• 한국임상약학회지
• /
• 제28권3호
• /
• pp.230-237
• /
• 2018

Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-the-counter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre's system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, "possible" (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while "possible" (44.0%) and "unlikely" (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-the-counter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.

• 한국임상약학회지
• /
• 제30권1호
• /
• pp.19-30
• /
• 2020

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

• 한국임상약학회지
• /
• 제27권4호
• /
• pp.221-227
• /
• 2017

Background: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. Methods: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. Results: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. Conclusion: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.

• 한국임상약학회지
• /
• 제32권3호
• /
• pp.204-214
• /
• 2022

Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.

• 한국의료질향상학회지
• /
• 제22권1호
• /
• pp.41-57
• /
• 2016

Objectives: This study aimed to investigate how many healthcare professionals experienced near misses, what types of near misses occurred most often, and healthcare professionals' opinions about near misses at one university hospital in Korea. Methods: The authors developed a questionnaire including 26 core types of near misses and 4 questions about preventability and reporting barriers. The survey was conducted from Oct. 31st to Nov. 18th 2011, about 3 weeks, using a self-administrated questionnaire that was administered to 697 healthcare professionals (registered nurses, pharmacists, technicians, and nurses aides) who worked at a university hospital. Medical doctors and employees working in the department of administration were excluded. Results: About half of hospital workers experienced at least one or more near misses during the past one year. The drug dispensing process was the most common subcategory of near misses. Among the 26 items, patient falls was highest. Over 95% of respondents reported that the near miss they experienced was preventable. Also, more than half of respondents did not report the near miss and the main reason for omission was fear of blame. Conclusion: Regarding patient safety issues, a near miss is a very significant factor because it can be a potential adverse event. Therefore, we should grasp the size of the problem through tracking and analyzing near misses and should make an effort to reduce them. To do so, we should check whether our reporting system is well designed and functioning.

• 한국임상약학회지
• /
• 제28권4호
• /
• pp.293-299
• /
• 2018

Background: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (statins) effectively reduce serum levels of low-density lipoprotein (LDL) and total cholesterol. High-intensity statins are recommended for all patients aged ${\leq}75$ with clinical atherosclerotic cardiovascular disease (ASCVD), diabetes mellitus aged 40-75 with ${\geq}7.5%$ estimated 10-year ASCVD risk and LDL-C ${\geq}190mg/dL$. High-intensity statins associated with more frequent adverse events (AEs) compared to moderate- to low-intensity statins. The aim of this study was to compare AEs between high-intensity and moderate- to low-intensity statin group using the Korea Adverse Event Reporting System (KAERS) database. Methods: Adults (${\geq}18years$) with statin-associated AEs from July 2009-June 2014 were included. Only AEs classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Center criteria were analyzed. Results: In total, 247 AEs from 196 patients [high-intensity statin group (HG), n = 25 (13%); moderate- to low-intensity statin group (MLG), n = 171 (87%)] were included. Mean age was higher in HG compared with MLG ($67{\pm}14$ vs $62{\pm}12$). The HG showed a significant higher frequency of liver/biliary system disorders (37% vs 14%, p = 0.001). Hepatic function abnormal was reported more frequently in HG compared to MLG (26% vs 9%, p = 0.006). Conclusion: According to KAERS data, liver/biliary system disorders were more frequently reported in HG compared to MLG.

• 한국식품위생안전성학회지
• /
• 제27권4호
• /
• pp.395-400
• /
• 2012

본 연구에서는 한 가지 제품에 여러 기능성 원료를 복합하여 사용하고 있는 복합 건강기능식품의 실태를 파악 및 분석하고 이들 원료들 간의 상호작용에 관한 문헌조사를 토대로 복합건강기능식품의 관리 방안을 도출하고자 하였다. 이를 위해 식약청에 품목제조신고되어 있는 database를 분석하였다. 분석대상이 되는 제품은 총 7319개의 제품 중 "복합 건강기능식품"으로 파악된 제품의 개수는 183개 제품이었으며 이들 제품 중 기능성 원료를 2개 함유하고 있는 제품은 총 177제품, 3가지 이상의 기능성 원료를 함유하고 있는 제품은 모두 6개 제품이 있다. 183개 복합건강기능식품에 기능성 원료로 사용되고 있는 원료들을 순위별로 나열하면 가장 많이 사용되는 기능성 원료가 가르시니아캄보지아로서 41개 제품에서 기능성 원료로 사용되었으며 "옥타코사놀"과 "쏘팔메토열매추출물"이 가장 많은 빈도로 제조되고 있었다. 복합건강기능식품에 사용되고 있는 원료들의 pair를 사용하여 안전성 정보를 검색한 결과 현재 복합 사용되고 있는 건강기능식품에서의 안전성 우려사항은 아직까지 보고된 바 없는 것으로 판단된다. 하지만 복합 건강기능식품의 섭취에 대한 안전선 우려는 여전히 남아있는 상태이므로 이를관리하기 위해서는 부작용에 대한 조기 시그날을 감지하기 위한 부작용 모니터링 제도를 강화할 필요가 있을 것이다. 최근에 개정된 건강기능식품법 시행규칙의 원활한 시행을 통해 복합 건강기능식품의 안전관리를 강화할 수 있을 것으로 기대된다.

