In the last few months, the Institute for Safe Medication Practices (ISMP) and the U.S. Food and Drug Administration (FDA) have received dozens of reports of wrong dose errors related to PAXLOVID (nirmatrelvir and ritonavir), which is indicated for the treatment of mild-to-moderate COVID-19. ISMP is alerting healthcare professionals, especially pharmacists, who have an important role to play in error prevention.
The cover article in the June 30, 2022, issue of the ISMP Medication Safety Alert!® Acute Care newsletter outlines the causes and contributing factors of reported errors and provides safe practice recommendations. Paxlovid currently is available in tablet form in two blister pack configurations, with different dosing and a specific blister pack for patients who have moderate renal impairment.
Several of the reported errors involved improper renal dosing, such as prescribing or dispensing Paxlovid to patients with severe renal impairment. There also have been many errors during self-administration, including patients taking the wrong number of tablets or taking tablets at the wrong time.
“ISMP is emphasizing the need to educate patients using the teach back method, since blister pack instructions can be quite confusing,” says ISMP President Rita K. Jew, PharmD, MBA, BCPPS, FASHP. “Providing patients with the Paxlovid Fact Sheet for Patients, Parents, and Caregivers (https://www.fda.gov/media/155051/download) is a requirement and provides printed instructions to follow; if patients have questions they should contact their pharmacist.”
ISMP safe practice recommendations for Paxlovid include:
- Increase awareness. Educate prescribers and pharmacists about the reduced-dose blister package for patients with moderate renal impairment and who should receive it.
- Check EHR configuration. Ensure it is intuitive to select 2 of the 150 mg nirmatrelvir tablets to make up a 300 mg dose. On drop down menus, it is safest to list Paxlovid as a 300 mg and 100 mg dose pack, or a 150 mg and 100 mg dose pack (as stated on cartons).
- Provide clinical decision support. If possible, give guidance for Paxlovid in prescribing systems, such as an order sentence with dosing for patients with moderate renal impairment.
- Check and confirm renal function. There is a screening checklist tool available from the FDA that can also help identify significant drug interactions: https://www.fda.gov/media/158165/download
- Avoid communicating the dose by tablet or blister color. Referring to color can cause the patient to misunderstand which to take.
- Educate patients. Show patients how the medication is labeled on the blister pack, and make sure they know which tablets to take and when, and to remove each tablet just prior to taking the dose.
For a copy of the ISMP newsletter article with more details and the full list of recommendations, visit: https://www.ismp.org/resources/numerous-wrong-dose-errors-paxlovid