ASSEMBLY THIRD READING

ATR Bill Id:AB 2983

Author:(Holden)

As Amended Ver:June 15, 2020

Majority vote

SUMMARY:

Beginning January 1, 2022, prohibits a pharmacy from using an automated computer system to contact a prescriber to authorize a prescription refill for any dangerous drug or device for more than a thirty-day supply, unless the prescriber or patient has provided authorization.

Major Provisions

1. Prohibits a pharmacy from using an automated computer system to contact a prescriber to authorize a prescription for any dangerous drug or device to be refilled for more than a thirty-day supply, unless the prescriber or patient has authorized the pharmacy to do so.
2. Proscribes a pharmacy from requesting more than the number of refills authorized in the original prescription.
3. Excludes from the bill's restrictions any pharmacy owned or operated by a nonprofit health care service plan with at least 3,500,000 enrollees that provides health care services to enrollees in a specific geographic area through a mutually exclusive contract with a single medical group.

COMMENTS:

Statute declares that the practice of pharmacy is a profession, and that pharmacy practice is a "dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes." Statute further declares that "pharmacists are health care providers who have the authority to provide health care services." Under the Pharmacy Law, pharmacists are professionally liable for failure to exercise their best professional judgment or corresponding responsibility with regard to the dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices.

While pharmacists are trusted to make determinations about whether certain medications are appropriate and safe to dispense to a patient, they generally may not refill a prescription for a dangerous drug or device without authorization from a prescriber. For prescriptions of dangerous drugs and devices, this authorization may be given orally or at the time of giving the original prescription. When no refills were authorized at the time the prescription was written, a refill may be subsequently requested by the patient or the pharmacist on behalf of the patient.

In early 2020, the New York Times (NYT) wrote extensively about medication errors resulting from chain pharmacy practices. The article described a corporate culture at large chain-store pharmacies in which pharmacists are pressured to dispense as many prescriptions as possible to fulfill a profit-based objective for their employer. One large retailer was alleged to have held employees to an expectation that 65% of patients picking up prescriptions sign up for "automatic refills" and 75% of patients have the pharmacy contact their doctor with a "proactive refill request" if a prescription was expiring or had no refills.

The NYT article insinuated that in many cases, prescribers are inundated with numerous requests from pharmacies for refills on behalf of patients whom the pharmacists believe do not warrant additional medication. The article describes how these activities are a nuisance for busy prescribers. It also discusses concerns regarding medication errors for patients who ultimately receive and take medication they wrongly assume they need because of the prescription refill.

The large retailer named in the article argues that "outreach to patients and doctors can help patients stay up-to-date on their medications, and lead to lower costs and better health." Nevertheless, the author of this bill contends that pharmacists should not be allowed to request refills from a provider unless they have been expressly asked to by the patient for each prescription. This bill would effectively eliminate any chain pharmacy programs that universally submit refill requests absent specific review by a health professional, arguably increasing the risk of delay of therapy but also potentially reducing medication errors.

According to the Author:

"In our overburdened healthcare system, we should ensure that the business practices of one industry do not endanger the health of patients or add additional complications to the system as a whole. The automatic refill request process employed by some pharmacies include the bombarding doctors with requests and changing refill amounts. However, those methods overwhelm both doctors and patients. The bill would limit automatic refill requests to restore the balanced method used effectively by many smaller pharmacies, which is to contact the doctor to request refills based on the doctor's prior prescription. This would prevent companies from seeking a number of refills beyond what is medically safe and remove the incentive to rely on increased future refills to increase their profits."

Arguments in Support:

The County Behavioral Health Directors Association of California (CBHDA) supports this bill. According to the CBHDA, "AB 2983 adds an additional checks and balances procedure to the process of filling prescriptions, reducing miscommunication, and misuse of prescribed medication. This bill will reduce the practice of patients requesting prescription refills and failing to see their primary or specialty care providers."

