FDA Authorizes Pharmacists to Prescribe Paxlovid with Sure Limitations
New Prescribing Authority May Enhance Entry for Some Sufferers at Excessive Threat for Extreme COVID-19
SILVER SPRING, Md., July 6, 2022 /PRNewswire/ — As we speak, the U.S. Meals and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible sufferers, with sure limitations to make sure acceptable affected person evaluation and prescribing of Paxlovid.
“The FDA acknowledges the necessary function pharmacists have performed and proceed to play in combatting this pandemic,” mentioned Patrizia Cavazzoni, M.D., director for the FDA’s Middle for Drug Analysis and Analysis. “Since Paxlovid have to be taken inside 5 days after signs start, authorizing state-licensed pharmacists to prescribe Paxlovid may broaden entry to well timed therapy for some sufferers who’re eligible to obtain this drug for the therapy of COVID-19.”
When testing optimistic for COVID-19, sufferers ought to first think about looking for care from their common well being care supplier or finding a Take a look at-to-Deal with website of their space. Whereas this motion permits state-licensed pharmacists to prescribe Paxlovid with sure limitations as described beneath, group pharmacies not already taking part as a Take a look at-to-Deal with website can determine if or how they are going to provide this service to sufferers.
Sufferers who’ve examined optimistic for COVID-19 and are looking for to find out their eligibility for receiving Paxlovid at areas the place prescribing by state-licensed pharmacists is offered ought to carry the next info to make sure that the state-licensed pharmacist has adequate info to find out their eligibility to obtain Paxlovid:
- Digital or printed well being data lower than 12 months outdated, together with the latest stories of laboratory blood work for the state-licensed pharmacist to evaluate for kidney or liver issues. State-licensed pharmacists may additionally obtain this info via a seek the advice of with the affected person’s well being care supplier.
- An inventory of all medicines they’re taking, together with over-the-counter medicines so the state-licensed pharmacist can display screen for medicine with doubtlessly severe interactions with Paxlovid.
Underneath the restrictions outlined within the authorization, the state-licensed pharmacist ought to refer sufferers for scientific analysis with a doctor, superior apply registered nurse, or doctor assistant licensed or approved beneath state legislation to prescribe medicine, if any of the next apply:
- Adequate info shouldn’t be accessible to evaluate renal and hepatic operate.
- Adequate info shouldn’t be accessible to evaluate for a possible drug interplay.
- Modification of different medicines is required on account of a possible drug interplay.
- Paxlovid shouldn’t be an acceptable therapeutic possibility primarily based on the present Truth Sheet for Healthcare Suppliers or on account of potential drug interactions for which advisable monitoring wouldn’t be possible.
Paxlovid is allowed for the therapy of mild-to-moderate COVID-19 in adults and pediatric sufferers (12 years of age and older weighing not less than 40 kilograms or about 88 kilos) with optimistic outcomes of direct SARS-CoV-2 viral testing, who’re at excessive threat for development to extreme COVID-19, together with hospitalization or demise. Sufferers within the approved inhabitants who report a optimistic house take a look at end result from a speedy antigen diagnostic take a look at, or a optimistic PCR take a look at, to their supplier are eligible for Paxlovid beneath the EUA. Affirmation of a optimistic house speedy antigen diagnostic take a look at with extra direct SARS-CoV-2 viral testing, corresponding to a PCR, shouldn’t be required. Antibody exams are usually not thought-about to be direct SARS-CoV-2 viral exams.
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The FDA, an company throughout the U.S. Division of Well being and Human Providers, protects the general public well being by assuring the protection, effectiveness, and safety of human and veterinary medicine, vaccines and different organic merchandise for human use, and medical units. The company is also accountable for the protection and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.
SOURCE U.S. Meals and Drug Administration