• Safety and Health at Work
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• v.13 no.2
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• pp.163-169
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• 2022

Background: It is estimated that about 13 million artisanal and small-scale miners carry out their activities under harsh, precarious, unfriendly, and risky conditions. Yet, our understanding of the extent to which these workers use personal protective equipment (PPE) and navigate through the various risks and hazards they face is still limited. This article has two main objectives. First, it explores the extent of usage of PPE among artisanal and small-scale miners for the prevention of hazards and risks. Second, it examines the coping strategies used by these miners as a response to experiences of occupational injuries and risks Methods: A cross-sectional survey of small-scale miners was conducted in six communities across three districts in Ghana, West Africa. The mixed methods approach was adopted. A total of 148 small-scale miners participated in the study. Six focus group discussions (FGDs) were held across the six communities. The data were analysed using descriptive statistics. Chi-square tests were used to analyse the relationship between some socio-demographic characteristics (sex, age, and educational background) and the usage of PPE. Open-ended questions and responses from FGDs were analysed based on the content and verbatim quotations from miners. Results: Findings suggest that 78% of the miners interviewed do not use the appropriate PPE citing reasons such as cost, and their personal discomfort associated with use of PPE. There was no significant relationship between socio-demographic characteristics (i.e., sex, age, education and major mining activity) and the usage of PPE. The study further revealed four main coping strategies used by miners to handle the risks. These are rest, taking unprescribed medication and hard drugs, registration with health insurance scheme and savings and investments. Conclusion: This study shows that very few artisanal miners use PPE despite the significant hazards and risks to which they are exposed. The study recommends to the government to put in place measures to ensure that miners adhere to health and safety regulations before undertaking mining activities. This means that health and safety plans and use of PPE should be linked to the license acquisition process for miners.

• The Journal of Internal Korean Medicine
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• v.33 no.4
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• pp.485-497
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• 2012

Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.

• Journal of the korean academy of Pediatric Dentistry
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• v.45 no.3
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• pp.393-399
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• 2018

The aim of this review is to introduce about the issue of benzocaine and methemoglobinemia. Through blocking the pain during dental treatment, fear and anxiety of patients will be reduced. Thus, anesthetic agent containing benzocaine is commonly used while controlling the pain of patients during treatment. However, on May 28, 2018, the Ministry of Food and Drug Safety reported a medication safety report about restricting the use of benzocaine-containing agents in infants under 24 months and children. Also, they recommended a cautious use to adolescents and adults to prevent methemoglobinemia (MHb). This report was published due to an advice from Food and Drug Administration (FDA) on May 23, 2018. When using agents containing benzocaine, dentists must consider the probability of MHb and prepare for early diagnosis and appropriate action. Since 1930s, methylene blue is known to cure MHb patients. Therefore, the proper use of methylene blue for emergencies and diagnosis methods for early diagnosis of MHb should be familiar to dentists planning for the use of topical anesthetic agents. Dentists should be trained for emergency situation of MHb caused by the use of benzocaine.

• Journal of Physiology & Pathology in Korean Medicine
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• v.17 no.6
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• pp.1514-1518
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• 2003

Angelica sinensis radix, Danggui, is a traditional oriental medication, which has been used to modulate immune response. We report here that aqueous extract of Angelica sinensis radix (ASR) can induces NO production, and inhibit LPS-induced NO production in dose-dependent manner in RAW 264.7 macrophage cells. ASR also induces iNOS mRNA and iNOS protein expression, and exhibit inhibitory effect on iNOS mRNA and protein expression in a dose-dependent manner in LPS-stimulated RAW 264.7 macrophage cells. Cytokines involved in the regulation of inflammatory reaction and immune response may play a role in the pathogenesis. ASR induces. pro-inflammatory cytokine gene expression (IL-1α, IL-1β and IL-6 gene) in a dose-dependent manner, and inhibits the expressions of these cytokines in LPS-stimulated RAW 264.7 macrophage cells. These data indicate that (1) ASR may be a potential therapeutic modulator of NO synthesis in various pathological conditions, and (2) the immunomodulatory effects of ASR may be, in part, associated with the inducing or suppression of pro-inflammatory cytokine gene expressions.

