News Release

ISMP Issues Warning about Possible Safety Issues with Newly-Authorized Paxlovid

The Institute for Safe Medication Practices (ISMP) has identified possible error risks with Paxlovid, which recently received Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19. An ISMP special alert has been issued to raise awareness and recommend ways to prevent errors, including highlighting special instructions for dispensing pharmacists.

Paxlovid is indicated for the treatment of patients with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing and who are at high risk for progression to severe COVID-19. A dose reduction is necessary for patients with moderate renal impairment, and patients with severe renal impairment should not receive the drug. Paxlovid is only available in a carton holding five blister cards, each with daily morning and evening doses consisting of two tablets of nirmatrelvir and one tablet of ritonavir (an FDA-approved antiretroviral agent).

Pharmacists should be aware that for patients with moderate renal impairment, one of the nirmatrelvir tablets for both the morning and evening doses need to be removed from each blister card before being dispensed. The empty blisters on all five cards should be covered with manufacturer-supplied stickers.  

Other possible safety issues include challenges with prescribing the dose, patients accidentally failing to take both tablets together, and drug interactions. For a copy of the ISMP alert, which provides safe practice recommendations, visit: https://www.ismp.org/alerts/medication-safety-issues-newly-authorized-paxlovid

All errors with Paxlovid should be reported internally within healthcare organizations as well as to the FDA MedWatch reporting program, which is mandatory for products under an EUA. ISMP also asks providers to report medication errors to ISMP's medication error reporting program. See the alert or Fact Sheet for details about faxing a copy of the MedWatch report to Pfizer.

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