• Title/Summary/Keyword: ADRs

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Detecting and classification ADRs using Named Entity Recognition on social media (개체명 인식을 이용한 소셜 미디어에서의 약물 부작용 표현 추출 및 분류)

  • Jeong, Hyeon-jeong;Kim, Hyon Hee
    • Proceedings of the Korea Information Processing Society Conference
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    • 2021.05a
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    • pp.443-446
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    • 2021
  • 의약품에 대한 안전성 정보 수집과 관리는 온라인, 오프라인을 통해 약물 이상 사례를 보고받는 형태로 진행되고 있다. 하지만 소비자들의 자발적인 참여로 이루어지므로 실제 발생하는 약물 부작용보다 데이터가 현저히 적다는 단점이 존재한다. 본 논문에서는 약물 이상 데이터 희소성 문제를 해결 할 수 있도록 소셜 미디어에서 약물 부작용 표현을 찾을 수 있도록 하였다. 소셜 미디어의 경우에는 표준 약물 부작용 용어를 사용하기보다는 일반인들이 자연어로 표현한 경우가 많으므로 개체명 인식 기법을 이용해 부작용을 추출할 수 있는 모델을 개발하였다. 또한 추출된 부작용 표현을 표준용어로 분류할 수 있는 모델을 제시하였다. 실험 결과 제안한 두 가지 모델은 0.9 이상의 정확도를 얻을 수 있었으며, 일반 사용자들이 자연어로 표현한 약물 부작용 표현을 효과적으로 찾아내고 표준 부작용 용어로 매핑할 수 있음을 보여준다.

Brief Observation on Arbitration Agreement and Arbitral Award - Focusing on Construction Disputes - (중재합의와 중재판정에 관한 소고 -건설분쟁을 중심으로-)

  • Cho Dae-Yun
    • Journal of Arbitration Studies
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    • v.14 no.1
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    • pp.273-314
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    • 2004
  • There is a belief in the construction industry that the traditional court system may not be an ideal forum to effectively and efficiently resolve construction disputes due to the protracted proceedings and the three tier appeal system resulting in a long delay in the final and conclusive settlement of the dispute, relatively high costs involved, the lack of requisite knowledge and experience in the relevant industry, etc. Hence, they assert that certain alternative dispute resolution ('ADR') methods, such as mediation, conciliation, arbitration or a new system for dispute settlement in the form of any combination thereof should be developed and employed for construction disputes so as to resolve them more promptly and efficiently to the satisfaction of all the disputants concerned. This paper discusses certain merits of such assertions and the need for additional considerations for effective resolution of the construction disputes in light of the complexity of the case, importance of expert witnesses, parties' relationship and non-level playing field of the construction industry and so on. At the same time, however, given the inherent nature of disputes rendering the parties involved in an adversarial position, it would rather be difficult, if not practically impossible, to satisfy all the parties concerned in the dispute. Accordingly, in this study, it is also purported to address the demerits of such assertions by studying the situation from a more balanced perspective, in particular, in relation to the operation of such ADRs. In fact, most of such ADRs as stipulated by special acts, such as the Construction Industry Basic Act of Korea, in the form of mediation or conciliation, have failed to get support from the industry, and as a result, such ADRs are seldom used in practice. Tn contrast, the court system has been greatly improved by implementing a new concentrated review system and establishing several tribunals designed to specialize in the review and resolution of specific types of disputes, including the construction disputes. These improvements of the court system have been warmly received by the industry. Arbitration is another forum for settlement of construction disputes, which has grown and is expected to grow as the most effective ADR with the support from the construction industry. In this regard, the Korean Commercial Arbitration Board ('KCAB') has established a set of internal rules end procedures in operation to efficiently handle construction disputes. Considering the foregoing, this paper addresses the most important elements of the arbitration, i.e., arbitration agreement and arbitral award, primarily focusing on the domestic arbitrations before the KCAB. However, since this parer is prepared for presentation at the construction disputes seminar for the public audience, it is not intended for academic purposes, nor does it delve into any specific acadcmic issues. Likewise, although this paper addresses certain controversial issues by way of introduction, it mainly purports to facilitate the understanding of the general public, including the prospective arbitrators on the KCAB roster without the relevant legal education and background, concerning the importance of the integrity of the arbitration agreement and the arbitral award. In sum, what is purported in this study is simply to note that there are still many outstanding issues with mediation, conciliation and arbitration, as a matter of system, institutional operation or otherwise, for further study and consideration so as to enhance them as effective means for settlement of construction disputes, in replacement of or in conjunction with the court proceeding. For this purpose, it is essential for all the relevant parties, including lawyers, engineers, owners, contractors and social activists aiming to protect consumers' and subcontractors' interests, to conduct joint efforts to study the complicated nature of construction works and to develop effective means for examination and handling of the disputes of a technical nature, including the accumulation of the relevant industrial data. Based on the foregoing, the parties may be in a better position to select the appropriate dispute resolution mechanism, a court proceeding or in its stead, an effective ADR, considering the relevant factors of the subject construction works or the contract structure, such as the bargaining position of the parties, their financial status, confidentiality requirements, technical or commercial complexity of the case at hand, urgency for settlements, etc.

