Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing
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{"title"=>"Adherence of pharmaceutical advertisements in medical journals to FDA guidelines and content for safe prescribing", "type"=>"journal", "authors"=>[{"first_name"=>"Deborah", "last_name"=>"Korenstein", "scopus_author_id"=>"9039488500"}, {"first_name"=>"Salomeh", "last_name"=>"Keyhani", "scopus_author_id"=>"8705564500"}, {"first_name"=>"Ali", "last_name"=>"Mendelson", "scopus_author_id"=>"50262603400"}, {"first_name"=>"Joseph S.", "last_name"=>"Ross", "scopus_author_id"=>"12789607900"}], "year"=>2011, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"362361051", "isbn"=>"1932-6203 (Electronic)\\r1932-6203 (Linking)", "sgr"=>"80051717782", "issn"=>"19326203", "pmid"=>"21858076", "scopus"=>"2-s2.0-80051717782", "doi"=>"10.1371/journal.pone.0023336"}, "id"=>"adbd611b-17e2-310d-860c-889e403a48d6", "abstract"=>"Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.", "link"=>"http://www.mendeley.com/research/adherence-pharmaceutical-advertisements-medical-journals-fda-guidelines-content-safe-prescribing", "reader_count"=>34, "reader_count_by_academic_status"=>{"Professor > Associate Professor"=>2, "Librarian"=>3, "Student > Doctoral Student"=>4, "Researcher"=>6, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>1, "Other"=>9, "Student > Master"=>2, "Student > Bachelor"=>3, "Professor"=>1}, "reader_count_by_user_role"=>{"Professor > Associate Professor"=>2, "Librarian"=>3, "Student > Doctoral Student"=>4, "Researcher"=>6, "Student > Ph. D. Student"=>3, "Student > Postgraduate"=>1, "Other"=>9, "Student > Master"=>2, "Student > Bachelor"=>3, "Professor"=>1}, "reader_count_by_subject_area"=>{"Agricultural and Biological Sciences"=>1, "Arts and Humanities"=>1, "Business, Management and Accounting"=>1, "Chemistry"=>2, "Decision Sciences"=>1, "Earth and Planetary Sciences"=>1, "Environmental Science"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Medicine and Dentistry"=>14, "Design"=>1, "Pharmacology, Toxicology and Pharmaceutical Science"=>3, "Psychology"=>1, "Social Sciences"=>6}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>14}, "Social Sciences"=>{"Social Sciences"=>6}, "Decision Sciences"=>{"Decision Sciences"=>1}, "Psychology"=>{"Psychology"=>1}, "Environmental Science"=>{"Environmental Science"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>3}, "Arts and Humanities"=>{"Arts and Humanities"=>1}, "Design"=>{"Design"=>1}, "Chemistry"=>{"Chemistry"=>2}, "Earth and Planetary Sciences"=>{"Earth and Planetary Sciences"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Business, Management and Accounting"=>{"Business, Management and Accounting"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}}, "reader_count_by_country"=>{"Denmark"=>1, "South Africa"=>1, "Australia"=>1, "India"=>1, "Spain"=>1}, "group_count"=>5}

