Multidisciplinary approach to improve spontaneous ADR reporting in the pediatric outpatient setting: a single-institute experience in Korea

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.

Interventions to improve adverse drug reaction reporting: A scoping review

“…Twenty‐six studies examined the impact of IMS by different methods in both developed and developing countries. The positive effect of IMS on ADR reporting varied widely, from 1.02 to 83.9‐fold . As shown in Table , the range of effect of IMS was nearly similar to the effect of educational interventions and computerized registration.…”

“…Out of the 90 studies, 16 were from France; eight from Italy; seven from the United States and Spain; six from the United Kingdom and Portugal; four from Iran and India; three from China, Sweden, and Mexico; two from Brazil, Denmark, Israel, Korea, the Netherlands, Switzerland, and the United Arab Emirates; and one each from Chile, Germany, Morocco, Nigeria, Saudi Arabia, South Africa, and Thailand. The interventions were designed as before‐after in 50 of the studies, non‐comparative in 17 studies, randomized controlled trial (RCT) and cluster RCT in nine studies, and other in 14 studies. In addition, most of the studies had been developed on HCPs, particularly physicians.…”

Knowledge, attitudes and practices of health care professionals towards adverse drug reaction reporting in public sector primary health care facilities in a South African district

“…Health care professionals (HCPs), especially in LMICs, should work together to remove barriers to ADR reporting across sectors and establish effective pharmacovigilance systems [15,17,[19][20][21][22][23][24]. This includes physicians, pharmacists and nurses in ambulatory care in LMICs including South Africa [25][26][27][28][29].…”

Clinical profiles of adverse drug reactions spontaneously reported at a single Korean hospital dedicated to children with complex chronic conditions

“…To determine the clinical profiles of ADRs, we analyzed the yearly data on ADR cases spontaneously reported in the Seoul National University Children’s Hospital (SNUCH) [ 17 ]. This institute is the only children’s hospital in Korea that covers not only all divisions of pediatrics but also all pediatric divisions of medicine by dedicated medical staff, which enables the institute to function as the nationwide referral hospital.…”