2015: Good Pharmacovigilance Practice (GvP) and Social Media

Good Pharmacovigilance Practice (GVP) at its core aims to prevent harm from adverse reactions in humans from medicines and to promote the safe and effective use of medicinal products. Pharmacovigilance professionals are aware that adverse reactions can be reported from a variety of sources – patients, healthcare professionals, competent authorities or marketing authorisation holders. Robust Pharmacovigilance however depends greatly on complete and timely reporting of adverse reactions. And herein lies the problem – it is estimated that over 90% of adverse drug reactions are under-reported1.

Is there a solution? Social media and big data have the potential to revolutionize the current approach to Pharmacovigilance. The advent of social media has been transformative in areas such as marketing, breaking news, recruitment and the way we interact with others around the world. And like anything else, people may share their experiences about their medication on such platforms or on patient forums. Problem solved you might think? Well not quite. Current Pharmacovigilance guidance dictates that a valid individual case safety report should include at least one identifiable reporter, one single identifiable patient, at least one suspect adverse reaction and at least one suspect medicinal product. Any or all of these items could be missing from a social media post. Patients or drug identity may be difficult to identify, the description of the adverse reaction or duration may be vague etc.

Social media as a reputable source of information for media outlets faced similar problem in the recent past. Here in Ireland, Dublin based Storyful was one such company that addressed this with their news verification offering.

While the FDA has issued social media guidance documents in 2014, these were focused on advertising and do not provide guidance on pharmacovigilance. There are a number of collaborations on-going between technology service providers and both regulators and big pharma. We expect to see significant movement in area in the years ahead.

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We updated this article in 2019.  You can read the new article here.

  1. Hazell L, Shakir SAW. Under-reporting of adverse drug reactions. Drug Saf. 2006;29:385–396.