우리나라 약물유해반응 감시체계

최남경,박병주,Choi, Nam-Kyong,Park, Byung-Joo 대한예방의학회 2007 예방의학회지 Vol.40 No.4

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.

부산지역 의원급 외래 노인 골관절염환자의 비스테로이드소염제 사용양상평가

최남경,김윤이,이승미,박병주,Choi, Nam-Kyong,Kim, Yoon-I,Lee, Seung-Mi,Park, Byung-Joo 대한예방의학회 2004 예방의학회지 Vol.37 No.2

Objectives : 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.

부산지역 노인환자의 병용금기약물 처방양상

최남경(Nam-Kyong Choi),정선영(Sun-Young Jung),박병주(Byung-Joo Park) 한국역학회 2008 Epidemiology and Health Vol.30 No.1

  Purpose: To estimate the prevalence of co-prescribing contraindicated drugs for elderly patients in Busan.   Methods: We used the Health Insurance Review Agency (HIRA) claims database. Study population consisted of elderly patients who visited clinics or hospitals in Busan metropolitan city from January 1, 2000 to December 31, 2001. Contraindicated drugs were defined as 162 combinations of contraindicated drugs announced by the Korea Ministry of Health and Welfare in 2004. The co-prescription of contraindicated drugs was defined as prescribing two or more contraindicated drugs in combination in the same prescription. The prevalence of co-prescribing contraindicated drugs was estimated as proportion of co-prescribed patients out of the study patients. We estimated and age-adjusted prevalence and its 95% confidence interval of co-prescription of contraindicated drugs among the elderly patients in Korean population in 2001.   Results: The study elderly patients were 262,952 with 2,483,227 prescriptions. Among the study patients 1,208 (4. 6%0) were prescribed contraindicated drugs in combination. A total of 16,255 patients were estimated as the number of co-prescribed patients among the Korean elderly in 2001. Age-standardized prevalence of co-prescription to the Korean elderly was estimated to be 45 per 10,000 persons. The most frequently prescribed combinations were cisapride & amitriptyline, roxithromycin & ergoloid mesylate, and terfenadine & erythromycin, and the frequency were 325 (16.8%), 149 (7.7%), and 132 (6.8%),respectively.   Conclusions: The contraindicated drugs were co-prescribed to the elderly patients in Korea. Many of these co-prescriptions should be avoided if unnecessary. The patients should be carefully monitored if they were inevitably prescribed the contraindicated drugs.

노인 인구에서 흡연과 대장암 발생 위험간의 관련성

김화정,이승미,최남경,김선하,송홍지,조용균,박병주,Kim, Hwa-Jung,Lee, Seung-Mi,Choi, Nam-Kyong,Kim, Seon-Ha,Song, Hong-Ji,Cho, Young-Kyun,Park, Byung-Joo 대한예방의학회 2006 예방의학회지 Vol.39 No.2

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 self-administered 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 & 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 & 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.

Tacrolimus를 근간으로 한 면역억제제를 복용하는 장이식 환자에서 이식 후 새로 발생한 당뇨병의 위험인자

허우성 ( Woo Seong Huh ),최유경 ( Yu Kyong Choi ),김예지 ( Ye Jee Kim ),최남경 ( Nam Kyong Choi ),김민영 ( Min Young Kim ),백나나 ( Na Na Baek ),염지연 ( Ji Youn Youm ),이정은 ( Jung Eun Lee ),김대중 ( Dae Joong Kim ),김윤구 ( Yoo 대한신장학회 2010 Kidney Research and Clinical Practice Vol.29 No.6

Purpose: This study was conducted to identify risk factors for new onset diabetes after transplantation (NODAT) among renal transplant recipients treated with tacrolimus-based immunosuppressant. Methods: We selected renal transplant recipients who underwent surgery at Samsung Seoul Hospital between May 2001 and July 2009. Exclusion criteria were as follows: recipients <18 years old, history of diabetes mellitus (DM) or impaired glucose tolerance. Analysis of possible risk factors for NODAT included age, gender, body mass index, co-morbid diseases, family history of DM, infection of hepatitis B or polyomavirus, type of donors (cadaver or living) and acute rejection. Overall incidence and median value of NODAT onset day were analyzed with Kaplan-Meier curve. We calculated crude incidence rate and relative risk (RR) and 95% confidence interval (CI) for independent risk factors of NODAT using Cox proportional hazard analysis. Results: A total of 278 patients were included and the incidence of NODAT was 13.3% (5.6/100 person-year) and the median duration of NODAT onset was 28 days. In Cox analysis, risk factors for NODAT were age (45-59 years: RR=1.41, 95% CI 1.09-1.83, 60> years: RR=4.36, 95% CI 2.00-9.49), family history of DM (RR=1.62, 95% CI 1.12-2.34) and polyomavirus infection (RR=1.40, 95% CI 1.08-1.81). Conclusion: The risk factors for NODAT among renal transplant recipients treated with tacrolimus- based regimen were age (>45 years old), family history of DM and polyomavirus infection.

