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Karen E. Lasser, MD, MPH; Diane L. Seger, RPh; D. Tony Yu, MD, MPH; Andrew S. Karson, MD, MPH; Julie M. Fiskio, BS; Andrew C. Seger, PharmD; Nidhi R. Shah, MD, MPH; Tejal K. Gandhi, MD, MPH; Jeffrey M. Rothschild, MD, MPH; David W. Bates, MD, MSc

Arch Intern Med. 2006;166:338-344.

Background  Few data are available regarding the prevalence of potentially dangerous drug-drug, drug-laboratory, and drug-disease interactions among outpatients. Our objectives were to determine how frequently clinicians prescribe drugs in violation of black box warnings for these issues and to determine how frequently such prescribing results in harm.

Methods  In an observational study of 51 outpatient practices using an electronic health record, we measured the frequency with which patients received prescriptions in violation of black box warnings for drug-drug, drug-laboratory, and/or drug-disease interactions. We performed medical record reviews in a sample of patients to detect adverse drug events. Multivariate analysis was conducted to assess the relationship of prescribing in violation of black box warnings to patient and clinician characteristics, adjusting for potential confounders and clustering.

Results  Of 324 548 outpatients who received a medication in 2002, 2354 (0.7%) received a prescription in violation of a black box warning. After adjustment, receipt of medication in violation of a black box warning was more likely when patients were 75 years or older or female. The number of medications taken, the number of medical problems, and the site of care were also associated with violations. Less than 1% of patients who received a drug in violation of a black box warning had an adverse drug event as a result.

Conclusions  About 7 in 1000 outpatients received a prescription violating a black box warning. Few incidents resulted in detectable harm.

Author Affiliations: Department of Medicine, Cambridge Health Alliance and Harvard Medical School, Cambridge, Mass (Dr Lasser); Partners HealthCare System, Wellesley, Mass (Mss Seger and Fiskio and Drs Seger and Bates); Division of General Medicine and Primary Care, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass (Drs Yu, Seger, Shah, Gandhi, Rothschild, and Bates); Department of Medicine, Massachusetts General Hospital and Harvard Medical School, Boston (Dr Karson); and Massachusetts College of Pharmacy and Health Sciences, Boston (Dr Seger).

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