In 2019, the Norwegian Medicines Agency (NoMA) received approximately 5,100 individual case safety reports (ICSRs) of adverse drug reactions from healthcare professionals and patients directly or via marketing authorisation holders (MAHs) in the national database for adverse drug reactions. The reports we receive from healthcare personnel are assessed by scientific staff at four regional pharmacovigilance centres, who also provide individual feedback to the reporter; the Norwegian Institute of Public Health assesses reports related to vaccines; and NoMA handles reports received directly from patients or caregivers. NoMA is also responsible for national signal detection.
Back in October 2017, NoMA implemented a new system for handling ICSRs. This was “off-the-shelf” software from an external contractor, and the original procurement included a module for signal detection and management. During implementation of the new system, NoMA encountered unexpected challenges related to that signal module.
Pernille Harg. Photo: NoMA
“Most signal detection tools are developed and customised for use by the pharmaceutical industry, and consequently these tools are not tailored for the needs of national competent authorities such as NoMA,” said Pernille Harg, senior pharmacovigilance adviser at NoMA.
“The most important difference is that MAHs only monitor a limited number of proprietary products, whereas national competent authorities monitor all drugs marketed or used nationally. In essence, the signal module provided for our software was designed to monitor a limited number of drugs – and was not suitable for monitoring the thousands of drugs on our market. This difference was particularly evident as challenges in interface, performance time, and workflow,” Harg said.
NoMA concluded that the signal module would need significant changes to be suitable for our purpose and, therefore, decided to look into alternative tools, particularly VigiLyze. Since VigiLyze is free of charge for national pharmacovigilance centres in member nations of the WHO Programme for International Drug Monitoring, there was no need for procurement or large investments. NoMA contacted UMC and was immediately included in the ongoing process of enhancing VigiLyze functionality. This positive and productive collaboration contributed to the new VigiLyze interface, and NoMA has used VigiLyze as its main signalling tool since 2019.
Gunnar Rimul. Photo: NoMA
“VigiLyze allows for a streamlined signal detection process and makes our internal process far more efficient,” said Gunnar Rimul, senior pharmacovigilance adviser of at NoMA.
“Analysis is performed without delay in a user friendly and impressively intuitive interface where it is easy to keep track of filters and data sets.”
VigiLyze’s features – such as analysing in both national and global datasets, along with the possibility to share work, not only with coworkers, but also with other national pharmacovigilance centres – give boundless possibilities for collaboration across borders in signal detection. Therefore, NoMA hopes that other national pharmacovigilance centres and competent authorities join us in the VigiLyze community, fulfilling its potential, and making signal detection easy.
