Green and Sustainable Pharmacy (eBook)

Foreword 5
Preface and Scope of the Book 6
Contents 9
Contributors 12
Part I General Aspects 15
1 Why Green and Sustainable Pharmacy? 16
1.1 How It Began 16
1.2 Why Green and Sustainable Pharmacy? 18
References 22
2 Pharmaceuticals in the Environment: Moving from a Problem to a Solution 24
2.1 Introduction 24
2.1.1 Problem 1: Many Pharmaceuticals Are Present in the Environment 25
2.1.2 Problem 2: Some Pharmaceuticals Have Been Shown to Have Adverse Effects on Wildlife 26
2.1.2.1 Feminisation of Fish by EE2 26
2.1.2.2 Acute Poisoning of Oriental Vultures by Diclofenac 28
2.1.3 Problem 3: Drinking Water May Be Contaminated with Human Pharmaceuticals 29
2.2 Possible Solutions to the Problems Created by Pharmaceuticals in the Environment 31
2.2.1 Solution-1: Develop ''Greener'' Pharmaceuticals 31
2.2.2 Solution-2: Prevent Pharmaceuticals Reaching the Environment 32
2.2.3 Solution-3: Improve the Efficiency of STWs 32
2.3 Conclusions 33
References 33
3 Pharmaceuticals in Society 36
3.1 Introduction 36
3.1.1 Global Challenges Require Global Cooperation 37
3.2 Tomorrows Pharmaceuticals: The Drug Discovery Process 37
3.2.1 Unrealized Potential 39
3.3 Tomorrows Drug Development: Alternative Models 40
3.3.1 No Money, No Drugs? 41
3.3.2 Supporting New Models 41
3.4 Alternatives to Pharmaceuticals: The Role of Public Health 42
3.4.1 Bad Habits as a Disease 42
3.4.2 The Expanding Scope of Lifestyle Drugs 43
3.4.3 Wealth and Health 43
3.5 The Road Ahead: Promises and Problems 44
3.5.1 Who Owns the Genes? 44
3.5.2 New Safety Concerns 45
References 46
4 Green(er) Pharmacy 49
4.1 Introduction 49
4.2 What Is a Pharmaceutical? 51
4.3 Standardised Methods of Measuring Greenness Across the Whole Lifecycle 52
4.4 Raw Materials and Pre-manufacturing 54
4.4.1 Raw Materials 54
4.4.2 Pre-manufacturing 55
4.4.2.1 Lead Identification 55
4.4.2.2 Lead Optimisation/Medicinal Chemistry 57
4.4.2.3 Candidate Selection 58
4.5 Manufacturing and Production 58
4.5.1 Process Chemistry 58
4.5.1.1 Process Chemistry: Clean Synthesis 58
4.5.1.2 Process Chemistry: Solvents 61
4.5.1.3 Process Chemistry: New Technologies 62
4.6 Product Use and Fate 63
4.6.1 Drug Efficacy and Delivery as Green Pharmacy 64
4.6.2 End-of-Life Issues 65
4.7 Engaging Key Stakeholders Across the Lifecycle 67
4.7.1 The Perceived Problem of Green Pharmacy? 67
4.7.2 The Opportunity of Green Pharmacy? 68
4.8 Conclusions 69
References 69
5 Creating a Sustainability Culture A (Human Resources) Management Perspective for Sustainable Pharmacy 72
5.1 Introduction: From Crisis to a New Business Platform 72
5.2 Clarifying Some Terms 73
5.2.1 CSR, CC, CS 73
5.2.1.1 Corporate Sustainability Management 74
5.2.2 Stakeholder Theory/Shareholder vs. Stakeholder Value 75
5.2.2.1 Pharma's Stakeholder Perspective 76
5.3 Business Case for Corporate Sustainability 76
5.3.1 Business Benefits as a Fact 78
5.3.2 Creating Win--Win 79
5.3.3 Testimonials 79
5.4 Implementation Challenges 79
5.4.1 Sustainability at the Core 80
5.4.2 Communications and Transparency 80
5.4.3 Metrics 80
5.4.4 Changing Behaviors and Attitudes 81
5.5 Creating a Sustainability Culture 81
5.5.1 Culture Change 81
5.5.2 Wanted: Role Models 83
5.5.3 Hard-Wire/Soft-Wire 83
5.5.4 Sustainability as Part of Company Fabric 84
5.5.5 Colleague Engagement 84
5.5.6 Feedback Loops 85
5.6 Going Forward 85
Bibliography 86
6 Reducing the Ecological Footprint of Pharmaceutical Usage: Linkages Between Healthcare Practices and the Environment 88
6.1 Introduction 88
6.2 Improving the Efficiency of Pharmacy 93
6.2.1 Mining of Healthcare Data 93
6.2.2 Electronic Systems 94
6.3 Personalized Medicine A Framework for a Sustainable Pharmacy 95
6.4 Pharmacogenomics (PGx) 97
6.5 Outlook for Personalized Medicine Extending the Focus from Treating Symptoms to Achieving Efficacious Therapeutic Outcomes 100
