Green and sustainable pharmacy [1st International Conference on Sustainable Pharmacy

Within recent years pharmaceuticals have come into focus as contaminants of the environment (see for example Kümmerer, K. editor: Pharmaceuticals in the Environment). At the same time the issue of sustainable chemistry gained momentum. Bringing both together would result in sustainable pharmacy. Sustainable pharmacy is a totally new issue and approach. It addresses environmental, economical and social aspects of pharmacy. In the present stage the focus will be on environmental issues along the whole lifecycle of a pharmaceutical entity. That is dealing with resources and energy input but also with waste issues for example during the synthesis and production of an active pharmaceutical ingredient. Furthermore, it would also look on the compounds themselves and will aim to improve the degradability of the compounds after their use in the environment to reduce the environmental risk caused by pharmaceuticals in the environment. Another issue is the people using pharmaceuticals such as pharmacists, medical doctors and patients. How can they contribute to more efficient use of pharmaceuticals with less environmental burden and less risk for drinking water. The book "Sustainable Pharmacy" will address all these issues and will be the first one dealing with this important topic. Foreword Preface and Scope of the Book Contents Contributors Part I General Aspects 1 Why Green and Sustainable Pharmacy? 1.1 How It Began 1.2 Why Green and Sustainable Pharmacy? References 2 Pharmaceuticals in the Environment: Moving from a Problem to a Solution 2.1 Introduction 2.1.1 Problem 1: Many Pharmaceuticals Are Present in the Environment 2.1.2 Problem 2: Some Pharmaceuticals Have Been Shown to Have Adverse Effects on Wildlife 2.1.2.1 Feminisation of Fish by EE2 2.1.2.2 Acute Poisoning of Oriental Vultures by Diclofenac 2.1.3 Problem 3: Drinking Water May Be Contaminated with Human Pharmaceuticals 2.2 Possible Solutions to the Problems Created by Pharmaceuticals in the Environment 2.2.1 Solution-1: Develop ''Greener'' Pharmaceuticals 2.2.2 Solution-2: Prevent Pharmaceuticals Reaching the Environment 2.2.3 Solution-3: Improve the Efficiency of STWs 2.3 Conclusions References 3 Pharmaceuticals in Society 3.1 Introduction 3.1.1 Global Challenges Require Global Cooperation 3.2 Tomorrows Pharmaceuticals: The Drug Discovery Process 3.2.1 Unrealized Potential 3.3 Tomorrows Drug Development: Alternative Models 3.3.1 No Money, No Drugs? 3.3.2 Supporting New Models 3.4 Alternatives to Pharmaceuticals: The Role of Public Health 3.4.1 Bad Habits as a Disease 3.4.2 The Expanding Scope of Lifestyle Drugs 3.4.3 Wealth and Health 3.5 The Road Ahead: Promises and Problems 3.5.1 Who Owns the Genes? 3.5.2 New Safety Concerns References 4 Green(er) Pharmacy 4.1 Introduction 4.2 What Is a Pharmaceutical? 4.3 Standardised Methods of Measuring Greenness Across the Whole Lifecycle 4.4 Raw Materials and Pre-manufacturing 4.4.1 Raw Materials 4.4.2 Pre-manufacturing 4.4.2.1 Lead Identification 4.4.2.2 Lead Optimisation/Medicinal Chemistry 4.4.2.3 Candidate Selection 4.5 Manufacturing and Production 4.5.1 Process Chemistry 4.5.1.1 Process Chemistry: Clean Synthesis 4.5.1.2 Process Chemistry: Solvents 4.5.1.3 Process Chemistry: New Technologies 4.6 Product Use and Fate 4.6.1 Drug Efficacy and Delivery as Green Pharmacy 4.6.2 End-of-Life Issues 4.7 Engaging Key Stakeholders Across the Lifecycle 4.7.1 The Perceived Problem of Green Pharmacy? 