title: 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.
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea.
authors.forename: Hyun Jeong
authors.initials: HJ
authors.lastname: Baek
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea.
authors.forename: Yoon Sook
authors.initials: YS
authors.lastname: Cho
authors.affiliation: Department of Pharmacy, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea.
authors.forename: Kwi Suk
authors.initials: KS
authors.lastname: Kim
authors.affiliation: Legional Drug Safety Monitoring Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea.
authors.forename: Jin
authors.initials: J
authors.lastname: Lee
authors.affiliation: Legional Drug Safety Monitoring Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea ; Division of Allergy, Department of Internal Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea.
authors.forename: Hye Ryun
authors.initials: HR
authors.lastname: Kang
authors.affiliation: Legional Drug Safety Monitoring Center, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea ; Department of Pediatrics, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea.
authors.forename: Dong In
authors.identifier: 0000-0002-7817-8728
authors.initials: DI
authors.lastname: Suh
keywords: Adverse drug reaction; Child; Korea; Outpatients; Pharmacovigilance