OTC Tamiflu: Coming Soon to an Aisle Near You?

OTC Tamiflu: Coming Soon to an Aisle Near You?
Meg Tapp, PharmD, Essentia Health

An article by Pharmacy Times published in December 2019 recently announced plans for the common prescription-only medication oseltamivir (Tamiflu®) to switch to over-the-counter (OTC) status. Manufacturer Sanofi signed a deal with current producer Roche Pharmaceuticals in July 2019 which grants exclusive OTC rights for Tamiflu®. Per the Pharmacy Times correspondence, Sanofi commented that OTC status for this medication will “support our global cough and cold strategy by expanding into flu” and increase affordability and availability of the product.

Tamiflu® is an antiviral neuraminidase inhibitor used for treating and preventing influenza post-exposure. It is FDA-approved for patients age 14 days and older, although prophylaxis is typically reserved for those age 3 months and older. Initiation of Tamiflu® must occur within 48 hours of influenza onset for maximum benefit; this is particularly important for patients who are hospitalized, have severe or complicated illness, or who are at higher risk of complications. Overall efficacy remains controversial, although one study cites Tamiflu® reduces time to symptom alleviation by 16.8 hours on average (Heneghan et al. 2016). The medication is typically well-tolerated, with most common side effects being nausea, vomiting, and headache.

A Tamiflu® switch to OTC status will undoubtedly expand the scope of pharmacist involvement in initiation of the product. With Tamiflu® on OTC shelves, pharmacists will often be the first line of contact for patients seeking self-treatment. Pharmacists will be relied upon to educate patients on the symptoms of flu versus common cold, as well as proper use, common side effects, and length of treatment duration for Tamiflu®. The pending switch will allow patients to access treatment faster, a proposed benefit given  increased efficacy within 48 hours of influenza onset. Still, there will undoubtedly be controversy surrounding appropriate use of Tamiflu® as an OTC product. Per Pharmacy Times, Sanofi will lead FDA negotiations and garner expert support before Tamiflu® hits pharmacy shelves.

While Sanofi has not defined an exact date for the release of OTC Tamiflu® as of this publication, pharmacists and other healthcare providers should be aware of this impending change and what it may mean for their future patients and practices.

References:

  1. Terrie YC. Tamiflu Set to Switch to OTC Status. Pharmacy Times. Available at https://www.pharmacytimes.com/publications/issue/2019/December2019/Tamif.... Published December 12, 2019. Accessed February 4, 2020. 

  2. Centers for Disease Control and Prevention. Influenza Antiviral Medications: Summary for Clinicians. Available at https://www.cdc.gov/flu/professionals/antivirals/summary-clinicians.htm. Updated periodically. Accessed February 12, 2020.

  3. Heneghan CJ, Onakpoya I, et al. Neuraminidase inhibitors for influenza: a systematic review and meta-analysis of regulatory and mortality data. 2016. Health Technol Assess. 20(42): 1-242.