Existing law, the Pharmacy Law, authorizes the California State Board of Pharmacy, during a declared federal, state, or local emergency, to waive application of any provisions of the law or the regulations adopted pursuant to it if, in the boards opinion, the waiver will aid in the protection of public health or the provision of patient care. Those provisions also authorize a pharmacist or a licensed clinic to furnish a dangerous drug or dangerous device in reasonable quantities without a prescription during a federal, state, or local emergency to further the health and safety of the public. Existing law, the Uniform Controlled Substances Act, regulates prescription forms for controlled substances and requires prescriptions to contain specified information and to be printed with specified security features.

This bill would authorize a pharmacist, during a declared local, state, or federal emergency pursuant to which the board issues a notice that the board is waiving the application of the provisions of the Pharmacy Law, to fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the declared local, state, or federal emergency, regardless of whether the prescription form meets the above-specified requirements, if certain other requirements are met, including that the prescription is written and dispensed within the first 2 weeks of the notice issued by the board. The bill would require the patient to demonstrate, to the satisfaction of the pharmacist, their inability to access medications. The bill would prohibit refills under these provisions and would limit the dispensing of a Schedule II controlled substance to a 7-day supply.

 UNFINISHED BUSINESS  

Bill No: SB 569

Author: Stone (R)

Amended: 7/2/19

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/22/19

AYES: Glazer, Chang, Archuleta, Dodd, Galgiani, Hill, Leyva, Pan, Wilk

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

SENATE FLOOR: 38-0, 5/9/19 (Consent)

AYES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dodd, Durazo, Galgiani, Glazer, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

ASSEMBLY FLOOR: 77-0, 9/3/19 - See last page for vote

SUBJECT: Controlled substances: prescriptions: declared local, state, or federal emergency

SOURCE: California State Board of Pharmacy

DIGEST:

This bill establishes prescription content requirements for a pharmacist to furnish a controlled substance without a standard prescription form during a declared state of emergency.

Assembly Amendments add requirements a pharmacist must meet in order to furnish a controlled substance during an emergency, including limiting the prescription to no greater than the amount needed for a seven-day supply, requiring the patient to demonstrate an inability to access medications, and prohibiting refills.

ANALYSIS:

Existing law:

1. Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs (DCA) to administer and enforce the Pharmacy Law (Law). (Business and Professions Code (BPC) § 4001).
2. Establishes requirements for writing, issuing, filling, compounding, and dispensing a prescription. (Health and Safety Code (HSC) §§ 1150 et seq.)
3. Establishes features for controlled substances prescription forms. (HSC § 11162.1)
4. Includes the following requirements for a controlled substance prescription:
   1. The prescription shall be signed and dated by the prescriber in ink and shall contain the prescriber’s address and telephone number; the name and address of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services; refill information, such as the number of refills ordered and whether the prescription is a first-time request or a refill; and the name, quantity, strength, and directions for use of the controlled substance prescribed.
   2. Allows any controlled substance to be dispensed upon an oral or electronically transmitted prescription, which shall be produced in hard copy form and signed and dated by the pharmacist filling the prescription or by any other person expressly authorized. Any person who transmits, maintains, or receives any electronically transmitted prescription shall ensure the security, integrity, authority, and confidentiality of the prescription. (HSC § 11164)
5. Provides exceptions to prescription requirements in an emergency, where failure to issue a prescription may result in loss of life or intense suffering. An order for a controlled substance may be dispensed on an oral order, an electronic data transmission order, or a written order not made on a controlled substance form, subject to specified requirements, including that the prescriber provides a written prescription on a controlled substance prescription form by the seventh day following the transmission of the initial order. (HSC § 11167)
6. Authorizes the BOP to waive provisions of law regarding furnishing dangerous drugs during a declared federal, state, or local emergency, if, in the BOP’s opinion, the waiver will aid in the protection of public health or the provision of patient care. (BPC § 4062 (b))
7. Requires a dispenser to report specified information to the Department of Justice’s CURES (Controlled Substance Utilization Review and Evaluation System) Prescription Drug Monitoring Program for each Schedule II, Schedule III, or Schedule IV controlled substance prescription as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed. (HSC § 11165)

This bill:

1. States that, if the BOP issues a notice that the BOP is waiving portions of the Law during a declared local, state, or federal emergency, a pharmacist may fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the emergency, regardless of whether the prescription form meets state law, if the prescription meets the following requirements:
   1. Contains specified information, including the prescriber’s signature and date, the name and address of the ultimate user, and the name, quantity, strength, and directions for use of the controlled substance prescribed.
   2. Indicates that the patient is affected by a declared emergency with the words “11159.3 exemption” or a similar statement.
   3. Is written and dispensed within the first two weeks of the notice issued by the BOP.
2. Requires a pharmacist filling a prescription pursuant to this section to do all of the following:
3. Exercise appropriate professional judgment, including reviewing the patient’s activity report from the CURES Prescription Drug Monitoring Program, before dispensing the medication.
4. If the prescription is for a Schedule II controlled substance, dispense no greater than the amount needed for a seven-day supply.
5. Require the patient to first demonstrate, to the satisfaction of the pharmacist, their inability to access medications. This demonstration may include, but is not limited to, verification of residency within an evacuation area.
6. Prohibits a pharmacist from refilling a prescription dispensed according to the provisions of the bill.

Background

The BOP was formed in 1891 as a state health regulatory agency. In 1971, the BOP became part of the DCA, which is part of the executive branch of the government of the State of California.

The BOP consists of 13 members who are appointed to four-year terms. The Governor appoints seven registered pharmacists and four public members. The Senate Rules Committee and the Speaker of the Assembly each appoint one public member.

The BOP regulates the practice of pharmacies, pharmacists, interns, pharmacy technicians, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license). The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.

In 2018, the BOP issued 139,640 licenses, registrations, permits, and certificates. Of those, over 35,000 were pharmacy technician licenses, 22,000 were pharmacist licenses, and nearly 300 were advanced practice pharmacist recognitions.

The BOP is totally self-funded and receives no tax money from the General Revenue Fund of the State of California. Funds necessary for its operation are generated primarily through its licensing fees.

California law requires 15 elements to appear on California Security Prescription Forms, and these forms must be produced by printers licensed by the California Department of Justice.

The elements are as follows:

1. A latent, repetitive “void” pattern across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word “void” shall appear in a pattern across the entire front of the prescription.
2. A watermark on the backside of the prescription blank; the watermark shall consist of the words “California Security Prescription.”
3. A chemical void protection that prevents alteration by chemical washing.
4. A feature printed in thermochromic (temperature sensitive) ink.
5. An area of opaque writing so that the writing disappears if the prescription is lightened.
6. A description of the security features included on each prescription form.
7. Six quantity check off boxes on the form so that the prescriber may indicate the quantity by checking the applicable box where the following quantities shall appear. In conjunction with the quantity boxes, a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form.
8. Prescription blanks shall contain a statement printed on the bottom of the prescription blank that the “Prescription is void if the number of drugs prescribed is not noted.”
9. The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner.
10. Check boxes on the form so that the prescriber may indicate the number of refills ordered.
11. The date of origin of the prescription.
12. A check box indicating the prescriber’s order not to substitute.
13. An identifying number assigned to the approved security printer by the Department of Justice.

1. A check box by the name of each prescriber when a prescription form lists multiple prescribers.
2. A unique serialized number.

