{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,2]],"date-time":"2025-10-02T13:26:25Z","timestamp":1759411585787},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2012,12,5]],"date-time":"2012-12-05T00:00:00Z","timestamp":1354665600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2013,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:sec><jats:title>Introduction<\/jats:title><jats:p>As of January 2006, the BCG vaccine SSI\u00ae became the only BCG vaccine available for tuberculosis vaccination in France. The use of this vaccine led to significant changes in vaccination technique which were accompanied by a rapid increase in the number of adverse reactions (ADRs) reported. A national pharmacovigilance follow\u2010up began in February 2006, and a risk management plan (RMP) was put in place in April 2006, made of three phases (carried out in June 2006, July 2006 and September 2006) with risk minimisation measures.<\/jats:p><jats:p>The goal of this study was to evaluate the impact of the RMP on the amount of ADRs reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Based on data collected by the regional pharmacovigilance centres and the MSD laboratory, the cases of locoregional ADRs spontaneously reported were analysed retrospectively from January 2005 to February 2006, and then prospectively up to June 2008, the date at which the national follow\u2010up ended. The locoregional ADRs were divided into three categories: abscesses, local reactions or lymphadenopathy of more than 1 cm and suppurative lymphadenopathy. A parallel was then drawn between these data and the different phases of the RMP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During the entire follow\u2010up period, we note 1050 locoregional ADRs, of which 764 were abscesses (73% of all cases), 266 were local reactions and 20 involved suppurative lymphadenopathy.Locoregional ADRs increased rapidly from January 2006 onward, reaching a peak in August 006 and then falling and stabilising from December 2007 onward.The RMP was implemented when there was an increase in the number of ADRs reported. The drop in the number of these effects began 3 months after the first phase and 2 months after the second phase of the RMP. The third phase was not accompanied by a variation in the number of ADRs reported.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The RMP appears to have positive effect on the evolution of the number of ADRs, their decrease occurring rapidly after the risk minimisation measures of the first two phases. Nonetheless, these data should be confirmed by other studies on the efficacy of RMPs. Copyright \u00a9 2012 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.3383","type":"journal-article","created":{"date-parts":[[2012,12,5]],"date-time":"2012-12-05T20:49:20Z","timestamp":1354740560000},"page":"359-364","source":"Crossref","is-referenced-by-count":10,"title":["Complications of BCG vaccine SSI\u00ae recent story and risk management plan: the French experience"],"prefix":"10.1002","volume":"22","author":[{"given":"Christelle","family":"Chol","sequence":"first","affiliation":[{"name":"Department of Dermatology CHU de Saint Etienne (Saint Etienne University Hospital)  Saint Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Claire","family":"Guy","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance CHU de Saint Etienne (Saint Etienne University Hospital)  Saint Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexis","family":"Jacquet","sequence":"additional","affiliation":[{"name":"Agence fran\u00e7aise de s\u00e9curit\u00e9 sanitaire et des produits de sant\u00e9 (French Health Products Safety Agency)  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Castot\u2010Villepelet","sequence":"additional","affiliation":[{"name":"Public Health Regional Agency  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carmen","family":"Kreft\u2010Jais","sequence":"additional","affiliation":[{"name":"INPES (National institute of prevention and health education)  Paris France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fr\u00e9d\u00e9ric","family":"Cambazard","sequence":"additional","affiliation":[{"name":"Department of Dermatology CHU de Saint Etienne (Saint Etienne University Hospital)  Saint Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marie\u2010Noelle","family":"Beyens","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance CHU de Saint Etienne (Saint Etienne University Hospital)  Saint Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Genevi\u00e8ve","family":"Mounier","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance CHU de Saint Etienne (Saint Etienne University Hospital)  Saint Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fakhria","family":"Marsille","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance CHU de Saint Etienne (Saint Etienne University Hospital)  Saint Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick","family":"Mismetti","sequence":"additional","affiliation":[{"name":"Department of Pharmacovigilance CHU de Saint Etienne (Saint Etienne University Hospital)  Saint Etienne France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,12,5]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicaments et des produits de Sant\u00e9 (ANSM).M\u00e9dicaments faisant l'objet d'un Plan de Gestion des Risques;2012. Available from URL:http:\/\/ansm.sante.fr\/Activites\/Surveillance\u2010des\u2010medicaments\/Medicaments\u2010faisant\u2010l\u2010objet\u2010d\u2010un\u2010plan\u2010de\u2010gestion\u2010des\u2010risques\/(offset)\/3"},{"key":"e_1_2_8_3_1","unstructured":"Agence fran\u00e7aise de s\u00e9curit\u00e9 sanitaire et des produits de sant\u00e9 (French Health Products Safety Agency).Mise au point sur la prise en charge des abc\u00e8s locaux et des ad\u00e9nopathies cons\u00e9cutifs \u00e0 la vaccination BCG (Update on the management of local abscesses and lymphadenopathy resulting from BCG vaccination).2007http:\/\/www.afssaps.fr\/Infos\u2010de\u2010securite\/Mises\u2010au\u2010point\/Prise\u2010en\u2010charge\u2010des\u2010abces\u2010locaux\u2010et\u2010des\u2010adenopathies\u2010consecutifs\u2010a\u2010la\u2010vaccination\u2010BCG\u2010Mise\u2010au\u2010point"},{"key":"e_1_2_8_4_1","unstructured":"Agence fran\u00e7aise de s\u00e9curit\u00e9 sanitaire et des produits de sant\u00e9 (French Health Products Safety Agency).Compte\u2010rendu de la commission nationale de pharmacovigilance du.2006(report of the National Commission of Pharmacovigilance November 28 2006). Available from URL:http:\/\/www.afssaps.fr\/Afssaps\u2010media\/Publications\/Ordres\u2010du\u2010jour\u2010comptes\u2010rendus\u2010de\u2010commissions"},{"key":"e_1_2_8_5_1","unstructured":"Agence de s\u00e9curit\u00e9 sanitaire et des produits de sant\u00e9 (French Health Products Safety Agency).Lettre aux prescripteurs (letter to prescribers) Informations importantes relatives \u00e0 l'utilisation du Vaccin BCG SSI (Important information concerning the use of BCG SSI\u00ae Vaccine). Available from URL:http:\/\/www.afssaps.fr\/Infos\u2010de\u2010securite\/Lettres\u2010aux\u2010professionnels\u2010de\u2010sante\/Informations\u2010importantes\u2010relatives\u2010a\u2010l\u2010utilisation\u2010du\u2010Vaccin\u2010BCG\u2010SSI\/(language)\/fre\u2010FR. [20 July 2006]."},{"key":"e_1_2_8_6_1","unstructured":"Agence de s\u00e9curit\u00e9 sanitaire et des produits de sant\u00e9 (French Health Products Safety Agency) communiqu\u00e9 de presse (press release).Effets ind\u00e9sirables au cours d'une vaccination par le vaccin BCG SSI\u00ae (Adverse effects during a vaccination with BCG SSI \u00ae). Avalaible from URL:http:\/\/www.afssaps.fr\/Infos\u2010de\u2010securite\/Communiques\u2010de\u2010presse\/Effets\u2010indesirables\u2010au\u2010cours\u2010d\u2010une\u2010vaccination\u2010par\u2010le\u2010vaccin\u2010BCG\u2010SSI\u2010R\/(language)\/fre\u2010FR. 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