WOONSOCKET, R.I. — Consumers get much less information in advertisements for drugs that went over the counter versus when they were prescription-only, new research sponsored by CVS Caremark Corp. finds.
The company said Tuesday that the study, part of its research collaboration with Harvard University and Brigham and Women’s Hospital and published in this week’s Journal of the American Medical Association (JAMA), spotlights differences between consumer-directed advertisements for drugs when they are available by prescription only versus when they transition to OTC status.
Ads 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 (DTC) advertising for prescription drugs is regulated by the Food and Drug Administration and requires balanced information about the risks and benefits of the medication. 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 nondeception 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," Troy Brennan, executive vice president and chief medical officer of CVS Caremark, said in a statement. "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 CVS, Harvard, and Brigham and Women’s Hospital analyzed all print and broadcast ads for four commonly used prescription drugs — loratadine, omeprazole, orlistat and cetirizine — that had extensive direct-to-consumer promotion before and after their shift to OTC. The team reviewed ads spanning 24 months before and six months after the 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).
"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," stated study lead author Jeremy Greene, M.D., of the division of pharmacoepidemiology and pharmacoecomomics at Brigham and Women’s Hospital. "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."
