Label Literacy for Over the Counter Drugs, Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Medicine misuse also can occur when important labeling information is difficult to find, says FDA's Bowen.

A person allergic to an ingredient in a drug product needs to know whether the product contains it. Although active ingredients are usually listed on OTC drug products, current rules don't require labels for all drugs to list inactive ingredients. And labels that do list the information about ingredients may include it in any paragraph virtually anywhere on the label, Bowen says. "If it's in tiny print, it's even harder to find."

Proper use of OTC drugs becomes more critical as potent prescription drugs increasingly switch to OTC use, as their safety profiles become more established. (See "Now Available Without a Prescription" in the November 1996 FDA Consumer.)

For example, Tagamet (cimetidine) and other drugs of this type are used at prescription strength for ulcer treatment. The OTC versions, approved only for heartburn, are at lower doses. "But Tagamet in particular can have interactions at higher doses with other drugs," Bowen says.

FDA wants to help as many people as possible understand OTC drug labels so they'll use the medicines properly.

The Proposed Solution

The agency proposes an easier-to-read, easier-to-understand OTC drug label that presents important required information as distinct elements in an uncluttered format, using simpler wording in larger type. Most importantly, Bowen says, "the proposal would standardize the order of the required labeling elements and where that information is on the label."

Standardization would eliminate current practices in which product directions, warnings and approved uses appear in different places on the label and the information can appear in varying type styles and with varying graphic features. These practices make it difficult for consumers to compare products to decide which is best for the symptoms they wish to treat.

Confirming the need for national standards, Michael Weintraub, M.D., director of FDA's Office of Drug Evaluation V, says, "No matter what the product, when a consumer in any part of the country turns over an OTC medicine package and reads the label, we want the different types of information to be easy to read and always in the same place. This will increase the likelihood of safe and effective use. Consumers won't have to hunt around anymore for information on the label."

To improve readability, FDA proposes a minimum 6-point type size for required information. (For comparison, newspapers usually use 9- or 10-point type.)

Bowen acknowledges that "the minimum type size is not going to address all people who have eyesight problems. But the larger type, along with a standard location and less clutter, will help."

In its proposal, FDA asks for public comment on whether to require a minimum type size for the principal display panel to improve readability and to require a package insert in larger print to help ensure proper use by people who can't read 6-point type.

Simpler, More Concise Language

To reduce the label information load, FDA proposes simplified wording. For example, three familiar warnings would be simplified to:

"If pregnant or breast-feeding, ask a health professional before use" instead of "As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product."

"Keep out of reach of children" instead of "Keep this and all drugs out of the reach of children."

"In case of overdose, get medical help right away" instead of "In case of accidental overdose, seek professional assistance or contact a poison control center immediately." This revision reflects the fact that not all states have poison control centers and that consumers may more readily obtain advice from more accessible medical professionals if the wording is changed.

Also, FDA proposes more than 35 simpler terms or phrases that can be used on the label in lieu of more complex or technical wording. For example, "lung" could be used instead of "pulmonary," "help" or "aid" instead of "assistance," "use(s)" instead of "indication(s), "drug" instead of "medication," and "hole in" instead of "perforation of."

Other changes under consideration include alternative packaging designs, such as extending a single side panel on small packages to increase label space, and placement of sodium, calcium, magnesium, and potassium contents on the label.

Industry Assistance

Last January, FDA formally recognized the Nonprescription Drug Manufacturing Association (NDMA) for its contributions to the proposal by presenting the group with a Special Recognition Award.

"Industry has been very forthcoming, giving us lots of good suggestions," says FDA's Weintraub. In nominating NDMA, he commended the group's "wholehearted effort in partnership with the agency," stating that its members "provided excellent concepts, promoted the free and collegial exchange of ideas with the agency, and contributed user-friendly wording for the labels."

Said NDMA President James Cope: "Everybody benefits — particularly the consumer — when industry and regulators strive to cooperate."

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.