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KMID : 1011320170090010027
Journal of Pharmacoepidemiology and Risk Management
2017 Volume.9 No. 1 p.27 ~ p.35
Analysis of Adverse Drug Reactions (ADRs) Related Anti-Cancer Drugs through Spontaneous Reporting System in a Korean Tertiary Hospital
Kwon Yoo-Jin

Ree Yoon-Sun
Kim Jae-Song
Kim Soo-Hyun
Son Eun-Sun
Park Jung-Won
Abstract
Objective: The purpose of this study was to analyze the adverse drug reactions (ADRs) related anti-cancer drugs through spontaneous reporting system in a Korean tertiary hospital. It is important to predict ADRs related anti-cancer drugs because ADRs related anti-cancer drugs decrease quality of life of patients and can be a reason for discontinuation of drug.

Methods: This study was analyzed the ADRs related anti-cancer drugs through spontaneous reporting system in the Severance hospital between Jan 1, 2014 and Jun 30, 2015. The reported cases (774 cases) that WHO-UMC causality categories correspond to certain, probable/likely and possible were retrospectively reviewed.

Results: The most frequent category of anti-cancer drugs was cytotoxic agent (549 cases, 70.9%), followed by monoclonal antibody (111 cases, 14.3%), protein kinase inhibitor (58 cases, 7.5%). The most frequently reported drug was oxaliplatin (119 cases, 15.4%), the second was fluorouracil (60 cases), and followed by cisplatin (53 cases), paclitaxel (52 cases), docetaxel (51 cases). The most frequent reported category of ADRs was skin and appendages disorders (214 cases, 27.6%), and followed by central and peripheral nervous system disorders (99 cases, 12.8%), body as a whole general disorders (97 cases, 12.5%), gastrointestinal system disorders (94 cases, 12.1%).

Conclusion: Sometimes, incidence and symptoms of ADRs of anti-cancer drugs in real clinics are different to ADRs in clinical trial settings. Through more spontaneous reported ADRs of anti-cancer drugs in real clinics and more analysis about ADRs, it could be possible to analyze and do proper preventions and management.
KEYWORD
Drug-Related Side Effects and Adverse Reactions, Antineoplastic Agents, Adverse Drug Reaction Reporting Systems
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