• 한국임상약학회지
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• 제21권2호
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• pp.138-144
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• 2011

In order to minimize such adverse drug reactions, governments and international organs have been on the watch for them. Also in South Korea, a system has been established in order that adverse drug reactions may be reported to Korea Food and Drug Administration(KFDA). This study is to analyze drugs to cause adverse reactions, the adverse reactions and patients concerned on the authority of the data of Korea FDA, which is expected to be the preliminary data on preventable adverse reactions. This study was conducted on the 74,037 cases of adverse drug reactions reported to Korea FDA between January 2007 and June 2010. Fentanyl, iopromide and tramadol caused adverse reactions with high frequencies. Oseltamivir showed a high frequency between 2009 and 2010 due to the influence of the new influenza A. Also, OTC drugs accounted for approximately 5% of the adverse reactions. In 2009, adverse drug reactions remarkably increased (2,106 cases; 10.1%) in infants and children due to the new influenza-A(H1N1). The patients aged between 31 and 64 accounted for approximately 55% during the given period. There was no significant intergender difference. In relation to regions, the adverse reactions most frequently occurred in the gastrointestinal system and the integumentary system for three and half years. In addition to anticancer drugs and immunosuppressive drugs that are known to cause adverse reactions frequently, not a few of OTC drugs and external preparations caused such reactions. In particular, the drugs containing specific ingredients caused adverse reactions more frequently than others from 2007 until the first half of 2010. It is advisable for prescribers to acquaint themselves with such adverse reactions and to prescribe drugs other than them. They also have need to sensibly cope with adverse drug reactions just in case they have no substitute drugs. In addition, patients also need to be trained to understand possible adverse reactions in order that they can sensibly accommodate them or choose healthcare services. The results of this study are expected to be helpful to minimize adverse drug reactions.

• 한국임상약학회지
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• 제20권2호
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• pp.151-158
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• 2010

Therapeutic drug monitoring of Mycophenolate mofetil(MMF) has been suggested in some clinical trials, but has not been widely adopted in Korea. The purpose of this study was to analyze the withdrawal rates of MMF and determine the characteristics of the patients who experienced adverse reactions with MMF therapy and to suggest the criteria for selecting patients who need monitoring of MMF levels. We retrospectively collected data of patients who started MMF between July 2007 and June 2008. A total of 154 adult patients were included in our study. Among them, ninety seven patients discontinued MMF with 59 cases being due to adverse drug reactions. Thirty one patients required dosage reduction of MMF with twenty three cases being due to adverse reactions. Twenty six patients continued the MMF without or with mild adverse reactions. Of the 82 adverse reaction cases, hematologic adverse reactions accounted for 38 cases (46%) and gastrointestinal (GI) adverse reactions accounted for 28 cases (34%). Older age and lower serum albumin levels were significantly different characteristics between the patients who withdraw MMF due to hematological adverse reactions and those who were able to continue therapy. The group who experienced GI adverse reactions had higher MMF dosages based on body weight and lower serum albumin levels. In conclusion, the factors affecting the adverse reactions of MMF were age, serum albumin level and higher dosage, therefore therapeutic drug monitoring of MMF should be considered in these patients.

• 한방안이비인후피부과학회지
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• 제31권3호
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• pp.50-59
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• 2018