• Journal of Fisheries and Marine Sciences Education
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• v.25 no.5
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• pp.1179-1191
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• 2013

Many sanitation control problems due to aging facilities and equipment were identified when applying an HACCP system to a flatfish (Paralichthys olivaceus) aquaculture farm. Specifically, the major problems included a lack of awareness about worker hygiene, lack of management of the use of fish medicines, and vulnerability to secondary contamination by cross-contamination owing to a failure to separate breeding tools used for healthy and unhealthy fish. Therefore, the management standards on the farm regarding the surrounding environment, facilities and equipment, breeding tools, feed and medication, and the hygiene of practitioners must be improved. The hygiene management standards were divided into different procedures such as the management of farm hygiene and environmental sanitation, facilities and equipment, fish hygiene, feed, medications, water, and the stocking and shipping of fish. For each procedure, we established the management standards, inspection period, inspection procedures, and how to deal with errors that occur, to enable hygiene management by a small number of managers. Additionally, an inspection system and record form to implement an HACCP system were developed to maintain systematic management. The management and inspection of all aspects of the farm were designed to be easily managed by the supervisor.

• Korean Journal of Clinical Pharmacy
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• v.28 no.2
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• pp.88-94
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• 2018

Background: We strived to evaluate the status of nivolumab use and associated factors on the clinical efficacy of the drug. Methods: The study was retrospectively conducted in patients who had been administered nivolumab at least once at the cancer center of Seoul National University Hospital from June 2015 to April 2017. Data were collected from electronic medical records. A medication-use evaluation was performed based on the American Society of Health-System Pharmacists mediation-use guidelines. Results: Sixty-six of the 74 patients (89.2%) showed indications approved for nivolumab use by the Korean Ministry of Food and Drug Safety (MFDS; n=55) or the US Food and Drug Administration (FDA; n=11). Approximately 73.0% of the patients were administered the approved dose of 3 mg/kg but 25.7% were administered an unapproved fixed dose of 100 mg. The overall response rate was 21.7%, and the response rate of non-small cell lung cancer patients, who accounted for the largest number of indications, was 18.8%. Adverse reactions were found in 90.1% of the patients and were mostly mild (86%). The expression of programmed death-ligand 1 (PD-L1) was analyzed as a factor affecting treatment response (p=0.028, odds ratio [OR]=11.331). Conclusion: PD-L1 expression was found to affect treatment response. However, caution is required while using an unapproved dosage and in the absence of monitoring for effectiveness and safety. Therefore, an effective protocol or instruction manual for the proper use of nivolumab should be considered.

• Korean Journal of Clinical Pharmacy
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• v.24 no.4
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• pp.265-271
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• 2014

Objective: This study aims to explore the perception of off-label use of medications and the provision of informed consents from the general public's perspective. Methods: The study subjects (n=291) were recruited from 7 cities in Korea through a convenience sampling method. The self-administered questionnaire with 13 items was issued and collected. The study subjects who have had a pharmaceutical job were excluded. Results: The total of 231 respondents was included. Only 23% of respondents were familiar with the concept of off-label use of medications. Eighty five percent of respondents (n=196) stated that the prescribers should explain the off-label use of a medication to their patients. The preferred method for delivering the message was the oral explanation (n=122, 53%), followed by oral explanation plus a pamphlet (n=94, 41%). The safety issue is the most concerned aspect regarding the off-label drug use, also effectiveness and insurance coverage. The majority of respondents (n=217, 94%) agreed that the prescriber should get a consent from patients before prescribing medications for off-label use. They preferred written consent to oral consent (140 vs. 77). Conclusion: This study demonstrated general publics are infrequently aware of off-label use of medications. It is important to raise public awareness of the off-label use of medications and to openly discuss its pros and cons for safe and effective drug therapy.