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Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity

  • Oh, Jaeseong;Yi, Sojeong;Gu, Namyi;Shin, Dongseong;Yu, Kyung-Sang;Yoon, Seo Hyun;Cho, Joo-Youn;Jang, In-Jin
    • Genomics & Informatics
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    • v.16 no.3
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    • pp.52-58
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    • 2018
  • In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.

Analysis of Drug Interaction Information (국내의약품의 약물상호작용 정보 분석)

  • Lee, Young-Sook;Lee, Ji-Seon;Lee, Suk-Hyang
    • Korean Journal of Clinical Pharmacy
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    • v.19 no.1
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    • pp.1-17
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    • 2009
  • Adverse drug reactions (ADR) caused by inappropriate prescription are responsible for major socioeconomic loss. Drug-drug interactions (DDI) has been recognized as a major part of ADRs and, therefore, healthcare professionals should prevent possible DDIs to minimize preventable ADRs. This study aimed to examine DDI information in drug information references and Korea Food & Drug Administration (KFDA) drug labeling information. Drug ingredients from the formulary of Health Insurance Review and Assessment Service in Korea (HIRA) were included for the study. DDI information source used for the study were Micromedex Drugdex and Drug Information Facts (DIF) with the DDI severity level of "moderate" or more. The DDI information in KFDA drug labeling were collected and compared. Drug ingredients were classified with KFDA Drug Classification and ATC Classification of WHO for the analysis. Among the total 1,355 drug ingredients satisfying inclusion criteria, 738 ingredients involved at least one DDI, which was described in Micromedex and/or DIF. Drug Ingredients of 176 involved DDI only described in KFDA drug labeling, but not Micromedex nor DIF. Drug ingredients of 35 which DDIs were described in Micromedex or DIF did not have DDI based on KFDA drug labeling. Micromedex and DIF retrieved 7,582 and 3,071 DDIs, respectively 57.6% and 58.5% of DDIs were also described in KFDA drug labeling. Central nervous system (CNS) drugs, cardiovascular system (CVS) drugs and the antiinfectives appeared to have higher frequency of DDIs among all drug classes. The highest number of DDIs with high severity level ("contraindicated" or "major") were the DDIs of CNS drugs. The antiinfectives are the second drug group having serious DDIs. The DDI pairs of the CNS drug and the antiinfective had the highest contraindication risk (13.6%). DDI information from Micromedex and DIF were not consistent with the result that only 465 ingredients' DDIs are common in both literature (total DDI numbers were 715 vs 488, respectively). And 1,652 DDI information are common in both references among 7,582 vs 3,071 DDIs, respectively. Only 55.2% of DDI information in the database contained in the KFDA drug labeling. Prescribers and pharmacists should pay attention to the drugs for CV system, CNS and infections because of higher risk of possible DDIs compared to other drug classes. KFDA drug labeling is not likely to be recommended as a good information source for DDI due to significant inconsistency of information. Drug information providers should be aware that DDI information from different sources are not consistent and therefore multiple references should be used.

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Comparative Evaluation between Environmental and Media ADR in terms of Legal Reservation of Compensation Clause (배상 규정의 법률유보 관점에서 환경과 언론 ADR 비교)

  • Um, Dan-Bi
    • Journal of Arbitration Studies
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    • v.22 no.1
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    • pp.43-63
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    • 2012
  • Media ADR is currently emerging as one of successful cases in South Korea while environmental ADR was known not to satisfy both defendants and offenders. Thus, this paper is intended to present proper remedies for typical compensation schemes of environmental ADR by comparing the two ADRs regarding legal reservation of compensation clause. It was found that the media ADR helped clients achieve a more fast and easy dispute resolution by providing compensation standards based on various categories such as types and scopes of compensation. However, the compensation scheme of environmental ADR brought out public complaints and inadequate services due to inconsistency and instability in terms of legal reservation. The results indicate that the compensation clause based on the reservation of laws in media ADR could be used not only as a checklist to confirm limitations of environmental ADR, but also as realistic evidences to adjust the compensation standard systematically that is under development and requires remodelling. As a result, the research findings have opened the new possibilities of "the quality assurance of environmental ADR based on the domestic legislation", proposed as an initial aim of this paper.

