| Old | New | Differences | |
|---|---|---|---|
| 1 | - | Amended IN Senate | |
| 1 | + | Amended IN Senate July 02, 2019 Amended IN Assembly May 20, 2019 Amended IN Assembly April 22, 2019 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 387Introduced by Assembly Member GabrielFebruary 05, 2019 An act to add add and repeal Section 2051.1 to 4078.5 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 387, as amended, Gabriel. Physician and surgeons: pharmacists: Task force: adverse drug events: prescriptions.The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and authorizes a licensed physician and surgeon to use drugs or devices in or upon human beings and to sever or penetrate the tissues of human beings and to use any and all other methods in the treatment of diseases, injuries, deformities, and other physical and mental conditions.This bill would require a physician and surgeon, on and after January 1, 2022, when providing a prescription for a drug or device to a patient, to discuss with the patient the opportunity to opt in to having the physician and surgeon indicate the purpose for the drug or device on the prescription.The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy. Existing law requires the California State Board of Pharmacy to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California.Under the bill, if the purpose of a drug or device is not indicated on a prescription for that drug or device as required by the bill, a dispensing pharmacist would not be responsible for ascertaining the purpose or, on or after January 1, 2022, determining whether the patient opted in to a drug or device purpose indication. The bill would require the California State Board of Pharmacy to adopt regulations by January 1, 2022, providing technical guidance regarding the format and manner in which a pharmacist is to incorporate drug or device purpose indications on the standardized, patient-centered, prescription drug label.This bill would create the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force, with membership as prescribed, to develop specified information and make recommendations to the boards and to the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. The bill would require the task force to report on its findings and recommendations. 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-in, and reducing the prevalence of adverse drug events.Digest KeySection 4078.5 is added to the Business and Professions Code, to read:4078.5. (a) As used in this section:(1) 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.(2) 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 Governors 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 community pharmacies.(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.(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 and the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d) The information developed pursuant to subdivision (c) shall include, but is not limited to, information on the following specific topics:(1) The prevalence of patient opt-in.(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-in, and reduce the prevalence of adverse drug events.(e) 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-in, and reducing the prevalence of adverse drug events.(f) (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. | |
| 2 | 2 | ||
| 3 | - | ||
| 3 | + | Amended IN Senate July 02, 2019 Amended IN Assembly May 20, 2019 Amended IN Assembly April 22, 2019 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Assembly Bill No. 387Introduced by Assembly Member GabrielFebruary 05, 2019 An act to add add and repeal Section 2051.1 to 4078.5 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGESTAB 387, as amended, Gabriel. Physician and surgeons: pharmacists: Task force: adverse drug events: prescriptions.The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and authorizes a licensed physician and surgeon to use drugs or devices in or upon human beings and to sever or penetrate the tissues of human beings and to use any and all other methods in the treatment of diseases, injuries, deformities, and other physical and mental conditions.This bill would require a physician and surgeon, on and after January 1, 2022, when providing a prescription for a drug or device to a patient, to discuss with the patient the opportunity to opt in to having the physician and surgeon indicate the purpose for the drug or device on the prescription.The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy. Existing law requires the California State Board of Pharmacy to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California.Under the bill, if the purpose of a drug or device is not indicated on a prescription for that drug or device as required by the bill, a dispensing pharmacist would not be responsible for ascertaining the purpose or, on or after January 1, 2022, determining whether the patient opted in to a drug or device purpose indication. The bill would require the California State Board of Pharmacy to adopt regulations by January 1, 2022, providing technical guidance regarding the format and manner in which a pharmacist is to incorporate drug or device purpose indications on the standardized, patient-centered, prescription drug label.This bill would create the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force, with membership as prescribed, to develop specified information and make recommendations to the boards and to the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. The bill would require the task force to report on its findings and recommendations. 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-in, and reducing the prevalence of adverse drug events.Digest KeySection 4078.5 is added to the Business and Professions Code, to read: | |
| 4 | 4 | ||
| 5 | - | ||
| 5 | + | Amended IN Senate July 02, 2019 Amended IN Assembly May 20, 2019 Amended IN Assembly April 22, 2019 | |
| 6 | 6 | ||
| 7 | - | Amended IN Senate August 12, 2019 | |
| 8 | 7 | Amended IN Senate July 02, 2019 | |
| 9 | 8 | Amended IN Assembly May 20, 2019 | |
| 10 | 9 | Amended IN Assembly April 22, 2019 | |
| 11 | 10 | ||
| 12 | 11 | CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION | |
| 13 | 12 | ||
