met and authorizes an intern pharmacist or a pharmacy technician to perform this task if certain conditions are satisfied.

Existing law:

1. Establishes the Board of Pharmacy (BOP) to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Grants the BOP the authority to adopt rules and regulations, not inconsistent with the laws of California, as may be necessary for the protection of the public pertaining to the practice of pharmacy; pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed; and providing for standards of minimum equipment for licensed establishments. (BPC § 4005(a))
   
3. Defines a “hospital pharmacy” to mean a pharmacy licensed by the BOP located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illness for which persons may be admitted for overnight stay and that meets all the requirements and rules and regulations of the BOP. (BPC § 4029)
   
4. Defines a “pharmacy technician (PT)” as an individual who assists a pharmacist in a pharmacy in the performance of his or her related duties, as specified. The pharmacist shall be responsible for the duties performed under his or her supervision by a PT. (BPC §§ 4038, 4115)
   
5. Authorizes the BOP to issue an intern pharmacist (IP) license to an individual currently enrolled in a pharmacy school, an individual who has graduated from pharmacy school and who has applied to become a licensed pharmacist, or a foreign graduate pharmacy student, as specified. Provides that an IP may perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist. (BPC §§ 4114, 4030)
6. Authorizes an advanced practice pharmacist (APP), as part of the care provided by a health care facility, in accordance with the policies, procedures, or protocols of that facility, initiate or adjust the drug regimen of a patient pursuant to a specific written order or authorization made by the individual patient’s treating prescriber, and accordance with the policies, procedures, or protocols of the health care facility. (BPC § 4052.2)
   
7. Requires a health facility to establish and implement a written policy to ensure that each patient shall receive information regarding each drug given at the time of discharge. This information shall include the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. This information shall be given by a pharmacist or registered nurse or the prescriber. (BPC § 4074 (e))
   
8. Requires every pharmacy to establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. The purpose of the quality assurance program shall be to assess errors that occur in the pharmacy in dispensing or furnishing prescription medications so that the pharmacy may take appropriate action to prevent a recurrence. (BPC § 4125)
9. Requires that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (Health and Safety Code § 11153)
10. Requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy. (California Code of Regulations (CCR) Title 16 Section 1707.1(a))
11. Requires a patient medication record to be maintained in an automated data processing or manual record mode such that specified information is readily retrievable during the pharmacy's normal operating hours. (CCR Title 16 Section 1707.1(a)(1))
    
12. Requires the patient medication record to be maintained for at least one year from the date when the last prescription was filled. (CCR Title 16 Section 1707.1(a)(2))

This bill:

1. Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission of the high-risk patient under the following conditions:
   
   1. The hospital has more than 100 beds.
      
   2. The medication profiles are acquired during the hospital pharmacy’s hours of operation.
2. Permits a PT or a pharmacy intern to perform the task of obtaining an accurate medication profile or list for a high-risk patient if the PT or pharmacy intern has been trained by the hospital pharmacy department and if the following conditions are satisfied:
   
   1. The hospital pharmacy has a quality assurance program, which is under the direction of the pharmacist-in-charge, to monitor competency.
      
   2. The hospital has established policies and procedures for training and proctoring PTs or pharmacy interns and the PT or pharmacy intern has completed that training and proctoring.
      
   3. Trained pharmacy technicians responsible for obtaining medications lists would not be included in the hospital required pharmacist to technician ratio.
3. Requires the hospital to establish criteria regarding who is a high-risk patient based on the patient populations served by the hospital.

FISCAL EFFECT:

Unknown. This bill is keyed “fiscal” by Legislative Counsel.

COMMENTS:

1. Purpose. The Author is the sponsor of this measure. As indicated by the Author, “currently medication lists are obtained by a variety of individuals with varying knowledge about medications including medical assistants in doctors’ offices and busy clinicians in hospitals who are focused on immediate patient care needs. Under current law, there is no requirement specifying what a hospital pharmacy must obtain when high-risk patients are admitted and discharged regarding their medication profile.”

The Author states that “There is a lack of defined responsibility to ensure medication lists are accurately obtained at hospital admission and discharge which puts patients at significant risk for harm and readmissions, which this bill aims to remedy.”

