California § 4113.1 - Except as specified in subdivision (e), a community pharmacy licensed pursuant to

§ 4113.1. Except as specified in subdivision (e), a community pharmacy licensed pursuant to

(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. (b) Any entity approved by the board shall have experience with the analysis of medication errors that occur in the outpatient setting. (c) For purposes of this section, “community pharmacy” includes any pharmacy that dispenses medication to an outpatient, but does not include facilities of the Department of Corrections and Rehabilitation. (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. 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. (e) 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 been reported to the State Department of Public Health pursuant to Section 1279.1 of the Health and Safety Code. The State Department of Public Health may share a report with the California State Board of Pharmacy. (f) A pharmacy licensed pursuant to Section 4112 shall only be required to report medication errors related to prescriptions dispensed to California residents.