• 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.

• Korean Journal of Clinical Pharmacy
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• v.21 no.2
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• pp.100-105
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• 2011

The perception of the 20 adverse events of targeted therapy for metastatic renal cell carcinoma was compared among medical professionals. Thirty-seven oncologists, 167 nurses and 79 pharmacists participated in the survey, and the response rate was 61.9%, 98.2%, 84.9%, respectively. Results showed that the most serious adverse event was GI perforation (8.83 points, 10 being the most serious), whereas the least serious was anemia (5.32 points). There were significant differences among oncologists, nurses and pharmacists especially for the moderately-serious adverse event such as wound-healing complication and lymphopenia. Adverse Events Composite Score (AECS) for each targeted therapy was calculated by multiplying adverse event incidence rate and seriousness score. Sunitinib had the highest score at 6.86 point and bevacizumab had the lowest at 2.1. Among professional groups oncologists showed the lowest AECS, whereas nurses had the highest. The gap on the perception of the adverse events among medical professionals needs to be reduced to get better outcomes of medical therapies for cancer patients.

• Korean Journal of Oriental Medicine
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• v.13 no.3
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• pp.79-85
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• 2007

Objective : To investigate documented surveys about adverse events of acupuncture therapy. Methods: We searched Medline with the terms of 'acupuncture/adverse event(s)', 'acupuncture/side effect(s)' and 'CAM/adverse event(s)' using Pubmed and set the limits to human study. Results: There were 5 prospective studies, 3 reviews and 3 surveys in our searching. There were 3 reports about acupuncture related adverse events in UK ranging from 10.7% to 15% of which the rate of significant events were from 0.13% to 0.14%. In Germany, there were 11% of acupuncture related adverse events in one report and 7.5%(significant events were 45 in 190,924 patients) in another report. In Australia, one study reported that every adverse event associated with acupuncture occurred in 8-9 month per one practitioner. In Japan, 0.14% of acupuncture related adverse events in 48 practitioners were reported in one systemic review. A cumulative review about significant adverse events associated with acupuncture reported 715 adverse events of which most frequent accidents were pneumothorax and central nervous system injury. Conclusion : The risk of adverse event associated with acupuncture is far lower than that associated with other general medical interventions. However, some safety guidelines about the acupuncture performance are needed.

• International journal of thyroidology
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• v.11 no.2
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• pp.75-77
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• 2018

Tyrosine kinase inhibitor is known to prolong progression free survival in radioiodine refractory thyroid cancer patients. Fatigue/asthenia/malaise is one of most common adverse events by the tyrosine kinase inhibitor treatment, and management of the adverse event is important to keep the drug medication longer which is essential for the survival benefit. In the case report, a radioiodine refractory thyroid cancer patient receiving tyrosine kinase inhibitor experienced severe fatigue, and a pathologic fracture of right humerus occurred by slipping down which was tightly linked with the adverse event of the drug. The pathologic fracture was surgically well managed and the adverse event was well controlled by supportive managements combined with dose reduction of the tyrosine kinase inhibitor. The drug administration to the patient was kept more than 1 year without progression of the disease.

• Korean Journal of Clinical Pharmacy
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• v.33 no.2
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• pp.122-127
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• 2023

Background: This study was aimed to identify the safety signals of metoclopramide in Korea Adverse Event Reporting System (KAERS) database by proportionality analysis methods. Methods: The study was conducted using Korea Institute of Drug Safety and Risk Management-Korea Adverse Event Reporting System Database (KIDS-KD) reported from January 2013 to December 2017 through KAERS. Signals of metoclopramide that satisfied the data-mining indices of proportional reporting ratio (PRR), reporting odds ratio (ROR) and information component (IC) were defined. The detected signals were checked whether they included in drug labels in the Ministry of Food and Drug Safety (MFDS), U.S. Food and Drug Administration (FDA) and Micromedex^®. Results: A total number of drug AE reports associated with all drugs of data in this study was 2,665,429. Among them, the number of AE reports associated with metoclopramide was 22,583. Forty-two meaningful signals of metoclopramide were detected that satisfied with the criteria of data-mining indicies. Especially neurological signals including extrapyramidal reactions, represented in the safety letter of regulatory agencies were identified in this study. Conclusion: Neurological signals of metoclopramide including extrapyramidal reactions were detected. It is believed that this search for signals can contribute to ensuring safety in the use of metoclopramide.

• Korean Journal of Acupuncture
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• v.29 no.3
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• pp.421-430
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• 2012

Objectives : We investigated the incidence rate and type of adverse events associated with RCTs(Randomized Controlled Trials) of acupuncture and moxibustion. Methods : This study included 949 patients who received acupuncture or moxibustion or usual care from 8 RCTs. We collected data including gender and age of patients, intervention, treatment frequency and type of adverse events in clinical trials from their case report forms. Results : Among the 949 patients, 83 patients(8.7%) suffered at least one adverse event throughout the clinical trials. Types of adverse event in acupuncture & moxibustion clinical trials are common cold, skin changes, pain, dizziness, bruise, gastrointestinal diseases, changes of blood chemistry, burn. Adverse events were significantly correlated to patients' age, intervention, body mass index and treatment group. Conclusions : A Guide-line for collecting and managing adverse events of acupuncture & moxibustion clinical trials are needed.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.171-178
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• 2019

This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

• Journal of the Korea Society of Computer and Information
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• v.14 no.3
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• pp.183-192
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• 2009

ADESS(Adverse drug event surveillance system) is the system which distinguishes adverse drug events using adverse drug signals. This system shows superior effectiveness in adverse drug surveillance than current methods such as volunteer reporting or char review. In this study, we built clinical data mart(CDM) for the development of ADESS. This CDM could obtain data reliability by applying data quality management and the most suitable clustering number(n=4) was gained through the reproducibility assessment in unsupervised learning techniques of knowledge discovery. As the result of analysis, by applying the clustering number(N=4) K-means, Kohonen, and two-step clustering models were produced and we confirmed that the K-means algorithm makes the most closest clustering to the result of adverse drug events.

• 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.4
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• pp.352-361
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• 2022

Objective: This study aimed to analyze the important medical adverse events (IMEs) of cyclosporine and tacrolimus using the reports in US FDA adverse event reporting system (FAERS) and to detect related signals. Methods: The FAERS database was used to analyze the IMEs reported for cyclosporine or tacrolimus during 2017-2021. Reporting odds ratio (ROR) and information component were used to analyze signals for adverse events of both drugs. It was investigated whether the detected signals were present on drug labels in Korea and the United States. Results: Among the total 24,688 reports, the reports on tacrolimus accounted 75.8%. Mean age of the patients was 47.9 years old and median number of adverse events was 2.0 per report. The number of patients hospitalized for adverse events was 7,979 (25.3%). Among the adverse reactions reported on the cyclosporine and tacrolimus, 576 and 1,363 events were detected as signals for cyclosporine and tacrolimus, respectively, and of these, IMEs accounted for 44.8 and 59.2%, respectively. The IMEs related with infections/infestations, renal/urinary disorders, and blood and lymphatic system disorders were reported frequently for both drugs. The most frequently detected IMEs were renal impairment for cyclosporine and acute kidney injury for tacrolimus. Among the top 3 IMEs for each reported SOC for cyclosporine and tacrolimus, 9 and 2 unexpected adverse events were identified, respectively. Conclusion: This study identified the IMEs and signals of cyclosporine and tacrolimus, and detected unidentified adverse events in a drug information database.