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Book Details
Abstract
About 4000 medical compounds are being used in the drugs applied today. It is estimated that worldwide consumption of active compounds amounts to some 100,000 tons or more per year. Consequently, there is a need to highlight the most important questions and issues related to presence of pharmaceuticals in the environment.
Pharmaceuticals in the Environment: current knowledge and need assessment to reduce presence and impact brings together results of previous and on-going EU projects with published data from both governmental sources and scientific literature and manufacturers’ data on production and usage of pharmaceuticals. This book puts together the current knowledge and emphasises questions that deserve attention such as: What is the spectrum of most relevant pharmaceutical products (PPs) for the aquatic environment? Which indicators for supporting environmental managers, health authorities? What is the efficiency of urban and industrial sewage treatment plants over a year? What is the fate and behaviour of PPs in sewage treatment plants? If receiving waters are used for potable water supplies, does the presence of these compounds represent a potential hazard to human health? Could we solve some problems by environmental or cleaner technologies? What regulatory approaches, incentives, prevention actions can be implemented in order to lower PPs concentration in the environment? Does a European practical guidance can be developed? Can the impacts of PPs on the environment be reduced through the use of eco-pharmaco-stewardship approaches including the use of clean synthesis, classification and labelling, and better communication of methods of 'good practice'? How can we better monitor the environmental impact of a pharmaceutical once it has received a marketing authorisation?
Table of Contents
| Section Title | Page | Action | Price |
|---|---|---|---|
| Half title page | 1 | ||
| Title page | 3 | ||
| Copyright page | 4 | ||
| Contents | 5 | ||
| Acknowledgements | 9 | ||
| Contributors | 11 | ||
| Foreword: Pharmaceuticals in the environment – Why should we care? | 13 | ||
| Chapter 1: Introduction | 19 | ||
| 1.1 PHARMACEUTICAL IN THE ENVIRONMENT: BACKGROUND | 19 | ||
| 1.2 OBJECTIVES OF THIS BOOK | 21 | ||
| 1.3 CHAPTER CONTENT | 22 | ||
| REFERENCES | 25 | ||
| Chapter 2: Policy framework at EU level | 27 | ||
| 2.1 INTRODUCTION | 27 | ||
| 2.2 POLICY FRAMEWORK AT EU LEVEL | 27 | ||
| 2.2.1 Medicinal regulations & policies | 28 | ||
| 2.2.1.1 Product authorisation and environment risk assessment | 28 | ||
| 2.2.1.2 Drug take-back schemes | 31 | ||
| 2.2.2 Environmental protection regulations & policies | 31 | ||
| 2.2.2.1 Water policies | 31 | ||
| 2.2.2.2 Other environmental policies and initiatives | 34 | ||
| 2.3 DISCUSSION OF CURRENT POLICY INSTRUMENTS | 35 | ||
| 2.3.1 Policy Framework in the light of the precautionary and prevention principles | 35 | ||
| 2.3.2 Policy framework and end-of-pipe solutions | 38 | ||
| 2.3.3 What Complicates further eu policy development to limit discharge if PPs into waters? | 39 | ||
| REFERENCES | 40 | ||
| Chapter 3: Exposure based on life cycle | 43 | ||
| 3.1 EXPOSURE ROUTES | 43 | ||
| 3.2 MODELLING OF EXPECTED CONCENTRATIONS IN VARIOUS MATRICES | 45 | ||
| 3.3 MODELLING TOXICITY | 46 | ||
| REFERENCES | 47 | ||
| Chapter 4: Real situation: Occurrence of the main investigated PPs in water bodies | 49 | ||
| 4.1 INTRODUCTION | 49 | ||
| 4.2 LITERATURE STUDY ON PPS | 50 | ||
| 4.2.1 Consumption | 50 | ||
| 4.2.2 Exposure | 51 | ||
