Pharmaceutical supply chain : Drug Quality and Security Act

204 Pages·2016·13.81 MB·English

by  Kuglin

Pharmaceutical K Pharmaceutical
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Error-proofing in the production process of pharmaceuticals isn’t just a matter l
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of good business, it has life-and-death implications for consumers. To that end,
Supply Chain
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 presents an overview of the
new mandate and its implications, including implementation strategies for P
track-and-trace programs along with presenting a fuller understanding of the H Drug Quality and Security Act
mechanics of intergovernmental policies and oversights. A
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The book focuses on the delicate balance between protecting the public through M
legislation against negligent compounding pharmacies and protecting patients
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by assuring a supply of needed compounded drugs by not over-regulating the
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industry. The author discusses lessons learned from the earlier e-pedigree
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initiatives, the technology advances that enable supply chain security, U
and how the industry will need to respond to the myriad threats facing the
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pharmaceutical drug supply chain and comply with this act. He reviews each I
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segment of the pharmaceutical supply chain in depth, describing the industry
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segment and how it will need to adapt to the new act.
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By incorporating real-world examples of industry leaders, the book underlines S
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the contributions of individuals who have made a difference through innova-
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tions and execution. It also addresses how laws are made, and specifically how
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the Drug Quality and Security Act was passed by Congress and signed into
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law. In an industry that is so big, you may feel that you cannot make a differ- Y
ence. This book provides you with key insights on how the forward supply
C
chain process should work and how anyone can make a difference at all levels.
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K24160
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w w w.c r c p r e s s .c o m

