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Adverse Drug Reactions in Paediatrics: Are We Getting the Full Picture?
Author(s) -
Carter Kylie L Easton,
Chapman Colin B,
Brien Joanne E
Publication year - 2003
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/jppr2003332106
Subject(s) - medicine , drug reaction , adverse drug reaction , emergency medicine , pediatrics , population , retrospective cohort study , causality (physics) , drug , population study , prospective cohort study , intensive care medicine , pharmacology , physics , environmental health , quantum mechanics
Aim: To investigate the frequency of adverse drug reactions (ADRs) occurring within the paediatric inpatient population of three hospitals and to obtain an estimate of the degree of under‐reporting with ADR monitoring methods commonly employed in hospitals. Method: All paediatric patients admitted to wards of three hospitals, excluding oncology patients, were considered for inclusion. Adverse drug reactions arising within the inpatient population were identified using two methods: spontaneous monitoring and retrospective intensive monitoring. An independent panel reviewed information collected on reactions and established the likelihood of an association between drug administration and the reported reaction. The frequency, causality, clinical significance and preventability of ADRs arising amongst inpatients, along with an estimate of the degree of under‐reporting of monitoring methods utilised was then determined. Results: Of the 17 432 eligible patients, 41 (0.2%, 95% CI 0.1‐0.3%) were determined by an independent panel to have experienced ADRs while inpatients of these hospitals. Causality was ranked as probable (31.7%) and possible (68.3%). The majority ( 48.8%) of cases were allocated a clinical significance classification of moderate , and 9.8% of all ADRs were considered preventable . Only 8.0% and 54.8% of cases identified via prospective intensive monitoring were detected using spontaneous monitoring and retrospective intensive monitoring respectively. Conclusion: The frequency of ADRs arising within the inpatient population in this study was substantially lower than in previous reports. Under‐reporting associated with the monitoring methods employed primarily contributed to this difference. Calls for greater surveillance of paediatric ADRs should therefore be heeded and acted upon by the relevant governing bodies.