4.7.2 The Opportunity of Green Pharmacy? 4.8 Conclusions References 5 Creating a Sustainability Culture A (Human Resources) Management Perspective for Sustainable Pharmacy 5.1 Introduction: From Crisis to a New Business Platform 5.2 Clarifying Some Terms 5.2.1 CSR, CC, CS 5.2.1.1 Corporate Sustainability Management 5.2.2 Stakeholder Theory/Shareholder vs. Stakeholder Value 5.2.2.1 Pharma's Stakeholder Perspective 5.3 Business Case for Corporate Sustainability 5.3.1 Business Benefits as a Fact 5.3.2 Creating Win--Win 5.3.3 Testimonials 5.4 Implementation Challenges 5.4.1 Sustainability at the Core 5.4.2 Communications and Transparency 5.4.3 Metrics 5.4.4 Changing Behaviors and Attitudes 5.5 Creating a Sustainability Culture 5.5.1 Culture Change 5.5.2 Wanted: Role Models 5.5.3 Hard-Wire/Soft-Wire 5.5.4 Sustainability as Part of Company Fabric 5.5.5 Colleague Engagement 5.5.6 Feedback Loops 5.6 Going Forward Bibliography 6 Reducing the Ecological Footprint of Pharmaceutical Usage: Linkages Between Healthcare Practices and the Environment 6.1 Introduction 6.2 Improving the Efficiency of Pharmacy 6.2.1 Mining of Healthcare Data 6.2.2 Electronic Systems 6.3 Personalized Medicine A Framework for a Sustainable Pharmacy 6.4 Pharmacogenomics (PGx) 6.5 Outlook for Personalized Medicine Extending the Focus from Treating Symptoms to Achieving Efficacious Therapeutic Outcomes 6.6 Improving Drug Delivery and Chemistry by Design 6.7 Pharmaceutical Care: An Avenue to Improved Health Care and Reduced Environmental Footprint 6.8 PharmEcovigilance: Vision for Optimal Integration of Medications Environmental Footprint, Healthcare Effectiveness, and Sustainability References Part II Development, Synthesis and Production and Distribution of Pharmaceuticals 7 Ecopharmacostewardship A Pharmaceutical Industry Perspective 7.1 The Stakeholders 7.2 Greener Drug Design 7.2.1 Degradable Pharmaceuticals 7.2.2 Current Improvements in Drug Design 7.3 Sustainability in Research, Manufacturing, Sales and Distribution 7.3.1 Sustainability in R&D and Manufacturing 7.3.2 Sales and Distribution 7.4 Product Use and Disposal 7.4.1 Unused Medicines 7.4.2 Excreted Medicines 7.4.3 Ecopharmacovigilance 7.5 Conclusions Reducing the Uncertainties References 8 Protein and Peptide Therapeuticals: An Example of Benign by Nature Active Pharmaceutical Ingredients 8.1 Introduction 8.2 Materials and Methods 8.2.1 Substances Tested 8.2.2 Tests Performed 8.2.3 Results 8.2.3.1 Biodegradability 8.2.3.2 Ecotoxicity 8.3 Discussion 8.4 Conclusion References 9 Rational Design of Molecules by Life Cycle Engineering 9.1 Introduction 9.2 Benign by Design 9.2.1 Safe and Sustainable Molecules 9.2.2 Stability of APIs 9.2.3 Stability vs. Reactivity 9.2.4 The General Approach References Part III Use and Disposal of Pharmaceuticals 10 Options for a More Environmentally Friendly Handling of Pharmaceuticals 10.1 Background 10.2 Objectives of Strategic Considerations 10.3 Approach 10.4 Results Strategic Approach of Behaviour Modification 10.4.1 Creating Parameters and Environmental Classification for Pharmaceuticals 10.4.2 Bringing About Change to Problem Awareness Amongst Doctors and Pharmacists 10.4.3 Avoidance and Reduction of Pharmaceutical Consumption 10.4.3.1 Controlling the Demand for Pharmaceuticals Through Transparent Costs and Quantities and via Co-payment 10.4.3.2 Prescribing Options that Don't Involve Drugs 10.4.4 Disposal of Medicines 10.5 Discussion and