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/375765", "https://ndownloader.figshare.com/files/375814"], "description"=>"<div><h3>Background</h3><p>Physician-directed pharmaceutical advertising is regulated in the United States by the Food and Drug Administration (FDA); adherence to current FDA guidelines is unknown. Our objective was to determine adherence rates of physician-directed print advertisements in biomedical journals to FDA guidelines and describe content important for safe prescribing.</p> <h3>Methods and Findings</h3><p>Cross-sectional analysis of November 2008 pharmaceutical advertisements within top U.S.-based biomedical journals publishing original research. We excluded advertisements for devices, over the counter medications, and disease awareness. We utilized FDA guideline items identifying unique forms of advertisement bias to categorize advertisements as adherent to FDA guidelines, possibly non-adherent to at least 1 item, or non-adherent to at least 1 item. We also evaluated advertisement content important for safe prescribing, including benefit quantification, risk information 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” advertisements presented only drug names, leaving 83 full unique advertisements. Fifteen advertisements (18.1%) adhered to all FDA guidelines, 41 (49.4%) were non-adherent with at least one form of FDA-described bias, and 27 (32.5%) were possibly non-adherent due to incomplete information. Content important for safe prescribing was often incomplete; 57.8% of advertisements did not quantify serious risks, 48.2% lacked verifiable references and 28.9% failed to present adequate efficacy quantification. Study limitations included its focus on advertisements from a single month, the subjectivity of FDA guidelines themselves, and the necessary subjectivity of determinations of adherence.</p> <h3>Conclusions</h3><p>Few physician-directed print pharmaceutical advertisements adhere to all FDA guidelines; over half fail to quantify serious risks. The FDA could better protect public health by creating new more objective advertisement guidelines requiring transparent presentation of basic safety and efficacy information.</p> </div>", "links"=>[], "tags"=>["adherence", "pharmaceutical", "advertisements", "journals", "fda", "guidelines", "prescribing"], "article_id"=>134230, "categories"=>["Medicine", "Pharmacology"], "users"=>["Deborah Korenstein", "Salomeh Keyhani", "Ali Mendelson", "Joseph S. Ross"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023336.s001", "https://dx.doi.org/10.1371/journal.pone.0023336.s002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Adherence_of_Pharmaceutical_Advertisements_in_Medical_Journals_to_FDA_Guidelines_and_Content_for_Safe_Prescribing/134230", "title"=>"Adherence of Pharmaceutical Advertisements in Medical Journals to FDA Guidelines and Content for Safe Prescribing", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2011-08-17 01:10:30"}
  • {"files"=>["https://ndownloader.figshare.com/files/744835"], "description"=>"a<p>Absolute risk reduction or NNT, or survival times for oncology advertisements.</p>b<p>Comparing to placebo rather than active control, or focusing on surrogate outcomes.</p>", "links"=>[], "tags"=>["prescribing", "physician-directed", "advertisements", "high-impact", "biomedical"], "article_id"=>415206, "categories"=>["Medicine", "Pharmacology"], "users"=>["Deborah Korenstein", "Salomeh Keyhani", "Ali Mendelson", "Joseph S. Ross"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023336.t004"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Content_related_to_safe_prescribing_among_physician_directed_print_advertisements_in_high_impact_biomedical_journals_/415206", "title"=>"Content related to safe prescribing among physician-directed print advertisements in high-impact biomedical journals.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-17 01:26:46"}
  • {"files"=>["https://ndownloader.figshare.com/files/744868"], "description"=>"a<p>Among 89 unique advertisements.</p>b<p>Providing only product name.</p>c<p>Among 83 full unique advertisements.</p>", "links"=>[], "tags"=>["characteristics", "physician-directed", "advertisements", "published", "high-impact", "biomedical", "journals", "november"], "article_id"=>415236, "categories"=>["Medicine", "Pharmacology"], "users"=>["Deborah Korenstein", "Salomeh Keyhani", "Ali Mendelson", "Joseph S. Ross"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023336.t001"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Sample_Description_and_Characteristics_of_Physician_Directed_Print_Advertisements_Published_in_High_Impact_Biomedical_Journals_during_November_2008_/415236", "title"=>"Sample Description and Characteristics of Physician-Directed Print Advertisements Published in High-Impact Biomedical Journals during November 2008.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-17 01:27:16"}
  • {"files"=>["https://ndownloader.figshare.com/files/744904"], "description"=>"a<p>Other items had identical rates, so the item with the highest combined rate is displayed.</p>", "links"=>[], "tags"=>["fda", "items", "advertisements", "non-adherent"], "article_id"=>415276, "categories"=>["Medicine", "Pharmacology"], "users"=>["Deborah Korenstein", "Salomeh Keyhani", "Ali Mendelson", "Joseph S. Ross"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023336.t003"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Top_3_FDA_guideline_items_to_which_advertisements_were_non_adherent_and_top_3_FDA_guideline_items_to_which_advertisements_were_possibly_non_adherent_a_/415276", "title"=>"Top 3 FDA guideline items to which advertisements were non-adherent and top 3 FDA guideline items to which advertisements were possibly non-adherent<sup>a</sup>.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-17 01:27:56"}
  • {"files"=>["https://ndownloader.figshare.com/files/744939"], "description"=>"<p>Notes: NA = Non-adherence; RR = Relative Risk; CI = Confidence Interval.</p>a<p>Content domains were non-exclusively categorized.</p>b<p>Defined as non-adherent to at least 1 item in the category.</p>c<p>Defined as no non-adherent items in the category, but a response of “not sure” for at least 1 item in the category.</p>d<p>Includes statistical testing and pooling of data questions.</p>", "links"=>[], "tags"=>["adherence", "fda", "guidelines", "physician-directed", "advertisements", "high-impact", "biomedical"], "article_id"=>415311, "categories"=>["Medicine", "Pharmacology"], "users"=>["Deborah Korenstein", "Salomeh Keyhani", "Ali Mendelson", "Joseph S. Ross"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0023336.t002"], "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Rates_of_adherence_to_FDA_guidelines_among_physician_directed_print_advertisements_in_high_impact_biomedical_journals_overall_by_FDA_guideline_item_content_a_/415311", "title"=>"Rates of adherence to FDA guidelines among physician-directed print advertisements in high-impact biomedical journals, overall by FDA guideline item content.<sup>a</sup>", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2011-08-17 01:28:31"}

PMC Usage Stats | Further Information

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Relative Metric

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