Green and Sustainable Pharmacy

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