| 14 | 13 | Assembly Bill | |
| 15 | 14 | ||
| 16 | 15 | No. 387 | |
| 17 | 16 | ||
| 18 | 17 | Introduced by Assembly Member GabrielFebruary 05, 2019 | |
| 19 | 18 | ||
| 20 | 19 | Introduced by Assembly Member Gabriel | |
| 21 | 20 | February 05, 2019 | |
| 22 | 21 | ||
| 23 | - | An act to add and repeal Section 4078.5 of the Business and Professions Code, relating to healing arts. | |
| 22 | + | An act to add add and repeal Section 2051.1 to 4078.5 of the Business and Professions Code, relating to healing arts. | |
| 24 | 23 | ||
| 25 | 24 | LEGISLATIVE COUNSEL'S DIGEST | |
| 26 | 25 | ||
| 27 | 26 | ## LEGISLATIVE COUNSEL'S DIGEST | |
| 28 | 27 | ||
| 29 | - | AB 387, as amended, Gabriel. Task force: adverse drug events: prescriptions. | |
| 28 | + | AB 387, as amended, Gabriel. Physician and surgeons: pharmacists: Task force: adverse drug events: prescriptions. | |
| 30 | 29 | ||
| 31 | - | The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and authorizes a licensed physician and surgeon to use drugs or devices in or upon human beings and to sever or penetrate the tissues of human beings and to use any and all other methods in the treatment of diseases, injuries, deformities, and other physical and mental conditions.The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy. Existing law requires the California State Board of Pharmacy to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California. | |
| 30 | + | The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and authorizes a licensed physician and surgeon to use drugs or devices in or upon human beings and to sever or penetrate the tissues of human beings and to use any and all other methods in the treatment of diseases, injuries, deformities, and other physical and mental conditions.This bill would require a physician and surgeon, on and after January 1, 2022, when providing a prescription for a drug or device to a patient, to discuss with the patient the opportunity to opt in to having the physician and surgeon indicate the purpose for the drug or device on the prescription.The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy. Existing law requires the California State Board of Pharmacy to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California.Under the bill, if the purpose of a drug or device is not indicated on a prescription for that drug or device as required by the bill, a dispensing pharmacist would not be responsible for ascertaining the purpose or, on or after January 1, 2022, determining whether the patient opted in to a drug or device purpose indication. The bill would require the California State Board of Pharmacy to adopt regulations by January 1, 2022, providing technical guidance regarding the format and manner in which a pharmacist is to incorporate drug or device purpose indications on the standardized, patient-centered, prescription drug label.This bill would create the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force, with membership as prescribed, to develop specified information and make recommendations to the boards and to the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. The bill would require the task force to report on its findings and recommendations. 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-in, and reducing the prevalence of adverse drug events. | |
| 32 | 31 | ||
| 33 | 32 | The Medical Practice Act provides for the licensure and regulation of physicians and surgeons by the Medical Board of California and authorizes a licensed physician and surgeon to use drugs or devices in or upon human beings and to sever or penetrate the tissues of human beings and to use any and all other methods in the treatment of diseases, injuries, deformities, and other physical and mental conditions. | |
| 34 | 33 | ||
| 34 | + | This bill would require a physician and surgeon, on and after January 1, 2022, when providing a prescription for a drug or device to a patient, to discuss with the patient the opportunity to opt in to having the physician and surgeon indicate the purpose for the drug or device on the prescription. | |
| 35 | 35 | ||
| 36 | 36 | ||
| 37 | - | The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy. Existing law requires the California State Board of Pharmacy to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California. 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. | |
| 38 | 37 | ||
| 39 | - | ||
| 38 | + | The Pharmacy Law provides for the licensure and regulation of the practice of pharmacy by the California State Board of Pharmacy. Existing law requires the California State Board of Pharmacy to promulgate regulations that require, on or before January 1, 2011, a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California. | |
| 40 | 39 | ||
| 41 | - | ||
| 40 | + | Under the bill, if the purpose of a drug or device is not indicated on a prescription for that drug or device as required by the bill, a dispensing pharmacist would not be responsible for ascertaining the purpose or, on or after January 1, 2022, determining whether the patient opted in to a drug or device purpose indication. The bill would require the California State Board of Pharmacy to adopt regulations by January 1, 2022, providing technical guidance regarding the format and manner in which a pharmacist is to incorporate drug or device purpose indications on the standardized, patient-centered, prescription drug label. | |
| 42 | 41 | ||
| 43 | - | ## Bill Text | |
| 44 | 42 | ||
| 45 | - | 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. (1)(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.(2)(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 Governors 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 community pharmacies. 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 and California, the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d)The information developed pursuant to subdivision (c) shall Pharmacy, and the Legislature that shall include, but is are not limited to, information on the following specific topics:(1) The prevalence of patient opt-in. 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-in, opt-ins, and reduce the prevalence of adverse drug events.(e)(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-in, opt-ins, and reducing the prevalence of adverse drug events.(f)(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. | |
