의약물질의 환경위해성 관리방안 연구

DC Field Value Language
dc.contributor.author 박정임 -
dc.contributor.other 김명현 -
dc.contributor.other 최경호 -
dc.contributor.other 김영희 -
dc.contributor.other 김민영 -
dc.date.accessioned 2017-07-05T01:35:14Z -
dc.date.available 2017-07-05T01:35:14Z -
dc.date.issued 20071228 -
dc.identifier A 환1185 2007 RE-06 -
dc.identifier.uri http://repository.kei.re.kr/handle/2017.oak/19315 -
dc.identifier.uri http://library.kei.re.kr/dmme/img/001/003/001/RE-06_Environmental Risk Assessment of Pharmaceuticals - Model Application for Estimating Pharmaceutical Exposures in the Han River Basin_박정임.pdf -
dc.description.abstract Abstract Pharmaceuticals are indispensable as they cure those who suffer from disease and their availability improves the quality of life. Veterinary medicines are also widely used to treat disease and improve the productivity of livestock farming. However, during their use, human and veterinary pharmaceuticals have the potential of being released into the environment. In recent years, the possible environmental (ecological) risk of pharmaceuticals in the aquatic environment has become a matter of increasing public concern. Potential ecological effects from the presence of pharmaceuticals in the environment have generally focused on the following two concerns: 1) the release of antibiotics into the environment increases the chance of antibiotic-resistant microorganisms and promotes the spread of resistant genes, and 2) when drugs affecting hormonal systems reach organisms in nature, it may result in a reproductive disturbance in the ecosystem. Environmental risk assessment (ERA) is considered the best scientifically based approach for evaluating the potential effects of contaminants on communities and ecosystems. The process includes problem formulation, exposure assessment, effects assessment, and risk characterization. Accurate exposure assessment is a key element of ERA. However, exposure assessment has been hampered by the continuing difficulties and expense involved in measuring the low ppt concentrations of pharmaceuticals in the environment. In addition, real-time monitoring data provides only snapshots of contaminant concentrations. Thus, when faced with the task of assessing the environmental exposure of pharmaceuticals, the utilization of exposure models becomes essential. The first objective of this report is to apply computerized exposure models to assess the environmental concentration of human and veterinary pharmaceuticals in the Han River and the Kyungahn stream, a major branch of the Han River. PhATETM and SWMM are identified as appropriate exposure models for this study based on data availability, researchers’ previous experience with models, and accessibility to models. The models investigated in this study intend to provide rapid predictions regarding the potential environmental fate of a compound. In this study, model-predicted PECs are compared to field data that either have been published previously or were empirically measured during this study (Chapters 2, 3, and 4). A second objective of this study is to estimate the total environmental