• Perspectives in Nursing Science
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• v.13 no.1
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• pp.1-9
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• 2016

Purpose: The purpose of this study was to identify the current state of research on healthcare professionals who make medical errors, who are known as "second victims", and support systems for them. Methods: An extensive search was conducted in electronic databases, Google, and websites related to patient safety using search terms such as "second victims", "medical errors", "adverse events", and "sentinel events". Results: Research to date in Korea has rarely focused on healthcare professionals' experiences after making medical errors. Abroad, there are comprehensive and systematic reviews of the impact of medical errors on healthcare professionals, their coping responses, and support systems for these second victims. Additionally, several institutes related to patient safety provide official guidelines and accessible support systems to support second victims in the aftermath of medical errors, especially serious adverse events. Conclusion: The impact of medical errors on healthcare professionals is profound and complex. Although systematic support systems for second victims are imperative, this has been overlooked in Korea. Thus, more research about the experiences of healthcare professionals after medical errors needs to be conducted prior to developing support systems or programs. Additionally, further efforts are required to raise awareness of the necessity of supporting healthcare professionals in healthcare systems.

• The Korean Journal of Pain
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• v.26 no.1
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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.

• The Journal of Internal Korean Medicine
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• v.43 no.1
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• pp.79-89
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• 2022

This study examined the clinical effects of Korean medicine therapy in a patient with hypopharyngeal cancer treated with chemotherapy. A 53-year-old male patient suffering from hypopharyngeal cancer was treated with docetaxel as well as acupuncture and herbal medicine. Tumor size was measured by computed tomography (CT) and adverse events were evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. After two months of combined treatment, the size of the tumor mass was reduced at the left side of the neck, posterior to the CCA and at the lymph node in the left retropharyngeal area and medial aspect of the carotid sheath. The adverse events of chemotherapy also improved. This study indicates that Korean medicine therapy, such as acupuncture and herbal medicine, may lessen the side effects of chemotherapy and may be effective in the treatment of hypopharyngeal cancer.

• Journal of Korean Neurosurgical Society
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• v.65 no.6
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• pp.853-860
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• 2022

Objective : This prospective, randomized, double-blinded trial aimed to evaluate the efficacy and safety of prophylactic ramosetron administration against postoperative nausea and vomiting (PONV) in patients undergoing microvascular decompression (MVD). Methods : In this study, 100 patients undergoing MVD were randomly allocated to the control (normal saline, 2 mL) or ramosetron (ramosetron, 0.3 mg) groups at the end of surgery. The incidence and severity of PONV, need for rescue antiemetics, patient satisfaction score, duration of hospital stay, and the occurrence of adverse events were evaluated 48 hours post-surgery. Results : Data obtained from 97 patients were included in the final analysis. The incidence of PONV was significantly lower in the ramosetron group than in the control group throughout the 48-hour postoperative period (29.2% vs. 51.0%, p=0.028). A similar trend was observed with regard to PONV severity (p=0.041). The need for rescue antiemetics, satisfaction score, duration of hospital stays, and the occurrence of adverse events did not significantly differ between the groups. Conclusion : Prophylactic ramosetron administration reduced the incidence and severity of PONV in patients undergoing MVD without causing serious adverse events. Thus, ramosetron use may improve patient recovery following MVD.

• Journal of Yeungnam Medical Science
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• v.38 no.4
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• pp.366-370
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• 2021

Immune checkpoint inhibitors (ICIs) have become the main drugs for programmed cell death receptor-1 or ligand-1 expressing non-small cell lung cancer (NSCLC) combined with conventional chemotherapy. ICIs are generally more tolerable than cytotoxic chemotherapies in terms of toxicity, and ICI-related adverse events are mild and manageable. However, these drugs may lead to unexpected severe adverse events such as immune-related hematologic toxicities, which could be life-threatening. Here, a rare case of a pembrolizumab-related adverse event in a patient with NSCLC who showed early-onset hemolytic anemia and recovered by high-dose steroid and a series of plasma exchanges is reported.

• Journal of the Korea Society of Computer and Information
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• v.14 no.3
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• pp.183-192
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• 2009

ADESS(Adverse drug event surveillance system) is the system which distinguishes adverse drug events using adverse drug signals. This system shows superior effectiveness in adverse drug surveillance than current methods such as volunteer reporting or char review. In this study, we built clinical data mart(CDM) for the development of ADESS. This CDM could obtain data reliability by applying data quality management and the most suitable clustering number(n=4) was gained through the reproducibility assessment in unsupervised learning techniques of knowledge discovery. As the result of analysis, by applying the clustering number(N=4) K-means, Kohonen, and two-step clustering models were produced and we confirmed that the K-means algorithm makes the most closest clustering to the result of adverse drug events.

