Medication Error: 6.3% of malpractice claims are for adverse drug events, 73% preventable

We are getting much better data on medication error from multiple studies published recently in leading medical journals. Here, we note that 6.3% of malpractice claims are for adverse drugs events, of which 43% are life threatening or fatal and 73% preventable.

Since there are about an equal number of inpatient and outpatient adverse events noted in malpractice claims, we can infer that the number of deaths due to medication error is at least double that estimated by the two studies noted in the recent Institute of Medicine reports, since those studies reported only inpatient errors.

Analysis of Medication-Related Malpractice Claims: Causes, Preventability, and Costs. Arch Intern Med. 2002;162:2414-2420

Jeffrey M. Rothschild, MD, MPH; Frank A. Federico, RPh; Tejal K. Gandhi, MD, MPH; Rainu Kaushal, MD, MPH; Deborah H. Williams, MHA; David W. Bates, MD, MSc

Background: Adverse drug events (ADEs) may lead to serious injury and may result in malpractice claims. While ADEs resulting in claims are not representative of all ADEs, such data provide a useful resource for studying ADEs. Therefore, we conducted a review of medication-related malpractice claims to study their frequency, nature, and costs and to assess the human factor failures associated with preventable ADEs. We also assessed the potential benefits of proved effective ADE prevention strategies on ADE claims prevention.

Methods: We conducted a retrospective analysis of a New England malpractice insurance company claims records from January 1, 1990, to December 31, 1999. Cases were electronically screened for possible ADEs and followed up by independent review of abstracts by 2 physician reviewers (T.K.G. and R.K.). Additional in-depth claims file reviews identified potential human factor failures associated with ADEs.

Results: Adverse drug events represented 6.3% (129/2040) of claims. Adverse drug events were judged preventable in 73% (n = 94) of the cases and were nearly evenly divided between outpatient and inpatient settings. The most frequently involved medication classes were antibiotics, antidepressants or antipsychotics, cardiovascular drugs, and anticoagulants. Among these ADEs, 46% were life threatening or fatal. System deficiencies and performance errors were the most frequent cause of preventable ADEs. The mean costs of defending malpractice claims due to ADEs were comparable for nonpreventable inpatient and outpatient ADEs and preventable outpatient ADEs (mean, $64 700-74 200), but costs were considerably greater for preventable inpatient ADEs (mean, $376 500).

Conclusions: Adverse drug events associated with malpractice claims were often severe, costly, and preventable, and about half occurred in outpatients. Many interventions could potentially have prevented ADEs, with error proofing and process standardization covering the greatest proportion of events.

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