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Drug Safety
Published in: Drug Safety 10/2012

01-10-2012 | Original Research Article

First French Experience of ADR Reporting by Patients After a Mass Immunization Campaign with Influenza A (H1N1) Pandemic Vaccines

A Comparison of Reports Submitted by Patients and Healthcare Professionals

Authors: Dr Geneviéve Durrieu, Aurore Palmaro, Laure Pourcel, Céline Caillet, Angeline Faucher, Alexis Jacquet, Shéhérazade Ouaret, Marie Christine Perault-Pochat, Carmen Kreft-Jais, Anne Castot, Maryse Lapeyre-Mestre, Jean-Louis Montastruc, French Network of Pharmacovigilance Centres

Published in: Drug Safety | Issue 10/2012

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Abstract

Background: Available data concerning the contribution of patient adverse drug reaction (ADR) reporting in practice are scarce. Few studies have compared patients’ reports with reports from healthcare professionals (HCPs). During the 2009–10 mass immunization campaign with A (H1N1)v2009 pandemic influenza vaccines, a reinforced pharmacovigilance plan was introduced in France according to European Medicines Agency recommendations. For the first time, patients were offered the opportunity to report suspected ADRs to pandemic vaccines directly to regional pharmacovigilance centres.
Objective: The aim of the study was to compare the characteristics of patient and HCP ADR reports in order to assess the qualitative and quantitative contribution of patient reporting to the French Pharmacovigilance System.
Methods: All spontaneous ADRs registered into the French Pharmacovigilance Database from 21 October 2009 to 15 June 2010, in which either one of the most frequently administered pandemic vaccines (i.e. Panenza® or Pandemrix®) was involved, were analysed. ADRs were classified as ‘serious’, ‘medically serious’ and ‘non-serious’. This study focused on ‘serious’ and ‘medically serious’ ADRs. An ADR was ranked as ‘medically serious’ when it required medical intervention or hospitalization within less than 24 hours. In each level of seriousness, frequency of ‘unlabelled’ ADRs, ADRs of ‘special interest’, imputability scores and category of ADRs according to Medical Dictionary for Regulatory Activitives (MedDRA®) primary System Organ Class were compared between patient and professional reports.
Results: Among the 4746 reports received during the study period, 1006 (21.2%) originated from patients. HCPs reported significantly more ‘medically serious’ or ‘serious’ ADRs than patients (15.1% [565/3740] vs 8.4% [85/1006], respectively; p < 0.001). No difference was found in ‘unlabelled, serious’ ADRs between patients and HCPs (56.5% [n= 13] vs 56.7% [n= 136], respectively).
Conclusions: In this first French experience of formal patient participation to ADR reporting, patient contribution to the total number of ADRs reached 21.2%. This study revealed no major qualitative difference between patient and HCP reports. ADR profiles reported by patients appeared to be consistent with those from professionals. Further investigations are necessary to assess the intrinsic quality of notification forms coming from non-professional reporters. However, this study is of particular interest in the context of publication of the first governmental decree that will formally integrate patient participation to the current French ADR reporting scheme.
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Arr eté du 10 juin 2011 pris pour l’application des articles R. 5121-154, R 5121-167 et R. 5121-179 du code de la santé publique et relatif aux modalités de signalement des événements indésirables par les patients et les associations agréées de patients
Metadata
Title
First French Experience of ADR Reporting by Patients After a Mass Immunization Campaign with Influenza A (H1N1) Pandemic Vaccines
A Comparison of Reports Submitted by Patients and Healthcare Professionals
Authors
Dr Geneviéve Durrieu
Aurore Palmaro
Laure Pourcel
Céline Caillet
Angeline Faucher
Alexis Jacquet
Shéhérazade Ouaret
Marie Christine Perault-Pochat
Carmen Kreft-Jais
Anne Castot
Maryse Lapeyre-Mestre
Jean-Louis Montastruc
French Network of Pharmacovigilance Centres
Publication date
01-10-2012
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 10/2012
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.1007/BF03261980

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