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Board seeks more comment, allows estimates for consultations in draft quality-assurance rules
Summary
The board approved modified text allowing an estimated number of patient consultations in quality assurance reports and sent the revised regulation to a 15-day comment period after discussion about data availability, central-fill tracking, and reporting burden.
The California State Board of Pharmacy voted to issue modified regulatory text for a 15-day public comment period to amend Title 16, section 1711, which sets quality assurance (QA) program requirements for pharmacies. The board specifically directed staff to change the rule language to permit reporting an estimated number of patient consultations rather than requiring an exact tally.
Members said the QA update stems from the board’s Medication Error Reduction and Workforce Committee and is intended to modernize QA regulations that “have largely remained unchanged for two decades.” During discussion members noted that certain data points — especially the number of patient consultations — are not routinely or consistently tracked by many pharmacies and systems, making exact reporting impracticable. Board member Satinder said the data sometimes are not visible to the PIC because employers control reporting systems; Jesse said some metrics should be readily retrievable but agreed that consultation counts often require estimates.
Several public commenters urged the board to reduce documentation burden. Sarah Polo Moose, speaking for the California Community Pharmacy Coalition, said the coalition “interpreted the regulations to say that medical errors need to be reported directly to the board instead of a board approved entity” and urged the board to avoid discouraging error reporting by clarifying that reports should go to a board-approved entity rather than directly to the board. Karen Yoonby of UCLA Health told the board that the estimated number-of-consultations data point is “currently not a data point that is being recorded in most pharmacies… so adding even an estimate of that number will add more documentation burden.”
Board members also discussed central-fill and shared systems; one member said improvements in technology and tracking should allow investigators to see “who was involved at every step in the verification process” as pharmacies increase automation.
The board’s motion accepts staff recommended responses to prior comments, modifies subsection 2(d) to permit an estimated consultations figure, and notices the revised text for a 15-day comment period. If the 15-day period returns no adverse comments, the executive officer is authorized to complete rulemaking and adopt section 1711 as noticed. The board recorded the motion as passed.
