FDA has revised the Emergency Use Authorization (EUA) for Pfizer’s (NYSE:PFE) Paxlovid (nirmatrelvir and ritonavir) to allow state-licensed pharmacists to prescribe the drug to some patients with a high risk of COVID-19.
While the move allows pharmacists to prescribe Paxlovid, it has limits. It instructs the professionals to refer patients to a physician if there is insufficient information to assess patients’ renal and hepatic function and the potential for a drug interaction. In addition, the updated EUA requires a physician to potentially modify the prescription of other medications to avoid an adverse drug interaction. As a result, pharmacists will not be able to prescribe the drug to patients with a potential drug interaction risk who are not able to be monitored.
The FDA rules also require pharmacists to confirm that Paxlovid is an appropriate treatment based on a Fact Sheet for Healthcare Providers.
To verify eligibility, pharmacists must ensure that patients have available health records from the past year with relevant documents of laboratory blood work. A physician also could provide this information to a pharmacist on behalf of a patient.
In addition, pharmacists must supply a list of medications patients are taking, including OTC medications.
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19.”
FDA also encourages patients who test positive for COVID-19 to attempt to obtain care from a regular healthcare provider or identify a Test-to-Treat site.
All patients prescribed Paxlovid must be at least 12 years of age and weigh at least 40 kilograms (about 88 pounds). Additionally, they must have a positive test result and face a high risk of developing severe COVID-19.