• 한국임상약학회지
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• 제34권1호
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• pp.71-78
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• 2024

Background: Oral cancer drugs, particularly tyrosine kinase inhibitors (TKIs), are increasingly popular due to their convenience. However, they pose challenges like drug interactions, especially with medications like azole antifungals. While the FDA provides some guidance, more detailed information is needed to manage these interactions effectively. A meta-analysis was conducted to understand the impact of interactions between TKIs and azole antifungals on adverse events during clinical studies. Methods: A meta-analysis followed PRISMA guidelines. Data from PubMed, EMBASE, and references were searched until November 30, 2021. Inclusion criteria encompassed studies on TKI-antifungal interactions in English. Study selection and quality assessment were conducted by two independent investigators. Results: Out of 158 articles, 11 were selected for analysis. Combination therapy showed a slight increase in adverse events but was not statistically significant (OR 1.02, 95% CI 0.49-2.13, p=0.95). AUC and Cmax fold changes did not significantly impact adverse event development. Both itraconazole and ketoconazole showed no significant difference in adverse event development compared to TKI alone. Conclusions: Study finds TKI-DDI not significantly linked to AE increase; azole antifungal types not related to AE. Future DDI research crucial for drug development.

• 한방비만학회지
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• 제18권1호
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• pp.1-9
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• 2018

Objectives: The objective of this study was to assess the safety of 'Gamitaeeumjowee-tang' by analyzing adverse events in weight loss program in combination with 'Gamitaeeumjowee-tang' and low-calorie diet. Methods: A retrospective review of adverse events in weight loss program in combination with 'Gamitaeeumjowee-tang' and low-calorie diet from the electronic medical chart (n=124) between June 2015 and December 2016 was conducted. Three Korean Medicine Doctors (KMDs) reviewed adverse events for two times, during week 2 to 4 and at week 10, after starting weight loss program. Adverse events were evaluated in terms of causality, severity and system-organ classes. Also, agreement among the three KMDs was made through further discussion in case of disagreement after independent review. Results: The overall rate of adverse events was 37.1% during week 2 to 4 and 16.9% at week 10. For causality of adverse events using the World Health Organization-Uppsala Monitoring Centre causality categories, 52.2% were evaluated 'possible' at week 2-4 and 57.1% were evaluated 'unlikely' at week 10. All symptoms were evaluated as 'mild' by LDS scale. Nausea (15, 12.1%) was the most frequent adverse event at week 2-4 and dizziness (6, 4.8%) was the most common at week 10. Conclusions: Adverse events decreased over time. There were no serious adverse events and none of the subjects were dropped due to adverse events. Continuous study is needed to prove the safety of 'Gamitaeeumjowee-tang' for treating obesity.

• Journal of Medicine and Life Science
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• 제21권3호
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• pp.83-91
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• 2024

Adverse drug reactions (ADRs) are closely associated with increased morbidity and mortality rates, prolonged hospitalization durations, and higher healthcare costs. This study aimed to estimate the incidence, clinical features, and reporting status of ADRs to improve the current ADR reporting system and prevent recurrent ADRs in hospitals. This retrospective study was conducted at a regional referral hospital. Patients diagnosed with ADRs over a 5-year period (2009-2014) were recruited for this study. An ADR was identified as an ADR-related diagnosis in a patient's medical record or an ADR registered through the in-hospital ADR reporting system. The incidence, culprit drug, clinical manifestations, reporting source, severity, related management, and recurrence rate were assessed. Among 1,112 patients, 1,375 ADR events were collected, an estimated 0.06% of the total number of patient visits. Diagnostic contrast agents (46.4%) were the most common culprit drugs, followed by antibiotics (22.0%), nonsteroidal anti-inflammatory drugs (9.9%), and opioids (4.5%). Skin reactions (67.5%) such as rashes and hives were the most frequent manifestations. Additional ADR-related medical attention was necessary in two thirds of cases. One hundred eighty ADR events (13.1%) were categorized as severe, and 19 patients (1.4%) experienced re-exposure to the culprit drugs. Four patients (0.3%) experienced fatal ADRs. Physicians were the most frequent ADR reporters in the in-hospital ADR reporting system. In conclusion, many ADR events may be overlooked, and re-exposure to causative drugs commonly occurs. Continuous education and maintenance of a reporting system may be important for preventing recurrent ADRs.

• The Korean Journal of Pain
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• 제26권1호
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• pp.3-13
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• 2013

Chronic noncancer pain is a significant and growing public health challenge in the United States. Lacking effective alternative interventions for effective chronic noncancer pain management, many physicians have turned to opioid pharmacotherapy. Increased opioid prescribing brings not only gains in therapeutic benefit but also a higher incidence of adverse drug events including increased medication misuse and opioid related mortality. Currently the United States must confront the dual problems of widespread undertreated chronic noncancer pain and a prescription opioid abuse crisis. Withholding pain relieving drugs from patients in need is unjustifiable, yet drug diversion, abuse and adverse drug events have become major social as well as medical problems. At the heart of this crisis is the lack of definitive evidence about the risk to benefit ratio of opioid pharmacotherapy for chronic noncancer pain both on an individual case and on a population basis. This article describes the extent and severity of the American chronic noncancer pain problem and the history of opioid pharmacotherapy for chronic noncancer pain in the United States. It then discusses the concept of evidence based practice and reviews current evidence supporting opioid pharmacotherapy for chronic noncancer pain as well as adverse drug events related to opioid pharmacotherapy including misuse and abuse. Finally, it considers the conflict of providing pain relief versus protecting society and reviews steps that governmental agencies, industry and others are taking to contain and ultimately resolve the problems of excessive prescribing and conflicting priorities.

