NMA: Nonprescription Medicines Academy

Consumers Hear Less About Medication Risks After Rx-to-OTC Switch

October 17th, 2012

When a prescription drug makes the switch to nonprescription status, direct-to-consumer (DTC) advertisements for the OTC version are likely to contain significantly less information about potential risks, based on an analysis by researchers from Harvard University, Brigham and Women's Hospital and CVS Caremark.

DTC advertising for prescription drugs is regulated by the FDA and requires the inclusion of balanced information about the risks and benefits associated with the drug. After an Rx-to-OTC switch, 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.

The researchers analyzed all print and broadcast ads for loratadine, omeprazole, orlistat, and cetirizine spanning 24 months before and 6 months after the Rx-to-OTC switch 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).

The number of ads describing potential benefits did not differ significantly for the prescription-only period (57 of 69; 83%) vs the OTC period (62 of 64; 97%) (prevalence ratio, 1.17; 95% CI, 1.04–1.32; P = 0.01). However, while 48 of 69 (70%) ads during the prescription-only period discussed potential risks, only 7 of 64 (11%) ads included that information during the OTC period (prevalence ratio, 0.17; 95% CI, 0.09–0.35; P <0.001). Print and broadcast ads during the OTC period also were significantly less likely to mention the generic name of the medication.

JAMA. 2012;308:973-5.