• Title/Summary/Keyword: 의약품 부작용

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Research Direction for Functional Foods Safety (건강기능식품 안전관리 연구방향)

  • Jung, Ki-Hwa
    • Journal of Food Hygiene and Safety
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    • v.25 no.4
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    • pp.410-417
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    • 2010
  • Various functional foods, marketing health and functional effects, have been distributed in the market. These products, being in forms of foods, tablets, and capsules, are likely to be mistaken as drugs. In addition, non-experts may sell these as foods, or use these for therapy. Efforts for creating health food regulations or building regulatory system for improving the current status of functional foods have been made, but these have not been communicated to consumers yet. As a result, problems of circulating functional foods for therapy or adding illegal medical to such products have persisted, which has become worse by internet media. The cause of this problem can be categorized into (1) product itself and (2) its use, but in either case, one possible cause is lack of communications with consumers. Potential problems that can be caused by functional foods include illegal substances, hazardous substances, allergic reactions, considerations when administered to patients, drug interactions, ingredients with purity or concentrations too low to be detected, products with metabolic activations, health risks from over- or under-dose of vitamin and minerals, and products with alkaloids. (Journal of Health Science, 56, Supplement (2010)). The reason why side effects related to functional foods have been increasing is that under-qualified functional food companies are exaggerating the functionality for marketing purposes. KFDA has been informing consumers, through its web pages, to address the above mentioned issues related to functional foods, but there still is room for improvement, to promote proper use of functional foods and avoid drug interactions. Specifically, to address these issues, institutionalizing to collect information on approved products and their side effects, settling reevaluation systems, and standardizing preclinical tests and clinical tests are becoming urgent. Also to provide crucial information, unified database systems, seamlessly aggregating heterogeneous data in different domains, with user interfaces enabling effective one-stop search, are crucial.

High-Quality Standard Data-Based Pharmacovigilance System for Privacy and Personalization (프라이버시와 개인화를 위한 고품질 표준 데이터 기반 약물감시 시스템 연구)

  • SeMo Yang;InSeo Song;KangYoon Lee
    • The Journal of Bigdata
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    • v.8 no.2
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    • pp.125-131
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    • 2023
  • Globally, drug side effects rank among the top causes of death. To effectively respond to these adverse drug reactions, a shift towards an active real-time monitoring system, along with the standardization and quality improvement of data, is necessary. Integrating individual institutional data and utilizing large-scale data to enhance the accuracy of drug side effect predictions is critical. However, data sharing between institutions poses privacy concerns and involves varying data standards. To address this issue, our research adopts a federated learning approach, where data is not shared directly in compliance with privacy regulations, but rather the results of the model's learning are shared. We employ the Common Data Model (CDM) to standardize different data formats, ensuring accuracy and consistency of data. Additionally, we propose a drug monitoring system that enhances security and scalability management through a cloud-based federated learning environment. This system allows for effective monitoring and prediction of drug side effects while protecting the privacy of data shared between hospitals. The goal is to reduce mortality due to drug side effects and cut medical costs, exploring various technical approaches and methodologies to achieve this.

제제설계 및 Scale Up

  • Hong, Sun-Eon
    • Journal of Pharmaceutical Investigation
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    • v.13 no.3
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    • pp.115-125
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    • 1983
  • 제제설계란 제형의 설계 및 그에 따른 처방설정(formulation)을 의미하며 경험적인 제제방법 및 그 기술측면에서의 제제화는 주악 및 첨가물의 종류와 배합비율의 설정등 비교적 단순한 내용을 의미하지만 의약품은 실제적으로 인체에 적용되므로 치료설계상의 연구와 생물약제학적 검토에 의한 유효정과 안전성을 발휘할 수 있도록 설계가 되어야 한다. 또한 약물의 효력은 체내 특정부위에 특정농도의 약물분포가 필요하고, 일정시간 지속되는 것이 요구되므로 약용량도 중요하지만 약물투여 후의 흡수, 체내이행, 대사, 배설등의 상태를 파악하고 이에 미치는 부형제의 영향도 검토하여야 한다. 제제물리학적 측면에서 품질보증을 위하여 preformulation단계에서 주약의 물성검토, 첨가제의 사용량, interaction 및 혼합순서 등과 처방설정 단계에서 제제화에 사용되는 기계장치의 특성 및 능력, 제제화 후의 포장용기 및 포장상태에서의 안정성 등도 면밀히 검토하여야한다. 제제설계란 단순한 dosage form의 design만이 아니고 유효성이 높고, 부작용이 적은 제제를 합리적으로 만드는 기술과 정보의 종합관리로 scale up과정에서 원료, 기계장치, 제조방법, 작업자 등에 의한 품질변동 요인을 극소화하고, 공정의 초기단계에서 즉시 조정될 수 있는 종합관리 system이 필요하다.

