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Board to standardize ADDS quality‑assurance reporting after finding underreporting and inconsistent data
Summary
The enforcement committee reported continued underreporting of automated drug delivery system (ADDS) quality‑assurance records and recommended staff create outreach and a standardized reporting template to improve compliance and data quality for future evaluation.
The California State Board of Pharmacy’s Enforcement and Compounding Committee told the full board that quality‑assurance reports tied to automated drug delivery systems (ADDS) remain inconsistent and likely underreported, hampering the board’s ability to evaluate and respond to ADDS‑related medication errors.
Committee chair Maria Serpa summarized presentations and committee discussion noting the board submitted a legislative report as required and that BPC section 4427.8 and 16 CCR §1711(f) create ongoing ADDS QA reporting duties. The committee recommended staff pursue outreach, revise FAQs, and develop a standardized template to collect consistent data elements from licensees.
Staff and committee members said many incoming QA reports lacked fields needed to determine cause, often marking items "not reported" or "not applicable," which prevents reliable analysis of whether errors were the result of human, technical, inventory, or access failures. "We have a significant underreporting," Serpa said; committee members urged education and a standardized form to improve compliance and data utility.
The committee described two different reporting obligations: licensed ADDS (commonly in some long‑term‑care or licensed clinic settings) must submit QA reports within 30 days of an error; unlicensed ADDS (most ADDS in acute care settings) must submit an annual summary as part of pharmacy renewal. Staff said confusion about these thresholds contributes to inconsistent submissions.
Committee members and public commenters urged careful selection of data elements so the board requests only information that is actionable. Board members also flagged concerns that ADDS installations and site‑specific choices (for example, whether system safety parameters were enabled) affect error rates and should be tracked.
Public commenters representing health systems—including John Gray of Kaiser Permanente and Andre Peters of Scripps Health—urged the board to weigh the value of continued ADDS reporting, to avoid forcing disclosure of peer‑review protected information, and to ensure reporting requirements are actionable. John Gray noted that the statutory impetus for the original reporting requirement stemmed from a sunset evaluation and legislative history, and suggested the board re‑examine whether the reporting obligation should continue now that the underlying legislative sunset report has been filed.
The committee asked staff to return with recommendations for FAQ revisions, an ADDS QA reporting template and additional education for licensees; the committee did not take regulatory action at the full board meeting but will return to the topic in future committee meetings.
