Existing law requires the county superintendent of schools, the superintendent of a school district, a charter school, or the owner or operator of a private school that provides transportation to or from a school or school activity to prepare a transportation safety plan containing procedures for school personnel to follow to ensure the safe transport of pupils, as prescribed.

This bill would make a nonsubstantive change in this provision.

CONCURRENCE IN SENATE AMENDMENTS

ATR Bill Id:AB 149

Author:(Cooper)

As Amended Ver:February 19, 2019

2/3 vote. Urgency

SUMMARY:

Clarifies 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 confirms the validity of prescriptions written on nonserialized forms until a delayed date for purposes of dispensing prescriptions written on nonserialized forms.

The Senate Amendments correct a nonsubstantive drafting error.

COMMENTS:

According to the Author:

AB 149 is an important measure to ensure patients continue to receive timely and uninterrupted access to necessary medications and care while all stakeholders work together to fine tune security requirements for prescription forms.

Arguments in Support:

The California Medical Association (CMA) is the sponsor of this bill. According to the CMA, "the Department of Justice implemented the new [serialization] requirements and the printers started printing the new security prescription pads on January 1st. However, because they did not print them until January 1st, prescribers could not obtain these new pads in time to begin utilizing them on the January 1st effective date." The CMA believes that "this error in timing has left patients unable to fill their essential prescriptions because their prescriber has not been able to get the newly formatted prescription pads fast enough." The CMA writes that "AB 149's delay in implementation will allow time for the Department of Justice to ensure the serial numbers on the prescription pads are valid and meet all state, federal, and industry requirements and will also deem prescriptions valid if they are on prescription forms that were valid prior to January 1, 2019, as well as prescription forms printed since January 1, 2019."

Arguments in Opposition:

None on file.

FISCAL COMMENTS:

According to the Senate Appropriations Committee, approximately $1,500 for the Department of Justice to obtain two memberships to the National Council for Prescription Drug Program Standards to monitor compliance.

VOTES:

ASM BUSINESS AND PROFESSIONS: 16-0-4

YES: Low, Arambula, Bloom, Chen, Chiu, Cunningham, Dahle, Eggman, Fong, Gloria, Grayson, Holden, Medina, Mullin, Obernolte, Ting

ABS, ABST OR NV: Brough, Gipson, Irwin, McCarty

ASM APPROPRIATIONS: 15-0-2

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

ABS, ABST OR NV: Calderon, Diep

ASSEMBLY FLOOR: 77-0-3

YES: Aguiar-Curry, Arambula, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Daly, Diep, Eggman, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo 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, O'Donnell, Obernolte, 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

ABS, ABST OR NV: Calderon, Dahle, Flora

SENATE FLOOR: 35-0-3

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

ABS, ABST OR NV: Bates, Glazer, Stern

UPDATED:

VERSION: February 19, 2019

CONSULTANT: Robert Sumner / B. & P. / (916) 319-3301 FN: 0000035

 THIRD READING  

Bill No: AB 149

Author: Cooper (D), et al.

Amended: 2/19/19 in Senate

Vote: 27 - Urgency

SENATE BUS., PROF. & ECON. DEV. COMMITTEE: 9-0, 2/19/19

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

SENATE APPROPRIATIONS COMMITTEE: 6-0, 2/20/19

AYES: Portantino, Bates, Bradford, Hill, Jones, Wieckowski

ASSEMBLY FLOOR: 77-0, 2/7/19 (Consent) - See last page for vote

SUBJECT: Controlled substances: prescriptions

SOURCE: California Medical Association

DIGEST:

This bill is an urgency measure that 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.

ANALYSIS:

Existing law:

1. Requires that all prescription forms for controlled substance prescriptions be obtained from security printers approved by the Department of Justice (DOJ). (Health and Safety Code (HSC) § 11161.5)
2. Establishes requirements for filling, compounding, or dispensing prescriptions for a controlled substance, including that the prescription be made on a form that contains a uniquely serialized number, among other requirements. (HSC § 11162.1 and 11164 (a))
3. Establishes the Controlled Substances Utilization Review and Evaluation System (CURES) for the electronic monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of Schedule II, III and IV controlled substance prescription information to the DOJ no more than seven days from the time prescriptions are dispensed. (HSC § 11165)
4. Requires the theft or loss of prescription forms to be reported immediately by the security printer or affected prescriber to CURES, no later than three days after the discovery of the theft or loss and enables security printers and prescribers to report stolen or lost prescription pads to the DOJ through CURES. (HSC § 11165.3)

This bill:

1. Delays implementation of the requirement, enacted through legislation in 2018, for uniquely serialized numbers on prescription forms.
2. Requires the serialized number on prescription forms to be compliant with all state and federal requirements, utilizable as a barcode that may be scanned by dispensers, and compliant with current National Council for Prescription Drug Program Standards.
3. Authorizes, until January 1, 2021, pharmacies to fill prescriptions on forms that were valid prior to January 1, 2019.
   