| 4.3 RESULTS AND DISCUSSION | 53 | ||
| 4.3.1 Predicted environmental concentrations | 53 | ||
| 4.3.2 Indicator pharmaceuticals | 54 | ||
| 4.3.3 Data gaps | 57 | ||
| 4.4 CONCLUSIONS AND OUTLOOK | 58 | ||
| REFERENCES | 103 | ||
| Chapter 5: Performance of conventional treatment processes of the most resistant PPs | 105 | ||
| 5.1 INTRODUCTION | 105 | ||
| 5.2 ANTIBIOTICS | 107 | ||
| 5.2.1 Sludge Retention Time (SRT) | 107 | ||
| 5.2.2 Hydraulic Retention Time (HRT) | 108 | ||
| 5.2.3 Reactor configuration | 109 | ||
| 5.2.4 Sludge adsorption | 110 | ||
| 5.2.5 Advanced technologies | 110 | ||
| 5.3 ANTICONVULSANTS | 111 | ||
| 5.3.1 Sludge Retention Time (SRT) | 111 | ||
| 5.3.2 Hydraulic Retention Time (HRT) | 111 | ||
| 5.3.3 Reactor configuration | 112 | ||
| 5.3.4 Sludge adsorption | 112 | ||
| 5.3.5 Advanced technologies | 112 | ||
| 5.4 ANTIINFLAMMATORIES (ANALGESICS) | 113 | ||
| 5.4.1 Sludge Retention Time (SRT) | 113 | ||
| 5.4.2 Hydraulic Retention Time (HRT) | 114 | ||
| 5.4.3 Reactor configuration | 115 | ||
| 5.4.4 Sludge adsorption | 116 | ||
| 5.4.5 Advanced technologies | 116 | ||
| 5.5 β-BLOCKERS | 116 | ||
| 5.5.1 Sludge Retention Time (SRT) | 116 | ||
| 5.5.2 Hydraulic Retention Time (HRT) | 116 | ||
| 5.5.3 Reactor configuration | 118 | ||
| 5.5.4 Sludge adsorpt | 118 | ||
| 5.6 HORMONES | 118 | ||
| 5.6.1 Sludge Retention Time (SRT) | 118 | ||
| 5.6.2 Hydraulic Retention Time (HRT) | 119 | ||
| 5.6.3 Reactor configuration | 120 | ||
| 5.6.4 Sludge adsorption | 120 | ||
| 5.6.5 Advanced technologies | 121 | ||
| 5.7 TRANQUILIZERS | 121 | ||
| 5.7.1 Sludge Retention Time (SRT) | 121 | ||
| 5.7.2 Hydraulic Retention Time (HRT) | 121 | ||
| 5.7.3 Reactor configuration | 121 | ||
| 5.7.4 Sludge adsorption | 122 | ||
| 5.7.5 Advanced technologies | 122 | ||
| 5.8 X-RAY CONTRAST MEDIA (CM) | 122 | ||
| 5.8.1 Sludge Retention Time (SRT) | 122 | ||
| 5.8.2 Hydraulic Retention Time (HRT) | 122 | ||
| 5.8.3 Reactor configuration | 123 | ||
| 5.8.4 Sludge adsorption | 123 | ||
| 5.8.5 Advanced technologies | 123 | ||
| 5.9 LIPID REGULATORS | 123 | ||
| 5.9.1 Sludge Retention Time (SRT) | 123 | ||
| 5.9.2 Hydraulic Retention Time (HRT) | 123 | ||
| 5.9.3 Reactor configuration | 124 | ||
| 5.9.4 Sludge adsorption | 124 | ||
| 5.9.5 Advanced technologie | 125 | ||
| 5.10 CONCLUSIONS | 125 | ||
| REFERENCES | 128 | ||
| Chapter 6: Biological monitoring and endpoints | 133 | ||
| 6.1 INTRODUCTION | 133 | ||
| 6.2 DATA AVAILABILITY AND DISTRIBUTION | 133 | ||
| 6.3 TRADITIONAL ECOTOXICITY STUDIES | 134 | ||
| 6.4 LIMITATIONS OF TRADITIONAL ECOTOXICITY STUDIES | 135 | ||
| 6.4.1 Validity of chronic and acute data | 135 | ||
| 6.4.2 Effects of mixtures | 143 | ||
| 6.4.3 Can the effects of pharmaceuticals be predicted using qsars or acute/chronic ratios? | 144 | ||
| 6.4.4 Do metabolites pose a risk? | 144 | ||
| 6.5 NON TRADITIONAL ENDPOINTS | 145 | ||
| 6.5.1 What are the limitations of the standardized test endpoints and methods? | 145 | ||
| 6.5.2 Use of biomarkers as novel end points | 146 | ||
| 6.6 THE USE OF NOVEL APPROACHES TO THE RAPID IDENTIFICATION OF POLLUTION INCIDENTS | 151 | ||
| 6.7 CONCLUSIONS | 151 | ||
| ACKNOWLEDGEMENT | 152 | ||
| REFERENCES | 152 | ||
| Chapter 7: Environmental risk assessment and prioritization strategies for human pharmaceuticals, review and discussion | 155 | ||
| 7.1 INTRODUCTION | 155 | ||
| 7.2 REVIEW OF ENVIRONMENTAL RISK ASSESSMENT AND PRIORITIZATION STRATEGIES FOR HUMAN PHARMACEUTICALS IN DIFFERENT COUNTRIES | 156 | ||
| 7.2.1 Denmark | 156 | ||
| 7.2.2 United Kingdom | 157 | ||
| 7.2.3 Germany | 159 | ||
