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.
Drug Products Associated with Medication Errors
FDA Drug Safety Communication: FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam) FDA Drug Safety Communication: Serious medication errors from intravenous administration of nimodipine oral capsules FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal FDA Drug Safety Communication: Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip)
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.
Regulations and Guidances
- Prescription Drug User Fee Act IV (PDUFA IV): Performance Goals and Procedures Fiscal Year 2008-2012
- FDA Regulations Regarding Misleading Labeling: 21 CFR 201.1(c) and 21 CFR 201.6(b)
- FDA Proposes Bar Codes for Drugs, Blood; New Adverse Reaction Reporting [ARCHIVED]
Guidance for Hospitals, Nursing Homes, and Other Health Care Facilities - FDA Public Health Advisory(PDF - 19KB) PDUFA Pilot Project: Proprietary Name Review - Concept Paper(PDF - 186KB)
- Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 306KB)
Public Workshop: Developing Guidance on Naming, Labeling, and Packaging Practices to Reduce Medication Errors[ARCHIVED]
- Guidance for Industry and FDA Premarket and Design Control Reviewers - Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management (PDF - 1.1MB)
Draft Guidance for Industry and Food and Drug Administration Staff - Applying Human Factors and Usability Engineering to Optimize Medical Device Design