Abstract
BackgroundOver the past decade, the volume of adverse events (AEs) reported to marketing authorization holders and regulators has been rapidly increasing each year, which has led to significant challenges in patient safety assessment. Three data sources that have largely contributed to the expansion in adverse event reports are patient support programs (PSPs), market research programs (MRPs), and social media. In this study, we sought to further understand the contribution of these safety data sources to the characterization of a product’s safety profile.MethodsThree separate approaches were taken that, when combined, can be used to evaluate each data source. The first identified any core company data sheet changes or drug safety label changes. The second evaluated the similarity of information through proportions of AEs between each solicited data source and spontaneous sources. Lastly, the completeness of information reported was evaluated through vigiGrade and compared across each data source.ResultsOne drug safety label change was identified from a patient support program, which involved regular contact with health care providers. No label changes were identified from market research programs or social media. Patient support programs, market research programs, and social media report similar proportions for HLGT as spontaneous sources. Market research programs and social media display very low vigiGrade scores. When broken down by subtype, traditional PSPs display high vigiGrade scores, while patient assistance programs display lower vigiGrade scores that were program dependent.ConclusionsThis study did not demonstrate that certain data sources such as market research programs, social media, and patient assistance programs meaningfully contributed to the further understanding of the characterization of a product’s safety profile.
Highlights
Over the past decade, the volume of adverse events (AEs) reported to marketing authorization holders and regulators has been rapidly increasing each year, which has led to significant challenges in patient safety assessment
The goal of the analyses described in this study was to assess the relative contribution of patient support program (PSP), market research program (MRP), and social media in the signal detection activities conducted with the purpose to improve the understanding of the safety profile of products following their commercialization
Across the 11 responding companies, an estimate of over 1,091,936 PSP-patient assistance program (PAP) cases, 50,026 MRP cases, and 33,738 social media cases were analyzed from January 1, 2014, to December 31, 2016, for a total of over 1,175,700 cases across all 3 categories
Summary
The volume of adverse events (AEs) reported to marketing authorization holders and regulators has been rapidly increasing each year, which has led to significant challenges in patient safety assessment. Three data sources that have largely contributed to the expansion in adverse event reports are patient support programs (PSPs), market research programs (MRPs), and social media. The second evaluated the similarity of information through proportions of AEs between each solicited data source and spontaneous sources. Results: One drug safety label change was identified from a patient support program, which involved regular contact with health care providers. No label changes were identified from market research programs or social media. Market research programs, and social media report similar proportions for HLGT as spontaneous sources. Conclusions: This study did not demonstrate that certain data sources such as market research programs, social media, and patient assistance programs meaningfully contributed to the further understanding of the characterization of a product’s safety profile
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