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U.S. Department of Health and Human Services

Drugs

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Summary of Public Hearing on FDA's Use of Medication Guides to Distribute Drug Risk Information to Patients June 12-13, 2007

The FDA considers the use of Medication Guides to be an essential tool to ensure that patients use certain drug and biological products that pose serious and significant public health risks appropriately. FDA called this meeting to hear specific feedback on the development, distribution, comprehensibility, and accessibility of Medication Guides, which include FDA-approved information, and are required to be distributed to patients in order convey drug risk information. FDA officials heard testimony from a member of Congress and 40 individuals representing academia, consumers and consumer groups, the pharmaceutical industry, healthcare professional groups, practicing physicians, and pharmacists as well as pharmacy organizations.

We heard that it is important that patients receive appropriate risk information in the form of Medication Guides in order to make informed decisions about certain prescribed medications. It was suggested, however, that the current Medication Guide program is too cumbersome and that it lacks a standard distribution system. The FDA was urged at the hearing to increase awareness of Medication Guides, make Medication Guides easier to read and understand, move toward facilitating the distribution of Medication Guides by electronic means, and consider combining the information contained in Medication Guides with other information such as in Consumer Medication Information (CMI).

The following recommendations were proposed to FDA:

Raise Awareness - There is a need to raise awareness of the Medication Guide program. Research and survey information was presented that indicated that a large number of consumers are not aware of, don’t receive, or don’t read Medication Guides. Proposals included placing a uniform symbol on the drug label that indicates a Medication Guide is available, making the medication guides easier to read and understand, and developing an educational program for patients, prescribers, and pharmacists calling attention to the Medication Guide Program.

Present Balanced Information - The information in Medication Guides is critically important for patients to receive. We heard personal testimony from consumers describing the consequences of not receiving this information. We also heard testimony about the potential public health and clinical consequences of overemphasizing risk information in Medication Guides without proper mention of benefit information.

Promote Cooperation and Collaboration – There is a greater need for cooperation between States and National Boards of Pharmacy, and other professional associations and alliances and the FDA, to ensure that all parties who share responsibility for producing and distributing Medication Guides are meeting these obligations.

Ensure the Availability of Medication Guides – Many presenters felt that the information in the Medication Guides should be discussed between the physician and the patient at the time the drug is prescribed so the patient can learn about the drug before filling the prescription. Medication Guides should also be made available at the pharmacy at the time the medicine is dispensed. Medication Guides should be made available on one easy-to-find website, and pharmacists should be able to call a toll-free phone number to order more Medication Guides. The possibility of FDA establishing a clearinghouse for the Medication Guides was proposed. It was also suggested that a system be adopted where Medication Guides can be emailed to patients.

Communication Strategies based on Science and Research - FDA regulatory decisions that impact on communication methods should be based on appropriate science and research. How information is displayed, using chunking, layering and various alternative representations, is important in making information cognitively accessible to a broad audience. Such research needs to focus on utility, balance, and comprehension to reach the broadest audience possible.

Implementation Challenges – There are practical challenges with effectively implementing this program from the pharmacy level. For example, we heard that Medication Guides are not regularly or uniformly distributed to or received by pharmacies. Pharmacies asked that they be permitted to electronically print Medication Guides, based on the National Drug Code number of the prescription being filled. However, the cost of printing and distributing the Medication Guides was raised as a concern for pharmacies. In addition, the dual systems of providing information to patients in the form of both Consumer Medication Information (CMI) and Medication Guides was considered unworkable. It was suggested that FDA consider allowing the combination of Medication Guide and CMI into one shorter document, that it be written at a sixth to eighth grade reading level, and it contain both benefit and risk information. Finally, we heard that the current requirement to distribute a Medication Guide with every refill should be reconsidered.