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U.S. Department of Health and Human Services

Drugs

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Medication Errors

Within the Center for Drug Evaluation and Research (CDER), the Division of Medication Error Prevention and Analysis (DMEPA) reviews medication error reports on marketed human drugs including prescription drugs, generic drugs, and over-the-counter drugs. The DMEPA uses the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP) definition of a medication error. Specifically, a medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

The DMEPA includes a medication error prevention program staffed with healthcare professionals. Among their many duties, program staff review medication error reports sent to MedWatch, evaluate causality, and analyze the data to provide solutions to reduce the risk of medication errors to industry and others at FDA.

Additionally, the DMEPA prospectively reviews proprietary names, labeling, packaging, and product design prior to drug approval to help prevent medication errors.  The DMEPA also works closely with federal partners, patient safety organizations such as Institute for Safe Medication Practices (ISMP), standard setting organizations such as the United States Pharmacopeia (USP), and foreign regulators to address broader product safety issues.

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Campaign to Eliminate Use of Error-Prone Abbreviations

FDA and the Institute for Safe Medication Practices (ISMP) have launched a national education campaign to eliminate the use of ambiguous medical abbreviations that are frequently misinterpreted and lead to mistakes that result in patient harm.

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