4. Permits the DOJ to extend the period during which prescriptions written on noncompliant prescription forms remain valid, for a period no longer than an additional six months, if the DOJ determines that there is an inadequate availability of compliant prescription forms to meet the demand on or before January 1, 2021.

Background

Under the DOJ’s Security Prescription Printers Program, all paper prescriptions of any Schedule II through V controlled substance must be issued on 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, once approved, these printers are required to retain records for inspection by the DOJ and may be fined or have their approval revoked for misconduct. Practitioners authorized to prescribe controlled substances select a vendor from the DOJ’s list of approved printers and obtain the tamper-resistant prescription forms directly from that company.

In response to concerns that the requirements for prescription pads did not include a uniquely serialized number, and delivery information reported by security printers to the DOJ did not include information specifically identifying prescription pads through a serial number, AB 1753 (Low, Chapter 479, Statutes of 2018) established the requirement for prescription forms to contain this feature. That bill took effect on January 1, 2019 and almost 40 printers approved by DOJ were ready to print pads containing uniquely serialized numbers. The California State Board of Pharmacy (BOP) and Medical Board of California (MBC) issued notices to their respective dispenser and prescriber licensee communities updating them about the pending change in requirements for prescription forms. However, in the weeks leading up to the new requirements, questions remained about implementation and there was unease about the timeframe for the change in law, coupled with the subsequent potential inability for prescribers to obtain new, compliant prescription forms by January 1 2019. The BOP and the MBC also received reports that some pharmacies in the state would not fill prescriptions issued on pads that did not conform to the new law, thus impacting patients’ ability to receive controlled substances prescriptions.

On January 10, 2019, DOJ, the BOP, and the MBC issued a joint statement acknowledging that full compliance with the serial number requirements may take more time and that prescribers may be using outdated prescription forms. The joint statement advised that the BOP “would not make an enforcement priority of actions against and/or investigations of pharmacists (or their employing pharmacies) who, in the exercise of his or her best professional judgment, determine that it is in the best interest of patient or public health or safety to fill a controlled substance prescription written on a form that would have been compliant prior to January 1, 2019.”

During this same period, questions arose as to whether additional time was necessary to determine the best format for these uniquely serialized numbers and whether California should require a 15-digit alphanumeric number, as some states with this requirement do, or if a different amount of digits would be more in line with standards across the nation.

This bill responds to these issues by delaying the requirement for a uniquely serialized number to be a necessary feature on prescription pads until a date determined by DOJ, but no later than January 1, 2020. This bill also outlines standards for the serial number, including compliance with all state and federal requirements, utilizable as a barcode that may be scanned by dispensers, and compliant with current standards established by the National Council for Prescription Drug Program Standards, a private multi-stakeholder forum for developing and promoting industry standards.

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

According to the Senate Appropriations Committee analysis dated February 20, 2019, “According to the Department of Consumer Affairs, no anticipated fiscal impact to the department or to the programs. The Department of Justice (DOJ) estimates costs of approximately $1,500 for two NCPDP memberships for staff to monitor state and federal requirements.”

SUPPORT: (Verified 2/22/19)

California Medical Association (source)

California Academy of Child and Adolescent Psychiatry

California Association for Nurse Practitioners

California Dental Association

California Hospital Association

California Pharmacists Association

California Psychiatric Association

California Retailers Association

California Society of Anesthesiologists

County Behavioral Health Directors Association

Kaiser Permanente

Medical Board of California

National Association of Chain Drug Stores

Providence St. Joseph Health

OPPOSITION: (Verified 2/22/19)

None received

ARGUMENTS IN SUPPORT: Supporters believe that this bill will remedy the unintended consequences of AB 1753 and appreciate the delayed implementation for that bill’s prescription form requirements. Supporters state that AB 149 will ensure patients continue to have access to medications and will allow prescribers sufficient time to comply with the new law. According to the California Dental Association, “providers, including dentists, and their patients are reporting that pharmacies are refusing to fill prescriptions in a timely manner and patients are having difficulties finding a pharmacy that will honor their prescription forms.”