concentration of pharmaceuticals, from both human and animal use, by integrating the simulation results from PhATETM and SWMM. Although the introduction routes into the environment for veterinary pharmaceuticals are different from those for human use, both human and animal pharmaceuticals eventually end up reaching surface water. Therefore, estimating the environmental concentration of such pharmaceuticals based solely on either human consumption or animal consumption results in an underestimation of environmental exposure. In this study, a workable framework to estimate PECs for these dual-usage pharmaceuticals is suggested (Chapter 5). Finally, a third objective is to perform an environmental risk assessment (ERA) for selected pharmaceuticals. Hazard quotients (the ratio of EC to PNEC) based on PECs are compared to those based on MECs. This exercise will demonstrate the applicability of modeling approaches in the risk assessment of pharmaceuticals in the environment. The potential benefit of using molecular level biomarkers to assess pharmaceutical toxicity is also discussed and methods are presented (Chapter 6). In order to minimize the deposition of pharmaceuticals into the environment, potential risk management actions are suggested; disposal labeling on pharmaceutical products, discharge guidelines for pharmaceutical manufacturing facilities, pretreatment of hospital wastewater, modification of wastewater treatment plant infrastructure or operating parameters, standardizing guidelines for the handling and disposal of unused medicine, and efficient dispensing practices and packaging (Chapter 7). -
dc.description.tableofcontents FOREWORD <br> <br>Abstract <br> <br>Acronym List <br> <br>Chapter 1. Introduction <br> <br>Chapter 2. Review and Background <br>1. Occurrence Studies of Pharmaceuticals in the Korean Aquatic Environment <br>2. Environmental Safety Regulations for Pharmaceuticals <br>2.1 The European Union <br>2.2 The United States <br>2.3 Canada <br>2.4 Australia <br>2.5 Japan <br>3. Models for Predicting PECs of Pharmaceuticals <br>3.1 Models for Predicting PECs of Human Pharmaceuticals <br>3.2 Models for Predicting PECs of Veterinary Pharmaceuticals <br>3.3 Selecting Models for This Study <br> <br>Chapter 3. Exposure Simulation for Human Pharmaceuticals in the Han River with PhATETM <br>1. Constructing PhATETM for the Han River <br>1.1 Watershed Data for the Han River <br>1.2 Target Compounds and Collection of Compound-Specific Data <br> <br>2. Modeling Human Pharmaceuticals in the Han River Watershed with PhATETM <br>3. Point-by-Point Comparisons of Model Data to Field Data <br>3.1 Field Measurement Data <br>3.2 Point-by-Point Comparisons <br> <br>Chapter 4. Predicting Environmental Exposure of Veterinary Pharmaceuticals with SWMM model in the Kyungahn Stream <br>1. Introduction <br>2. Materials and Methods <br>2.1 Study Area <br>2.2 Selection of Target Pharmaceuticals <br>2.3 Application of SWMM <br>3. Results and Discussion <br>3.1 Simulation of Runoff Flowrate <br>3.2 Simulation of Runoff Quality <br>4. Conclusions <br> <br>Chapter 5. Environmental Exposure Modeling