Social media analytics ‘The WEB RADR trials’

Web RADR (Recognising Adverse Drug Reactions) is platform which provides technological solutions for robust pharmacovigilance. Web RADR has its key contributions in Governance and policy, Social media and Analytics.

Web RADR is led by the European Medical Agency to provide its recommendation on developing mobile based application and use of social media for monitoring adverse drug reactions. Web- RADR goes in consultation with bodies like Eudravigilance- Expert Working Group (EV- EWG), Patient’s and Consumer Working Party (PCWP).

Key stakeholders in this project include Novartis Pharma, Janssen Pharmaceutica, Sanofi-Aventis, UCB and Amgen

Web RADR along with Epidemico (An organization with the capability to analyse and visualize data, comprising of public health leaders, software experts and data scientist) is now working its way to provide access to social media content by visualization using technology by Epidemico in detecting signals. Analysis of social media content through Big Data Analytics would be applied in forecasting problems with marketed medicinal products, it would enable the regulators to understand nature of safety signals and all of the content screening would be done on data which would be publically available, without violating data protection act adding further to this where social networking users would also have the provision to opt out of data collection.

Through a recent it was determined that in 2016, Facebook has highest number of threads with 2.2 Billion post, Twitter following with around 318 millions tweets and You tube with 1.5 billion videos.

Alongside with screening digital content from social media, Web RADR in collaboration with World Health Organization’s, Uppsala Monitoring Centre would be developing analytical tool, which would help in extraction of relevant and quality data from social media for  screening and would also focus on case triaging and linkage of duplicate reports.

Another initiative led by Web-RADR is designing android/ IOS based apps with key functions to report ADR and provide alerts. The apps would be linked with various regulatory agencies and would provide tailored alerts to the users about safety issues and warnings. The app would also facilitate anonymous ADR submissions using customized reporting forms. Web-RADR would be making the app soon available in different languages and additional products would be added in the product list for easy recognition of suspect.

In UK almost 4000+ users have used Yellow Card app with 400+ safety reports being sent to MHRA

Web- RADR , together with University Medical Centre Groningen and University College London would analysing barriers for patient and healthcare professionals to use mobile application for reporting ADR, studies through conjoint analysis where different versions of app are tested on different levels of health, literacy and usability on focussed population groups of patients adolescents, orphan disease populations and elderly patients have been undertaken by the University.

Web-RADR would also be conducting Scientific Impact Evaluation, together with University of Liverpool to determine whether mobile based application and social media content screening would be a value addition to Pharmacovigilance as output of these activities would impact policy recommendations.

Reference:

·         WEB-RADR, Work Packages (url: https://web-radr.eu/work-packages/wp5/ )

·         EPIDEMICO (url: https://www.epidemico.com/ )

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MHRA’s Black Triangle Report

In United Kingdom, there are certain drugs in which although they were granted marketing approval by the Medicines and healthcare product regulatory agency (MHRA), they need to be closely monitored, since limited information were available about these drugs.

One of the key reasons attributed to this may be, less subjects being enrolled in the clinical trials, short therapy duration etc.…thus, in order to identify rare adverse reactions, effect of the drug in different populations or effect of the drug under different co-morbidities, such drugs are tagged with an inverted black triangle (▼) on their package insert, to ensure that these drugs are intensively monitored.

The Commission on Human Medicines (CHM) and MHRA encourages expedited reporting within 15 calendar days of all such drugs with an inverted black triangle symbol if, found to have caused serious or non-serious adverse drug reaction.

You may find the black triangle drugs at the Electronic Medicines Compendium, British National Formulary, Nurse Prescribers’ Formulary etc.… A black triangle symbol may be assigned to any new active drug / vaccine or even a Biosimilar (Biosimilar are similar biological therapeutic products). Black triangle is not restricted to only drugs, it may also include new route of administration, new drug delivery systems or even new patient population.

Black triangle drugs are reviewed every 2 years by the MHRA and monitoring black triangles reports helps in identifying benefit risk profile of drug and unrecognized adverse effects.

Reference:

·         List of medicines under additional monitoring, European Medical Agency (url: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000366.jsp&mid=WC0b01ac058067c852 )

·         EMC (https://www.medicines.org.uk/emc/ )

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