• Kidney Research and Clinical Practice
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• v.36 no.3
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• pp.257-263
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• 2017

Background Rituximab (RTX) can be used as a rescue therapy for steroid-dependent nephrotic syndrome (SDNS). However, the efficacy and safety of long-term, repeated use of RTX are not established. This study was conducted to assess the efficacy and safety of long-term, repeated RTX treatment in children. Methods Eighteen consecutive child patients with SDNS who were treated with three or more cycles of RTX for one year or longer were recruited, and their medical records were retrospectively reviewed. Results The patients were followed for $4.7{\pm}1.9years$ and received $5.2{\pm}2.3cycles$ of RTX over $2.8{\pm}1.1years$. Approximately 70% of the additional RTX cycles were administered due to recovery of B-cells without relapse. The relapse rate decreased from $3.4{\pm}2.0per$ year initially to $0.4{\pm}0.8per$ year at the third year after RTX treatment. Approximately 10% of the RTX infusions were accompanied by mild infusion reactions. Eight patients showed sustained remission without any oral medication after the last cycle of RTX, while 10 patients had one or more episodes of relapse after the last cycle of RTX. The relapse rate in the latter group decreased from $2.8{\pm}1.5per$ year before RTX treatment to $1.3{\pm}0.8per$ year after cessation of RTX treatment. No significant differences in clinical parameters were found between the two groups. Conclusion This retrospective study showed that pre-emptive and long-term, repeated RTX treatment is relatively effective and safe in children with SDNS. However, well-designed prospective studies are needed to confirm these findings.

• The Journal of Korean Obstetrics and Gynecology
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• v.27 no.3
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• pp.94-103
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• 2014

Objectives: The aim of this study is to identify effects and safety of Korean traditional medicine, especially including Pinelliae Rhizoma, for hyperemesis gravidarum, and to suggest appropriate dosage and treatment duration of Pinelliae Rhizoma. Methods: The study was performed based on the medical records of 19 hyperemesis gravidarum patients treated with Korean traditional medicine including Pinelliae Rhizoma. Change of symptoms, continuance of pregnancy, malformation of infants, and delivery outcomes were analysed. Results: The symptoms of hyperemesis gravidarum were improved in 13 patients. With regards to pregnancy outcome, normal fullterm delivery was 16 case, preterm delivery was 1 case and abortion was 2 case, Infants malformation was not found in any case. The average daily dosage of Pinelliae Rhizoma was 6.53 g/day, and the average treatment duration of Pinelliae Rhizoma was 11.53 (day). Conclusions: In this study, using Korean traditional medicine including Pinelliae Rhizoma for hyperemesis gravidarum patients is considered safe if patients are treated with proper clinical dosage and duration of medication. More cases and studies in the future will be required for the appropriate use of Pinelliae Rhizoma for hyperemesis gravidarum patients.

• Korean Journal of Clinical Pharmacy
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• v.34 no.1
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• pp.39-61
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• 2024

Background: The Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Ministry of Food and Drug Safety (MFDS) have been implementing the expedited programs that promote the innovative approval of new medications to be used for serious diseases. The authors comprehensively investigated, analyzed, and compared the regulations and guidelines associated with the expedited programs. Methods: The expedited programs for innovative drug development and approval were searched from the homepages of FDA, EMA and MFDS. The detailed information on the regulations and guidelines associated with the programs was comprehensively extracted from various electronic repositories of each regulatory authority. The information on each program was analyzed, categorized, and compared from the points of benefits, applicability with scientific rationale, application procedure, and maintenance. Results: FDA's programs include Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. EMA's regulation implements PRIority MEdicines (PRIME), Accelerated Assessment, Marketing Authorization under Exceptional Circumstances (MAEC), and Conditional Marketing Authorization (CMA). MFDS has a single Expedited Program. These programs are broadly categorized into those that 1) facilitate early and proactive communication with regulatory authorities, 2) shorten the review time after submitting a marketing application, and 3) temporarily approve a marketing authorization under certain conditions. Conclusion: Each expedited program requires a different level and amount of safety and efficacy evidence to be submitted to each regulatory authority. This article will likely provide the comprehensive information on which program provides scientific and regulatory advantages to be taken for innovative medication development.