of Pharmaceuticals with the PhATETM-SWMM Combined Model in the Kyungahn Stream <br>1. Materials and Methods <br>1.1 Target Pharmaceuticals <br>1.2 Model Application <br>2. Results <br>2.1 PhATETM model in the Kyungahn stream <br>2.2 Integrated Concentration of Sulfamethoxazole and Trimethoprim <br> <br>Chapter 6. Environmental Risk Assessment for Selected Pharmaceuticals <br>1. Introduction <br>2. Materials and Methods <br>2.1 Daphnia Chronic Test <br>2.2 Fish Test <br>2.3 Risk Assessment <br>3. Results and Discussion <br>3.1 Daphnia Test <br>3.2 Fish Test <br>3.3 Risk Assessment <br>4. Conclusions <br> <br>Chapter 7. Summary and Conclusions <br>1. Summary of This Study <br>2. Suggested Potential Risk Management Actions <br> <br>References <br>Appendix 1: PhATETM Input Data in the Han River <br>Appendix 2: SWMM Model Verification Data <br> <br>Abstract in Korean <br> <br> -
dc.description.tableofcontents <br>   <br> -
dc.description.tableofcontents - Contents - <br> FOREWORD <br> Abstract <br> Acronym List <br> Chapter 1. Introduction <br> Chapter 2. Review and Background <br>1. Occurrence Studies of Pharmaceuticals in the Korean Aquatic Environment <br>2. Environmental Safety Regulations for Pharmaceuticals <br>2.1The European Union <br>2.2The United States <br>2.3Canada <br>2.4Australia <br>2.5Japan <br>3. Models for Predicting PECs of Pharmaceuticals <br>3.1Models for Predicting PECs of Human Pharmaceuticals <br>3.2Models for Predicting PECs of Veterinary Pharmaceuticals <br>3.3Selecting Models for This Study <br> Chapter 3. Exposure Simulation for Human Pharmaceuticals in the Han River with PhATETM <br>1. Constructing PhATETM for the Han River <br>1.1Watershed Data for the Han River <br>1.2Target Compounds and Collection of Compound-Specific Data <br> <br>2. Modeling Human Pharmaceuticals in the Han River Watershed with PhATETM <br>3. Point-by-Point Comparisons of Model Data to Field Data <br>3.1Field Measurement Data <br>3.2Point-by-Point Comparisons <br> Chapter 4. Predicting Environmental Exposure of Veterinary Pharmaceuticals with SWMM model in the Kyungahn Stream <br>1. Introduction <br>2. Materials and Methods <br>2.1Study Area <br>2.2Selection of Target Pharmaceuticals <br>2.3Application of SWMM <br>3. Results and Discussion <br>3.1Simulation of Runoff Flowrate <br>3.2Simulation of Runoff Quality <br>4. Conclusions <br> Chapter 5. Environmental Exposure Modeling of Pharmaceuticals with the PhATETM-SWMM Combined Model in the Kyungahn Stream <br>1. Materials and Methods <br>1.1Target Pharmaceuticals <br>1.2Model Application <br>2. Results <br>2.1PhATETM model in the Kyungahn stream <br>2.2Integrated Concentration of Sulfamethoxazole and Trimethoprim <br> Chapter 6. Environmental Risk Assessment for Selected Pharmaceuticals <br>1. Introduction <br>2. Materials and Methods <br>2.1Daphnia Chronic Test <br>2.2Fish Test <br>2.3Risk Assessment <br>3. Results and Discussion <br>3.1Daphnia Test <br>3.2Fish Test <br>3.3Risk Assessment <br>4. Conclusions <br> Chapter 7. Summary and Conclusions <br>1. Summary of This Study <br>2. Suggested Potential Risk Management Actions <br> References <br>Appendix 1: PhATETM Input Data in the Han River <br>Appendix 2: SWMM Model Verification Data <br> Abstract in Korean -
