COVID Drug Rule and Guidance for Pharmacist Managers
BOARD PASSES EMERGENCY RULES TO MITIGATE CERTAIN DRUG SHORTAGES. On March 10, 2020, the Governor of North Carolina, by issuing Executive Order No. 116, declared a state of emergency to coordinate a response and enact protective measures to help prevent the spread of COVID-19. COVID-19 is respiratory disease that can result in serious illness or death. The search for potential treatments for COVID-19 has caused shortages and threatens to cause further shortages in certain drugs. On March 24, 2020, the North Carolina Secretary of Health and Human Services and the State Health Director requested that the Medical Board and the Board of Pharmacy adopt the COVID-19 Drug Preservation Rule in order to alleviate shortages and ensure that these drugs are available to patients who need them. The Pharmacy Board’s emergency rule is found here.
An overview of the rule:
- What drugs does the emergency rule apply to? The rule creates a list of “restricted drugs”: hydroxychloroquine, chloroquine, lopinavir-ritonavir, ribavirin, oseltamivir, darunavir, and azithromycyin.
- What restrictions does the rule apply to dispensing any of the Restricted Drugs? A pharmacist shall fill or refill a prescription for a Restricted Drug only if that prescription bears a written diagnosis from the prescriber. The diagnosis must be included in any electronic prescription as well. A prescription for a Restricted Drug may be phoned in by a prescriber or a prescriber’s agent, but all of the information required by this rule must be recorded by the pharmacy, as well as the identity of the prescriber or prescriber’s agent transmitting the prescription.
- What if the diagnosis is COVID-19? In that case, a pharmacist may dispense no more than a 14-day supply. And that prescription may not be refilled. Only a new prescription meeting the requirements of the rule may be filled. No emergency refill may be provided for a Restricted Drug prescribed for a COVID-19 diagnosis.
- May a Restricted Drug be dispensed for prevention of, or in anticipation of, a COVID-19 infection? No. No prescription for a Restricted Drug may be dispensed to prevent on in anticipation of a COVID-19 infection.
- What if a patient was already taking a Restricted Drug for something other than COVID-19 prior to this rule? The rule does not apply to prescriptions for a Restricted Drug for a patient previously established on that particular Restricted Drug on or before March 10, 2020.
- Does the emergency rule affect dispensing to in-patients at health-care facilities? No. Orders to administer a Restricted Drug to an inpatient of a health-are facility are not affected by this rule.
- Are prescribers governed by similar restrictions? Secretary Cohen has requested the North Carolina Medical Board to pass a substantively identical rule governing prescribers. Questions concerning the Medical Board’s progress on Secretary Cohen’s request should be directed to the Medical Board.
BOARD ISSUES ADDITIONAL GUIDANCE TO PHARMACIST-MANAGERS TAKING IN-PHARMACY MEASURES TO REDUCE THE RISK OF COVID-19 TRANSMISSION. North Carolina law requires that a pharmacy, among other things, be "kept in a clean, orderly, and sanitary condition." 21 NCAC 46.1601. "Sanitary" conditions plainly include conditions sufficient to minimize the risk of transmission of communicable disease within a pharmacy.
Under North Carolina law, the pharmacist-manager is the person to whom the Board issues a pharmacy permit (NCGS 90-85.21) and is, therefore, "the person who accepts responsibility for the operation of a pharmacy in conformance with all statutes and rules pertinent to the practice of pharmacy." 21 NCAC 46.1317(27).
The Board’s Expanded Emergency Services Waiver issued on March 17, 2020 stated, in part:
The Board strongly supports efforts by pharmacies and pharmacists to adjust work flows and processes within a pharmacy to reduce the risk of person-to-person coronavirus transmission. Such efforts might include, but are not limited to: not physically handling patient identifications at the point of dispensing; not requiring a physical signature for pick-up of a prescription; increasing use of prescription delivery service; limiting the number of patients physically entering a pharmacy; enforcing social distancing within a pharmacy.
The Board emphasizes that the pharmacist-manager is the person authorized by law to ensure compliance with these standards. Improper interference with a pharmacist-manager’s carrying out these duties and responsibilities subjects a pharmacy permit to potential disciplinary action, up to and including revocation. Likewise, a person licensed by, or registered with, the Board who improperly interferes with a pharmacist-manager’s carrying out these duties and responsibilities is subject to potential disciplinary action, up to and including revocation.