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;
- 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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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
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 and ISMP Launch Campaign to Reduce Medication Mistakes Caused by Unclear
Federal Regulations and Guidances
proposes bar codes for drugs, blood; new adverse reaction reporting.
Guidance for Hospitals, Nursing
Homes, and Other Health Care Facilities - FDA Public Health Advisory.
(Issued and Posted 4/5/2001). This guidance is intended to alert hospitals, nursing homes, and other health care
facilities to the hazards of medical gas mix-ups.
Flyer on FDA Public Health Advisory:
Medical Gas Mix-Ups Can Cause Death and Serious Injury(Posted
10/10/2001). This one-page, color flier is intended to
alert people who handle medical
gases about the hazards of mix-ups. Please feel free to copy and
distribute this flier. Comments and suggestions are welcome.
FDA Proposed New Format for
Physician Prescription Drug Labeling. FDA has proposed a new, user-friendly format for the labeling information
doctors get about prescription drugs. FDA believes that this new, user-
friendly format will reduce errors in drug prescribing.
Federal Food, Drug and
Cosmetic Act, as Amended, Section 502 (e).
of Federal Regulations 21 CFR 201.10 (c); 201.56(b);
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Date created: August 3, 2000, updated March 14, 2008