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결핵균 등 내성균 천국, 약물 오$\cdot$남용 사회

  • 대한결핵협회
    • 보건세계
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    • v.46 no.8 s.516
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    • pp.28-29
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    • 1999
  • 최근 한국보건사회연구원이 국민의 의약품 사용실태를 조사한 결과에 의하면 1천명중 33명이 매일 항생제를 복용한다. 이는 OECD 회원국가의 평균치 21명보다 월등히 높은 비율로, 약물남용이 우려할 만한 수준임을 보여준다. 이 조사는 또 97년도 의료보험 환자중 병$\cdot$의원에서 58.9$\%$가 항생제를 처방받았다고 밝혔다. 폐렴구균의 70$\~$80$\%$가 항생제 남용으로 페니실린에 내성을 보였는데 이는 아시아 최고수준이다. 약물남용은 항생제 뿐 아니다. 많은 사람들이 의사처방 없이 자가처방으로 약을 구입하며, 자가처방의 절반은 감기약을 구입하는데 이 경우 부적절한 처방이 문제된다. 더구나 감기약은 1가지만으로도 남용할 경우 부작용이 많은데 `판피린과 콘택 600을 주세요` 라는 식으로 물약과 알약을 동시에 주문한다. 이와 같은 약의 중복사용은 약물의 남용효과를 더욱 크게 한다.

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의약품 시판 후 조사의 연구방법 개발에 관한 연구 - Angiotensin 전환효소 억제제의 부작용을 중심으로-

  • 김영식;조홍준;송윤미;서홍관;최현림;서학은;김영주;신호철;박은숙
    • Proceedings of the Korean Society of Applied Pharmacology
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    • 1993.04a
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    • pp.94-94
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    • 1993
  • Angiotensin 전환효소 억제제를 재료로하여 다기관 협동을 통한 시판 후 조사방법론을 개발하고, 아울러 Angiotensin 전환효소 억제제 투여시 나타나는 기침의 발생율과 이와 관련된 요인을 밝히고자 시판 후 조사를 시도하였다. 방법: 1992년 2월부터 1992년 10월까지 11개 병원 가정의학과를 방문하여 Angiotensin 전환효소 억제제를 투여한 고혈압 환자 348명을 연구대상으로 하였다. 이중 남자가 147명, 여자가 201명이었으며, 연령별로는 39세이하 38명, 40-54세 156명, 55세 이상이 154명이었다. 최초 약물투여 후 2, 4, 8, 12주에 추적 관찰하였으며, 기침의 발생율은 PC-SAS 6.04를 이용하여 Kaplan-Meier 방법과 Log-Rank 방법으로 분석하였다.

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Investigation on Perceptions, Attitudes, and Contributing Factors to Spontaneous Adverse Drug Reaction Reporting among Community Pharmacists: Results from a Web-based Survey (지역 약사의 자발적 부작용 보고에 대한 인식 및 태도와 영향요인 조사: 설문조사 결과를 중심으로)

  • Lee, Mo-Se;Choi, Ah-Hyung;Jang, Bo-Hyun;Kim, Na-Young;Lee, Jung-Min;Shin, Ju-Young;Jeon, Ha-Lim
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.2
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    • pp.125-132
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    • 2019
  • Objective: To examine the perceptions and attitudes toward spontaneous adverse drug reaction (ADR) reporting system among community pharmacists and identify factors that influence reporting, by implementing a survey. Methods: A structured questionnaire was developed and distributed online. Request for the survey was posted on the website of pharmacy's billing program, and the survey was conducted for 8 days. We collected the participants' response on their work environment, experience of ADR reporting, and their perception and attitude on the reporting system. Multivariate logistic regression was used to evaluate factors influencing ADR reporting. Results: A total of 382 pharmacists participated in the survey. Significant contributing factors for reporting level were age (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.84-0.96), knowledge of reporting method (OR, 53.56; 95% CI, 9.10-315.41), installation of reporting program (OR, 31.92; 95% CI, 4.16-244.75), and encouragement from the Korean pharmaceutical association (OR, 4.13; 95% CI, 1.11-15.35). Regarding the attitude toward spontaneous ADR reporting system, 'lack of time for reporting' (OR, 0.29; 95% CI, 0.15-0.53) and 'complexity of reporting procedure' (OR, 0.51; 95% CI, 0.31-0.84), were associated with a low likelihood of reporting. Conclusion: Our results indicated that the knowledge of ADR reporting method, installation of the reporting program, and encouragement from the Korean Pharmaceutical Association contribute to active reporting. It is necessary to simplify the reporting method, make the ADR reporting program user-friendly, and provide educational interventions to increase participation in spontaneous reporting by the community pharmacists.

