The Med Safety App is a mobile application for healthcare professionals and members of the public to submit reports of suspected adverse events from medicines and vaccines. The App was developed through collaboration between IMI, WEB-RADR, the World Health Organisation (WHO) and the WHO Collaborating Centre for International Drug Monitoring, the Uppsala Monitoring Centre (UMC). The technology is made available by MHRA on behalf of the WEB-RADR project on a not-for-profit basis.

The Med Safety App’s primary function is to report suspected adverse events from medicines and vaccines via the Medicine Adverse Drug Reaction (ADR) form and Adverse Events Following Immunisation (AEFI) form respectively. The Med Safety App also allows users to access safety related news articles and alerts from a country’s national health products regulator, view global safety data of all registered medicines and vaccines in their country, and to create a watch list of products of interest.

The Med Safety App provides a quick and easy way to report suspected adverse events, particularly when compared to traditional paper reporting systems. In the long-term, effective usage of the Med Safety App and/or other electronic reporting tools will help countries to eliminate less effective paper-based reporting systems.

For more information about the features and functionality of the Med Safety App, please click here. To view communication materials that have previously been used to promote the Med Safety App, see a repository of previous App launch events here.

The Med Safety App is available to download for free from the Apple App Store and Google Play Store.

The AU-3S team has developed and launched a vaccine-specific reporting form for the Med Safety App based on the 25 WHO core variables for adverse event following immunisation (AEFI) reporting. This form can be used to report an AEFI for any vaccine that a country has approved for use. The form was designed to replace the use of paper forms with the aim of supporting countries to collect AEFI reports from vaccines more swiftly and efficiently. There are three major benefits, amongst others, that the form provides:

• Enables real-time visibility of all AEFIs being reported to both the national immunisation programme and the regulatory authority (EPIs and NRAs) – more swiftly identifying cases requiring follow-up to gather more information and/or obtain an update from the reporter.

• Enforces the use of drop-down lists or other data validation criteria when capturing information such as drug names or drug reactions, instead of capturing non-standardised free text. This improves data quality and ease of downstream safety data analysis.

• Allows a case to be updated, by the reporter, with additional information such as an outcome resolution or with further information on areas such as medical history or diagnosis test results.

The Vigilance Hub is the back-end system of the Med Safety App. The Vigilance Hub is available to staff of national regulators and immunisation programmes (NRAs and EPIs) based on granted access permissions.

The Vigilance Hub allows a user to:

• View all submitted reports, from the Med Safety App and other linked channels.

• Edit case reports submitted. This is particularly relevant for updating cases with any follow-up information obtained via case investigations. This functionality is also important when one needs to recode a drug-name if a non-MedDRA term had originally been captured or to update vaccine names if the vaccine drop-down list was not used when generating the report.

• Manually enter paper form cases directly into the Vigilance Hub.

• Export reports of cases.

• Analyse volume and sources of cases received for specified time periods.

• Configure news items for users of the Med Safety App and create watch lists for medical products of interest – therefore acting as a two-way communication channel.

It is important to note that reports entered into or updated within the Vigilance Hub are automatically updated in the VigiFlow environment.

There are two access levels that can be granted to Vigilance Hub users, allowing for safety data access to be tailored to country requirements. Both ‘standard users’ and ‘organisation leads’ can create and update case reports. Additionally, ‘organisation leads’ can access analytics and download functionalities for all cases in the Vigilance Hub. They can also specify what permissions each ‘standard user’ is to receive when creating new accounts (e.g., may limit EPI users to only be able to access vaccine related reports). The AU-3S team is putting in place a network of national Vigilance Hub super users so that each country using the tool can be self-supporting and manage their own user access requirements going forward. Further information about capability strengthening via the Vigilance Hub super user network can be found here .

A detailed guidance document outlining how to use the Vigilance Hub can be found here. For more information about the Vigilance Hub, please click here.

The AU-3S programme is assisting countries to use the high profile of COVID-19 vaccines to raise general awareness of the Med Safety App. The aim is to ensure that it is well-utilised for electronic reporting for both medicines and vaccines. The programme has been working with national communication teams to support the development of communication plans and the production of content. There has been significant uptake of the Med Safety App due to COVID-19 need and the above-mentioned communication efforts. Since AU-3S commenced the pilot programme, there has been ~17,500 new users of the Med Safety App across all pilot countries. For the first half of 2021, there was a 900% average increase in monthly Med Safety App active users relative to 2020 across the pilot countries. In Nigeria, the Med Safety App is now the primary safety reporting tool of choice and the country is working towards a 90% target of all vaccine related national safety reports being submitted through the App (vs. other reporting channels).

The AU-3S team has produced the following teaser videos that countries can use, particularly on social media, to provide a short overview of the Med Safety App. These videos can be customised to specific country requirements such as NRA branding and/or translation needs. Non-customised versions of the videos, in English, are readily available for any country to use straight away. This video can be seen below:

The AU-3S team have also developed 2 longer more detailed videos which again can be used by countries as is or rebranded with the NRA logos or other county specific requirements. The first is for how to efficiently navigate the App and the second provides a demo of how to report an AEFI using the App:

In addition to these videos, the AU-3S programme has prepared a set of Med Safety App FAQs and an instructional guideline. This guideline provides step by step details on how a health care professional can report either an AEFI or an ADR. There is a slightly modified, less technical version for member of the public or patient use. Again these materials are available to any country who uses the Med Safety App and can be easily branded to NRA requirements.

AU-3S pilot countries launched successful promotion campaigns to encourage AEFI reporting through the Med Safety App. See highlights from select countries below:

Ghana:

• Ghana FDA Facebook video posts promoting the download and submission of side effects via the Med Safety App:

• February 2021 – Overview

• July 2021 – How to get the Med Safety App

• July 2021 – Safety Hero

• Ghana FDA use their LinkedIn page to help target promotion of materials to relevant industry groups or individuals

• Twitter thread from March 2021 for how to report COVID-19 vaccine side effects to Ghana FDA: https://twitter.com/fdaghana/status/1369637831786823682

Nigeria:

• Press articles from 2021 promoting use of Med Safety App for PV of COVID-19 vaccines and summarising related AEFI statistics:

• https://www.thecable.ng/you-can-report-adverse-effects-of-covid-19-vaccine-via-this-app

• https://www.sunnewsonline.com/covid-19-vaccine-one-death-recorded-due-to-wrong-drug-combination/

South Africa:

• SAHPRA created a dedicated microsite for the App: https://medsafety.sahpra.org.za/

• SAHPRA YouTube videos promoting the App: 

  • Med Safety App Promo Video

  • How to Use the Med Safety App

  • Navigation Video

  • National News Interview about the Med Safety App

  • SAHPRA Facebook post promoting the South African population to download and use the Med Safety App: https://web.facebook.com/watch/?v=470660154011672

Press article covering how to use the Med Safety App: https://www.news24.com/health24/medical/infectious-diseases/coronavirus/app-allows-users-to-report-adverse-effects-from-medicines-including-covid-19-vaccines-20210422

The following updates are planned for the Med Safety App and/or Vigilance Hub:

• Near the end of 2021, the data standard for the Vigilance Hub will be upgraded from ICH E2B(R2) to ICH E2B(R3).

• In early 2022, an upgrade to the Vigilance Hub will enable users to attach files such as case investigation forms to cases stored in the system.

This list will be updated as updates are completed, or as additional updates are planned. For questions or further information on planned upgrades, please email WEB-RADR.