• Korean Journal of Clinical Pharmacy
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• v.29 no.2
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• pp.125-132
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• 2019

Objective: To examine the perceptions and attitudes toward spontaneous adverse drug reaction (ADR) reporting system among community pharmacists and identify factors that influence reporting, by implementing a survey. Methods: A structured questionnaire was developed and distributed online. Request for the survey was posted on the website of pharmacy's billing program, and the survey was conducted for 8 days. We collected the participants' response on their work environment, experience of ADR reporting, and their perception and attitude on the reporting system. Multivariate logistic regression was used to evaluate factors influencing ADR reporting. Results: A total of 382 pharmacists participated in the survey. Significant contributing factors for reporting level were age (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.84-0.96), knowledge of reporting method (OR, 53.56; 95% CI, 9.10-315.41), installation of reporting program (OR, 31.92; 95% CI, 4.16-244.75), and encouragement from the Korean pharmaceutical association (OR, 4.13; 95% CI, 1.11-15.35). Regarding the attitude toward spontaneous ADR reporting system, 'lack of time for reporting' (OR, 0.29; 95% CI, 0.15-0.53) and 'complexity of reporting procedure' (OR, 0.51; 95% CI, 0.31-0.84), were associated with a low likelihood of reporting. Conclusion: Our results indicated that the knowledge of ADR reporting method, installation of the reporting program, and encouragement from the Korean Pharmaceutical Association contribute to active reporting. It is necessary to simplify the reporting method, make the ADR reporting program user-friendly, and provide educational interventions to increase participation in spontaneous reporting by the community pharmacists.

• Journal of Korean Medicine Rehabilitation
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• v.30 no.4
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• pp.133-142
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• 2020

Objectives Studies on Chinese herbal injections are increasing. But, its safety are still not well reported. We have reviewed the literature related to the safety of Chinese herbal injection, especially those related to anaphylaxis. Methods The PubMed database was used to select the literatures related to anaphylaxis in China and to study the quality control and safety of Chinese herbal injection. Results Chinese herbal injection is a major traditional medical treatment in China, but it is the cause of adverse drug reactions including anaphylaxis. In order to solve this problem, various proposals have been made to identify the pharmacological and chemical causes of major side effects and to use them safely clinically. In addition, various researches have been conducted from preclinical to postmarketing surveillance to secure the safety of Chinese herbal injection. Based on this, it was found that various efforts are needed to secure the safety of bee sting needles. Conclusion In order to secure the safety of chinese herbal injections, it is necessary to identify the main mechanism of action and the pharmacological components contributing to it, and to develop a standardized formulation based on this. In addition, institutional pharmacovigilance is required.

• 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.

• Korean Journal of Clinical Pharmacy
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• v.29 no.3
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• pp.209-214
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• 2019

Doxycycline is frequently prescribed to treat urogenital infections or acne vulgaris. A 39-year-old man was prescribed doxycycline as a treatment for his skin infection. He took each tablet on an empty stomach in the morning, and just before going to bed with insufficient water. After taking the prescribed medication for approximately 3 weeks, he was diagnosed with esophageal ulcer. He had not experienced these symptoms before, and the drug label says that doxycycline rarely causes esophageal ulcer. After discontinuing the medication, the symptoms disappeared. Using the World Health Organization-Uppsala Monitoring Center criteria, the causality for doxycycline-induced esophageal ulcer was evaluated as "possible." Additionally, using the Naranjo scale and Korean causality assessment algorithm (Ver. 2), the causality was evaluated as "probable." Previous reports have stated that most patients who took doxycycline with insufficient water just before going to bed or in the supine position developed esophageal ulcer. Therefore, all patients taking doxycycline must be provided with detailed instructions about the appropriate administration methods.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.33-44
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• 2015