Recent Studies on Natural Products that Improve Browning (Browning 촉진에 관여하는 최근 천연물의 동향)

  • Lee, Eunbi;Nam, Ju-Ock
    • Journal of Life Science
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    • v.31 no.11
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    • pp.1037-1045
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    • 2021
  • The prevalence of obesity is increasing worldwide, and since obesity is associated with dietary factors and sedentary lifestyles, it is a disease that is readily developing in the modern population. Because obesity is accompanied by serious complications such as diabetes and cardiovascular disease, prevention and treatment are important. Currently, drugs such as liraglutide and phentermine are used to treat obesity by suppressing appetite and inducing gastrointestinal motility delay. However, various side effects may occur, including thyroid cancer, cardiovascular problems, and central nervous system disorders. Therefore, to explore an obesity treatment method with relatively few side effects, a method known as "fat browning" was introduced to change white adipose tissue into brown adipose tissue to increase energy consumption. Ongoing studies are attempting to find effective natural substances to safely induce browning. Many natural substances have been identified. The induction of browning by treatment with natural substances generally involves three mechanisms: positive control of browning-inducing factors, inhibition of differentiation into white adipose tissue, and the activation of mechanisms related to browning. In this study, we describe plant extracts with known browning-inducing effects, such as strawberry, black raspberry, cinnamomum cassia, and Ecklonia stolonifera extracts. We also summarize the underlying mechanisms of action identified thus far, including the signaling pathway mediated by these extracts to induce browning. Furthermore, the effects of brown adipose tissue generated through browning on heart disease as an endocrine organ disruptor are discussed.

Real-world Adverse Events Associated with Fluconazole and Itraconazole: Analysis of Nationwide Data Using a Spontaneous Reporting System Database (의약품부작용보고시스템 데이터베이스를 이용한 fluconazole 및 itraconazole 관련 이상사례 분석)

  • Lee, Yu gyeong;Lee, Jungmin;Chun, Pusoon
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.3
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    • pp.204-214
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    • 2022
  • Objective: This study aimed to investigate the occurrence and types of the adverse events (AEs) associated with oral fluconazole and itraconazole and factors associated with specific types of AEs. Methods: We analyzed AEs reported by community pharmacies nationwide over 10 years using the Korea Adverse Event Reporting System database. Various AE terms were categorized into 18 types, and concomitant medications were classified by drug-drug interaction (DDI) severity. The relationship between the specific type of AE and age, sex, and number of concomitant medications was investigated using multiple logistic regression analysis. Results: A total of 879 AE reports of fluconazole and 401 reports of itraconazole were analyzed; of these reports, 321 and 83 reports of fluconazole and itraconazole, respectively, described concomitant drug administration categorized as DDI severity of contraindicated or major. Women had a higher risk of psychiatric AEs associated with fluconazole use (OR, 1.587; p=0.042). Polypharmacy increased the risk for psychiatric AEs (OR, 3.598; p<0.001 for fluconazole and OR, 2.308; p=0.046 for itraconazole). In dermatologic AEs, the mean age of patients who received itraconazole was lower than that of patients who received fluconazole (46.3±16.8 vs. 54.9±15.4; p<0.001). Co-administration of fluconazole with 1-3 drugs increased the risk of neurological AEs (OR, 1.764; p=0.028). Conclusion: When using fluconazole and itraconazole, psychiatric AEs should be noted, particularly in women and in case of polypharmacy; moreover, when fluconazole is co-administered with other drugs, attention should be paid to the occurrence of neurological AEs.

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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Manufacture and evaluation of hydrogel preparations that are easy to use in emergency allergy situations (응급알레르기 상황에서 사용하기 쉬운 하이드로겔 제제의 제조 및 평가 과정)

  • Kim, Chul-tae;Kim, Hoon
    • Journal of Digital Convergence
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    • v.19 no.3
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    • pp.287-293
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    • 2021
  • Tablets were conventionally used to treat choline urticaria. Disadvantages of tablets included sleep inducing problems, accessibility and reduced dosage. To address this, hydrogel containing Cetirizine HCl was manufactured. The experimental method was to measure viscosity, gel fraction, degree of swelling, content evaluation, and permeability. Studies have shown that hydrogels containing Cetirizine HCl can be directly applied to occurrence area to improve Cholinergic urticaric with minimal side effects associated with the marketable tablets. This hydrogel includes other important substances including steroids which gives it an advantage when applied on the skin, improving its accessibility. In addition, it is expected that the drug manufacturing process will be able to proceed as this hydrogel is effective even when used alone.