Challenge, facts and solutions of Pharma-covigilance monitoring

Tarik Messaoud

Abstract

Challenge, facts and solutions of Pharma-covigilance monitoring

Social media is a common way to learn about news and information in today’s world. While social media provides excellent opportunities for marketing and communication, it may also generate risk to the Company. Across 37 countries, 204+ Companyowned social media channels (e.g., Facebook, Twitter, Instagram, WeChat) with 70+ social listening projects with an impact that enquired PV screening and result in a large volume of product-event combinations, increased noise in safety database, and increased PV resources. Current post marketing safety reporting model is built on vertical organizations having the resources to find, collect and process safety information. Manufacturers have been the de facto owners of safety information and responsible for it (focus of regulations) because they were the only organizations able to afford the transaction costs. Findings: Social media is a potentially invaluable reservoir of information for pharmacovigilance, adverse drug reactions come at a considerable cost on MAH (marketed authorized holders). In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. Recommendations: We outline these key challenges identifying relevant current research and present possible solutions: • Collect, process and evaluate data in an independent system outside of the MAH safety database, in collaboration with vendors. • Ensure PV oversight and regulatory compliance without increasing noise in MAH safety database • Drive consistency and efficiency with a centralized process • Support company’s digital strategy.

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