• Tuberculosis and Respiratory Diseases
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• 제80권2호
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• pp.143-152
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• 2017

Background: Fluoroquinolones are considered important substitutes for the treatment of tuberculosis. This study investigates the current status of fluoroquinolone for the treatment of tuberculosis. Methods: In 2009, a retrospective analysis was performed at one tertiary referral center for 953 patients diagnosed with tuberculosis. Results: A total of 226 patients (23.6%), who received fluoroquinolone at any time during treatment for tuberculosis, were enrolled in this study. The most common reasons for fluoroquinolone use were adverse events due to other anti-tuberculosis drugs (52.7%), drug resistance (23.5%), and underlying diseases (16.8%). Moxifloxacin (54.0%, 122/226) was the most commonly administered fluoroquinolone, followed by levofloxacin (36.3%, 82/226) and ofloxacin (9.7%, 22/226). The frequency of total adverse events from fluoroquinolone-containing anti-tuberculosis medication was 22.6%, whereas fluoroquinolone-related adverse events were estimated to be 2.2% (5/226). The most common fluoroquinolone-related adverse events were gastrointestinal problems (3.5%, 8/226). There were no significant differences in the treatment success rate between the fluoroquinolone and fluoroquinolone-$na{\ddot{i}}ve$ groups (78.3% vs. 78.4%, respectively). Conclusion: At our institution, fluoroquinolones are commonly used for the treatment of both multidrug-resistant tuberculosis and susceptible tuberculosis, especially as a substitute for adverse event-related drugs. Considering the low adverse event rates and the comparable treatment success rates, fluoroquinolones seem to be an invaluable drug for the treatment of tuberculosis.

• 한국임상약학회지
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• 제32권3호
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• pp.204-214
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• 2022

Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.

• Journal of Acupuncture Research
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• 제27권4호
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• pp.195-202
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• 2010

Objectives : This study was performed to report adverse events in Ojeok-san extract powders RCT. Methods : 180 patients with LBP were randomized into groups for a double blind, placebo-controlled clinical study. They received Ojeok-san simple Extract, Ojeok-san complex Extract or placebo in powders, orally dissolved 3times a day for 4weeks. During 4weeks, we researched the symptoms and duration of adverse events and Digest ability, Milk hypersensitivity, Starch hypersensitivity, Caramel hypersensitivity, West-med hypersensitivity, Herb-med hypersensitivity in patients who had adverse events. Results : 52patients(28.9%) had adverse events and of them 44patients(28.9%) had lost adverse events naturally. But 5patients(2.8%) were withdrawn from the research because of the adverse events. Most of the symptoms of adverse event was Gastrointestinal symptom(88.3%) and adverse events frequency was not different from Ojeok-san simple Extract, Ojeok-san complex Extract and placebo. Conclusions : Ojeok-san extract powders had adverse events no different from the placebo, which shows that it is a safe drug.

• 한국임상약학회지
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• 제21권2호
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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.

• 약학회지
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• 제50권3호
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• pp.145-153
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• 2006

The adverse events which do not appear in the approval process tend to occur more frequently at the early stage of the use. Therefore new drugs, drugs with different active substances or routes of administration, or drugs with explicitly different efficacy added are particularly chosen for re-examination, and go through a study, which is conducted on 600 to 3,000 subjects over 4 to 6 years. Since the re-examination system was implemented in January 1995, 880 drug products have been designated as the subject of re-examination and among them 194 drugs have been completed their re-examination as of until March 2005. Post Marketing Surveillance to insure drug safety should be correlated with re-examination of new drug, re-evaluation of drug, and adverse event monitoring system. And the first labeling change should reflect all information collected for a defined period of time after the marketing authorization is granted. Furthermore centralized management through spontaneous reporting system of adverse event for whole period of time would be the most desirable type of system.

• 의학교육논단
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• 제22권1호
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• pp.32-45
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• 2020

This narrative review introduces global trends in pharmacovigilance (PV) education for healthcare professionals and the status of PV education in Korea. Proactive participation of healthcare professionals, including physicians, pharmacists, and nurses in reporting suspected adverse events is the main driving force for effective operation of the spontaneous adverse event reporting system database, which in turn facilitates early safety signal detection of otherwise unknown suspected adverse events. The World Health Organization recognizes PV education curriculum as a key aspect in promoting awareness of PV and adverse event reporting among healthcare professionals, and multiple studies have demonstrated that PV educational interventions for healthcare professionals have increased overall adverse event reporting. Considering the global trends in PV education, the curriculum in Korean universities still has room for improvement in promoting PV obligation among future healthcare professionals. Further research is needed to develop PV education curriculum. We suggest a three-step project for innovating PV education in Korea to meet the global PV educational standards: a survey to gauge current PV competencies among healthcare professionals, reform of current PV academic curriculum, and evaluation and fine-tuning of the reformed curriculum.