One of the most significant outputs of IMI’s WEB-RADR project was a mobile application (app) which allows patients and healthcare professionals to report adverse drug reactions (ADRs, or side effects) directly to the relevant authorities. The WEB-RADR 2 project aims to take the app to the next level by making its functionalities available through application programming interfaces (APIs). This will allow third party organisations to embed the WEB-RADR platform’s functionality into their own systems, apps and websites. To achieve this, the team will collaborate with main organisations involved in pharmacovigilance to map the terminologies used. They will also work closely with the WEB RADR project’s networks of regulatory authorities, health charities and system providers to ensure the tools developed are what end users need.
Achievements & News
Once clinical trials are over and medicines have been approved for sale, they still need to be monitored for safety. The WEB-RADR project created a mobile app for smartphone users to report side effects of medicines directly to the regulatory authorities. ###The app was first rolled out in three European countries (UK, Netherlands, Croatia).
In Europe, systems for reporting side effects are well established. However, in some low-and middle-income countries there are no electronic systems in place and adverse effects are reported via paper forms. The WHO recognised the potential of the WEB-RADR app to fill this gap, and a generic multi-country version of the app, the Med Safety App was created for wider adoption. The Med Safety App has been rolled out in 12 countries to date, from far afield as Pakistan to Nigeria and Armenia.
Some of the Med Safety App functionalities include the ability to have multiple languages including local dialects, use the app without internet connection, partially create reports and save them for completing later, and have tailored logos and branding. The future for the WEB-RADR project will be less about rolling out apps and more about developing additional functionality. The project has received extra funding to adapt its code to allow reporting on medical devices, which will become increasingly important as digital health devices become more commonly used.
The UK regulator, the MHRA, has recently funded adaptation of the platform to help with the reporting of medicines used to treat coronavirus symptoms in the UK. Such functionality has been made available to Med Safety App countries and a number of countries have implemented the COVID-19 reporting form. The MHRA are discussing how to further develop this functionality to support the reporting of adverse effects following immunisation, known by the acronym AEFI, which will be crucial because these campaigns will use brand new vaccines on a massive scale.
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Generally speaking, social media is currently not suitable for detecting new safety issues in marketed medicines, according to a new paper published by the WEB-RADR project in the journal Drug Safety. Nevertheless, it may be beneficial in certain specific circumstances, and advances in technology may make it more useful in the future. Once a medicine is on the market, drug companies and medicines regulators monitor its safety in the general population in the long term. To do this, they rely on patients and healthcare professionals to report suspected problems (known as adverse drug reactions or ADRs). However, many suspected ADRs go unreported. WEB-RADR set out to determine if social media could be used to identify ADRs. To do this, the team studied some 4.2 million tweets and Facebook posts as well as over 42 000 posts from over 400 online patient fora. Overall, they conclude that social media, such as Facebook and Twitter, are not recommended for detecting potential safety issues. However, social media may prove useful in certain niche areas, such as exposure to medicines during pregnancy and the abuse (or misuse) of medicines. Furthermore, advances in technology could mean that social media could be used as a source of information on ADRs in the future.
ParticipantsShow participants on map
- Abbvie Inc, North Chicago, Illinois, United States
- Csl Behring GMBH, Marburg, Germany
- Novartis Pharma AG, Basel, Switzerland
- Pfizer Limited, Sandwich, Kent , United Kingdom
Universities, research organisations, public bodies, non-profit groups
- Agencia Espanola De Medicamentos Y Productos Sanitarios, Madrid, Spain
- Agencija Za Lijekove I Medicinske Proizvode, Zagreb, Croatia
- International Health Terminology Standards Development Organisation, London, United Kingdom
- Laegemiddelstyrelsen, Kobenhavn S, Denmark
- Medicines And Healthcare Products Regulatory Agency, London, United Kingdom
- Stichting Lareb, 's Hertogenbosch, Netherlands
- Stiftelsen WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
- The International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use, Geneve, Switzerland
|Name||IHI funding in €|
|Agencia Espanola De Medicamentos Y Productos Sanitarios||47 500|
|International Health Terminology Standards Development Organisation||238 750|
|Medicines And Healthcare Products Regulatory Agency||712 500|
|Stichting Lareb||62 500|
|Stiftelsen WHO Collaborating Centre for International Drug Monitoring||25 000|
|Total Cost||1 168 750|