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Medication Errors


FDA receives medication error reports on marketed human drugs (including prescription drugs, generic drugs, and over-the-counter drugs) and nonvaccine biological products and devices.  The National Coordinating Council for Medication Error Reporting and Prevention defines a medication error as "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 American Hospital Association lists the following as some common types of medication errors:

  • incomplete patient information (not knowing about patients' allergies, other medicines they are taking, previous diagnoses, and lab results, for example);
  • unavailable drug information (such as lack of up-to-date warnings);
  • miscommunication of drug orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations;
  • lack of appropriate labeling as a drug is prepared and repackaged into smaller units; and
  • environmental factors, such as lighting, heat, noise, and interruptions, that can distract health professionals from their medical tasks.

In 1992, the FDA began monitoring medication error reports that are forwarded to FDA from the United States Pharmacopeia (USP) and the Institute for Safe Medication Practices (ISMP). The Agency also reviews MedWatch reports for possible medication errors. Currently, medication errors are reported to the FDA as manufacturer reports (adverse events resulting in serious injury and for which a medication error may be a component), direct contact reports (MedWatch), or reports from USP or ISMP.

The Division of Medication Errors and Technical Support includes a medication error prevention program staffed with pharmacists and support personnel. Among their many duties, program staff review medication error reports sent to the USP Medication Errors Reporting Program and MedWatch, evaluate causality, and analyze the data to provide feedback to others at FDA. 

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Drug Products Associated with Medication Errors

Medication Safety Information from Drug Topics FDA Safety Page

Medication Errors Information from FDA

Medication Safety Alerts from Institute for Safe Medication Practices

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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. The campaign seeks to promote safe practices among those who communicate medical information.

As part of the campaign, FDA recommends that healthcare professionals consider ISMP’s List of Error-Prone Abbreviations, Symbols, and Dose Designations at  http://www.ismp.org/tools/errorproneabbreviations.pdf
[external link] whenever medical information is communicated. In addition, FDA and ISMP have provided a toolkit of resource materials available at www.ismp.org/tools/abbreviations. [external link]

FDA News: FDA and ISMP Launch Campaign to Reduce Medication Mistakes Caused by Unclear Medical Abbreviations.

Federal Regulations and Guidances

Other Resources

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Date created: August 3, 2000, updated March 14, 2008

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