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Analysis of Medication-Related Malpractice Claims
Causes, Preventability, and Costs
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
Arch Intern Med. 2002;162:2414-2420.
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.
From the Division of General Medicine, the Department of Medicine, Brigham and Women's Hospital (Drs Rothschild, Gandhi, Kaushal, and Bates and Ms Williams), and the Risk Management Foundation of the Harvard Medical Institutions (Mr Federico), Boston, Mass.
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