August 14, 2017

fda drug safety


FDA Drug Safety

Medication Errors Related to Drugs


FDA drug safety 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.  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.

fda drug safety

FDAAdditionally, 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.


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