Jeremy Greene, MD, PhD

What is your viewpoint on the switch of prescription drugs to OTC status?
I am not necessarily opposed, but I have serious concerns. The FDA regulates not only the safety of prescription drugs, but also the content of direct-to-consumer advertising. Consumers must be informed of the drug’s risks. But regulatory oversight of OTC drugs shifts from the FDA to the Federal Trade Commission (FTC), which mandates non-deception in direct-to-consumer drug advertising, as it does for any other product. But the FTC does not require disclosure of contraindications and potential adverse effects.

My colleagues and I analyzed advertisements for four commonly used prescription drugs  that were the subject of extensive direct-to-consumer advertising promotion both before and after OTC shift.9 We found that during the prescription period, 70% of advertisements presented potential risks of the drugs, vs. 11% after OTC shift. With the exception of print advertisements for one of these drugs, no post-switch advertisements mentioned contraindications or adverse effects.


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What are the implications of these findings?
The concern is that consumers may use the drugs without awareness of contraindications or side effects. Acetaminophen, for example, carries substantial risk of hepatic damage, and is one of the leading causes of liver failure in the United States. There have been attempts to create labeling that helps consumers understand the risks and use it appropriately, but these measures are insufficient. Regulation of direct-to-consumer advertising should not be more lax for OTC than for prescription drugs because consumers are placed at risk.

Do you believe OTC drugs offer advantages such as increased adherence with recommended therapies?
Patients tend to be more adherent when medications are more affordable, and there is no evidence suggesting that OTC drugs are cheaper. On the contrary, insured patients sometimes have lower out-of-pocket copays for prescription than for OTC drugs. For example, Medicaid no longer covers PPIs that are available OTC. So to make treatment with PPIs affordable for the patient, some of my colleagues prescribe a prescription PPI. The patient pays less, but the cost is absorbed by the payer and healthcare system.

Conclusion

Both experts agree that availability of OTC drugs can potentially benefit patients, if used correctly and safely. But patients need to be informed of side effects, contraindications, and drug interactions. Physicians can play a role by asking patients what OTC products they are taking, and discussing potential risks.

References

  1. US Food and Drug Administration (FDA). Prescription to over-the-counter (OTC) Switch List (2014). Available at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm106378.htm. Accessed: September 10, 2014.
  2. Sanofi, Lilly pursue OTC ED drug approval. Monthly Prescribing Reference. May 28, 2014. Available at: https://www.empr.com/home/news/sanofi-lilly-pursue-otc-ed-drug-approval/. Accessed: September 10, 2014.
  3. Lee F, Citron D. Prescription-free birth control pills up for debate. USA Today. November 28, 2012. Available at: http://www.usatoday.com/story/news/2012/11/28/over-the-counter-birth-control/1732205/. Accessed: September 11, 2014.
  4. American Academy of Family Physicians (AAFP). Over-the-counter oral contraceptives. (2014) Available at: http://www.aafp.org/about/policies/all/otc-oral-contraceptives.html. Accessed: September 11, 2014.
  5. Finer LB, Zolna MR. Shifts in intended and unintended pregnancies in the United States, 2001-2008. Am J Public Health. 2014;104 Suppl 1:S43-S8.
  6. Frost JJ, Singh S, Finer LB. U.S. women’s one-year contraceptive use patterns, 2004. Perspect Sex Reprod Health. 2007;39(1):48-55.
  7. Grossman D, Grindlay K, Li R, et al. Interest in over-the-counter access to oral contraceptives among women in the United States. Contraception. 2013;88(4):544-552.
  8. Doshi JS, French RS, Evans HE, Wilkinson CL. Feasibility of a self-completed history questionnaire in women requesting repeat combined hormonal contraception. J Fam Plann Reprod Health Care. 2008;34(1):51-4.
  9. Greene JA, Choudhry NK, Kesselheim AS, et al.  Changes in direct-to-consumer pharmaceutical advertising following shifts from prescription-only to over-the-counter status. JAMA. 2012;308(10):973-975.