Consequences 10.6 Recommendations and Outlook References 11 Disposal of Pharmaceutical Waste in Households A European Survey 11.1 Pharmaceutical Waste Reducing the Environmental Burden 11.2 Legislation 11.3 The EEA Questionnaire on Disposal of Unused Pharmaceuticals in Households 11.4 Educating and Informing Citizens 11.5 Amounts of Pharmaceutical Waste 11.6 Classification of Pharmaceutical Waste 11.7 Collection Points for Pharmaceutical Waste 11.8 Consumer Behaviour and Return Rate 11.9 Participation of Pharmacies as a Legal Duty? 11.10 Conclusions References 12 Pharmaceutical Waste: The Patient Role 12.1 What Makes Pharmaceutical Waste a Problem? 12.2 Proper Pharmaceutical Waste Management 12.3 Objective and Methodology of This Review 12.4 Pharmaceuticals Wasted 12.4.1 How Are Pharmaceuticals Disposed of ? 12.4.2 Type and Volume of Disposed Pharmaceuticals 12.4.3 How Much Is Left in the Package After Use and How Old Are Pharmaceuticals that Are Disposed of ? 12.5 The Patient Behind the Wasted Pharmaceuticals 12.5.1 Return Patterns of Unwanted Pharmaceuticals 12.5.2 Reasons for Unwanted or Leftover Drugs 12.6 Sustainable Drug Use 12.7 Conclusion References 13 Forecast of Pharmaceutical Consumption in the Netherlands Using Demographic Projections 13.1 Demographic Make-up of Population Influences Burden of Disease 13.2 Pharmaceutical Consumption in the Netherlands in 2007 13.3 Forecast of Pharmaceutical Consumption up to 2020 Based on Demographic Projections 13.4 European Perspective of the Dutch Forecasts 13.5 Discussion References Part IV Emission Management 14 Point Sources of Human Pharmaceuticals into the Aquatic Environment 14.1 Sources of Human Pharmaceuticals 14.2 Hospital Effluents 14.3 Manufacturing Sites 14.4 Conclusion References 15 Pharmaceuticals for Human Use: An Integrated Strategy for Reducing the Contamination of Water Bodies 15.1 Introduction 15.2 The Current Legal Situation 15.3 Risk and the Precautionary Principle 15.4 Options of Action for Reducing the Contamination of Water Bodies 15.4.1 Sphere of Activity ''Drug Development'' 15.4.2 Sphere of Activity ''Handling of Drugs'' 15.4.3 Sphere of Activity ''Technical Emissions Control in Urban Water Management'' 15.5 Discussion 15.5.1 Sphere of Activity ''Drug Development'' 15.5.2 Sphere of Activity ''Handling of Drugs'' 15.5.3 Sphere of Activity ''Emissions Control in Urban Water Management'' 15.6 Towards an Integrated Strategy 15.7 Conclusions References 16 Experiences with the Swedish Environmental Classification Scheme 16.1 Background 16.1.1 The Stockholm Model for Environmental Classification of Human Medicines 16.1.2 The Swedish Model for Environmental Classification of Human Medicines 16.2 Outcome and Experiences of the Risk and Hazard Assessments 16.3 Comments on the Experiences of the Swedish Model References Part V Incentives, Regulation and the Market 17 European Regulations 17.1 Introduction 17.2 Policy Framework at EU Level 17.2.1 Medicinal Regulations and Policies 17.2.1.1 Product Authorisation and Environment Risk Assessment 17.2.1.2 Drug Take-Back Schemes 17.2.2 Environmental Protection Regulations and Policies 17.2.2.1 Water Policies 17.2.2.2 Other Environmental Policies and Initiatives 17.3 Discussion of Current Policy Instruments 17.3.1 Policy Framework in the Light of the Precautionary and Prevention Principles 17.3.2 Policy Framework and End-of-Pipe Solutions 17.3.3 What Complicates Further EU Policy Development to Limit Discharge of PPs into Waters? References 