dc.format.extent 178 p. -
dc.language 영어 -
dc.publisher 한국환경정책·평가연구원 -
dc.subject Environmental risk assessment -
dc.title 의약물질의 환경위해성 관리방안 연구 -
dc.title.alternative 한강수계의 의약물질 농도예측 모형연구을 중심으로 -
dc.type 기본연구 -
dc.title.original Environmental risk assessment of pharmaceuticals -
dc.title.alternativeoriginal model application for estimating pharmaceutical exposures in the Han river basin -
dc.title.partname 연구보고서 -
dc.title.partnumber 2007-06 -
dc.description.keyword 정책일반 -
dc.description.bibliographicalintroduction 국문요약 의약물질의 환경위해성 관리방안 연구 - 한강수계의 의약물질 농도예측 모형연구를 중심으로 의약물질은 질병을 치료하고 삶의 질을 향상시키기 위해 없어서는 안되는 중요한 물질이다. 동물용 의약품은 질병치료 목적 뿐만 아니라 축산의 생산성 향상을 위하여 광범위하게 사용되고 있다. 그러나 아무리 우리 생활에 이로운 물질이라도 의약물질을 사용하는 동안 인체용 또는 동물용 의약물질은 환경 중으로 흘러들어갈 우려가 있다. 최근 들어, 물환경에 존재하는 의약물질로 인한 환경위해성은 대중적인 관심의 대상이 되었다. 환경 중에 존재하는 의약물질로 인한 생태영향은 다음과 같은 두 가지 측면에서 가장 우려가 된다; 1) 환경 중으로 유출된 항생물질로 인하여 항생제 내성균이 출현할 위험이 커지거나 내성유전자의 확산이 촉진될 우려가 증가한다는 점, 2) 내분비계에 영향을 미치는 물질이 자연에 존재할 경우 생태계의 교란을 초래할 수 있다는 점 등이다. 환경위해성평가(Environmental Risk Assessment)는 어떤 오염물질이 생태계나 지역사회에 미칠 수 있는 잠재된 영향을 평가하기위한 가장 과학적인 접근방법이다. 이를 위해서는 문제 구체화, 노출평가, 영향평가, 위해 특성평가 등 4단계를 거치게 되는데, 정확한 노출평가야말로 환경위해성평가의 핵심 단계라 할 수 있다. 하지만 환경 중 의약물질 문제의 경우 ppt 수준의 매우 낮은 농도를 측정해야하기 때문에 기술적인 어려움, 비용 등의 문제로 노출평가가 쉽지 않다. 또한 현장시료를 분석하여 얻은 농도는 노출의 전체 그림이 아니라 한 순간의 농도값만을 보여주는 데에서 오는 제한점도 있다. 따라서 의약물질의 환경 중 노출을 평가하기 위해서는 노출모형을 활용하는 것이 필수적이다. 본 연구의 첫 번째 목적은 한강과 경안천을 대상으로 인체용 및 동물용 의약물질의 환경농도를 노출모형을 이용하여 추정하는 것이다. 모형 운용에 가용한 자료, 연구자의 선행 경험, 모형의 접근성 등을 고려하여 PhATETM 와 SWMM 모형이 본 연구에 적합한 것으로 선정되었다. 이 모형들은 실제농도를 정확히 예측하는 것이 목적이 아니라 의약물질의 환경 중 잠재된 거동을 빠르게 추정하는 것을 목적으로 하는 Screening 단계의 모형이다. 모형을 통하여 추정된 농도값을 본 연구 또는 선행연구에서 측정한 환경 중 농도값과 비교하였다(보고서 제2-4장). 두 번째 목적은 PhATETM 와 SWMM 모형 결과를 통합함으로써 인체용과 동물용에 공통으로 사용되는 의약물질의 농도를 추정하는 것이다. 물론 동물용 의약물질의 환경 중 유입경로가 인체용 의약물질과는 전혀 다르지만 결국 환경중으로 유입된 의약물질은 지표수에서 만나게 될 것이다. 따라서 지표수에서 의약물질 농도를 추정할 때 인체에 사용된 분량만을 근거로 추정하거나 동물용 사용 부분만을 고려하여 추정하는 것은 실제 환경 중 예상농도를 과소추정할 우려가 있다. 본 연구에서는 인체와 동물에 모두 사용되는 의약물질의 환경 중 예상농도 추정의 방법을 제안하였다(보고서 제5장). 마지막으로 일부 의약물질에 대하여 환경위해성 평가를 실시하였다. 의약물질의 환경독성은 표준시험법으로 시험하여 도출하였고, 부족한 경우 문헌값을 활용하였다. 모형으로 추정한 예측농도(PEC)와 실제 측정농도(MEC) 각각에 대하여 위해성평가를 실시하여 비교하였다. 이로써 환경 중 의약물질의 환경위해성 평가에 노출모형을 활용하는 것이 적절함을 제시하였다. 또한 분자수준의 바이오마커를 이용하여 의약물질의 환경독성을 평가하는 방법을 소개하고 기대되는 편익에 대하여 제안하였다(보고서 제6장). 의약물질의 환경위해성에 관한 체계적이고 종합적인 결론이 나오기 이전이라도 의약물질이 환경 중으로 유입되는 것을 최소화하기 위한 조치를 취하는 것이 바람직하다. 의약품 용기에 폐기에 관한 지침 제시, 제약공장의 방출수 관리 가이드라인, 병원하수의 전처리, 하수처리장의 설비나 가동조건의 최적화, 폐기의약물질의 처리방법, 효율적인 약처방과 포장 등에 관한 방안이 필요할 것이다. -
dc.contributor.authoralternativename Park -
dc.contributor.authoralternativename Jeong-Im -
dc.contributor.otheralternativename Kim -
dc.contributor.otheralternativename Myung-Hyun -
dc.contributor.otheralternativename Choi -
dc.contributor.otheralternativename Kyungho -
dc.contributor.otheralternativename Kim -
dc.contributor.otheralternativename Young-Hee -
dc.contributor.otheralternativename Kim -
dc.contributor.otheralternativename Min-Young -
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