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Adverse drug reaction-related admissions in paediatrics, a prospective single-centre study
  1. Anke A G Posthumus1,6,
  2. Carien C W Alingh1,6,
  3. Christian C M Zwaan2,
  4. Kees K van Grootheest3,4,
  5. Lidwien L M Hanff2,
  6. Bregje B C M Witjes5,
  7. Geert W ‘t Jong2,
  8. Matthijs de Hoog2
  1. 1Erasmus MC, Rotterdam, The Netherlands
  2. 2Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands
  3. 3The Netherlands Pharmacovigilance Centre Lareb, Den Bosch, The Netherlands
  4. 4Department of Pharmacy Section Pharmacotherapy and Pharmaceutical Care, University of Groningen, The Netherlands
  5. 5VU University Medical Center, Amsterdam, The Netherlands
  6. 6AP and CA contributed equally to the publication
  1. Correspondence to Dr Matthijs M de Hoog; m.dehoog{at}erasmusmc.nl

Abstract

Objective To investigate the incidence and characteristics of hospital admissions related to adverse drug events in the paediatric setting.

Design Prospective single-centre study.

Setting A secondary and tertiary paediatric care centre.

Participants A total of 683 acutely admitted patients, aged 0–18 year. All acutely admitted patients, using medication before admission, were prospectively screened for possible Adverse Drug Reactions (ADR)-related admission with a trigger list. Included cases were analysed with the Naranjo score for the assessment of causality.

Main outcome measures This research explored the incidence of ADR-related admissions and investigated the relation between ADR and the licensing status of the medicines, as well as the severity and potential to prevent the ADRs.

Results A total of 683 patients were admitted acutely during the study period, 47 of them were exposed to cancer chemotherapy. Fifteen patients not exposed to chemotherapy (2.4%) were admitted due to an ADR. Five of these 15 ADRs (33%) were caused by unlicensed or off-label used drugs. Thirty-two patients exposed to chemotherapy (68.1%) were admitted due to an ADR; 27 of these (84%) were caused by unlicensed or off-label used drugs.

Conclusions In conclusion, this study shows that ADR-related hospital admissions occur more frequently in the paediatric population compared with adults, and more frequently in patients exposed to cancer chemotherapy. No relation was found between the unlicensed and off-label used drugs and the incidence of ADRs.

  • Paediatrics
  • Clinical Pharmacology
  • Therapeutics
  • Adverse events

This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/3.0/ and http://creativecommons.org/licenses/by-nc/3.0/legalcode

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