1. Duty to Maintain Medication Profiles (Patient Medication Records). Under current BOP regulations, pharmacies are required to maintain medication profiles for all patients who have prescriptions filled in that pharmacy. The information required to be listed on this medication profile includes the patient's full name and address, telephone number, date of birth or age and gender. For each prescription dispensed by the pharmacy, information includes the name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed; the prescriber's name and where appropriate, license number, Drug Enforcement Agency registration number or other unique identifier; the date on which a drug was dispensed or refilled; the prescription number for each prescription; and other information as specified pursuant to regulations of the BOP.
   
   Medication profiles must include any of the following which may relate to drug therapy: patient allergies, idiosyncrasies, current medications and relevant prior medications including nonprescription medications and relevant devices, or medical conditions which are communicated by the patient or the patient's agent; as well as any other information which the pharmacist, their professional judgment, deems appropriate.
2. Training and Proctoring of Pharmacy Technicians and Interns. An “intern pharmacist” is authorized to perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the BOP. "Direct supervision and control" means that a pharmacist is on the premises at all times and is fully aware of all activities performed by either a pharmacy technician or intern pharmacist. At the discretion of the BOP, an intern pharmacist license may be issued for a period of one to six years to a person who is currently enrolled in a school of pharmacy recognized by the BOP; two years to a person who is a graduate of a school of pharmacy recognized by the BOP and who has applied to become licensed as a pharmacist in California; two years to a foreign graduate who has met specified educational requirements; one year to a person who has failed the pharmacist licensure examination four times and has reenrolled in a school of pharmacy to satisfy specified requirements. The BOP may issue an intern pharmacist license to an individual for the period of time specified in a decision of reinstatement adopted by the BOP.
   
   Before applying for the pharmacist licensure examination, an intern pharmacist is required to complete 1,500 hours of pharmacy practice experience. This pharmacy practice experience must comply with the Standards of Curriculum established by the Accreditation Council for Pharmacy Education (ACPE) or with regulations adopted by the BOP. This pharmacy practice experience must include 900 hours of pharmacy practice experience in a pharmacy as a pharmacist and shall include pharmacy practice experience in both a community and institutional pharmacy practice setting. Certification of an applicant’s licensure in another state shall be submitted in writing and signed, under oath, by a duly authorized official of the state in which the license is held. An applicant for the examination who has graduated after January 1, 2016, from an ACPE accredited college of pharmacy or school of pharmacy recognized by the board shall be deemed to have satisfied the specified pharmacy practice experience requirements.
   
   A PT is an individual who assists a pharmacist in a pharmacy in the performance of his or her pharmacy related duties. A PT may perform packaging, manipulative, repetitive, or other nondiscretionary tasks, only while assisting, and while under the direct supervision and control of a pharmacist. The BOP may issue a PT license to an individual if he or she is a high school graduate or possesses a general educational development certificate equivalent, and meets any one of the following requirements: (1) Has obtained an associate's degree in pharmacy technology; (2) Has completed a course of training specified by the BOP; (3) Has graduated from a school of pharmacy recognized by the BOP and; (4) Is certified by a PT certifying organization offering a PT certification program accredited by the National Commission for Certifying Agencies that is approved by the BOP.
3. Arguments in Support. University of California San Francisco and other numerous individuals including physicians and pharmacists write in support, noting that “The safe, effective use of medications is critically important, particularly in patients receiving multiple medications and those with concomitant co-morbidities. We strongly support a collaborative approach between pharmacists and physicians and other health care providers in ensuring medication safety. However, these efforts are often limited by the quality of the medication list. In our opinion, the proposed legislation will serve as a key first step toward maximizing medication safety in our hospitalized patients.”
   
   Supporters state that up to 20 percent of readmissions are medication-related, especially in patients who are considered high risk as a result of chronic diseases, the number of medications they are taking, and other factors such as age and literacy. To illustrate, geriatric patients on average are prescribed 15 different medications simultaneously. Up to 70 percent of patients have errors on their medication lists and up to 59 percent of these have the potential to cause moderate to severe harm. A recent study in high risk patients demonstrated that patients have an average of eight errors on their medication lists, which resulted in an average of three errors per patient when they were admitted to the hospital. There was an 80 percent reduction in medication errors when pharmacists and trained technicians obtained medication lists in comparison to standard care and the risk of patient harm was also significantly reduced.
   