Arguments in Opposition:

The California Retailers Association (CRA) and the National Association of Chain Drug Stores (NACDA) oppose this bill. A stated in a joint letter, "Requiring pharmacists to contact patients and physicians to obtain an additional authorization to call and request fill authority is an overly burdensome step and will not result in increased patient safety. Patients may call to request a refill not realizing that their prescription has no refills. Such requests are often left on the pharmacy's voicemail or submitted online or electronically, resulting in a notation that the pharmacy should call for refill authorization. This has always been pharmacy practice and is an efficient way to ensure patients receive their refills. AB 2983 would require pharmacists to obtain an extra authorization from the physician and the patient in order to obtain the refill authorization. This is unnecessary, as a physician who does not wish to authorize the refill request simply denies the refill and requests that the patient make an appointment."

FISCAL COMMENTS:

According to the Assembly Appropriations Committee, minor and absorbable costs to the Board of Pharmacy to implement the new prohibition, and a $2,500 information technology cost associated with creating a new enforcement code to the Department of Consumer Affairs.

VOTES:

ASM BUSINESS AND PROFESSIONS: 10-4-5

YES: Low, Arambula, Bloom, Gipson, Gloria, Holden, McCarty, Medina, Mullin, Ting

NO: Brough, Cunningham, Fong, Obernolte

ABS, ABST OR NV: Chen, Chiu, Eggman, Grayson, Irwin

ASM APPROPRIATIONS: 11-6-1

YES: Gonzalez, Bloom, Bonta, Calderon, Carrillo, Chau, Gabriel, Eduardo Garcia, Petrie‑Norris, McCarty, Robert Rivas

NO: Bigelow, Bauer-Kahan, Megan Dahle, Diep, Fong, Voepel

ABS, ABST OR NV: Eggman

UPDATED:

VERSION: June 15, 2020

CONSULTANT: Robert Sumner / B. & P. / (916) 319-3301 FN: 0003083

ASSEMBLY THIRD READING

ATR Bill Id:AB 2983

Author:(Holden)

As Amended Ver:May 11, 2020

Majority vote

SUMMARY:

Prohibits a pharmacy from automatically contacting a prescriber to authorize a prescription refill for any dangerous drug or device for more than a seven-day supply, unless the prescriber or patient has provided written authorization.

Major Provisions

1. Prohibits a pharmacy from automatically contacting a prescriber to authorize a prescription for any dangerous drug or device to be refilled for more than a seven-day supply, unless the prescriber or patient has expressly authorized the pharmacy to automatically contact the prescriber to refill that prescription.
2. Requires the pharmacy to obtain separate written authorization to automatically contact the prescriber for each prescription and requires the pharmacy to retain a record of that authorization for at least three years.
3. Proscribes a pharmacy from requesting more than the number of refills authorized in the original prescription.
4. Excludes from the bill's restrictions any pharmacy owned or operated by a nonprofit health care service plan with at least 3,500,000 enrollees that provides health care services to enrollees in a specific geographic area through a mutually exclusive contract with a single medical group.

COMMENTS:

Statute declares that the practice of pharmacy is a profession, and that pharmacy practice is a "dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes." Statute further declares that "pharmacists are health care providers who have the authority to provide health care services." Under the Pharmacy Law, pharmacists are professionally liable for failure to exercise their best professional judgment or corresponding responsibility with regard to the dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices.

While pharmacists are trusted to make determinations about whether certain medications are appropriate and safe to dispense to a patient, they generally may not refill a prescription for a dangerous drug or device without authorization from a prescriber. For prescriptions of dangerous drugs and devices, this authorization may be given orally or at the time of giving the original prescription. When no refills were authorized at the time the prescription was written, a refill may be subsequently requested by the patient or the pharmacist on behalf of the patient.

In early 2020, the New York Times (NYT) wrote extensively about medication errors resulting from chain pharmacy practices. The article described a corporate culture at large chain-store pharmacies in which pharmacists are pressured to dispense as many prescriptions as possible to fulfill a profit-based objective for their employer. One large retailer was alleged to have held employees to an expectation that 65% of patients picking up prescriptions sign up for "automatic refills" and 75% of patients have the pharmacy contact their doctor with a "proactive refill request" if a prescription was expiring or had no refills.