| 46 | 43 | ||
| 47 | - | The | |
| 44 | + | This bill would create the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force, with membership as prescribed, to develop specified information and make recommendations to the boards and to the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. The bill would require the task force to report on its findings and recommendations. 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-in, and reducing the prevalence of adverse drug events. | |
| 48 | 45 | ||
| 49 | - | ## The | |
| 46 | + | ## Digest KeySection 4078.5 is added to the Business and Professions Code, to read: | |
| 50 | 47 | ||
| 51 | - | ||
| 48 | + | 4078.5. (a) As used in this section:(1) 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.(2) 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 Governors 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 community pharmacies.(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.(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 and the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d) The information developed pursuant to subdivision (c) shall include, but is not limited to, information on the following specific topics:(1) The prevalence of patient opt-in.(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-in, and reduce the prevalence of adverse drug events.(e) 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-in, and reducing the prevalence of adverse drug events.(f) (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. | |
| 52 | 49 | ||
| 53 | - | SECTION | |
| 50 | + | 4078.5. (a) As used in this section:(1) 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.(2) 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 Governors 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 community pharmacies.(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.(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 and the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d) The information developed pursuant to subdivision (c) shall include, but is not limited to, information on the following specific topics:(1) The prevalence of patient opt-in.(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-in, and reduce the prevalence of adverse drug events.(e) 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-in, and reducing the prevalence of adverse drug events.(f) (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. | |
| 54 | 51 | ||
| 55 | - | ### SECTION 1. | |
| 56 | - | ||
| 57 | - | 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. (1)(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.(2)(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 Governors 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 community pharmacies. 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 and California, the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d)The information developed pursuant to subdivision (c) shall Pharmacy, and the Legislature that shall include, but is are not limited to, information on the following specific topics:(1) The prevalence of patient opt-in. 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-in, opt-ins, and reduce the prevalence of adverse drug events.(e)(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-in, opt-ins, and reducing the prevalence of adverse drug events.(f)(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. | |
| 58 | - | ||
| 59 | - | 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. (1)(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.(2)(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 Governors 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 community pharmacies. 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 and California, the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d)The information developed pursuant to subdivision (c) shall Pharmacy, and the Legislature that shall include, but is are not limited to, information on the following specific topics:(1) The prevalence of patient opt-in. 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-in, opt-ins, and reduce the prevalence of adverse drug events.(e)(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-in, opt-ins, and reducing the prevalence of adverse drug events.(f)(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. | |
| 60 | - | ||
| 61 | - | 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. (1)(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.(2)(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 Governors 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 community pharmacies. 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 and California, the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d)The information developed pursuant to subdivision (c) shall Pharmacy, and the Legislature that shall include, but is are not limited to, information on the following specific topics:(1) The prevalence of patient opt-in. 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-in, opt-ins, and reduce the prevalence of adverse drug events.(e)(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-in, opt-ins, and reducing the prevalence of adverse drug events.(f)(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. | |
| 52 | + | 4078.5. (a) As used in this section:(1) 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.(2) 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 Governors 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 community pharmacies.(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.(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 and the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. (d) The information developed pursuant to subdivision (c) shall include, but is not limited to, information on the following specific topics:(1) The prevalence of patient opt-in.(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-in, and reduce the prevalence of adverse drug events.(e) 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-in, and reducing the prevalence of adverse drug events.(f) (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. | |
