Article Text

  1. K A Nguyen1,
  2. F Planchamp1,
  3. T Vial4,
  4. S Nasri4,
  5. E Javouhey2,
  6. Y Gillet2,
  7. B Ranchin3,
  8. F Villard3,
  9. D Floret2,
  10. P Cochat3,
  11. F Gueyffier1,
  12. B Kassai1
  1. 1INSERM, CIC201, EPICIM, Universite Lyon, CNRS UMR 5558, CHU Lyon, Hopital L Pradel, Service de Pharmacologie Clinique, Lyon, France
  2. 2Reanimation et Urgences Pediatriques, EPICIM, Universite Lyon, CHU Lyon, Hopital E Herriot, Lyon, France
  3. 3Departement de Pediatrie, EPICIM, Universite Lyon, CHU Lyon, Hopital E Herriot, Lyon, France
  4. 4Centre Regional de Pharmacovigilance, CHU Lyon, Lyon, France


Objectives This study aimed systematically to evaluate adverse drug reactions (ADR) in children attending a paediatric emergency ward.

Method A prospective study was carried out in Lyon general hospital in cooperation with the regional drug monitoring centre (CRPV) and the department of clinical pharmacology. All potential ADR among patients younger than 18 years of age who visited the paediatric emergency ward were recorded by a pharmacologist who attended the daily staff meetings and were then screened and validated by the CRPV. For validated cases, the preventability and seriousness were evaluated.

Results From 1 March to 1 September 2005, 90 children presented with potential ADR. ADR were validated in 43 patients, 19 females and 24 males. Thirty-four patients (79%) were under the age of 5 years. According to the European definition, 14 patients (33%) had serious ADR, three were life-threatening: anaphylactic shock after amoxicillin injection; error of antimalarial prophylaxis leading to convulsive status epilepticus; convulsion and coma after hepatitis B and MMR vaccines. Three ADR were considered avoidable. Antibiotics and vaccines were the frequent causes of ADR (76%). Skin reactions (n  =  27), fever (n  =  8) and gastric disorders (n  =  5) were the most common clinical manifestations. This active drug monitoring of ADR doubled the number of validated cases (43 versus 17) compared with a similar period without active monitoring one year before.

Conclusions Close interaction between the CRPV, pharmacologist and clinician is necessary and feasible and helped to improve the monitoring of ADR in the emergency department.

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