In the past two decades, an increasing number of prescription drugs have been switched to over-the-counter (OTC) status. Therapeutic classes include vaginal antifungal preparations, antihistamines, decongestants, proton pump inhibitors (PPIs), laxatives, and emergency contraception. In 2013, oxybutynin transdermal patches and triamcinolone acetonide nasal spray became OTC, followed by esomeprazole and fluticasone proprionate in 2014.1 FDA approval of Cialis (tadalafil) as OTC treatment for erectile dysfunction is currently being pursued as well.2 And the proposed switch of oral contraceptives (OCs) from prescription to OTC continues to generate controversy.3
To gain insight into this complex issue, Monthly Prescribing Reference has interviewed two experts. Jennifer Frost, MD, Medical Director for the Health of the Public and Science Division of the American Academy of Family Physicians (AAFP), will speak in favor of switching, while Jeremy Greene, MD, PhD, Associate Professor of the History of Medicine, Johns Hopkins University School of Medicine and Internist at East Baltimore Medical Center, will offer a countervailing cautionary viewpoint.
Jennifer Frost, MD
What is the position of AAFP regarding the switch of prescription drugs to OTC status?
AAFP has issued a formal statement regarding OTC access to OCs, but there are no formal position statements regarding any other classes of drugs. AAFP supports making OCs available on an OTC basis.4 However, the reasons for supporting the OC switch to OTC can also be applied to other drug classes.
What are these reasons?
Unintended pregnancies, a major public health concern, occur mainly because many women lack access to OCs, or find them too costly.5, 6 We regard it as essential to make these products as available as possible, both OTC and also on a prescription basis, with full coverage by insurers, regardless of prescription status. Additionally, making OCs available OTC saves the healthcare system money, and also saves the woman and her provider time, because she does not need to make unnecessary medical visits.7
Does the same reasoning apply to other classes of medications?
I think it does. Any time a patient can safely use an OTC product, the patient, provider, and healthcare system benefit.
Isn’t there a concern that patients might ignore contraindications or neglect physician visits?
In the case of OCs, evidence shows that women correctly self-identify contraindications via a standardized check list.8 Moreover, there is no evidence to suggest that OTC access to contraceptives decreases patient visits to healthcare providers.6 The same holds true for other medications. Most patients do consult a physician if their symptoms are not resolved. For example, many women self-diagnose vaginal yeast infections and self-treat with OTC anti-fungal preparations, which were once prescription items. But if their symptoms do not resolve, they consult their provider.
Do you think that OTC availability increases adherence?
I think adherence is a problem, with or without prescription. It depends on a variety of factors, and I don’t think this is the decisive issue.
Is there a population that requires more vigilance regarding the use of OTC products?
The geriatric population is vulnerable to the impact of polypharmacy, which might be increased with access to new OTC products. So it is especially important for providers to talk to geriatric patients about safety issues, and to inquire about OTC products and herbal supplements that patients may be taking.