March 16, 2020
BOARD OF PHARMACY UPDATES
Pursuant to Chapter 3.2 (§ 44-146.13 et seq.) of Title 44, the Virginia Board of Pharmacy (the “Board”) issued its current position on acceptable practice of pharmacy measures in the Commonwealth.[1] These measures, which may periodically be updated, will remain in effect for the duration of the declared emergency. To address certain challenges posed by the declared state of emergency in Executive Order Number Fifty-One (2020) regarding COVID-19, the Board has followed suit with many other states in relaxing various provisions of the Drug Control Act (§ 54.1-3400 et seq.) and Virginia regulations governing the practice of pharmacy (18 VAC 110-20-10 et seq.) in order to permit the provision of needed drugs, devices, and pharmacy services. In addition to practical reminders to pharmacy personnel related to engagement with customers and sanitary practices, several key updates to pharmacy practice have been made. A summary of these updates relevant to both retail and health system pharmacies, several of which place a significant burden on pharmacy, is provided below.
DISPENSING OF NEW PRESCRIPTIONS OR REFILLS
For Schedule VI drugs, pharmacists should exercise professional judgement regarding dispensing early refills. Where dispensed early, the rationale must be clearly documented. Only where a patient’s health is in imminent danger without such early refill should the drugs be dispensed without prescriber authorization.
For Schedule III-V drugs, pharmacists may dispense a one-time early refill. Again, documentation of the rationale must accompany the practice.
For Schedule II drugs, pursuant to the emergency allowance in 18VAC110-20-290, pharmacists may dispense upon receiving oral authorization from the prescriber provided that the quantity is limited to the amount adequate to treat the
patient during the emergency period, the oral order is immediately reduced to writing by the pharmacist who will make a reasonable effort to ensure the practitioner’s identity where the pharmacist does not have an established relationship with the prescriber. Additionally, within seven (7) days, the prescriber must follow that oral order with a written prescription delivered to the pharmacist (via listed modality). The written prescription must include the notation “Authorization for Emergency Dispensing” and the date of the oral order. The dispensing pharmacist must attach the paper prescription to the oral emergency prescription. Of note, pharmacists are required to notify both the nearest office of the Drug Enforcement Administration and the Board when the prescriber fails to deliver the written script within that window, placing a significant recordkeeping and reporting burden on pharmacy.
INPATIENT HOSPITAL PHARMACY DISPENSING TO DISCHARGE PATIENT
Labeling requirements for drugs dispensed to discharge patients by inpatient pharmacies have been significantly relaxed. In addition to drug name and strength, date of dispensing and directions for use, the labels need only include the name of the patient, prescriber, and pharmacy. Pharmacists are also permitted to compound hand sanitizer containing at least 60% isopropyl or ethyl alcohol without a prescription for sale to the general public under USP <795> standards. These products must be sold at a “reasonable price.”
CONSERVING GARB
The Board has indicated that it will use enforcement discretion where pharmacists reuse garb and masks in a manner that does not compromise the microbial state of control in cleanrooms. Associated policies and procedures must be in place.
ASSISTANCE FROM PHARMACISTS AND PHARMACY TECHNICIANS LICENSED IN OTHER STATES
Of particular relevance to pharmacies located in areas bordering other states, pharmacists and pharmacy technicians licensed in other states may practice pharmacy in Virginia (including accessing his/her employer pharmacy’s database from a remote location) and may provide central/remote order processing or order verification services on behalf of an out-of-state pharmacy subject to certain provisions.
EMERGENCY CLOSING OF PHARMACY
During this emergency period, a pharmacy must notify the Board of any emergency closing period longer than 72 hours. Such notification must include the anticipated duration of the closing and actions taken to ensure continuity of care and to mitigate diversion of drugs.
CONCLUSION
Retail pharmacies, hospitals and health systems should implement careful risk assessment in implementing relaxed pharmacy standards to promote public safety and respond to COVID-19 challenges. Further accommodations are likely to be made by the Board as we know more about the nature of those challenges.
If you have any questions about these pharmacy measures, please contact Liz Whalley Buono. For any other concerns arising from the pandemic, please contact a member of our COVID-19 Task Force.
Click here for a full PDF of this advisory.
The information contained in this advisory is for
general educational purposes only. It is presented with the understanding that
neither the author nor Hancock, Daniel & Johnson, P.C., is offering any
legal or other professional services. Since the law in many areas is complex
and can change rapidly, this information may not apply to a given factual
situation and can become outdated. Individuals desiring legal advice should
consult legal counsel for up-to-date and fact-specific advice. Under no
circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable
for any direct, indirect, or consequential damages resulting from the use of
this material.
[1] https://www.dhp.virginia.gov/pharmacy/news/PharmacyCoronavirusInformation3-13-2020.pdf.