This bill allows a pharmacist to furnish controlled substances during an emergency without these forms, if certain other patient- and drug-specific information is provided.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Assembly Appropriations Committee, negligible costs.

SUPPORT: (Verified 9/3/19)

California State Board of Pharmacy (source)

California Hospital Association

OPPOSITION: (Verified 9/3/19)

None received

ARGUMENTS IN SUPPORT: The California State Board of Pharmacy writes, “As part of its consumer protection role, the board undertook review of recent declared disasters that have negatively impacted Californians to determine if gaps in legal provisions exist. As part of this process the board received testimony from pharmacists involved in relief efforts. One of the challenges noted was a barrier to access to controlled substances caused by the security forms required for such medications. As the board lacks the authority to waive a provision of the Health and Safety Code during a declared disaster and being mindful of the opioid epidemic, the board’s proposal strikes a balance between removing the barrier to access to medications during the initial phases of a disaster and preventing the possible exploitation of such an exemption.

“Patient care areas during a declared disaster may occur in nontraditional settings such as emergency shelters in public schools or churches. Such locations are not equipped to provide traditional medical patient care services, and volunteer medical providers may not have access to compliant controlled substances security forms.”

ASSEMBLY FLOOR: 77-0, 9/3/19

AYES: Aguiar-Curry, Arambula, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Calderon, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Daly, Diep, Eggman, Flora, Fong, Friedman, Gabriel, Gallagher, Cristina Garcia, Gipson, Gloria, Gonzalez, Gray, Grayson, Holden, Irwin, Jones-Sawyer, Kalra, Kamlager-Dove, Kiley, Lackey, Levine, Limón, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Muratsuchi, Nazarian, Obernolte, O'Donnell, Patterson, Petrie-Norris, Quirk, Quirk-Silva, Ramos, Reyes, Luz Rivas, Robert Rivas, Rodriguez, Blanca Rubio, Salas, Santiago, Smith, Mark Stone, Ting, Voepel, Waldron, Weber, Wicks, Wood, Rendon

NO VOTE RECORDED: Frazier, Eduardo Garcia

Prepared by: Sarah Mason / B., P. & E.D. /

9/3/19 18:18:29

**** END ****

SENATE THIRD READING

STR Bill Id:SB 569

Author:(Stone)

As Amended Ver:July 2, 2019

Majority vote

SUMMARY:

Gives discretion to the California State Board of Pharmacy (Board) to, during a declared emergency, authorize pharmacists to fill prescriptions for controlled substances regardless of whether they possess a valid prescription form for that drug, under certain conditions.

Major Provisions

1. Authorizes the Board to issue a notice that it is waiving the application of the provisions of, or regulations adopted pursuant to, the Pharmacy Law regarding prescription forms during a declared local, state, or federal emergency.
2. Pursuant to a waiver made by the Board during a declared emergency, allows a pharmacist to fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the emergency, regardless of whether the prescription form meets the security printer form requirements, if the prescription meets the following requirements:
   1. The prescription is signed and dated by the prescriber and contains the basic information including the address for both the prescriber and the patient.
   2. The prescription indicates that the patient is affected by a declared emergency with the words "11159.3 exemption" or a similar statement.
   3. The prescription was written and dispensed within the first two weeks of the notice.
3. Requires a pharmacist filling a prescription pursuant to the waiver to do all of the following:
   1. Exercise appropriate professional judgment, including reviewing the patient's activity report from the Controlled Substance Utilization, Review and Evaluation System (CURES) Prescription Drug Monitoring Program before dispensing.
   2. Dispense no greater than a seven-day supply for any Schedule II drug prescriptions.
   3. Require the patient to demonstrate their inability to access medications.
4. Prohibits a pharmacist from refilling any prescription dispensed under the waiver.

COMMENTS:

The author contends that in the event of a declared emergency, patients may not have access to prescriptions written on compliant security printer prescription forms. Because this would lead to a patient's inability to access medication, the intent of this bill is to allow the Board to waive the majority of a prescription form's requirements for purposes of allowing a controlled substance prescription to be dispensed. It should be noted that this bill would not be necessary in instances where prescriptions are written electronically. Pharmacists are expected to exercise their professional judgment when dispensing a drug pursuant to the waiver, and are required to check the CURES database as a precaution against potential diversion or abuse.

According to the Author:

"During the Camp Fire, many individuals were displaced and significant damage occurred to infrastructure and healthcare facilities. One of the challenges identified to the Board of Pharmacy was limited access to prescription medications including for controlled medications, like pain, ADHD, depression, and anxiety treatment medications. Existing law establishes requirements for controlled substance security forms, including required elements that must be included on the printed security form. But, there is currently no exemption from these requirements for a declared disaster. Also, under current law, the Board of Pharmacy has the authority to waive provisions of pharmacy law in a declared disaster. However, this authority oddly does not extend to Health and Safety Code provisions. In addition, during a declared disaster many patient care areas occur in emergency shelters, public schools, and even churches. These non-traditional medical patient care settings may not have access to compliant controlled substances security forms. SB 569 will fix all this by creating a limited exemption to the controlled substances forms requirements during the initial phase of a local, state, or federal declared disaster."

Arguments in Support:

This bill is sponsored by the California State Board of Pharmacy. According to the Board, "As part of its consumer protection role, the board undertook review of recent declared disasters that have negatively impacted Californians to determine if gaps in legal provisions exist. As part of this process the board received testimony from pharmacists involved in relief efforts. One of the challenges noted was a barrier to access to controlled substances caused by the security forms required for such medications. As the board lacks the authority to waive a provision of the Health and Safety Code during a declared disaster and being mindful of the opioid epidemic, the board's proposal strikes a balance between removing the barrier to access to medications during the initial phases of a disaster and preventing the possible exploitation of such an exemption."

Arguments in Opposition:

None.

FISCAL COMMENTS:

According to the Assembly Committee on Appropriations, negligible costs.

VOTES:

SENATE FLOOR: 38-0-0

YES: Allen, Archuleta, Atkins, Bates, Beall, Borgeas, Bradford, Caballero, Chang, Dodd, Durazo, Galgiani, Glazer, Grove, Hertzberg, Hill, Hueso, Hurtado, Jackson, Jones, Leyva, McGuire, Mitchell, Monning, Moorlach, Morrell, Nielsen, Pan, Portantino, Roth, Rubio, Skinner, Stern, Stone, Umberg, Wieckowski, Wiener, Wilk

ASM BUSINESS AND PROFESSIONS: 19-0-0

YES: Low, Brough, Arambula, Bloom, Chen, Chiu, Cunningham, Eggman, Fong, Gipson, Gloria, Grayson, Holden, Irwin, McCarty, Medina, Mullin, Obernolte, Ting

ASM APPROPRIATIONS: 18-0-0

YES: Gonzalez, Bigelow, Bloom, Bonta, Brough, Calderon, Carrillo, Chau, Diep, Eggman, Fong, Gabriel, Eduardo Garcia, Maienschein, Obernolte, Petrie-Norris, Quirk, Robert Rivas

UPDATED:

VERSION: July 2, 2019

CONSULTANT: Robert Sumner / B. & P. / (916) 319-3301 FN: 0001392

Date of Hearing: August 14, 2019

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 569

Author:(Stone) – As Amended Ver:July 2, 2019

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

SUMMARY:

This bill allows pharmacists to fill prescriptions for controlled substances that do not have the security features normally required under state law, in cases where the Board of Pharmacy has waived the law pursuant to the board’s authority during a declared state of emergency and provided the prescriptions meet other requirements, as specified.

FISCAL EFFECT:

Negligible.

COMMENTS:

1. Purpose. This bill is sponsored by the Board of Pharmacy to address a lack of authority to waive statutory requirements related to security features on prescriptions for controlled substances. The California Hospital Association also supports this bill and it has no opposition.
2. Background. Controlled substances are defined by the federal Drug Enforcement Agency and are placed into schedules I through V based their currently accepted medical use, relative abuse potential and likelihood of causing dependence when abused. Prescription drugs with the highest likelihood of abuse are on Schedule II and include narcotics such as morphine, opium, codeine and hydrocodone.

The board has expansive authority to waive pharmacy laws and regulations in the case of a declared state of emergency to ensure prescriptions can still be filled. According to the board, it reviewed pharmacy operations during recently declared disasters to assess any gaps in legal authority. The board received testimony from pharmacists involved in relief efforts that security forms required to prescribe controlled substances posed a barrier to access. In spite of increased security measures recently adopted by the state to prevent diversion of controlled substances, the board believes the bill strikes the appropriate balance between access to medications during the initial phases of a disaster and the ability to prevent possible exploitation of such an exemption.

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

Date of Hearing: June 25, 2019

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

SBPCA Bill Id:SB 569

Author:(Stone) – As Amended Ver:April 1, 2019

SENATE VOTE: 38-0

SUBJECT: Controlled substances: prescriptions: declared local, state, or federal emergency

SUMMARY: Gives discretion to the California State Board of Pharmacy (Board) to, during a declared emergency, authorize pharmacists to fill prescriptions for controlled substances regardless of whether they possess a valid prescription form for that drug.

EXISTING LAW:

1. Establishes the Board to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Provides that protection of the public shall be the highest priority for the Board in exercising its licensing, regulatory, and disciplinary functions. (BPC § 4001.1)
3. Authorizes the Board to adopt rules and regulations as may be necessary for the protection of the public. (BPC § 4005)
4. Allows only a physician, dentist, podiatrist, veterinarian, naturopathic doctor, registered nurse, certified nurse-midwife, optometrist, or out-of-state prescriber to write or issue a prescription. (Health and Safety Code Section (HSC) § 11150)
5. States 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, and that 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. (HSC § 11153)
6. Establishes the Controlled Substance Utilization Review and Evaluation System (CURES), a PDMP maintained by the California Department of Justice (DOJ) for the purposes of collecting records of dispensed controlled substances for review by licensed prescribers and dispensers, regulatory investigators, law enforcement, and statistical researchers. (HSC § 11165)
7. Requires certain health care practitioners to consult the CURES database to review a patient’s controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every four months thereafter if the substance remains part of the treatment of the patient, with certain exceptions. (HSC § 11165.4)
8. Requires that all prescription forms for controlled substance prescriptions be obtained from security printers approved by the DOJ and sets a number of parameters for the DOJ’s approval process. (HSC § 11161.5)
9. Provides that when a prescriber’s authority to prescribe controlled substances is restricted, the law enforcement agency or licensing board that sought the restrictions shall provide the prescriber’s name, category of licensure, license number, and the nature of the restrictions imposed on the prescriber to security printers, the DOJ, and the Board of Pharmacy. (HSC § 11161.7)
10. Lists a number of required features that must be included for all prescription forms for controlled substances, including fraud-prevention identifiers, printing information, information relating to the prescribing practitioner, and a uniquely serialized number. (HSC § 11162.1)
11. Enables security printers and prescribers to report stolen or lost prescription pads to the DOJ through CURES. (HSC § 11165.3)
12. Prohibits any person from obtaining or attempting to obtain a prescription for controlled substances, by fraud, deceit, misrepresentation, subterfuge, or the concealment of a material fact. (HSC § 11173)

THIS BILL:

1. Authorizes the Board to issue a notice that it is waiving the application of the provisions of, or regulations adopted pursuant to, the Pharmacy Law regarding prescription forms during a declared local, state, or federal emergency.
2. Pursuant to a waiver made by the Board during a declared emergency, allows a pharmacist to fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the emergency, regardless of whether the prescription form meets the security printer form requirements, if the prescription meets the following requirements:
   1. The prescription is signed and dated by the prescriber and contains the basic information including the address for both the prescriber and the patient to whom the controlled substance was prescribed.
   2. The prescription indicates that the patient is affected by a declared emergency with the words “11159.3 exemption” or a similar statement.
   3. The prescription was written and dispensed within the first two weeks of the notice issued by the board.
3. Requires a pharmacist filling a prescription pursuant to the waiver to exercise appropriate professional judgment, including reviewing the patient’s activity report from the CURES Prescription Drug Monitoring Program before dispensing the medication.

FISCAL EFFECT: Pursuant to Senate Rule 28.8, negligible state costs.

COMMENTS:

Purpose. This bill is sponsored by the California State Board of Pharmacy. According to the author:

During the Camp Fire, many individuals were displaced and significant damage occurred to infrastructure and healthcare facilities. One of the challenges identified to the Board of Pharmacy was limited access to prescription medications including for controlled medications, like pain, ADHD, depression, and anxiety treatment medications. Existing law establishes requirements for controlled substance security forms, including required elements that must be included on the printed security form. But, there is currently no exemption from these requirements for a declared disaster. Also, under current law, the Board of Pharmacy has the authority to waive provisions of pharmacy law in a declared disaster. However, this authority oddly does not extend to Health and Safety Code provisions. In addition, during a declared disaster many patient care areas occur in emergency shelters, public schools, and even churches. These non-traditional medical patient care settings may not have access to compliant controlled substances security forms. SB 569 will fix all this by creating a limited exemption to the controlled substances forms requirements during the initial phase of a local, state, or federal declared disaster.

Background.

Security Printers and Prescription Pads. Written prescriptions have been regulated in the State of California since 1929, when a statute was first enacted to require that certain drugs be dispensed only with a written prescription from a licensed physician, dentist, or veterinarian. These prescriptions were required to include the name and address of the individual receiving the drug, and for three years all prescription records were required to remain “open to inspection by the prescriber and properly authorized officers of the law, including all inspectors of the division of narcotic enforcement and of the state board of pharmacy.” This requirement was later expanded to include all prescription drugs.

Under the DOJ’s Triplicate Prescription Program (TPP), first launched in 1939 under Attorney General Earl Warren, health practitioners were required to use serialized triplicate prescription forms when prescribing a Schedule II controlled substance. One copy was provided to the patient; another was retained for the prescriber’s records. The third copy of each triplicated prescription was sent to the Bureau of Narcotics Enforcement within the DOJ’s Division of Law Enforcement, which used the records to investigate potential fraud or criminal diversion of controlled substances. When the TPP was replaced by the CURES database in 2005, the triplicate prescription form requirement for Schedule II drugs was replaced with a new requirement that these prescriptions be issued on a special form obtained from an approved printer.

Under the DOJ’s Security Prescription Printers Program, all paper prescriptions of any Schedule II through V controlled substance must use special tamper-resistant forms obtained from manufacturers approved by the DOJ. Vendors wishing to operate as approved security printers submit an application to the DOJ and are initially required to provide an applicant’s name, address, and telephone number along with a description of the applicant’s intended policies and procedures for ensuring that prescription pads are delivered only to valid prescribers. The DOJ then generally screens the applicant and any other individuals affiliated with the applicant’s business for any disqualifying criminal history records. Once approved, printers are required to retain records for inspection by the DOJ and may have be fined or have their approval revoked for misconduct.

