Handbook of Pharmaceutical Public Policy 1st Edition by Thomas R Fulda, Albert I Wertheimer ISBN 1439804265 9781439804261

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ISBN 10: 1439804265 
ISBN 13: 9781439804261
Author: Thomas R Fulda, Albert I Wertheimer

Pharmacy and pharmaceutical drug use are highly regulated and the various regulatory forces interact with diverse goals. Pharmaceutical Public Policy is a comprehensive review of the legislation, trends, business developments, and policy interpretations that have shaped drug use during the last 50 years. This unique single source explains drug regulatory activity, the major insurance and payment systems, and the impact of economics and politics on drug use in the United States. Leading experts provide a thorough and objective look at public policy issues, making this text perfect for upper level undergraduate and graduate level pharmacy, medical, and public health educators and students.

Pharmacists and pharmacy students must learn more than just the physical sciences and clinical aspects of the pharmaceutical industry. The rationale for policies, rules, and regulations is integral to understanding how to best serve patients and make the entire pharmaceutical sector more equitable and cost-effective. Pharmaceutical Public Policy examines the most pressing issues facing the industry, including control of the rising costs for drugs and ensuring correct drug usage by patients. This insightful text offers an in depth perspective of the policies and the debates that surround them. Chapters are well-referenced and many include helpful figures and tables to illustrate facts and ideas.

Handbook of Pharmaceutical Public Policy 1st Table of contents:

Part I: Foundations of Pharmaceutical Public Policy

1. Introduction to Pharmaceutical Public Policy

   • What is Pharmaceutical Public Policy?
   • Historical Evolution of Pharmaceutical Regulation
   • Global Perspectives on Pharmaceutical Policy
   • Key Stakeholders: Governments, Industry, and Public Health Organizations

2. Pharmaceutical Regulation: An Overview

   • Government Agencies Involved in Pharmaceutical Regulation
   • Regulatory Frameworks Around the World
   • Pharmaceutical Approval Processes
   • Role of the FDA, EMA, and Other Regulatory Bodies

3. Pharmaceutical Innovation and Research

   • The Drug Development Process
   • Innovation and Intellectual Property Protection
   • Public-Private Partnerships in Pharmaceutical R&D
   • Orphan Drugs and Incentives for Rare Diseases

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Part II: Economic Dimensions of Pharmaceutical Policy

4. Pharmaceutical Market Dynamics

   • Global Pharmaceutical Market Overview
   • Pricing and Market Access
   • Market Competition and Patent Expiry
   • Generic Drugs and Biosimilars

5. Pharmaceutical Pricing and Cost Control

   • Pricing Models in the Pharmaceutical Industry
   • Government Approaches to Pharmaceutical Pricing
   • Price Transparency and Public Policy
   • Price Controls and International Approaches
   • Negotiation and Reimbursement Systems

6. Health Insurance and Pharmaceutical Coverage

   • Private vs. Public Health Insurance Models
   • Pharmaceutical Benefits and Insurance
   • Government-Sponsored Pharmaceutical Programs (e.g., Medicaid, Medicare)
   • Universal Healthcare and Pharmaceutical Policy

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Part III: Public Health and Pharmaceutical Policy

7. Pharmaceuticals in Public Health Systems

   • Access to Medicines in Low- and Middle-Income Countries
   • Public Health Programs and Pharmaceutical Distribution
   • Global Health Initiatives and Pharmaceutical Policy
   • International Trade Agreements and Access to Medicines

8. Pharmaceutical Policy and Disease Prevention

   • Vaccination Policy and Access to Vaccines
   • Antibiotic Resistance and Policy Responses
   • Chronic Disease Management and Medication Access
   • Mental Health and Pharmaceutical Interventions

9. Pharmaceutical Safety and Regulation

   • Drug Safety Monitoring and Post-Market Surveillance
   • Risk-Benefit Analysis in Pharmaceutical Policy
   • Pharmacovigilance and Adverse Drug Reactions
   • Managing Drug Shortages and Emergencies

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Part IV: Ethical and Social Considerations

10. Ethics in Pharmaceutical Policy

    • Balancing Public Health and Commercial Interests
    • The Ethics of Drug Pricing
    • Equity and Fair Access to Pharmaceuticals
    • Pharmaceutical Marketing Ethics

11. Pharmaceuticals and Social Justice

    • Health Inequities and Pharmaceutical Access
    • Policies to Address Pharmaceutical Disparities
    • Pharmaceuticals and Global Development Goals
    • Corporate Social Responsibility in the Pharmaceutical Sector

12. Pharmaceutical Policy and Patient Advocacy

    • Role of Patient Advocacy Groups in Pharmaceutical Policy
    • Engagement with Policymakers and Public Health Campaigns
    • The Impact of Patient-Driven Movements on Drug Development and Access

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Part V: Pharmaceutical Policy in Practice

13. Pharmaceutical Policy in the United States

    • FDA Regulatory Authority and Policy Impact
    • Pharmaceutical Legislation in the U.S.
    • Public Health Programs and Pharmaceutical Access in the U.S.
    • Pharmaceutical Policy and Drug Pricing Reform in the U.S.

14. Pharmaceutical Policy in Europe and the EU

    • EMA and EU Pharmaceutical Regulations
    • The European Medicines Agency and Public Health
    • Pharmaceutical Policy in EU Member States
    • Pharmaceutical Pricing and Access Across Europe

15. Pharmaceutical Policy in Emerging Economies

    • Pharmaceutical Challenges in Developing Countries
    • Government and NGO Roles in Access to Medicines
    • Innovative Financing for Pharmaceuticals in Low-Income Nations
    • Public Health Strategies for Developing Countries

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Part VI: Future Directions in Pharmaceutical Public Policy

16. The Future of Pharmaceutical Regulation and Innovation

    • New Technologies in Drug Development
    • Pharmaceutical Policy and Artificial Intelligence
    • Personalized Medicine and Policy Implications
    • The Role of Big Data in Shaping Future Pharmaceutical Policy

17. Global Health and the Future of Pharmaceutical Access

    • Sustainable Development Goals and Pharmaceutical Policy
    • Global Health Initiatives Post-COVID-19
    • Advances in Global Pharmaceutical Access and Equity
    • Collaboration Between Nations for Drug Availability

18. Challenges and Opportunities for Pharmaceutical Policy Reform

    • Reforming Drug Pricing Models
    • Innovations in Global Health Policy
    • The Role of Advocacy and Public Engagement in Shaping Policy
    • The Future of Public-Private Partnerships in Pharmaceuticals

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Thomas R Fulda,Albert I Wertheimer,Pharmaceutical Public Policy