- Adverse Drug Reaction Surveillance System in Korea.
-
Nam Kyong Choi, Byung Joo Park
-
J Prev Med Public Health. 2007;40(4):278-284.
-
DOI: https://doi.org/10.3961/jpmph.2007.40.4.278
-
-
5,532
View
-
158
Download
-
34
Crossref
-
 Abstract
 PDF
- 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.
-
Summary
-
Citations
Citations to this article as recorded by  - 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
- Smoking and Colorectal Cancer Risk in the Korean Elderly.
-
Hwa Jung Kim, Seung Mi Lee, Nam Kyong Choi, Seon Ha Kim, Hong Ji Song, Yuong Kyun Cho, Byung Joo Park
-
J Prev Med Public Health. 2006;39(2):123-129.
-
-
-
Abstract
PDF
- OBJECTIVES
The incidence of colorectal cancer increased greatly among the elderly in Korea, but the relationship between smoking and colon cancer remains controversial. Few studies have targeted Asian elderly people. We analyzed the smoking status, the amount smoked, and the smoking duration as risk factors of colorectal cancer to determine their association and causality. METHODS: The cohort members (n=14,103) consisted of 4,694 males and 9,409 females, and they were derived from the Korea Elderly Phamacepidemilogic Cohort (KEPEC), which was a population-based dynamic cohort. They were aged 65 years or more and they lived in Busan Metropolitan City between from 1993-1998; they were beneficiaries of the Korean Medical Insurance Corporation (KMIC). The baseline information was surveyed by a selfadministered mailed questionnaire; after 8.7 person-years of mean follow up period, 100 cases of colorectal cancer occurred. The adjusted relative ratio (aRR) of smoking status, the smoking amount and the smoking duration were calculated from the Cox's proportional hazard model with the never-smokers as a reference group and the Cox model controlled for age, gender, precancerous lesions of CRC, medication history of NSAIDs and antibiotics, the alcohol drinking status and BMI. RESULTS: Compared with the never smokers, the aRRs were 2.03 (95% CI=1.02-4.03) and 1.36 (95% CI=0.80-2.32) for the ex-smokers and current smokers, respectively. Statistical significant trends were not observed for the dose-relationship among the elderly, either for the mean daily amount smoked (p for trend=0.28) or for the total amount (p for trend=0.15). Still, the aRRs were 1.51 (95% CI=0.97-2.34) for the elderly who smoked less than 40 years and 2.35 (95% CI=1.16-4.74) for the elderly who had 40 years or more of smoking (p for trend=0.06). Smokers who started smoking before the age 20 had an increased aRR of 2.15 (95% CI=1.17-3.93) compared to the never smokers. CONCLUSIONS: After controlling for age, gender, precancerous lesion of CRC, medication history of NSAIDs and antibiotics, the alcohol drinking status and BMI, smoking increases the risk of colorectal cancer among elderly people. The age when starting smoking is also important.
-
Summary
- Nonsteroidal Anti-inflammatory Drugs Utilization Patterns among the Elderly with Osteoarthritis at Primary Ambulatory Care Units in Busan Metropolitan City, Korea.
-
Nam Kyong Choi, Yooni Kim, Seung Mi Lee, Byung Joo Park
-
J Prev Med Public Health. 2004;37(2):150-156.
-
-
-
Abstract
PDF
- OBJECTIONS: To investigate the utilization patterns of non-steroidal anti-inflammatory drugs (NSAIDs) among the elderly with osteoarthritis (OA) undergoing primary ambulatory care in Busan metropolitan city, Korea. METHODS: OA patients, aged 65 years and over, were identified from the Korean National Health Insurance Review Agency drug prescription database. The subjects had at least one episode of claim for OA (ICD-10-CM: M15-M19) between August 1, 2000 and February 28, 2002. Trends in the determinations of NSAIDs utilization were identified using chi-squared tests for trend. RESULTS: There were 47, 711 osteoarthritic patients. The total number of visits by these patients was 177, 443, with a total frequency for NSAID prescriptions of 214, 952. Seventy-nine percent of the OA patients were female. NSAIDs were prescribed on 133, 284 visits (75.1%) and the proportion of prescriptions was significantly increased with age. Only the proportion of visit when NSAIDs were prescribed decreased, from 65.1 to 43.5%, during the study period (p< 0.001). However, the proportion of combined treatments with anti-ulcer drugs was increased. The use of NSAIDs injections was decreased. Of the individual NSAIDs, diclofenac (28.7% of total frequency of NSAID prescriptions), piroxicam (15.0%) and talniflumate (8.7%), were the most frequently prescribed. Among the NSAIDs prescribed OA visits, 45.7% used two or more NSAIDs. CONCLUSION: The total proportion of NSAIDs prescribed to the osteoarthritic patients was higher than in other studies. The decline in the use of NSAIDs during the study period, and the frequent selection of safer medications, such as combination therapy with anti-ulcer drug, may reflect the risk awareness of the use of NSAIDs.
-
Summary
|
KSPM
