Abstract
Despite extensive researches and pre-market clinical trials, only limited information on the adverse drug reactions (ADRs) of a drug can be collected at the time of market approval from regulatory agency. ADRs constitute a major public health problem. Post-marketing surveillance of drugs is important to detect signals for ADR. In Korea, one of the main methods for monitoring the safety of marketed drugs is spontaneous reporting system of suspected ADRs. Re-examination and re-evaluation system are in force for monitoring safety of new market approval drugs and currently under marketing drugs, respectively. Recently, regional pharmacovigilance centers were designated from Korean Food and Drug Administration for facilitating ADR surveillance. Over recent years, with the development of information technology, there has been an increased interest in establishing data mining system for detecting signals from Health Insurance Review Agency database. The purpose of this paper is to review the current status of Korean ADR surveillance system and suggest the possible solutions for developing active pharmacovigilance system in Korea.
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- Signal Detection of DPP-IV Inhibitors using Spontaneous Adverse Event Reporting System in Korea
Hyejung Pyo, Tae Young Kim, Su Been Choi, Hyeong Jun Jo, Hae Lee Kang, Jung Sun Kim, Hye Sun Gwak, Ji Min Han
Korean Journal of Clinical Pharmacy.2024; 34(2): 100. CrossRef - Adverse event reports of tonifying herbal medicine products
Yujin Choi, Jee-youn Jung, Hyeun-kyoo Shin
Journal of Korean Medicine.2024; 45(3): 54. CrossRef - Drug_SNSMiner: standard pharmacovigilance pipeline for detection of adverse drug reaction using SNS data
Seunghee Lee, Hyekyung Woo, Chung Chun Lee, Gyeongmin Kim, Jong-Yeup Kim, Suehyun Lee
Scientific Reports.2023;[Epub] CrossRef - Prevalence of Drug-related Admissions and Associated Factors among Geriatric Center Patients
Seoyoung Kim, Dahye Kim, Soyeon Park, Yoonhee Kim, Ju-Hyun Rho, Hyungwook Namgung, Jeonghwa Lee, Euni Lee, Jung-Yeon Choi, Ju-Yeun Lee, Kwang-il Kim
Journal of Korean Society of Health-System Pharmacists.2023; 40(4): 409. CrossRef - Data mining for detecting signals of adverse drug reaction of doxycycline using the Korea adverse event reporting system database
Jae Young Heo, Moon Kyun Cho, Sooyoung Kim
Journal of Dermatological Treatment.2022; 33(4): 2192. CrossRef - Signal detection for adverse event of varenicline in Korea Adverse Event Reporting System
Min-Gyo Jang, Hyun-Jin Gu, Junwoo Kim, Kwang-Hee Shin
Korean Journal of Clinical Pharmacy.2022; 32(1): 1. CrossRef - Analysis of Adverse Drug Reactions to First-Line Anti-Tuberculosis Drugs Using the Korea Adverse Event Reporting System
Soo Jie Chung, Sun-ju Byeon, Jeong-Hee Choi
Journal of Korean Medical Science.2022;[Epub] CrossRef - Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019
Sanghoon Oh, Sun-ju Byeon, Soo Jie Chung
Journal of Psychopharmacology.2022; 36(9): 1041. CrossRef - Identifying the Patterns of Adverse Drug Responses of Cetuximab
Ji Hyun Park
Korean Journal of Clinical Pharmacy.2022; 32(3): 226. CrossRef - Gender differences in the adverse events associated with cardiovascular drugs in a spontaneous reporting system in South Korea
Han-Heui Park, Ju Hwan Kim, Dongwon Yoon, Hyesung Lee, Ju-Young Shin
International Journal of Clinical Pharmacy.2021; 43(4): 1036. CrossRef - Change Point Analysis for Detecting Vaccine Safety Signals
Seung-Hun You, Eun Jin Jang, Myo-Song Kim, Min-Taek Lee, Ye-Jin Kang, Jae-Eun Lee, Joo-Hyeon Eom, Sun-Young Jung
Vaccines.2021; 9(3): 206. CrossRef - Patient Drug Database: Construction of Database for Patient Leading Drug Side Effects Exploration Using Patient Generated Health Data
Sang Min Lee, Suehyun Lee, Jong Yeup Kim
Journal of Health Informatics and Statistics.2021; 46(3): 315. CrossRef - The Characteristics of Adverse Drug Reactions in Cancer Patients: An Analysis of Spontaneously Reported Cases
Hae-Soo Jeon, Hee-Kyoo Kim, Gil-Soon Choi
The Korean Journal of Medicine.2020; 95(2): 104. CrossRef - Post-marketing surveillance to assess the safety and tolerability of a combined diphtheria, tetanus, acellular pertussis and inactivated poliovirus vaccine (DTaP-IPV) in Korean children
Soon Min Lee, Sung Jin Kim, Jing Chen, Rok Song, Joon-Hyung Kim, Raghavendra Devadiga, Yun-Kyung Kim
Human Vaccines & Immunotherapeutics.2019; 15(5): 1145. CrossRef - Signal Detection for Cardiovascular Adverse Events of DPP-4 Inhibitors Using the Korea Adverse Event Reporting System Database, 2008–2016
Hyemin Yi, Ji-Ho Lee, Ju-Young Shin
