Pharmacovigilance is the monitoring of the safety of medicines to identify new or changing risks to support the safe and effective use of medicines. This includes the monitoring and reporting of adverse drug reactions (ADRs), i.e. side effects that can be experienced during treatment. Patients experiencing ADRs and their healthcare professionals are requested to report these side effects to their national pharmacovigilance centre. However, paper-based report forms are not always available and are often perceived as inconvenient and complex. If more reports were submitted, this could facilitate the faster identification of risks.
To address this, IMI’s WEB-RADR project has developed a mobile app that allows users of pharmaceutical products to directly report ADRs to relevant health authorities, find out about reported side effects and opt to receive alerts on specific medicines. During the project, the app was rolled out across three EU countries – Croatia, the Netherlands, and the UK – and had about 10 000 downloads in those countries alone.
Thanks to collaboration with the World Health Organization, the app was also rolled out to support malaria programmes in two African countries: Burkina Faso and Zambia. The implementation of the app in those countries had a substantial impact, with Burkina Faso receiving more ADR reports in the first six months after the roll out than they had in all the time previously.
A dozen additional countries around the world have also expressed interest in the app and some have already adopted it. For example, in early 2018 the United Arab Emirates also launched the app.
The reports received via the app have already contributed to the identification of new safety issues with various medicines, enabling regulatory authorities in relevant countries to take appropriate action.
Social media data mining
The WEB-RADR project team also explored the value of social media data for pharmacovigilance. They found that in certain circumstances it could be hugely valuable and that people are far more likely to discuss issues like medicine misuse on social media than with their doctor. To mine this wealth of data, the team developed methods to detect, extract, standardise and analyse medicine-related information reported in unstructured free text by social media users.
This has already led to concrete insights. For example, thanks to social media mining, the team uncovered patterns of misuse of a particular medicine by communities of students who want to improve their performance around examination time. This has provided additional information to the traditional sources, because students would normally not share this information with their doctors and pharmacists.
WEB-RADR policy recommendations on the collection and use of data – both through the app and social media mining – have been passed on to the European Medicines Agency (EMA) for implementation in future guidance on how the pharmacovigilance legislation in the EU should be operated.
Ethical and data protection issues
A consistent area of concern for the project was potential conflicts over data gathering and privacy regulations, as well as ethical considerations about harvesting social media data. To address this, the researchers engaged leading medical ethicists and data protection experts to assist them. That set a sound and robust framework for the analysis that they were doing, ensuring that they were both operating within the law and conducting the work in accordance with the highest ethical standards.
Benefits for industry, academia and SMEs
The industry is already benefitting from the tools and resources developed within this project, especially from the guidelines on how they can use social media to monitor drug safety issues and improve their interaction with patients and carers.
The academic community has benefitted from the exchange of ideas and viewpoints with different stakeholders in the project, as well as from innovative research ideas and identification of new research areas. SMEs have also benefitted from the network formed within the project, and have expanded their businesses.
Finally, patients and healthcare providers benefitted from gaining a new, user-friendly way to report adverse drug reactions and receive official, reliable and regulator-approved information on their treatments via the mobile app.
In order to enable other countries in the EU and beyond to benefit from the tools developed in the project, the project partners have put in place a sustainability plan. Among other things, the project set up a management board that will support the growth of the mobile app as well as its continued development and enhancements beyond the lifetime of the project.
In line with IMI’s open innovation approach, the data and reference standards obtained during the course of the project will soon be published so that other researchers could build on the WEB-RADR work. Furthermore, the project’s scientific deliverables have been described in two scientific papers – as of August 2018, their publication is still pending.
Read the interview with project coordinators.
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.
Find out more
- Read the article in full
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.
