FDA drug prescribing warnings: is the black box half empty or half full?
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Auteurs : Anita K. Wagner [États-Unis] ; K. Arnold Chan [États-Unis] ; Inna Dashevsky [États-Unis] ; Marsha A. Raebel [États-Unis] ; Susan E. Andrade [États-Unis] ; Jennifer Elston Lafata [États-Unis] ; Robert L. Davis [États-Unis] ; Jerry H. Gurwitz [États-Unis] ; Stephen B. Soumerai [États-Unis] ; Richard Platt [États-Unis]Source :
- Pharmacoepidemiology and Drug Safety [ 1053-8569 ] ; 2006-06.
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.
Url:
DOI: 10.1002/pds.1193
Affiliations:
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Wagner</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="1"><country wicri:rule="url">États-Unis</country></affiliation><affiliation wicri:level="2"><country xml:lang="fr" wicri:curation="lc">États-Unis</country><wicri:regionArea>Correspondence address: Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, 133 Brookline Avenue, 6th Floor, Boston, MA 02215</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Chan, K Arnold" sort="Chan, K Arnold" uniqKey="Chan K" first="K. 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Raebel</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Kaiser Permanente of Colorado, Denver, CO</wicri:regionArea><placeName><region type="state">Colorado</region></placeName></affiliation></author><author><name sortKey="Andrade, Susan E" sort="Andrade, Susan E" uniqKey="Andrade S" first="Susan E." last="Andrade">Susan E. Andrade</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Foundation and Fallon Community Health Plan, Worcester, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Lafata, Jennifer Elston" sort="Lafata, Jennifer Elston" uniqKey="Lafata J" first="Jennifer Elston" last="Lafata">Jennifer Elston Lafata</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Center for Health Services Research, Henry Ford Health System, Detroit, MI</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Davis, Robert L" sort="Davis, Robert L" uniqKey="Davis R" first="Robert L." last="Davis">Robert L. Davis</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Group Health Cooperative of Puget Sound, Seattle, WA</wicri:regionArea><placeName><region type="state">Washington (État)</region></placeName></affiliation></author><author><name sortKey="Gurwitz, Jerry H" sort="Gurwitz, Jerry H" uniqKey="Gurwitz J" first="Jerry H." last="Gurwitz">Jerry H. Gurwitz</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Meyers Primary Care Institute, University of Massachusetts Medical School, Fallon Foundation and Fallon Community Health Plan, Worcester, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Soumerai, Stephen B" sort="Soumerai, Stephen B" uniqKey="Soumerai S" first="Stephen B." last="Soumerai">Stephen B. Soumerai</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author><author><name sortKey="Platt, Richard" sort="Platt, Richard" uniqKey="Platt R" first="Richard" last="Platt">Richard Platt</name><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>The HMO Research Network Center for Education and Research in Therapeutics, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation><affiliation wicri:level="2"><country xml:lang="fr">États-Unis</country><wicri:regionArea>Channing Laboratory, Department of Medicine, Brigham and Women's Hospital, Boston, MA</wicri:regionArea><placeName><region type="state">Massachusetts</region></placeName></affiliation></author></analytic><monogr></monogr><series><title level="j" type="main">Pharmacoepidemiology and Drug Safety</title><title level="j" type="alt">PHARMACOEPIDEMIOLOGY AND DRUG SAFETY</title><idno type="ISSN">1053-8569</idno><idno type="eISSN">1099-1557</idno><imprint><biblScope unit="vol">15</biblScope><biblScope unit="issue">6</biblScope><biblScope unit="page" from="369">369</biblScope><biblScope unit="page" to="386">386</biblScope><biblScope unit="page-count">18</biblScope><publisher>John Wiley & Sons, Ltd.