In today’s era of medical data explosion, the reporting of adverse events (AEs) both poses a challenge to drug safety assessment and drives advances in drug safety. According to the latest research by Jeremy Jokinen’s team, data sources such as patient support programs (PSPs/PAPs), market research programs (MRPs) and social media are of great value for the collection and statistics of drug safety data. The study found that the drug safety data provided by PSPs is more valuable and usable than other sources.
Data Sources and Drug Safety
As the pharmaceutical industry becomes more data-reliant on data, data collection from PSPs/PAPs, MRPs to social media has become indispensable. This data is uniquely valuable in identifying potential risks and adverse effects of pharmaceutical products, but it also presents challenges for data integrity and reliability.
Jeremy Jokinen’s research team used three methods to evaluate the impact of different data sources on drug safety labels. First, the research team examined changes to drug safety labeling due to PSPs and found that PSPs/PAPs were able to influence drug safety assessments through regular contact with healthcare providers. However, MRPs and social media did not result in any labeling changes, suggesting that their direct contribution to drug safety was limited.
Further analysis of the vigiGrade scoring system showed that traditional PSPs/PAPs performed better in terms of data integrity, while MRPs scored lower in terms of social media, pointing out the shortcomings of these platforms in terms of data quality and integrity.
Industry impact and future direction
Traditional PSPs/PAPs have proven to have a significant impact on drug safety monitoring due to their structured interaction patterns and deep contact with healthcare professionals. In contrast, MRPs and social media, while contributing only to a further understanding of drug safety profiles, have the potential to become more influential data sources in the future, given their broad user base and data collection capabilities. As a result, the industry needs to develop more advanced data analysis tools and methodologies to improve the data quality and usability of these platforms.
The value of drug safety advancements brought by PAPs/PSPs
The study highlights the direct impact of PSPs/PAPs in the drug safety assessment process, and contrasts the potential role of market research and social media in this regard, showing the value of patient support programs in bringing real-world drug safety advancements.
Zhang Xiangxin, General Manager of PatientsForce Caihong Health Group
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