Evaluation of Postmarketing Reports from Industry-Sponsored Programs in Drug Safety Surveillance

Lisa Harinstein (), Dipti Kalra, Cindy M. Kortepeter, Monica A. Muñoz, Eileen Wu and Gerald J. Dal Pan
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Lisa Harinstein: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration
Dipti Kalra: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration
Cindy M. Kortepeter: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration
Monica A. Muñoz: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration
Eileen Wu: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration
Gerald J. Dal Pan: Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration

Drug Safety, 2019, vol. 42, issue 5, No 7, 649-655

Abstract: Abstract Introduction and Objective Adverse event reports from industry-sponsored programs, such as patient support programs, have contributed to a rise in the number of individual case safety reports in the US Food and Drug Administration Adverse Event Reporting System database. This study aimed to characterize individual case safety reports from industry-sponsored program and non-industry-sponsored program sources and compare their usefulness in safety signal detection. Methods Individual case safety reports of six drug and biological products were identified in the Food and Drug Administration Adverse Event Reporting System database between the date of Food and Drug Administration product approval and the first quarter of 2017. A random subset of industry-sponsored program and non-industry-sponsored program individual case safety reports were then compared to identify differences in reporters, outcomes, data completeness, and usefulness. The ‘usefulness’ of individual case safety reports was assessed by manually reviewing the availability of key information in the narrative (e.g., temporality, comorbidities). Results Compared with non-industry-sponsored program reports, more industry-sponsored program reports were associated with a serious outcome (51.4% vs. 58.8%, p = 0.02) and were reported by consumers (35.5% vs. 50.4%, p

Date: 2019
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DOI: 10.1007/s40264-018-0759-7

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