Yonsei Medical Journal.2019; 60(2): 200. CrossRef - Differences in Adverse Reactions Among Iodinated Contrast Media: Analysis of the KAERS Database
Jin An, Heewon Jung, Oh Young Kwon, Yewon Kang, Ji-Hyang Lee, Ha-Kyeong Won, Woo-Jung Song, Hyouk-Soo Kwon, You Sook Cho, Hee-Bom Moon, Tae-Bum Kim
The Journal of Allergy and Clinical Immunology: In Practice.2019; 7(7): 2205. CrossRef - Adverse drug reactions
Min-Kyung Cho, Dong Yoon Kang, Hye-Ryun Kang
Journal of the Korean Medical Association.2019; 62(9): 472. CrossRef - Characteristics of Herbal Medicine Users and Adverse Events Experienced in South Korea: A Survey Study
Soobin Jang, Kyeong Han Kim, Seung-Ho Sun, Ho-Yeon Go, Eun-Kyung Lee, Bo-Hyoung Jang, Yong-Cheol Shin, Seong-Gyu Ko, Karin Kraft
Evidence-Based Complementary and Alternative Medicine.2017;[Epub] CrossRef - Data-mining for detecting signals of adverse drug reactions of fluoxetine using the Korea Adverse Event Reporting System (KAERS) database
Seonji Kim, Kyounghoon Park, Mi-sook Kim, Bo Ram Yang, Hyun Jin Choi, Byung-Joo Park
Psychiatry Research.2017; 256: 237. CrossRef - Analysis of Adverse Drug Reactions in Elderly Patients Based on a Spontaneous Reporting System in a Single Tertiary Hospital
Kyung-Hwan Lim, Min-Koo Kang, Byung-Keun Kim, Ju-Young Kim, Min-Gyu Kang, Han-Ki Park, Hye-Ryun Kang, Sang-Heon Cho
The Korean Journal of Medicine.2017; 92(3): 277. CrossRef - Past, present, and future of pharmacovigilance in Korea
Dong Yoon Kang, Kyung-Min Ahn, Hye-Ryun Kang, Sang-Heon Cho
Asia Pacific Allergy.2017; 7(3): 173. CrossRef - Problems within the post-marketing surveillance system in Korea: Time for a change
Hyoyoung Song, Dong-Seok Yim
Translational and Clinical Pharmacology.2016; 24(2): 63. CrossRef - Clinical implication of adverse drug reaction surveillance in children
Eun Hee Chung
Allergy, Asthma & Respiratory Disease.2016; 4(5): 309. CrossRef - Increased use in propofol and reported patterns of adverse events among anesthetics in Korea
Hyo-Ju Park, Ju-Young Shin, Mi-Hee Kim, Byung-Joo Park
Regulatory Toxicology and Pharmacology.2015; 71(3): 478. CrossRef - Analysis of Drugs Causing Severe Cutaneous Adverse Reactions, Based on the Korean Database of Spontaneously Reported Adverse Drug Reactions
Mi-Yeong Kim, Min-Suk Yang, Hye-Ryun Kang, Sang-Heon Cho, Kyung-Up Min
Korean Journal of Medicine.2014; 86(6): 710. CrossRef - Awareness of Adverse Drug Reaction Reporting System in General Population
So Hyeon Ahn, Sooyoun Chung, Sun-Young Jung, Ju-Young Shin, Byung-Joo Park
Health Policy and Management.2014; 24(2): 164. CrossRef - Usage patterns and adverse experiences in traditional Korean medicine: results of a survey in South Korea
Hyeun-Kyoo Shin, Soo-Jin Jeong, Dae Sun Huang, Byoung-Kab Kang, Myeong Soo Lee
BMC Complementary and Alternative Medicine.2013;[Epub] CrossRef - Comparison of the Safety of Seven Iodinated Contrast Media
Jong-Mi Seong, Nam-Kyong Choi, Joongyub Lee, Yoosoo Chang, Ye-Jee Kim, Bo Ram Yang, Xue-Mei Jin, Ju-Young Kim, Byung-Joo Park
Journal of Korean Medical Science.2013; 28(12): 1703. CrossRef - Post-marketing Surveillance of the Safety and Effectiveness of Rosiglitazone/Metformin in Korean Patients with Type 2 Diabetes
HanKyu Lee, So-Hyun Park, Shin-Young Oh, Yil-Seob Lee
Journal of Korean Society for Clinical Pharmacology and Therapeutics.2012; 20(2): 195. CrossRef - The role of the KIDS for enhancing drug safety and risk management in Korea
Soo Youn Chung, Sun-Young Jung, Ju-Young Shin, Byung-Joo Park
Journal of the Korean Medical Association.2012; 55(9): 861. CrossRef - Spontaneous Reporting of Adverse Drug Reactions through Electronic Submission from Regional Society Healthcare Professionals in Korea
Jae-Hyun Lee, Kyung Hee Park, Hyun Joo Moon, Yong Won Lee, Jung-Won Park, Chein-Soo Hong
Yonsei Medical Journal.2012; 53(5): 1022. CrossRef - Recent international initiatives of drug safety management
Nam-Kyong Choi, Joongyub Lee, Byung-Joo Park
Journal of the Korean Medical Association.2012; 55(9): 819. CrossRef - Comparison and validation of data‐mining indices for signal detection: using the Korean national health insurance claims database
Nam‐Kyong Choi, Yoosoo Chang, Ju‐Young Kim, Yu‐Kyong Choi, Byung‐Joo Park
Pharmacoepidemiology and Drug Safety.2011; 20(12): 1278. CrossRef - Signal detection of rosuvastatin compared to other statins: data‐mining study using national health insurance claims database
Nam‐Kyong Choi, Yoosoo Chang, Yu Kyong Choi, Seokyung Hahn, Byung‐Joo Park
Pharmacoepidemiology and Drug Safety.2010; 19(3): 238. CrossRef
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