The NYT article insinuated that in many cases, prescribers are inundated with numerous requests from pharmacies for refills on behalf of patients whom the pharmacists believe do not warrant additional medication. The article describes how these activities are a nuisance for busy prescribers. It also discusses concerns regarding medication errors for patients who ultimately receive and take medication they wrongly assume they need because of the prescription refill.

The large retailer named in the article argues that "outreach to patients and doctors can help patients stay up-to-date on their medications, and lead to lower costs and better health." Nevertheless, the author of this bill contends that pharmacists should not be allowed to request refills from a provider unless they have been expressly asked to by the patient for each prescription. This bill would effectively eliminate any chain pharmacy programs that universally submit refill requests absent specific review by a health professional, arguably increasing the risk of delay of therapy but also potentially reducing medication errors.

According to the Author:

"In our overburdened healthcare system, we should ensure that the business practices of one industry do not endanger the health of patients or add additional complications to the system as a whole. The automatic refill request process employed by some pharmacies include the bombarding doctors with requests and changing refill amounts. However, those methods overwhelm both doctors and patients. The bill would limit automatic refill requests to restore the balanced method used effectively by many smaller pharmacies, which is to contact the doctor to request refills based on the doctor's prior prescription. This would prevent companies from seeking a number of refills beyond what is medically safe and remove the incentive to rely on increased future refills to increase their profits."

Arguments in Support:

The County Behavioral Health Directors Association of California (CBHDA) supports this bill. According to the CBHDA, "AB 2983 adds an additional checks and balances procedure to the process of filling prescriptions, reducing miscommunication, and misuse of prescribed medication. This bill will reduce the practice of patients requesting prescription refills and failing to see their primary or specialty care providers."

Arguments in Opposition:

The California Retailers Association (CRA) and the National Association of Chain Drug Stores (NACDA) oppose this bill. A stated in a joint letter, "Requiring pharmacists to contact patients and physicians to obtain an additional authorization to call and request fill authority is an overly burdensome step and will not result in increased patient safety. Patients may call to request a refill not realizing that their prescription has no refills. Such requests are often left on the pharmacy's voicemail or submitted online or electronically, resulting in a notation that the pharmacy should call for refill authorization. This has always been pharmacy practice and is an efficient way to ensure patients receive their refills. AB 2983 would require pharmacists to obtain an extra authorization from the physician and the patient in order to obtain the refill authorization. This is unnecessary, as a physician who does not wish to authorize the refill request simply denies the refill and requests that the patient make an appointment."

FISCAL COMMENTS:

According to the Assembly Appropriations Committee, minor and absorbable costs to the Board of Pharmacy to implement the new prohibition, and a $2,500 information technology cost associated with creating a new enforcement code to the Department of Consumer Affairs.

VOTES:

ASM BUSINESS AND PROFESSIONS: 10-4-5

YES: Low, Arambula, Bloom, Gipson, Gloria, Holden, McCarty, Medina, Mullin, Ting

NO: Brough, Cunningham, Fong, Obernolte

ABS, ABST OR NV: Chen, Chiu, Eggman, Grayson, Irwin

ASM APPROPRIATIONS: 11-6-1

YES: Gonzalez, Bloom, Bonta, Calderon, Carrillo, Chau, Gabriel, Eduardo Garcia, Petrie-Norris, McCarty, Robert Rivas

NO: Bigelow, Bauer-Kahan, Megan Dahle, Diep, Fong, Voepel

ABS, ABST OR NV: Eggman

UPDATED:

VERSION: May 11, 2020

CONSULTANT: Robert Sumner / B. & P. / (916) 319-3301 FN: 0002807

Date of Hearing: June 2, 2020

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

ABPCA Bill Id:AB 2983

Author:(Holden) – As Amended Ver:May 11, 2020

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

SUMMARY:

This bill prohibits a pharmacy from automatically contacting a prescriber to authorize a prescription for drugs or devices to be refilled for more than a seven day supply, unless the prescriber or patient has expressly authorized the pharmacy to do so.