Objectives : The aim of this review is to investigate studies on skin adverse reactions and to demonstrate subjects related to the adverse effects in dermatology. Methods : Electric searches were performed with KISS(Korean studies Information Search System) and the key words were combination of 'skin' and 'adverse effect'. 87 literatures investigated in this review were issued from 1900 to 2016. Results : Among the 87 papers, dermatologic adverse reactions were reported in 83 papers in medicine, accounting for 95.4%. Of the adverse effects seen on the skin, 84 discoloration such as erythema, pigmentation and hemotelangiosis were the most common, accounting for 21%. Among the medical adverse reactions not seen on the skin, 21 infection were the most common, accounting for 25%. Among the subjective adverse reactions, of which 32 pruritus were the most common, accounting for 43%. Among the 87 papers, there were 3 cases with underlying diabetes and 3 cases with underlying hypertension, followed by 2 cases with chronic renal failure, HBV, atopic dermatitis and respectively 1 case with alcoholism, depression addiction, multiple myeloma, arthritis and psoriasis. The most frequent period until adverse reactions appeared was within 2 weeks, accounting for 13 papers. And 4 were the most frequent adverse reactions lasting less than 1 month, and 4 were more than 3 months and less than 6 months. There were 48 cases where adverse reactions were caused by nonmedical practioner's treatment. The adverse reactions by the pharmacist were the highest at 11 cases (23%). There were 17 cases of adverse reactions due to medical treatment, among which dermatologists and nondermatologists accounted for the majority of 5 cases, 29%. The most common cause of adverse reactions was the application of external medicine (41 cases), followed by 36 cases of foreign body implantation, eyebrow tattooing, ear piercing, etc. Conclusions : In this report, we demonstrated patterns of adverse reactions in the medical field of dermatology caused by non-medical personnel than medical personnel. We suggest that more effort should be followed by medical personnel to establish clear awareness of skin disease and by patients to be aware of the risks of the illegal medical treatment by non-medical personnel.

• Journal of Korean Biological Nursing Science
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• 제6권2호
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• pp.57-68
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• 2004

The contrast medium is very commonly used in more than 90% of computed tomography(CT) scans. It is difficult to predict the occurrence of adverse reactions and the degree of adverse reactions are diverse from mild urticaria, itching, nausea, vomiting to even cardiopulmonary arrest. The purpose of this study was to evaluate the symptoms, occurrence rate and risk factors of the adverse reactions in patients after contrast injection during CT examinations. Two hundreds sixty-five patients showed symptoms of adverse reactions out of 71,117 adult patients who received intravenous contrast administration during CT scans from January 2003 to December 2003 at a general hospital. Data was collected by reviewing adverse reaction records and electronic medical record. The results of this study were as follows; 1. Adverse reactions occurred in 265 out of a total of 71,117 patients(0.37%). Clinical symptoms of adverse reactions were most commonly dermatologic problems such as urticaria(69.81%) and itching(63.02%), followed by dyspnea(14.34%), dizziness(11.70%), nausea(6.79%), and vomiting(7.17%). 2. Anaphylactoid reactions occurred in 47 out of a total of 265 patients, and their pattern of symptoms were most commonly related to cardiovascular system(90.91%), followed by respiratory system(82.22%), gastrointestinal system(51.72%), and dermatologic system(16.51%). Eleven patients were transferred to emergency room for further treatment and two patients needed cardiopulmonary resuscitation. 3. The adverse reactions were significantly more common in women than in men(0.46% vs.0.32%, p=.003) and in type D contrast medium than the others(p<.001). The occurrence rate of adverse reactions was not significantly different according to the age and infusion speed of the contrast medium.

• 한국임상약학회지
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• 제18권1호
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• pp.18-27
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• 2008

This study investigated social relief schemes for serious adverse drug reactions in foreign countries and deduced lessons and implications for Korea to implement the scheme. A social relief scheme for serious adverse drug reactions provides reliefs for diseases and such health effects as disabilities or deaths that were caused by adverse reactions to pharmaceuticals prescribed at hospitals and clinics as well as those purchased at pharmacies notwithstanding their proper use. The US and the UK do not have specific relief schemes for adverse drug reactions but apply rules of strict liability or negligence. New Zealand and Nordic countries provide no-fault compensation schemes for health effects or injuries caused by medical treatments or medicinal products. Japan and Taiwan have operated the schemes since 1980 and 2000, respectively. In designing the scheme in Korea, we suggested that cases eligible for relief be confined to serious adverse reactions such as death or disability and then extended to diseases. It is desirable to encourage the reporting system of adverse drug reactions and quality use of medicines for the relief scheme to work efficiently.

