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.
Table of Contents
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
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
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
Problems in 2012
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
Local Pharmacies and Pill Mills
CVS Pharmacy in Sanford, Florida
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
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
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
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.