Objectives: The aim of this study was to understand the characteristics of herbal-drug-associated adverse events (AEs) reported in the internet newspaper articles and to take a countermeasure against the safety issue of herbal drugs. Methods: We searched the internet newspaper articles published from 2010 to 2014 in the 3 major portal sites in Korea, NAVER, DAUM, and GOOGLE. Search terms were the Korean words equivalent of 'herbal drug' and 'side effects'. Informations on the type and characteristics of suspected herbal drugs, AEs, and the patient records were extracted from the articles reporting the herbal-drug-associated AE occurred in Korea. Results: From 8,806 articles, a total of 36 AEs were found. The most frequently reported age group was 20s, and women outnumbered men. Obesity was the most common cause of administration. Doctors of Korean medicine clinic were the most commonly referred prescribers and purchasing route (11 cases). The most frequently mentioned medicinal herb was Ephedra sinica (7 cases) and the most commonly reported AEs were abdominal pain (8 cases), dizziness (6 cases), diarrhea (5 cases), and vomiting (5 cases) were followed in order. Ten cases were judged as serious AEs, and the others were not. Conclusions: Current customers demand health care providers to offer them sufficient information on the safety of herbal drugs. To satisfy their requirements, physicians of Korean medicine should be able to explain, predict, prepare, recognize, and deal with the herbal-drug-associated AEs. We propose an establishment of pharmacovigilance system for herbal medicine, in which doctors of Korean medicine are participated as important personnel, to collect and analyze the related AEs and offer credible information on the safety of herbal drug.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.81-87
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• 2018

Objective: There have been many cases of spontaneous adverse drug reactions to fentanyl at a regional pharmacovigilance center in the hospital. To assess the factors causing the adverse drug reactions reported in patients receiving fentanyl patient-controlled analgesia (PCA) monotherapy or in combination with fentanyl transdermal therapeutic system (TTS) for acute post-operative pain management. Methods: We conducted a retrospective cohort study with all patients prescribed fentanyl PCA for pain management after orthopedic surgery at a single university hospital from June 2012 to May 2013. We analysed the factors causing adverse drug reactions reported by a spontaneous reporting system in patients receiving fentanyl PCA monotherapy and those receiving fentanyl TTS in combination with fentanyl PCA. Results: Based on the spontaneous adverse drug reaction reporting, the risk ratio for the incidence rate of adverse drug reaction in the fentanyl TTS combination therapy group was 3.04 (95 % CI: 2.4-4.00, P < 0.0001), which was approximately 3-fold higher than that reported for fentanyl PCA monotherapy. Only 60 % of the adverse drug reactions were reported. Conclusion: It is inappropriate to add fentanyl TTS to fentanyl PCA to manage post-operative acute pain. There is a need to improve adverse drug reaction reporting. We expect that regular analysis of adverse drug reactions reported at regional pharmacovigilance centre would aid in appropriate drug utilization by patients.

• Journal of Korean Society of Health-System Pharmacists
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• v.35 no.4
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• pp.430-440
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• 2018

Background : Hyponatremia is the most common electrolyte disturbance in hospitalized patients and has been associated with increased morbidity and mortality. Tolvaptan, a vasopressin receptor antagonist, is increasingly used for the treatment of euvolemic and hypervolemic hyponatremia. The aim of this study was to evaluate the effectiveness and safety of tolvaptan for the management of hyponatremia. Methods : This study was a retrospective evaluation of 106 patients who received at least one dose of tolvaptan for hyponatremia at a single tertiary academic hospital between January 2014 and June 2015. The primary endpoint was the change in serum sodium concentration after tolvaptan administration within 24 hours, with secondary endpoints of overcorrection and adverse effects. Results : The mean initial dose of tolvaptan was $20.2{\pm}7.2mg$ and the median duration of treatment was 15 days (range, 1-261 days). The maximal changes in sodium levels at 24 and 48 hours were $8.2{\pm}4.7mmol/L$ and $10.5{\pm}15.3mmol/L$, respectively. Of 99 patients in whom sodium concentrations were followed up, sodium overcorrection was observed in 26 (26.3%) patients, which was associated with concomitant use of an enzyme inhibitor (odds ratio [OR] = 4.80, 95% Cl: 1.27-18.15). However, sex, body mass index (BMI), serum albumin, a daily dose of tolvaptan, and concomitant use of hypertonic saline did not show any significant difference in overcorrection. The most commonly reported adverse effects were mild and related to aquaresis, such as polyuria, thirst, and constipation. However, severe adverse effects such as hyperkalemia, hypotension, and one death related to osmotic demyelination were also reported. Conclusions : Tolvaptan is effective for treating hyponatremia. Nevertheless, the drug should be used cautiously due to serious adverse effects related to sodium overcorrection.