| 62 | 53 | ||
| 63 | 54 | ||
| 64 | 55 | ||
| 65 | 56 | 4078.5. (a) As used in this section: | |
| 66 | 57 | ||
| 67 | - | (1) | |
| 58 | + | (1) 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. | |
| 68 | 59 | ||
| 69 | - | (2) Independent community pharmacy means a pharmacy owned by a person or entity who owns no more than four pharmacies in California. | |
| 70 | - | ||
| 71 | - | (1) | |
| 72 | - | ||
| 73 | - | ||
| 74 | - | ||
| 75 | - | (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. | |
| 76 | - | ||
| 77 | - | (2) | |
| 78 | - | ||
| 79 | - | ||
| 80 | - | ||
| 81 | - | (4) Task force means the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force created by subdivision (b). | |
| 60 | + | (2) Task force means the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force created by subdivision (b). | |
| 82 | 61 | ||
| 83 | 62 | (b) (1) There is hereby created the Prescription Labeling and Adverse Drug Event Prevention Advisory Task Force. | |
| 84 | 63 | ||
| 85 | 64 | (2) The task force shall be composed of the following individuals: | |
| 86 | 65 | ||
| 87 | 66 | (A) A representative from the Medical Board of California. | |
| 88 | 67 | ||
| 89 | 68 | (B) A representative from the California State Board of Pharmacy. | |
| 90 | 69 | ||
| 91 | 70 | (C) A representative with pharmacy or medical expertise appointed by the Governors office. | |
| 92 | 71 | ||
| 93 | 72 | (D) A representative from the State Department of Public Health. | |
| 94 | 73 | ||
| 95 | 74 | (E) A representative with pharmacy or medical expertise appointed by the Senate Committee on Rules. | |
| 96 | 75 | ||
| 97 | 76 | (F) A representative with pharmacy or medical expertise appointed by the Speaker of the Assembly. | |
| 98 | 77 | ||
| 99 | - | (G) A representative from community pharmacies. | |
| 78 | + | (G) A representative from community pharmacies. | |
| 100 | 79 | ||
| 101 | 80 | (H) A representative from retail pharmacies. | |
| 102 | 81 | ||
| 103 | 82 | (I) A representative from a patient advocacy group. | |
| 104 | 83 | ||
| 105 | 84 | (J) A representative from a physician organization. | |
| 106 | 85 | ||
| 107 | 86 | (K) A representative from a family physician organization. | |
| 108 | 87 | ||
| 109 | - | (L) A representative from an obstetrics and gynecology organization. | |
| 110 | - | ||
| 111 | - | (M) A representative from an infectious disease specialty organization. | |
| 112 | - | ||
| 113 | - | (N) A representative from a cardiologist organization. | |
| 114 | - | ||
| 115 | 88 | (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. | |
| 116 | 89 | ||
| 117 | 90 | (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. | |
| 118 | 91 | ||
| 119 | - | (c) The task force shall develop information and make recommendations to the Medical Board of California and | |
| 92 | + | (c) The task force shall develop information and make recommendations to the Medical Board of California and the California State Board of Pharmacy and the Legislature on the ways to increase adherence to prescription medication and decrease adverse drug events. | |
| 120 | 93 | ||
| 121 | - | (d)The information developed pursuant to subdivision (c) shall | |
| 94 | + | (d) The information developed pursuant to subdivision (c) shall include, but is not limited to, information on the following specific topics: | |
| 122 | 95 | ||
| 123 | - | (1) The prevalence of patient opt-in. | |
| 96 | + | (1) The prevalence of patient opt-in. | |
| 124 | 97 | ||
| 125 | 98 | (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. | |
| 126 | 99 | ||
| 127 | 100 | (3) Barriers to increasing the number of patient opt-ins. | |
| 128 | 101 | ||
| 129 | 102 | (4) A cost-benefit analysis of the benefits of increasing patient opt-ins versus the administrative burden caused by increased patient opt-ins. | |
| 130 | 103 | ||
| 131 | 104 | (5) Prevalence of adverse drug events for varying demographics, including, but not limited to: race, age, gender, income, disabilities, and geographic location. | |
| 132 | 105 | ||
| 133 | - | (6) Recommendations to improve the patient opt-in process, increase the prevalence of patient opt-in, | |
| 106 | + | (6) Recommendations to improve the patient opt-in process, increase the prevalence of patient opt-in, and reduce the prevalence of adverse drug events. | |
| 134 | 107 | ||
| 135 | - | (e) | |
| 108 | + | (e) 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-in, and reducing the prevalence of adverse drug events. | |
| 109 | + | ||
| 110 | + | (f) (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. | |
| 111 | + | ||
| 112 | + | (2) Pursuant to Section 10231.5 of the Government Code, this section is repealed on January 1, 2024. | |
| 136 | 113 | ||
| 137 | 114 | ||
| 138 | 115 | ||
| 139 | - | (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-in, opt-ins, and reducing the prevalence of adverse drug events. | |
| 140 | 116 | ||
| 141 | - | (f) | |
| 117 | + | ||
| 118 | + | (a)On and after January 1, 2022, a physician and surgeon, when providing a prescription for a drug or device to a patient, shall discuss with the patient the opportunity to opt in to having the physician and surgeon indicate the purpose for that drug or device on that prescription. Nothing shall prohibit a physician and surgeon from describing the purpose for a drug or device in a manner that protects patient privacy. | |
| 142 | 119 | ||
| 143 | 120 | ||
| 144 | 121 | ||
| 145 | - | ( | |
| 122 | + | (b)(1)If the purpose of a drug or device is not indicated on a prescription for that drug or device pursuant to subdivision (a), a dispensing pharmacist shall not be responsible for ascertaining the purpose or, on or after January 1, 2022, determining whether the patient opted in pursuant to subdivision (a). | |
| 146 | 123 | ||
| 147 | - | (2) Pursuant to Section 10231.5 of the Government Code, this section is repealed on January 1, 2024. | |
| 124 | + | ||
| 125 | + | ||
| 126 | + | (2)The California State Board of Pharmacy, by January 1, 2022, shall adopt regulations providing technical guidance regarding the format and manner in which a pharmacist is to incorporate drug or device purpose indications on the standardized, patient-centered, prescription drug label pursuant to Section 4076.5. |