Author Insight: When Prescription Drugs Become Available Over-the-Counter, Their Ads Fall Silent on Risks

Once a drug becomes available over-the-counter, companies often omit risk information from the product’s advertisements, found Jeremy Greene, MD, PhD, and colleagues from Brigham and Women’s Hospital in Boston and CVS Caremark. Image: Nathaniel Comfort

When 4 popular medications became available to consumers over-the-counter (OTC), risk information all but disappeared from advertisements for the products, according to an analysis published today in JAMA.

When the US Food and Drug Administration (FDA) began allowing direct-to-consumer advertising of prescription medications in 1997, it required that drug makers present balanced information about the drugs’ risks and benefits. But after a drug is granted OTC status, these rules no longer apply, because oversight of nonprescription medication advertising falls to the Federal Trade Commission (FTC) rather than the FDA. The FTC regulates advertisements for drugs the same way it regulates advertisements for other consumer products, requiring that ads not be misleading to a “reasonable consumer.”

To determine the effect that the shift to OTC status had on the content of ads for medications, Jeremy Greene, MD, PhD, of Brigham and Women’s Hospital in Boston, and colleagues from the hospital and CVS Caremark compared the risk and benefit information in advertisements for 4 drugs—the allergy medications loratadine and cetirizine, the gastric reflux medication omeprazole, and the weight loss drug orlistat—in the 24 months before the products became available OTC and during the 6 months after. They found that ads provided similar information about the benefits of the medications during both time periods, but information about drug risks and contraindications was missing from nearly all of the OTC advertisements.

Greene, who is now an associate professor at Johns Hopkins University, discussed the findings with news@JAMA.

news@JAMA: Why did you and your colleagues decide to do this study?

Dr Greene: My colleagues and I have been concerned that OTC drugs bear risks for the population and that those risks are often minimized. For example, ibuprofen has been OTC for years so many consumers assume it is safe. But it can cause gastrointestinal bleeding and has recently been associated with an elevated risk of heart disease.

news@JAMA: Why is it important to include risk information in advertisements?

Dr Greene: When the average consumer thinks about an OTC drug, they think this drug has to be safe or it wouldn’t be available without a prescription. But as any pharmacologist knows, there is no such thing as a safe drug. Our most potent cures can be poison if used improperly, and that is just as true for OTC drugs.

news@JAMA: How would you like physicians to use your findings?

Dr Greene: It is increasingly important to know all of the substances a patient is taking. We understand that the total amount of acetaminophen consumed can shift it from a safe medication to one of the leading causes of emergency department visits and liver failure. It’s important for us to know the landscape of promotion and how it influences consumers’ perceptions of medication risks.

news@JAMA: How can patients use this information?

Dr Greene: There are tools patients can use to make themselves smart consumers. While all prescription drug advertisements are required to provide the generic name of the drug, the generic name was largely absent from OTC ads. One of the reasons this is relevant is that the knowledge of the generic name of drug is a valuable tool to help the patient access information from the scientific literature to access the full range risk and benefits of the drug.

news@JAMA: Do you think the findings suggest a change in oversight of OTC drug ads is needed?

Dr Greene: Our research highlights a problem. There are many potential solutions. The FTC could revisit its policy that pharmaceuticals are treated the same as other consumer products. They could adopt some of the FDA’s policies. Another avenue to explore would be to have the FDA continue the oversight of medications after they become OTC.

news@JAMA: Is the quality of information in the prescription drug ads better?

Dr Greene: Our research demonstrates a difference in presentation of risk before and after a drug becomes OTC. The immediate assumption is not enough risk is being presented in the OTC period. But merely presenting a lot of risks—a rapidly read list of trivial or serious things that can happen while taking a drug—isn’t necessarily effective. Some critics have suggested that risk fatigue can occur. The consumer can’t tell which risks are important and tunes it all out. There are many proposals to improve the presentation of risks in advertisements.

I don’t want to hold up the FDA’s fair-balance rule as a paragon of risk presentation. But it is certainly better than presenting no risk.



Categories: Health Policy, Patient Safety/Medical Error, Primary Care/Family Medicine

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