• Korean Journal of Clinical Pharmacy
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• v.32 no.1
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• pp.1-7
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• 2022

Objective: The purpose of this study was to detect signals of Adverse Events (AEs) after varenicline treatment using spontaneous AEs reporting system in Korea. Methods: This study was conducted by Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through Korea Adverse Event Reporting System. Signals of varenicline that satisfied the data-mining indices, proportional reporting ratio, reporting odds ratio and information component were defined. The detected signals were checked whether they included in drug labels in South Korea and United States of America (USA). Results: A total number of drug AE reports associated with all drugs in the KIDS-KD reported between January 2013 and December 2017 was 2,665,429. Among them, the number of AE reports associated with varenicline was 1,398. Eighteen meaningful signals of varenicline were detected that satisfied with the criteria of data-mining indices. Finally, two signals such as hypotonia, incorrected dose administered were not included in the drug labels. Conclusion: New AE signals of varenicline that were not listed on the drug labels in South Korea and USA were detected. However, further pharmacoepidemiological studies such as randomized controlled trial are needed to evaluate the causality of the signals of varenicline.

• Korean Journal of Clinical Pharmacy
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• v.32 no.3
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• The Journal of Internal Korean Medicine
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• v.45 no.1
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• pp.55-74
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• 2024

Objectives: This study reviewed the status of adverse event (AE) reporting in VigiAccess using anti-obesity agents as examples and explored the possibility of its use and future challenges. Methods: AE reports related to some representative drugs among herbal medicines (HMs), complex HM prescriptions, ingredients of supplements, and over-the-counter and prescription medicines were investigated using VigiAccess on February 1, 2024. Results: AE reports on prescription drugs were overwhelmingly higher than those on HMs or supplements. Although most reports were submitted from North America, reports on Ephedra sinica and green tea extract (GTE) were more from Asia and Europe, respectively. The female population reported more, and the difference in the sex ratio was the smallest for Ephedra spp. The age group was concentrated on young adults, but many older patients reported GLP-1 receptor agonist-related AEs. Symptoms related to the gastrointestinal and nervous systems were most commonly reported, but mental and cardiac disorders were common in Ephedra-type HMs. Hepatobiliary disorders are also commonly found in GTE-related reports. Conclusions: VigiAccess was useful for easily checking the global status of AE reporting for prescription drugs. However, several limitations were observed in using VigiAccess for HMs because of the few reports. Thus, it is necessary to increase the number of reports by education and to promote AE reporting among HM prescribers and users. The full range of HMs should be included in the pharmacovigilance system, and the coding and classification of HMs should be revised.

• The Journal of Korean Medicine
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• v.42 no.4
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• pp.40-60
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• 2021

Objectives: This study aimed to evaluate the impact of a training course on pharmacovigilance for future doctors of Korean medicine (DKM). Methods: In 2020, a pharmacovigilance training course was conducted for 57 senior students of a Korean medicine (KM) college, and its impact to the students were assessed in terms of the knowledge, attitudes, and perceptions of these students at three-time points: pre-training, post-training, and 4-6 months after the end of the training. Results: A total of 38 students completed the survey. The average score from the knowledge test increased significantly after training compared to prior to the training (5.47±2.140, 6.61±1.001, respectively, p<0.001) and was maintained until the final survey (6.61±1.220). The rate of correct answers to most of the knowledge test questions increased after the training but decreased in the final survey. In terms of attitudes, self-confidence in causality assessment (2.63±1.025, 4.58±0.826, p<0.001) and spontaneous reporting (2.08±1.050, 4.74±0.446, p<0.001) significantly increased after the training and then slightly decreased (3.92±1.171, 4.40±0.755). The perception level was high prior to the training, and this pattern was maintained throughout the study period. Students responded that pharmacovigilance education was necessary for DKM after training, and for the undergraduates of KM colleges. Conclusions: This study shows that this pharmacovigilance training course is effective for students majoring in KM but that retraining is required at least 6 months after the initial training. Further follow-up studies are needed to ensure that students actively participate in spontaneous reporting after graduation, and continuous education should be provided to graduates.

• The Journal of Korean Medicine
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• v.41 no.1
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• pp.21-44
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• 2020

Objectives: This study was aimed to develop a pharmacovigilance practice training course for future doctors of Korean medicine, the graduate students of a college of Korean medicine, and to verify the educational effect of the curriculum. Methods: Fifty-six students were given a training course designed as follows: 1) pre-class homework (basic theory self-study, online course, causality assessment, and adverse event reporting simulation); 2) in-class: homework submission and case discussion; 3) after-class: homework revision and resubmission. An online survey to assess the change of the level of basic knowledge and attitudes toward pharmacovigilance, the willingness to report adverse events, and self-efficacy for the causality assessment and adverse event reporting was conducted before and after education. Results: The survey participation rate was 96.5% in pre-education and 64.3% in the post-education survey. After education, knowledge level was improved (mean score from 4.3±2.11 to 6.7±1.96 points, modal value from 3 to 8 points) and positive changes were observed in almost all questions on attitudes. In the post-education survey, more students felt that they could do causality assessment (from 13% to 80.5%), could report adverse events to the agency in charge (from 7.4% to 96.2%), and expressed their strong willingness to report adverse events in the future (from 77.8% to 88.9%) than in the pre-education survey. Conclusions: More schools of Korean medicine need to adopt pharmacovigilance training courses in their curriculum to foster future doctors of Korean medicine with pharmacovigilance capabilities. Such efforts will be the basis for achieving an evidence-based, safe use of herbal medicine.