의약품부작용보고원시자료를 활용한 와파린과 스타틴 동시복용의 약물 상호작용 실마리정보 탐색

원희현(Heehyun Won),최현영(HyunYoung Choi),박수빈(Suvin Park),최남경(Nam-Kyong Choi) 대한약학회 2023 약학회지 Vol.67 No.1

The increase in polypharmacy in elderly patients is recognized as a serious health, economic, and social problem. Warfarin and statins are commonly co-administered to cardiovascular disease patients. However, there is a potential risk of drug-drug interaction (DDI). The objective of this study was to detect signals of adverse events (AEs) for DDI after concomitant use of warfarin and statins using Korea adverse events reporting system (KAERS) database. KAERS database from January 2016 to December 2020 was used. Omega (Ω) shrinkage measure model and Chi-square statistics model were used to calculate the criteria for detecting AEs signal resulting from concomitant use of warfarin and statins. Three indices were used to define signals: Ω025 (frequentist) >0, Ω025 (Bayesian) >0, and >2. Detected signals were compared with AEs listed on the drug label in Korea, Micromedex, and SIDER for warfarin and statins, respectively. Twenty-seven AEs on reports of concomitant use were detected as signals. Of 27 detected signals, 11 signals, including breath odour not otherwise specified (NOS), depersonalization, gastrointestinal neoplasm NOS, pleural effusion, medical device complication, menopausal symptoms, oedema cerebral, osteitis, prostatic hyperplasia, lipoma, and skin hypertrophy, were not listed on drug label. We identified signals for concomitant use of warfarin and statins. Careful monitoring and further pharmacoepidemiological studies of DDI associated with new signals using other databases are needed.

외국의 백신 능동적 감시 시스템 소개

정나영 ( Na-young Jeong ),박상신 ( Sangshin Park ),임은선 ( Eunsun Lim ),최남경 ( Nam-kyong Choi ) 한국보건정보통계학회(구 한국보건통계학회) 2019 한국보건정보통계학회지 Vol.44 No.4

Vaccines require higher safety standards than most other medicinal products because they are given to healthy individuals, including infants, children, and elderly. Despite various activities by national agencies, public concern about vaccine safety often arises. Post-marketing activities for vaccine safety can be broadly classified into passive and active surveillances. Many countries as well as Korea operate passive vaccine safety surveillance systems that report adverse events related to vaccines. However, the active surveillance systems operate only in several countries, such as the United States of America (USA), Europe, Canada and Australia. In the US, Vaccine Safety Datalink (VSD) and Post-Licensure Rapid Immunization Safety Monitoring (PRISM) were developed in 1990 and 2009 respectively for monitoring vaccine actively. In the case of Europe, the Vaccine Adverse Event Surveillance and Communication (VAESCO) consortium was launched in 2008. After the end of VAESCO, the Accelerated Development of VAccine beNefit-risk Collaboration in Europe (ADVANCE) was organized to establish a vaccine benefit-risk monitoring framework in 2013. Canada has been operating a vaccine active monitoring system known as the Canadian Immunization Monitoring Program, ACTive (IMPACT) since 1991. The objective of this review was to describe and compare background, databases, and analysis systems of various vaccine active surveillance systems in the US, Europe, and Canada. We described the examples of studies on the safety of influenza A (H1N1) vaccines carried out in each system. This review could help provide directions for the future development of the ideal active vaccine safety surveillance system in Korea.

국내 65세 이상 노인의 폐렴구균 23가 다당질 백신 접종 현황

김정아(Jeong Ah Kim),원희현(Heehyun Won),정나영(Na-Young Jeong),최남경(Nam-Kyong Choi) 대한약학회 2023 약학회지 Vol.67 No.4

의약품사용평가(Drug Utilization Review)에 대한 설문조사: 고양시 의사 및 약사 대상 병용 및 연령금기 약물 처방경험

신주영 ( Ju Young Shin ),이애영 ( Ai Young Lee ),손성욱 ( Seong Wook Shon ),최남경 ( Nam Kyong Choi ),신선미 ( Sun Mi Shin ),박효주 ( Hyo Ju Park ),박병주 ( Byung Joo Park ) 대한보건협회 2014 대한보건연구 Vol.40 No.4

