Complications of BCG vaccine SSI® recent story and risk management plan: The French experience

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 4, 2013, Pages 359-364

  Chol, Christelle ^a   Guy, Claire ^a   Jacquet, Alexis ^b   Castot Villepelet, Anne ^c   Kreft Jais, Carmen ^d   Cambazard, Frédéric ^a   Beyens, Marie Noelle ^a   Mounier, Geneviève ^a   Marsille, Fakhria ^a   Mismetti, Patrick ^a  

^a UNIVERSITY HOSPITAL OF SAINT ETIENNE   (France)

^b Agence francaise de securite sanitaire et des produits de sante French Health Products Safety Agency   (France)

^c Public Health Regional Agency   (France)

^d INPES (National institute of prevention and health education)   (France)

Author keywords

Abscess; BCG SSI vaccine; Pharmacoepidemiology; Risk management plan; Suppurative lymph node

Indexed keywords

BCG VACCINE; SSI; UNCLASSIFIED DRUG;

ABSCESS; ARTICLE; BCG VACCINATION; DRUG INDUCED DISEASE; DRUG SURVEILLANCE PROGRAM; FOLLOW UP; HUMAN; INJECTION SITE ABSCESS; INJECTION SITE ERYTHEMA; INJECTION SITE INDURATION; INJECTION SITE NECROSIS; INJECTION SITE NODULE; INJECTION SITE ULCER; LYMPHADENITIS; PRIORITY JOURNAL; RISK MANAGEMENT; TUBERCULOSIS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; BCG VACCINE; FRANCE; HUMANS; PHARMACOVIGILANCE; RISK MANAGEMENT;

EID: 84875810370     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3383     Document Type: Article

References (29)

