Label Literacy for Over the Counter Drugs

by Food and Drug Administration (FDA)

Information on a medicine label should be in "plain English" and larger type and should emphasize side effects and warnings with boldface type and bullets, a sampling of consumers told the Food and Drug Administration. They said this would help them understand how the drug works and would lessen their concerns about any risk from using it.

Their comments, gathered in a 1996 focus group study, as well as several years' worth of comments from meetings with industry, health professionals, other consumers, and interested groups, enabled FDA on Feb. 27 to propose labeling rules for over-the-counter drugs that would make information on the label easier to read and understand.

"We want the label to be easier to read so people will indeed read it," says William Gilbertson, Pharm.D., associate director for FDA's OTC drug monographs. "And we want it to be easier to understand so people will react correctly."

This is especially important as many new potent medicines become available OTC, says Debra Bowen, M.D., director of FDA's division of OTC drug products. "These are pharmacologically active agents that have side effects, as well as beneficial effects. To use them correctly and not get into trouble from using them, people are going to have to read the label and make sure they're appropriately selecting and using them with other drugs they may be taking."

Ilisa Bernstein, a senior science policy advisor with FDA's Office of Policy, compares the proposed changes with those imposed in 1992 for food labeling and a new public-private plan that will give patients better prescription drug information.

"Our overall goal is to ensure that consumers read the labels, choose the product that is right for them, and use the product correctly," says Bernstein, who coordinated the agency's efforts to develop the OTC labeling proposal.

Knowing Proper Medicine Use: Ay, There's the Rub

FDA rules already require OTC drug labels to include all the information consumers need for safe and effective use. But consumers can use the information only if they first read the entire label and understand what they read.

Most OTC medicines are subject to rules known as monographs, which require certain labeling information for certain types of drugs. For example, there is an antacids monograph for all OTC antacid products.

A few products, such as Ivy Block (bentoquatam) to prevent and treat poison ivy, are marketed under new drug applications, which require certain information on a specific product's label. Other rules require additional labeling information, such as the statement to keep medicine out of children's reach.

Ensuring proper use of these medicines is no small job, as FDA points out in the OTC labeling proposal, because:

• There are about 100,000 OTC drug products on the market.
• Consumers self-treat four times more health problems than doctors treat.
• Sixty to 95 percent of all illnesses are initially treated with self-care, including self-treatment with OTC drugs.

And with health-care costs on the rise, so is the use of OTC medicines. To save money, consumers increasingly treat common ailments themselves instead of seeing a doctor, FDA notes.

Increased use of both prescription and OTC medicines is also partially due to the growing population of older people, who live longer due to improved medical care that often calls for several medicines. Experts estimate that by the year 2000, older people will account for up to half of all medicine use.

Unfortunately, failing eyesight often accompanies old age, putting older people at increased risk for medicine misuse and consequent health risk because they can't read the labels. For example, an arthritic older person who can't see well may catch a cold and decide to use an OTC cough-cold product. If the label has tiny print and cluttered information, the person may not be able to read that the product contains aspirin. And if the person already takes a prescription arthritis drug similar to aspirin, a harmful effect could occur — in this instance, too much of the same type of medicine may cause stomach or intestinal bleeding.

In reviewing studies that looked at whether people could read OTC drug labels, FDA found one in which a significant number of people 60 and older could not read the print on some labels because the letter width was too compressed and the letter height too short. Another study showed that people had to have eyesight much better than normal to read most labels on 25 OTC drugs.

The Pharmacists Planning Service Inc., Sausalito, Calif., petitioned FDA in the early 1990s to adopt standards for print size and style on OTC drug labels, stating that most people can't read the small print on some labels.

FDA's Gilbertson agrees that "to include the vast amount of information now required for some medicines, the print could get so small some people may not be able to read it." Required information on an aspirin label, for example, now consists of about 500 words, he says. But about 2,000 words are required if aspirin is added to a cough-cold medicine that also contains a cough suppressant, a nasal decongestant, and an expectorant.

"Yet people should read the entire label," Gilbertson says, "especially when using a medicine the first time. Some people assume if a drug is OTC, it's 100 percent safe. Not true. All drugs pose risk. And risk increases with improper use. If people have questions after reading the label, they should talk to their doctor, pharmacist, or other health-care professional."

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.