의약품에 의한 환경오염문제와 대응방안 연구

Title
의약품에 의한 환경오염문제와 대응방안 연구
Authors
박정임
Issue Date
2005-12-31
Publisher
한국환경정책·평가연구원
Series/Report No.
연구보고서 : 2005-12
Page
xii, 139 p.
URI
http://repository.kei.re.kr/handle/2017.oak/19192
Language
영어
Keywords
Pollution- Environmental aspects- Korea (Republic of)
Abstract
The occurrence of pharmaceuticals in the environment is a growing concern. The number of reports on measurable concentrations of pharmaceuticals found in the environment is growing. Despite the numerous reports on environmental occurrence of pharmaceuticals at levels in the range of ng to low ?g/L, the environmental significance is largely unknown. The purpose of this research was to provide new perspectives on a previously hidden environmental concern, or Pharmaceuticals in the Environment in Korea. The scope of this study was limited to human pharmaceuticals. This report provided an overview of issues pertaining to the input, occurrence and fate of pharmaceuticals in the environment, the risks they pose, as well as the environmental risk assessments developed for regulatory purposes in the EU, Canada, and the US. A database of pharmaceutical products was compiled in order to predict a pharmaceutical compound’s potential to cause adverse effects in the environment in advance to applying a complicated assessment protocol. This study also proposed a list of necessary approaches for managing human pharmaceuticals in the environment. Pharmaceutical compounds are developed and manufactured for specific biological effects. Because of their physicochemical and biological properties, when released into the environment, it may be possible for such drugs to cause serious impacts on non-target species. With a growing population and an increased demand for medicine, the amount of pharmaceuticals entering into the environment is steadily growing. Pharmaceuticals enter into the environment through various routes. Pharmaceutical compounds, including their metabolites and conjugates, are mainly excreted in urine or feces. They enter municipal sewage treatment systems where they can be degraded, absorbed to sewage sludge, or eventually diluted into surface water. Sewage treatment facilities are not always effective in removing active pharmaceuticals from wastewater. Pharmaceuticals that adsorb into sludge can reach the terrestrial environment and reach surface water and groundwater, and eventually into the aquatic environment. In addition to the excretion from human bodies, effluent from pharmaceutical plants, hospital wastewater containing various pharmaceuticals at relatively high levels, direct dumping of excess or expired medication from households can be significant sources of pharmaceuticals in the environment. It is desirable to be able to predict a pharmaceutical’s potential for environmental significance. In order to estimate the probability of a pharmaceutical causing undesirable environmental effects, an environmental risk assessment (ERA) is required for new medical compounds in the United States, EU, and Canada. In the United States, the National Environmental Policy Act of 1969 (NEPA) requires all federal agencies to assess environmental impacts of their actions and ensure that the interested and affected public is informed of environmental analyses. The Food and Drug Administration (FDA) is therefore required under NEPA to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process. Specific product types are given in the “Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications” (FDA 1998) and ,in particular, some pharmaceuticals anticipated no expected impact on the environment are categorically excluded from assessment and data requirements. In the European Union, an application for the marketing authorization for a medicinal product for human use shall include an ERA (Council Directive 2001/83/EC as amended by Council Directive 2004/27/EC). ERA procedures for pharmaceuticals, based on principles already applied in the ERAs of chemicals, have been developed for regulatory purposes in the EU. In order to arrive at reliable ERAs, adequate data on environmental exposure and ecotoxic potency of pharmaceutical compounds are needed. An ERA in accordance with regulatory guidelines is a tiered procedure starting with rough estimates and progressing into more refined methods, if a potential risk cannot be excluded. The assessment may be terminated either when sufficient information is available indicating that the product/compound is unlikely to represent an environmental risk, or when a risk has been identified and sufficiently characterized. The outcome of an ERA is dependent on amount used, environmental fate, and the ecotoxicity of the pharmaceutical compound in question. Health Canada is currently at the last stage of a regulatory process that requires the assessment of medicinal products regulated under the Food and Drug Act (F&DA) with respect to their potential effect on the environment. In Korea, increased attention is currently being placed on pharmaceutical substances as a class of emerging environmental contaminants. Related national agencies in Korea involved in various aspects of pharmaceuticals as pollutants are the MOE (Ministry of Environment), MOHW (Ministry of health and Welfare), KFDA (Korea Food and Drug Agency), MAF (Ministry of Agriculture and Forest), and potentially the MOMAF (Ministry of Maritime Affairs and Fisheries). The most important role of the MOE is to catalyze and foster interest among various ministries/agencies as well as research organizations. A proactive approach that can encompass research agendas, practices for minimizing drugs in the environment and public education (or non-regulatory), and environmental risk assessment regulation is necessary. Approaches for minimizing the disposition of Drugs to the environment can be implemented in the near term. Practices need to be developed and communicated to relevant audiences, as appropriate. Relative audiences include consumers, medical professionals, farmers (for veterinary pharmaceuticals), and manufacturers. Practices cover far-reaching approaches such as source control/reduction actions, controlled largely by pharmaceutical industry as well as actions tied more closely to the end users (patients) and the issues associated with Drug disposal/recycling. The focus of actions this report is primarily on pharmaceuticals originating from end-use rather than from manufacturing (Regarding manufacturing side, it needs to be investigated as a part of “Green Chemistry”). Emphasis is on the use/disposal of pharmaceuticals as originating from the activities/actions of individuals (including hospitals) and from the manufacturing sector. The major drivers of science executing research on the PIE are 1) identification of “hidden”, previously unrecognized, or “emerging” environmental concerns before they become critical, 2) characterization of the critical sources of uncertainty that affect the assessment of risk to human health and ecological integrity, and 3) determination of an efficient means for reducing risk (via voluntary stewardship measures or by regulation) installed in the near-term and then in the long-term. The most important task is to prioritize the wide spectrum of issues encompassed by pharmaceuticals as environmental pollutants. It should be developed based on the compilation of needs and gap/uncertainty analysis of current knowledge. It is significant to note that scientists and regulators in the human and domestic animal health communities have traditionally been disconnected from their counter-parts in the environmental arena. This leads to two major consequences: 1) Knowledge is not shared across disciplines; non-intersecting literatures remain largely unexplored; 2) Accountability is often absent for issues emanating from the interface of human medicine and the environment. This is exactly one of the concerns expressed regarding the lack of interaction between the MOHW and the MOE (with respect to environmental assessment of new Drugs and any follow-up regarding the possible presence of pharmaceuticals in the environment (e.g., Monitoring project). With respect to the introduction of environmental risk assessment systems for pharmaceuticals, three options were suggested in this study: 1) applying the current TCCA (Toxic Chemical Control Act) 2004, 2) creating a new regime under the TCCA for pharmaceuticals to be regulated, or 3) creating a new regime of environmental risk assessment under the “Pharmaceutical Affairs Act” (or a relating MOHW act). Conducting option identification and analysis is suggested prior to developing the final options, recommendations, the regulatory framework, and guidelines. Currently, there is a need to develop an investigation plan for assessing the environmental and/or human health risk from the occurrence of pharmaceuticals in the environment in Korea. However, there are too many pharmaceuticals in the market to be analyzed. Approximately 15,000 different human pharmaceutical products are registered for use in Korea (2003, KPMA). Therefore, prior to performing environmental hazard and risk assessments for selected pharmaceutical compounds based on Korean retail figures and existing environmental data, it is necessary to build a database of production volume by pharmaceutical compounds not by products. In this study, a database of annual production volume (in kg) of Antimicrobials (KFDA Class 610) was constructed, which will be utilized in preliminary environment risk assessments of compounds in the aquatic compartment in the near future.

