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Clinical Aspects of Unpredictable Adverse Drug Reaction and Assessment of Drug Casuality
J. Kor. Soc. Health-syst. Pharm. 2018;35:331-339
Published online August 31, 2018
© 2018 Korean Society of Health-System Pharmacists

Kwang Joon Kima, In Choea and Yong Eun Kwonb,†

Department of Pharmacy, Chosun University Hospital, 365, Pilmundaero, Dong-gu, Gwangju, 61453, Republic of Koreaa
Department of Internal Medicine, Division of Allergy, Chosun University Hospital, 365, Pilmundaero, Dong-gu, Gwangju, 61453, Republic of Koreab
Correspondence to: 권용은 Tel:062-220-3691
Received March 27, 2018; Revised June 15, 2018; Accepted June 22, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Objective : The aim of this study was to provide basic data for predicting adverse drug reaction (ADR) by investigating drugs that cause type B ADR, the related clinical features and the frequency by age group.
Methods : We retrospectively investigated the ADR reported from August 2015 to July 2016 at Chosun University Hospital Regional Drug Safety Center using electronic medical records. The type and clinical features of type B ADR were investigated. The Naranjo scale score was used to evaluate the ADR.
Results : During the study period, 26,362 patients were hospitalized and 4,110 (15.6%) adverse drug reactions were reported. The incidence of Type B ADRs was rated as 6.6% (269 cases). Due to the results of casualty assessment with drug, 190 cases (70.6%) were categorized as “possible”, 61 cases (22.7%)“ probable”and 17 cases (6.3%)“ definite”. The incidence of type B ADR was slightly higher in females (140 cases, 52.0%) than in males (129 cases, 48.0%). According to the hypersensitivity, 117 cases (43.5%) showed true allergic reaction when 99 cases (36.8%) showed pseudoallergic reaction. Antibiotics (100 cases, 37.2%), contrast agents (55 cases, 20.4%) and analgesics (39 cases, 14.5%) were the causes of type B ADR. Moreover, type B ADR was mainly reported in the age groups of 40s (48 cases, 17.8%), 50s (62 cases, 23.0%), 60s (34 cases, 12.6%) and 70s (38 cases, 14.1%).
Conclusions : When patients take medications that have a type B ADR risk of occurrence, it is necessary to evaluate the patient medication history. Based on this evaluation, an antibiotic skin test and sufficient pretreatment process should be carried out to prevent drug side effects. Furthermore, pharmacist’s efforts are needed to provide adequate information on ADR.
Keywords : ADR (Adverse Drug Reaction), Type B, Naranjo Scale, Hypersensitivity

November 2018, 35 (4)