18 Regulation and the Market-Incentives 18.1 Introduction 18.2 Strategies for the Increased Development of Greener Pharmaceutical Products 18.3 Strategies for Integrating Education and Awareness of the Issues Surrounding the Environmental Impacts of PPs References 19 Do Pharmaceuticals in the Environment Present an Investment Risk? 19.1 Bank Sarasins Sustainable Investments 19.2 Sustainability Aspects of the Pharmaceutical Industry 19.3 A New Theme: Pharmaceuticals in the Environment 19.4 Concentrations Very Low, Risks Not Adequately Researched 19.5 Activities of the Pharmaceutical Industry 19.6 Green Drug Design 19.7 Water Utilities Concerned About Higher Costs 19.8 No Plans for Tougher Legislation 19.9 Consumers Wear Different Hats 19.10 Drug Residues Are Still a Controversial Topic 19.11 Sustainably Minded Investors Should Keep an Eye on This Theme References Part VI Outlook 20 Sustainable Health Products and Service Solutions in the Year 2050 20.1 Introduction 20.2 Drivers 20.3 Criteria for Sustainable Health Products and Services in the Year 2050 20.3.1 Manufacturing 20.3.2 Prevention and Diagnosis 20.3.3 Services and Products 20.3.4 Post Treatment 20.3.5 Social Aspects 20.4 Environment 20.5 Conclusion 21 Summary and Outlook 21.1 The Presence of Pharmaceuticals in the Environment 21.2 Sustainable Pharmacy 21.3 Raw Materials 21.4 Synthesis and Manufacturing 21.5 Drug Targeting and Drug Delivery on Site 21.6 Benign by Design 21.7 Stakeholders 21.8 (Advanced) Sewage Treatment 21.9 Incentives 21.10 Outlook Index Why Green and Sustainable Pharmacy? / Klaus Kümmerer Pharmaceuticals in the Environment: Moving from a Problem to a Solution / John P. Sumpter Pharmaceuticals in Society / David J. Triggle Green(er) Pharmacy / James H. Clark, Simon W. Breeden, Louise Summerton Creating a Sustainability Culture - A (Human Resources) Management Perspective for Sustainable Pharmacy / Michael Läufer Reducing the Ecological Footprint of Pharmaceutical Usage: Linkages Between Healthcare Practices and the Environment / Christian G. Daughton, Ilene S. Ruhoy Ecopharmacostewardship - A Pharmaceutical Industry Perspective / David Taylor Protein and Peptide Therapeuticals: An Example of "Benign by Nature" Active Pharmaceutical Ingredients / Jürg Oliver Straub Rational Design of Molecules by Life Cycle Engineering / Klaus Kümmerer Options for a More Environmentally Friendly Handling of Pharmaceuticals / Konrad Götz, Jutta Deffner Disposal of Pharmaceutical Waste in Households: A European Survey / Gerald Vollmer Pharmaceutical Waste: The Patient Role / Staffan Castensson, Anders Ekedahl Forecast of Pharmaceutical Consumption in the Netherlands Using Demographic Projections / Monique van der Aa, Geertjan Kommer Point Sources of Human Pharmaceuticals into the Aquatic Environment / Kevin V. Thomas, Katherine H. Langford Pharmaceuticals for Human Use: An Integrated Strategy for Reducing the Contamination of Water Bodies / Florian Keil Experiences with the Swedish Environmental Classification Scheme / Åke Wennmalm, Bo Gunnarsson European Regulations / Eleftheria Kampa, Thomas Dworak, Cornelius Laaser, Rodrigo Vidaurre Regulation and the Market-Incentives / Benoît Roig, Evelyne Touraud Do Pharmaceuticals in the Environment Present an Investment Risk? / Andreas Holzer Sustainable Health Products and Service Solutions in the Year 2050 / Ludwig Metz, Klaus Kümmerer Summary and Outlook / Klaus Kümmerer, Maximilian Hempel, Hans-Christian Schaefer, Florian Keil.