Pharmacovigilance monitoring in social media: Challenge, facts and solution

Joint Event on 12^th International Conference and Exhibition on Pharmacovigilance & Drug Safety & 22^nd International Conference and Exhibition on Pharmaceutical Formulations & 21^st Euro-Global Summit on Toxicology

July 04-06, 2019 Valencia, Spain

Tarik Messaoud

Merck, Canada

Keynote: J Formul Sci Bioavailab

Abstract :

Social media is a common way to learn about news and information in todayâ??s world. While social media provides excellent opportunities for marketing and communication, it may also generate risk to the Company. Across 37 countries, 204+ Company-owned 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:

â?¢ Collect, process and evaluate data in an independent system outside of the MAH safety database, in collaboration with vendors.

â?¢ Ensure PV oversight and regulatory compliance without increasing noise in MAH safety database â?¢ Drive consistency and efficiency with a centralized process

â?¢ Support companyâ??s digital strategy.

Recent Publications

1. Jing Liu (2018) Pharmacovigilance from social media. Elsevier 1386-5056

2. Ola Caster (2018) Assessment of the Utility of Social Media for Broadâ??Ranging Statistical Signal Detection in Pharmacovigilance: Results from the WEBâ??RADR Project. Drug Safety (2018) 41:1355â??1369

3. Cedric Bousquet (2018) Comment on â??Assessment of the Utility of Social Media for Broadâ??Ranging Statistical Signal Detection in Pharmacovigilance. Drug Safety (2018) 41:1371â??1373

4. Andrea C. Tricco (2018) Utility of social media and crowd-intelligence data for pharmacovigilance: A scoping review. Tricco et al. BMC Medical Informatics and Decision Making (2018) 18:38

5. Sarker, Abeed (2015) Utilizing social media data for pharmacovigilance: A review. Elsevier 1532-0464.

Biography :

Drug safety physician / Medical science liaison focus in patient safety and compliance, with an over 15 years of clinical experience at innovative pharmaceutical companies Merck Canada, GlaxoSmithKline and hospital environment. Recognized for a knowledgeable approach to interacting with multidisciplinary stakeholders within the healthcare community and patients.