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Author: Admin | 2025-04-28
A British Medical Journal article published in 2005. Patients can obtain low-dose simvastatin without a prescription, but the medications are placed behind the pharmacy counter and distributed after a pharmacist’s consultation. In this context, the pharmacist is consulted as to whether or not a statin is appropriate.Similarly, since 2018 in the U.K. one can purchase the erectile dysfunction drug sildenafil without a prescription from a pharmacy after a discussion with the pharmacist. The person will be asked questions about his general health to make sure sildenafil is safe to take and the pharmacist will convey which potential side effects to be aware of.Without a behind-the-counter alternative that involves pharmacist consultations, it’s hard to envision statins or a drug like sildenafil making the switch in the U.S. from Rx to OTC.Indeed, the history of attempts to bring statin therapy to OTC status in the U.S. dates back more than 25 years, and three attempts—lovastatin, pravastatin and atorvastatin—since then have failed.In 2015, Pfizer pulled its application to make their cholesterol drug atorvastatin available to patients OTC because in an actual use study patients were not using the drug correctly.There are therapeutic classes which would seem candidates for Rx-to-OTC switches in the U.S. This includes drugs for erectile dysfunction,* migraine and high cholesterol, among other categories. The introduction by the FDA of the Nonprescription Safe Use Regulatory Expansion or NSURE initiative in 2013 was supposed to spur a new wave of Rx-to-OTC switches, with a focus on facilitating switches in new therapeutic classes. But it hasn’t happened. Perhaps part of the reason is the lack of a formal behind-the-counter class of drugs.* In June of last year the FDA did approve a topical gel for erectile dysfunction, Eroxon, but it wasn’t an Rx-to-OTC switch.
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