(Management Case Study) Charting the Future of California Health-System Pharmacy Practice by Establishing the California Health-System Advocacy and Regulatory Team (CHART)

Purpose: The purpose of chartering a grassroot advisory team made up of pharmacy leaders from California health systems is to provide a forum to review proposed regulatory changes and determine advocacy opportunities to advance pharmacy practice. While state and national professional organizations play a key role in advocacy, a grassroot team can be nimble in response to proposed regulatory changes. Through a team approach to analysis and discussion of proposed regulatory changes and healthcare policies, members collaborate on communication strategies to support regulatory change, patient safety and public health.

Methods: In December 2022, leaders at a large academic medical center in California chartered a grassroot advisory team, California Health-System Advocacy and Regulatory Team (CHART), to establish a forum for pharmacy leaders to monitor and evaluate regulations and advocacy opportunities that may impact patient care and pharmacy practice. CHART membership includes pharmacy leaders from ten (10) hospitals in California who convene on quarterly and as needed. Meeting preparation includes: 1) summarizing regulatory updates from all relevant regulatory bodies (e.g., the board of pharmacy, the state and federal government, California Department of Public Health (CDPH) and The Joint Commission (TJC); 2) reviewing the state board’s meeting agendas and minutes; 3) performing gap analyses to evaluate impact on health system pharmacy practice; 4) draft recommendations/input to submit to regulatory bodies and/or pharmacy professional associations; and 5) keeping members abreast of upcoming important meeting dates.
During the meetings, members discuss proposed regulations and legislation that will significantly impact practice, need clarification, or may have unintended consequences. Based on the group consensus, recommendations are developed which are then submitted or discussed at state board meetings or with pharmacy professional associations. To measure the effectiveness of CHART in addressing regulatory changes and advocacy opportunities, comments made and resulting impact are tracked. Additionally, a survey will be administered to assess the effectiveness of CHART based upon feedback from team members.

Results: Since December 2022, CHART members have provided input to the California State Board of Pharmacy on the following topics: sterile compounding (USP chapter 797 and 800); medication error reduction; standard of care enforcement model; Automated Drug Delivery Systems (ADDS) pharmacy self-assessment; 2023 Senate Bills (SB) 873; and Assembly Bills (AB) 913, 1286, 1557, and 1619. For each of these regulatory items, at least one recommendation has been either accepted or resulted in a revision to the proposed language.
Survey results for members to provide input and feedback on the effectiveness of CHART are pending.

Conclusion: Consistent with the best practices outlined in the high-value pharmacy enterprise framework (HVPE), published in February 2021, the California Health-System Advocacy/Regulatory Team (CHART), chartered by the pharmacy leadership team at a large academic center in California, advocates for pharmacy services by actively engaging other leaders to contribute to the profession on a local, state, and national level. This grassroot advisory team has successfully impacted changes on health-system pharmacy regulatory issues such as sterile compounding, medication error reporting, standard of care and more.