연구목적 : 의약전문가를 대상으로 Drug Utilization Review(DUR) 금기 의약품 사용경험과 DUR정보에 대한 인식도 및 금기 약물 사용 배경을 조사하고자 하였다. 연구방법 : 병용금기 및 연령금기 약물에 대한 의약품사용평가 현황 조사를 위한 설문지를 개발하였으며, 경기도 고양시의 대한의사협회 또는 대한약사회 회원으로 등록되어 있는 의사 612명과 약사 342명를 대상으로 2008년 2월 15일부터 21일까지 방문조사를 실시하였다. 연구결과 : 전체 응답자는 의사 219명, 약사 90명으로 총 309명이 응답하였다. 이중, 병용금기 약물을 한번 이상 처방 또는 조제한 적이 있다고 응답한 사람은 90명(29.1%)이었으며, 병용금기 약물 중 HMG CoA 환원효소 억제제와 triazole계 항진균제 또는 macrolides 계열 약물간의 병용(26.8%)과 ketorolac과 NSAIDs의 병용(26.2%)이 가장 다빈도로 나타났다. 한편, 연령금기 약물을 한번 이상 처방 또는 조제한 적이 있다고 응답한 사람은 82명(26.5%)이었으며, 가장 다빈도 성분은 12세 미만에서 처방 또는 조제한 acetaminophen 서방형 제제(65.0%)인 것으로 나타났다. 금기약물의 처방 또는 조제에 대한 주요 이유로는 과거 처방하였을 때 문제가 없었기 때문인 경우가 34건(25%), 금기약물인줄 몰랐던 경우가 32건(23.5) 으로 꼽혔다. 결론 : DUR 발전을 위해서는 의사, 약사가 처방 또는 조제시 참고할 수 있도록 신뢰도 높은 DUR정보 개발이 필요하며, 더불어 임상 현장에 도움을 줄 수 있는 풍부한 정보 제공과 이와 관련된 교육 및 홍보를 활성화해야 할 것이다. Objective : To evaluate the attitudes and awareness of healthcare professionals (physicians and pharmacists) toward Drug Utilization Review (DUR) and their experiences of prescribing drugs with drug-drug interactions and agecontraindications in Goyangsi, Korea. Methods : Face-to-face interview was conducted using a structured questionnaire for 612 physicians and 342 pharmacists, who were registered with Korean Medical Association or Korean Pharmaceutical Association in Goyangsi between February 15th, 2008 and February 21st, 2008. Results : The total number of respondent was 309, which included 219 physicians and 90 pharmacists. The total number of prescribing or dispensing of drug combinations with drug-drug interactions was 90 (29.1%). The most frequently prescribed drug combination was HMG-CoA reductase inhibitors and triazole antifungals or macrolides (26.8%), which was followed by ketorolac and NSAIDs (26.2%). And the total number of respondents who reported experiences with prescribing or dispensing drugs with age contraindications was 82 (26.5%). The frequency of using extended-release acetaminophen under 12 years of age was the highest. The main reason for prescribing or dispensing contraindicated drugs was that no adverse events were observed with previous use (34 of 118 cases (25.0%)). And 32 cases (23.5%) were due to unawareness of the contraindications by the physicians and pharmacists. Conclusion : A substantial number of physicians and pharmacists had experiences of prescribing or dispensing contraindicated drugs. Continuous education with the development of credible DUR information is necessary for a successful DUR system in Korea.

사람유두종 바이러스 백신 미접종 관련 요인: 미국 국민건강영양조사 자료를 이용한 단면연구

김민주 ( Min-ju Kim ),임은선 ( Eunsun Lim ),박상신 ( Sangshin Park ),최남경 ( Nam-kyong Choi ) 한국보건정보통계학회(구 한국보건통계학회) 2021 보건정보통계학회지 Vol.46 No.1

The purpose of this study was to investigate the human papillomavirus (HPV) vaccination proportion and the factors associated with HPV non-vaccination according to the characteristics of Americans. Methods: The 2015-2018 National Health and Nutrition Survey (NHANES) data were analyzed. The subjects aged 9 to 26 were divided into subgroups according to age and sex. Results: The meaningful variables influencing HPV vaccination included birth country, health insurance, hepatitis A vaccine, hepatitis B vaccine, routine place to go for healthcare and times receive healthcare last year. The factors associated with HPV non-vaccination were income, hepatitis A vaccine, hepatitis B vaccine and times receive healthcare last year. Conclusions: This study was based on a survey of Americans, so the factors associated with HPV non-vaccination may differ from those of Koreans.