• Title/Summary/Keyword: Report on Adverse Drug Reactions

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Promotion of Adverse Drug Reactions Report through Expansion of Drug Utilization Review (의약품 사용평가(DUR) 확대를 통한 의약품 부작용 보고 활성화 방안)

  • Jeong, Su-Cheol
    • The Journal of the Korea Contents Association
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    • v.19 no.1
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    • pp.234-241
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    • 2019
  • The side effects of using drugs can greatly threaten the health of the public. The reality is that there are very few reports of current side effects. This can be activated by linking adverse drug reactions reporting to the Drug Utilization Review (DUR) currently used by pharmacies. A study of the U.S. medication management system, where drug use assessment is activated, can find ways to activate adverse drug reactions reporting. In 'Pharm IT 3000', which is used as a medication management program in pharmacies, we examined how to enable reporting of adverse drug reactions. The literature study and research on actual program operation have found a convenient way to report side effects by linking the Pharm IT 3000 prescription preparation assessment to the item.

A Study on the Introduction of Self-directed Pharmaceutical Training Education through the Analysis of Pharmaceutical Education in Korea and the U.S. (한국과 미국의 약사 연수 교육 분석을 통한 자기 주도적 약사 연수 교육 도입 방안)

  • Jeong, Su-Cheol
    • The Journal of the Korea Contents Association
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    • v.19 no.1
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    • pp.598-607
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    • 2019
  • The side effects of using drugs can greatly threaten the health of the public. The reality is that there are very few reports of current side effects. This can be activated by linking adverse drug reactions reporting to the Drug Utilization Review (DUR) currently used by pharmacies. A study of the U.S. medication management system, where drug use assessment is activated, can find ways to activate adverse drug reactions reporting. In 'Pharm IT 3000', which is used as a medication management program in pharmacies, we examined how to enable reporting of adverse drug reactions. The literature study and research on actual program operation have found a convenient way to report side effects by linking the Pharm IT 3000 prescription preparation assessment to the item.

Analysis of Adverse Drug Reaction Reports using Text Mining (텍스트마이닝을 이용한 약물유해반응 보고자료 분석)

  • Kim, Hyon Hee;Rhew, Kiyon
    • Korean Journal of Clinical Pharmacy
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    • v.27 no.4
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    • pp.221-227
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    • 2017
  • Background: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. Methods: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. Results: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. Conclusion: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.

Adverse Drug Reactions of Patient with Cervical Spondylotic Myelopathy Treated by Soshiho-tang (Cervical Spondylotic Myelopathy 환자에게 소시호탕(小柴胡湯) 투여 후 발생한 약물유해반응에 관한 임상 보고)

  • Park, Jae Kyung
    • 대한상한금궤의학회지
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    • v.9 no.1
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    • pp.47-58
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    • 2017
  • Objective : The purpose of this paper is to report the adverse drug reactions of patient with cervical spondylotic myelopathy(CSM) treated by herb medicine, Soshiho-tang. Methods : The patient was prescribed Soshiho-tang herbal medicine for 9days. The patient complained of dizziness, difficulty of concentration and elevation of blood pressure on the 6th day. The doctor made the patient stop to take the herbal medicine and every symptoms and abnormal blood pressure are normalized after 6 days. The abnormal responses were assessed by WHO-UMC Causality Categories and LDS scale. Results : The WHO-UMC Causality is 'probable/likely' and LDS scale is 5, it means 'moderate' severity. Conclusions : The herbal medicine, Soshiho-tang is relevant to abnormal responses of the patient with CSM. This is a first case report of hypertension induced by herbal medicine, Soshiho-tang in Korea.

Clinical characteristics of adverse reaction to radiocontrast media in children - A single center experience (소아에서 방사선 조영제 유해반응의 임상적 특징)

  • Kim, Min Jung;Lee, Bo Ra;Choi, Young Hun;Kang, Dong Yoon;Kang, Hye-Ryun;Suh, Dong In
    • Allergy, Asthma & Respiratory Disease
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    • v.6 no.6
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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.

Simultaneous hypersensitivity reactions to trimethoprim-sulfamethoxazole and amoxicillin-clavulanate in a dog

  • Yunho Jeong ;Yoon-Hwan Kim ;Jin-Ok Ahn;Jin-Young Chung
    • Journal of Veterinary Science
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    • v.24 no.6
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    • pp.77.1-77.7
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    • 2023
  • Antibiotics are known to be able to cause hypersensitivity reactions through various mechanisms. We present a case of drug-induced immune thrombocytopenia (DITP) and anaphylactic shock occurring simultaneously in a dog after the administration of two classes of antibiotics, namely trimethoprim-sulfamethoxazole (TMP-SMX) and amoxicillin-clavulanate (AMC). The patient recovered completely from DITP on discontinuation of TMP-SMX and the anaphylactic shock caused by AMC was treated with intensive care. DITP is a rare adverse drug reaction (ADR), and anaphylactic shock is a life-threatening ADR. This is the first case report of a dog manifesting two types of hypersensitivity reactions caused by two antibiotics.

