By Ariana Hussing
At its January 8, 2025, meeting, the California State Board of Pharmacy (Board) reviewed proposed amendments to section 1711 to Article 2 of Division 17 of Title 16 of the California Code of Regulations (CCR) regarding the Quality Assurance (QA) program. The proposed changes to this regulation aim to prevent future medication errors through more thorough documentation review and to ensure the QA program has current data on pharmacy practices.
On February 7, 2024, the Board approved the proposed text for section 1711, prompted by recommendations from the Board’s Medication Error Reduction and Workforce Committee. This ad hoc committee had identified that existing QA regulations, which have remained unchanged for two decades, must be updated to address medication errors and workforce concerns. After the Board’s 45-day public comment period ended on September 23, 2024, and further modifications were discussed in the Board’s November 7, 2024, meeting, a second 15-day comment period was initiated.
According to the initial statement of reasons, The QA program evaluates medication errors to determine their cause and develop appropriate responses for consumers. Section 1711 defines a “medication error” as “any variation from a prescription or drug order not authorized by the prescriber.” To assess and document medication errors, the QA program works to identify data and factors that contribute to medication errors. One such contributing factor is workforce strains, and the proposal addresses this concern. Some of the pertinent data includes information regarding when the error occurred, the use of automated dispensing processes, the volume of the workload of pharmacy staff when the error occurred, and an estimation of patient consultations. As previously addressed, the updated regulation seeks to ensure that pharmacies systematically address the causes of medication errors, improve workflow processes, and ultimately enhance patient safety and service quality.
The recent January meeting discussed provision e(2)(D) of the amendment and responded to feedback received during the comment periods. Board members debated the feasibility of tracking patient consultations as part of the QA process. Some members expressed concern that pharmacists may not have access to exact consultation numbers, as these figures are not consistently recorded in pharmacy systems. Estimation, rather than precise data, was suggested as a solution. However, there were differing opinions about whether this approach would provide sufficient accountability, given there may be too much “wiggle room” if the information is estimated. Some argued that this information may not be readily available, but it should be accessible promptly. Additionally, Vice President Jessica Crowley advocated that tracking who verifies prescriptions across shared or central-fill systems is crucial for accountability and should be part of the data collection process. During public comments, a member of the public from UCLA Health highlighted the proposed amendment’s potential burden of additional documentation requirements, particularly regarding patient consultations, noting that many pharmacies currently do not record this data.
The Board moved to accept the Board staff’s recommended comment responses and modify the text in 2(D) to allow for an estimate of the number of consultations when exact figures are unavailable.
On January 9, 2025, The Board provided notice of the second modified text for 15-day comment period. If no further adverse comments are received, the Board’s executive officer will be authorized to complete the rulemaking to adopt the regulation at section 1711 as noticed.