Food and Drug Administration, U.S. Department of Health and Human Services - August 23, 1995
Don McLearn; (301) 443-1130

The proposal provides for clearly-presented leaflets that would give consumers information on proper use of the product and possible hazards, like drug interactions.

"Consumers deserve clear, readable information to help them use drugs correctly," said HHS Secretary Donna E. Shalala. "This effort will give American consumers more control over their own health care. It should be especially helpful to older persons who often need to know the importance of using drugs according to the prescribed schedule, and who may need to know about drug interactions as well."

Assistant Secretary for Health Philip R. Lee, M.D., who heads the U.S. Public Health Service, said: "The FDA targets for the dissemination of written drug information match the goals set forth in the Public Health Service program Healthy People 2000. This program will help educate patients about their medications and empower them to take a more active role in their own health care."

FDA Commissioner David A. Kessler, M.D., drew a comparison between this program and the food label education program. "Consumers and patients want to know more about the foods they eat and the drugs they take. This program will increase patient participation in decisions about their health, and encourage adherance to medical regimens, resulting in savings of health care dollars."

The first goal of the proposal is that by the year 2000 at least 75 percent of consumers who have new prescriptions filled will receive written, adequate and useful information about their medication. Under the proposal, the information would have to meet quality standards for both content and format, which are to be established by the agency in close cooperation with health care professionals and consumer organizations.

After reaching this goal, FDA's program would seek to make sure that by the year 2006, such written information is given to at least 95 percent of recipients of new prescriptions.

The proposed rule describes seven characteristics of useful written medication information for patients: scientific accuracy, consistency with a standard format, nonpromotional tone and content, specificity, comprehensiveness, understandable language and legibility. FDA intends to hold public meetings to further define these characteristics.

To meet the proposed standards, the written leaflet would have to include such information as the product's approved uses, circumstances under which it should not be used, serious adverse reactions, proper use of the medication and cautions related to proper use.

The proposal provides incentives for the private sector to reach the program's goals by setting criteria and letting health professionals select and distribute the necessary information.

The agency is proposing to work with private organizations on how pharmacists can meet specific goals by the year 2000 and 2006. It offers two alternatives if the program does not succeed in achieving the goals.

After the public comment process, the agency will decide how to proceed if the goals are not met. Under one option, FDA would require that FDA-approved written information be distributed with all prescription drugs. Under the other option, the FDA would seek public comment in the year 2000 or 2006 on how a mandatory patient leaflet program should be established or whether other steps could be taken to meet the patient information goal. As it has in the past, the FDA will continue to require patient information leaflets for drugs that pose a serious and significant public health concern.

In recent years, the widespread use of computers by pharmacists and a law requiring oral counseling for Medicaid patients have increased the amount of drug information provided to consumers.

According to a new FDA survey, the proportion of patients who received substantial written information about their prescription drugs rose from 23 percent in 1992 to 55 percent at the end of last year although the quality of that information appears to vary greatly. The aim of the patient education program is to bring helpful medication facts to all those who need them, and to make sure that the information is useful, reliable and adequate.

FDA is a PHS agency within HHS.
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SOURCE: Food and Drug Administration (FDA).

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