• Korean Journal of Clinical Pharmacy
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• v.34 no.2
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• pp.100-107
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• 2024

Background: The purpose of this study was to detect signals of adverse events (AEs) of DPP-IV inhibitors using the KIDs-Korea Adverse Event Reporting System (KAERS) database. Methods: This study was conducted using AEs reported from January 2009 to December 2018 in the KIDs-KAERS database. For signal detection, disproportionality analysis was performed. Signals of DPP-IV inhibitor that satisfied the data-mining indices of reporting odds ratio (ROR) were detected. Results: Among the total number of 10,364 AEs to all oral hypoglycemic agents, the number of reported AEs related to DPP-IV inhibitors was 1,674. Analysis of reported AEs of DPP-IV inhibitors at the SOC levels showed that Respiratory system disorders were the highest at 4.31 (95% CI 3.01-6.17), followed by Skin and appendages disorders at 2.04 (95% CI 1.74-2.38). When analyzing AEs reported at the PT level, pharyngitis was the highest at 73.90 (95% CI 17.59-310.49), followed by arthralgia at 6.08 (95% CI 2.04-18.11), and coughing at 5.21 (95% CI 2.07-13.15). Conclusions: Based on the result of the study, deeper consideration is required according to the characteristics of the patients in prescribing DPP-IV inhibitors among oral hypoglycemic agents, and continuous monitoring of the occurrence of related Adverse Drug Reactions during administration is also required.

• Journal of the Korea Convergence Society
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• v.11 no.7
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• pp.377-387
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• 2020

This study is a retrospective and descriptive research to identify the factors affecting development of spontaneous abortion in women of childbearing age. The subjects totaled 198 females aged 20~45 who had experienced childbirth or spontaneous abortion at least once, and data was collected for one month since July 2019 through self-reporting questionnaires. The results showed that the factors affecting development of spontaneous abortion were use of panty liners (daily: reference, 1~2 times a week: B=-1.74, no: B=-0.77) and antimicrobials (often or a lot: reference, small or normal: B=-0.71, no: B=0.79), occupational groups (inoccupation: reference, service industry employee: B=0.73, white collar: B=1.22, professional: B=0.63, manager: B=1.54), and exposure-risk behavior toward endocrine-disrupting chemicals (B=0.81) during pregnancy, and their explanatory power for development of spontaneous abortion was 24.4% (R²=.24). As a result, it is necessary to prevent endocrine-disrupting chemicals exposure and pay attention to the occupational environment during pregnancy in order to reduce the development of spontaneous abortion.

• Journal of Preventive Medicine and Public Health
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• v.40 no.4
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• pp.278-284
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• 2007

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.

• Safety and Health at Work
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• v.3 no.2
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• pp.92-100
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• 2012

Objectives: The French National Occupational Diseases Surveillance and Prevention Network (RNV3P) is a French network of occupational disease specialists, which collects, in standardised coded reports, all cases where a physician of any specialty, referred a patient to a university occupational disease centre, to establish the relation between the disease observed and occupational exposures, independently of statutory considerations related to compensation. The objective is to compare the relevance of disproportionality measures, widely used in pharmacovigilance, for the detection of potentially new disease ${\times}$ exposure associations in RNV3P database (by analogy with the detection of potentially new health event ${\times}$ drug associations in the spontaneous reporting databases from pharmacovigilance). Methods: 2001-2009 data from RNV3P are used (81,132 observations leading to 11,627 disease ${\times}$ exposure associations). The structure of RNV3P database is compared with the ones of pharmacovigilance databases. Seven disproportionality metrics are tested and their results, notably in terms of ranking the disease ${\times}$ exposure associations, are compared. Results: RNV3P and pharmacovigilance databases showed similar structure. Frequentist methods (proportional reporting ratio [PRR], reporting odds ratio [ROR]) and a Bayesian one (known as BCPNN for "Bayesian Confidence Propagation Neural Network") show a rather similar behaviour on our data, conversely to other methods (as Poisson). Finally the PRR method was chosen, because more complex methods did not show a greater value with the RNV3P data. Accordingly, a procedure for detecting signals with PRR method, automatic triage for exclusion of associations already known, and then investigating these signals is suggested. Conclusion: This procedure may be seen as a first step of hypothesis generation before launching epidemiological and/or experimental studies.

• Journal of Physiology & Pathology in Korean Medicine
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• v.24 no.5
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• pp.753-757
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• 2010

The objectives of this paper is to propose the pharmacoepidemiologic methodology to Research for Sasang Constitutional Pharmacology. We mainly searched "Journal of Pharmacoepidemiology and Risk Management". And we also searched "J Korean Oriental Med.", "J of Sasang Constitutional Med.", "J. Oriental Physiology & Pathology", "Korean J Orient Int Med." using these kew words - "adverse event" or "side effect" and "Sasang Contitution" or "Constitution" or "Constitutional medicine". Through the examination of the Pharmacoepidemiologic methodology and current research for sasang constitiutional pharmacology, we could establish the proposal to collect objective constitutional medical reaction. For the actualization of this proposal, the more advanced studies will have to be carried out continuously.