• Journal of Korean Medicine Rehabilitation
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• v.21 no.2
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• pp.265-278
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• 2011

Objectives : This trial were conducted to evaluate the efficacy and adverse events of Bofutsusho-san(BTS) and Boiogiot-tang(BOT) by oriental obesity pattern identification on obese subjects, as compared to placebo. Methods : 166 subjects(body mass index ${\geq}25kg/m^2$) were recruited and randomized to receive BT(n=55), FH(n=55) or placebo(n=56) for 8 weeks. Anthropometric factors, serum lipid, glucose, blood pressure(BP), pulse rate, resting metabolic rate and oriental obesity pattern identification questionnaire were measured at baseline and 8 weeks. Adverse events and safety outcome variables were also checked during trials. Results : The frequency of top-scored oriental obesity pattern was ordered by indigestion(食積) > stagnation of the liver qi(肝鬱) > yang deficiency(陽虛) > spleen deficiency(脾虛) > phlegm(痰飮) > blood stasis(瘀血) in subjects. BTS group significantly decreased body weight, body mass index(BMI), waist circumference(WC), body fat mass, total cholesterol and HDL-cholesterol in stagnation of the liver qi(肝鬱) and WC in indigestion(食積). BOT group showed significant decrease of body weight, BMI, WC, and body fat mass in indigestion(食積) not in deficiency(虛症). Adverse events were reported most frequently in yang deficiency(陽虛) by BT group and stagnation of the liver qi(肝鬱) by BOT group. Conclusions : Bofu-tsusho-san was effective in treating obesity with stagnation of the liver qi(肝鬱). Obesity pattern identification could be a useful diagnostic tool predicting treatment effects and adverse events.

• Journal of Korean Medicine Rehabilitation
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• v.28 no.3
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• pp.119-124
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• 2018

Three cases of simple exanthematous eruption were suspected during Sumsu (Bufonis Venenum) pharmacopuncture (SP) topical anesthesia for acupotomy. Patients had skin rash with pruritus on both ankle, posterior neck, and left shoulder after 11, 12, and 7 times of SP treatment, respectively. There were no cases of systemic manifestations or changes in vital signs. As a result of using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment, all the cases were evaluated as 'unlikely'. However, the results of using the Korean algorithm for assessing the causality of drug adverse reactions version 2.0 were evaluated as 'possible'. This report is the first case report on adverse events suspected of occurring after SP treatment. Although the causal relationship between suspected intervention and the adverse event is not clear, there was a difficulty in completely excluding the possibility. Additional safety studies will be required to make SP more widely available.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.171-178
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• 2019

This study was conducted to observe the differences in perspective of medical device adverse events and report exchange for domestic stakeholders. The post-market surveillance of medical device not only improves the usability and functionality of the device but also identifies new or growing risks caused by the device. APEC (Asia-Pacific Economic Cooperation) have established and operated post-market surveillance systems for medical devices based on IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) guidelines. However, there are significant gaps in many aspects. It is essential to apply harmonized guidelines internationally but also to interpret and apply the guidelines consistently to report and exchange medical device adverse event in domestic. This study retrospectively analyzed the results of surveys conducted by providing examples of the adverse events and guidelines for post-market surveillance. The results of the study showed that there was a considerable difference in the judgment on the phase of using medical device for patient. In the case of medical device adverse event, different opinions shown according to knowledge and experience. Education and training are needed to have a harmonized perspective on the reporting and exchanging international guidelines of the adverse event for domestic stakeholders.

• Korean Journal of Radiology
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• v.23 no.8
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• pp.828-834
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• 2022

Objective: This study aimed to assess the outcomes of outpatient day-care management of unruptured intracranial aneurysm (UIA), and to present the risks associated with different management strategies by comparing the outcomes and adverse events between outpatient day-care management and management with longer admission periods. Materials and Methods: This retrospective cohort study used prospectively registered data and was approved by a local institutional review board. We enrolled 956 UIAs from 811 consecutive patients (mean age ± standard deviation, 57 ± 10.7 years; male:female = 247:564) from 2017 to 2020. We compared the outcomes after embolization among the different admission-length groups (1, 2, and ≥ 3 days). The outcomes included pre- and post-modified Rankin Scale (mRS) scores and rates of adverse events, cure, recurrence, and reprocedure. Events were defined as any cerebrovascular problems, including minor and major stroke, death, or hemorrhage. Results: The mean admission period was 2 days, and 175 patients (191 aneurysms), 551 patients (664 aneurysms), and 85 patients (101 aneurysms) were discharged on the day of the procedure, day 2, and day 3 or later, respectively. During the mean 17-month follow-up period (range 6-53 months; 2757 patient years), no change in post-mRS was observed compared to pre-mRS in 99.6% of patients. Cure was achieved in 95.6% patients; minimal recurrence that did not require re-procedure occurred in 3.5% patients, and re-procedure was required in 2.3% (22 of 956) patients due to progressive enlargement of the recurrent sac during follow up (mean 17 months, range, 6-53 months). There were eight adverse events (0.8%), including five cerebrovascular (two major stroke, two minor strokes and one transient ischemic stroke), and three non-cerebrovascular events. Statistical comparison between groups with different admission lengths (1, 2, and ≥ 3 days) revealed no difference in the outcomes. Conclusion: This study revealed no difference in outcomes and adverse events according to the admission period, and suggested that UIA could be managed by outpatient day-care embolization.