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A new non-iterative procedure to estimate seismic demands of structures

  • Mechaala, Abdelmounaim;Chikh, Benazouz
    • Earthquakes and Structures
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    • v.22 no.6
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    • pp.585-595
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    • 2022
  • Using the nonlinear static procedures has become very common in seismic codes to achieve the nonlinear response of the structure during an earthquake. The capacity spectrum method (CSM) adopted in ATC-40 is considered as one of the most known and useful procedures. For this procedure the seismic demand can be approximated from the maximum deformation of an equivalent linear elastic Single-Degree-of-Freedom system (SDOF) that has an equivalent damping ratio and period by using an iterative procedure. Data from the results of this procedure are plotted in acceleration- displacement response spectrum (ADRS) format. Different improvements have been made in order to have more accurate results compared to the Non Linear Time History Analysis (NL-THA). A new procedure is presented in this paper where the iteration process shall not be required. This will be done by estimation the ductility demand response spectrum (DDRS) and the corresponding effective damping of the bilinear system based on a new parameter of control, called normalized yield strength coefficient (η), while retaining the attraction of graphical implementation of the improved procedure of the FEMA-440. The proposed procedure accuracy should be verified with the NL-THA analysis results as a first implementation. The comparison shows that the new procedure provided a good estimation of the nonlinear response of the structure compared with those obtained when using the NL-THA analysis.

Comparison of Propacetamol plus Fentanyl and Fentanyl alone with Patient Controlled Analgesia after Total Knee Arthroplasty (수술 후 자가통증조절장치 사용 환자에서 propacetamol과 fentanyl 복합제 및 fentanyl 단일제제의 효과 비교)

  • Kim, Minhyung;Jeong, Hyokeun;Park, Sohyun;Rhie, Sandy Jeong
    • Korean Journal of Clinical Pharmacy
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    • v.28 no.1
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    • pp.17-23
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    • 2018
  • Objective: Opioid analgesics, for postoperative pain management, are an indispensable group of medication; however, they also have a variety of adverse drug reactions (ADR). Multimodal methods, combining non-opioid analgesics with opioid analgesics, have been investigated to increase the effects of analgesics and reduce ADR with opioid-sparing effects. The purpose of this study was to compare the effects of patient-controlled analgesia (PCA) with fentanyl alone, and PCA with fentanyl and intravenous (i.v.) propacetamol to determine the effects of pain control, cumulative opioid usage, and opioid ADR. Methods: The subjects were patients who underwent total knee arthroplasty at the Seoul Veterans hospital from January 1, 2015 to December 31, 2016. The study period was from postoperative day 0 (POD0) to day 3 (POD3), and the retrospective study was conducted using electronic medical records. Results: Pain severity was significantly low at POD1 (p = 0.017), POD2 (p = 0.003), and POD3 (p = 0.002) in the multimodal group. The fentanyl only group frequently reported both moderate and severe pain at a statistically significant level. This was consistent with the analysis of the pro re nata (PRN) intramuscular analgesia usage at the time of numerical rating scale (NRS) 4 and above. The opioid-sparing effect confirmed that the average opioid dose equivalent to i.v. morphine dose was 9.4 mg more than that used for the multimodal group in the fentanyl only group. The ADRs and length of stay between the two groups were not statistically different. Conclusion: The results of this study suggest that the combination therapy of fentanyl and i.v. propacetamol is superior to fentanyl monotherapy.

Adverse Drug Event Surveillance System using Electronic Data and the Signals (전산 데이타를 활용한 약물이상반응검토 및 시그널)

  • Kim, Eun-Young;Kang, Won-Ku;Kwon, Kwang-Il
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.383-389
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    • 2011
  • CSS for identifying ADEs are sufficiently developed for broad use and they are much more accurate than spontaneous reporting and more time- and cost-effective than manual chart review. Also computer alert systems can be used to identify opportunities to prevent or reduce patient injury associated with a broad range of ADEs. This CSS can be used to identify opportunities to prevent or reduce patient injury associated with preventable ADEs and increase patient safety, increase quality of drug therapy and decrease the extra-cost of the treatment for ADEs. In the future, increasing utilization of this concurrent CSS should have an enormous beneficial impact on the quality of medical care.

Evaluation of Drug Use Causing Delirium and Drowsiness in Elderly Patients of Korea (한국의 노인환자에 대한 섬망 및 졸음 유발 약물의 사용평가)

