Data is the currency of science, and researchers always want more. But it’s a mistake to think that huge data sets are a prerequisite to effective pharmacovigilance. In fact, in their quest for improved patient safety, national pharmacovigilance centres are able to perform significant signal detection work, even with relatively small data sets.
A new handbook by UMC is now available to help pharmacovigilance professionals make the most of the data available to them.
Signal Detection for National Pharmacovigilance Centres with Small Data Sets is a free publication that sets out to provide concise, structured guidance for signal management, primarily in national centres with small databases and limited resources.
For many national centres, the number of individual case safety reports (ICSRs) is relatively small, and the range of medicinal products and the event profiles may be unique to each location.
“The challenge for staff in these centres is to employ a structured manual method to process available data and to reliably discover potential safety issues,” says Pia Caduff-Janosa, chief medical officer at UMC, who co-authored the publication with Ambrose Isah of University of Benin.
To address that problem, the guidebook provides a clear, 10 step process primarily focused on qualitative signal detection methods, describing a workflow that takes pharmacovigilance professionals all the way from identifying potential signals, through case building, analysis and evaluation, actions, and communication.