FDA Wisely Permits Pharmacists to Prescribe Paxlovid

By Jeffrey A. Singer of Cato.

"When the Food and Drug Administration granted Emergency Use Authorization to the antiviral drugs Paxlovid and monupiravir in the beginning of this year, I co‐​authored an oped in the New York Daily News, along with Josh Bloom of the American Council on Science and Health, complaining about, among other things, the FDA’s requirement that a patient who tests positive for COVID must get a prescription from a doctor, nurse practitioner, or physician assistant to obtain the drug. For the drugs to be effective they must be started within five days of the start of COVID symptoms. Not everyone has ready access—or the time—to get in to a busy medical office to get a prescription.

We also complained about the requirement that a patient get a positive test. In those days, self‐​administered at‐​home tests were not readily available, and results obtained from testing centers could take a few days to get back.

With at‐​home self‐​administered tests now plentiful, one obstacle to rapid and efficient antiviral treatment is gone. Yesterday the FDA removed a second obstacle: the agency added pharmacists to the list of health care practitioners who can prescribe Paxlovid.

I argued in a March 2022 blogpost that the “Test to Treat” program set up by the Biden Administration was a good idea. It allowed patients to get a quick test at a pharmacy and, if it is positive, get the treatment while still in the store. Unfortunately, the American Medical Association protested, claiming it was “unsafe” for anyone other than a physician to prescribe the antivirals. I stated in that blogpost:

The AMA understandably worries about “scope creep,” i.e., expansions in the scope of practice of the various adjunct and/​or competing licensed health professions. For example, state chapters of the AMA frequently fight attempts by nurse practitioners and physician assistants to deliver primary care and other services to patients. They always claim to be concerned about patient safety but are arguably concerned about the competition as well.

The Biden Administration engineered a compromise to the “Test to Treat” program, designed to assuage the physician lobby: only pharmacy‐​based clinics would be allowed to participate in the program. These are pharmacies that have a licensed physician, nurse practitioner, or physician assistant on the premises working in a clinic. An example is the CVS MinuteClinic. That severely restricted the number of locations where patients can take advantage of the new program. The revised policy should make rapid COVID diagnosis and treatment immensely more convenient.

Pharmacists are experts—often more knowledgeable than doctors—about drug side effects and drug‐​drug interactions. Many states are increasing their scope of practice to allow them to prescribe birth control pills, HIV pre‐ and post‐​exposure prophylaxis, and perform vaccinations. I have argued here that states should expand their scope even further. Pharmacists should be able to test and treat influenza (with antivirals) influenza and strep throat (with antibiotics) and uncomplicated urinary tract infections, among other things.

Because the COVID antivirals have only received Emergency Use Authorization, the FDA has the authority to permit pharmacists to prescribe them. Pfizer is seeking full approval for the drug. Once the drug receives full approval, the authority will revert to the states and their legislatures to determine the scope of practice of their licensed health professionals. Hopefully the FDA’s recent decision to allow pharmacists to prescribe this drug will set an example for state lawmakers to expand pharmacists’ scope of practice to the full extent of their training. That will help improve health care access and affordability."