This bill exempts pharmacies operated by a nonprofit healthcare service plan, as specified (in practical terms, it exempts Kaiser Permanente system pharmacies).

FISCAL EFFECT:

Minor and absorbable costs to the Board of Pharmacy to implement the new prohibition, and a $2,500 information technology cost associated with creating a new enforcement code to the Department of Consumer Affairs (Pharmacy Board Contingent Fund).

COMMENTS:

1. Purpose. According to the author, automatic refill request processes, generally employed by large chain pharmacies, bombard doctors with requests to approve and change refill amounts. The author indicates a better method used by many smaller pharmacies is to contact the doctor to request refills based on the doctor’s prior prescription and patient request. This bill is intended to prevent companies from seeking a number of refills beyond need and remove the profit motive to increase future refills.
2. Background. In early 2020, the New York Times published an investigative report about medication errors resulting from chain pharmacy practices. In the report, prescribers describe being inundated with numerous requests from pharmacies for refills on behalf of patients who did not request additional medication. The article describes how these activities are a nuisance for busy prescribers. It also discusses concerns regarding medication errors for patients who ultimately receive and take medication they wrongly assume they need because of the prescription refill. This bill attempts to address these issues by inserting an additional safeguard prior to prescription refills being requested.
3. Support and Opposition. This author-sponsored bill is supported by the County Behavioral Health Directors Association, who indicates it should reduce the practice of patients requesting prescription refills and failing to see their primary or specialty care providers. The California Retailers Association and the National Association of Chain Drug Stores oppose this bill, citing inefficiency and an additional burden that will not improve patient safety.

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

Date of Hearing:

ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS

Evan Low, Chair

ABPCA Bill Id:AB 2983

Author:(Holden) – As Amended Ver:May 11, 2020

SUBJECT: Pharmacies: automatic refills.

SUMMARY: Prohibits a pharmacy from automatically contacting a prescriber to authorize a prescription refill for any dangerous drug or device for more than a seven-day supply, unless the prescriber or patient has provided written authorization.

EXISTING LAW:

1. Establishes the California State Board of Pharmacy (BOP) to administer the Pharmacy Law and regulate the pharmacy profession. (Business and Professions Code (BPC) §§ 4000 et seq.)
2. Authorizes the BOP to adopt rules and regulations as may be necessary for the protection of the public. (BPC § 4005)
3. Defines “pharmacist” as a natural person to whom a license has been issued by the BOP which is required for any person to manufacture, compound, furnish, sell, or dispense a dangerous drug or dangerous device, or to dispense or compound a prescription. (BPC §§ 4036, 4051)
4. Establishes a corresponding responsibility for licensed pharmacists to protect their patients when dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices, or the provision of services. (BPC § 4306.5)
5. Requires every pharmacy to establish a quality assurance program that shall, at a minimum, document medication errors attributable, in whole or in part, to the pharmacy or its personnel. (BPC § 4125)
6. Requires a health facility to establish and implement a written policy to ensure that each patient receives information regarding each drug given at the time of discharge, including the use and storage of each drug, the precautions and relevant warnings, and the importance of compliance with directions. (BPC § 4074)
7. Requires a pharmacy to maintain medication profiles on all patients who have prescriptions filled in that pharmacy except when the pharmacist has reasonable belief that the patient will not continue to obtain prescription medications from that pharmacy. (California Code of Regulations (CCR) Title 16 Section 1707.1)
8. Establishes the Medical Practice Act, which provides for the state’s licensure and regulation of physicians and surgeons. (BPC §§ 2000 et seq.)
9. Establishes the Medical Board of California (MBC), a regulatory board within the Department of Consumer Affairs comprised of 15 appointed members. (BPC § 2001)
10. 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 (HSC) § 11150)
11. Lists a number of required features that must be included for all prescription forms for controlled substances, including fraud-prevention identifiers, printing information, and information relating to the prescribing practitioner. (HSC § 11162.1)
12. States that a prescription for a controlled substance shall only be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice, and that the responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. (HSC § 11153)
13. Prohibits a pharmacy from refilling a prescription for any dangerous drug or dangerous device without the authorization of the prescriber, which may be given orally or at the time of giving the original prescription; additionally prohibits prescriptions for controlled substances from being designated as refillable. (BPC § 4063)
14. Allows for a prescription for a dangerous drug or dangerous device to be refilled without the prescriber’s authorization if the prescriber is unavailable to authorize the refill and if, in the pharmacist’s professional judgment, failure to refill the prescription might interrupt the patient’s ongoing care and have a significant adverse effect on the patient’s well-being; requires the pharmacist to report both the patient and the prescriber of these circumstances and the decision to refill the medication. (BPC § 4064)
15. Allows for a prescription for a controlled substance to be refilled without the prescriber’s authorization if the prescriber is unavailable to authorize the refill and if, in the pharmacist’s professional judgment, failure to refill the prescription might present an immediate hazard to the patient’s health and welfare or might result in intense suffering. (HSC § 11201)