   According to supporters, having pharmacy staff involved in making sure lists are accurate allows physicians and nurses to spend more time focusing on critical patient needs. Ensuring additional medication safety measures is increasingly important as the number of complex medications available to treat conditions and diseases continues to increase. Supporters believe that this bill would increase patient safety in both the hospital setting and in the post-discharge home setting as well.
4. Related Legislation. SB 1229 (Stone) of 2018 would require a pharmacist to provide oral consultation to a patient before dispensing any opioid medication and prohibits a patient from declining this consultation. (Status: This bill is also set for a hearing before this Committee on April 23, 2018.)
   
   AB 2859 (Caballero) of 2018 would require a chain community pharmacy or an independent community pharmacy that dispenses Schedule II, III, or IV controlled substances to display safe storage products within the pharmacy department. (Status: This bill has been referred to the Assembly Committee on Business and Professions.)

SB 528 (Stone) of 2017 would provide an alternative program to authorize a pharmacy to provide pharmacy services to clinics that qualify as covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined, and declares that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivery system would be the responsibility of the pharmacy and would increase the level of the pharmacist’s involvement in the delivery of drugs from the system. (Status: This bill is pending before the Assembly Business and Professions Committee.)

AB 1589 (Bocanegra) of 2017 would raise the limit on the number of pharmacy technicians a pharmacy with one pharmacist may have to four and would raise the limit on the ratio of pharmacy technicians to any additional pharmacists to four to one. (Status: This bill is pending before the Assembly Appropriations Committee.)

1. Policy Concerns:
   
   1. How to Identify High-Risk Patients? This measure requires a hospital to establish criteria regarding who is a high-risk patient based on the patient populations served by the hospital for purposes of implementing the requirements of this bill; to obtain an accurate medication profile or list for each high-risk patient upon admission and discharge of the patient. It has been indicated in several articles that this may be difficult for hospitals to determine. Some doctors have indicated that “they may know one when they see one” but trying to define a patient as “high risk” is more difficult. Some hospitals have a process of separating patient populations into high-risk and low-risk and use a process of risk stratification to identify these patients. It does not seem, however, that there is a universal approach to identifying those patients considered as high-risk. The Author may want to consider whether this is something that can be clearly identified in all hospital settings where the accurate medication profiles or lists will be maintained for their patients by the pharmacist. Allowing each hospital to define “high risk” makes it very difficult for the BOP to enforce this law, and a hospital may define “high risk” to be zero patients. Alternatively, “high risk” may be based on the fact of being admitted to the hospital and therefore should include all patients.
      
   2. Use of the List or Profile? The bill does not actually say what a pharmacist, PT, or IP should do with the list once he or she has it. Should the list be integrated into the health record? Is the pharmacist supposed to do medication therapy management? Why should the pharmacist be responsible for having the list and not the prescribing physician or other members of the health care team, especially if the pharmacist is not likely to be the individual interacting directly with the patient? “Medication Therapy Management” is a program already offered to certain Medicare patients.
   3. How to Obtain an “Accurate” List or Profile? This bill does not say how an accurate list may be obtained; a patient may consume vitamins and other medications not filled by the hospital pharmacy. Accurate information may not be available, especially upon admission to a hospital, if the patient is impaired.
   4. BOP Regulations? Should the BOP promulgate regulations to specify the requirements of both compiling and obtaining the list and how the list should be utilized?
   5. Hospital Pharmacists Only? Why just a hospital pharmacist? Why not pharmacist working at a clinic or other outpatient facility?
      
2. Suggested Amendment: Current law refers to an “intern pharmacist,” not a “pharmacy intern.” The Author should consider using the correct reference for the “intern pharmacist.”
   

SUPPORT AND OPPOSITION:

Support:

University of California at San Francisco

Numerous Individuals including pharmacists and physicians

Opposition:

None on file as of April 17, 2018.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Jerry Hill, Chair

2017 - 2018 Regular

Bill No: SB 1254 Hearing Date: April 9, 2018

Subject: Hospital pharmacies: medication profiles or lists for high-risk patients

SUMMARY:

Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission and discharge of the patient and would authorize an intern pharmacist or a pharmacy technician to perform this task if certain conditions are satisfied.

Existing law:

1. Establishes the Board of Pharmacy (BOP) to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Grants the BOP the authority to adopt rules and regulations, not inconsistent with the laws of California, as may be necessary for the protection of the public pertaining to the practice of pharmacy; pertaining to establishments wherein any drug or device is compounded, prepared, furnished, or dispensed; and providing for standards of minimum equipment for licensed establishments. (BPC § 4005(a))
   
3. Defines a “hospital pharmacy” to mean pharmacy, licensed by the BOP, located within any licensed hospital, institution, or establishment that maintains and operates organized facilities for the diagnosis, care, and treatment of human illness for which persons may be admitted for overnight stay and that meets all the requirements and rules and regulations of the BOP. (BPC § 4029)
   
4. Defines a “pharmacy technician (PT)” as an individual who assists a pharmacist in a pharmacy in the performance of his or her related duties, as specified. The pharmacist shall be responsible for the duties performed under his or her supervision by a PT. (BPC §§ 4038, 4115)
   
5. Authorizes the BOP to issue an intern pharmacist (IP) license to an individual currently enrolled in a pharmacy school, an individual who has graduated from pharmacy school and who has applied to become a licensed pharmacist, or a foreign graduate pharmacy student, as specified. Provides that an IP may perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist. (BPC §§ 4114, 4030)
6. Authorizes an advanced practice pharmacist, as part of the care provided by a health care facility, in accordance with the policies, procedures, or protocols of that facility, initiate or adjust the drug regimen of a patient pursuant to a specific written order or authorization made by the individual patient’s treating prescriber, and accordance with the policies, procedures, or protocols of the health care facility. (BPC § 4052.2)
   
7. Requires a health facility to establish and implement a written policy to ensure that each patient shall receive information regarding each drug given at the time of discharge. This information shall include the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. This information shall be given by a pharmacist or registered nurse or the prescriber. (BPC § 4074 (e))
   
8. Requires every pharmacy to establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. The purpose of the quality assurance program shall be to assess errors that occur in the pharmacy in dispensing or furnishing prescription medications so that the pharmacy may take appropriate action to prevent a recurrence. (BPC § 4125)
9. Requires that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (Health and Safety Code § 11153)
   
10. Requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy. (California Code of Regulations (CCR) Title 16 Section 1707.1(a))
11. Requires a patient medication record to be maintained in an automated data processing or manual record mode such that specified information is readily retrievable during the pharmacy's normal operating hours. (CCR Title 16 Section 1707.1(a)(1))
    
12. Requires the patient medication record to be maintained for at least one year from the date when the last prescription was filled. (CCR Title 16 Section 1707.1(a)(2))

This bill:

1. Requires a pharmacist at a hospital pharmacy to obtain an accurate medication profile or list for each high-risk patient upon admission and discharge of the high-risk patient.
2. Permits a PT or a pharmacy intern to perform the task of obtaining an accurate medication profile or list for a high-risk patient if both, the hospital pharmacy has a quality assurance program, which is under the direction of the pharmacist-in-charge, to monitor competency, and the hospital has established policies and procedures for training and proctoring PTs or pharmacy interns and the PT or pharmacy intern has completed that training and proctoring.
3. Requires the hospital to establish criteria regarding who is a high-risk patient based on the patient populations served by the hospital.

FISCAL EFFECT:

Unknown. This bill is keyed “fiscal” by Legislative Counsel.

COMMENTS:

1. Purpose. The Author is the sponsor of this measure. As indicated by the Author, currently medication lists are obtained by a variety of individuals with varying knowledge about medications including medical assistants in doctors’ offices and busy clinicians in hospitals who are focused on immediate patient care needs. Under current law, there is no requirement specifying what a hospital pharmacy must obtain when high-risk patients are admitted and discharged regarding their medication profile.

There is a lack of defined responsibility to ensure medication lists are accurately obtained at hospital admission and discharge which puts patients at significant risk for harm and readmissions, which this bill aims to remedy.

