FDA drug prescribing warnings: is the black box half empty or half full?

Authors

  • Anita K. Wagner PharmD, MPH, DPH,

    Corresponding author
    1. Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA
    2. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    • Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, 133 Brookline Avenue, 6th Floor, Boston, MA 02215, USA.
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  • K. Arnold Chan MD, ScD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    2. Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA
    3. Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA
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  • Inna Dashevsky MSc,

    1. Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA
    2. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
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  • Marsha A. Raebel PharmD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    2. Kaiser Permanente of Colorado, Denver, CO, USA
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  • Susan E. Andrade ScD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    2. Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Foundation and Fallon Community Health Plan, Worcester, MA, USA
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  • Jennifer Elston Lafata PhD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    2. Center for Health Services Research, Henry Ford Health System, Detroit, MI, USA
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  • Robert L. Davis MD, MPH,

    1. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    2. Group Health Cooperative of Puget Sound, Seattle, WA, USA
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  • Jerry H. Gurwitz MD,

    1. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    2. Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Foundation and Fallon Community Health Plan, Worcester, MA, USA
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  • Stephen B. Soumerai ScD,

    1. Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA
    2. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
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  • Richard Platt MD, MS

    1. Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA, USA
    2. The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA, USA
    3. Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA
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  • No conflict of interest was declared.

Abstract

Purpose

Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high-risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings. The purpose of the present study was to assess the frequency of use of BBW medications in ambulatory care and prescribing compliance with BBW recommendations.

Methods

This retrospective study used automated claims data of 929 958 enrollees in 10 geographically diverse health plans in the United States to estimate frequency of use in ambulatory care of 216 BBW drugs/drug groups between 1/1/99 and 31/6/01. We assessed dispensing compliance with the BBW requirements for selected drugs.

Results

During a 30-month period, more than 40% of enrollees received at least one medication that carried a BBW that could potentially apply to them. We found few instances of prescribing during pregnancy of BBW drugs absolutely contra-indicated in pregnancy. There was almost no co-prescribing of contra-indicated drugs with the two QT-interval-prolonging BBW drugs evaluated. Most non-compliance occurred with recommendations for baseline laboratory monitoring (49.6% of all therapy initiations that should have been accompanied by baseline laboratory monitoring were not).

Conclusions

Many individuals receive drugs considered to carry the potential for serious risk. For some of these drugs, use is largely consistent with their BBW, while for others it is not. Since it will not be possible to avoid certain drug- associated risks, it will be important to develop effective methods to use BBWs and other methods to minimize risks. Copyright © 2005 John Wiley & Sons, Ltd.

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