SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals

22 April 2021

SAHPRA is pleased to announce the launch of the Med Safety App. The Med Safety App is a mobile application (App) that is designed to simplify and promote the reporting of suspected adverse drug reactions (ADRs), including adverse events following immunisation (AEFIs) by both the public and healthcare providers. The App also allows the public and healthcare providers to learn about medicine safety news from SAHPRA, thereby creating an awareness of medicines; their potential adverse effects and pharmacovigilance.

Pharmacovigilance, also known as medicine safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

The Med Safety App is developed by WEB-Recognising Adverse Drug Reactions (WEB-RADR), which is a European Union-based project dedicated to developing and evaluating digital tools to support pharmacovigilance activities. The App is compatible with the latest iOS and Android operating systems.

SAHPRA is utilising this App as one of its strategies to improve the reporting of adverse effects of medicines and vaccines, thereby promoting pharmacovigilance and medicine safety in South Africa.

The purpose of the data reported through the Med Safety App is to contribute to the understanding of medicines’ safety profiles of marketed medicines, including that of COVID-19 vaccines.

SAHPRA is committed to the protection of the reporters’ information. The app only collects the minimum required personal information that will inform clinical decision making. More details can be found on the privacy statement contained in the App. Reporters would have to read and acknowledge the privacy statement before submitting a report.

The App has the following benefits:

  • It facilitates simple and convenient reporting of ADRs by the public and healthcare practitioners.
  • It provides a readily available platform to reporters for feedback about their submitted report
  • Users are able to create a “watch list” to follow medicines of interest, which enables them to view information that is relevant to them.
  • The App will only be available in English at this point. Soon the user will have the option of to choose a language of choice.
  • It enables the following activities related to ADR reporting:
    • Storage of incomplete and un-submitted reports in the user’s device.
    • Saving of an unfinished report for completion at a later time
    • Generation and sending of an email to the user to acknowledge the submitted report

“In an era where mobile technology is predominant, this application will be a huge benefit for all South Africans who encounter ADRs. The App allows for seamless reporting of all ADRs and AEFIs related to COVID-19 vaccines and will accelerate how SAHPRA manages the reports,” indicates Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA.

For details of the app, please click the button below

Med Safety App