1. Duty to Maintain Medication Profiles (Patient Medication Records). Under current regulations of the BOP, pharmacies are required to maintain medication profiles on all patients who have prescriptions filled in that pharmacy. The information required to be listed on this medication profile includes the patient's full name and address, telephone number, date of birth or age and gender. For each prescription dispensed by the pharmacy: the name, strength, dosage form, route of administration, if other than oral, quantity and directions for use of any drug dispensed; the prescriber's name and where appropriate, license number, Drug Enforcement Agency (DEA) registration number or other unique identifier; the date on which a drug was dispensed or refilled; the prescription number for each prescription; and other information as specified pursuant to regulations of the BOP.
   
   Medication profiles must include any of the following which may relate to drug therapy: patient allergies, idiosyncrasies, current medications and relevant prior medications including nonprescription medications and relevant devices, or medical conditions which are communicated by the patient or the patient's agent; as well as any other information which the pharmacist, their professional judgment, deems appropriate.
2. Training and Proctoring of Pharmacy Technicians and Interns. An “intern pharmacist” is authorized to perform all functions of a pharmacist at the discretion of and under the direct supervision and control of a pharmacist whose license is in good standing with the BOP. "Direct supervision and control" means that a pharmacist is on the premises at all times and is fully aware of all activities performed by either a pharmacy technician or intern pharmacist. At the discretion of the BOP, an intern pharmacist license may be issued for a period of one to six years to a person who is currently enrolled in a school of pharmacy recognized by the BOP; two years to a person who is a graduate of a school of pharmacy recognized by the BOP and who has applied to become licensed as a pharmacist in California; two years to a foreign graduate who has met specified educational requirements; one year to a person who has failed the pharmacist licensure examination four times and has reenrolled in a school of pharmacy to satisfy specified requirements. The BOP may issue an intern pharmacist license to an individual for the period of time specified in a decision of reinstatement adopted by the BOP.
   
   Before applying for the pharmacist licensure examination, an intern pharmacist is required to complete 1,500 hours of pharmacy practice experience. This pharmacy practice experience must comply with the Standards of Curriculum established by the Accreditation Council for Pharmacy Education (ACPE) or with regulations adopted by the BOP. This pharmacy practice experience must include 900 hours of pharmacy practice experience in a pharmacy as a pharmacist and shall include pharmacy practice experience in both a community and institutional pharmacy practice setting. Certification of an applicant’s licensure in another state shall be submitted in writing and signed, under oath, by a duly authorized official of the state in which the license is held. (d) An applicant for the examination who has graduated after January 1, 2016, from an ACPE accredited college of pharmacy or school of pharmacy recognized by the board shall be deemed to have satisfied the specified pharmacy practice experience requirements.
   
   A "PT" means an individual who assists a pharmacist in a pharmacy in the performance of his or her pharmacy related duties. A PT may perform packaging, manipulative, repetitive, or other nondiscretionary tasks, only while assisting, and while under the direct supervision and control of a pharmacist. The BOP may issue a PT license to an individual if he or she is a high school graduate or possesses a general educational development certificate equivalent, and meets any one of the following requirements: (1) Has obtained an associate's degree in pharmacy technology. (2) Has completed a course of training specified by the BOP. (3) Has graduated from a school of pharmacy recognized by the BOP. (4) Is certified by a PT certifying organization offering a PT certification program accredited by the National Commission for Certifying Agencies that is approved by the BOP.
3. Arguments in Support. University of California San Francisco and other numerous individuals including physicians and pharmacists write in support, “The safe, effective use of medications is critically important, particularly in patients receiving multiple medications and those with concomitant co-morbidities. We strongly support a collaborative approach between pharmacists and physicians and other health care providers in ensuring medication safety. However, these efforts are often limited by the quality of the medication list. In our opinion, the proposed legislation will serve as a key first step toward maximizing medication safety in our hospitalized patients.”
   
