South Africa’s pharmacovigilance system has come a long way since the country became a member of the WHO Programme for International Drug Monitoring (WHO PIDM) in 1992. The National Adverse Drug Event Monitoring Centre, which was established in 1987, became part of the South African Health Products Regulatory Authority (SAHPRA), then called Medicine Control Council (MCC), in 2015. At the same time, SAHPRA started using VigiFlow for safety surveillance. The switch not only helped them meet the international standards for medicines safety reporting but also made it easier to share data with VigiBase, the WHO global database of adverse event reports for medicines and vaccines, a requirement of WHO PIDM membership.
What is VigiFlow?
VigiFlow is a fully ICH-compliant national safety surveillance system for collecting, managing, analysing, and sharing adverse event data. It features integrated applications for medicine and vaccine adverse event reporting; built-in coding to standard medical terminologies such as WHODrug Global and MedDRA; automated workflow support; and interoperability with other data collection systems based on ICH E2B standards.
South Africa’s pharmacovigilance system is the product of nearly a decade of development, which, according to Victoria Sekiti, would not have been possible without VigiFlow. “Without VigiFlow we would not have been able to decentralise data collection and management, as well as harmonise and coordinate the many different pharmacovigilance efforts in our country.”
Today, South Africa has a decentralised pharmacovigilance system which has grown to accommodate disease-specific programmes and immunisation programmes that are also required to report to SAHPRA. In this setup, data are managed at national and subnational levels (province, district, and health facility). Each programme and level of the overall pharmacovigilance system remain autonomous – organisational units have access to their own data as well as any data from sub-organisations – with SAPHRA having oversight nationally. “By using the same system [VigiFlow], all healthcare practitioners at various levels of monitoring can view their data and make informed decisions,” Sekiti says.
As South Africa’s pharmacovigilance system has continued to evolve, so too has VigiFlow. “The flexibility and customisability of VigiFlow means it can be adapted to our unique needs,” Sekiti says. “VigiFlow connects our pharmacovigilance efforts, providing a platform for effective and secure information sharing between different pharmacovigilance programmes and SAHPRA, and SAHPRA and VigiBase. It also prevents data leakage that can occur when sending data via other channels like paper and email.”
Data sharing is further supported by the interoperability of VigiFlow with other systems that use the E2B standard. During the pandemic, this allowed reports of possible side effects from vaccines submitted by patients and health workers through the Med Safety App to be integrated into VigiFlow, allowing SAHPRA to work with reports as they appeared in the national database. They were then able to share this data with VigiBase and, using UMC’s signal detection and signal management application, VigiLyze, compare their national data with global insights.
What advice would you give to other national pharmacovigilance centres just starting with VigiFlow?
“Make it work for you! Every pharmacovigilance system is different, so don’t be afraid to adapt it in even in the smallest way to meet your specific needs. And remember UMC is always there to help you.”
SAPHRA has benefited from both ongoing technical support and skills training, Sekiti adds. “UMC has always been quick to respond to our requests. From adapting VigiFlow to support data entry at the facility level to assisting with data mapping where necessary, especially data sharing with systems that are not E2B compatible. The online courses UMC offers have also made it easier to train new staff.”