Using a claims database to investigate drug-induced Stevens-Johnson syndrome

Authors

  • Brian L. Strom,

    1. Clinical Epidemiology Unit, Section of General Internal Medicine of the Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, U.S.A.
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  • Jeffrey L. Carson,

    1. Clinical Epidemiology Unit, Section of General Internal Medicine of the Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, U.S.A.
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    • Also Section of General Medicine of the Department of Medicine, UMDNJ-Robert Wood Johnson Medical School, New Brunswick, New Jersey, U.S.A.

  • Allan C. Halpern,

    1. Clinical Epidemiology Unit, Section of General Internal Medicine of the Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, U.S.A.
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    • Also Department of Dermatology.

  • Rita Schinnar,

    1. Clinical Epidemiology Unit, Section of General Internal Medicine of the Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, U.S.A.
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  • Ellen Sim Snyder,

    1. Clinical Epidemiology Unit, Section of General Internal Medicine of the Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, U.S.A.
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  • Paul D. Stolley,

    1. Clinical Epidemiology Unit, Section of General Internal Medicine of the Department of Medicine, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania, U.S.A.
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  • Michele Shaw,

    1. Department of Post-Marketing Surveillance, Health Information Designs, Inc., Arlington, Virginia, U.S.A.
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  • Hugh H. Tilson,

    1. Epidemiology, Information and Surveillance, Burroughs Wellcome Company, Research Triangle Park, North Carolina, U.S.A.
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  • Michael Joseph,

    1. Epidemiology, Information and Surveillance, Burroughs Wellcome Company, Research Triangle Park, North Carolina, U.S.A.
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  • Wanju S. Dai,

    1. Pharmacoepidemiology, Department of Drug Safety, Hoffman-La Roche, Inc., Nutley, New Jersey, U.S.A.
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  • Diane Chen,

    1. Drug Regulatory Affairs, Hoffman-La Roche Company, Ltd., Basel, Switzerland
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  • Robert S. Stern,

    1. Department of Dermatology, Harvard Medical School, Beth Israel Hospital, Boston, Massachusetts, U.S.A.
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  • Ulf Bergman,

    1. Department of Clinical Pharmacology, Karolinska Institutet at Huddinge, University Hospital, Huddinge, Sweden
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  • Frank Lundin

    1. Office of Epidemiology and Biostatistics, Food and Drug Administration, Rockville, Maryland, U.S.A.
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Abstract

In order to explore a priori hypotheses about drug-induced Stevens-Johnson Syndrome (SJS), a case-ontrol study was initiated using data from COMPASSR, a computerized data base consisting of Medicaid claims data. The records of 3.8 million patients in five U.S. states were searched to identify patients with an inpatient diagnosis of ICD-9-M code 695.1 (erythema multiforme-EM). Out of the total of 367 cases that were identified, primary medical records for 249 were sought and 128 (51.4 per cent) of these were obtained. The remainder could not be obtained because: in 36 (29.8 per cent) the hospital refused to provide medical records; in 33 (27.3 per cent) there were transcription errors; in 20 (16.5 per cent) the state could not translate the identification number, primarily because the patients lost Medicaid eligibility too long before our request; in 27 (22.3 per cent) the hospital could not locate the patient's record; and in 5 (4.1 per cent) there were other reasons. Of those with a medical record, 121 (94.5 per cent) had a skin diagnosis and 109 (85.2 per cent) had a diagnosis compatible with ICD-9-CM code 695.1 specified on their discharge summary. However, in 35 (27.3 per cent) an expert reviewer felt that the discharge diagnosis was incorrect. In 50 (39 per cent) the computer diagnosis was incorrect. Only 19 (14.8 per cent) were judged by the expert reviewer to truly have Stevens-Johnson Syndrome, and an additional 37 (28.9 per cent) were judged to have erythema multiforme minor. Thus, the computerized diagnosis agreed very well with the diagnoses specified on the discharge summary. However, EM is frequently misdiagnosed, ICD-9-CM code 695.1 contains multiple other diagnoses which are not EM, and much of hospitalized EM is EM minor. Thus, studies of SJS cannot be performed except in patients whose medical records are available.

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