Medical products regulator the South African Health Products Regulatory Authority (Sahpra) has launched the Med Safety mobile app for self-reporting of suspected adverse drug reactions (ADRs) by the public and healthcare professionals, it said on April 22.
The app is designed to simplify and promote the reporting of suspected ADRs, including adverse events following immunisation (AEFIs) by the public and healthcare providers.
The regulator is using the 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 app is to contribute to the understanding of marketed medicines' safety profiles. This includes that of Covid-19 vaccines, it said.
"Sahpra is committed to the protection of the reported information. The app only collects the minimum required personal information that will inform clinical decision-making, and detailed in the privacy statement contained in the app," the authority said.
“In an era where mobile technology is predominant, this application will be a huge benefit to 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,” said Sahpra CEO Dr Boitumelo Semete-Makokotlela.
Pharmacovigilance, also known as medicine safety, is the pharmacological science relating to the collection, detection, assessment, monitoring and prevention of adverse effects of pharmaceutical products.
The Med Safety app was developed by European Union-based WEB-Recognising Adverse Drug Reactions, or WEB-RADR, which is a project dedicated to developing and evaluating digital tools to support pharmacovigilance activities.