All prescription forms used to prescribe controlled substances must contain the following:

• A latent, repetitive “void” pattern shall be printed across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word “void” shall appear in a pattern across the entire front of the prescription.
• A watermark shall be printed on the backside of the prescription blank; the watermark shall consist of the words “California Security Prescription.”
• A chemical void protection that prevents alteration by chemical washing.
• A feature printed in thermochromic ink.
• An area of opaque writing so that the writing disappears if the prescription is lightened.
• A description of the security features included on each prescription form.
• Six quantity check off boxes printed on the form so that the prescriber may indicate the quantity, consisting of ranges of 25, and a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form.
• A statement printed on the bottom of the prescription blank that the “Prescription is void if the number of drugs prescribed is not noted.”
• The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner.
• Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered.
• The date of origin of the prescription.
• A check box indicating the prescriber’s order not to substitute.
• An identifying number assigned to the approved security printer by the DOJ.
• A check box by the name of each prescriber when a prescription form lists multiple prescribers; each prescriber who signs the prescription form shall identify himself or herself as the prescriber by checking the box by the prescriber’s name.
• A uniquely serialized number, in a manner prescribed by the DOJ.

The author contends that in the event of a declared emergency, patients may not have access to prescriptions written on compliant security printer prescription forms. Because this would lead to a patient’s inability to access medication, the intent of this bill is to allow the Board to waive the majority of a prescription form’s requirements for purposes of allowing a controlled substance prescription to be dispensed. It should be noted that this bill would not be necessary in instances where prescriptions are written electronically. Pharmacists are expected to exercise their professional judgment when dispensing a drug pursuant to the waiver, and are required to check the CURES database as a precaution against potential diversion or abuse.

Current Related Legislation. AB 973 (Irwin) would establish minimum standards for pharmacy compounding. This bill is pending in the Senate Appropriations Committee.

AB 528 (Low) would require pharmacists to submit information to the CURES database within the next working day of a prescription being dispensed. This bill is pending in the Senate Business, Professions, and Economic Development Committee.

Prior Related Legislation. SB 734 (Torlakson, Chapter 487, Statutes of 2005) gave the DOJ exclusive duties for approving applications by vendors to become security printers authorized to manufacture prescription pads eligible for controlled substance prescriptions.

AB 1753 (Low, Chapter 479, Statutes of 2018) added a uniquely serialized number to the list of required features for security printer forms.

AB 149 (Cooper, Chapter 4, Statutes of 2019) clarified the specifications for the uniquely serialized number required in the printing of new prescription forms by security printers approved by the Department of Justice, and expressly confirmed the validity of prescriptions written on nonserialized forms until a delayed date.

ARGUMENTS IN SUPPORT:

This bill is sponsored by the California State Board of Pharmacy. According to the Board, “As part of its consumer protection role, the board undertook review of recent declared disasters that have negatively impacted Californians to determine if gaps in legal provisions exist. As part of this process the board received testimony from pharmacists involved in relief efforts. One of the challenges noted was a barrier to access to controlled substances caused by the security forms required for such medications. As the board lacks the authority to waive a provision of the Health and Safety Code during a declared disaster and being mindful of the opioid epidemic, the board’s proposal strikes a balance between removing the barrier to access to medications during the initial phases of a disaster and preventing the possible exploitation of such an exemption.”

ARGUMENTS IN OPPOSITION:

None on file.

POLICY ISSUES:

Recent Issues Regarding Security Printer Prescription Forms. Prior to January 1, 2019, a uniquely serialized number was not a required feature on security printer forms, making prescriptions written on stolen or fraudulent prescription pads difficult to identify and track. A uniquely serialized number was added to the list of required features for prescription forms produced by security printers through Chapter 479, Statutes of 2018. Language in the bill creating the requirement for unique serialization did not expressly provide for a timeline for implementation; however, statute delegated broad discretion to regulators, stating that the specifications for the new requirements be adopted “in a manner prescribed” by the DOJ.

While this language generated an expectation that the new serial number requirement would be rolled out and enforced by regulators through a gradual phase-in process, a bulletin was issued by the DOJ in December of 2018 indicating that all prescriptions for controlled substances must be written on uniquely serialized prescription forms immediately beginning January 1, 2019. Further, the specifications for unique serialization were not prescribed by the DOJ until several weeks prior to that implementation date, causing concern within the prescribing and dispensing communities that many patients would be in possession of prescriptions written on nonserialized forms after January 1, 2019.

On January 10, 2019, a joint statement was issued by the DOJ, the Board of Pharmacy, and the Medical Board of California, aiming to “provide further clarification and guidance on implementation” of the serialization requirement. The three regulators reiterated that prescriptions written on nonserialized forms would remain “presumptively valid” and that while “prescribers are encouraged to procure compliant security forms at their earliest opportunity,” there would be a commitment that “enforcement staff not make an enforcement priority of actions against and/or investigations of pharmacists … who, in the exercise of his or her best professional judgement, determine that it is in the best interest of patient or public health or safety to fill a controlled substance written on a security form that would have been compliant prior to January 1, 2019.”

Notwithstanding the implementation guidance provided by state regulators in regards to prescriptions written on nonserialized forms, a broad consensus emerged that clarification in statute was necessary to prevent further confusion amongst prescribers and dispensers and ensure that pharmacists are able to confidently fill prescriptions written on outdated prescription pads. In response, AB 149 (Cooper, Chapter 4, Statutes of 2019) was chaptered to clarify the specifications for the uniquely serialized number required in the printing of new prescription forms by security printers approved by the Department of Justice, and expressly confirm the validity of prescriptions written on nonserialized forms until a delayed date.

As the state continues to sort out existing issues concerning security printer prescription form requirements, this bill would seek to allow for waivers of these requirements altogether under certain conditions. Considering the uncertain context that these waivers would currently be made, it may be an inappropriate time to contemplate additional changes to when and how security printer prescription forms must be used.

Potential Diversion or Abuse Resulting from Waivers. In October of 2017, the White House declared the opioid crisis a public health emergency, formally recognizing what had long been understood to be a growing epidemic responsible for devastation in communities across the country. According to the Centers for Disease Control and Prevention, as many as 50,000 Americans died of an opioid overdose in 2016, representing a 28 percent increase over the previous year. Additionally, the number of Americans who died of an overdose of fentanyl and other opioids more than doubled during that time with nearly 20,000 deaths. These death rates compare to, and potentially exceed, those at the height of the AIDS epidemic.

In the opioid crisis’s broader national context, there has been a persistent perception that California represents a relatively minor segment of an epidemic more typically identified with states like New Hampshire and West Virginia. However, there is substantial evidence that communities in California have been much harder hit than may be generally believed. For example, in 2015, several rural counties in California saw as many or more drug overdose deaths per 100,000 residents than some Midwestern states. It has been reported than some small counties had more opioid prescriptions than residents. In total, the California Department of Public Health estimates that nearly 2,000 Californians died of an opioid overdose in 2016.

The state’s security printer program was established in large part to prevent the abuse and diversion of controlled substances such as opioids. While these forms may present a barrier to medication access for some patients during an emergency, waiving their requirements may result in individuals seeking to divert or abuse controlled substances exploiting declared emergencies to unlawfully obtain prescription drugs. Sufficient data has not been provided demonstrating that the number of patients who are historically unable to receive prescription medications in an emergency outweighs this concern.

