To: Virginia Society of Health-System Pharmacists (VSHP)
From: Mark Hickman, Commonwealth Strategy Group
Re: Board of Pharmacy Meeting
The Virginia Board of Pharmacy (the Board of BOP) convened a virtual meeting on June 16, 2020 (virtual meetings of government bodies during the COVID-19 public health emergency have been allowed by the Governor and General Assembly). All Board members were present.
Licensees can obtain CE credit for participating in the Board meeting; review the agenda packet and email Board staff for more information. The agenda packet can be found here.
Public Hearings and Adoption of Minutes
Delivery of Dispensed Prescriptions; Labeling (pp. 10-22). A public hearing was held specifically on this matter, which was extended from previous public comment periods and Board meetings. CVS testified in support. VPhA testified in opposition. VSHP testified with the following statement: “VSHP would like the Board to consider and provide context to the various situations of alternate delivery sites and potential impact to patient safety and pharmacist-patient relationships in its decision-making on this matter.”
The full Board meeting was then called to order, and the agenda and minutes from the previous Board meeting were approved, as amended.
Covetrus Maine testified to reiterate their comments from the previous Board meeting in regard to Credentials for Nonresident Pharmacies Dispensing Only for Animals (see below).
VPhA made public comment including asking that the petition to Allow Remote Order Processing by Pharmacy Technicians Outside of a Pharmacy be referred to the pharmacy technician expansion of duties work group created by HB 1304 and SB 830. VSHP concurs with that position and also testified to support the regulatory amendment that would allow for live or real-time CE credit applied for a pharmacist providing services without compensation to low income individuals receiving health services through a local health department or a free clinic, and to support the consideration to extend the timeframe for change of PIC from 14 to 30 days within the context of pharmacy acquisition.
Board members had several questions for Natalie Nguyen, VSHP Legislative Chair, regarding the PIC transition issue. Nguyen provided answers about the application to health system pharmacies and the relevant situations and dynamics at hospitals.
Walgreens commented on the two-year PIC requirement and change timeframe, stating that there are many factors taken into consideration when the company names a PIC (such as previous experience with the company). The two-year requirement is already a concern, and the process is an additional concern. Some locations need a PIC quickly.
MedMen Enterprise spoke in favor of PharmaCann’s pharmaceutical processor corrective action plan. MedMen is now the owner of PharmaCann, which had obtained the provisional permit to operate in HSA III (Southwest Virginia).
DHP Director’s Report
Department of Health Professions (DHP) Director David Brown spoke about the recent developments on police reform and racial inequality, COVID-19 updates, and the executive actions taken to provide flexibility to the healthcare workforce to combat the pandemic in Virginia. The duration of pharmacy related waivers during the emergency declaration is under discussion by staff, who are considering recommending their effect through the end of this calendar year, but need to discuss with the Board Chairman.
Legislative/Regulatory/Guidance
Update on Regulatory/Policy Actions Resulting from 2020 General Assembly and the Report of Regulatory Actions (pp. 23-26). Elaine Yeatts, DHP Senior Policy Analyst, noted that the pharmacist scope protocols are to be adopted at the September Board meeting, and that the brown/white bagging proposed final regulations are now at the office of the Secretary of Health and Human Resources for review. Recall that the Board accepted VSHP’s comments requesting an exemption of the proposed regulations on brown/white bagging for patients receiving hemophilia treatment.
Adopt Exempt Regulations for Pharmaceutical Processors (pp. 27-69). These proposed actions are exempted from the regular rulemaking process in order to expedite conforming regulations to current law, primarily to update the definition of CBD/THC-A oil to cannabis oil as passed in legislation this year – Adopted.
Consider Petition for Rulemaking to Amend 18VAC110-20-276 to Allow Remote Order Processing by Pharmacy Technicians Outside of a Pharmacy (pp. 70-80). A letter from NACDS seeking additional modifications, beyond the submitted petition, to pharmacy technician duties was displayed on the screen for the Board to read and will be made available to the public electronically. The practice requested in the petition is happening now under emergency COVID-19 waivers. The pharmacy technician expansion of duties work group will not meet until 2021. The Board voted to deny the petition and refer the matter to the Regulation Committee.
Consider Adoption of Fast-track Regulation to Allow Volunteer CE to Satisfy Live CE Requirement (pp. 81-83). Staff recommended adding new language to allow for a maximum of 2 hours of delivery of volunteer pharmacy services in accordance with current regulations, for a total of 6 hours of volunteer CE – Adopted.
Adoption of Emergency Regulations for Limited-Use License and Permit for Non-Profit Facilities (pp. 84-89) – The Board discussed the definition of “non-profit” and the potential use of a limited-use license and permit by different kinds of non-profits. The Board voted to defer adoption and request that counsel and staff conduct additional research for presentation at the next Board meeting.
