Assembly Bill No. 1286 was signed into California law by the Governor on October 8, 2023, rendering the new law effective January 1, 2024. As noted within the relevant portion of this bill’s language:
The bill would require a licensed community pharmacy ... to report all medication errors to an entity approved by the board and to maintain records, as prescribed. The bill would deem these reports confidential and not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act, except that the board would be authorized to publish certain deidentified information compiled from the data in the reports in accordance with specified requirements.1
This new law is codified in California Business and Professions Code § 4113.1, as follows:
(a) Except as specified in subdivision (e), a community pharmacy licensed pursuant to this article 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. A community pharmacy shall submit the report no later than 14 days following the date of discovery of the error. These reports are deemed confidential and are not subject to discovery, subpoena, or disclosure pursuant to the California Public Records Act (Division 10 (commencing with Section 7920.000) of Title 1 of the Government Code), except that the board may publish deidentified case summary information compiled from the data in the reports so long as deidentification is done in accordance with the requirements set forth in Section 164.514(b)(2) of Title 45 of the Code of Federal Regulations, and includes omitting the name of the reporting pharmacy. The community pharmacy shall maintain records demonstrating compliance with this requirement for three years and shall make these records immediately available at the request of an inspector. A medication error report made pursuant to this section shall not be subject to investigation, discipline, or other enforcement action by the board based solely on a report received pursuant to this section. However, if the board receives other information regarding the medication error independent of the medication error report, that information may serve as basis for discipline or other enforcement by the board.2
Question: What is the government’s interest served behind this new law?
Answer: To advance patient safety through medication error reduction ... by analyzing individually and collectively medication error data that occurs in the community pharmacy setting to identify contributing factors and to broadly disseminate information on preventative measures and best practices for safe medication use, to advise regulators as part of its ongoing activities to monitor and improve the safety of medication use, and to advise policymakers to advance patient safety.3
Question: What is the new requirement for Community Pharmacies?
Answer: All community pharmacies subject to this new law must report to the “designated third party” -- as of the date of this article, the California State Board of Pharmacy has not yet named such an entity.
Question: What are the requirements of this “Designated Third Party?”
Answer: B&P § 4113.1(b) solely requires that “[a]ny entity approved by the board shall have experience with the analysis of medication errors that occur in the outpatient setting.”
Question: Must pharmacies report any medication errors to anyone today?
Answer: No – the California State Board of Pharmacy issued a mass email notification on December 15, 2023, under the subject header, “Assembly Bill 1286 Implementation,” stating that “[d]uring this intervening period [of the Board designating an approved third-party entity,] reporting of such errors is not required nor will it be retroactive. It is anticipated that reporting of such errors will only be expected after approval of such an entity with an appropriate transition period for implementation.”
Question: If I really wanted to, may I self-report my pharmacy’s medication errors directly to the California State Board of Pharmacy?
Answer: Yes, of course, but this would be tantamount to filing a complaint on yourself, which may trigger an investigation that will likely lead to agency enforcement action.
Question: What is a medication error?
Answer: per B&P § 4113.1(d):
For purposes of this section, “medication error” includes 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 ....
This is the very same definition as found in existing regulation, CCR § 1711(b):
“[M]edication error” means any variation from a prescription or drug order not authorized by the prescriber, as described in Section 1716. Medication error, as defined in the section, does not include any variation that is corrected prior to furnishing the drug to the patient or patient's agent or any variation allowed by law.”
Question: What is not considered a medication error?
Answer: B&P § 4113.1(d): ... A medication error does not include any variation that is corrected prior to dispensing to the patient or patient’s agent or any variation allowed by law. As noted above, this mirrors the existing regulation found in CCR § 1711(b).
Question: What is not required to be reported for which pharmacists might think otherwise?
Answer: Near-miss incidents in which the patient almost got an erroneous prescription are not considered a medication error, and therefore, the government does not require any reporting.
Question: Upon implementation of this new law, when must a medication error be reported?
Answer: B&P § 4113.1(a) requires by no later than 14 days following the date of discovery of the error.
Question: Who must follow this new law?
Answer: B&P § 4113.1(c) only requires community pharmacies – which includes any pharmacy that dispenses medication to an outpatient.
Question: Who is not required to follow this new law?
Answer: B&P § 4113.1(c): ... facilities of the Department of Corrections and Rehabilitation.
B&P § 4113.1(e) also states that “an outpatient hospital pharmacy shall not be required to report a medication error that meets the requirements of an adverse event, as specified in subdivision (a), that has [already] been reported to the State Department of Public Health pursuant to Section 1279.1 of the Health and Safety Code.”
Question: Does this mean that the government can use these newly self-reported medication errors as the basis for prosecution against my pharmacy license?
Answer: No, because B&P § 4113.1(a) assures its licentiates that “[a] medication error report made pursuant to this section shall not be subject to investigation, discipline, or other enforcement action by the board based solely on a report received pursuant to this section.”
Question: Does this mean that I no longer need to follow existing laws regarding quality assurance and internal medication error reporting?
Answer: No – B&P § 4125 and the Board’s promulgated CCR § 1711 are still active and enforced, which imposes many pharmacy requirements to maintain a quality assurance program and to draft medication error reports for internal peer review.
In conclusion, the daily operational impact of this new law on community pharmacies should be minimal. But given the legislative query regarding the pervasiveness of medication errors in California, future legislative efforts may give rise to thwart their occurrence, which will invariably include enhanced education and enforcement by the California State Board of Pharmacy.
