• 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.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.

• 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.

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

• 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.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.45-60
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• 2015

Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.256-268
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• 2013

Objective: To study the attitudes and awareness of healthcare professionals (physicians, pharmacists, nurses and others) toward the Pharmacovigilance system and experience for adverse drug reactions (ADRs) from a Single University Hospital in Deajeon. Methods: A survey was performed using a structured questionnaire involving 360 health-care professionals at the hospital between $1^{st}$ November and $16^{th}$ November, 2012. Results: Sixty-five percent (n=235) of all respondents were experienced incidences of ADRs for their patients and 55.8% (n=201) knew the ADR Spontaneous Reporting System in the hospital. However, three-fourths (n=273, 75.8%) of respondents did not know the existence of the Korean Association of Regional Pharmacovigilance Centers (KARP) and 61.7% (n=222) were unaware of the obligation of ADR report from KFDA in cases of serious ADRs. About 83% (n=299) answered that the electronic ADR report system of the hospital was helpful while their work and most (n=336, 93.3%) agreed on the necessaries of the promotion and education about ADR. Conclusion: Seventy-five percent (n=271) of respondents wanted to continue the work for evaluation and feedback for ADRs reported in the hospital. However, the barriers to reporting ADR were; inconvenient ADR reporting system and the lack of time to report ADRs. This study showed that the easier ADR reporting system and education and promotion about ADRs for health-care providers are needed to improve the ADR reporting.

• Korean Journal of Clinical Pharmacy
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• v.31 no.3
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• pp.180-187
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• 2021

Objective: We investigated arthralgia and myalgia associated with the use of oral bisphosphonate (BP) by conducting a survey of patient. Methods: The pharmacists conducted a survey between 1 Oct 2019 and 30 Sep 2020 among patients who were dispensed BP in community pharmacies to assess their demographic and medical characteristics, and their experiences with, and process for pain. Logistic regression analyses were performed to find the risk factors associated with the pain, and the odds ratios (OR) and 95% confidence intervals (CI) were determined. Results: A total of 160 patients who used BP participated in the survey (74 [46.3%] used risedronate; 61 [38.1%] used alendronate; 23 [14.4%] used ibandronate), and 20 (12.5%) of them experienced pain. Significant statistical differences of the characteristics between patients who experienced pain or not were observed regarding menopause, and parity. Compared with women who had one or two parity, women who had more than three parity were associated with the decreased risk of pain (OR, 0.24; 95% CI, 0.04-0.98). Moreover, steady exercise was associated with the decreased risk of pain compared to less exercise (OR, 0.37; 95% CI, 0.14-0.98). Conclusion: Our findings suggest that the risk of pain in BP-treated patients might be different regarding the different ingredients of BP, and dosing frequency. This survey highlights a need for a further safety research to understand the factors influencing the pain associated with the BP treatment.