Detecting the adverse effects of medicines – as well as their misuse – poses a big challenge for health authorities. Under-reporting is an issue, with individuals sometimes more likely to express their frustration via social media channels than consult their doctor. By bringing together industry and academic experts, regulators, patients and small and medium-sized enterprises, IMI’s WEB-RADR project developed a mobile application which allows patients to directly report potential medicine side effects and also receive reliable information on their drugs. ###The work done in this project is already helping medicine manufacturers and regulators to detect new safety signals and intervene earlier in case of adverse drug reactions, thus improving medicine monitoring and patient safety. In an interview with the IMI Programme Office, the project coordinators, David Lewis of Novartis and Phil Tregunno of the UK’s Medicines and Healthcare products Regulatory Agency, explain how the project outputs are already helping in the earlier detection of drug safety issues for the benefit of patients. ‘It was the engagement of a consortium, the public-private partnership open dialogue, and the IMI funding structure that allowed us to do this in a very rapid time frame,’ said Lewis.
- Read the full interview
Detecting and preventing the adverse effects of available pharmaceutical drugs – as well as their misuse – is a challenge for health authorities. The vast majority of referrals come from healthcare professionals and under-reporting of the issue is a problem. Individuals are often more likely to go online to express frustration than consult their doctor.
To address this, IMI’s WEB-RADR project has developed an app ###that enables users of pharmaceutical products to directly report adverse drug reactions (ADRs) to relevant health authorities, find out about reported side effects and opt to receive alerts on specific medicines. The project team also found that gathering social media data on the misuse of medicines could be hugely valuable in understanding what preventive strategies should be taken. WEB-RADR policy recommendations on the collection and use of data – both through the app and social media mining – have been passed on to the European Medicines Agency (EMA) for implementation into future guidance.
- Read the full story
IMI project WEB-RADR has launched a pair of surveys, one for healthcare professionals and one for patients and consumers of medicines. The goal of the surveys is to gather opinions on an app that people can use to report adverse drug reactions (side effects) and receive safety information about medicines.### The results will help the project to improve the app they have already developed and raise awareness about reporting side effects and receiving safety information. The project will also use the results to quantify the main facilitators and barriers for a mobile app as a tool of two-way risk communication, and determine whether there are differences in preferences and expectations between stakeholder groups (type of patient, healthcare professionals, countries). The surveys are available in seven languages: Croatian, Dutch, English, French, German, Portuguese, and Spanish. The deadline for contributing to the survey is early September.
Croatia has become the third country in Europe to benefit from the WEB-RADR mobile app for reporting suspected adverse drug reactions (side effects). The Croatian app, which is available via both Apple’s App Store and Google Play was launched by HALMED, Croatia’s Agency for Medicinal Products and Medical Devices, at a conference in Zagreb.### The mobile application allows patients, healthcare professionals, carers and others to directly report ADRs as well as receive the latest information concerning medicinal products using their mobile devices. ‘After HALMED was the first in the world to begin using the online application of the World Health Organization (WHO), the introduction of our mobile application represents the logical continuation of our efforts to apply new digital technologies in order to make the ADR reporting system more accessible to patients and health care professionals. Croatia, the United Kingdom and the Netherlands are the first member states of the European Union which have implemented such applications, and a mobile application meant for use in all the other member states of the European Union will be developed based on our experiences,’ said Darko Krnić, Head of HALMED’s Department for Pharmacovigilance and Rational Pharmacotherapy.
Read HALMED’s press release.
IMI’s WEB-RADR project has launched a Dutch version of its smartphone app that patients, carers and healthcare providers can use to report side effects of medicines. Like the UK version of the app, which was launched last year, the Dutch app allows users to quickly and easily report side effects and find out about reported side effects. In addition, users can set up alerts to receive the latest information on specific medicines.### The app is available for iOS and Android phones. Information submitted via the Dutch app is collected by the Netherlands Pharmacovigilance Centre Lareb. Lareb is responsible for collecting and analysing information on reported adverse drug reactions in the Netherlands. Collecting, registering and analysing information on side effects in this way provides those responsible for monitoring medicines safety with vital information that can be transformed into guidelines on medicines if needed. WEB-RADR is planning on releasing a Croatian version of the app later this year. The project is also developing a generic version of the app which will be available for adoption by countries who wish to use the technology to supplement existing reporting mechanisms.