ASSEMBLY FLOOR: 77-0, 2/7/19

AYES: Aguiar-Curry, Arambula, Bauer-Kahan, Berman, Bigelow, Bloom, Boerner Horvath, Bonta, Brough, Burke, Carrillo, Cervantes, Chau, Chen, Chiu, Choi, Chu, Cooley, Cooper, Cunningham, Daly, Diep, Eggman, Fong, Frazier, Friedman, Gabriel, Gallagher, Cristina Garcia, Eduardo 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: Calderon, Dahle, Flora

Prepared by: Sarah Mason / B., P. & E.D. / 916-651-4104

2/22/19 14:34:57

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2019 - 2020 Regular Session

AB 149 (Cooper) - Controlled substances: prescriptions.

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

Bill Summary:

AB 149 would require the Department of Justice to determine a date, no later than January 1, 2020, for the uniquely serialized numbers to be a required feature in new prescription forms by approved security printers.

Fiscal Impact:

According to the Department of Consumer Affairs, no anticipated fiscal impact to the department or to the programs. The Department of Justice (DOJ) estimates costs of approximately $1,500 for two NCPDP memberships for staff to monitor state and federal requirements. For further detail, please see Staff Comments.

Background:

• 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 from DOJ-approved manufacturers. AB 1753 (Low), Chapter 479, Statutes of 2018, authorized the DOJ to, by regulation, reduce the number of approved security printers that manufacture regulated prescription pads to no fewer than three vendors, and also, required, by January 1, 2019, prescription forms to have serial numbers that are to be reported to the Controlled Substance Utilization Review and Evaluation System (CURES) database.

Since AB 1753’s enactment in September 2018, the DOJ issued guidance related to the security printers and reporting requirements, and developed a prescription pad format for security printers. Thirty-eight security printers are compliant with the new requirement. In addition, the DOJ tested a secure file transfer site for each of the secure printers to transfer prescription pad and delivery data. While the DOJ has modified the CURES database to manually accept the prescription serial numbers, the department is in the process of building the web-based application to facilitate the submission of requirement information.

On January 10, 2018, the DOJ, Board of Pharmacy, and Medical Board issued a joint statement, notifying prescribers and dispensers that there may be a period of weeks or months during which prescribers may use outdated security forms due to this “absence of a grandfathering or transition period” in AB 1753. Currently, when prescribers use non-serialized prescription pads for patient prescriptions, dispensers must validate, typically over the phone, specific prescription with prescribers. The Pharmacy Board’s Enforcement Committee noted they would not prioritize actions against pharmacists, or their employing pharmacies until July 1, 2019, if dispensers use the outdated non-serialized forms and are exercising their best professional judgment. The letter’s signatories encouraged prescribers to procure compliant security forms at their earliest opportunity.

Proposed Law:

Assembly Bill 149 includes the following provisions:

• Provides an extension on the requirement that uniquely serialized number on the prescription form for controlled substance be a required feature in the printing of new prescription forms produced by approved security printers until a date determined by the Department of Justice (DOJ), which must be no later than January 1, 2020.
• Requires the DOJ to prescribe specifications for the serialized number, which must meet the following minimum requirements: (1) be compliant with all state and federal requirements, (2) be utilizable as a barcode that can be scanned by dispensers, and be compliant with current National Council for Prescription Drug Program Standards (NCPDP), (3) be compliant with current National Council for Prescription Drug Program Standards.
• Makes any prescription written on a form that was valid prior to January 1, 2019, but does not include a serialized number, be a valid prescription that may be filled, compounded, or dispensed until January 1, 2021.
• Authorizes the Department of Justice to extend the time period during which prescriptions written on noncompliant prescription forms remain valid no more than an additional six additional months, if there is an inadequate availability of compliant prescription forms.
• Makes other technical changes, including making the term “prescribers” non-gendered.

Related Legislation:

Assembly Bill 1753 (Low), Chapter 479, Statutes of 2018.

