Abstract
Objective(s)To obtain reliable information about the incidence of adverse drug reactions, and identify potential areas where intervention may reduce the burden of ill-health.DesignProspective observational study.SettingA large tertiary children’s hospital providing general and specialty care in the UK.ParticipantsAll acute paediatric admissions over a one year period.Main ExposureAny medication taken in the two weeks prior to admission.Outcome MeasuresOccurrence of adverse drug reaction.Results240/8345 admissions in 178/6821 patients admitted acutely to a paediatric hospital were thought to be related to an adverse drug reaction, giving an estimated incidence of 2.9% (95% CI 2.5, 3.3), with the reaction directly causing, or contributing to the cause, of admission in 97.1% of cases. No deaths were attributable to an adverse drug reaction. 22.1% (95% CI 17%, 28%) of the reactions were either definitely or possibly avoidable. Prescriptions originating in the community accounted for 44/249 (17.7%) of adverse drug reactions, the remainder originating from hospital. 120/249 (48.2%) reactions resulted from treatment for malignancies. The drugs most commonly implicated in causing admissions were cytotoxic agents, corticosteroids, non-steroidal anti-inflammatory drugs, vaccines and immunosuppressants. The most common reactions were neutropenia, immunosuppression and thrombocytopenia.ConclusionsAdverse drug reactions in children are an important public health problem. Most of those serious enough to require hospital admission are due to hospital-based prescribing, of which just over a fifth may be avoidable. Strategies to reduce the burden of ill-health from adverse drug reactions causing admission are needed.
Highlights
Children are vulnerable to adverse drug reactions (ADRs). [1,2,3,4,5,6] Spontaneous reporting systems, such as the UK Yellow Card scheme, [7] are subject to under reporting of ADRs, even those which are severe. [8] To obtain reliable information about the incidence of ADRs prospective studies are needed
240/8345 admissions in 178/6821 patients admitted acutely to a paediatric hospital were thought to be related to an adverse drug reaction, giving an estimated incidence of 2.9%, with the reaction directly causing, or contributing to the cause, of admission in 97.1% of cases
[12] The definition of ADR used was that of Edwards and Aronson which is ‘‘an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.’’ [13] This definition was chosen as it describes only clinically significant adverse reactions that cause harm and it includes the concept of preventive action
Summary
Children are vulnerable to adverse drug reactions (ADRs). [1,2,3,4,5,6] Spontaneous reporting systems, such as the UK Yellow Card scheme, [7] are subject to under reporting of ADRs, even those which are severe. [8] To obtain reliable information about the incidence of ADRs prospective studies are needed. A systematic review of observational studies of ADRs causing paediatric hospital admissions, between 1976 to 1996, estimated the rate of ADR admissions to be 2.1% (95% CI 1.0, 3.8). [9] A further review of prospective paediatric studies published between 2001 and 2007 did not identify any large studies of the incidence and nature of ADRs causing hospital admission. The aim of this study was to prospectively identify ADRs in children causing hospital admission during a one year period in order to quantify the burden of ADRs and characterise their features. The investigators aimed to determine the avoidability of identified ADRs and detail the reasons for determining reactions as avoidable This aspect of ADRs causing admission in children has not been fully addressed in previous studies
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