| 7.2.4 Italy | 160 | ||
| 7.2.5 Sweden | 160 | ||
| 7.2.6 United States | 162 | ||
| 7.2.7 Swiss | 163 | ||
| 7.2.8 France | 164 | ||
| 7.2.9 Sum up and compilation of data | 165 | ||
| 7.3 EXAMPLE OF PRIORITIZATION STRATEGY | 165 | ||
| 7.3.1 Exposure assessment | 170 | ||
| 7.3.2 Effect assessment | 171 | ||
| 7.3.3 Results and discussion | 171 | ||
| 7.4 DISCUSSION | 173 | ||
| 7.4.1 Exposure assessment | 173 | ||
| 7.4.1.1 Accuracy of PEC calculation for surface water with field measurements | 173 | ||
| 7.4.1.2 Parameters, uncertainties and limitations in the exposure assessment for surface water | 174 | ||
| 7.4.1.3 Calculation of PEC for other compartments (sludge and sediment) | 176 | ||
| 7.4.1.4 Use of calculated and modelled values to assess the environmental behaviour of pharmaceuticals | 176 | ||
| 7.4.2 Effect assessment | 178 | ||
| 7.4.2.1 Ecotoxicological data | 178 | ||
| 7.4.2.2 PBT Criteria | 178 | ||
| 7.4.2.3 Liability to bioaccumulate | 180 | ||
| 7.4.2.4 Pharmacological data | 180 | ||
| 7.4.2.5 Evolutionnary approaches | 182 | ||
| 7.5 CONCLUSION | 182 | ||
| REFERENCES | 183 | ||
| Chapter 8: Recommendations on research and development | 187 | ||
| 8.1 INTRODUCTION | 187 | ||
| 8.2 DESIGNING ‘GREENER’ PHARMACEUTICAL PRODUCTS | 188 | ||
| 8.2.1 Towards greener drugs | 189 | ||
| 8.2.1.1 Existing ‘‘greener’’ drugs | 189 | ||
| 8.2.1.2 Improving the eco-compatibility of pharmaceutical products | 189 | ||
| 8.3 ECOLOGICAL PHARMACOVIGILANCE | 192 | ||
| 8.3.1 Monitoring strategies and scenarios for newly registered, existing and high risk medicines | 193 | ||
| 8.3.2 Removal and/or transformation of medicines in sewage treatment plants | 194 | ||
| 8.3.3 Hospital wastewater | 197 | ||
| 8.3.4 Urine separation | 197 | ||
| 8.3.5 Spatial and temporal variations in concentrations of pharmaceutical products in the aquatic environment | 198 | ||
| 8.3.5.1 Factors affecting spatial and temporal variations in concentrations of pharmaceuticals | 198 | ||
| 8.3.5.2 Use of indicators of input of pharmaceutical products into surface and ground waters | 198 | ||
| 8.3.6 Assessment of possible movement of pharmaceutical products from landfill and following agricultural applications of sludge and manure | 200 | ||
| 8.3.7 Fate and distribution of medicines in river, estuarine and marine environments | 200 | ||
| 8.3.8 Protection of drinking water | 201 | ||
| 8.3.9 Assessment of the impact of pharmaceuticals on biota | 203 | ||
| 8.3.10 Estimation of total load of pharmaceutical products in the aquatic environment at local, river basin levels | 203 | ||
| 8.3.11 Estimation of fraction of pharmaceutical products associated with suspended matter/sludge and risk posed following land application | 205 | ||
| 8.4 CONCLUSIONS | 206 | ||
| REFERENCES | 206 | ||
| Chapter 9: Recommendations on communication and education | 209 | ||
| 9.1 INTRODUCTION | 209 | ||
| 9.2 LESSONS LEARNED FROM EXISTING INITIATIVES | 209 | ||
| 9.2.1 Classification and labelling schemes for pharmaceuticals: The Swedish example | 210 | ||
| 9.2.1.1 The ‘‘Stockholm model’’ | 210 | ||
| 9.2.1.2 The ‘‘Swedish model’’ | 210 | ||
| 9.2.2 Drug take-back schemes | 212 | ||
| 9.2.2.1 France | 213 | ||
| 9.2.2.2 Sweden | 213 | ||
| 9.3 RECOMMENDATIONS GOING BEYOND EXISTING INITIATIVES: APPROACHES TO COMMUNICATING METHODS OF ‘‘GOOD PRACTICE’’ | 214 | ||
| 9.3.1 Informing the public | 214 | ||
| 9.3.2 Ecolabels for pharmaceuticals | 214 | ||
| 9.3.3 Involvement of producers and distributors | 215 | ||
| 9.3.4 Professional training – Taking up the subject in schools | 215 | ||
| REFERENCES | 216 |