PubMed · 12433504
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2002-11-09. Improving ADR reporting.. https://pubmed.ncbi.nlm.nih.gov/12433504/
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On the basis of adverse events reported to the US Food and Drug Administration, it was observed that atorvastatin-associated adverse event reports were 3.1 times more likely to list rosiglitazone or pioglitazone as a concomitant medication compared with simvastatin-associated adverse event reports.
Adverse drug events cause substantial morbidity and mortality, yet they remain underappreciated and misunderstood. The terminology to describe errors and patient harm associated with medications causes much confusion. This article uses the case study of a patient with multiple adverse drug events to clarify key terms, such as adverse event, adverse drug reaction, adverse drug event, medication error, and side effect. The case discussion illustrates clinical approaches to analyzing the causal connection between a suspect drug and an adverse event. Examples and rationale for meaningful documentation of adverse drug events are provided, along with an outline of the types of events that should be reported to regulatory agencies.
PURPOSE: Records from USP's MEDMARX database of medication errors for 2002 were studied. METHODS: Records of medication errors submitted to MEDMARX by participating health care institutions during 2002 were analyzed for error category index (whether a medication error actually occurred, whether it reached the patient, and, if so, the effect), node (the point in the medication-use process where the error occurred), type of error, cause, contributing factors, and drug products involved. RESULTS: The number of participating institutions was 482, and the number of medication error records released to MEDMARX was 192,477, an 82.2% increase from 2001. Errors that did not reach the patient were seen in 35% of the records, errors that reached the patient were seen in 49%, and errors that may have contributed to or resulted in harm were seen in 2%. The nodes, types of errors, causes of errors, contributing factors, and leading products by generic name are discussed. CONCLUSION: An analysis of over 192,000 records of medication errors submitted by nearly 500 health care facilities to USP's MEDMARX database in 2002 produced detailed information on the scope and nature of medication errors.