Paediatric pharmacovigilance

Paediatric and Perinatal Drug Therapy

Volumn 7, Issue 2, 2006, Pages 50-53

  Choonara, Imti ^a  

^a UNIVERSITY OF NOTTINGHAM   (United Kingdom)

Author keywords

Adverse drug reactions; Children; Surveillance

Indexed keywords

CISAPRIDE; INDOMETACIN; NITRIC OXIDE; PALIVIZUMAB; PROPOFOL;

ARTICLE; CLINICAL TRIAL; DRUG EFFICACY; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; HEALTH PRACTITIONER; HUMAN; TEACHING HOSPITAL; UNSPECIFIED SIDE EFFECT;

EID: 33748070490     PISSN: 14630095     EISSN: None     Source Type: Journal    
DOI: 10.1185/146300905X75352     Document Type: Article

References (42)

1. 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.
2. Choonara I, Rieder MJ. Drug toxicity and adverse drug reactions in children - a brief historical review. Paed Perinat Drug Ther 2002;5:12-18.
3. Waller PC, Evans SJW. A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 2003;12:17-29.
4. Conroy S, Choonara I, Impicciatore P et al. Survey of unlicensed and off-label drug use in paediatric wards in European countries. BMJ 2000;320:79-82.
5. Conroy S, McIntyre J, Choonara I. Unlicensed and off label drug use in neonates. Arch Dis Child Fetal Neonatal Ed 1999;80:F142-F145.
6. McIntyre J, Conroy S, Avery A, Corns H, Choonara I. Unlicensed and off label prescribing of drugs in general practice. Arch Dis Child 2000;83:498-501.
7. Whyte J, Greenan E. Drug usage and adverse drug reactions in paediatric patients. Acta Paediatr Scand 1977;66:767-775.
8. Choonara IA, Harris F. Adverse drug reactions in medical inpatients. Arch Dis Child 1984;59:578-580.
9. McKenzie MW, Stewart RB, Weiss CF, Cluff LE. A pharmacist based study of the epidemiology of adverse drug reactions in pediatric medicine patients. Am J Hosp Pharm 1973;30:898-903.
10. Mitchell AA, Goldman P, Shapiro S, Slone D. Drug utilisation and reported adverse reactions in hospitalised children. Am J Epidemiol 1979;110:196-204.
11. Vazques de la Villa A, Luna del Castillo JD, Galdo-Munoz G, Puche-Canas E. Recciones adversas causdas por medicamentos et pediatria. An Esp Pediatr 1989;31:49-53.
12. Sanz E, Boada J. Adverse drug reactions in pediatric outpatients. In J Clin Pharm Res 1987;7:169-172.
13. Cirko-Begovic A, Vrhovac B, Bakran I. Intensive monitoring of adverse drug reactions in infants and preschool children. Eur J Clin Pharmacol 1989;36:63-65.
14. Menniti-Ippolito F, Raschetti R, Da Gas R, Giaquinto C, Cantarutti L. Active monitoring of adverse drug reactions in children. Lancet 2000;355:1613-1614.
15. Woods CG, Rylance ME, Cullen RE, Rylance GW. Adverse reactions to drugs in children. BMJ 1987;294:869-870.
16. Gill AM, Leach HJ, Hughes J et al. Adverse drug reactions in a paediatric intensive care unit. Acta Paediatr 1995;84:438-441.
17. Turner S, Nunn AJ, Fielding K, Choonara I. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study. Acta Paediatr 1999;88:965-968.
18. Martinez-Mir I, Garcia-Lopez M, Palop V et al. A prospective study of adverse drug reactions in hospitalised children. Br J Clin Pharmacol 1999;47:681-688.
19. Gonzales-Martin G, Caroca CM, Paris E. Adverse drug reactions (ADRs) in hospitalised pediatric patients. A prospective study. Int J Clin Pharm Ther 1998;36:530-533.
20. Jonville-Béra AP, Giraudeau B, Blanc P, Beau-Salinas F, Autret-Leca E. Frequency of adverse drug reactions in children: A prospective study. Br J Clin Pharmacol 2002;53:207-210.
21. Horen B, Montastruc JL, Lapeyre-Mestre M. Adverse drug reactions and off-label drug use in paediatric outpatients. Br J Clin Pharmacol 2002;54:665-670.
