• 한국임상약학회:학술대회논문집
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• 한국임상약학회 2007년도 추계학술대회
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• pp.196-197
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• 2007

• 한국임상약학회지
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• 제27권4호
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• pp.221-227
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• 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
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• 제21권4호
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• pp.353-363
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• 2011

The World Health Organization (WHO) declared the outbreak of H1N1 pandemic in 2009. South Korea also had outbreaks of H1N1 virus and used oseltamivir in large volume with increased reports of adverse drug reaction(ADR). The present study was aimed to investigate the ADR frequency, the factors related to ADR, and characteristics of oseltamivir's ADR. Participants for the study were patients randomly drawn from those who were prescribed oseltamivir for treatment from CHA Bundang Medical Center during October 1 and October 30. The information examined as factors related to ADR were collected by a subsequent cross-sectional telephone survey. The factors are the following; a) age; b) gender; c) patient medical history; d) diagnosis of H1N1 virus; e) adherence; f) whether taking other medication with oseltamivir or not; and g) the number of combined medications. We also asked ADR after taking oseltamivir. Total subjects were 86 patients. The average age is $22.6{\pm}18.48$ years old. The gender was 45.3% women and 54.7% men. Half (50%) of all respondents showed one or more ADR, 67.4% were positively diagnosed for H1N1 virus, and 54.7% were completed the full course of oseltamivir (i.e. twice daily x 5days). The most frequently reported ADR symptoms were: dizziness (15.1%), nausea (11.6%), lethargy (10.4%), diarrhea (10.4%), abdominal pain (8.1%), headache and vomiting (6.9%). ADR classifications by categories are gastro intestinal (44.2%), neuropsychiatric events (22.1%), systemic symptom (20.9%), skin events (5.8%), eye events (4.7%), and other cases (2.3%). The onset of ADR 'after taking 1~3 doses' was 69.7%. No increase in neuropsychiatric events was detected in children and adolescents. No factors examined for the study do have significant influence on the presence of ADR. This study showed that ADR of oseltamivir have occurred in half of the patients. The use of oseltamivir is essential for treatment and prophylaxis of influenza A(H1N1). But mass treatment should be properly monitored for ADR.

• 동의생리병리학회지
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• 제35권6호
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• pp.219-227
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• 2021

The purpose of this study is to analyze the side effects (ADR) of Traditional Chinese Medicine (TCM) injections by age, injection type, symptoms, and causes, and to find preventive solutions for ADR. For the ADR of TCM injection data collected during the search period from January 1, 2010 to December 31, 2020, the correlation between each section was analyzed by subdividing it into age, injection type, symptoms and causes. CNKI, PubMed, and EMBASE were used to collect the clinical data. 'Chinese herbal injection', 'Traditional Chinese Medicine injection', 'Chinese herbal injection side effect', 'Chinese herbal injection adverse drug reaction' were used for the keyword from the database. All data were collected mainly for TCM injection and the causes of ADR due to TCM injection. However, data not related to the relevant study or TCM injection were excluded from this study. Among a total of 941 studies collected during the search period from January 1, 2010 to December 31, 2020, a total of 10 studies were selected for final analysis. In 1462 clinical data sets, ADR by gender was higher in males than females. By age, 41 to 60 years were the most common. The incidence of ADR by injection type was highest in the blood regulating injection type. Data analysis showed Xueshuantong injection had the highest ADR. Among the symptoms of ADR, skin diseases were the most common. The most common cause of ADR was the unreasonable use of drugs. In China, for ADR management, the use of TCM injections is recommended according to the basic principles for the clinical use of TCM injections established by the Chinese government. In this study, we analyzed the current status and causes of ADR in TCM injections, and found a preventive solution. It is expected that it can be used as basic data to increase the usability of pharmacopuncture and herbal medicines in Korea in the future.

• Journal of Preventive Medicine and Public Health
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• 제40권4호
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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.

