Boards of pharmacy can face unexpected challenges while working to protect the public health. Here, board executive directors talk about how they worked around these obstacles.
Jack W. “Jay” Campbell, JD, RPh
Executive Director, North Carolina Board of Pharmacy
How long have you served as executive director of the North Carolina Board of Pharmacy? What was your role prior to working with the Board?
I have served as executive director for 16 years. Prior to my service on the Board, I practiced as an appellate litigator in Washington, DC, and Charlotte, NC. At the time of my hire, I was also teaching the pharmacy law and regulation course at a school of pharmacy.
What is one of the most significant challenges or issues that your Board addressed in the past year or so?
As is true for most state boards, the coronavirus disease 2019 (COVID-19) pandemic response has consumed the bulk of the North Carolina Board’s time and effort over the past two years. Key areas of regulatory focus included empowering expanded remote pharmacy practice to reduce the risk of COVID-19 transmission among pharmacy personnel and patients, facilitating cross-jurisdictional practice to mitigate the risk of pharmacy manpower shortages, and guiding implementation of expanded pharmacy practice created by Public Readiness and Emergency Preparedness Act (PREP Act) declarations. The pandemic also created significant operational challenges for Board staff, requiring a long-term pivot to work from home for in-house staff, highly modified (and restricted) processes for field-based investigators and inspectors, and virtual Board business and committee meetings.
What actions were taken by the Board to address the issue?
North Carolina law affords the Board a broad authority to waive provisions of the Pharmacy Practice Act and regulations in time of declared emergency, where those waivers are necessary to ensure continuity of pharmacy services to the public. The Board has a standard “baseline” emergency services waiver that it created several years ago and preemptively authorizes anytime a state of emergency is declared. Though designed with a natural disaster in mind, the baseline waiver’s provisions are aimed at preserving operational continuity and applied well to the pandemic circumstances. The Board continued to monitor developments and, as necessary, issued supplements to the baseline waiver – mostly focused on authorizing broad-based remote pharmacy practice options. Expanded remote pharmacy operations – both “intra-pharmacy” and “inter-pharmacy” in nature – proved popular. As a result, the Board recently completed rulemakings to permanently expand remote pharmacy operation authority across all practice types. That rulemaking also led the Board to adopt NABP Verify as an alternative to licensure for out-of-state pharmacists performing certain remote medication order processing services on behalf of North Carolina pharmacies – the first state to do so. Because PREP Act expansions will go away once the federal public health emergency ends, the Board has worked closely with stakeholders and legislators to preserve these expansions in state law.
What other key issues has the Board been focusing on?
The Board has had an active rulemaking docket over the past year. In addition to those laws discussed above, the Board has completed – or is the process of completing – rulemaking to implement newly granted pharmacist authority to administer long-acting injectables; create a new pharmacy intern registration system that includes an on-line method for recording and validating non-curricular experiential hours clarify and simplify eligibility criteria for “limited-service” pharmacy permits; and replace the in-person meeting requirement for pharmacy permit issuance with an on-line pharmacist-manager education system. Board committees are focused on community pharmacy working conditions matters and direct-to-patient dispensing technologies. The Board substantially revised its policies concerning pharmacist to technician ratios, providing more flexibility for pharmacist-managers.
What insights do you have for other states that may be facing similar challenges?
If there is a silver lining to the COVID-19 pandemic, it is that stresses on pharmacy provoked needed (and often long-overdue) reevaluations of the ways that practice is regulated and empowered. Leaning on the experience and input of colleagues at other boards has been crucial – and appreciated. Leaning on the experience and input of public health officials in other North Carolina agencies, particularly the Department of Health and Human Services, has helped shape and focus these reevaluations productively. NABP’s fostering of dialog among the state boards and its creation of new tools to oversee increasingly multijurisdictional practice issues has been invaluable. All of this is to say that none of us is an island (I do not mean this literally, of course. I see you Hawaii, United States Virgin Islands, and Puerto Rico!), and our regulatory opportunities and challenges have much in common. Reach out – broadly, early, and often.
This article was originally featured in the June-July 2022 issue of Innovations.