App allows users to report adverse effects from medicines, including Covid-19 vaccines

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  • Sahpra has launched a free app available to iOS and Android users
  • It will allow users to report adverse effects to hundreds of medicines and therapies, including the Covid-19 vaccine
  • More than 10 000 people have already downloaded the app

The South African Health Products Regulatory Authority (Sahpra) has launched a free mobile-based application that allows individuals to report any adverse side effects to several medicines and therapies, including the Covid-19 vaccines.  

Named the Med Safety App, it offers the following features:

  • Report adverse drug reactions (ADRs)
  • Report adverse events following Covid immunisation (AEFIs)
  • Learn about medicine safety news from Sahpra
  • View numbers of reports received in the World Health Organization (WHO) database of suspected ADRs
  • Receive official, personalised news and alerts about medicines you are taking or interested in via the “watch list” feature

In a statement released on Thursday, the regulatory body said the app will help to create awareness of various medicines, their potential adverse effects, and pharmacovigilance. Pharmacovigilance refers to the practice of monitoring the effects of medicines registered for use.

What are adverse events?

Adverse events, or adverse side effects, refers to any unexpected medical problems that arise when one has taken a medical drug or other therapy, such as a vaccine.

Professor Linda-Gail Bekker, co-lead investigator of South Africa's Sisonke Covid vaccine trial, previously told Health24 that in the case of the J&J vaccine, there have been a very small number reports of adverse events seen in people who received the jab, including severe allergic reactions.

Up to five of those individuals were admitted to hospital, “more for observation and precaution than anything else”, Bekker explained. All five patients recovered and are doing well, she added.

Compatible with iOS and Android

The Med Safety App is compatible with the latest iOS (minimum version 8) and Android operating systems (minimum version 3.0). 

It was developed by WEB-Recognising Adverse Drug Reactions (WEB-RADR), a European Union-based project dedicated to developing and evaluating digital tools to support pharmacovigilance activities.

“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,” the website explains.

How to use the app

Currently, the app is only available in English. According to Sahpra, users will soon have the option of choosing a language of their choice. 

The app can be downloaded from the Google Play or App Store.

Med Safety
The Med Safety App by Sahpra.

When the download is complete, it will require you to select your region. 

You will then have to log in using your email address and password. If you do not have an account, you can create one or simply continue as a guest.

The “News” tab will display a list of news articles that you can click on to read in detail.

Under “Products”, you can search for the drug you are interested in reporting on. For example, typing in “Covid” under the search bar will display two results: the Covid-19 vaccine NRVV Ad (ChAdOx1 nCoV-19), which is the Oxford-AstraZeneca vaccine that is no longer available in South Africa, and the Ad26.COV2.S Covid-19 vaccine, which is the Johnson & Johnson vaccine that’s available in the country.

Med Safety
The MedSafety App by Sahpra.

Once you click on the specific product, it will give you the option to add it to your watch list, report a side effect, or read any news articles related to it. 

For further instructions, watch the video below. 

Why does it matter?

Medicines are developed to be as safe and effective as possible, but they can still cause side effects, explains the app. Reporting adverse effects to medicines can be used to identify previously unknown issues with those medicines and helps professionals to identify and investigate unknown or poorly described adverse effects, it adds.

“In an era where mobile technology is predominant, this application will be a huge benefit for all South Africans who encounter ADRs,” said Boitumelo Semete-Makokotlela, CEO of Sahpra.

“The App allows for seamless reporting of all ADRs and AEFIs related to Covid-19 vaccines and will accelerate how Sahpra manages the reports,” she explained.

*For more Covid-19 research, science and news, click here. You can also sign up for our Daily Dose newsletter here.

READ | Vaccine side effects are not uncommon - so, with J&J's jab: What are they, who gets them, and why?

READ | J&J Covid-19 vaccine: Are blood clots and the pausing of SA’s rollout a cause for major concern?

READ | OPINION | Johnson & Johnson vaccine suspension – what this means for you

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