1st Edition

Pharmaceutical Public Policy

ISBN 9781498748506
Published April 14, 2016 by CRC Press
504 Pages 26 B/W Illustrations

USD $140.00

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Book Description

As the most common health-care intervention, prescription drug use shares the most important characteristics of the health-care system in the United States. When everything works well, it makes possible breathtakingly successful applications of science to the prevention and cure of human suffering. But everything doesn’t always work well.

Pharmaceutical Public Policy provides the understanding and framework required for effective organization, financing, and delivery of pharmaceutical products and services. It supplies an overview of the policy process as well as the roles of legislation and regulation in pharmaceutical policy.

The book identifies the goals, objectives, and key policy issues of concern to stakeholders involved in the development of products, use of pharmaceuticals in healthcare, and administration of insurance programs by both the private and government sectors. Policy issues examined include the appropriateness of prescribing and patient adherence.

Addressing questions of access, quality, and cost, the book considers the operation of the Affordable Care Act and Medicare Part D. It details the responsibilities of Federal providers of pharmaceutical care and private and public payers such as managed care organizations, pharmacy benefit managers, Medicare, and Medicaid.

The book covers the policies and practices involved in promoting pharmaceutical products. It also considers pharmacoeconomics as a response to market failure. Finally, the book describes the market, the role of the manufacturer, drug shortages, and the responsibilities of the FDA.

The book includes a Foreword by Jerry Avorn, MD, Professor of Medicine, Harvard Medical School; and Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Woman’s Hospital.

Table of Contents

Policy Process
Alan Lyles

Federal Legislative Process
Valerie Heitshusen

Role of Federal Regulations and How They Are Developed
Curtis W. Copeland

Access, Quality, and Cost
Julie A. Schmittdiel and Marsha Raebel

Why Is Medication Use Less than Appropriate?
Duane M. Kirking, David Nau, and Jill Augustine

Medication Adherence and Health Policy
Meghan M. Kelly and Jon C. Schommer

Good Governance and Corruption in the Pharmaceutical System
Jillian Clare Kohler

U.S. Food and Drug Administration
Gregory Dolin

Risk Minimization: A New Regulatory Challenge Directive
Louis A. Morris and Eva Lydick

Drug Shortages
Anna Gu, Dhamil Patel, and Rajesh Nayak

Drug Reimportation into the United States
Albert I. Wertheimer and Qian Ding

Competition between Brand-Name and Generic Drugs
Jianfei J. Guo and Christina M.L. Kelton

Structure and Dynamics of the Pharmaceutical Industry
Earlene Lipowski

Health Policy and Economic Issues in Biotechnology and Personalized Medicine
Louis P. Garrison, Jr.

Pharmaceutical Promotion in the United States
Alan Lyles

Health Technology Assessment
Laura T. Pizzi and Tony Amos

Pharmacoeconomics as a Response to Market Failure: An International Perspective
Ruth Lopert

Market for Pharmaceuticals
David H. Kreling

Managed Care Pharmacy and Pharmacy Benefit Management
Perry Cohen and Mary Claire Wohletz

Drug Insurance Design and Management
Earle "Buddy" Lingle and William N. Yates

Electronic Information Technology: Role in Supporting Drug Use and Policy
Gordon Schiff, Tewodros Eguale, and Bill G. Felkey

Assessing Medicare Part D after 10 Years
Jack Hoadley

Brian K. Bruen and Linda Elam

Medication Therapy Management Services
Brian J. Isetts

The Affordable Care Act: Potential Impacts on Pharmaceutical Markets
Steven H. Sheingold and Pierre L. Yong

Role of Government as Regulator, Payer, and Provider of Care
W. Mike Heath and John Spain

Department of Veterans Affairs Pharmacy Programs
Vaiyapuri Subramaniam and Michael A. Valentino

Public Health Service
Robert E. Pittman


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Thomas R. Fulda was a federal civil servant for 30 years and held positions at the Social Security Administration and the Health Care Financing Administration. He conducted research on prescription drug pricing, participated in the development and implementation of the Federal Maximum Allowable Cost Program, participated in the planning for the implementation of the prescription drug provisions of the Medicare Catastrophic Coverage Act of 1988, and was responsible for the implementation of the Medicaid Drug Utilization Review provisions of the Omnibus Budget Reconciliation Act of 1990. He also worked at the U.S. Pharmacopeial Convention (Director of Drug Utilization Review), where he managed an expert scientific panel developing drug utilization review criteria. Fulda earned a Health Care Financing Administration Administrator’s Citation, received a Secretary’s Award for Exceptional Achievement for his work, and, in 1995, was named an honorary pharmacist by the American Pharmaceutical Association.

