1st Edition

Pharmaceutical Supply Chain Drug Quality and Security Act

By Fred A. Kuglin Copyright 2016
    208 Pages 44 B/W Illustrations
    by CRC Press

    206 Pages 44 B/W Illustrations
    by CRC Press

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    Error-proofing in the production process of pharmaceuticals isn’t just a matter of good business, it has life-and-death implications for consumers. To that end, the 2013 Drug Quality and Security Act in large part requires new mandates on tracking and tracing chain of custody in the supply chain. Pharmaceutical Supply Chain: Drug Quality and Security Act overviews the new mandate and its implications, including implementation strategies for track-and-trace programs along with presenting a fuller understanding of the mechanics of intergovernmental policies and oversights.

    The book focuses on the delicate balance between protecting the public through legislation against negligent compounding pharmacies and protecting patients by assuring a supply of needed compounded drugs by not over-regulating the industry. The author discusses lessons learned from the earlier e-pedigree initiatives, the technology advances that enable supply chain security, and how the industry will need to respond to the myriad of threats facing the pharmaceutical drug supply chain and comply with this act. He goes in depth into each segment of the pharmaceutical drug supply chain, describing the industry segment and how it will need to adapt to the new act.

    By incorporating real-world examples of industry leaders, the book underlines the contributions of individuals who have made a difference through innovations and execution. It also addresses how laws are made, and specifically how the Drug Quality and Security Act was passed by Congress and signed into law. In an industry that is so big, you may feel that you cannot make a difference. This book provides you with key insights on how the forward supply chain process should work and how anyone can make a difference at all levels.

    Introduction: The Good, the Bad, the Ugly, and the Necessary
    Who Gives It a Second Thought?
    The Pharma Industry: The Good—Positive Impact on Human Life
    The Pharma Industry: The Bad—Negative Impact on Human Life
    Recalls—A Way of Life
    The Pharma Industry: The Ugly—Human Life Lost
    The Pharma Industry: The Necessary—The Drug Quality and Security Act (H.R. 3204)
    The Book Chapters

    H.R. 3204: The Journey and Expected Destination

    How Did We Get to November 27, 2013?
    The FDA Modernization Act of 1997
    Thompson versus Western States Medical Center
    Are We Making Progress?
    So Where Are We?
    Blue State, Purple State, Red State—Now It Makes Sense
    How H.R. 3204 Became Law
    Once Again, What Just Happened—and How Did We Get to the Drug Quality and Security Act?
    Quick Level Set of Definitions
    The States—Tag, You’re It!

    The World of Human Drug Compounding: Hope and Change
    What Is Pharmacy Compounding?
    A Look at Compounded Drugs/Medications
    Drug Quality and Security Act
    Food and Drug Modernization Act of 1997
    and 503A Revisited
    FDA Trials: Why Exemptions Are a Big Deal
    Title I: Pharmacy Compounding and 503B
    Traditional Compounding
    And We Have Liftoff—Maybe
    Issues to Be Resolved
    Governance and Leadership
    Governance, Leadership, and the NECC

    Pharmacy Compounding: The Supply Chain World

    Pharmacy Compounding Supply Chain Defined
    From Patient/Doctor Prescription to Ingredients
    From APIs and Compounding Ingredients to Compounded Medicines

    Track and Trace: Not Hide and Seek

    From Planning to Execution
    Back to the Future
    The Silver Lining: Serialization
    The Silver Lining: Track and Trace Technology
    The Silver Lining: The Authentication Connection
    Enter the Bad Guys—and Gals
    ePedigree: Act 2?
    Where Do We Go from Here?

    Land of the Giants—and Land of the Totes

    The Big Three
    McKesson Company: The Largest and the Oldest
    Cardinal Health
    Why the History Perspective of the Big Three?
    Back to Standing in Line for a Prescription
    The Drug Quality and Security Act: Wholesale Distributors
    Transaction Information and Transaction History
    The Big Three and Technology
    The Other 15%
    Wholesale Distributors, Repackaging, and the Drug Quality and Security Act
    Transaction Statement
    Problems in 2012
    Other Problems

    The Customer/Patient Touchpoint—Literally and Electronically: Internet Pharmacies, Pill Mills, and Other Lurking Dangers

    Drug Quality and Security Act and Local Pharmacies
    The Pharmacy Prescription Order-Fill Process
    The Legal Online Prescription Order-Fill Process
    The Illegal Internet Prescription Order-Fill Process
    Legal versus Illegal Internet Pharmacies
    Why Do Internet Pharmacies Exist?
    The FDA, the U.S. Justice Department, and Internet Pharmacies
    The Drug Quality and Security Act and Illegal Internet Pharmacies
    Why a Courier Service?
    Illegal Internet Pharmacies and Courier Services
    Back to the Drug Quality and Security Act and the FFDCA
    Pill Mills
    Local Pharmacies and Pill Mills
    CVS Pharmacy in Sanford, Florida
    Walgreens Settlement

    When Things Go Bump in the Night: Reverse Logistics

    What Is Reverse Logistics?
    The Human Factor
    Enter Stage Right: Reverse Distributors and Third-Party Logistics Providers
    Why Do Reverse Distributors Exist?
    The Drug Quality and Security Act:
    Back to Third-Party Logistics Providers
    Reverse Distributors
    The Physical Process of Returns
    Title II and the Value of Returns
    What Are the Critical Inhibitors?

    All Those "Lettered" Government Agencies

    The Federal and State Boys and Girls
    U.S. Food and Drug Administration
    U.S. Drug Enforcement Administration
    The State Boards of Pharmacy
    The State Departments of Public Safety
    The State Medical Boards

    Pulling It All Together: Public Policy and Other Items of Note

    Public Policy
    Drug Shortages
    Faster FDA Trials and Drug Shortages
    Ebola, FDA Trials, and Public Policy
    Pharmaceutical Drug Companies
    and the Drug Quality and Security Act
    Trucking Companies and the Drug Quality and Security Act
    One Barrier between Patients and Adulterated and Counterfeit Drugs: Nurses
    Summary—Title I: Compounding Quality Act
    Summary—Title II: Drug Supply Chain Security Act

    Drug Quality and Security Hall of Fame
    David Sparks, Founder of PCCA
    The Eli Lilly Family
    John McKesson, Founder, Neil E. Harmon and Alan Seelenfreund, CEOs, McKesson and Company
    Herb Sheer: GENCO—Third Generation
    Dr. Harvey W. Wiley, FDA
    Legislature—Fred Upton
    David Joseph Ballard, Chief Quality Officer, Baylor Scott & White Health


    Karl F. Kuglin is a professional services consultant with Ernst & Young LLP in the EY Life Sciences industry group. He helps pharmaceutical companies to adapt and lead change to the industry, including emerging science, new products and services, shifting demographics, evolving regulations (such as the Drug Quality and Security Act), transforming business models, and increased stakeholder expectations.
    Kuglin has operational leadership experience with one of the leading return logistics companies in the pharmaceutical industry. This experience includes an in-depth knowledge of the regulations governing pharmaceutical drugs (including controlled substances). He led a team responsible for the receipt, processing, return to manufacturer, and destruction of returned pharmaceutical drugs, and the accuracy of the application for credit allowances to pharmaceutical manufacturers. His contribution to Chapter 7, “When Things Go Bump in the Night: Reverse Logistics,” was invaluable. Kuglin is a graduate of Indiana University with a major in business administration.