Staff Comments:

The August 6, 2018 Senate Appropriations Committee and Department of Finance (DOF) fiscal analyses identified AB 1753 costs at $966,000 (General Fund) in 2018-19 and $180,000 (GF), in 2019-20 and ongoing, for a one-time external consultant ($221,000 GF) for development of the web-based application, a contract with Department of Technology (CDT) for project oversight ($83,000), network costs ($475,000 GF), and department costs ($105,000). The Governor’s 2019-20 January Budget did not include any funding for AB 1753 implementation.

The DOJ provided staff further clarification of AB 149’s needs “if AB 1753 funding is not received”, noting that AB 149 builds on the requirements of AB 1753. It appears that the evaluation of AB 149 costs may have coincided with an operational reassessment of AB 1753 implementation needs. For example, since September 2018, the DOJ now anticipates higher than projected costs for AB 1753, due to increased contract costs with CDT oversight and a longer contract period for an external consultant (previously estimated for six-months, now expected to be 18-months). These refined costs for AB 1753 implementation were included in AB 149’s estimate. As such, staff does not include some of DOJ’s estimate in the Fiscal Section because costs for AB 149 are strongly linked to AB 1753, which were previously scored last year.

-- END --

SENATE COMMITTEE ON

BUSINESS, PROFESSIONS AND ECONOMIC DEVELOPMENT

Senator Steven Glazer, Chair

2019 - 2020 Regular

Bill No: AB 149 Hearing Date: February 19, 2019

Subject: Controlled substances: prescriptions.

SUMMARY:

1. An urgency measure that 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.

Existing law:

1. Requires that all prescription forms for controlled substance prescriptions be obtained from security printers approved by the Department of Justice (DOJ). (Health and Safety Code (HSC) § 11161.5)
2. Establishes requirements for filling, compounding, or dispensing prescriptions for a controlled substance, including that the prescription be made on a form that contains a uniquely serialized number, among other requirements. (HSC § 11162.1 and 11164 (a))
3. Establishes CURES for the electronic monitoring of Schedule II, III and IV controlled substance prescriptions. CURES provides for the electronic transmission of Schedule II, III and IV controlled substance prescription information to the DOJ no more than seven days from the time prescriptions are dispensed. (HSC § 11165)
4. Requires the theft or loss of prescription forms to be reported immediately by the security printer or affected prescriber to CURES, no later than three days after the discovery of the theft or loss and enables security printers and prescribers to report stolen or lost prescription pads to the DOJ through CURES. (HSC § 11165.3)

This bill:

1. Delays implementation of the requirement, enacted through legislation in 2018, for uniquely serialized numbers on prescription forms.
2. Requires the serialized number on prescription forms to be compliant with all state and federal requirements, utilizable as a barcode that may be scanned by dispensers, and compliant with current National Council for Prescription Drug Program Standards.
3. Until January 1, 2021, authorizes pharmacies to fill prescriptions on forms that were valid prior to January 1, 2019.
   
4. Permits the DOJ to extend the period during which prescriptions written on noncompliant prescription forms remain valid, for a period no longer than an additional six months, if the DOJ determines that there is an inadequate availability of compliant prescription forms to meet the demand on or before January 1, 2021.

FISCAL EFFECT: This bill is keyed fiscal by Legislative Counsel. According to the Assembly Committee on Appropriations analysis dated February 4, 2019, this bill will result in minor and absorbable administrative costs to modify guidance and inform internal and external stakeholders of the new requirements.

COMMENTS:

1. Purpose. The California Medical Association is the Sponsor of this bill. According to the Author, this bill will allow patients to regain access to their critically needed medication. “AB 149’s delay in implementation will allow time for the Department of Justice to ensure the serial numbers on the prescription pads are valid and meet all state, federal, and industry requirements and will also deem prescriptions valid if they are on prescription forms that were valid prior to January 1, 2019 as well as prescription forms printed since January 1, 2019.”
2. Background. Under the DOJ’s Security Prescription Printers Program, all paper prescriptions of any Schedule II through V controlled substance must be issued on 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, once approved, these printers are required to retain records for inspection by the DOJ and may be fined or have their approval revoked for misconduct. Practitioners authorized to prescribe controlled substances select a vendor from the DOJ’s list of approved printers and obtain the tamper-resistant prescription forms directly from that company.