IMI project WEB-RADR has launched a smartphone app that will make it easier for patients, carers and healthcare professionals to report side effects of medicines. The app, which is available via the UK iTunes App Store and Google Play, is the only app that allows people to report side effects directly to the UK Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card Scheme.### The MHRA uses the scheme to collate and review reports of suspected adverse drug reactions, and if needed, make changes to the warnings and advice given to people taking a medicine or vaccine. Users can select specific medicines or vaccines to track and receive news and alerts about them. In a video, UK Life Sciences Minister George Freeman commented: ‘The Yellow Card Scheme has played a vital role in the safety of medicines for the last 50 years and the launch of this new mobile app brings it into the 21st century. By making the scheme accessible to researchers, healthcare professionals and millions of patients, it will not only improve the safety of reporting but ultimately better protect people's health and support research.’ WEB-RADR will draw on user feedback to develop the app further and adapt it for additional countries. Over the coming year, the WEB-RADR project will launch versions of the app in the Netherlands and Croatia, and by the end to the project will have a generic version of the app which will be available for adoption by Member States who wish to use the technology to supplement existing reporting mechanisms.
- For more information on the app, read the MHRA press release
IMI’s WEB-RADR project has held its first workshop on the use of mobile technologies and social media in pharmacovigilance. The goal of the event was to lay the foundations for future collaboration with consumers, patients, healthcare professionals and medicines regulators throughout the WEB-RADR project.### During the event, the 80 participants discussed issues such as:
- the application of mobile technologies to facilitate adverse drug reaction (ADR) reporting and access to information on medicines;
- the potential use of public social media as a data source together with analytical tools to supplement existing signal detection approaches;
- personal data protection and ethical considerations;
- the elaboration of recommendations to aid policy development on the future use of mobile technologies and social media as new tools in pharmacovigilance.
The goal of the WEB-RADR project is to develop a mobile app for patients and healthcare professionals to report suspected adverse drug reactions to national EU regulators, and investigate the potential for publicly available social media data for identifying drug safety issues.
ParticipantsShow participants on map
- Amgen, Brussels, Belgium
- Astrazeneca AB, Södertälje, Sweden
- Bayer Pharma AG, Berlin, Germany
- Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
- Janssen Pharmaceutica Nv, Beerse, Belgium
- Novartis Pharma AG, Basel, Switzerland
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
- UCB Biopharma, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
- Academisch Ziekenhuis Groningen, Groningen, Netherlands
- Department of Health, Leeds, United Kingdom
- Stichting Lareb, 's Hertogenbosch, Netherlands
- Stiftelsen WHO Collaborating Centre for International Drug Monitoring, Uppsala, Sweden
- The European Medicines Agency, Canary Wharf, London, United Kingdom
- The University Of Liverpool, Liverpool, United Kingdom
- University College London, London, United Kingdom
Small and medium-sized enterprises (SMEs)
- Epidemico LTD, Irishtown, Ireland
- Srdc Yazilim Arastirma Ve Gelistirme Ve Danismanlik Ticaret Anonim Sirketi, Ankara, Turkey
- Eurordis - European Organisation For Rare Diseases Association, Paris, France
Non EFPIA companies
- Agencija Za Lijekove I Medicinske Proizvode, Zagreb, Croatia
|Name||IHI funding in €|
|Academisch Ziekenhuis Groningen||100 526|
|Agencija Za Lijekove I Medicinske Proizvode||49 374|
|Department of Health||330 342|
|Epidemico LTD||519 335|
|Eurordis - European Organisation For Rare Diseases Association||80 475|
|Srdc Yazilim Arastirma Ve Gelistirme Ve Danismanlik Ticaret Anonim Sirketi||75 000|
|Stichting Lareb||138 249|
|Stiftelsen WHO Collaborating Centre for International Drug Monitoring||340 773|
|The European Medicines Agency||246 878|
|The University Of Liverpool||276 548|
|University College London||112 500|
|Total Cost||2 270 000|