• CELLMED
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• v.5 no.1
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• pp.3.1-3.3
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• 2015

Pharmacovigilance is the study of the safety of drugs under the practical conditions of clinical usage in large communities. Aim of this study was to assess the pharmacovigilance awareness among a focus group of Ayurveda physicians in Sri Lanka who participated for their postgraduate studies. A questionnaire which was suitable for assessing the basic knowledge, attitude and the practice of pharmacovigilance was designed and submitted among group of Ayurveda physicians (n = 30) who participated for postgraduate studies in Institute of Indigenous Medicine, University of Colombo, Sri Lanka. Among participants30% of the subjects knew the term pharmacovigilance, 20% were aware of the unavailability of the National Pharmacovigilance Program for Ayurveda and Traditional Medicine in Sri Lanka, 70% believe about Adverse Drug Reactions (ADRs) may be occurred from Ayurveda medicine, 60% indicated that Most labeled counterfeit drugs, inappropriate use and standardization problems as the most important causes of ADRs associated with Ayurvedicdrugs, 70% physicians accepted their ignorance about pharmacovigilance and admitted that there was a need for better training of this subject and 90% admitted that there should be a national pharmacovigilance programme for Ayurveda medicines in Sri Lanka. We strongly suggest that there is an urgent need for a regular training and the introduce ADRs reporting system among the Ayurveda physicians. Also systematic pharmacovigilance programme is essential to build up for reliable information on the safety and effective practice of Ayurveda medicine in Sri Lanka.

• 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.24 no.1
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• pp.45-52
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• 2014

Objective: To evaluate the clinical manifestations and causative drugs of the outpatient adverse drug reactions (ADRs) reported by community pharmacy. Methods: From April 2013 to September 2013, all outpatient ADRs reported by community pharmacy to Regional Pharmacovigilance Center of Korean Pharmaceutical Association were included. The causality of ADRs was assessed by the criteria of WHO-Uppsala Monitoring Centre. The clinical features and the offending drugs were analyzed using the WHO-Adverse Reaction Terminology and the classification of American Hospital Formulary Service Drug Information, respectively. Results: 2,826 (97.0%) of the total 2,912 ADRs had causal relationship. The 1,923 patients with mean age of 55.1 years and female fraction of 66.5% were included in the ADRs. Gastrointestinal (33.6%), nervous system (14.9%), and skin (13.5%) symptoms were common in ADRs. Analgesic drugs (19.7%), gastrointestinal drugs (17.7%), and central nervous system drugs (11.0%) were prevalent offending drugs. The leading causative generic drug was the complex of acetaminophen and tramadol. Among 203 ADRs by the nonprescription drugs, the most common clinical features were skin (37.4%) and gastrointestinal (23.6%) symptoms and the most prevalent offending drugs were analgesic drugs (40.0%) and mucocutaneous system drugs (16.3%). The combination of acetaminophen and chlorzoxazone was the leading causative generic in nonprescription drugs. Conclusion: In this study, gastrointestinal symptom was the most common manifestation and analgesic drug was the most common causative drug in outpatient ADRs reported by community pharmacy.

• 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.

• 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.

• Korean Journal of Clinical Pharmacy
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• v.21 no.2
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• pp.161-169
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• 2011

The purpose of this study is to survey on the pharmacists' medication teaching service for topical steroids in regions without separation of dispensary from medical practice. The questionnaire was sent to 199 pharmacists who work inregions without separation of dispensary from medical practice via mail, e-mail or fax. 112 out of 199 pharmacists requested have answered the survey (response rate 56.28%). The questionnaire was composed of 4 categories with demographic characteristics, generally explained contents, adverse effects and precaution in pregnancy, breastfeeding and children. We analyzed the questionnaire by the 6 items with reference to the practical guidelines for medication teaching service. The medication teaching service for topical steroids in terms of generic name, physical characteristics, efficacy, usage and dosage, warning and precaution has been well provided by pharmacists in regions without separation of dispensary except for means and duration of optimal storage. The majority of pharmacists provided their patients with 4 and more kinds of items (69.64%), but the generally recommended 4 kinds of items such as generic name, efficacy, usage and dosage, warning and precaution were provided in as low as 48.22% of the respondents. These results show that the medication teaching service for topical steroids in terms of means and duration of optimal storage (45.54%) and the generally recommended 4 kinds of items have not been enough provided by pharmacists in regions without separation of dispensary. Taken together pharmacists in these regions should make a proper guideline for medication teaching service that can prevent the adverse effects of topical steroids.

• Korean Journal of Clinical Pharmacy
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• v.24 no.1
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• pp.39-44
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• 2014

Purpose: To investigate adverse drug reactions (ADR) and causative drugs in the elderly 65 years of age or older, using Korean spontaneous reporting adverse events reporting database from June 2009 to December 2010. Methods: We estimated the association between ADRs and implicated medications by calculating a proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). We reexamined the most frequently implicated medications and ADRs, and the seriousness of ADRs. Then, we assessed reports and concordant rate of ADRs due to medications designated as "high-risk" in elderly by 2012 healthcare effectiveness data and information set (HEDIS) or "potentially inappropriate" by 2012 American Geriatrics Society updated Beers criteria for potentially inappropriate medications (PIMs). Results: Among 15,484 elderly reports, data-mining analysis by PRR, ROR and IC showed that 421 drug-ADR pairs were detected as signals (3,189). The most frequently reported ADR and causative drug were urticaria (470) and contrast media agents (647), respectively. One hundred eighty nine ADR cases were graded as serious. Twenty-two kinds of high-risk medications were shown to be implicated in only 0.9% of ADRs. Only thirty-nine cases were consistent with 2012 Beers criteria or HEDIS. Conclusion: These results suggest that management of the other medications including contrast media agents as well as close monitoring of PIMs are necessary for reducing ADRs in the elderly.

• Korean Journal of Clinical Pharmacy
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• v.28 no.3
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• pp.230-237
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• 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.

• 대한임상약리학회:학술대회논문집
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• 2005.12a
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• pp.19-19
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• 2005

• 대한임상약리학회:학술대회논문집
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• 2005.12a
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• pp.27-28
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• 2005