</publisher><pubPlace>Chichester, UK</pubPlace><date type="published" when="2006-06">2006-06</date></imprint><idno type="ISSN">1053-8569</idno></series></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1053-8569</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">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.</div></front></TEI><affiliations><list><country><li>États-Unis</li></country><region><li>Colorado</li><li>Massachusetts</li><li>Michigan</li><li>Washington (État)</li></region></list><tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Wagner, Anita K" sort="Wagner, Anita K" uniqKey="Wagner A" first="Anita K." last="Wagner">Anita K. Wagner</name></region><name sortKey="Andrade, Susan E" sort="Andrade, Susan E" uniqKey="Andrade S" first="Susan E." last="Andrade">Susan E. Andrade</name><name sortKey="Andrade, Susan E" sort="Andrade, Susan E" uniqKey="Andrade S" first="Susan E." last="Andrade">Susan E. Andrade</name><name sortKey="Chan, K Arnold" sort="Chan, K Arnold" uniqKey="Chan K" first="K. Arnold" last="Chan">K. Arnold Chan</name><name sortKey="Chan, K Arnold" sort="Chan, K Arnold" uniqKey="Chan K" first="K. Arnold" last="Chan">K. Arnold Chan</name><name sortKey="Chan, K Arnold" sort="Chan, K Arnold" uniqKey="Chan K" first="K. Arnold" last="Chan">K. Arnold Chan</name><name sortKey="Dashevsky, Inna" sort="Dashevsky, Inna" uniqKey="Dashevsky I" first="Inna" last="Dashevsky">Inna Dashevsky</name><name sortKey="Dashevsky, Inna" sort="Dashevsky, Inna" uniqKey="Dashevsky I" first="Inna" last="Dashevsky">Inna Dashevsky</name><name sortKey="Davis, Robert L" sort="Davis, Robert L" uniqKey="Davis R" first="Robert L." last="Davis">Robert L. Davis</name><name sortKey="Davis, Robert L" sort="Davis, Robert L" uniqKey="Davis R" first="Robert L." last="Davis">Robert L. Davis</name><name sortKey="Gurwitz, Jerry H" sort="Gurwitz, Jerry H" uniqKey="Gurwitz J" first="Jerry H." last="Gurwitz">Jerry H. Gurwitz</name><name sortKey="Gurwitz, Jerry H" sort="Gurwitz, Jerry H" uniqKey="Gurwitz J" first="Jerry H." last="Gurwitz">Jerry H. Gurwitz</name><name sortKey="Lafata, Jennifer Elston" sort="Lafata, Jennifer Elston" uniqKey="Lafata J" first="Jennifer Elston" last="Lafata">Jennifer Elston Lafata</name><name sortKey="Lafata, Jennifer Elston" sort="Lafata, Jennifer Elston" uniqKey="Lafata J" first="Jennifer Elston" last="Lafata">Jennifer Elston Lafata</name><name sortKey="Platt, Richard" sort="Platt, Richard" uniqKey="Platt R" first="Richard" last="Platt">Richard Platt</name><name sortKey="Platt, Richard" sort="Platt, Richard" uniqKey="Platt R" first="Richard" last="Platt">Richard Platt</name><name sortKey="Platt, Richard" sort="Platt, Richard" uniqKey="Platt R" first="Richard" last="Platt">Richard Platt</name><name sortKey="Raebel, Marsha A" sort="Raebel, Marsha A" uniqKey="Raebel M" first="Marsha A." last="Raebel">Marsha A. Raebel</name><name sortKey="Raebel, Marsha A" sort="Raebel, Marsha A" uniqKey="Raebel M" first="Marsha A." last="Raebel">Marsha A. Raebel</name><name sortKey="Soumerai, Stephen B" sort="Soumerai, Stephen B" uniqKey="Soumerai S" first="Stephen B." last="Soumerai">Stephen B. Soumerai</name><name sortKey="Soumerai, Stephen B" sort="Soumerai, Stephen B" uniqKey="Soumerai S" first="Stephen B." last="Soumerai">Stephen B. Soumerai</name><name sortKey="Wagner, Anita K" sort="Wagner, Anita K" uniqKey="Wagner A" first="Anita K." last="Wagner">Anita K. Wagner</name><name sortKey="Wagner, Anita K" sort="Wagner, Anita K" uniqKey="Wagner A" first="Anita K." last="Wagner">Anita K. Wagner</name><name sortKey="Wagner, Anita K" sort="Wagner, Anita K" uniqKey="Wagner A" first="Anita K." last="Wagner">Anita K. Wagner</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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