6.6 Improving Drug Delivery and Chemistry by Design 102
6.7 Pharmaceutical Care: An Avenue to Improved Health Care and Reduced Environmental Footprint 105
6.8 PharmEcovigilance: Vision for Optimal Integration of Medications Environmental Footprint, Healthcare Effectiveness, and Sustainability 107
References 108
Part II Development, Synthesis and Production and Distribution of Pharmaceuticals 114
7 Ecopharmacostewardship A Pharmaceutical Industry Perspective 115
7.1 The Stakeholders 116
7.2 Greener Drug Design 117
7.2.1 Degradable Pharmaceuticals 119
7.2.2 Current Improvements in Drug Design 120
7.3 Sustainability in Research, Manufacturing, Sales and Distribution 122
7.3.1 Sustainability in R& D and Manufacturing
7.3.2 Sales and Distribution 126
7.4 Product Use and Disposal 127
7.4.1 Unused Medicines 128
7.4.2 Excreted Medicines 129
7.4.3 Ecopharmacovigilance 131
7.5 Conclusions Reducing the Uncertainties 133
References 134
8 Protein and Peptide Therapeuticals: An Example of Benign by Nature Active Pharmaceutical Ingredients 137
8.1 Introduction 137
8.2 Materials and Methods 137
8.2.1 Substances Tested 138
8.2.2 Tests Performed 138
8.2.3 Results 138
8.2.3.1 Biodegradability 138
8.2.3.2 Ecotoxicity 140
8.3 Discussion 141
8.4 Conclusion 142
References 143
9 Rational Design of Molecules by Life Cycle Engineering 144
9.1 Introduction 144
9.2 Benign by Design 147
9.2.1 Safe and Sustainable Molecules 147
9.2.2 Stability of APIs 148
9.2.3 Stability vs. Reactivity 149
9.2.4 The General Approach 151
References 153
Part III Use and Disposal of Pharmaceuticals 156
10 Options for a More Environmentally Friendly Handling of Pharmaceuticals 157
10.1 Background 157
10.2 Objectives of Strategic Considerations 157
10.3 Approach 159
10.4 Results Strategic Approach of Behaviour Modification 160
10.4.1 Creating Parameters and Environmental Classification for Pharmaceuticals 161
10.4.2 Bringing About Change to Problem Awareness Amongst Doctors and Pharmacists 163
10.4.3 Avoidance and Reduction of Pharmaceutical Consumption 164
10.4.3.1 Controlling the Demand for Pharmaceuticals Through Transparent Costs and Quantities and via Co-payment 164
10.4.3.2 Prescribing Options that Don't Involve Drugs 165
10.4.4 Disposal of Medicines 166
10.5 Discussion and Consequences 167
10.6 Recommendations and Outlook 169
References 170
11 Disposal of Pharmaceutical Waste in Households A European Survey 172
11.1 Pharmaceutical Waste Reducing the Environmental Burden 172
11.2 Legislation 173
11.3 The EEA Questionnaire on Disposal of Unused Pharmaceuticals in Households 173
11.4 Educating and Informing Citizens 174
11.5 Amounts of Pharmaceutical Waste 176
11.6 Classification of Pharmaceutical Waste 178
11.7 Collection Points for Pharmaceutical Waste 178
11.8 Consumer Behaviour and Return Rate 180
11.9 Participation of Pharmacies as a Legal Duty? 182
11.10 Conclusions 183
References 184
12 Pharmaceutical Waste: The Patient Role 186
12.1 What Makes Pharmaceutical Waste a Problem? 186
12.2 Proper Pharmaceutical Waste Management 187
12.3 Objective and Methodology of This Review 188
12.4 Pharmaceuticals Wasted 189
12.4.1 How Are Pharmaceuticals Disposed of ? 189
12.4.2 Type and Volume of Disposed Pharmaceuticals 189
12.4.3 How Much Is Left in the Package After Use and How Old Are Pharmaceuticals that Are Disposed of ? 193
12.5 The Patient Behind the Wasted Pharmaceuticals 193
12.5.1 Return Patterns of Unwanted Pharmaceuticals 193
12.5.2 Reasons for Unwanted or Leftover Drugs 197
12.6 Sustainable Drug Use 202
12.7 Conclusion 202
References 203
13 Forecast of Pharmaceutical Consumption in the Netherlands Using Demographic Projections 208
13.1 Demographic Make-up of Population Influences Burden of Disease 208
13.2 Pharmaceutical Consumption in the Netherlands in 2007 208
13.3 Forecast of Pharmaceutical Consumption up to 2020 Based on Demographic Projections 210
13.4 European Perspective of the Dutch Forecasts 211
