Pharmacovigilance in children;Pharmacovigilance en pédiatrie

Archives de Pediatrie

Volumn 19, Issue 8, 2012, Pages 848-855

  Autret Leca, E ^a,b   Marchand, M S ^a   Cissoko, H ^a   Beau Salinas, F ^a   Jonville Bera A P ^a  

^a UNIVERSITY HOSPITAL OF TOURS   (France)

^b UNIVERSITÉ DE TOURS   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBIOTIC AGENT; ANTICONVULSIVE AGENT; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; CENTRAL NERVOUS SYSTEM AGENTS; CISAPRIDE; DERMATOLOGICAL AGENT; DESMOPRESSIN; ERGOCALCIFEROL; GROWTH HORMONE; METOCLOPRAMIDE; MUCOLYTIC AGENT; PSYCHOTROPIC AGENT; RESPIRATORY TRACT AGENT; ROTAVIRUS VACCINE;

ADVERSE DRUG REACTION; ANALGESIA; BRAIN; BRAIN DEVELOPMENT; CHILD CARE; CHILD GROWTH; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; FRANCE; GASTROINTESTINAL TRACT; HUMAN; INCIDENCE; OFF LABEL DRUG USE; PHARMACOEPIDEMIOLOGY; PRENATAL DRUG EXPOSURE; PRESCRIPTION; RISK MANAGEMENT; SHORT SURVEY;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CHILD; HUMANS; INFANT; OFF-LABEL USE; PHARMACEUTICAL PREPARATIONS; PHARMACOVIGILANCE;

EID: 84864298073     PISSN: 0929693X     EISSN: 1769664X     Source Type: Journal    
DOI: 10.1016/j.arcped.2012.05.013     Document Type: Short Survey

References (15)

1. Mentzer D., Day S. Paediatric pharmacovigilance in clinical research and drug development. Guide to paediatric drug development and clinical research 2010, 131-137. Karger, Basel. K. Rose, J.N. Van den Anker (Eds.).
2. Hazell L., Shakir S.A. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006, 29:385-396.
3. Adverse Drug Reactions Advisory Committee (ADRAC) Please report paediatric adverse reactions. Aust Adv Drug Reactions Bull Oct 2005, 24:19.
4. Aagaard L., Christensen A., Hansen E.H. Information about adverse drug reactions reported in children: a qualitative review of empirical studies. Br J Clin Pharmacol 2010, 70:481-491.
5. Conroy S., Choonara I., Impicciatore P., et al. Survey of unlicensed and off label drug use in paediatrics wards in European countries network for drug investigation in children. Br Med J 2000, 320:79-82.
6. Tafuri G., Trotta F., Leufkens H.G.M., et al. Off-label use of medicines in children: can available evidence avoid useless paediatric trials?. Eur J Clin Pharmacol 2009, 65:209-216.
7. Star K., Noren G.N., Nordin K., et al. Suspected adverse drug reactions reported for children worldwide. Drug Saf 2011, 34:415-428.
8. Horen B., Montastruc J.L., Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002, 54:665-670.
9. Wallerstedt S.M., Brunlöf G., Sundström A. Rates of spontaneous reports of adverse drug reactions for drugs reported in children. Drug Saf 2011, 34:669-682.
10. Impicciatore P., Choonara I., Clarkson A., et al. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol 2001, 52:77-83.
11. Clavenna A., Bonati M. Adverse drug reactions in childhood: a review of prospective studies and safety alerts. Arch Dis Child 2009, 94:724-728.
12. Jonville-Béra A.P., Giraudeau B., Blanc P., et al. Frequency of adverse drug reactions in children: a prospective study. Br J Clin Pharmacol 2002, 53:207-210.
13. Knopf H., Du Y. Perceived adverse drug reactions among non-institutionalized children and adolescents in Germany. Br J Clin Pharmacol 2009, 70(3):409-417.
14. Aagaard L., Weber C.B., Hansen E.H. Adverse drug reactions in the paediatric population in Denmark. A retrospective analysis of reports made to the danish medicines agency from 1998 to 2007. Drug Saf 2010, 33:327-339.
15. Bourgeois F.T., Mandl K.D., Valim C., et al. Pediatric adverse drug events in the outpatient setting: an 11-year national analysis. Pediatrics 2009, 124:e744-e750.