AMENDMENTS:

1. To reduce the risk of abuse or diversion of serious prescription drugs that may result from the Board’s waiver of the security printer prescription form requirements:

Provide that a pharmacist shall dispense any Schedule II controlled substance as a partial fill of no greater than the amount needed for seven days when filling a prescription pursuant to the bill.

1. To require patients to subsequently obtain a valid prescription written on a security printer form prior to receiving any refills on the prescription:

Provide that prescriptions issued pursuant to the bill’s provisions shall not be refilled.

1. To ensure that the waiver provided under the bill applies only to patients whose access is actually impacted by a declared emergency:

Require a patient to first demonstrate, to the satisfaction of the prescriber, their inability to access medications, and provide that such demonstration can include verification of residency within an evacuation area.

REGISTERED SUPPORT:

California State Board of Pharmacy (Sponsor)
California Hospital Association

REGISTERED OPPOSITION:

None on file.

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

Date of Hearing: June 18, 2019

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

SBPCA Bill Id:SB 569

Author:(Stone) – As Amended Ver:April 1, 2019

SENATE VOTE: 38-0

SUBJECT: Controlled substances: prescriptions: declared local, state, or federal emergency

SUMMARY: Gives discretion to the California State Board of Pharmacy (Board) to, during a declared emergency, authorize pharmacists to fill prescriptions for controlled substances regardless of whether they possess a valid prescription form for that drug.

EXISTING LAW:

1. Establishes the Board to administer and regulate the Pharmacy Law. (Business and Professions Code (BPC) § 4001)
2. Provides that protection of the public shall be the highest priority for the Board in exercising its licensing, regulatory, and disciplinary functions. (BPC § 4001.1)
3. Authorizes the Board to adopt rules and regulations as may be necessary for the protection of the public. (BPC § 4005)
4. Allows only a physician, dentist, podiatrist, veterinarian, naturopathic doctor, registered nurse, certified nurse-midwife, optometrist, or out-of-state prescriber to write or issue a prescription. (Health and Safety Code Section (HSC) § 11150)
5. States 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, and that 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. (HSC § 11153)
6. Establishes the Controlled Substance Utilization Review and Evaluation System (CURES), a PDMP maintained by the California Department of Justice (DOJ) for the purposes of collecting records of dispensed controlled substances for review by licensed prescribers and dispensers, regulatory investigators, law enforcement, and statistical researchers. (HSC § 11165)
7. Requires certain health care practitioners to consult the CURES database to review a patient’s controlled substance history before prescribing a Schedule II, Schedule III, or Schedule IV controlled substance to the patient for the first time and at least once every four months thereafter if the substance remains part of the treatment of the patient, with certain exceptions. (HSC § 11165.4)
8. Requires that all prescription forms for controlled substance prescriptions be obtained from security printers approved by the DOJ and sets a number of parameters for the DOJ’s approval process. (HSC § 11161.5)
9. Provides that when a prescriber’s authority to prescribe controlled substances is restricted, the law enforcement agency or licensing board that sought the restrictions shall provide the prescriber’s name, category of licensure, license number, and the nature of the restrictions imposed on the prescriber to security printers, the DOJ, and the Board of Pharmacy. (HSC § 11161.7)
10. Lists a number of required features that must be included for all prescription forms for controlled substances, including fraud-prevention identifiers, printing information, information relating to the prescribing practitioner, and a uniquely serialized number. (HSC § 11162.1)
11. Enables security printers and prescribers to report stolen or lost prescription pads to the DOJ through CURES. (HSC § 11165.3)
12. Prohibits any person from obtaining or attempting to obtain a prescription for controlled substances, by fraud, deceit, misrepresentation, subterfuge, or the concealment of a material fact. (HSC § 11173)

THIS BILL:

1. Authorizes the Board to issue a notice that it is waiving the application of the provisions of, or regulations adopted pursuant to, the Pharmacy Law regarding prescription forms during a declared local, state, or federal emergency.
2. Pursuant to a waiver made by the Board during a declared emergency, allows a pharmacist to fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the emergency, regardless of whether the prescription form meets the security printer form requirements, if the prescription meets the following requirements:
   1. The prescription is signed and dated by the prescriber and contains the basic information including the address for both the prescriber and the patient to whom the controlled substance was prescribed.
   2. The prescription indicates that the patient is affected by a declared emergency with the words “11159.3 exemption” or a similar statement.
   3. The prescription was written and dispensed within the first two weeks of the notice issued by the board.
3. Requires a pharmacist filling a prescription pursuant to the waiver to exercise appropriate professional judgment, including reviewing the patient’s activity report from the CURES Prescription Drug Monitoring Program before dispensing the medication.

FISCAL EFFECT: Pursuant to Senate Rule 28.8, negligible state costs.

COMMENTS:

Purpose. This bill is sponsored by the California State Board of Pharmacy. According to the author:

During the Camp Fire, many individuals were displaced and significant damage occurred to infrastructure and healthcare facilities. One of the challenges identified to the Board of Pharmacy was limited access to prescription medications including for controlled medications, like pain, ADHD, depression, and anxiety treatment medications. Existing law establishes requirements for controlled substance security forms, including required elements that must be included on the printed security form. But, there is currently no exemption from these requirements for a declared disaster. Also, under current law, the Board of Pharmacy has the authority to waive provisions of pharmacy law in a declared disaster. However, this authority oddly does not extend to Health and Safety Code provisions. In addition, during a declared disaster many patient care areas occur in emergency shelters, public schools, and even churches. These non-traditional medical patient care settings may not have access to compliant controlled substances security forms. SB 569 will fix all this by creating a limited exemption to the controlled substances forms requirements during the initial phase of a local, state, or federal declared disaster.

Background.

Security Printers and Prescription Pads. Written prescriptions have been regulated in the State of California since 1929, when a statute was first enacted to require that certain drugs be dispensed only with a written prescription from a licensed physician, dentist, or veterinarian. These prescriptions were required to include the name and address of the individual receiving the drug, and for three years all prescription records were required to remain “open to inspection by the prescriber and properly authorized officers of the law, including all inspectors of the division of narcotic enforcement and of the state board of pharmacy.” This requirement was later expanded to include all prescription drugs.

Under the DOJ’s Triplicate Prescription Program (TPP), first launched in 1939 under Attorney General Earl Warren, health practitioners were required to use serialized triplicate prescription forms when prescribing a Schedule II controlled substance. One copy was provided to the patient; another was retained for the prescriber’s records. The third copy of each triplicated prescription was sent to the Bureau of Narcotics Enforcement within the DOJ’s Division of Law Enforcement, which used the records to investigate potential fraud or criminal diversion of controlled substances. When the TPP was replaced by the CURES database in 2005, the triplicate prescription form requirement for Schedule II drugs was replaced with a new requirement that these prescriptions be issued on a special form obtained from an approved printer.

Under the DOJ’s Security Prescription Printers Program, all paper prescriptions of any Schedule II through V controlled substance must use special tamper-resistant forms obtained from manufacturers approved by the DOJ. Vendors wishing to operate as approved security printers submit an application to the DOJ and are initially required to provide an applicant’s name, address, and telephone number along with a description of the applicant’s intended policies and procedures for ensuring that prescription pads are delivered only to valid prescribers. The DOJ then generally screens the applicant and any other individuals affiliated with the applicant’s business for any disqualifying criminal history records. Once approved, printers are required to retain records for inspection by the DOJ and may have be fined or have their approval revoked for misconduct.

