Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing 英文参考文献.docVIP
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Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing 英文参考文献
AdherenceofPharmaceuticalAdvertisementsinMedical
JournalstoFDAGuidelinesandContentforSafe
Prescribing
DeborahKorenstein1*,SalomehKeyhani2,3,AliMendelson4,JosephS.Ross5
1DepartmentofMedicine,MountSinaiSchoolofMedicine,NewYork,NewYork,UnitedStatesofAmerica,2DepartmentofHealthEvidenceandPolicy,MountSinai
School ofMedicine,New York, New York, United States ofAmerica, 3HSRDResearch Enhancement Award Program andGeriatrics Research, Education, and Clinical
Center,JamesJ.PetersVAMedicalCenter,Bronx,NewYork,UnitedStatesofAmerica,4WeillCornellMedicalCollege,NewYork,NewYork,UnitedStatesofAmerica,
5SectionofGeneralInternalMedicine,DepartmentofMedicine,YaleUniversitySchoolofMedicineandCenterforOutcomesResearchandEvaluation,Yale-NewHaven
Hospital,NewHaven,Connecticut,UnitedStatesofAmerica
Abstract
Background: Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug
Administration(FDA);adherencetocurrentFDAguidelinesisunknown.Ourobjectivewastodetermineadherenceratesof
physician-directedprintadvertisementsinbiomedicaljournalstoFDAguidelinesanddescribecontentimportantforsafe
prescribing.
MethodsandFindings:Cross-sectionalanalysisofNovember2008pharmaceuticaladvertisementswithintopU.S.-based
biomedical journalspublishingoriginalresearch. Weexcludedadvertisementsfor devices,overthecountermedications,
and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize
advertisementsasadherenttoFDAguidelines,possiblynon-adherenttoatleast1item,ornon-adherenttoatleast1item.
Wealsoevaluatedadvertisementcontentimportantforsafeprescribing,includingbenefitquantification,riskinformation
and verifiable references. All advertisements were evaluated by 2 or more investigators, with differences resolved by
discussion. Twelve journals met inclusion criteria. Nine contained pharmaceutical advertisements, including 192
advertisements for 82 unique products; median 2 per product (range 1–14). Six ‘‘teaser’
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