In response to concerns that the requirements for prescription pads did not include a uniquely serialized number, and delivery information reported by security printers to the DOJ did not include information specifically identifying prescription pads through a serial number, AB 1753 (Low, Chapter 479, Statutes of 2018) established the requirement for prescription forms to contain this feature. The measure took effect on January 1, 2019 and almost 40 printers approved by DOJ were ready to print pads containing uniquely serialized numbers. The California State Board of Pharmacy (BOP) and Medical Board of California (MBC) issued notices to their respective dispenser and prescriber licensee communities updating them about the pending change in requirements for prescription forms. However, in the weeks leading up to the new requirements, questions remained about implementation and there was unease about the timeframe for the change in law, coupled with the subsequent potential inability for prescribers to obtain new, compliant prescription forms by January 1 2019. The BOP and the MBC also received reports that some pharmacies in the state would not fill prescriptions issued on pads that did not conform to the new law, thus impacting patients’ ability to receive controlled substances prescriptions.

On January 10, 2019, DOJ, the BOP, and the MBC issued a joint statement acknowledging that full compliance with the serial number requirements may take more time and that prescribers may be using outdated prescription forms. The joint statement advised that the BOP “would not make an enforcement priority of actions against and/or investigations of pharmacists (or their employing pharmacies) who, in the exercise of his or her best professional judgment, determine that it is in the best interest of patient or public health or safety to fill a controlled substance prescription written on a form that would have been compliant prior to January 1, 2019.”

During this same period, questions arose as to whether additional time was necessary to determine the best format for these uniquely serialized numbers and whether California should require a 15-digit alphanumeric number, as some states with this requirement do, or if a different amount of digits would be more in line with standards across the nation.

This bill responds to these issues by delaying the requirement for a uniquely serialized number to be a necessary feature on prescription pads until a date determined by DOJ, but no later than January 1, 2020. The bill also outlines standards for the serial number, including compliance with all state and federal requirements, utilizable as a barcode that may be scanned by dispensers, and compliant with current standards established by the National Council for Prescription Drug Program Standards, a private multi-stakeholder forum for developing and promoting industry standards.

1. Arguments in Support. Supporters believe that this bill will remedy the unintended consequences of AB 1753 and appreciate the delayed implementation for that bill’s prescription form requirements. Supporters state that AB 149 will ensure patients continue to have access to medications and will allow prescribers sufficient time to comply with the new law. According to the California Dental Association, “providers, including dentists, and their patients are reporting that pharmacies are refusing to fill prescriptions in a timely manner and patients are having difficulties finding a pharmacy that will honor their prescription forms.”
2. Technical Amendment. The bill should be amended as follows to correct a drafting error:

On page 5, in line 6, strike “complaint” and replace with “compliant”

6 (1) The serialized number shall be complaint compliant with all state and

7 federal requirements.

SUPPORT AND OPPOSITION:

Support:

California Association for Nurse Practitioners

California Academy of Child and Adolescent Psychiatry

California Dental Association

California Hospital Association

California Medical Association

California Pharmacists Association

California Retailers Association

California Society of Anesthesiologists

Kaiser Permanente

Medical Board of California

National Association of Chain Drug Stores

Opposition:

None received as of February 15, 2019.

-- END --

Date of Hearing: February 4, 2019

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 149

Author:(Cooper) – As Amended Ver:January 30, 2019

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

SUMMARY:

This bill delays implementation of a provision of law that became effective January 1^st of this year, which requires prescription medication forms to include a unique serialized number, as specified.

It also imposes new requirements for the forms and allows prescriptions written on non-compliant forms—those approved as of January 1, 2019 or before— to be considered valid and able to be filled until January 1, 2021.

FISCAL EFFECT:

Minor and absorbable administrative costs to Department of Justice (DOJ), California Medical Board, and Board of Pharmacy to modify guidance and inform internal and external stakeholders of the new requirements.

COMMENTS:

1. Purpose. Pursuant to a provision in AB 1753 (Low), Chapter 479, Statutes of 2018, all prescription forms must include a unique serialized number as of January 1, 2019, rendering invalid prescriptions written on forms that are out of compliance with the serialized number requirement. The provision was intended to tighten control over the pads, minimizing potential fraudulent or excessive prescriptions to ameliorate the opioid epidemic. However, given the bill was signed into law in mid-September 2018, its rapid implementation means many patients have been provided prescriptions on forms that are not yet compliant, and many providers are not yet using compliant forms. Accordingly, patients are being denied needed medications when attempting to fill prescriptions, because the law and DOJ guidance requires forms to be compliant as of January 1, of this year.

