Graeme Nadasy
Communications Officer & Editor, UMC
Today, over 100 members of the WHO Programme for International Drug Monitoring use VigiFlow and its connected applications to ensure the safety of medicines and vaccines. Now, all programme members will be able to use it for free.
The news aligns with UMC’s new vision of ensuring the safer use of medicines and vaccines for everyone, everywhere by supporting programme members in developing, implementing, and strengthening national safety surveillance programmes, and providing solutions for the secure exchange and global use of pharmacovigilance data.
Mirroring how pharmacovigilance is organised in a country, VigiFlow gives national regulatory authorities full oversight of safety issues with medicines and vaccines so that problems can be dealt with quickly and appropriate action taken if necessary.
In VigiFlow, they can consolidate safety data from various reporters into a single, unified national database through multiple data entry applications. These include:
- Connected web and mobile applications that simplify online reporting of suspected side effects to medicines and vaccines by the public and health workers.
- Marketing authorisation holders can use the industry e-reporting module to upload ICH E2B-compliant XML files or manually enter reports if they are not E2B ready.
- Safety data can be transferred from other systems, such as DHIS2, ODK Collect, and the Med Safety app, using the international E2B standard.
Additionally, VigiFlow offers several key features to enhance efficiency and data quality:
- Automated workflows streamline processes and maximise efficiency, with cases automatically routed to appropriate organisations for processing and evaluation.
- International standards for coding and structuring data are fully integrated across all applications, harmonising and improving the quality and usability of data for analysis.
- One-click sharing to VigiBase, the WHO global database of adverse event reports, allows national regulatory authorities to benefit from global insights while at the same time enriching the global database with their own data.
“By offering VigiFlow at no cost, we are strengthening all members’ capacity to effectively monitor the safety of medicines and vaccines,” says Pinelopi Lundquist, head of UMC’s WHO Liaison department which coordinates the programme’s activities with WHO. “This initiative reflects our commitment to both supporting national efforts and enhancing global pharmacovigilance.”
Read about Botswana, Colombia, and South Africa’s experience with VigiFlow in the VigiVerse Deep Dives page of Uppsala Reports.