• 한국임상약학회지
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• 제10권1호
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• pp.30-37
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• 2000

Adverse drug reactions (ADR) may result in increased hospital admissions, morbidity and mortality, adding extra cost to healthcare expenditures. Thus, it is critical to activate ADR monitoring and reporting program in tertiary hospitals in developing countries such as Korea. This study was performed to identify the types of ADR being reported in a tertiary hospital, Samsung Medical Center, and to find out the ways to improve current ADR monitoring system. Of 464 ADR reports submitted to the pharmacy department during the 6-month survey period, $97.8\%$ of the reports were from out patient and $48.5\%$ were from patients aged between 50 and 60. The medical department with the highest frequency in ADR reporting was Internal Medicines $(35.6\%)$. The most common ADR manifestations were gastrointestinal complaints $(43.4\%)\;and\;75\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $32.8\%$. In terms of causality assessment, $85.1\%$ of the reports were probable cases by WHO causality assessment criteria. In regards to sources of report, $75.6\%$ of ADR were reported by physicians and $24.4\%$ by nurses. There were no ADR reported by pharmacists. In conclusion, there is an urgent need to improve ADR monitoring system for inpatient and to motivate pharmacist involvement in ADR monitoring and reporting in Korea.

• 대한한방내과학회지
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• 제33권4호
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• pp.485-497
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• 2012

Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.

• Clinical and Experimental Pediatrics
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• 제54권7호
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• pp.304-309
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• 2011

Purpose: There are very few reports of adverse drug reactions (ADR) and almost no study of drug provocation test (DPT) in Korean children. We aimed to assess the role of DPT in children with unpredictable ADRs, and compare the causative drugs and clinical characteristics between detailed history of ADRs and result of DPTs. Methods: We included 16 children who were experienced ADRs referred to pediatric allergy clinic at Ajou University Hospital (January 2006 to December 2009). With various suspected drugs, 71 DPTs were done in 16 patients using our own protocol, and skin tests to antibiotics were combined in ADRs to antibiotics in medical history. Results: There were 17 (23.9%) positive DPTs results out of 71 individual DPTs, and 11 patients (68.8%) from 16 patients were positive to at least one drug. Drugs causing positive reactions were acetaminophen in 5 (31%), Non-steroidal anti-inflammatory drugs in 4 (25%), penicillin in 3 (19%), cephalosporin in 2 (13%), and cotrimoxazole, macrolide and lactose in 1 each. Conclusion: DPT seems a safe and useful procedure to confirm causative drug and identify safely administering alternative drugs in children with ADR.

• 한국임상약학회지
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• 제22권1호
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• pp.41-46
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• 2012

Adverse drug reaction (ADR) is a global problem of major concern in health care. ADRs can be accrued in any organs or systems. However, cardiovascular ADRs could be a more serious problem if they are irreversible or severe. For this reason, this study was conducted to analyze pattern and severity of cardiovascular ADRs, and suspicious medication. Total 646 reports including cardiovascular ADRs reported to the KFDA between January and June 2010 were analyzed. Amlodipine besylate (36 reports, 3.3%), iopromide (29 reports, 2.7%), tramadol HCl (28 reports, 2.6%) were most suspicious drugs that occurred cardiovascular ADRs. The most common cardiovascular ADRs were hypotension( 236 reports, 33.1%), palpitation (134 reports, 18.8%), and hypertension (89 reports, 12.5%). The most frequent ADRs were occurred in the age group of more than 60. This result could be of help to prescribers and other healthcare providers to predict and prevent cardiovascular ADRs. Also this study suggested that patients with cardiovascular ADR risk factors should be intensively monitored during the medications.

• 한국임상약학회지
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• 제17권1호
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• pp.46-51
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• 2007

This study was aimed to provide the controlled terminology for adverse drug reactions by selecting an appropriate internationally standardized classifications (WHO-ART or MedDRA). We collected the relevant information on ADR terminology systems including WHO-ART and MedDRA by online searching and visiting pharmaceutical companies and WHO UMC (Uppsala Monitoring Centre, Uppsala, Sweden). For MedDRA, project leader directly communicated with the officer of MSSO (Maintenance and Support Services Organization). Collecting all the pertinent information, two possible terminology classifications or systems (WHO-ART and MedDRA) were compared in the views of acceptability, cost-effectiveness and international feasibility and reviewed by the consultation committee and finally WHO-ART was selected.