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Special Article
Patient Safety
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Volume 348:1556-1564 April 17, 2003 Number 16
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Adverse Drug Events in Ambulatory Care
Tejal K. Gandhi, M.D., M.P.H., Saul N. Weingart, M.D., Ph.D., Joshua Borus, B.A., Andrew C. Seger, R.Ph., Josh Peterson, M.D., Elisabeth Burdick, M.S., Diane L. Seger, R.Ph., Kirstin Shu, B.A., Frank Federico, R.Ph., Lucian L. Leape, M.D., and David W. Bates, M.D.

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ABSTRACT

Background Adverse events related to drugs occur frequently among inpatients, and many of these events are preventable. However, few data are available on adverse drug events among outpatients. We conducted a study to determine the rates, types, severity, and preventability of such events among outpatients and to identify preventive strategies.

Methods We performed a prospective cohort study, including a survey of patients and a chart review, at four adult primary care practices in Boston (two hospital-based and two community-based), involving a total of 1202 outpatients who received at least one prescription during a four-week period. Prescriptions were computerized at two of the practices and handwritten at the other two.

Results Of the 661 patients who responded to the survey (response rate, 55 percent), 162 had adverse drug events (25 percent; 95 percent confidence interval, 20 to 29 percent), with a total of 181 events (27 per 100 patients). Twenty-four of the events (13 percent) were serious, 51 (28 percent) were ameliorable, and 20 (11 percent) were preventable. Of the 51 ameliorable events, 32 (63 percent) were attributed to the physician's failure to respond to medication-related symptoms and 19 (37 percent) to the patient's failure to inform the physician of the symptoms.

The medication classes most frequently involved in adverse drug events were selective serotonin-reuptake inhibitors (10 percent), beta-blockers (9 percent), angiotensin-converting–enzyme inhibitors (8 percent), and nonsteroidal antiinflammatory agents (8 percent). On multivariate analysis, only the number of medications taken was significantly associated with adverse events.

Conclusions Adverse events related to drugs are common in primary care, and many are preventable or ameliorable. Monitoring for and acting on symptoms are important. Improving communication between outpatients and providers may help prevent adverse events related to drugs.


Source Information

From the Division of General Internal Medicine, Brigham and Women's Hospital (T.K.G., J.B., A.C.S., J.P., E.B., D.L.S., K.S., D.W.B.); the Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center (S.N.W.); the Harvard Risk Management Foundation (F.F.); and the Harvard School of Public Health (L.L.L.) — all in Boston.

Address reprint requests to Dr. Gandhi at the Division of General Medicine, Brigham and Women's Hospital, 75 Francis St., Boston, MA 02115, or at tgandhi{at}partners.org.

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Related Letters:

Adverse Drug Events in Ambulatory Care
Hernández J., Vargas M. L., Snow D., Gandhi T. K., Weingart S. N., Bates D. W., Tierney W. M.
Extract | Full Text | PDF  
N Engl J Med 2003; 349:303-305, Jul 17, 2003. Correspondence

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