13.5 Discussion 214
References 214
Part IV Emission Management 216
14 Point Sources of Human Pharmaceuticals into the Aquatic Environment 217
14.1 Sources of Human Pharmaceuticals 217
14.2 Hospital Effluents 218
14.3 Manufacturing Sites 225
14.4 Conclusion 227
References 228
15 Pharmaceuticals for Human Use: An Integrated Strategy for Reducing the Contamination of Water Bodies 230
15.1 Introduction 230
15.2 The Current Legal Situation 231
15.3 Risk and the Precautionary Principle 233
15.4 Options of Action for Reducing the Contamination of Water Bodies 234
15.4.1 Sphere of Activity ''Drug Development'' 234
15.4.2 Sphere of Activity ''Handling of Drugs'' 235
15.4.3 Sphere of Activity ''Technical Emissions Control in Urban Water Management'' 238
15.5 Discussion 239
15.5.1 Sphere of Activity ''Drug Development'' 240
15.5.2 Sphere of Activity ''Handling of Drugs'' 241
15.5.3 Sphere of Activity ''Emissions Control in Urban Water Management'' 242
15.6 Towards an Integrated Strategy 243
15.7 Conclusions 244
References 245
16 Experiences with the Swedish Environmental Classification Scheme 247
16.1 Background 247
16.1.1 The Stockholm Model for Environmental Classification of Human Medicines 248
16.1.2 The Swedish Model for Environmental Classification of Human Medicines 249
16.2 Outcome and Experiences of the Risk and Hazard Assessments 251
16.3 Comments on the Experiences of the Swedish Model 252
References 253
Part V Incentives, Regulation and the Market 254
17 European Regulations 255
17.1 Introduction 255
17.2 Policy Framework at EU Level 255
17.2.1 Medicinal Regulations and Policies 256
17.2.1.1 Product Authorisation and Environment Risk Assessment 256
17.2.1.2 Drug Take-Back Schemes 260
17.2.2 Environmental Protection Regulations and Policies 261
17.2.2.1 Water Policies 261
17.2.2.2 Other Environmental Policies and Initiatives 266
17.3 Discussion of Current Policy Instruments 268
17.3.1 Policy Framework in the Light of the Precautionary and Prevention Principles 269
17.3.2 Policy Framework and End-of-Pipe Solutions 273
17.3.3 What Complicates Further EU Policy Development to Limit Discharge of PPs into Waters? 274
References 277
18 Regulation and the Market-Incentives 280
18.1 Introduction 280
18.2 Strategies for the Increased Development of Greener Pharmaceutical Products 280
18.3 Strategies for Integrating Education and Awareness of the Issues Surrounding the Environmental Impacts of PPs 284
References 285
19 Do Pharmaceuticals in the Environment Present an Investment Risk? 287
19.1 Bank Sarasins Sustainable Investments 287
19.2 Sustainability Aspects of the Pharmaceutical Industry 287
19.3 A New Theme: Pharmaceuticals in the Environment 288
19.4 Concentrations Very Low, Risks Not Adequately Researched 288
19.5 Activities of the Pharmaceutical Industry 289
19.6 Green Drug Design 289
19.7 Water Utilities Concerned About Higher Costs 290
19.8 No Plans for Tougher Legislation 290
19.9 Consumers Wear Different Hats 291
19.10 Drug Residues Are Still a Controversial Topic 291
19.11 Sustainably Minded Investors Should Keep an Eye on This Theme 292
References 292
Part VI Outlook 293
20 Sustainable Health Products and Service Solutions in the Year 2050 294
20.1 Introduction 294
20.2 Drivers 294
20.3 Criteria for Sustainable Health Products and Services in the Year 2050 295
20.3.1 Manufacturing 295
20.3.2 Prevention and Diagnosis 295
20.3.3 Services and Products 296
20.3.4 Post Treatment 296
20.3.5 Social Aspects 296
20.4 Environment 296
20.5 Conclusion 296
21 Summary and Outlook 298
21.1 The Presence of Pharmaceuticals in the Environment 298
21.2 Sustainable Pharmacy 298
21.3 Raw Materials 299
21.4 Synthesis and Manufacturing 299
21.5 Drug Targeting and Drug Delivery on Site 299
21.6 Benign by Design 300
21.7 Stakeholders 300
21.8 (Advanced) Sewage Treatment 300
21.9 Incentives 301
21.10 Outlook 301
Index 303