Pharmacists Urged to Curtail Off-Label Prescribing for Experimental COVID-19 Treatments

March 24, 2020

Pharmacies nationwide are struggling to keep up with the demand for new prescriptions of hydroxychloroquine, chloroquine and mefloquine, the decades-old immunosuppressant and/or anti-inflammatory agents used for treating rheumatoid arthritis and lupus, and preventing and treating malaria.

While health experts recently indicated they may hold promise as off-label treatment of COVID-19, no peer-reviewed clinical studies have shown hydroxychloroquine to be effective against COVID-19. Further controlled studies will be required to determine whether these medications are safe and effective for widespread use. To date, all evidence is anecdotal. Even with expedited approval pathways and the federal government’s promise to remove barriers to market, experts are grappling with how to best preserve the nation’s limited supply of these lifesaving drugs.

Pharmacists have reported receiving an exponential increase in the number of new prescriptions for the drugs. Many of these new prescriptions are being issued by general practitioners, dentists, gynecologists and other prescribers who typically do not issue such prescriptions in the usual course of practice. Pharmacists have reported that many prescribers are writing these prescriptions for family members and office staff as a preventative measure, which has led the Texas State Board of Pharmacy to adopt an emergency rule discouraging pharmacists from filling these medically unnecessary prescriptions.

The Texas provision reads in relevant part: “No prescription or medication order for chloroquine, hydroxychloroquine, mefloquine, or azithromycin may be dispensed or distributed unless all the following apply:

  1. The prescription or medication order bears a written diagnosis code from the prescriber consistent with the evidence for use;
  2. The prescription or medication order is limited to no more than a fourteen (14) day supply, unless the patient was previously established on the medication; and
  3. No refills may be permitted unless a new prescription or medication order is furnished.” (See 22 Tex. Admin. Code § 291.30.)

This new provision specifically targets the current overutilization of hydroxychloroquine. However, as clearly delineated in 22 Tex. Admin. Code § 291.29, the pharmacist has always had a responsibility to determine that a prescription is being issued for a “legitimate medical purpose by a practitioner in the course of medical practice.” The Drug Enforcement Administration spells out a “corresponding responsibility” of prescribers and pharmacists: “The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” (See 21 CFR §1306.04.) Most states have similar provisions extending a pharmacist’s corresponding responsibility beyond controlled substances, requiring the pharmacist to ensure that prescriptions are issued for a legitimate medical purpose by a prescriber in the usual course of his or her professional practice.

Furthermore, state boards of pharmacy are emphasizing that pharmacists should be leveraging their corresponding responsibility to ensure that prescriptions for hydroxychloroquine are being issued only for legitimate medical diagnoses, that such a diagnosis is reasonably related to the practitioner’s field of expertise (i.e., a dentist should not be prescribing hydroxychloroquine as off-label treatment for COVID-19), and any prescriptions are consistent with recognized quantity and duration limitations.

Other state boards of pharmacy are likely to follow suit, taking positions consistent with the one put forth by the Texas State Board of Pharmacy. McGuireWoods has a dedicated team of specialists that will continue to monitor the approval and availability of COVID-19 therapies, as well as official guidance at the state and federal levels. Please reach out to our team if you have questions.

McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial COVID-19-related business and legal issues.