Table Of Contents

Foreword
Abstract
Acronym List

Chapter 1. Introduction
1. Research Background and Rationale
2. Scopes and Objectives

Chapter 2. Pharmaceuticals in the Environment
1. Entry Routes of Human Pharmaceuticals into the Environment
2. Occurrence of the Pharmaceuticals in the Environment
3. Fate of Pharmaceuticals in the Environment
4. Effects of Pharmaceuticals in the Environment

Chapter 3. Environmental Risk Assessment Methods
1. Introduction
2. Regulations in the European Union
3. Regulations in Canada
4. Regulations in the United States

Chapter 4. A proactive approach for Managing Pharmaceuticals in the Environment
1. Best Practices for Minimizing Drug Entering into
the Environment
2. Science and Research
3. Environmental Risk Assessment Regulation

Chapter 5. Preliminary Selection of Target Drugs
for Surveillance
1. Production Trends of Pharmaceuticals in Korea
2. Estimated Production Amount by Pharmaceutical Compounds
3. Predicted Environmental Concentrations of KFDA Class 610

Chapter 6. Conclusions
Reference

Appendix A. Toxicity Data of Freshwater Organisms

Appendix B. Chronic Toxicity Data of Marine Organisms
Appendix C. Toxicity Data of Marine Organisms

Appendix D. Toxic Chemical Control Act (TCCA)
Appendix E. Anatomical Therapeutic Chemical Classification
System

Appendix F. Korea Food and Drug Administration (KFDA)’s
classification system on pharmaceuticals etc.

Appendix G. Estimated production amounts of
pharmaceutical compounds in the KFDA
Class 610 (antibiotics)

Summary in Korean

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