CVS Caremark Sponsored Research Finds Consumers Hear Less About Medication Risks When Drugs Switch from Prescription to Over-the-Counter

WOONSOCKET, R.I., Sept. 11, 2012 /PRNewswire/ -- New research sponsored by CVS Caremark and published in this week's issue of the Journal of the American Medical Association (JAMA) identifies differences between consumer-directed advertisements for drugs when they are available by prescription-only vs. when they transition to over-the-counter (OTC) status.  The researchers found that advertisements for the OTC versions of the drugs contained significantly less information about the risks of the medication, with only 11 percent of the ads discussing potential risks for the OTC drugs, vs. 70 percent of the ads used when the drug was available by prescription only.

"When a prescription drug moves to over-the-counter status, providing consumers with on-demand access to the medication, consumers need to have good information available to them in order to make an informed decision about whether the drug is right for them," said Jeremy Greene, MD, PhD of the Division of Pharmacoepidemiology and Pharmacoecomomics, Brigham and Women's Hospital, and the lead author of the study.  "Our research found, however, that although the drug's risk and benefit profile does not change when it moves to OTC status, the ads for OTC medications contained less information about the potential risks related to the drug."

Direct-to-Consumer (DTC) advertising for prescription drugs is regulated by the Food and Drug Administration (FDA) and requires the inclusion of balanced information about the risks and benefits associated with the drug.  When a prescription drug switches to over-the-counter (OTC) status, regulatory oversight of consumer advertising transitions to the Federal Trade Commission (FTC), which holds drug advertisements to the same standards of truthfulness and non-deception as any other consumer product. 

"This study provides some interesting insights into how drug information is presented to consumers based on the medication's prescription or over-the-counter status," said Troyen A. Brennan, MD, MPH, executive vice president and chief medical officer of CVS Caremark.  "Ads for prescription drugs that become available over-the-counter probably should carry the same level of information regarding the medication's risks, benefits and side effect profile as consumers continue to need this information in order to make appropriate and informed treatment decisions."

Researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark, analyzed all print and broadcast ads for four commonly used prescription drugs (loratadine, omeprazole, orlistat and cetirizine) that were the subject of extensive direct-to-consumer promotion before and after the shift to OTC availability.  The team reviewed ads spanning 24 months prior and six months following OTC shift for each drug.  A total of 133 ads were reviewed for descriptive characteristics, presentation of health benefits (specific indications and claims of general health improvement) and potential health harms (side effects, contraindications, warnings and precautions).

This study is a product of a research collaboration between CVS Caremark, Harvard and Brigham and Women's Hospital that is focused on understanding why many consumers do not take their prescriptions as directed, and developing solutions to assist patients in using their medications effectively.  Excess health care costs due to medication non-adherence in the U.S. are estimated to be as much as $300 billion annually.