Board of Pharmacy Undergoes Sunset Review

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By Anna Schwartz

On December 1, 2020, the Board of Pharmacy published its Sunset Review Supplemental Report (Volume 1, Volume 2) in preparation for its Sunset Review Oversight Hearing before the Assembly Business and Professions Committee and the Senate Business, Professions and Economic Development Committee. The Board’s enabling act, section 4000, et seq. of the Business and Professions Code is scheduled to “sunset” or be repealed on January 1, 2022, if it is not extended during sunset review.

The Board initially published its Sunset Review Report (Volume 1, Volume 2) on December 1, 2019, in preparation for the Board’s original sunset date on January 1, 2021. Because of the COVID-19 pandemic, the legislature passed SB 1474 (Committee on Business, Professions and Economic Development) (Chapter 312, Statutes of 2020) to provide a one-year extension of the Board’s sunset date from January 1, 2021, to January 1, 2022. As a result, the Board released the Supplemental Report to augment the Board’s Sunset Review Report. While the Board’s Sunset Review Report included a summary of the Board’s activities over the previous four years [see 25:2 CRLR 42–43], the Supplemental Report covers the one-year supplemental reporting period.

As stated in the combined Sunset reports, the Board sponsored and enacted ten pieces of legislation, made twenty-eight regulation changes, and issued two major studies over the last five years.

The Board’s Supplemental Report also highlights the Board’s response to the pandemic—specifically, the Board’s issuance of pharmacy law waivers to increase access to COVID-19 testing and the Board’s partnerships with other agencies to release guidance documents on pandemic protocol. In addition to the new issues identified in the Board’s Sunset Review Report, the Supplemental Report identifies three supplemental issues related to the issuance of waivers that the Board would like the legislature to consider during the review process. As waivers are temporary in nature, the Board believes that permanent changes in several areas would be in consumers’ best interest. First, the Board seeks permanent statutory changes to allow pharmacists to perform point-of-care, Clinical Laboratory Improvement Amendments of 1988 (“CLIA”)-waived tests for influenza and COVID-19. Second, the Board seeks permanent expansion of authority for pharmacy technicians to administer influenza and COVID-19 vaccinations under specified conditions. Third, the Board believes its authority to issue temporary licenses for testing facilities should be permanently extended to all facility license types issued by the Board.

The Legislative Background Paper for the California State Board of Pharmacy was originally published prior to March 2020 [see 25:2 CRLR 42–43]; however, when the sunset review hearing was postponed due to the COVID-19 pandemic, the legislative staff updated and republished a new background paper in preparation for the rescheduled hearing on November 18, 2020. In the background paper, the legislative staff raised twenty-six current issues for the Board to respond to under the topics of administrative issues, fiscal issues, licensing issues, education, and examination issues, enforcement issues, practice issues, implementation issues, COVID-19 pandemic issues, technical clean-up, and continued regulation of the pharmacy profession by the California State Board of Pharmacy.

First, the background paper raised several concerns related to the Board’s administrative composition. Specifically, the legislature requested that the Board: clarify whether an active licensee or member of the Board is prohibited from filling the position of Executive Officer, provide solutions to addressing the Board’s current vacancy rate, and specify what efforts it has taken to ensure its decision-making is subject to state supervision so as to safeguard its members from antitrust allegations under North Carolina State Board of Dental Examiners v. Federal Trade Commission, 574 U.S. 494 (2015).

Under the topic of licensing issues, the legislative staff highlighted the Board’s proposal to establish a new mid-level pharmacy practitioner license category: “Advanced Pharmacy Technicians.” These proposed advanced pharmacy technicians would be authorized to carry out certain duties that pose a low risk of harm but may currently only be performed by pharmacists, thereby allowing pharmacists to spend more time engaged in patient care. The legislature recommends the Board provide the legislative committees with an overview of whether and why the advanced pharmacy technician license type should be established and what steps may be taken to begin a constructive dialogue with stakeholders on the issue.

Among its listed concerns, the background paper also highlighted the compromised 2019 California Practice Standards and Jurisprudence Examination for Pharmacists (CPJE) [see 25:1 CRLR 68–70], wherein questions on the examination were made widely available over the internet. As a result, examination scores for about 1,400 individuals were invalidated. In the background paper, the legislative staff questioned whether additional action is necessary to address the subversion of the CPJE and whether the adoption of the Multistate Pharmacy Jurisprudence Exam (MPJE), a national alternative to the CPJE that includes board-approved questions for each state in which it is administered, is feasible. On this topic, the Board’s Supplemental Report explained that the Board contracted with the Office of Professional Examination Services to conduct an audit of the CPJE and its administration. The report is anticipated to be finalized in early 2021.

On November 18, 2020, Board of Pharmacy President Gregory N. Lippe and Executive Director Anne Sodergren testified at the Sunset Review Hearing. Executive Director Sodergren fielded questions from committee members about how the 2019 CPJE mishap affected non-cheating test-takers. Director Sodergren explained that the Board had no choice but to invalidate all results from the compromised CPJE because there was no way to distinguish blameless test-takers who had not seen the leaked online answers from those who had. Director Sodergren commented that the Board handled the issue swiftly and offered an additional test date a month after the decision to invalidate all scores. Finally, the committee heard comments from three public members as to the Board’s performance. Of note, a member of the public voiced concern over the Board’s proposal to establish the “Advanced Pharmacy Technician” license. The member critiqued the new role as unnecessary and noted that the role would further strain pharmacists’ supervisory responsibilities and subvert low-income and largely minority pharmacy technicians who cannot pay for additional schooling and licensing.

AB 1533 (Committee on Business and Professions), as introduced on February 19, 2021, would amend section 4001 of the Business and Professions Code to extend the Board’s sunset date to 2026. At this writing, the bill has not yet been amended to include more substantive matters addressed by the committees at the Sunset Hearing.

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