All prescription forms used to prescribe controlled substances must contain the following:

• A latent, repetitive “void” pattern shall be printed across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word “void” shall appear in a pattern across the entire front of the prescription.
• A watermark shall be printed on the backside of the prescription blank; the watermark shall consist of the words “California Security Prescription.”
• A chemical void protection that prevents alteration by chemical washing.
• A feature printed in thermochromic ink.
• An area of opaque writing so that the writing disappears if the prescription is lightened.
• A description of the security features included on each prescription form.
• Six quantity check off boxes printed on the form so that the prescriber may indicate the quantity, consisting of ranges of 25, and a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form.
• A statement printed on the bottom of the prescription blank that the “Prescription is void if the number of drugs prescribed is not noted.”
• The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner.
• Check boxes shall be printed on the form so that the prescriber may indicate the number of refills ordered.
• The date of origin of the prescription.
• A check box indicating the prescriber’s order not to substitute.
• An identifying number assigned to the approved security printer by the DOJ.
• A check box by the name of each prescriber when a prescription form lists multiple prescribers; each prescriber who signs the prescription form shall identify himself or herself as the prescriber by checking the box by the prescriber’s name.
• A uniquely serialized number, in a manner prescribed by the DOJ.

The author contends that in the event of a declared emergency, patients may not have access to prescriptions written on compliant security printer prescription forms. Because this would lead to a patient’s inability to access medication, the intent of this bill is to allow the Board to waive the majority of a prescription form’s requirements for purposes of allowing a controlled substance prescription to be dispensed. It should be noted that this bill would not be necessary in instances where prescriptions are written electronically. Pharmacists are expected to exercise their professional judgment when dispensing a drug pursuant to the waiver, and are required to check the CURES database as a precaution against potential diversion or abuse.

Current Related Legislation. AB 973 (Irwin) would establish minimum standards for pharmacy compounding. This bill is pending in the Senate Appropriations Committee.

AB 528 (Low) would require pharmacists to submit information to the CURES database within the next working day of a prescription being dispensed. This bill is pending in the Senate Business, Professions, and Economic Development Committee.

Prior Related Legislation. SB 734 (Torlakson, Chapter 487, Statutes of 2005) gave the DOJ exclusive duties for approving applications by vendors to become security printers authorized to manufacture prescription pads eligible for controlled substance prescriptions.

AB 1753 (Low, Chapter 479, Statutes of 2018) added a uniquely serialized number to the list of required features for security printer forms.

AB 149 (Cooper, Chapter 4, Statutes of 2019) clarified the specifications for the uniquely serialized number required in the printing of new prescription forms by security printers approved by the Department of Justice, and expressly confirmed the validity of prescriptions written on nonserialized forms until a delayed date.

ARGUMENTS IN SUPPORT:

This bill is sponsored by the California State Board of Pharmacy. According to the Board, “As part of its consumer protection role, the board undertook review of recent declared disasters that have negatively impacted Californians to determine if gaps in legal provisions exist. As part of this process the board received testimony from pharmacists involved in relief efforts. One of the challenges noted was a barrier to access to controlled substances caused by the security forms required for such medications. As the board lacks the authority to waive a provision of the Health and Safety Code during a declared disaster and being mindful of the opioid epidemic, the board’s proposal strikes a balance between removing the barrier to access to medications during the initial phases of a disaster and preventing the possible exploitation of such an exemption.”

ARGUMENTS IN OPPOSITION:

None on file.

POLICY ISSUES:

Recent Issues Regarding Security Printer Prescription Forms. Prior to January 1, 2019, a uniquely serialized number was not a required feature on security printer forms, making prescriptions written on stolen or fraudulent prescription pads difficult to identify and track. A uniquely serialized number was added to the list of required features for prescription forms produced by security printers through Chapter 479, Statutes of 2018. Language in the bill creating the requirement for unique serialization did not expressly provide for a timeline for implementation; however, statute delegated broad discretion to regulators, stating that the specifications for the new requirements be adopted “in a manner prescribed” by the DOJ.

While this language generated an expectation that the new serial number requirement would be rolled out and enforced by regulators through a gradual phase-in process, a bulletin was issued by the DOJ in December of 2018 indicating that all prescriptions for controlled substances must be written on uniquely serialized prescription forms immediately beginning January 1, 2019. Further, the specifications for unique serialization were not prescribed by the DOJ until several weeks prior to that implementation date, causing concern within the prescribing and dispensing communities that many patients would be in possession of prescriptions written on nonserialized forms after January 1, 2019.

On January 10, 2019, a joint statement was issued by the DOJ, the Board of Pharmacy, and the Medical Board of California, aiming to “provide further clarification and guidance on implementation” of the serialization requirement. The three regulators reiterated that prescriptions written on nonserialized forms would remain “presumptively valid” and that while “prescribers are encouraged to procure compliant security forms at their earliest opportunity,” there would be a commitment that “enforcement staff not make an enforcement priority of actions against and/or investigations of pharmacists … who, in the exercise of his or her best professional judgement, determine that it is in the best interest of patient or public health or safety to fill a controlled substance written on a security form that would have been compliant prior to January 1, 2019.”

Notwithstanding the implementation guidance provided by state regulators in regards to prescriptions written on nonserialized forms, a broad consensus emerged that clarification in statute was necessary to prevent further confusion amongst prescribers and dispensers and ensure that pharmacists are able to confidently fill prescriptions written on outdated prescription pads. In response, AB 149 (Cooper, Chapter 4, Statutes of 2019) was chaptered to clarify the specifications for the uniquely serialized number required in the printing of new prescription forms by security printers approved by the Department of Justice, and expressly confirm the validity of prescriptions written on nonserialized forms until a delayed date.

As the state continues to sort out existing issues concerning security printer prescription form requirements, this bill would seek to allow for waivers of these requirements altogether under certain conditions. Considering the uncertain context that these waivers would currently be made, it may be an inappropriate time to contemplate additional changes to when and how security printer prescription forms must be used.

Potential Diversion or Abuse Resulting from Waivers. In October of 2017, the White House declared the opioid crisis a public health emergency, formally recognizing what had long been understood to be a growing epidemic responsible for devastation in communities across the country. According to the Centers for Disease Control and Prevention, as many as 50,000 Americans died of an opioid overdose in 2016, representing a 28 percent increase over the previous year. Additionally, the number of Americans who died of an overdose of fentanyl and other opioids more than doubled during that time with nearly 20,000 deaths. These death rates compare to, and potentially exceed, those at the height of the AIDS epidemic.

In the opioid crisis’s broader national context, there has been a persistent perception that California represents a relatively minor segment of an epidemic more typically identified with states like New Hampshire and West Virginia. However, there is substantial evidence that communities in California have been much harder hit than may be generally believed. For example, in 2015, several rural counties in California saw as many or more drug overdose deaths per 100,000 residents than some Midwestern states. It has been reported than some small counties had more opioid prescriptions than residents. In total, the California Department of Public Health estimates that nearly 2,000 Californians died of an opioid overdose in 2016.

The state’s security printer program was established in large part to prevent the abuse and diversion of controlled substances such as opioids. While these forms may present a barrier to medication access for some patients during an emergency, waiving their requirements may result in individuals seeking to divert or abuse controlled substances exploiting declared emergencies to unlawfully obtain prescription drugs. Sufficient data has not been provided demonstrating that the number of patients who are historically unable to receive prescription medications in an emergency outweighs this concern.

