I am looking for an answer to the question with specific examples from practical use.
Hi Nabeela,
In the Democratic Republic of Congo, we are setting up a signal detection system that follows a process in 4 steps, using available tools from Uppsala Monitoring Center (UMC):
1) Tracking of potential signal through rumors, media, social media, other PV systems, UMC, WHO, etc.
2) Quantitative analysis of potential signals using VigiLyze (IC 0005 for subgroup countries) and cluster analysis of potential signal using our database from VigiFlow search and statistics.
3) Qualitative analysis (SmPC listedness, literature review, pharmacology, etc.) of potential signals identified as needing further attention
4) Escalation to national pharmacovigilance committee for decision making
We will also be happy to learn from other countries experience.
Kind Regards,
Didier
Thank you Didier. Could you provide any specific example for better understanding and use of statistics in detecting a strong and weak signal
Hi Nabeela,
PV-Analyzer - Signal Detection and Analysis Software.
Signals arising from spontaneous reports also could be detected via:
Monitoring large adverse drug reaction databases such as Eudravigilance and the FDA AERs system Published articles PSURs Ongoing benefit-risk monitoring.
Some information also available at
https://www.diaglobal.org/productfiles/22993/day%202/303/s303%2005_wayne%20kubick.pdf
Looking at statistical signals are important but might not be relevant to countries with small databases. Thus, in Eritrea we do weekly case-by-case assessment of individual case safety reports. We do this in collaboration with our Volunteer Pharmacovigilance Medical Officers. Once, we identified a potential safety signal during the assessment, we assign staff to work on it.
As mentioned by Didier, we first need to check if the adverse event of ineterest is not documented, if we are working with a new ADR, by looking at the SPC of the product in the reputable webpages like USFDA, MHRA, EMA and so on. Moreover, we try to do exhaustive literature review to check labeledness. Once, we confirm that the adverse event is undocumented or incompletely documented, we do search on Vigiflow and Vigilyze (VigiBase) to see if there are similar reports. It is at this stage, where we try to see if there is a statistical signal as well (IC value). But, if you simply wait to see statistical signals, which are not a true signal, you will miss several important safety issues and/or may take you time to identify it.
We then try to export the cases to excel spread sheet and do cases series assessment using Austin Brad-Ford-Hill Criteria. For countries with small databases, we found this as a best practice we are able to identify dozens of safety signals only in the last three years. By doing this, we identified many safety signals triggered by one case report submitted to the Eritrean Pharmacovigilance Centre.
I would be very much interested to hear thoughts from other countries too.
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