September 26, 2012

Ads for OTC Products Underplay Harm Compared
to Prescription Drugs

BostonPharmacists may need to make an extra effort to educate customers about potential adverse reactions to drugs that have switched to OTC status.

A research letter published recently in the Journal of the American Medical Association suggests that information is less readily available for those drugs than for medications requiring a prescription.

With prescription drugs, the FDA requires prescription drug manufacturers to provide consumers with a "fair balance" of risks and benefits. Regulatory oversight of advertising shifts to the Federal Trade Commission (FTC) when prescription drugs switch to OTC status.

"Unlike the FDA, the FTC holds drug advertisements to the same standards as any consumer product: it applies a 'reasonable consumer' standard of truthfulness and non-deception that does not require any balancing of potential benefits and harms. Such a shift may be associated with changes in content," writes Jeremy A. Greene, MD, PhD, of Brigham and Women's Hospital, Boston, and colleagues.

For the report, researchers analyzed all print and broadcast advertisements from four commonly used prescription drugs promoted heavily with direct-to-consumer advertising before and after their shift to OTC: loratidine, omeprazole, orlistat, and cetirizine.

Looking at 24 months before the shift and 6 months after, the authors coded television and print materials for descriptive characteristics, presentation of health benefits, and potential health harms.

After the OTC switch, researchers found significant differences existed in the presentation of potential harm. During the prescription-only period, 70% of advertisements—48 of 69—presented that information compared to 11% of advertisements—7 of 64—after the switch to OTC.

Except for print advertisements for orlistat, the researchers found, no post-switch advertisements mentioned contraindications or adverse effects.

In addition, according to the research letter, print and broadcast advertisements after OTC switch were less likely to mention drugs' generic names, 52%, compared to 94% before the switch.

"Pharmaceuticals do not lose their capacity for harm after moving from behind the pharmacist's counter to in front of it," the authors write. "Closer attention should be paid to how such drugs are promoted to consumers."

U.S. Pharmacist Social Connect