Child overdose: the value of the French pharmacovigilance causality assessment method.
BACKGROUND
In France, the regional pharmacovigilance centres manage drug overdose as adverse drug reactions (ADRs) using the French ADR causality assessment method, and some poison control centres (e.g. in Paris) do likewise for the most serious cases.


OBJECTIVE
The aim of the study was to analyse and compare the chronological and semiological scores calculated with this method, in cases of drug overdose and ADRs in children recorded in the French pharmacovigilance ADR database.


RESULTS
In total, 7963 cases were analysed. The distribution of semiological criteria in drug overdose and ADR cases differed significantly (G-test), with a similar result for chronological criteria (but to a lesser degree).


CONCLUSIONS
The distinction of two types of criteria in the French ADR causality assessment method appears useful for analysing cases of drug overdose in children. This finding triggers a renewed interest in the use of this method of causality assessment of drug overdose in children, and possibly in adults.
Rajab
Mazen
M
Centre Régional de Pharmacovigilance, Hôpital Fernand Widal (AP-HP), Paris, France. pharmacovigilance.fwd@lrb.ap-hop-paris.fr
Lagier
Georges
G
Eftekhari
Pirayeh
P
Ginisty
Sixtine
S
Bazire
Alexandre
A
Garnier
Robert
R
D000367:Age Factors; D002648:Child; D003625:Data Collection; D004347:Drug Interactions; D062787:Drug Overdose / Q000453:epidemiology / Q000517:prevention & control*; D064420:Drug-Related Side Effects and Adverse Reactions; D005602:France / Q000453:epidemiology; D006801:Humans; D011358:Product Surveillance, Postmarketing