State-licensed pharmacists can now prescribe Paxlovid (nirmatrelvir tablets co-packaged with ritonavir tablets) with certain limitations to eligible patients, according to the Food and Drug Administration (FDA).
Paxlovid is authorized for the treatment of mild to moderate COVID-19 in patients 12 years of age and older weighing at least 40kg with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The Emergency Use Authorization (EUA) for Paxlovid has been revised to reflect the new prescribing authority given to state-licensed pharmacists.
Patients who test positive for COVID-19 (either with a positive home rapid antigen test or a positive PCR test) should first consider seeking care from their health care provider or locating a Test-to-Treat site. Community pharmacies not participating as a Test-to-Treat site can decide if or how pharmacists will offer Paxlovid to patients.
Under the revised EUA, patients who test positive for COVID-19 must provide the following information to ensure pharmacists can determine their eligibility to receive Paxlovid:
- Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work to review for renal or hepatic problems. This information may also be provided through consultation with the patient’s health care provider.
- A list of all medications, including over-the-counter medications, so that the pharmacist can screen for potentially serious interactions with Paxlovid.
Pharmacists should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized to prescribe medication if any of the following apply: 1) there is insufficient information to assess renal and hepatic function; 2) there is insufficient information to assess for potential drug interactions; 3) a dosage modification of another medication is required to avoid a potential drug interaction with Paxlovid; or 4) if Paxlovid is deemed to be an inappropriate therapeutic option based on the authorized Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
“The FDA recognizes the important role pharmacists have played and continue to play in combatting this pandemic,” said Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research. “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.”
The authorized dose for Paxlovid is 300mg of nirmatrelvir (two 150mg tablets) with 100mg of ritonavir (one 100mg tablet) for a total of 3 tablets taken together orally twice daily for 5 days. For patients with moderate renal impairment (eGFR ≥30 to <60mL/min), the authorized dose is 150mg of nirmatrelvir (one 150mg tablet) with 100mg ritonavir (one 100mg tablet), with both tablets taken together twice daily for 5 days. The treatment is not recommended for patients with severe renal or hepatic impairment.
Paxlovid is supplied in 2 different dose packs:
- 300mg nirmatrelvir; 100mg ritonavir: each carton contains 30 tablets divided in 5 daily-dose blister cards; each daily blister card contains 4 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each).
- 150mg nirmatrelvir; 100mg ritonavir: each carton contains 20 tablets divided in 5 daily-dose blister cards; each daily blister card contains 2 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each).
In the event that the Paxlovid 150mg; 100mg dose pack is unavailable, pharmacists should refer to the provided instructions entitled “IMPORTANT PAXLOVID™ EUA DISPENSING INFORMATION FOR PATIENTS WITH MODERATE RENAL IMPAIRMENT” for dispensing of Paxlovid to patients with moderate renal impairment and patients should be informed that their daily blister card has been altered to ensure they receive the correct dose.
Paxlovid is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19; for use as preexposure or postexposure prophylaxis for prevention of COVID-19; or for use for longer than 5 consecutive days.
Coronavirus (COVID-19) update: FDA authorizes pharmacists to prescribe Paxlovid with certain limitations. News release. US Food and Drug Administration. Accessed July 6, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-pharmacists-to-prescribe-paxlovid-with-certain-limitations-301581671.html