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. 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."
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, DMEPA prospectively reviews proprietary names, labeling, packaging, and product design prior to drug approval to help prevent medication errors.
Although DMEPA encourages manufacturers to perform their due diligence when naming their drug products and we strive to avoid approving confusing proprietary names for drug products, there are cases of adverse events where a name of a marketed product is identified as a source of confusion and error. Therefore, we continue to encourage healthcare providers, patients and consumers to report all medication errors to MedWatch so that we can be made aware of potential problems related to drug names and the Agency can provide effective interventions that will minimize further errors. In some situations, changing a proprietary name while the product is marketed may be necessary to address safety issues resulting from the name confusion errors.
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.
FDA Drug Safety Communications for Drug Products Associated with Medication Errors
FDA Drug Safety Communication: FDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor) FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved FDA Drug Safety Communication: FDA cautions about dose confusion and medication error with antibacterial drug Avycaz (ceftazidime and avibactam)
- FDA Drug Safety Communication: FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam)
- FDA Drug Safety Communication: FDA Alerts Pharmacists and Health Care Professionals to Potential for Injury when Dispensing the Similar-Sounding Drugs Durezol and Durasal [ARCHIVED]
FDA Drug Safety Communication: FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients FDA Drug Safety Communication: FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death
- FDA Drug Safety Communication: FDA warns about potential medication errors resulting from confusion regarding nonproprietary name for breast cancer drug Kadcyla (ado-trastuzumab emtansine)
Medication Error Safety Alerts
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
- Guidance for Industry: Safety Considerations for Product Design to Minimize Medication Errors (PDF - 212KB)
- Guidance for Industry: Contents of a Complete Submission for the Evaluation of Proprietary Names (PDF - 146KB)
- Draft Guidance for Industry: Best Practices in Developing Proprietary Names for Drugs (PDF - 279KB)
- Draft Guidance for Industry: Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors (PDF - 608KB)
PDUFA Pilot Project: Proprietary Name Review - Concept Paper(PDF - 186KB)