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Study: Consumers hear less about risks when Rx drugs switch to OTC status


WOONSOCKET, R.I. — Most advertisements for over-the-counter versions of drugs did contain significantly less information about the risks of the medication, compared with the ads for the drug prior to its transition to OTC status, according to new research sponsored by CVS Caremark.

The research, published in this week's issue of the Journal of the American Medical Association, identified differences between consumer-directed advertisements for drugs when they are available by prescription only, compared with when they transition to OTC.

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% of the ads discussing potential risks for the OTC drugs, compared with 70% of the ads used when the drug was available by prescription only.

Direct-to-consumer advertising for prescription drugs is regulated by the Food and Drug Administration and requires the inclusion of balanced information about the risks and benefits associated with the drug. When a prescription drug switches to OTC status, regulatory oversight of consumer advertising transitions to the Federal Trade Commission, 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," stated Troyen Brennan, EVP 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 healthcare costs due to medication nonadherence in the U.S. are estimated to be as much as $300 billion annually.

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