The Food and Drugs Authority (FDA), the Consortium’s lead institution for Work Package 4 (WP4), held an internal stakeholder engagement on Tuesday 8 February 2022, to engage the stakeholders on their views and opinions on the low uptake of the Med Safety App and elicit practical suggestions on how to increase patronage of the App in order to improve its utility among Ghanaians. This engagement had representations from various Departments and Divisions of the FDA.
Dr. Edwin Nkansah, Acting Director for Safety Monitoring and Clinical Trials Directorate, read opening remarks on behalf of Mr. Seth Seaneke, Deputy Chief Executive for Health Products and Technologies, which emphasised that, as a critical healthcare intervention to support pharmacovigilance in Ghana, the App has several benefits, including: ease of reporting adverse reactions; receiving immediate response for adverse reactions reported; and enabling users to create their own watchlist for particular medicines of interest; the App also provides regular news updates and can be accessed even when offline.
Mrs. Adela Ashie and Mrs. Abena Asamoa-Amoakohene of the Safety Monitoring Department, delivered presentations on the background to the FDA’s Safety Monitoring System and the Impact of the Med Safety App since its introduction, respectively.
FDA has had several years of experience in monitoring the safety of medicines, vaccines and other health products. The Authority has effectively coordinated the introduction of new vaccines including the pneumococcal/rotavirus vaccines, measles rubella and the ongoing Malaria Vaccine Pilot Implementation Program, which has gone on for close to two years without major safety concerns. The FDA is also a Regional Centre of Regulatory Excellence (RCORE). Its Safety Monitoring Department serves as a training center for regulators from other African Countries.
FDA rolled out the Med Safety Mobile App to encourage reporting of harmful, unexpected side effects of health products, including medicines and vaccines, by consumers, patients and health care professionals. The app also provides users with safety information and allows them to create their own watch list to receive personalized product-specific news. Also, FDA launched a project dubbed “Take Back Unwanted Medicine from Consumers” (TBUM) which is aimed to take back unused and expired medicines from consumers and dispose them off safely as enshrined in the Public Health Act 2012, Act 851.
Mr. George Sabblah, Head Safety Monitoring Department, led a focus group discussion that engaged stakeholders on their views, opinions and recommendations on how the use of the Med Safety App could be improved to gain more traction across the country. Next steps for implementation were also discussed.
WP4 subsequently participated in the Consortium’s IR workshop organized by WP2 from February 14 to 18, where one of the aims was to identify and address gaps in health interventions. Following that workshop, WP4 will be conducting IR to explore the possible challenges with the uptake of the mobile app and the TBUM initiative.