Rashed, Asia Nasser; (2012) International Paediatric Drug Safety Studies. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

There are limited data on incidences of drug related problems (DRPs) including adverse drug reactions (ADRs) in children. The aim of this thesis is to increase knowledge of the incidence of ADRs and other DRPs and to enhance the understanding of risk factors for ADRs across several countries. This should facilitate the development of appropriate prevention strategies. Two large prospective cohort studies were conducted; ADVISE" recruited patients from five countries to investigate the incidence and characteristics of ADRs. Multivariable regression analysis was conducted to identify risk factors associated with ADRs in hospitalised children. The second study investigated DRPs in children attending the A&E department and/or admitted to a hospital in the Kingdom of Saudi Arabia (KSA) and the UK. ADRs and other DRPs were identified using intensive chart review. In the ADVISE study, 1278 children were included (Australia n=149, Germany n=376, UK n=313, HK n=143, Malaysia n=300). The overall ADR incidence was 18.5% (95% CI, 16.3-20.9). There was significant variation in incidence between countries (p<0.001), the highest was in the UK (34.9%). The use of ≥five low risk drugs per patient or ≥three high risk drugs (e.g. opioids) were strong predictors for ADRs (OR 4,7, 95% CI, 2.4-9.3; OR 6.5, 95% CI, 2.7-16.0; respectively, p<0.001). In the second study, 990 children were included (KSA n=507, UK n=483). The overall incidence of DRPs was 39.2% (95% CI, 36.1-42.3). Incidence was highest in the paediatric intensive care units (59.7%; 95% CI, 47.0-71.5). Dosing problems were the most frequent DRP (n=303, 55.5%). 80.0% (n=437) of DRPs were preventable. Using standardised methods in both studies enabled comparison of incidences of ADRs and DRPs between countries. The variation between countries was considered to be mainly due to differences in treatment strategies. These studies indicated that improvements to current procedures could reduce DRPs and hence improve patients' health. Also, a focus on paediatric pharmacology and pharmacotherapy within paediatric medical education is important to improve prescribing practices and paediatric patient safety.

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