22. Buajordet I, Wesenberg F, Brors O, Langslet A. Adverse drug events in children during hospitalization and after discharge in a Norwegian University Hospital. Acta Paediatr 2002;91:88-94.
23. Ufer M, Kimland E, Bergman U. Adverse drug reactions and off-label prescribing for paediatric outpatients: a one-year survey of spontaneous reports in Sweden. Pharmacoepidemiol Drug Saf 2004;13:147-152.
24. Temple ME, Robinson RF, Miller JC, Hayes JR, Nahata MC. Frequency and preventability of adverse drug reactions in paediatric patients. Drug Saf 2004;27:819-829.
25. Schirm E, Tobi H, van Puijenbroek EP, Monster-Simons MH, de Jong-van den Berg LTW. Reported adverse drug reactions and their determinants in Dutch children outside the hospital. Pharmacoepidemiol Drug Saf 2004;13:159-165.
26. Impicciatore P, Mohn A, Chiarelli F, Pandolfini C, Bonati M. Adverse drug reactions to off-label drugs on a paediatric ward: an Italian prospective pilot study. Paed Perinat Drug Ther 2002;5:19-24.
27. Clarkson A, Choonara I, Martin P. Suspected toxicity of atracurium in the neonate. Paed Anaesthesia 2001;11:631-632.
28. Hughes J, Gill A, Leach HJ et al. A prospective study of the adverse effects of midazolam on withdrawal in critically ill children. Acta Paediatr 1994;83:1194-1199.
29. Norris E, Marzouk O, Nunn AJ, McIntyre J, Choonara I. Respiratory depression in children receiving diazepam for acute seizures - a prospective study. Dev Med Child Neurol 1999;41:340-343.
30. Gill AM, Cousins A, Nunn AJ, Choonara I. Opiate induced respiratory depression in paediatric patients. Ann Pharmacother 1996;30:125-129.
31. McIntyre J, Robertson S, Norris E et al. Safety and efficacy of buccal midazolam versus rectal diazepam for emergency treatment of seizures in children: a randomised controlled trial. Lancet 2005;366:205-209.
32. Committee on Safety of Medicines. Vigabatrin (Sabril) and visual field defects. Curr Problems Pharmacovigilance 1998;24:1.
33. Clarkson A, Conroy S, Burroughs K, Choonara I. Surveillance for adverse drug reactions in children: a paediatric regional monitoring centre. Paed Perinat Drug Ther 2004;6:20-23.
34. Morales-Olivas FJ, Martinez-Mir I, Ferrer JM, Rubio E, Palop V. Adverse drug reactions in children reported by jeans of the yellow card in Spain. J Clin Epidemiol 2000;53:1076-1080.
35. Kimland E, Rane A, Ufer M, Panagiotidis G. Paediatric adverse drug reactions reported in Sweden from 1987 to 2001. Pharmacoepidemiol Drug Saf 2005;14:493-499.
36. Clarkson A, Choonara I. Surveillance of fatal suspected adverse drug reactions in the UK. Arch Dis Child 2002;87:462-467.
37. Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Reported adverse drug events in infants and children under 2 years of age. Pediatrics 2002;110:e53.
38. Committee for Medicinal Products for Human Use (CHMP). Guideline on conduct of pharmacovigilance for medicines used by the paediatric population (draft). EMEA, 27 July 2005, London (www.emea.eu.int).
39. van den Ouweland FA, Brown E, Carr DJ. Data monitoring committees in paediatric research. Paed Perinat Drug Ther 2004;6:81-88.
40. Parke TJ, Stevens JE, Rice ASC et al. Metabolic acidosis and fatal myocardial failure after propofol infusion in children: five case reports. BMJ 1992;305:613-616.
41. Bray RJ. Propofol infusion syndrome in children. Paediatr Anaesth 1998;8:491-499.
42. Roberts R, Rodriguez W, Murphy D, Crescenzi T. Pediatric drug labelling: improving the safety and efficacy of pediatric therapies. JAMA 2003;290:905-911.