Treatment of Drug-Induced Erythema Multiforme: Case Report

  • Lee, Hae-Ohk;Ju, Hye-Min;Lee, Ji-Yeon;Jeon, Hye-Mi;Kim, Kyung-Hee;Ok, Soo-Min;Ahn, Yong-Woo;Jeong, Sung-Hee
    • Journal of Oral Medicine and Pain
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    • v.44 no.4
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    • pp.183-188
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    • 2019
  • Erythema multiforme (EM) is an inflammatory immune-mediated mucosal disease. EM is classified as EM minor or EM major, depending on the severity of symptoms. Most patients with minor or major forms of EM have oral lesions. EM can occur as a result of adverse drug reactions but this is difficult to establish. Several indicators have been developed that can be used as a criterion of evaluation to ensure objectivity in identifying the causality of adverse drug reactions. The Naranjo algorithm was used in the evaluation to ensure objectivity in identifying the causality of adverse drug reactions. There were two cases of patients suspected of having EM induced by drugs. They were both assessed using the Naranjo algorithm to confirm the causality of the disease.

A Clinical Report on the Adverse Reactions of Sasangin by the Prescriptions of Soeumin.Soyangin (소음인(少陰人).소양인(少陽人) 처방에 대한 사상인(四象人)의 반응에 대한 임상보고)

  • Kim, Hyo-Jung;Kim, Jong-Yoel
    • Journal of Sasang Constitutional Medicine
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    • v.20 no.3
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    • pp.107-117
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    • 2008
  • 1. Objective The aim of this study was to survey the adverse reactions by the prescriptions of Soeumin.Soyangin and to compare the tendency of their symptoms according to Sasang constitutional type. 2. Methods The clinical data for this study were based on the medical records of total 91 cases collected from an oriental clinic during 1996-2004. Their constitutional types were diagnosed by a specialist and then confirmed by drug reactions. To evaluate reliability of the analysis, we only analysed the cases above grade C. The target prescriptions were Palmulgunja-tang, Bojungikgi-tang, Hyangsayangwi-tang, Ijung-tang, Hyeongbangsabaek-san, Jeoryeongchajeonja-tang, Yanggyeoksanhwa-tang, Yangdokbaekho-tang and the sorts of Jihwang-tang. 3. Results and Conclusion The prescriptions which were not suitable for their Sasang constitutional type induced indigestion, stomachache and evacuation troubles basically. Besides, the prescriptions of Soeumin caused some fever of the upper body and skin on Taeeumin and Soyangin. And the prescriptions of Soyangin lead to more severe digestive and evacuation troubles on Taeeumin and Soeumin. 4. Conclusion: This study need to be compensated by additional clinical studies which are more systematic and continuous. This way we can make the firm evidence for approving the difference of drug susceptibility according to the Sasang constitutional type.

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Analysis of Herbal-drug-associated Adverse Drug Reactions Using Data from Spontaneous Reporting System in Electronic Medical Records (EMR의 자발적 약물부작용보고 시스템을 이용한 한약약물유해반응 분석)

  • Kim, Mikyung;Han, Chang-Ho
    • The Journal of Korean Medicine
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    • v.36 no.1
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    • pp.45-60
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    • 2015
  • Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

The Surveillance of Adverse Drug Reaction(ADR) Reported (3차 병원에서 보고된 의약품 부작용 현황 조사와 약물 부작용 관리를 위한 약사의 인식도 조사)

  • Choi, Yun Hee;Sohn, Uy Dong
    • Korean Journal of Clinical Pharmacy
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    • v.13 no.2
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    • pp.72-81
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    • 2003
  • Adverse drug reaction (ADR) may increase hospital admission, morbidity and mortality and adding extra cost to healthcare expenditures. AIMS: This study was performed to identify the types of ADR being reported in a tertiary hospital, and to find out the ways to improve current ADR monitoring system. To investigate the attitudes of hospital pharmacists towards, and their understanding of ADR reporting. METHODS: Of 117 reports submitted to the pharmacy department during 3 months survey period, A questionnaire survey of 75 randomly selected hospital pharmacists was conducted. RESULT: Of the report was from patients aged between 60 and 70. The medical department with the high frequency in ADR reporting was Internal Medicines $(60\%)$. The most common ADR manifestations were gastrointestinal complaints $(47.8\%)\;and\;80\%$ of the reported cases were mild in their severity. The most common drugs suspected of causing ADR were CNS drugs which accounted for $38.4\%.\;55.5\%$ of respondent were aware of the need to education and information about ADR monitoring. The important reasons for unreporting ADR were unknown of how to report ADRs $(94.6\%)$. CONCLUSIONS: An ADR reporting system based on reporting by staff pharmacists has been effective increasing the number of reported reactions and pharmacist involvement in monitoring patients for ADRs. Pharmacists have the knowledge and responsibility to contribute to ADR reporting program. A great opportunity exists for pharmacists to contribute in this area of patient care.

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