The South African Health Products Regulatory Authority (SAHPRA), an entity of the National Department of Health, has introduced a mobile app to simplify and promote the reporting of suspected adverse drug reactions (ADRs), including any adverse effects experienced following immunisation (AEFIs).
SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products and clinical trials in SA.
According to a statement, the Med Safety App is developed by WEB-Recognising Adverse Drug Reactions, 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.
It also allows the public and healthcare providers to learn about medicine safety from SAHPRA, 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.
SAHPRA says it is utilising the app as one of its strategies to improve the reporting of adverse effects of medicines and vaccines, thereby promoting pharmacovigilance and medicine safety among South Africans.
“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,” says Dr Boitumelo Semete-Makokotlela, CEO of SAHPRA.
The purpose of the data reported through the Med Safety App is to contribute to the understanding of the safety profiles of marketed medicines, including that of COVID-19 vaccines, according to the health organisation.
SAHPRA says it is committed to the protection of users’ information – the app only collects the minimum required personal information that will inform clinical decision-making. More details can be found in the privacy statement contained in the app.
The app will only be available in English at this point; however, the user will soon have the option to choose a language of choice.
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 / users 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.
* It enables the following activities related to ADR reporting:
- Storage of incomplete and unsubmitted reports in the user’s device.
- Saving of an unfinished report for completion at a later time.
- Generation and sending of an e-mail to the user to acknowledge the submitted report.
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