On October 8, 2023, Governor Gavin Newsom signed Assembly Bill 1286 (AB 1286), a sweeping pharmacy measure with several components aimed at promoting patient safety. Chief among AB 1286’s mandates is a new law requiring that community pharmacies report outpatient medication errors to the California Board of Pharmacy. But beyond the mandatory reporting requirement, AB 1286 contains various other important provisions governing the practice of pharmacy in California.

Background

In April 2021, the California Board of Pharmacy (the “Board”) approved a community pharmacy workforce survey as part of its efforts to evaluate medication errors and determine whether certain workforce issues contributed to medication errors. The Board received the results of the survey in December 2021. 

In April 2022, the Board published its Medication Error Reduction and Workforce Chair Report which summarized the Board’s findings from the 2021 survey and a January 2022 Pharmacy Well-Being Index State report.

The survey revealed that 91% of retail pharmacists reported insufficient staffing to ensure safe patient care, 83% reported a lack of sufficient time to provide safe patient consultation, and 78% reported inadequate time to perform proper health screenings prior to administering immunizations.

In its Report, the Board also noted that in year 2020-2021, it had initiated 521 investigations involving an allegation of a medication error and that it was common for its staff to “review operational issues including system issues and staffing as part of the investigation.”

As a result of these findings, the Board established a Medication Error Reduction and Task Force Ad Hoc Committee. The Committee began convening public meetings and sponsored AB 1286 to establish mandatory reporting of patient errors.

Medication Error Reporting

AB 1286 added Business and Professions Code §4113.1 (effective January 1, 2024) which states that “a community pharmacy licensed … shall report, either directly or through a designated third party, including a component patient safety organization as defined in Section 3.20 of Title 42 of the Code of Federal Regulations, all medication errors to an entity approved by the board.”

The term “community pharmacy” is defined as “any pharmacy that dispenses medication to an outpatient but does not include facilities of the Department of Corrections and Rehabilitation.” Business and Professions Code §4113.1(c).

A “medication error” is defined as “any variation from a prescription drug order not authorized by the prescriber, including, but not limited to, errors involving the wrong drug, the wrong dose, the wrong patient, the wrong directions, the wrong preparation, or the wrong route of administration.” However, the term does not include “any variation that is corrected prior to dispensing to the patient or patient’s agent or any variation allowed by law.” Business and Professions Code §4113.1(d).

Outpatient hospital pharmacies are not required to report medication errors if the errors are reported to the California Department of Public Health pursuant to Health and Safety Code §1279.1 (governing adverse events in health facilities).

Confidentiality

The law provides that medication reports are confidential and not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act. However, the Board is authorized to publish certain deidentified information compiled from the data in the reports in accordance with specified requirements.

Discipline

Medication error reports submitted to the Board will not alone trigger a Board investigation, discipline, or other enforcement action. However, the Board is authorized to initiate an investigation or disciplinary proceedings based on “other information regarding the medication error independent of the medication error report.”

Recordkeeping

Business and Professions Code §4113.1 requires that community pharmacies maintain records demonstrating compliance with the new law for three years and are required to make the records immediately available to Board inspectors.

Although the Board has not yet updated its Community Pharmacy Self-Assessment form and regulations to include this three-year recordkeeping requirement, California pharmacies should update their quality assurance program accordingly and begin maintaining records. The Board has indicated that it will “consider actions taken to secure compliance when areas of non-compliance are identified through the inspection or investigation process. The Board “encourages licensees to maintain documentation of actions taken to achieve compliance” with AB 1286.

Implementation of AB 1286

To implement AB 1286, the Board will engage an independent third-party vendor through the state procurement process. Until the Board has approved the third-party entity, medication error reports should be maintained but do not need to be reported. The Board will announce the approval of the third-party entity and the implementation schedule through its subscriber alert system.

The Board of Pharmacy invited two health reporting agencies, the Canadian Medication Incident Reporting and Prevention System and the Agency for Healthcare Research and Quality (AHRQ), to present their experiences with medication error and safety reporting at its January 23, 2024 Enforcement Committee Meeting.

Summary of AB 1286’s Additional Changes

• AB 1286 amended Business and Professions Code §4192, which now requires that a Surgical Clinic’s consulting pharmacist complete a Surgical Clinic Self-Assessment Form promulgated by the Board. As part of the Surgical Clinic’s renewal process, the consulting pharmacist is required to certify compliance with quarterly inspections and provide the most recent self-assessment form. The Board of Pharmacy is currently developing the Surgical Clinic Self-Assessment Form.
• Business and Professions Code §4113 was amended to authorize the Pharmacist-in-Charge (PIC) to make staffing decisions that ensures sufficient personnel are present in the pharmacy to prevent fatigue, distraction, or other conditions that may interfere with the pharmacist’s ability to practice competently and safely.

If the PIC is not available, the pharmacist on duty is authorized to adjust staffing according to workload. Pharmacists are required to notify management of any condition that presents a risk of harm to patient safety. If the conditions are not resolved within 24 hours, pharmacists are required to inform the Board. The Board may then take immediate enforcement action.

• Business and Professions Code §4113.6 now requires chain community pharmacies to be staffed at all times with at least one clerk or pharmacy technician fully dedicated to pharmacy related services, unless any of the following conditions apply:

(1) the pharmacist on duty waives the requirement in writing during specified hours based on workload needs;
(2) the pharmacy is open beyond normal business hours (8:00am to 7:00pm); or
(3) the prescription volume of the pharmacy is generally less than 75 prescriptions a day and the pharmacist is not required to provide additional services such as immunizations or CLIA waived tests.

Additionally, the law states that if staffing of pharmacist hours within a chain community pharmacy does not overlap sufficiently, scheduled closures for lunch time for all pharmacy staff must be established, publicly posted, and included on the outgoing telephone message.

• AB 1286 also expanded the list of actions that constitute unprofessional conduct under Business and Professions Code §4301. The list now includes actions or conduct that would subvert the efforts of a pharmacist to comply with laws and regulations including laws and regulations, or the pharmacist’s professional judgment, governing patient care, patient safety, staffing levels.

• A specially trained pharmacy technician is authorized, under the direct supervision and control of a pharmacist, to prepare and administer influenza and COVID-19 vaccines via injection or intranasally. Pharmacy technicians are also authorized to prepare and administer epinephrine, perform specimen collection for specified tests receive prescription transfers, and accept clarification on prescriptions under prescribed conditions.

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