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Board seeks 15-day comment on updated quality-assurance rules; allows estimated consultation counts
Summary
The State Board of Pharmacy voted to publish modified regulation text for a 15-day comment period to amend CCR Title 16 Section 1711 on pharmacy quality assurance, including allowing an estimated number of patient consultations where exact counts are not reliably tracked.
The California State Board of Pharmacy directed staff to notice modified regulation text for a 15-day public comment period to update Title 16 Section 1711, which governs pharmacy quality assurance programs. The motion authorized the executive officer to adopt the regulation if no adverse comments are received and to make technical edits required by control agencies.
Board members said the board’s medication error reduction and workforce committee had identified updating the quality-assurance regulations as an action item; the regulations had not been substantially revised in roughly two decades, staff said. The board’s earlier 45-day comment period on the proposal closed Sept. 23, 2024.
Board staff counsel Jennifer told members that adding the word “estimate” to a data field would change the requirement and that the board could allow an estimated count when exact numbers aren’t available. Several board members and public commenters urged flexibility because pharmacies often do not track exact counts of “patient consultations.” Karen Yoonby of UCLA Health told the board that the consultation count “is currently not a data point that is being recorded in most pharmacies … adding even an estimate of that number will add more documentation burden.”
Board member Jesse proposed, and staff offered revised motion language, to accept staff responses to comments, modify the draft to allow an estimate for the number of consultations in section e(2)(d), and notice the modified text for 15 days; the executive officer would be authorized to complete rulemaking if no adverse comments are received. Jeff seconded the motion. Members recorded “yes” votes and the motion passed.
Sarah Polo Muz, speaking for the California Community Pharmacy Coalition, urged the board not to require pharmacists to report medication errors directly to the board where doing so could deter reporting; the coalition asked that the regulation refer to reporting to a “board-approved entity” rather than “directly to the Board.” Board staff clarified that the quality-assurance program itself does not require submission to the board and that the item under consideration is distinct from the Board’s medication error reduction plan.
The board’s action initiates a 15-day public comment period on the modified text; if no adverse comments are received the executive officer may complete the rulemaking and adopt the amended Section 1711.