• Allergy, Asthma & Respiratory Disease
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• 제6권6호
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• pp.315-321
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• 2018

Purpose: Radiocontrast media are widely used in medical imaging to improve diagnostic accuracy. However, studies on the adverse reactions of radiocontrast media in children are limited. We aimed to describe the characteristics of adverse reactions to radiocontrast media among children who had a computed tomography scan or magnetic resonance imaging in a tertiary university hospital. Methods: We retrospectively collected data on adverse reactions to radiocontrast media by the reporting system of a tertiary university hospital. We selected data from children under the age of 19 from July 2011 to December 2017 and analyzed their characteristics. We focused mainly on the characteristics of the index case which is defined by the first adverse event of each subject. Results: During the period, a total of 88,050 radiocontrast media-enhanced imaging studies were performed and 184 cases of adverse reactions were reported. A total of 71 were identified as index cases. Forty-nine (69.0%) were male and the mean age was $12.7{\pm}3.2$ years. The incidence of radiocontrast media-related adverse reactions was 0.09% and severe reactions were 0.002%. The most common clinical feature was skin manifestations (54.9%), followed by gastrointestinal symptoms (40.8%) and neuropsychiatric symptoms (7.4%). Conclusion: Adverse reactions to radiocontrast media rarely occur in children and the incidence of severe reactions is low. Most reactions are mild and are related to the skin and gastrointestinal system. This report would provide good evidence for establishing a management strategy in children scheduled for imaging studies using radiocontrast media.

• 대한방사선기술학회지:방사선기술과학
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• 제44권1호
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• pp.47-52
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• 2021

The incidence of adverse reactions to iodide contrast media was found to have increased owing to their increased use in computed tomography, but the exact reasons were unknown. Based on reported iodide contrast media adverse reactions data, it is recommended to the components of iodide contrast media before use to minimize adverse reactions. It was found that the use of iopromide and iomeprol in iodide contrast media resulted in a higher incidences of death and threat of life resulting from adverse reactions than other ingredients. Patients who are administered iodide contrast media containing iopromide and iomeprol during the computed tomography test should be carefully examined by the relevant medical professional, as the significance of gender and age varies from component to component. As multiple iodide contrast agents are available, the use of an appropriate iodide contrast media will reduce the incidence of iodide contrast media adverse reactions.

• Journal of Interdisciplinary Genomics
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• 제3권1호
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• pp.7-12
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• 2021

Adverse drug reactions (ADRs) is a hypersensitivity reactions to specific medications, and remain a common and major problem in healthcare. ADRs suchc as drug-induced liver injury and life-threatening severe cutaneous adverse drug reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms can be occurred by uncontrolled expansion of oligoclonal T cells according to genetically predisposing HLA. In this review, I summarized the alleles of HLA genes which have been proposed to have association with ADRs caused by different drugs.

• 한국콘텐츠학회논문지
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• 제19권1호
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• pp.234-241
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• 2019

의약품을 사용할 때 나타나는 부작용은 국민의 건강을 크게 위협할 수 있다. 현재 의약품 부작용에 대한 보고가 매우 미흡한 것이 현실이다. 이에 현재 약국에서 사용하고 있는 의약품 사용평가(DUR:Drug Utilization Review)에 의약품 부작용 보고를 연계하게 된다면 활성화될 수 있다. 의약품 사용평가가 활성화되어 있는 미국 의약품 관리 체계 연구를 통해 의약품 부작용 보고 활성화 방안을 찾을 수 있다. 약국에서 의약품 관리 프로그램으로 사용되는 'Pharm IT 3000'에서 의약품 부작용 보고의 활성화 방안을 연구해 보았다. 문헌연구와 실제 프로그램 운영 방식 연구를 통해 Pharm IT 3000 처방 조제 현황 항목에 의약품 사용평가를 연동시켜 부작용 보고가 편리하게 되는 방안을 찾게 되었다.

• 한국임상약학회지
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• 제28권2호
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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.