Alan Lyles is the Henry A. Rosenberg Professor of government, business, and nonprofit partnerships at the University of Baltimore’s College of Public Affairs, Baltimore, Maryland, and a fellow in the National Academy of Public Administration, Washington, DC. His professional interests focus on access to pharmaceuticals (policy, benefits, and evidence) and the role(s) of public–private arrangements. Professor Lyles serves on the editorial advisory panel of the International Pharmacy Journal and on the editorial advisory board of the Generics and Biosimilar Initiative Journal’s International. In 2006, he was visiting chair of pharmacoeconomics, and in 2007 and 2011 he was a Fulbright specialist at the University of Helsinki. He was a student of Shifu Ryan Velivlis and is a life member of the United States Kuo Shu Federation.

Albert I. Wertheimer has had extensive active involvement in the pharmaceutical field for more than 40 years and has held numerous leadership positions. He is author or coauthor of 35 books and more than 400 journal articles. Dr. Wertheimer has guided more than 100 PhD and MS students. He has had experience in the private sector at a pharmaceutical company and with a pharmaceutical benefit management (PBM) firm, in addition to his experience in the academic world. He is a popular lecturer and consultant, having worked in nearly 75 countries.


"Pharmaceutical policy has evolved over the last 50 years to be an enormously complex area of policy analysis. From the decisions that led to the exclusion of pharmaceutical coverage in Medicare at inception to the present, public and private sector policy makers have struggled to create and execute appropriate decisions on the optimal development, utilization and coverage of medications. This text is a must read resource for all health policy makers. While constituting only about 10 percent of total health spending in the US, the use of medications influences an enormous percentage of health spending. This includes the prevention and effective management of virtually all chronic conditions, hospital admissions and readmissions, and many other elements of health services. The editors have identified the leading experts across the entire landscape of pharmaceutical health policy and their contributions in the text will guide strong health policy development in this era of major change in health services design and -delivery."

—Lucinda L. Maine, PhD, RPh, Executive Vice President and CEO American Association of Colleges of Pharmacy

"Pharmaceutical Public Policy examines critical issues in health care from the public policy perspective, providing contemporary information, learned commentary, and fascinating reading. A typical chapter includes current tables and statistics, a review of federal government policy, and an international health care perspective.  Those with an interest in the history of public policy will find facts, background, and insights especially valuable.  The review of current topics coupled with future policy implications is useful to both students and scholars of pharmaceuticals in the marketplace."   

—Peter D. Hurd, Ph.D. Professor and Department Chair, Pharmaceutical and Administrative Sciences St. Louis College of Pharmacy

"Marrying pharmaceutical public policy to population health begets offspring who can radically transform our broken system. Fulda, Lyles, and Wertheimer are the matchmakers who brought this unlikely couple together!"

—David B. Nash, MD, MBA, Dean, Jefferson School of Population Health

"Pharmaceutical Public Policy is a comprehensive resource for understanding public policies influencing access, pricing and prescribing of pharmaceuticals. It contains critical information on how medications are managed in the US healthcare system. I highly recommend it for health care providers and administrators, policy makers, legislators, businessmen, and others involved with pharmaceuticals. As many of the issues dealt with in this book reflect concerns of other countries, international audiences would also benefit from its comprehensive, integrated presentation."

—Marja Airaksinen, PhD, MSc(Pharm), Professor of Social Pharmacy, Faculty of Pharmacy, University of Helsinki

"Fulda; Lyles and Wertheimer’s Pharmaceutical Public Policy book investigates the myriad of facades of the health policy process, giving light to the numerous stakeholders and forces that come into play when developing such policies. In an era, where the government is pressed to find an equitable balance between access to care, quality of care and the cost of care, this book is a must read for anyone trying to navigate through these complexities. The authors did an incredible job giving a voice to all the controversial topics currently affecting the healthcare system going from specific issues such as medication adherence; good governance and health technology assessment to more general issues such as the dynamics of the pharmaceutical care industry; the affordable care act and the public health services amongst others. In a simple but yet sophisticated language the authors, gracefully succeeded in breaking down multidimensional subject matters into more accessible topics. This book provides for a tremendous read and reference for those interested in furthering their learning around pharmaceutical policies and more specifically the regulation of the medication use system debate in this country.

Overall, Pharmaceutical Public Policy is a fascinating book that delivers a remarkable unbiased perspective around the health care regulation forces at play and would provide for an excellent discussion springboard not only in a classroom setting but also amongst critical thinkers and avid "health policy-trend" readers. I highly recommend it."

—Batoul Senhaji-Tomza Pharm.D/ MPH, Professor, Touro College of Pharmacy, New York, New York, USA