• 대한한의학회지
• /
• 제36권1호
• /
• pp.33-44
• /
• 2015

Objectives: The aim of this study was to understand the characteristics of herbal-drug-associated adverse events (AEs) reported in the internet newspaper articles and to take a countermeasure against the safety issue of herbal drugs. Methods: We searched the internet newspaper articles published from 2010 to 2014 in the 3 major portal sites in Korea, NAVER, DAUM, and GOOGLE. Search terms were the Korean words equivalent of 'herbal drug' and 'side effects'. Informations on the type and characteristics of suspected herbal drugs, AEs, and the patient records were extracted from the articles reporting the herbal-drug-associated AE occurred in Korea. Results: From 8,806 articles, a total of 36 AEs were found. The most frequently reported age group was 20s, and women outnumbered men. Obesity was the most common cause of administration. Doctors of Korean medicine clinic were the most commonly referred prescribers and purchasing route (11 cases). The most frequently mentioned medicinal herb was Ephedra sinica (7 cases) and the most commonly reported AEs were abdominal pain (8 cases), dizziness (6 cases), diarrhea (5 cases), and vomiting (5 cases) were followed in order. Ten cases were judged as serious AEs, and the others were not. Conclusions: Current customers demand health care providers to offer them sufficient information on the safety of herbal drugs. To satisfy their requirements, physicians of Korean medicine should be able to explain, predict, prepare, recognize, and deal with the herbal-drug-associated AEs. We propose an establishment of pharmacovigilance system for herbal medicine, in which doctors of Korean medicine are participated as important personnel, to collect and analyze the related AEs and offer credible information on the safety of herbal drug.

• 대한의용생체공학회:의공학회지
• /
• 제41권1호
• /
• pp.35-41
• /
• 2020

In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome^®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

• Pediatric Infection and Vaccine
• /
• 제8권2호
• /
• pp.135-149
• /
• 2001

목 적 : 예방접종 사업의 안정화를 위해서는 발생된 이상반응이 적절하게 보고되고, 발견된 이상반응에 대하여 신속하고 정확한 원인 규명을 위한 역학조사를 시행하여 조사된 결과에 따라 적절하게 대응하는 것이 필요하다. 이에 연구자들은 1995년부터 2000년까지 국가 보상을 신청하거나 보고된 예방접종 후 이상반응 감시체계를 통해 보고된 이상반응 사례들을 수집하여 보고 사례와 국가 보상의 변화 양상과 사례의 역학적 특성을 파악하여 이상반응 감시체계의 개선 방향을 제시할 수 있는 기반을 마련하고자 하였다. 방 법 : 1995년부터 1996년까지 예방접종 후 이상반응에 대하여 국가보상신청을 하거나 국립보건원 방역과로 보고된 61건을 대상으로 국가보상 신청시 제출한 자료와 역학조사와 관련된 모든 자료들을 수집, 정리하여 사례들의 역학적 특성들을 파악하였으며, 역학조사 방법과 보상과 관련된 사항들에 대하여 정리 분석하였다. 결 과 : 연도별 보고 건수는 1995년 12명, 1996년 3명, 1998년 12명, 1999년 5명, 2000년 29명으로 총 61명이었으며, 이 중 사망자는 24명(39.3%)이고, 이 중 16명(66.7%)에서 부검이 시행되었다. 보상 심의를 신청한 경우는 36건(59.0%)이었는데, 이 중 17건(47.2%)이 보상받았고, 역학조사를 실시한 경우는 49건(80.3%)이었다. 보고 사례 중 보상 신청 사례는 1995~1998년에는 17건 중 15건(88.2%), 1999~2000년에는 38건 중 15건(76.3%)으로 감소하였으나, 심의 결과 보상을 받는 비율은 1995~1998년 26.6%에서 1999~2000년 53.3%로 증가하였다. 보고 사례 중 역학조사가 이루어진 경우는 1995~1998년에는 17건 중 14건(82.4%), 1999~2000년에는 38건 중 29건(76.3%)으로 역학조사를 실시하는 비율은 감소하였으나 반드시 역학조사가 필요하나 누락되는 경우는 개선되었다. 이상반응 발생을 인지한 후 역학조사에 착수하기까지의 소요시간이 1일 이내인 경우가 1995~1998년에는 전체의 25%에 불과하던 것이 1999년 이후에는 전체의 43.5%로 증가하였다. 전체 이상반응 발생에 있어 남녀간 차이는 보이지 않지만 사망자 21명만을 살펴보면 남자가 14명(66.7%), 여자가 7명(33.3%)으로 남자가 2배나 많았다. 연령별 분포는 정기예방접종이 집중되어 있는 생후 2개월부터 24개월까지가 전체의 75.4%를 차지하고 있다. 접종에서 발병까지의 기간은 전체의 78.4%가 접종 후 일주일 이내에 발생하였다. 결 론 : 보고체계 도입 이후 역학조사가 필요한 경우 대부분에서 조사가 시행되었고, 보고를 받고 신속하게 조사를 착수하는 비율이 증가한 것은 긍정적인 변화로 평가된다. 그러나, 전체적으로 보았을 때 외국에 비하여 감시체계를 통해 보고되는 사례 수가 매우 적어 이상반응의 역학적 양상을 파악함에는 제한점이 있다. 예방접종 사업의 안정성 확보라는 목표를 달성하기 위해서는 무엇보다 보고율 향상을 위한 노력이 경주되어야 할 것으로 생각된다.