pLOG

2024-05-14

Research Finds Patient Assistance Program Data Beneficial for Advancements in Drug Safety

In today's era of medical data explosion, adverse event (AE) reporting presents both challenges and opportunities for advancing drug safety. According to recent research by Dr. Jeremy Jokinen and colleagues, data sources such as Patient Assistance Programs (PSPs/PAPs), Market Research Programs (MRPs), and social media hold significant value for the collection and dissemination of drug safety data. The study found that safety data provided by PSPs is more valuable and usable compared to other sources.

Sources of Data and Drug Safety

As the pharmaceutical industry increasingly relies on data, the collection of data from PSPs/PAPs, MRPs, and social media has become indispensable. These data sources hold unique value in identifying potential drug risks and adverse reactions but also pose challenges regarding data integrity and reliability.

Jeremy Jokinen's research team employed three methods to evaluate the impact of different data sources on drug safety labeling. First, the team examined drug safety labeling changes prompted by PSPs and found that PSPs/PAPs, through regular interaction with healthcare providers, could influence drug safety assessments. However, MRPs and social media did not lead to any labeling changes, indicating their limited direct contribution to drug safety.

Further analysis using the vigiGrade scoring system showed that traditional PSPs/PAPs performed better in terms of data completeness, whereas MRPs and social media scored lower, highlighting deficiencies in data quality and completeness on these platforms.

 

Industry Impact and Future Direction

Traditional PSPs/PAPs have been proven to have significant influence on drug safety monitoring due to their structured interaction model and deep engagement with healthcare professionals. In contrast, while MRPs and social media contribute to a limited extent in further understanding drug safety profiles, considering their extensive user base and data collection capabilities, they have the potential to become more influential data sources in the future. Therefore, the industry needs to develop more advanced data analysis tools and methods to enhance the data quality and usability of these platforms.

 

The value of drug safety advancements brought by PAPs/PSPs

This study emphasizes the direct impact of PSPs/PAPs on drug safety assessment and contrasts the potential roles of market research and social media in this regard, demonstrating the value of patient assistance programs in bringing about advancements in drug safety in the real world.

 

PatientsForce President Sean Chang

 

Reference
Industry Assessment of the Contribution of Patient Support Programs, Market Research Programs, and Social Media to Patient Safety