Pharmaceutical
Supply Chain
Drug Quality and Security Act

Pharmaceutical
Supply Chain
Drug Quality and Security Act
Fred A. Kuglin
CRC Press
Taylor & Francis Group
6000 Broken Sound Parkway NW, Suite 300
Boca Raton, FL 33487-2742
© 2016 by Taylor & Francis Group, LLC
CRC Press is an imprint of Taylor & Francis Group, an Informa business
No claim to original U.S. Government works
Version Date: 20150602
International Standard Book Number-13: 978-1-4822-5894-3 (eBook - PDF)
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Contents
Preface .................................................................................................xiii
Acknowledgments ................................................................................xv
Author .................................................................................................xvii
Introduction: The Good, the Bad, the Ugly, and the Necessary ......xix
Chapter 1 H.R. 3204: The Journey and Expected Destination .........1
How Did We Get to November 27, 2013? ..................................1
The FDA Modernization Act of 1997 .........................................2
Thompson versus Western States Medical Center .....................3
Are We Making Progress? ...........................................................4
So Where Are We? ........................................................................4
Blue State, Purple State, Red State—Now It Makes Sense ......5
How H.R. 3204 Became Law .......................................................5
Once Again, What Just Happened—and How Did
We Get to the Drug Quality and Security Act? ........................8
Quick Level Set of Definitions ....................................................9
The States—Tag, You’re It! .........................................................10
Massachusetts: Their Response ............................................10
Michigan: Representative Fred Upton’s State ....................11
California ................................................................................11
Florida .....................................................................................12
Colorado ..................................................................................13
Texas ........................................................................................13
Summary .....................................................................................14
Endnotes ......................................................................................15
Chapter 2 The World of Human Drug Compounding:
Hope and Change .............................................................17
What Is Pharmacy Compounding? .........................................17
A Look at Compounded Drugs/Medications .........................18
Example of Nonsterile, Traditional Compounding ..........18
Example of Sterile Compounding for Office Use .............20
Summary .................................................................................21
v
vi • Contents
Drug Quality and Security Act .................................................22
Food and Drug Modernization Act of 1997
and 503A Revisited .....................................................................22
FDA Trials: Why Exemptions Are a Big Deal ........................23
Title I: Pharmacy Compounding and 503B ............................24
Outsourcing Facility Registration and Reporting.............24
Traditional Compounding ........................................................26
And We Have Liftoff—Maybe ...................................................27
Issues to Be Resolved ..................................................................27
Governance and Leadership ....................................................28
Governance, Leadership, and the NECC ................................29
Summary .....................................................................................31
Endnotes ......................................................................................32
Chapter 3 Pharmacy Compounding: The Supply Chain World .....33
Pharmacy Compounding Supply Chain Defined ..................33
From Patient/Doctor Prescription to Ingredients .................33
PCCA: Overview ...................................................................34
Order Aggregation and Supplier Sourcing .........................35
Order Placement, Supplier
Base Compound Shipment and PCCA Receipt .................36
The Drug Quality and Security Act ....................................37
Compounding Pharmacy Order Fill ...................................38
From APIs and Compounding Ingredients to
Compounded Medicines ...........................................................38
The Complication...................................................................39
Good Manufacturing Practices: The Foundation
to Ensure a Safe and Sterile Environment ..........................41
Are We There Yet? .................................................................43
One Best Practice to Model .................................................43
The Best Defense Is a Good Offense ...................................44
Back to PCCA .........................................................................45
Eagle Analytical Services .....................................................46
PCCA and the AIB Industry Audit Solution
for Compounding Pharmacies .............................................47
Summary ....................................................................................48
Endnotes ......................................................................................49
Contents • vii
Chapter 4 Track and Trace: Not Hide and Seek ..............................51
Overview ......................................................................................51
Key Provisions .............................................................................52
Product Identification ...........................................................52
Product Tracing .....................................................................53
Product Verification .............................................................54
Detection and Response .......................................................54
Notification ............................................................................54
Wholesale Distributor Licensing .........................................55
Third-Party Logistics Provider Licensing ..........................55
From Planning to Execution ....................................................56
Back to the Future .....................................................................56
The Silver Lining: Serialization .................................................58
The Silver Lining: Track and Trace Technology .....................59
The Silver Lining: The Authentication Connection ..............60
Enter the Bad Guys—and Gals .................................................61
Authentix .....................................................................................62
ePedigree: Act 2? .........................................................................63
Where Do We Go from Here? .................................................64
Summary .....................................................................................65
Endnotes .....................................................................................66
Chapter 5 Land of the Giants—and Land of the Totes ...................69
Overview ......................................................................................69
The Big Three ...............................................................................70
McKesson Company: The Largest and the Oldest .................71
AmerisourceBergen ....................................................................72
Cardinal Health ..........................................................................73
Why the History Perspective of the Big Three? ......................74
Back to Standing in Line for a Prescription ............................75
The Drug Quality and Security Act:
Wholesale Distributors ..............................................................77
Transaction Information and Transaction History ...............77
The Big Three and Technology .................................................78
The Other 15% .............................................................................79
Wholesale Distributors, Repackaging,
and the Drug Quality and Security Act ..................................79
Transaction Statement ..............................................................80
viii • Contents
Problems in 2012 .........................................................................81
Other Problems ...........................................................................82
Summary .....................................................................................83
Endnotes ......................................................................................85
Chapter 6 The Customer/Patient Touchpoint—Literally
and Electronically: Internet Pharmacies, Pill Mills,
and Other Lurking Dangers ............................................87
Overview ......................................................................................87
Drug Quality and Security Act and Local Pharmacies ........88
Pharmacy Prescription Order-Fill Process ............................88
Legal Online Prescription Order-Fill Process .......................90
Illegal Internet Prescription Order-Fill Process ....................90
Legal versus Illegal Internet Pharmacies .................................92
Why Do Internet Pharmacies Exist? ........................................92
The FDA, the U.S. Justice Department,
and Internet Pharmacies ............................................................94
The Drug Quality and Security Act
and Illegal Internet Pharmacies ................................................94
Why a Courier Service? ............................................................96
Illegal Internet Pharmacies and Courier Services ................96
Back to the Drug Quality and Security Act
and the FFDCA ...........................................................................97
Pill Mills .......................................................................................98
Local Pharmacies and Pill Mills ..............................................99
CVS Pharmacy in Sanford, Florida .........................................99
Walgreens Settlement..............................................................100
Summary ...................................................................................101
Endnotes ....................................................................................102
Chapter 7 When Things Go Bump in the Night:
Reverse Logistics ............................................................105
Overview ....................................................................................105
What Is Reverse Logistics? ......................................................105
The Human Factor ....................................................................107