1. Agence Nationale de Sécurité du Médicaments et des produits de Santé (ANSM). Médicaments faisant l'objet d'un Plan de Gestion des Risques; 2012. Available from URL: http://ansm.sante.fr/Activites/Surveillance-des-medicaments/Medicaments-faisant-l-objet-d-un-plan-de-gestion-des-risques/(offset)/3
2. Agence française de sécurité sanitaire et des produits de santé (French Health Products Safety Agency). Mise au point sur la prise en charge des abcès locaux et des adénopathies consécutifs à la vaccination BCG (Update on the management of local abscesses and lymphadenopathy resulting from BCG vaccination). 2007 http://www.afssaps.fr/Infos-de-securite/Mises-au-point/Prise-en-charge-des-abces-locaux-et-des-adenopathies-consecutifs-a-la-vaccination-BCG-Mise-au-point
3. Agence française de sécurité sanitaire et des produits de santé (French Health Products Safety Agency). Compte-rendu 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-media/Publications/Ordres-du-jour-comptes-rendus-de-commissions
4. Agence de sécurité sanitaire et des produits de santé (French Health Products Safety Agency). Lettre aux prescripteurs (letter to prescribers), Informations importantes relatives à l'utilisation du Vaccin BCG SSI (Important information concerning the use of BCG SSI® Vaccine). Available from URL: http://www.afssaps.fr/Infos-de-securite/Lettres-aux-professionnels-de-sante/Informations-importantes-relatives-a-l-utilisation-du-Vaccin-BCG-SSI/(language)/fre-FR. [20 July 2006].
5. Agence de sécurité sanitaire et des produits de santé (French Health Products Safety Agency), communiqué de presse (press release). Effets indésirables au cours d'une vaccination par le vaccin BCG SSI® (Adverse effects during a vaccination with BCG SSI ®). Avalaible from URL: http://www.afssaps.fr/Infos-de-securite/Communiques-de-presse/Effets-indesirables-au-cours-d-une-vaccination-par-le-vaccin-BCG-SSI-R/(language)/fre-FR. [20 July 2006].
6. Prakash MJ, Meera K et al. Safety of intradermal Copenhagen 1331 BCG vaccine in neonates in Durban, South Africa. Bull World Health Organ 2001; 79: 337-343.
7. Dommergues MA, De la Rocque F, Guy C et al. Local and regional reactions to BCG-SSI® vaccination: A 12-month cohort follow-up study. Vaccine 2009; 27: 6967-6973.
8. Daoud W. Control of an outbeak of BCG complications in Gaza. Respirology 2003; 8(3): 376-378.
9. Lotte A, Wasz-Hockert O, Poisson N, et al. Second IUATLD study on complications induced by intradermal BCG-vaccination. Bull Int Union Tuberc Lung Dis 1988; 63(2): 47-59.
10. Orwa L, Mahon R, Arthur N, et al. Adverse reactions to the Danish BCG vaccine in Ireland. ESPID 2005, Abst 396.
11. Turnbull FM, McIntyre PB, Achat HM, et al. National study of adverse reactions after vaccination with Bacille Calmette-Guérin. Clin Infect Dis 2002; 34(4): 447-453.
12. Bolger T, O'Connell M, Menon A, et al. Arch Dis Child 2006; 91: 594-597.
13. Romanus V, Fasth A, Tordai P, et al. Adverse reactions in healthy and immunocompromised children under six years of age vaccinated with the Danish BCG vaccine, strain Copenhagen 1331: implications for the vaccination policy in Sweden. Acta Paediatr 1993; 82: 1043-1052.
14. Teo SS, Smeulders N, Shingadia DV. BCG vaccine-associated suppurative lymphadenitis. Vaccine 2005; 23(20): 2676-2679.
15. BCG vaccine SSI. Retrospective review of serious Local adverse reactions. Drug Safety Newslett 2006; 21: 3.
16. Haramburu F. Estimation de la sous-notification. In Analyse d'incidence en pharmacovigilance: application à la notification spontanée, 2ème édition, ARME pharmacovigilance éditions, 1992; 39-51.
17. Ekman E, Backstrom M. Attitudes among hospital physicians to the reporting of adverse reactions in Sweden. Eur J Clin Pharmacol 2009; 65: 43-46.
18. Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf 2009; 32(1): 19-31.
19. Irujo M, Beitia G, Bes-Rastrollo M, et al. Factors that influence under-reporting of suspected adverse drug reactions among community pharmacists in a Spanish region. Drug Saf 2007; 30(11): 1073-1082.
20. Aziz Z, Siang TC, Badarudin NS. Reporting of adverse drug reactions: predictors of under-reporting in Malaysia, Pharmacoepidemiol. Drug Saf 2007; 16(2): 223-228.
21. Alvarez-Requejo A, Carjaval A, Bégaud B, et al. Under-reporting of adverse drug reactions: estimate based on a spontaneous reporting schme and a sentinel system. Eur J Clin Pharmacol 1998; 54(6): 483-488.
22. Moride Y, Haramburu F, Requejo A, et al. Under-reporting of adverse drug reactions in general practice. Br J Clin Pharmacol 1997; 43: 177-181.
23. Cosentino M, Leoni O, Banfi F, et al. Attitudes to adverse drug reaction reporting by medical practitioners in a northern Italian district. Pharmacol Res 1997; 35(2): 85-88.
24. Eland IA, Belton KJ, Van Grootheest AC, et al. Attitudinal survey of voluntary reporting of adverse drug reactions. Br J Clin Pharmacol 1999; 48(4): 623-627.
25. Hasford J, Goettler M, Munter KH, et al. Physicians'knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol 2002; 55(9): 945-950.
26. Backstrom M, Mjorndal T, Dahlqvist R, et al. Attitudes to reporting adverse drug reactions in northern Sweden. Eur J Clin Pharmacol 2000; 56(9-10): 729-732.
27. Kreft-Jais C. Le vaccin BCG: profil de sécurité d'emploi. In Société française de santé publique, Audition publique sur la vaccination des enfants par le BCG: levée de l'obligation vaccinale?, collection santé et société n°12, Mai 2007: 71-73.
28. Gony M, Badie K, Sommet A, et al. Improving adverse drug reaction reporting in hospitals: results of the French pharmacovigilance in Midi-Pyrénées region (pharmacoMIP) Network 2-year Pilot study. Drug Saf 2010; 33(5): 409-416.
29. Castel JM, Figueras A, Pedros C, et al. Stimulating adverse drug reaction reporting: effect of a drug safety bulletin and of including Yellow cards in prescriptions pads. Drug Saf 2003; 26(14): 1049-1055.