FDA: Pharmacists Can Prescribe Paxlovid to Eligible Patients
The revised Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir) allows these providers to offer this COVID-19 therapy.
The Food and Drug Administration (FDA) announced today it has authorized state-licensed pharmacists to prescribe Paxlovid to eligible patients. In the decision, the federal agency said it is with certain limitations to ensure appropriate patient assessment and prescribing this COVID-19 therapy.
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research, said in the FDA announcement.
Pharmacists play a significant role in clinical care and the FDA recognizes the need for timely considerations when treating COVID-19. “Since Paxlovid must be taken within 5 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,” Cavazzoni said.
For those patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid from state-licensed pharmacists, they will need the following information to ensure that the state-licensed pharmacist has sufficient information to determine the individual’s eligibility for the Pfizer therapy:
- Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient’s health care provider.
- A list of all medications they are taking, including over-the-counter medications so the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.
Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
- Sufficient information is not available to assess renal and hepatic function.
- Sufficient information is not available to assess for a potential drug interaction.
- Modification of other medications is needed due to a potential drug interaction.
- Paxlovid is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
The therapy was initially authorized by the FDA late last year. During that time, the EUA for Paxlovid was indicated for people with COVID-19 in trying to prevent them from progressing to more severe disease including hospitalization.