SAFETY REPORTING VIA THE MED SAFETY APP, INCLUDING AEFIs

The Med Safety App offers a low-cost and electronic approach for data collection and viewing of Adverse Drug Reaction (ADR) data as well as the sharing of safety communications. 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. Ethiopia, Ghana and Nigeria already had the Med Safety app in place for medicines reporting but the AU-3S team supported SAHPRA in obtaining and launching the app in South Africa.

The AU-3S team has developed and launched a vaccine-specific reporting form for the Med Safety App based on the WHO core variables for AEFI reporting. This is designed to replace paper forms with the aim of supporting countries to collect AEFI reports from vaccines more efficiently and timeously.  It provides real time visibility of the AEFIs being reported to both the EPI programme and the regulatory authority and ensures that all data required for causality assessments is readily available.  This form can be used to report an AEFI for any vaccine that the country has approved for use.

The AU-3S programme is assisting countries to use the high profile of COVID-19 vaccines to raise awareness of the Med Safety App in general to ensure it is well-utilised for electronic reporting for both medicines and vaccines and has been working with the local communications teams to support the development of communications plans and the production of content. The team has produced the following video for use by the countries, mainly on social media, as a short overview of the Med Safety App:

A more detailed video for how to efficiently navigate the app can also be accessed below: