Abstract
In order to improve the reporting of adverse drug reactions (ADRs) as part of the routine practice at the pediatric outpatient department (OPD), we modified our ADR reporting strategy into one that facilitates the reporting process by means of a multi-disciplinary approach. In this study, we retrospectively reviewed ADR records during the period from March to September 2014 when we changed our reporting process as a part of institutional quality assurance (QA) activity. Yearly differences in the number and composition of ADRs were compared, and the descriptive analyses were done for cases reported from OPD during the QA activity in terms of the suspected drugs, type, causality, and severity of ADRs. There were 1211 pediatric ADR reports including 520 cases with underlying hemato-oncologic diseases during the period of 2014. Among the 691 non-oncologic cases, 76 were reported from the OPD, which was a significant increase (347 %) from the 17 cases reported during the previous year. Further analyses of these 76 cases revealed that the caregivers (47.4 %) initiated about half of the reports, the most frequently affected organ was the skin (32.9 %), and the most frequent suspected drugs were anticonvulsants (14.5 %). In contrast to the in-ward system, moderate cases were more frequent (51.3 %) than mild ones. In conclusion, this study provides a profile of pediatric ADRs in the OPD, which were largely under-reported during the usual clinical practice. A multi-disciplinary approach would improve spontaneous ADR reporting at the pediatric OPD.
Highlights
As children grow and develop, their pharmacodynamic and pharmacokinetic characteristics continuously change until they reach those of adults for whom treatments are often designed (Batchelor and Marriott 2015)
Under a surveillance system based on spontaneous reporting, adverse drug reaction (ADR) collection is largely affected by the disease type and the resources available to the physician during the patient visit, i.e. time allowed for each patient, available diagnostic tools, access to an electronic system for recording and reporting ADRs, and a cultural acceptance to discuss the adverse reactions (Vallano et al 2005; Black et al 2015)
We aim to (1) share the experience of our activities to promote ADR reporting in outpatient department (OPD), (2) compare the numbers of ADR cases before and after modifying the surveillance system, and (3) describe the current profile of ADRs in a Korean tertiary children’s hospital, excluding anti-neoplastic treatments and vaccinations
Summary
As children grow and develop, their pharmacodynamic and pharmacokinetic characteristics continuously change until they reach those of adults for whom treatments are often designed (Batchelor and Marriott 2015). Under a surveillance system based on spontaneous reporting, ADR collection is largely affected by the disease type and the resources available to the physician during the patient visit, i.e. time allowed for each patient, available diagnostic tools, access to an electronic system for recording and reporting ADRs, and a cultural acceptance to discuss the adverse reactions (Vallano et al 2005; Black et al 2015). Baek et al SpringerPlus (2016) 5:1435 largely shared by the governmental insurance system so that patients can access tertiary hospitals (Song 2009), which are located mostly in large cities. Such institutions have transformed their practice pattern to maximize the number of treated patients by constraining the required time per subject. Even for some physicians, reporting is deferred for fear of legal issues (Al-arifi et al 2015)
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