New data sources for pharmacovigilance
Over the last decade, the volume of adverse events collected through pharmacovigilance activities has increased significantly, with annual growth rates ranging from 10% to 20%. This increase has been driven in part by new sources of safety data, including patient support programs (patient support programs, PSPs), market research programs (market research programs, MRPs), and social media.
Both PSPs—company-sponsored programs designed to provide patients with access to products or treatments—and MRPs—programs that systematically collect, record, and analyze data related to a marketing authorization holder (MAH)—follow the same pharmacovigilance requirements applied to post-marketing surveillance and fall within the category of solicited reports.
Despite the large volume of safety information generated through these programs and through social media monitoring, the extent to which these new data sources contribute to understanding the safety profile of medicines remains unclear.
The contribution of new data sources to signal detection
According to a study published in Therapeutic Innovation & Regulatory Science, between 2014 and 2016 post-marketing programs and social media generated a substantial amount of pharmacovigilance data, corresponding to 1,091,936 cases from PSPs, 5,026 from MRPs, and 33,738 from social media.
Despite this large volume of reports, only nine valid safety signals were identified over the three-year period, none of which were ultimately confirmed. These signals led to only one change in the safety information of a medicinal product.
Most of the valid signals originated from PSPs involving the participation of a healthcare professional. By contrast, data obtained from MRPs and social media proved to be less informative. PSP data were generally of higher quality, particularly in terms of their similarity to MedDRA terminology and the completeness of information as assessed using the vigiGrade score.
Conversely, MRPs and social media frequently provided limited information, making follow-up activities necessary in order to obtain a complete dataset.
Making the best use of new data sources: an individualized and risk-based approach
The fact that these new data sources are not fully suited to pharmacovigilance purposes is not unexpected, as these tools were not originally designed specifically for the collection of safety information.
Starting from the assumption that increased reporting—supported in part by the expansion of data sources—is a positive development, it is necessary to better define the role of these tools within the signal detection process in order to direct reporting and data collection efforts toward effective and efficient safety monitoring.
To achieve this goal, innovative strategies are required that differ from the approaches traditionally used in standard pharmacovigilance activities. Examples include the adoption of a proportionate and risk-based data collection approach as well as the simplification of current regulatory guidance for PSPs and MRPs.
In addition, it is essential to conduct further research on social media and digital technologies to better understand how these tools can be used most effectively in the field of drug safety.
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