This bill addresses this problem by delaying the operative date. The bill also imposes new requirements on the prescription forms, such as the ability to scan serialized numbers using a barcode scanner. This bill is sponsored by the California Medical Association and has no opposition.

1. Recent State Guidance. On January 10, 2019, the state DOJ, Board of Pharmacy, and Medical Board of California issued a joint statement acknowledging questions remain about the implementation of the new requirement for serialized numbers on prescription forms. The guidance notes there may be a period of weeks or months during which prescribers continue to use outdated forms.

While the guidance acknowledges the law requires serialized numbers, it implies enforcement actions against pharmacists who use their best professional judgement in filling a prescription on an outdated form prior to July 1, 2019, will be de-prioritized, and suggests strategies pharmacists should consider to meet patient needs if presented with an outdated form.

1. Prior Legislation. AB 1753 (Low), Chapter 479, Statutes of 2018, required prescription forms to contain unique serialized numbers.

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

Date of Hearing: January 29, 2019

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

ABPCA Bill Id:AB 149

Author:(Cooper) – As Amended Ver:January 24, 2019

SUBJECT: Controlled substances: Prescriptions.

SUMMARY: Clarifies the specifications for the uniquely serialized number required in the printing of new prescription forms by security printers approved by the Department of Justice (DOJ), and expressly confirms the validity of prescriptions written on nonserialized forms until a delayed date for purposes of dispensing prescriptions written on nonserialized forms.

EXISTING LAW:

1. 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)
2. 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)
3. 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)
4. 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)

THIS BILL:

1. Specifies that the format for the uniquely serialized number prescribed by the DOJ must meet state and federal requirements, must be utilizable as a scannable barcode, and must be compliant with National Council for Prescription Drug Program Standards (NCPDPS).
2. Provides that an otherwise compliant prescription for controlled substances is valid and may be filled, compounded or dispensed, notwithstanding whether it contains a uniquely serialized number, until January 1, 2021.

FISCAL EFFECT: Unknown.

COMMENTS:

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

“AB 149 is an important measure to ensure patients continue to receive timely and uninterrupted access to necessary medications and care while all stakeholders work together to fine tune security requirements for prescription forms.”

Background. 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. These prescription forms are required to contain a number of security features and identifying markers. Prior to January 1, 2019, a uniquely serialized number was not a required feature, 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 addition to this clarification, this bill would also provide greater specificity to the required serialized number to ensure compliance with various dispensing requirements and operational needs.

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.

ARGUMENTS IN SUPPORT:

The California Medical Association (CMA) is the sponsor of this bill. According to the CMA, “the Department of Justice implemented the new [serialization] requirements and the printers started printing the new security prescription pads on January 1st. However, because they did not print them until January 1st, prescribers could not obtain these new pads in time to begin utilizing them on the January 1st effective date.” The CMA believes that “this error in timing has left patients unable to fill their essential prescriptions because their prescriber has not been able to get the newly formatted prescription pads fast enough.” The CMA writes that “AB 149’s delay in implementation will allow time for the Department of Justice to ensure the serial numbers on the prescription pads are valid and meet all state, federal, and industry requirements and will also deem prescriptions valid if they are on prescription forms that were valid prior to January 1, 2019 as well as prescription forms printed since January 1, 2019.”

ARGUMENTS IN OPPOSITION:

None on file.

AMENDMENTS:

1. To ensure that the validity of prescriptions for medication written on nonserialized prescription forms is confirmed as quickly as possible to allow for pharmacists to confidently dispense all otherwise valid prescriptions, an urgency clause should be adopted.
2. To remove unnecessary language creating the express possibility of formal rulemaking by the DOJ that would potentially exceed the timelines specified in the bill, Section 11162.2(c) should be struck in its entirety.
3. To resolve an ambiguity in language intended to confirm the validity of both serialized and nonserialized prescription forms until January 1, 2021, amend Section 11164(e)(1) to read:

Notwithstanding any other law, a prescription written on a prescription form that was otherwise valid prior to January 1, 2019 but does not comply with paragraph (15), or a valid controlled substance prescription form approved by the Department of Justice as of January 1, 2019, is a valid prescription that may be filled, compounded, or dispensed until January 1, 2021.

REGISTERED SUPPORT:

California Medical Association

REGISTERED OPPOSITION:

None.

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