/publications/issue/2007/2007-07/2007-07-6609

FDA SEEKS HELP IN ENHANCING MEDGUIDE Rx DRUG INFO PROGRAM

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The FDA is considering an overhaul of the agency's Medication Guide program and is seeking help from pharmacists and other providers to make the patient prescriptiondrug information program more effective.

The number of Medication Guide handouts that the FDA requires pharmacists to distribute with certain prescription medicines has increased significantly in recent years. Currently, pharmacists are required to distribute Medication Guides with some 240 prescription products, and it has become more common for these handouts to be required for entire classes of drugs (such as nonsteroidal anti-inflammatory drugs).

"We want to hear from manufacturers, distributors, pharmacies, health professionals, and patients about what concrete steps can be taken to ensure that consumers get the information they need to make informed decisions about the use of medicines," said Paul Seligman,MD, associate director for safety policy and communication at the FDA's Center for Drug Evaluation and Research.