FDA presents First Phase findings of Implementation Research on the Med Safety App to Stakeholders

The Food and Drugs Authority (FDA), Work Package 4 of the SAVING (Sustainable Access and Delivery of New Vaccines in Ghana), Consortium has held a stakeholder meeting to present findings on Implementation Research (IR) conducted to identify factors contributing to the low uptake of the Med Safety App.

The Med Safety App is a mobile app that can be downloaded free of charge from Google Play and the App Store for Android and iOS devices respectively.  The app is used to report adverse reactions (side effects) of medicines, vaccines, and other medicinal products to the FDA.

The objectives of the stakeholders’ meeting were two-fold:

First, share the results from the Phase 1 implementation research on the Med Safety App and second, work with the stakeholders to identify key interventions to be incorporated into Phase 2 of the implementation research to improve the usage of the Med Safety App.

To make it easier for patients or consumers and healthcare professionals to report adverse reactions to drugs, vaccinations, and other medicinal products, the FDA launched the Med Safety Mobile App in 2019.The app among other things, provides users with safety information and allows them to create their own watch list to receive personalized product-specific news.

In a speech read on behalf of the Chief Executive Officer of FDA, Dr. Delese Darko, by Mr. Seth Seaneke, the Deputy Chief Executive Officer (DCEO) of Health Products and Technologies Division at FDA underscored the significance of the occasion and reiterated FDA’s commitment to ensuring the safety and efficacy of medicines on the Ghanaian market. The Chief Executive officer expressed gratitude for the efforts of the SAVING Consortium in building the capacities of not just the FDA staff but multiple stakeholders in identifying and addressing implementation challenges and the invaluable contributions of all stakeholders present towards the utilization of the Med Safety App. She stated that, “today’s meeting is not just about sharing results; but also, to chart innovative ways forward that will enhance the utility of the Med Safety App and potentially transform medication safety in Ghana and globally.”

Presenting the phase 1 findings of the study, which was conducted using a mixed approach, Mrs. Adela Ashie of the Safety Monitoring Department of the FDA stated some of the key bottlenecks to the use of the app to include the inability to operate the App, log-in and internet challenges and the App not providing reminders or notifications when news items are posted.

Participants engaged in group discussions to deliberate on strategies to address the bottlenecks identified from the phase 1 study.

Professor David Ofori-Adjei, a renowned Ghanaian physician, medical researcher, academic, and medical journal editor who chaired the meeting in his closing remarks, emphasized on the importance of stakeholder engagements and assured stakeholders that their recommended strategies would go a long way in improving the use of the app.

The engagement had representations from healthcare professionals, patient groups, public health programs, other regulatory authorities such as South African Health Products Regulatory Authority and Medicines and Healthcare products Regulatory Agency, UK as well as representatives from United Nations Development Program, World Health Organization, Access and Delivery Program, and AUDA NEPAD’s African Union Smart Safety Surveillance program.

The SAVING Consortium project builds on the framework of the Access and Delivery Partnership value chain and stresses on the importance of an efficient regulatory control systems using Implementation Research (IR) to build technical and IR capacities in its partner institutions, namely- the University of Health and Allied Sciences, Ministry of Health and the FDA.