THIS BILL:

1. Prohibits a pharmacy from automatically contacting a prescriber to authorize a prescription for any dangerous drug or device to be refilled for more than a seven-day supply, unless the prescriber or patient has expressly authorized the pharmacy to automatically contact the prescriber to refill that prescription.
2. Requires the pharmacy to obtain separate written authorization to automatically contact the prescriber for each prescription and requires the pharmacy to retain a record of that authorization for at least three years.
3. Proscribes a pharmacy from requesting more than the number of refills authorized in the original prescription.
4. Excludes from the bill’s restrictions any pharmacy owned or operated by a nonprofit health care service plan with at least 3,500,000 enrollees that provides health care services to enrollees in a specific geographic area through a mutually exclusive contract with a single medical group.

FISCAL EFFECT: Unknown; this bill is keyed fiscal by the Legislative Counsel.

COMMENTS:

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

In our overburdened healthcare system, we should ensure that the business practices of one industry do not endanger the health of patients or add additional complications to the system as a whole. The automatic refill request process employed by some pharmacies include the bombarding doctors with requests and changing refill amounts. However, those methods overwhelm both doctors and patients. The bill would limit automatic refill requests to restore the balanced method used effectively by many smaller pharmacies, which is to contact the doctor to request refills based on the doctor’s prior prescription. This would prevent companies from seeking a number of refills beyond what is medically safe and remove the incentive to rely on increased future refills to increase their profits.

Background.

Statute declares that the practice of pharmacy is a profession, and that pharmacy practice is a “dynamic, patient-oriented health service that applies a scientific body of knowledge to improve and promote patient health by means of appropriate drug use, drug-related therapy, and communication for clinical and consultative purposes.” Statute further declares that “pharmacists are health care providers who have the authority to provide health care services.” Under the Pharmacy Law, pharmacists are professionally liable for failure to exercise their best professional judgment or corresponding responsibility with regard to the dispensing or furnishing of controlled substances, dangerous drugs, or dangerous devices.

While pharmacists are trusted to make determinations about whether certain medications are appropriate and safe to dispense to a patient, they generally may not refill a prescription for a dangerous drug or device without authorization from a prescriber. For prescriptions of dangerous drugs and devices, this authorization may be given orally or at the time of giving the original prescription. When no refills were authorized at the time the prescription was written, a refill may be subsequently requested by the patient or the pharmacist on behalf of the patient.

In early 2020, the New York Times (NYT) wrote extensively about medication errors resulting from chain pharmacy practices.^[1] The article described a corporate culture at large chain-store pharmacies in which pharmacists are pressured to dispense as many prescriptions as possible to fulfill a profit-based objective for their employer. One large retailer was alleged to have held employees to an expectation that 65 percent of patients picking up prescriptions sign up for “automatic refills” and 75 percent of patients have the pharmacy contact their doctor with a “proactive refill request” if a prescription was expiring or had no refills.

The NYT article insinuated that in many cases, prescribers are inundated with numerous requests from pharmacies for refills on behalf of patients whom the pharmacists believe do not warrant additional medication. The article describes how these activities are a nuisance for busy prescribers. It also discusses concerns regarding medication errors for patients who ultimately receive and take medication they wrongly assume they need because of the prescription refill.

The large retailer named in the article argues that “outreach to patients and doctors can help patients stay up-to-date on their medications, and lead to lower costs and better health.” Nevertheless, the author of this bill contends that pharmacists should not be allowed to request refills from a provider unless they have been expressly asked to by the patient for each prescription. This bill would effectively eliminate any chain pharmacy programs that universally submit refill requests absent specific review by a health professional, arguably increasing the risk of delay of therapy but also potentially reducing medication errors.

Prior Related Legislation. SB 1109 (Bates, Chapter 693, Statutes of 2018) requires a warning label on all containers for dispensed prescriptions of opioids.

AB 788 (Chu) would have required that every prescription include a legible, clear notice of the condition or purpose for which the drug is prescribed. This bill died in the Assembly Health Committee.

SB 472 (Corbett, Chapter 470, Statutes of 2007) required the California State Board of Pharmacy to promulgate regulations requiring a standardized, patient-centered, prescription drug label on all prescription medication dispensed to patients in California.

ARGUMENTS IN SUPPORT:

The County Behavioral Health Directors Association of California (CBHDA) supports this bill. According to the CBHDA, “AB 2983 adds an additional checks and balances procedure to the process of filling prescriptions, reducing miscommunication, and misuse of prescribed medication. This bill will reduce the practice of patients requesting prescription refills and failing to see their primary or specialty care providers.”

ARGUMENTS IN OPPOSITION:

The California Retailers Association (CRA) and the National Association of Chain Drug Stores (NACDA) oppose this bill. A stated in a joint letter, “Requiring pharmacists to contact patients and physicians to obtain an additional authorization to call and request fill authority is an overly burdensome step and will not result in increased patient safety. Patients may call to request a refill not realizing that their prescription has no refills. Such requests are often left on the pharmacy’s voicemail or submitted online or electronically, resulting in a notation that the pharmacy should call for refill authorization. This has always been pharmacy practice and is an efficient way to ensure patients receive their refills. AB 2983 would require pharmacists to obtain an extra authorization from the physician and the patient in order to obtain the refill authorization. This is unnecessary, as a physician who does not wish to authorize the refill request simply denies the refill and requests that the patient make an appointment.”

POLICY ISSUE(S) FOR CONSIDERATION:

As the state continues to work to address the COVID-19 public health crisis, the BOP and the Department of Consumer Affairs have issued various waivers of the Pharmacy Law aimed at removing potential barriers to medication and increasing access to pharmacy services. While this bill is intended to improve quality of care for patients, it is arguably poorly timed in the context of activities responding to the global pandemic. In particular, patients with limited capacity to engage with their health providers potentially derive substantial benefit from an automated system for requesting refills during states of emergency such as the COVID-19 crisis.

It is also worth noting that while automatic refill requests may be an annoyance for prescribers, patients will still not receive a prescription refill unless approved by their provider. Current chain pharmacy practices of automatically generating refill requests do not remove any opportunities for clinical judgement, as a pharmacist is already unable to refill prescriptions in the majority of cases without approval by a physician or other prescribing professional. While there is no doubt cogent criticism of any pharmacy practice perceived as benefiting financial transactions over patient care, is unclear to what extent the practices sought to be eliminated by this bill are truly impacting the health and safety of patients.

REGISTERED SUPPORT:

County Behavioral Health Directors Association

REGISTERED OPPOSITION:

California Retailers Association
National Association of Chain Drug Stores

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

1. Gabler, Ellen. “How Chaos at Chain Pharmacies is Putting Patients at Risk.” The New York Times, 31 Jan. 2020 ↑