Currrent as of February 4, 2022
Assembly Bill No. 387
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Introduced by Assembly Member Gabriel |
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An act to add and repeal Section 4078.5 of the Business and Professions Code, relating to healing arts.
LEGISLATIVE COUNSEL’S DIGEST
AB 387, as amended, Gabriel. Task force: adverse drug events: prescriptions.
The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy. Existing law prohibits a pharmacist from dispensing a prescription unless the prescription container contains specified information, including the condition or purpose for which the drug was prescribed if the condition or purpose is indicated on the prescription.
This bill would create the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force, with membership as prescribed, to develop information, make recommendations, and report findings to the California State Board of Pharmacy, the Medical Board of California, and to the Legislature on matters relating to the inclusion of the condition or purpose for which a drug is prescribed on prescription labels and adverse drug events. The bill would require each board, following submission of the report, to adopt regulations to implement recommendations in the report that are within the jurisdiction of the relevant board to enact through regulation if, in the independent determination of the board, the regulations will achieve the goals of improving the patient opt-in process, increasing the prevalence of patient opt-ins, as defined, and reducing the prevalence of adverse drug events.
Vote: majority Appropriation: no Fiscal Committee: yes Local Program: no
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1.
Section 4078.5 is added to the Business and Professions Code, to read:
4078.5.
(a) As used in this section:
(1) “Family physician” means a board-eligible or board-certified physician specializing in family medicine.
(2) “Independent community pharmacy” means a pharmacy owned by a person or entity who owns no more than four pharmacies in California.
(3) “Patient opt-in” means that, at the request of the patient, the condition or purpose for which a drug was prescribed is indicated on the prescription label in accordance with subparagraph (D) of paragraph (1) of subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations.
(4) “Task force” means the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force created by subdivision (b).
(b) (1) There is hereby created the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force.
(2) The task force shall be composed of the following individuals:
(A) A representative from the Medical Board of California.
(B) A representative from the California State Board of Pharmacy.
(C) A representative with pharmacy or medical expertise appointed by the Governor’s office.
(D) A representative from the State Department of Public Health.
(E) A representative with pharmacy or medical expertise appointed by the Senate Committee on Rules.
(F) A representative with pharmacy or medical expertise appointed by the Speaker of the Assembly.
(G) A representative from an independent community pharmacy.
(H) A representative from retail pharmacies.
(I) A representative from a patient advocacy group.
(J) A representative from a physician organization.
(K) A representative from a family physician organization.
(L) A representative from an obstetrics and gynecology organization.
(M) A representative from an infectious disease specialty organization.
(N) A representative from a cardiologist organization.
(3) The representatives from the Medical Board of California and the California State Board of Pharmacy shall serve as the chairs of the task force.
(4) Notwithstanding any other law, members of the task force shall not receive compensation or any other payment for their service on the task force. All administrative expenses for the task force shall be absorbed by the Medical Board of California and the California State Board of Pharmacy. The task force may also receive funding pursuant to an appropriation in the Budget Act.
(c) The task force shall develop information and make recommendations to the Medical Board of California, the California State Board of Pharmacy, and the Legislature that shall include, but are not limited to, information on the following specific topics:
(1) The prevalence of patient opt-ins.
(2) Prescriber and pharmacy compliance with subparagraph (D) of paragraph (1) of subdivision (a) of Section 1707.5 of Title 16 of the California Code of Regulations.
(3) Barriers to increasing the number of patient opt-ins.
(4) A cost-benefit analysis of the benefits of increasing patient opt-ins versus the administrative burden caused by increased patient opt-ins.
(5) Prevalence of adverse drug events for varying demographics, including, but not limited to: race, age, gender, income, disabilities, and geographic location.
(6) Recommendations to improve the patient opt-in process, increase the prevalence of patient opt-ins, and reduce the prevalence of adverse drug events.
(d) The task force shall prepare and submit to the Legislature, the Medical Board of California, and the California State Board of Pharmacy, by September 1, 2020, a report on its findings and recommendations. Following submission of the report, the Medical Board of California and the California State Board of Pharmacy shall adopt regulations to implement recommendations in the report that are within the jurisdiction of the relevant board if, in the independent determination of the board, the regulations will achieve the goals of improving the patient opt-in process, increasing the prevalence of patient opt-ins, and reducing the prevalence of adverse drug events.
(e) (1) A report to be submitted to the Legislature pursuant to subdivision (d) shall be submitted in compliance with Section 9795 of the Government Code.
(2) Pursuant to Section 10231.5 of the Government Code, this section is repealed on January 1, 2024.
AB 387