REGISTERED SUPPORT:

California State Board of Pharmacy (Sponsor)
California Hospital Association

REGISTERED OPPOSITION:

None on file.

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

 CONSENT  

Bill No: SB 569

Author: Stone (R)

Amended: 4/1/19

Vote: 21

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 4/22/19

AYES: Glazer, Chang, Archuleta, Dodd, Galgiani, Hill, Leyva, Pan, Wilk

SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8

SUBJECT: Controlled substances: prescriptions: declared local, state, or federal emergency

SOURCE: California State Board of Pharmacy

DIGEST:

This bill establishes prescription content requirements for a pharmacist to furnish a controlled substance without a standard prescription form during a declared state of emergency.

ANALYSIS:

Existing law:

1. Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs (DCA) to administer and enforce the Pharmacy Law (Law). (Business and Professions Code (BPC) § 4001).
2. Establishes requirements for writing, issuing, filling, compounding, and dispensing a prescription. (Health and Safety Code (HSC) §§ 1150 et seq.)
3. Establishes features for controlled substances prescription forms. (HSC § 11162.1)
4. Includes the following requirements for a controlled substance prescription:
   1. The prescription shall be signed and dated by the prescriber in ink and shall contain the prescriber’s address and telephone number; the name and address of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services; refill information, such as the number of refills ordered and whether the prescription is a first-time request or a refill; and the name, quantity, strength, and directions for use of the controlled substance prescribed.
   2. Allows any controlled substance to be dispensed upon an oral or electronically transmitted prescription, which shall be produced in hard copy form and signed and dated by the pharmacist filling the prescription or by any other person expressly authorized. Any person who transmits, maintains, or receives any electronically transmitted prescription shall ensure the security, integrity, authority, and confidentiality of the prescription. (HSC § 11164)
5. Provides exceptions to prescription requirements in an emergency, where failure to issue a prescription may result in loss of life or intense suffering. An order for a controlled substance may be dispensed on an oral order, an electronic data transmission order, or a written order not made on a controlled substance form, subject to specified requirements, including that the prescriber provides a written prescription on a controlled substance prescription form by the seventh day following the transmission of the initial order. (HSC § 11167)
6. Authorizes the BOP to waive provisions of law regarding furnishing dangerous drugs during a declared federal, state, or local emergency, if, in the BOP’s opinion, the waiver will aid in the protection of public health or the provision of patient care. (BPC § 4062 (b))
7. Requires a dispenser to report specified information to the Department of Justice’s CURES (Controlled Substance Utilization Review and Evaluation System) Prescription Drug Monitoring Program for each Schedule II, Schedule III, or Schedule IV controlled substance prescription as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed. (HSC § 11165)

This bill:

1. States that, if the BOP issues a notice that the BOP is waiving portions of the Law during a declared local, state, or federal emergency, a pharmacist may fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the emergency, regardless of whether the prescription form meets state law, if the prescription meets the following requirements:
   1. Contains specified information, including the prescriber’s signature and date, the name and address of the ultimate user, and the name, quantity, strength, and directions for use of the controlled substance prescribed.
   2. Indicates that the patient is affected by a declared emergency with the words “11159.3 exemption” or a similar statement.
   3. Is written and dispensed within the first two weeks of the notice issued by the BOP.
2. Requires a pharmacist filling a prescription pursuant to this section to exercise appropriate professional judgment, including reviewing the patient’s activity report from the CURES Prescription Drug Monitoring Program, before dispensing the medication.

Background

The BOP was formed in 1891 as a state health regulatory agency. In 1971, the BOP became part of the DCA, which is part of the executive branch of the government of the State of California.

The BOP consists of 13 members who are appointed to four-year terms. The Governor appoints seven registered pharmacists and four public members. The Senate Rules Committee and the Speaker of the Assembly each appoint one public member.

The BOP regulates the practice of pharmacies, pharmacists, interns, pharmacy technicians, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license). The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.

In 2018, the BOP issued 139,640 licenses, registrations, permits, and certificates. Of those, over 35,000 were pharmacy technician licenses, 22,000 were pharmacist licenses, and nearly 300 were advanced practice pharmacist recognitions.

The BOP is totally self-funded and receives no tax money from the General Revenue Fund of the State of California. Funds necessary for its operation are generated primarily through its licensing fees.

California law requires 15 elements to appear on California Security Prescription Forms, and these forms must be produced by printers licensed by the California Department of Justice.

The elements are as follows:

1. A latent, repetitive “void” pattern across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word “void” shall appear in a pattern across the entire front of the prescription.
2. A watermark on the backside of the prescription blank; the watermark shall consist of the words “California Security Prescription.”
3. A chemical void protection that prevents alteration by chemical washing.
4. A feature printed in thermochromic (temperature sensitive) ink.
5. An area of opaque writing so that the writing disappears if the prescription is lightened.
6. A description of the security features included on each prescription form.
7. Six quantity check off boxes on the form so that the prescriber may indicate the quantity by checking the applicable box where the following quantities shall appear. In conjunction with the quantity boxes, a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form.
8. Prescription blanks shall contain a statement printed on the bottom of the prescription blank that the “Prescription is void if the number of drugs prescribed is not noted.”
9. The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner.
10. Check boxes on the form so that the prescriber may indicate the number of refills ordered.
11. The date of origin of the prescription.
12. A check box indicating the prescriber’s order not to substitute.
13. An identifying number assigned to the approved security printer by the Department of Justice.
14. A check box by the name of each prescriber when a prescription form lists multiple prescribers.
15. A unique serialized number.

This bill allows a pharmacist to furnish controlled substances during an emergency without these forms, if certain other patient- and drug-specific information is provided.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

SUPPORT: (Verified 5/7/19)

California State Board of Pharmacy (source)

California Hospital Association

OPPOSITION: (Verified 5/7/19)

None received

ARGUMENTS IN SUPPORT: The California State Board of Pharmacy writes, “As part of its consumer protection role, the board undertook review of recent declared disasters that have negatively impacted Californians to determine if gaps in legal provisions exist. As part of this process the board received testimony from pharmacists involved in relief efforts. One of the challenges noted was a barrier to access to controlled substances caused by the security forms required for such medications. As the board lacks the authority to waive a provision of the Health and Safety Code during a declared disaster and being mindful of the opioid epidemic, the board’s proposal strikes a balance between removing the barrier to access to medications during the initial phases of a disaster and preventing the possible exploitation of such an exemption.

“Patient care areas during a declared disaster may occur in nontraditional settings such as emergency shelters in public schools or churches. Such locations are not equipped to provide traditional medical patient care services, and volunteer medical providers may not have access to compliant controlled substances security forms.”

Prepared by: Sarah Huchel / B., P. & E.D. /

5/8/19 15:24:21

**** END ****

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Steven Glazer, Chair

2019 - 2020 Regular

Bill No: SB 569 Hearing Date: April 22, 2019

Subject: Controlled substances: prescriptions: declared local, state, or federal emergency

SUMMARY:

Establishes prescription content requirements for a pharmacist to furnish a controlled substance without a standard prescription form during a declared state of emergency, as specified.

