No time to read now?
-> Download the article as a handy pdf
List of contents
Why is France reporting so many deaths caused by adverse drug reactions?
Investigating the roots of a startling deviation
Martti Ahtola | Apr 7, 2022
Eurostat data
We wanted to follow up on this and tried to find out why the numbers in France are so much higher than in other countries. Is there a difference in how the causes of death are determined, are the French using medicinal products more frequently, are they using those medicinal products incorrectly?
The Eurostat information shows that a little over 800 deaths are caused by ADRs in Europe with more than 500 of those originating in France, per year.
Deaths reported to be caused by ADRs – France and rest of the EU countries
Compared to similar-sized neighbouring countries Germany and Italy, there are 5-10 times more fatal reports in France.
Deaths reported to have been caused by adverse events – detailed table (2010-18)
This stands out even more when looking at the number of ICSRs reported to EudraVigilance. There are fewer reports of adverse events coming from France than Germany and only slightly more than from Italy.
Number of ICSRs per country (www.adrreports.eu)
ANSM and French colleagues
We performed search on Google and medical literature databases for more information but with no luck. We could not find anything related to this. So, we decided to do our own grass-root research and contacted ANSM on 19th October 2021 (and still haven’t heard back from them). While waiting for response from ANSM, we contacted a few French pharmacovigilance colleagues and ANSM again through another email address in December 2021
The French colleagues seemed surprised by these numbers. None of them had heard about this before. Unfortunately, they were not able to provide any insights into the topic, which seems completely understandable as there is very little reliable information about fatal ADRs per country and apparently no deeper analysis about the causes and differences between countries.
First research steps did not bring any new information
Contacting Insee
We contacted Insee in January 2022. Insee is the French National Institute of Statistics and Economic Studies. Their website provided the following information: “All events concerning the civil register should be covered by an act drawn up in line with very precise rules, in a special format, by a person invested with the functions of civil registrar. Each municipality has its own registry service. The mayor is the legal civil registrar. The registrar must record all events which occur in his municipality (births, deaths, marriages).” Insee responded very quickly and informed us that they do not produce data on causes of death and only record the total number of deaths reported by the municipalities. They directed us to CépiDc who produces data on medical causes of death in France.A tool managed by CépiDc
According to CépiDc website the “data from the declaration and coding of causes of death have been collected officially and regularly in France since 1968. You can access data on medical causes of death in France via the tool managed by CépiDc. The tool lists data since the year 1980.”
Communication with Insee and CépiDc also did not lead to much progress
Waiting for the reply
We contacted CépiDc on 21st of January 2022 and quickly got the initial response. However, the initial response was just advising us to use either the French tool or the Eurostat tool. Trying to get more information about the background and root-cause lead to no response. So, thus far we have not been able to come up with any reason for the higher number of deaths caused by ADRs in France, but we hope to receive more information from CépiDc or one of the readers of this blog. We will make sure to follow up on this as soon as we have more data. Right now, we can just ponder where the reasons for this discrepancy lie.Did you like the article? Share with your network!
…or tell us your opinion.
Follow our newsletter!
Keep up with industry trends and get interesting reads like this one 1x per month into your inbox.
Learn more about Tepsivo
We deliver modern PV solutions to fulfill your regulatory needs using less resources. See how we do it >
Hi! After a first (quick) read, my first thought was maybe the French are incorporating all fatal AEs (adverse events) rather than ADRs (adverse drug reactions), thus ignoring the causal relationship with medicinal product?