Adopt Guidance Document 110-49 Credentials for Nonresident Pharmacies Dispensing Only for Animals (pp. 90-92) – Approved.
Adopt Guidance Document 110-48 Verification Sources for a Pharmaceutical Processor (pp. 93-96). In addition to the proposed document, the Board voted to change the definition of CBD/THC-A oil to conform to the new definition of “cannabis oil” (referenced above) to be consistent with other document references – Approved.
Adopt draft Guidance Document for use of telemedicine by registered practitioners of cannabis oil (this proposed document was not included in the board agenda packet and will be made available to the public electronically). The document complies with federal telemedicine guidelines as mandated by state law, requiring secure two-way audio-visual interaction – Approved.
Amend Guidance Documents 110-4, 110-8, 110-9, 110-16, 110-20, 110-22, 110-27, 110-35 (pp. 97-151). These updates are a result of periodic review and contain technical and “clean-up” updates and references – Approved in a block except for 110-4 (see below).
Guidance Document 110-4 was discussed separately as staff provided an updated version regarding CE, which will be made available electronically – Approved as amended.
Repeal Guidance Documents 110-14, 110-19, 110-32, and 110-40 (pp. 152-158). References in these Guidance Documents are now in law or regulation, which make the documents no longer necessary – Approved.
Request to Amend Guidance Document 110-39 Guidance for Continuous Hours Worked by Pharmacists and Breaks (pp. 159-160). The Board has received complaints of confusion and conflicts when a pharmacist is on break but the pharmacy is still open to patients, so the pharmacist often does not have an uninterrupted break. The Board discussed patient access vs. pharmacist wellness and patient safety. The Board voted to refer the matter to the Regulation Committee.
Request for Guidance for Granting Exception to Minimum Two Years’ Experience for PIC Eligibility (pp. 161-163). The Board discussed that various factors are taken into consideration when authority is delegated to the Executive Director (ED) and Board Chairman to ensure safety and operational continuity. A motion was made to accept the proposed guidance for due process and delegate authority to the ED and Chairman to grant exceptions, consistent with Board bylaws (staff to develop final language) – Adopted.
Request to Amend Regulation to Extend Change of PIC Timeframe from 14 to 30 Days (pp. 164-166). The Board had discussion around the need for PIC to PIC transition, PIC training, periodic inventory timeline, and needs in various contexts and settings. A few members proposed 21 instead of 30 days. The Board voted to refer the matter to the Regulation Committee.
Consideration for Requiring CE on a Specific Topic in 2021 (pp. 167-168). The Board discussed various possible topics but decided to defer to next year.
Verbal Update on Action Item from December 2019 Board Meeting regarding Virginia Immunization Information System. Staff reached out to the Virginia Department of Health (VDH) and wrote an article that was included in the March licensee newsletter. Any future COVID-19 vaccination will be required to be reported. Registration in the information system is encouraged now.
Election of Chairman and Vice Chairman. The Board elected Kris Ratliff as Chairman and Cheryl Nelson as Vice Chairman.
Chairman’s Report. Chairman Warriner expressed her thanks and farewell as she completes her final term on the Board.
Report on Board of Health Professions. The BHP meeting was canceled so no report.
Reports on Licensure Program (pp. 170) and Inspection Program (pp. 171-181). Refer to the reports provided in the agenda packet.
Report on Pharmaceutical Processors (p. 182). Columbia Care in Portsmouth and Green Leaf Medical in Richmond have been awarded final permits. Dharma in Bristol has underdone inspection. 2500 patients have registered.
Report on Disciplinary Program (pp. 183-209). Disciplinary proceedings were suspended in March, April and May due to the COVID-19 public health emergency. A large backlog of cases is expected when proceedings resume.
Executive Director’s Report (p. 210). Caroline Juran stated that if the Governor does not make timely Board appointments, Warriner and Thornbury, who are completing their 8-year terms, may need to continue to serve until replacements are appointed. Juran said she has been invited to give a presentation on July 7, 2020 to a legislative committee on drug pricing.
Review of the inspection report for PharmaCann’s pharmaceutical processor location, PharmaCann’s submitted corrective action plan, and PharmaCann’s application for a pharmaceutical processor permit (p. 169). The Board went into closed session to discuss this matter. When it came out of close session, the Board reported that PharmaCann has 90 days to correct their inspection, and that the Board will be issuing an RFA for the license.
ADA examination accommodation requests – After going into closed session, the Board reported that all requests were approved.
The next Board meeting is scheduled for September 9, 2020 at 9:00AM. The next Regulation Committee meeting is scheduled for November 12, 2020 at 9:00AM.
