Patient Information and Education Activities
CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) conducts and monitors research on factors that may influence or improve drug use by consumers, patients, and health care professionals.
Objective 12.8 of Healthy People 2000: This objective reads: "Increase to at least 75% the proportion of people who receive useful information verbally and in writing for new prescriptions from prescribers or dispensers." Two approaches undertaken by FDA to influence private sector initiatives are: (1) the development of performance goals for the quantity as well as the quality of distributed information and (2) research and development activities to better understand how to communicate prescription drug information to patients.
Medication Guides: A proposed rule for Medication Guide requirements was published on August 24, 1995. The proposed rule was intended to increase the dissemination of useful written prescription drug information to patients who receive prescription drugs on an outpatient basis. FDA believes that such information must be widely distributed and be of sufficient quality to promote the proper use of prescription drugs. The agency proposed goals (performance standards) that would define acceptable levels of information distribution and quality. To meet the performance standards for distribution of patient information, the agency proposed that by the year 2000, at least 75% of people receiving new prescriptions receive useful written information. This goal was adapted from the Public Health Service's "Healthy People 2000" report. In addition, the agency proposed that by the year 2000, at least 95% of the people who receive new prescription drugs receive useful written information.
A public meeting was held in February 1996 to discuss standards for Medication Guides. In August 1996, Congress passed a law requiring that the private sector be given the opportunity to develop a plan, acceptable to the Department of Health and Human Services (DHHS), to reach the goals specified in the proposed Medication Guide rule. On December 13, 1996, the private sector steering committee submitted its plan to reach these goals. The Secretary of DHHS accepted the plan on January 13, 1997. FDA will continue to assess progress toward the goals and to assist the private sector to achieve them in the specified time frames.
Prescription Drug Counseling Surveys: Trends in providing prescription drug information have been followed through periodic surveys of people who recently obtained a new prescription at a retail pharmacy. Nationwide surveys have been undertaken in 1982, 1984, 1992, and 1994. Data from the surveys have been used to support proposed regulations and private sector initiatives in improving the quality and quantity of drug information. Data collection from the 1996 survey has recently been completed and analysis is under way.
Women's Health: A study is being undertaken to investigate gender differences in consumer understanding of and response to the presentation of risk and benefit information about medications. A questionnaire to assess men's and women's understanding of risk and benefit communications was recently approved by the Office of Management and Budget (OMB). Research funds are being sought from the Office of Women's Health. By examining gender differences in processing benefit and risk information, the goal is to develop ways of presenting labeling for patients that are useful and meaningful to all patients.
Over-the-Counter (OTC) Labeling: Studies to evaluate newly proposed formats and labeling language for OTC drugs are being designed. Focus group testing is currently under way.