• 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.

• Korean Journal of Clinical Pharmacy
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• v.22 no.4
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• pp.340-346
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• 2012

Background: Amphotericin B is a mainstay in the treatment of many systemic fungal infections due to its wide antifungal spectrum and low incidence of resistance. However, the use of amphotericin B is limited by its nephrotoxicity. Objectives: The objective of this study was to evaluate the incidence and risk factors of renal adverse drug reactions (ADRs) of conventional amphotericin B (Fungizone$^{(R)}$). In addition, we compared the changes of serum creatinine (SCr) between patients who remained conventional amphotericin B and patients who were switched to liposomal amphotericin B after occurrence of renal adverse reactions. Methods: Adult hospitalized patients who reported renal adverse reactions caused by conventional amphotericin B from January 2011 to July 2012 at pharmacovigilance center in Yonsei University Healthcare System included in this study. ADRs scored as 'doubtful' in Naranjo probability ADR scale were excluded. We retrospectively analyzed patients' basic clinical characteristics, concurrent diseases or nephrotoxic drugs in order to find variables that can correlate with occurrence of renal ADRs. Changes in SCr were compared between conventional amphotericin B group and liposomal amphotericin B group. Results: A total of 231 ADRs after administration of conventional amphotericin B in 75 patients were reported to pharmacovigilance center and assessed their severities as 'possible', 'probable', or 'definite'. Renal adverse reaction was the most common ADR with incidence rate of 42% (96 of 231 ADRs). Mean change in SCr from baseline was 0.26 mg/dL (change % 37.8) and statistically significant (p=0.000). Simple correlations analysis revealed that the number of concurrent diseases and number of nephrotoxic drugs were positively correlated with changes in SCr, but these results were not statistically significant. Among 43 patients who remained amphotericin B after occurrence of renal ADRs, 27 patients was administered conventional amphotericin B and 16 patients changed to liposomal amphotericin B. Mean change in SCr in amphotericin B group was 0.23 mg/dL (32.75%), whereas mean change in SCr in liposomal amphotericin B group were -0.28 mg/dL (19.38%) and difference between two groups was statistically significant (p=0.003). The numbers of patient with SCr elevation more than 30% were 9 (33.3%) in amphotericin B group and 2 (12.5%) in liposomal amphotericin B group (Odd Ratio=3.50, 95% Confidence Interval 0.65-18.85; p=0.130). Conclusion: An analysis of ADRs due to amphotericin B administration revealed significant mean changes in SCr from baseline. Switching to liposomal amphotericin B showed significant decrease in SCr compared with conventional amphotericin B.

• Journal of Society of Preventive Korean Medicine
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• v.22 no.3
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• pp.11-19
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• 2018

Objectives : The aim of this study is to investigate the current research trend of herbal medicine based on the published articles in pharmacoepidemiologic journals. Methods : A total of 3 electronic journals, Pharmacoepidemiology and Drug Safety(PDS), Drug Safety and Journal of Pharmacoepidemiology and Risk Management(JPERM) from January 2013 to August 2018 were used for searching articles about herbal medicine. Selected articles were reviewed and classified under 5 categories-collection of adverse events in herbal medicine, statistical modeling and methodology, pharmaco-epidemiologic outcome study, drug utilization review(DUR), risk management system and regulation. Results : A total of 8 articles were finally included for analysis. 2 articles were categorized in collection of adverse events in herbal medicine, 1 was statistical modeling and methodology, 2 were pharmacoepidemiologic outcome study and 3 were risk management system and regulation. There was no article in DUR. And then pharmacoepidemiologic research trends of herbal medicine were summarized in classification of 5 categories. Conclusions : To sum up with these 8 articles of herbal medicine in pharmacoepidemiologic journals, herbal medicine was of interesting concern among researchers. The need for research on safety and risk management of herbal medicine is steadily increasing, pharmacoepidemiologic research about herbal medicine must be activated in Korea.