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Retrospective analysis of mortalities associated with medication errors
J Phillips1, S Beam, A Brinker
1Office of Post-Marketing Drug Risk Assessment, Center for Drug Evaluation and Research , Food and Drug Administration, Rockville, MD 20857, USA. phillipsj@cder.fda.gov
Abstract:
The types, causes, contributing factors, and patient demographics of fatal medication errors were reviewed. Case reports of medication errors from hospitals, ambulatory care settings, and patients' homes that were entered in FDA's Adverse Event Reporting System during 1993-98 were the source of information on fatal medication errors. Each report was classified using predefined criteria and a taxonomy developed by the National Coordinating Council for Medication Error Reporting and Prevention. The types, causes, contributing factors, and patient demographics were identified, and the causality of each case was assessed to prevent future fatalities. The data indicated 5,366 medication error reports. Fifty-nine reports were excluded and classified as duplicate reports or intentional overdoses. Of the remaining medication error reports, 68.2% resulted in serious patient outcomes and 9.8% were fatal. Of the 469 fatal medication error reports, 48.6% occurred in patients over 60 years. The most common types of errors resulting in patient death involved administering an improper dose (40.9%), administering the wrong drug (16%), and using the wrong route of administration (9.5%). The most common causes of errors were performance and knowledge deficits (44%) and communication errors (15.8%). Fatal medication errors accounted for approximately 10% of medication errors reported to FDA and were most frequently the result of improper dosing of the intended drug and administration of an incorrect drug. A review of case reports of medication errors from 1993 to 1998 yielded information on the most frequent causes of and contributing factors involved in fatal medication errors.
Insights
Fatal medication errors, often due to improper dosing or wrong drug administration, account for nearly 10% of reported errors. Most fatal errors occurred in patients over 60, highlighting the need for improved medication safety protocols.
Area of Science:
- Patient Safety
- Pharmacovigilance
- Medical Error Analysis
Background:
- Medication errors pose a significant threat to patient safety.
- Understanding the causes and demographics of fatal medication errors is crucial for prevention.
Purpose of the Study:
- To review the types, causes, contributing factors, and patient demographics of fatal medication errors.
- To identify trends and assess causality to prevent future fatalities.
Main Methods:
- Analysis of 5,366 medication error reports from the FDA's Adverse Event Reporting System (1993-1998).
- Classification of reports using predefined criteria and the National Coordinating Council for Medication Error Reporting and Prevention taxonomy.
- Assessment of causality for fatal medication error reports.
Main Results:
- Approximately 9.8% of medication errors reported were fatal (469 cases).
- Improper dosing (40.9%) and wrong drug administration (16%) were the most common fatal error types.
- Patients over 60 years old represented 48.6% of fatal medication error cases.
Conclusions:
- Fatal medication errors are a serious concern, particularly in elderly patients.
- Performance deficits, knowledge gaps, and communication failures are primary causes.
- Targeted interventions focusing on dosing accuracy and drug verification are needed to reduce fatal medication errors.