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Table 1.
Med error reports to FDA show a mixed bag
he medication errors staff in the Office of Post-Marketing Drug Risk Assessment (OPDRA) search the Food & Drug Administration Adverse Event Reporting System (AERS) database for all cases of medication errors. Since the FDA often receives multiple reports regarding one case, the best representative report (with the most complete information) is reviewed and classified according to the Taxonomy of Medication Errors developed by the National Coordinating Council for Medication Errors Reporting and Prevention (NCC-MERP) and adopted by the FDA in 1999. In May 2001, the FDA received 273 reports of medication errors. Excluding duplicated reports and those associated with intentional suicide, 265 cases were identified for review and classification. Among these, 129 cases were serious and 136 were nonserious. The FDA defines serious as any adverse event that is fatal; life-threatening;
Medication errors by cause, May 2001
Causes
Communication (n = 64, 19%)
Number
1 28 35 35 9 32 15 15 1 2 3 42 45 24 8 24 1 1 10 9 1
% of total (n = 341)
0.3% 8.1 10.3 10.3 2.6 9.4 4.4 4.4 0.3 0.6 1 12.3 13.2 7 2.3 7 0.3 0.3 3 2.6 0.3
T
associated with disability, hospitalization, or congenital anomaly; or which required intervention to prevent permanent impairment. Out of the 129 cases that were classified as serious, 18 were fatal, 12 were life-threatening, 56 required hospitalization, eight were disability reports, and 35 required intervention to prevent permanent impairment/damage. Each report was reviewed and classified into one of the following: 1. Communication (written miscommunication, misinterpretation of the order) 2. Name confusion (proprietary name confusion and established name confusion) 3. Labeling (immediate container labels of product manufacturer, distributor, or repackager, labels of dispensed product—practitioner, package insert, printed reference material) 4. Human factors (knowledge deficit, performance deficit, miscalculation of dosage or infusion rate, drug preparation error, transcription error, stress) 5. Packaging/design (inap-
Verbal miscommunication Written miscommunication Misinterpretation of the order Name confusion (n = 44, 13%) Proprietary name confusion Established name confusion Labeling (n = 68, 20%) Immediate container labels of product manufacturer, distributor, or repackager Labels of dispensed product – practitioner Carton labeling of product Package insert Electronic reference material Printed reference material Human factors (n = 145, 42%) Knowledge deficit Performance deficit Miscalculation of dosage or infusion rate Drug preparation error Transcription error Fatigue Computer error Packaging/design (n = 20, 6%) Inappropriate packaging or design Dosage form (tablet/ capsule) confusion Devices (infusion) Table 2.
Medication errors by type, May 2001
Type
Dose omission Noncompliance Overdosage Underdosage Extra dose Wrong strength/concentration Wrong drug Wrong dosage form Wrong technique Wrong route of administration Wrong duration Wrong time Wrong rate Wrong patient Monitoring error Deteriorated drug Other
Number
3 16 40 6 8 16 52 1 16 19 2 5 2 2 16 3 29
% of total (n = 36)
1% 7 17 2.5 3 7 22 0.5 7 8 1 2 1 1 7 1 12 23
By Maria R. Thomas, M.D.; Carol Holquist, R.Ph.; and Jerry Phillips, R.Ph.
To report a problem with an FDA-regulated product, please call 1-(800) FDA-1088.
www.drugtopics.com
DRUG TOPICS OCTOBER 1 2001
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caine and 4.5% for Novolin propriate packaging or design, Table 3. 70/30. dosage form—tablet/capsule— Number of medication error case reports In summary, these results confusion) demonstrate that the most The analysis of the 265 cases for the top 10 suspect drugs, May 2001 Number of % of total common causes of medication revealed a total of 341 causes cases (n = 265) errors were human factors (see Table 1). The most com- Drugs (42%), followed by labeling mon causes identified were Morphine sulfate 22 8% problems (20%), and commuhuman factors represented by Xylocaine 14 5 nication problems (19%). In 42%, followed by labeling 12 4.5 addition, the most common problems represented by 20%, Novolin 70/30 type of error was wrong drug and communication problems Aricept 5 2 administered (22%), followed represented by 19%. Aciphex 5 2 by improper dose adminisAdditionally, the analysis of 5 2 tered resulting in overdosage each of the 265 cases showed Timolol maleate 4 1.5 (17%) and the “other” category 236 types of medication errors Estratest (12%). Of the 265 cases re(see Table 2). Twenty-two per- Zyrtec 4 1.5 viewed, 18 (5%) were fatal cent of them were wrong drug 4 1.5 errors and 43 (13%) were errors, followed by improper Depakote 4 1.5 potential errors. Moreover, 8% dose administered to a patient Lovenox of the medication error cases resulting in overdosage (17%) and by the “other” category medication error cases reported in were related to morphine sulfate. May 2001. Among the 265 cases Maria R. Thomas, M.D., and Carol Holquist, R.Ph., (12%). evaluators, and Jerry Phillips, R.Ph., is Table 3 shows the top 10 suspect reviewed, 8% pertained to morphine are safetydirector for medication error prevention at associate drugs with the greatest number of sulfate, followed by 5% for Xylo- the Food & Drug Administration.