Label Literacy for OTC Drugs

by Dixie Farley

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. (See also " 'Nutrition Facts' to Help Consumers Eat Smart" in the FDA Consumer special report Focus on Food Labeling and "Plan Will Give Consumers Better Prescription Drug Info" in the Updates section of the April 1997 issue.)

"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."

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."

Dixie Farley is a staff writer for FDA Consumer.

Commenting on the Proposal

The public has until June 27 to submit written comments on FDA's proposal for more readable labels for OTC drugs. Comments should be sent to the FDA Dockets Management Branch, HFA-305, Room 1-23, 12420 Parklawn Drive, Rockville, MD 20857.

FDA published its proposal in the Feb. 27, 1997, Federal Register, available in some libraries and on the World Wide Web at http://www.access.gpo.gov/su_docs/aces/aaces002.html. Select "Federal Register, Volume 62 (1997)" in the list of databases, then scroll down the page to submit this search request: "fda" and "february 27" and "otc drugs."

After FDA reviews the comments and other submitted information, it will issue a final rule requiring the new format on nearly all OTC drug products. Consumers can expect to see the new labels on OTC products about two years after that.

Key Aspects of the Proposed OTC Drug Label

A proposed prototype label would make it easier for consumers to read, understand and, it is hoped, follow the important information on OTC drug labels. A comparison of the current and proposed label format can be viewed in a 34K PDF file. The basic components of the new label are described below.

The outline format is designed to cue consumers to the information's organization, increasing their attention to the main messages. Other proposed improvements include easier-to-read 6-point Helvetica type; distinct sections presented in a standard order; and adequate spacing between letters, words and lines of text. The required use of uppercase and lowercase letters and dark type on a light background also would improve readability.

Headings and subheadings, boldface type, bullets, and simpler, concise language would emphasize and clarify important information.
Active ingredients would be listed alphabetically with their quantity per dosage unit. Consumers could clearly see the purpose of each ingredient.
The list of uses in the next section would help consumers readily compare products to find the appropriate medicine for their specific symptoms.
Placing all warnings in one continuous space would help ensure that every warning is noticed.

FDA Consumer magazine (May-June1997)