   Up to 20 percent of readmissions are medication-related, especially in patients who are considered high risk as a result of chronic diseases, the number of medications they are taking, and other factors such as age and literacy. To illustrate, geriatric patients on average are prescribed 15 different medications simultaneously. Up to 70 percent of patients have errors on their medication lists and up to 59 percent of these have the potential to cause moderate to severe harm. A recent study in high risk patients demonstrated that patients have an average of eight errors on their medication lists, which resulted in an average of three errors per patient when they were admitted to the hospital. There was an 80 percent reduction in medication errors when pharmacists and trained technicians obtained medication lists in comparison to standard care and the risk of patient harm was also significantly reduced.
   
   Having pharmacy staff involved in making sure lists are accurate allows physicians and nurses to spend more time focusing on critical patient needs. Ensuring additional medication safety measures is increasingly important as the number of complex medications available to treat conditions and diseases continues to increase. This bill would increase patient safety in both the hospital setting and in the post-discharge home setting as well.
4. Related Legislation. SB 1229 (Stone) of 2018 would require a pharmacist to provide oral consultation to a patient before dispensing any opioid medication and the patient may not decline the consultation. (Status: This bill is pending before this Committee.)
   
   SB 528 (Stone) of 2017 would provide an alternative program to authorize a pharmacy to provide pharmacy services to clinics that qualify as covered entities that are eligible for discount drug programs under federal law, as specified, through the use of an automated drug delivery system, as defined, and declares that, under the alternative program, the responsibility for the safety and security of the drugs in the automated drug delivery system would be the responsibility of the pharmacy and would increase the level of the pharmacist’s involvement in the delivery of drugs from the system. (Status: This bill is pending before the Assembly Business and Professions Committee.)
   
   AB 2859 (Caballero) of 2018 would require a chain community pharmacy or an independent community pharmacy that dispenses Schedule II, III, or IV controlled substances to display safe storage products within the pharmacy department. (Status: This bill has been referred to the Assembly Committee on Business and Professions.)
   
   AB 1589 (Bocanegra) of 2017 would raise the limit on the number of pharmacy technicians a pharmacy with one pharmacist may have to four and would raise the limit on the ratio of pharmacy technicians to any additional pharmacists to four to one. (Status: This bill is pending before the Assembly Appropriations Committee.)
   
5. Policy Concerns:
   
   1. How to Identify High-Risk Patients? This measure requires the hospital to establish criteria regarding who is a high-risk patient based on the patient populations served by the hospital for purposes of implementing the requirements of this bill; to obtain an accurate medication profile or list for each high-risk patient upon admission and discharge of the patient. It has been indicated in several articles that this may be difficult for hospitals to determine. Some doctors have indicated that “they may know one when they see one” but trying to define a patient as “high risk” is more difficult. Some hospitals have a process of separating patient populations into high-risk and low-risk and use a process of risk stratification to identify these patients. It does not seem, however, that there is a universal approach to identifying those patients considered as high-risk. The Author may want to consider whether this is something that can be clearly identified in all hospital settings where the accurate medication profiles or lists will be maintained for their patients by the pharmacist. Allowing each hospital to define “high risk” makes it very difficult for the BOP to enforce this law, and a hospital may define “high risk” to be zero patients.
      
   2. Use of the List or Profile? The bill does not actually say what a pharmacist, PT, or IP should do with the list once he or she has it. Should the list be integrated into the health record? Is the pharmacist supposed to do medication therapy management? Why should the pharmacist be responsible for having the list and not the prescribing physician or other members of the health care team, especially if the pharmacist is not likely to be the individual interacting directly with the patient? “Medication Therapy Management” is a program already offered to certain Medicare patients.
   3. How to Obtain an “Accurate” List or Profile? This bill does not say how an accurate list may be obtained; a patient may consume vitamins and other medications not filled by the hospital pharmacy. Accurate information may not be available, especially upon admission to a hospital, if the patient is impaired.
   4. Hospital Pharmacists Only? Why just a hospital pharmacist? Why not pharmacist working at a clinic or other outpatient facility?
      
6. Suggested Amendment: Current law refers to an “intern pharmacist,” not a “pharmacy intern.” The Author should consider using the correct reference for the “intern pharmacist.”
   

SUPPORT AND OPPOSITION:

Support:

University of California at San Francisco

Numerous Individuals

Opposition:

None on file as of April 4, 2018.

-- END --