Existing law:

1. Establishes the Board of Pharmacy (BOP) within the Department of Consumer Affairs to administer and enforce the Pharmacy Law (Law). (Business and Professions Code (BPC) § 4001).
2. Establishes requirements for writing, issuing, filling, compounding, and dispensing a prescription. (Health and Safety Code (HSC) §§ 1150 et seq.)
3. Establishes features for controlled substances prescription forms. (HSC § 11162.1)
4. Includes the following requirements for a controlled substance prescription:
   1. The prescription shall be signed and dated by the prescriber in ink and shall contain the prescriber’s address and telephone number; the name and address of the ultimate user or research subject, or contact information as determined by the Secretary of the United States Department of Health and Human Services; refill information, such as the number of refills ordered and whether the prescription is a first-time request or a refill; and the name, quantity, strength, and directions for use of the controlled substance prescribed.
   2. Allows any controlled substance to be dispensed upon an oral or electronically transmitted prescription, which shall be produced in hard copy form and signed and dated by the pharmacist filling the prescription or by any other person expressly authorized. Any person who transmits, maintains, or receives any electronically transmitted prescription shall ensure the security, integrity, authority, and confidentiality of the prescription. (HSC § 11164)
5. Provides exceptions to prescription requirements in an emergency, where failure to issue a prescription may result in loss of life or intense suffering. An order for a controlled substance may be dispensed on an oral order, an electronic data transmission order, or a written order not made on a controlled substance form, subject to specified requirements, including that the prescriber provides a written prescription on a controlled substance prescription form by the seventh day following the transmission of the initial order. (HSC § 11167)
6. Authorizes the BOP to waive provisions of law regarding furnishing dangerous drugs during a declared federal, state, or local emergency, if, in the Board’s opinion, the waiver will aid in the protection of public health or the provision of patient care.
   (BPC § 4062 (b))
7. Requires a dispenser to report specified information to the Department of Justice’s CURES Prescription Drug Monitoring Program for each Schedule II, Schedule III, or Schedule IV controlled substance prescription as soon as reasonably possible, but not more than seven days after the date a controlled substance is dispensed. (HSC § 11165)

This bill:

1. States that, if the BOP issues a notice that the BOP is waiving portions of the Law during a declared local, state, or federal emergency, a pharmacist may fill a prescription for a controlled substance for use by a patient who cannot access medications as a result of the emergency, regardless of whether the prescription form meets state law, if the prescription meets the following requirements:
   1. Contains specified information, including the prescriber’s signature and date, the name and address of the ultimate user, and the name, quantity, strength, and directions for use of the controlled substance prescribed.
   2. Indicates that the patient is affected by a declared emergency with the words “11159.3 exemption” or a similar statement.
   3. Is written and dispensed within the first two weeks of the notice issued by the BOP.
2. Requires a pharmacist filling a prescription pursuant to this section to exercise appropriate professional judgment, including reviewing the patient’s activity report from the CURES Prescription Drug Monitoring Program, before dispensing the medication.

FISCAL EFFECT:

Unknown. This bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

1. Purpose. This bill is sponsored by the California State Board of Pharmacy. According to the Author’s office, “SB 569 authorizes a pharmacist the ability to dispense a controlled substance based on a noncompliant security prescription form during limited period of time during a declared local, state, or federal emergency.

“Patient care areas during a declared disaster may occur in nontraditional settings such as emergency shelters in public schools or churches. Such locations are not equipped to provide traditional medical patient care services, and volunteer medical providers may not have access to compliant controlled substances security forms.

“[This bill is necessary because] there is currently no exemption for a declared disaster from required controlled substances security forms. In addition, the California State Board of Pharmacy does not have the authority to waive provisions of the Health and Safety Code in the event of local, state or federal disasters.”

1. Background on the BOP. The BOP was formed in 1891 as a state health regulatory agency. In 1971, the BOP became part of the DCA, which is part of the executive branch of the government of the State of California.

The BOP consists of 13 members who are appointed to four-year terms. The Governor appoints seven registered pharmacists and four public members. The Senate Rules Committee and the Speaker of the Assembly each appoint one public member.

The BOP regulates the practice of pharmacies, pharmacists, interns, pharmacy technicians, and exemptees (those who are involved with the wholesale or manufacturer of drugs and medical devices, but not required to hold a pharmacist license). The BOP also regulates all types of firms that distribute prescription drugs and devices in California, including community pharmacies and those located in hospitals, clinics, home and community support services facilities, and out-of-state mail order pharmacies that fill prescriptions and deliver them in California.

In 2018, the BOP issued 139,640 licenses, registrations, permits, and certificates. Of those, over 35,000 were PT licenses, 22,000 were pharmacist licenses, and nearly 300 were APP recognitions.

The Board is totally self-funded and receives no tax money from the General Revenue Fund of the State of California. Funds necessary for its operation are generated primarily through its licensing fees.

1. Controlled Substances Prescription Drug Forms. California law requires 15 elements to appear on California Security Prescription Forms, and these forms must be produced by printers licensed by the California Department of Justice.

The elements are as follows:

• • 1. A latent, repetitive “void” pattern across the entire front of the prescription blank; if a prescription is scanned or photocopied, the word “void” shall appear in a pattern across the entire front of the prescription.
    2. A watermark on the backside of the prescription blank; the watermark shall consist of the words “California Security Prescription.”
    3. A chemical void protection that prevents alteration by chemical washing.
    4. A feature printed in thermochromic (temperature sensitive) ink.
    5. An area of opaque writing so that the writing disappears if the prescription is lightened.
    6. A description of the security features included on each prescription form.
    7. Six quantity check off boxes on the form so that the prescriber may indicate the quantity by checking the applicable box where the following quantities shall appear. In conjunction with the quantity boxes, a space shall be provided to designate the units referenced in the quantity boxes when the drug is not in tablet or capsule form.
    8. Prescription blanks shall contain a statement printed on the bottom of the prescription blank that the “Prescription is void if the number of drugs prescribed is not noted.”
    9. The preprinted name, category of licensure, license number, federal controlled substance registration number, and address of the prescribing practitioner.
    10. Check boxes on the form so that the prescriber may indicate the number of refills ordered.
    11. The date of origin of the prescription.
    12. A check box indicating the prescriber’s order not to substitute.
    13. An identifying number assigned to the approved security printer by the Department of Justice.
    14. A check box by the name of each prescriber when a prescription form lists multiple prescribers.
    15. A unique serialized number.

This bill allows a pharmacist to furnish controlled substances during an emergency without these forms, if certain other patient- and drug-specific information is provided.

1. Current Related Legislation. SB 159 (Weiner) of 2019 authorizes a pharmacist to furnish pre- and post-exposure prophylaxis, as specified. (Status: This bill is currently pending in the Senate Health Committee.)

AB 149 (Cooper, Chapter 4, Statutes of 2019) authorizes pharmacies to fill prescriptions issued on forms that were valid prior to January 1, 2019 for two years and delays implementation of a requirement, enacted through legislation in 2018, for uniquely serialized numbers on prescription forms.

1. Arguments in Support. The BOP writes, “This measure will provide a limited exemption from the controlled substances security form requirement during a declared local, state, or federal disaster.

“As part of its consumer protection role, the board undertook review of recent declared disasters that have negatively impacted Californians to determine if gaps in legal provisions exist. As part of this process the board received testimony from pharmacists involved in relief efforts. One of the challenges noted was a barrier to access to controlled substances caused by the security forms required for such medications. As the board lacks the authority to waive a provision of the Health and Safety Code during a declared disaster and being mindful of the opioid epidemic, the board’s proposal strikes a balance between removing the barrier to access to medications during the initial phases of a disaster and preventing the possible exploitation of such an exemption.”

SUPPORT AND OPPOSITION:

Support:

California State Board of Pharmacy

Opposition:

None on file as of April 17, 2019.

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