  • Cho, Ha-Na;Lee, Ok-Sang;Lim, Sung-Cil
    • Korean Journal of Clinical Pharmacy
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    • v.22 no.1
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    • pp.30-40
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    • 2012
  • In Korea, elderly population aged 65 and older are about 5.0% and 10.7% in 1990 and 2009, respectively. Since elderly people may experience physiologic changes with aging and their pharmacodynamic and pharmcokinetic parameters also have been undergone changes, several adverse drug reactions can occur more frequently than young people. Especially, neuropsychiatric adverse drug reactions such as delirium and drowsiness endanger elderly patients more. The purpose of this study is to evaluate the outpatient prescriptions using drug causing delirium and drowsiness in elderly patients aged 65 and older. We retrospectively reviewed prescriptions for elderly patients collected from four community pharmacies from January 2nd to February 1st, 2010. One pharmacy was located closed to a general hospital, and others were located closed to a internal medicine or an ENT clinic. The each number of the collected prescriptions was followings; Group A (n=496) from internal medicine department of a general hospital; Group B (n=44) from ENT department of general hospital; Group C (n=144) from internal medicine clinic; Group D (n=110) from ENT clinic. In result, in Group A, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.38 In Group B, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.09 In Group C, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.51. In Group D, the average number of prescribed drugs causing delirium or drowsiness per Rx was 2.72. Especially, in Group D, the percentage of prescription that drugs causing delirium or drowsiness per Rx prescribed more than 3 is 52.73% In all the 4 groups, over the 60% of drugs causing delirium and/or drowsiness per prescription of elderly patients were prescribed. It means elderly patients take 2 drugs causing delirium and/or drowsiness among 3 drugs, which is very serious. Frequently prescribed drugs causing delirium and/or drowsiness were followings; GI agents, antitussives & expectorants, histamine H1 antagonist, analgesics, antibiotics. Among these drugs, GI agents was high raking in all the 4 groups, and pharmacists should caution elderly patients when counseling. In the internal medicine groups (Group A,C), drugs concerning chronic diseases were prescribed frequently. In conclusion, pharmacist's role is important. Pharmacists are well informed of the drugs causing delirium or drowsiness and it is important to explain about ADRs slowly and easily to the elderly patients that receive drugs causing delirium or drowsiness. And institutional device is needed. For example, when doctors prescribe drugs for the elderly patients, message is needed that supply some informations about drugs causing delirium or drowsiness.

Evaluation of Prescription Data for Development of Warfarin Nomogram in Korean Patients with Cerebral Infarction (뇌졸중 환자군의 Warfarin Nomogram 설정을 위한 실제 처방전 평가)

  • Jang, Ju-Young;Ko, Kyung-Mi;Yoon, Ji-Yeon;Han, Ok-Yeon;Lim, Sung-Cil
    • YAKHAK HOEJI
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    • v.53 no.2
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    • pp.83-88
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    • 2009
  • Warfarin is the most widely used oral anticoagulant in the world but maintenance of proper therapeutic range and prevention of adverse drug events always need to be careful. Especially, in Korea, warfarin dosing for patients with cerebral infarction is currently based on the nomogram which is done by foreign clinical trials not for the Korean. Therefore we evaluate warfarin dose of patients in the neurology and eventually get the base data of warfarin nomogram for Korean with stroke. We performed this study retrospectively on reviewing the medical charts to evaluate the prescribed loading dose (LD) and maintenance dose (MD) of warfarin and each responding International Normalized Ratio (INR) with any bleeding adverse drug reaction including of patient's characteristics for total 75 patients with stroke in the department of neurology of Kangnam ST. Mary's Hospital from January 2005 to June 2008. All evaluated patients should not be treated with warfarin in the past at all and should be initiated warfarin therapy first.ly at this time. All evaluated patients were divided as two classes by wafarin LD which is; 1) HDG - a high loading dosing group prescribed over 5mg, and 2) LDG - a low loading dosing group prescribed 5mg or below. As a result, average LD was $9.34{\pm}0.22$ mg (p=0.000) in HDG and $4.25{\pm}0.39$ mg (p=0.000) in LDG. Average baseline INR was $0.91{\pm}0.05$ (p=0.161) in HDG and $1.26{\pm}0.14$ (p=0.002) in LDG. On the first and second week, daily MD was $4.21{\pm}0.14$ mg (p=0.000) and $2.96{\pm}0.19$ mg (p=0.696) in HDG and also in LDG, $2.95{\pm}0.29$ mg (p=0.000) and $3.14{\pm}0.36$ mg (p=0.696). Also average reacting daily INR was respectively $2.53{\pm}0.12$ (p=0.141) and $2.51{\pm}0.16$ (p=0.678) in HDG, and in LDG, $2.11{\pm}0.17$ (p=0.141) and $2.42{\pm}0.14$ (p=0.678). After the second week, INR was not measured in regularly. Also most of underlying diseases were hypertension (n=38), diabetes mellitus (n=14), dyslipidemia (n=8) in order. Four ADRs with simple hemorrhage were occurred and those were due to drug interaction by comedication. In the conclusion, proper starting LD for Korean with stroke is 10 mg if baseline INR is around 1.0 or 5 mg if over 1.3. Proper MD need to be more evaluated in the future for setting up warfarin nomogram to make prospective study.