Medications Available Without a Prescription : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 3)

Benefit-Risk Comparison

When considering an Rx-to-OTC switch, the key question for FDA is whether patients alone can achieve the desired medical result without endangering their safety.

No drug is absolutely safe. There are risks associated with every medication, so FDA does a benefit-to-risk comparison to determine whether it is appropriate for consumers to self-medicate with a drug for a certain use.

On the safety side, the agency looks at the drug's toxicity — its potential for poisonous effects — when the drug is used according to its labeled directions, and also from foreseeable misuse of the drug.

While misuse by some consumers is inevitable — some people may overmedicate on the mistaken assumption that more is better — the Heller study showed that consumers appreciate the risks of taking any drug. Ninety percent of those surveyed said medications should be used only when absolutely necessary. Seventy percent said they prefer to fight symptoms without any medication.

FDA weighs a drug's safety against its benefit to patients. The agency considers whether consumers will be able to understand and follow label directions, whether patients can diagnose the condition themselves — or at least recognize the symptoms they want to treat — and whether routine medical examinations or laboratory tests are required for continued safe use of a drug.

No easy risk-benefit formula exists. FDA does a case-by-case review of each drug. Recently, the agency considered OTC switch applications for two very different drugs — Rogaine for hair growth and the nicotine patch for smoking cessation. Each raised unique issues, yet the risk-benefit comparison led FDA to the same conclusions in the two assessments — over-the-counter status is appropriate. (See accompanying articles.)

Concerns about side effects can sometimes be managed by approving OTC drugs at lower doses than their prescription counterparts. The drugs must still be effective for the short-term symptoms for which they're intended.

The issue of whether a condition can be self-diagnosed was a central one for the Rogaine advisory committee. Most OTC drugs are intended for treatment of symptoms that can be easily recognized, like headache or upset stomach. Others, though, are intended to treat diseases like asthma or vaginal fungal infections, which cannot be consumer-diagnosed.

Consumer-Friendly Labeling

Labeling is an influential element in the OTC risk-benefit comparison. The decision about a drug's safety for OTC use can't be made in a vacuum, by looking only at the drug ingredients. Every drug, used improperly, can cause adverse reactions. Even appropriate use can lead to side effects (antihistamine use may cause drowsiness, for example). And some drugs can be dangerously unsafe or ineffective if taken while using certain other drugs.

Labeling can alert consumers to such potential problems. Labeling of all drugs must be clear and truthful. For OTC drugs, the intended uses, directions and warnings have to be written so consumers, including individuals with low reading comprehension, can understand them.

FDA is working with the pharmaceutical industry to increase the readability of OTC labels by making the language more consumer-friendly and standardizing the format, including where important information is placed.

In some cases, Bowen says, consumers can get more information in the OTC labeling than they would get from their doctors. "For the nicotine patch, we developed a package — a package containing not only a drug that relieves withdrawal symptoms, but also behavioral modification information. The package provides an element of support that studies showed some people weren't getting from their doctors, by telling them when they'll most likely feel the urge to smoke, what they can do in place of smoking, and where they can go for support."

A Popular Alternative

Under the law, OTC drugs may be advertised directly to consumers without the many restrictions placed on Rx products. OTC status provides a greater opportunity for direct communication with the consumer, not only by advertising in magazines and on television, but also with packaging, brochures, and retail displays.

Nicorette gum magazine ads announce, "Nicorette Gum Is Now Available Full Strength Without A Prescription. Hallelujah!" "Hallelujah" may be the victory cry for those who, with the aid of OTC nicotine gum, were able to beat the cravings. But consumers aren't the only ones with something to gain from Rx-to-OTC switches.

Some manufacturers are exclaiming "Hallelujah" as well, over profits gained from direct access to millions of consumers. Pepcid AC for heartburn, for example, had sales topping $200 million in the first year after the product's April 1995 switch approval, making it the most profitable switch to date.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.