Pharmacovigilance & Social Media in 2020
We have been tracking the role of social media in pharmacovigilance in social media since 2015. We first wrote about it here. 5 years on, we are glad to say that the field has moved on substantially in terms of research into the practical applications of social media in Pharmacovigilance. Regulatory guidance for the industry, however, has yet to be updated.
The Impact of Social Media on PharmacovigilanceA Pubmed review of the use of social media in pharmacovigilance today turns up many more hits than 3 years ago. As an example, a 2018 study (Kürzinger et al) comparing the detection of signals of disproportionate reporting (SDRs) assessed patients’ medical forums in France versus VigiBase, the WHO individual case safety reports (ICSR) database. Messages posted on patients’ forums between 2005 and 2015 were assessed and three drugs (insulin glargine, teriflunomide, and zolpidem) were selected for the study to cover different therapeutic areas and different lengths of use since market authorization. What the study showed is that up to 38% of common SDRs were detected earlier (up to 128 months earlier) in the forums than in VigiBase. What these and other studies show is that mining alternative sources such as social media or online platforms could at least be considered as a complementary source of data to traditional sources, allowing events to be detected earlier and, thus aiding patient safety.
The European Perspective
In Europe, Good Pharmacovigilance Module VI provides guidance for screening for suspected adverse reactions from the internet or digital media. MAHs are instructed to regularly screen the internet or digital media under their management or responsibility, for potential reports of suspected adverse reactions. With respect to this, a digital medium is considered to be company sponsored if it is owned, paid for and/or controlled by the marketing authorisation holder.
The frequency of the screening should allow for potential valid ICSRs to be submitted to the competent authorities within the appropriate regulatory submission time frames based on the date the information was posted on the internet site/digital medium.
Marketing authorisation holders may also consider utilising their websites to facilitate the collection of reports of suspected adverse reactions. GVP VI also refers to the “identifiability” of the reporter i.e. the existence of a real person, that is, it is possible to verify the contact details of the reporter (e.g., an email address under a valid format has been provided).
The Web-Recognizing Adverse Drug Reactions Project
Since our lfirst post on this topic, the most exciting development here in Europe is the EU Innovative Medicines Initiative (IMI) project called Web-Recognizing Adverse Drug Reactions or WEB-RADR. The project will explore the powers of social media and new technologies for pharmacovigilance purposes. The initiative has been organized into several work packages (WPs). The WEB-RADR WP1 objective is to elaborate a policy framework for the monitoring and analysis of ADRs originating from social media with recommendations to also address ethical, legal, and data protection aspects.
Despite the current guidance outlined above in GVP Module VI, additional specific guidance is required to provide clear guidance for MAHs on how to analyze social media for adverse reactions, signal detection and risk minimization activities.
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Further Reading About WEB-RADR
The WEB-RADR 2 project, launched in September 2018, seeks to exploit the outputs of WEB-RADR 1. Over the project, the mobile app has been enhanced and a Vigilance Hub has been created to manage the back-end system. There is now the ability to embed WEB-RADR functionality into systems, applications and websites by use of Application Programming Interfaces (APIs). Another key arm of WEB-RADR 2 is the bi-directional mapping of SNOMED CT and MedDRA terminologies. This work has been led by SNOMED International and MedDRA MSSO (ICH). Connectivity protocols with electronic healthcare record (EHR) databases have also been explored within United Kingdom and Danish settings, such that ADRs and regulatory information can be made available in the care record.
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