U.S. Drug Supply Chain Integrity:
Protecting Patient Safety
CDR Connie Jung, PharmD, PhD
LCDR Eleni Anagnostiadis, RPh
Office of Drug Security, Integrity, and Recalls
Office of Compliance/Center for Drug Evaluation and Research
U.S. Food and Drug Administration
USPHS Scientific and Training Symposium
June 21, 2012
Objectives
At the end of this session participants will be able to:
1) Describe the threats and vulnerabilities of the
pharmaceutical supply chain, such as counterfeiting,
diversion, and cargo theft.
2) Identify initiatives undertaken by FDA to ensure that
patients receive quality prescription medications.
3) Define the pharmacist's role in educating patients how
to identify and report suspect counterfeit or other
substandard drug issues.
2
Agenda
• Overview of Pharmaceutical Supply Chain
• Supply Chain Risks
–
–
–
–
Counterfeit Drugs
Diverted Drugs
Cargo Theft
Internet Pharmacies
• Current FDA action
– Office of Drug Security, Integrity, and Recalls
– Response to Counterfeit Avastin and Altuzan Incidents
– Operation Pangea IV
• Pharmacist’s Role
3
Threats Throughout the Drug Supply Chain
Globalization
Counterfeit
Terrorism
Diversion
Counterfeit
Cargo theft
Unknown
threats
Intentional
Adulteration
Manufacturer
Importer
Wholesaler
Finished dosage form or
API
Unknown
threats
Manufacturer
Wholesaler
Pharmacy
Terrorism
API and Inactive
Ingredients
Patient
4
Supply Chain for
Finished Drugs
Pharmacy
Distributor (Primary)
Manufacturer
Distributor (Secondary)
Repackager
Complexity of the supply chain is increased by:
Example of vulnerabilities in the supply chain:
–
Multiple participants
–
Stolen products reintroduced
–
Globalization of supply chains
–
Counterfeit/falsified drugs sold to suppliers
–
Criminal activities such as diversion, cargo theft,
and counterfeiting
–
Diverted drugs resold
–
Other adulterated/misbranded drugs introduced
–
Rules that vary by state
5
Supply Chain for
Finished Drugs
Pharmacy
Distributor (Primary)
Vulnerabilities/
Threats
Manufacturer
Distributor (Secondary)
Repackager
Complexity of the supply chain is increased by:
Example of vulnerabilities in the supply chain:
–
Multiple participants
–
Stolen products reintroduced
–
Globalization of supply chains
–
Counterfeit/falsified drugs sold to suppliers
–
Criminal activities such as diversion, cargo theft,
and counterfeiting
–
Diverted drugs resold
–
Other adulterated/misbranded drugs introduced
–
Rules that vary by state
6
Public Health Concerns
Public health risk created by:
• Introduction of stolen product into
the legitimate supply chain
• Resurfacing of product many
months or years after the theft
• Improper Storage
• Expired Products
• Dilution and adulteration
• Counterfeiting
• Importation
7
Compromised Integrity:
Examples of Supply Chain Threats
• Counterfeit drugs
• Diverted drugs
• Cargo Theft/ Stolen drugs
8
Recent Counterfeit Drugs
• Counterfeit Adderall
• Counterfeit Avastin
• Counterfeit Altuzan
Counterfeit
Counterfeit
9
Counterfeit Drug Cases Opened by FDA’s
Office of Criminal Investigations per Fiscal Year
80
72
70
65
58
60
56
54
59
50
Number of
cases
40
27
30
30
32
31
21
20
10
11
9
5
6
0
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
Year
10
Diverted Drugs
• The sale of drugs
outside of the
distribution channels for
which they were
originally intended
• Can originate
domestically or
internationally
• Counterfeiting is usually
associated with a
diversion scheme
Reselling of Rx drugs obtained by doctors
11
Cargo Theft/Stolen Drugs
multiple adverse event reports of patients who suffered
poor glycemic control after using a vial from a stolen lot
12
Internet – Illegitimate Drug Sellers
• Problems with current ‘buying online’ practices
– High volume
– Vast scope
– Unknown origin
• Drug quality concerns
– Lack of “sameness”
– Counterfeits or not FDA-approved
– Potentially confusing names
• Websites
– Misleading (fake online pharmacies, counterfeit products, false health claims)
• How patients can buy drugs online safely (www.fda.gov/buyonline)
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14
15
New Office of Drug Security,
Integrity, and Recalls (ODSIR)
• Enhanced and targeted resources
• Address increasing supply chain threats
– Intentional adulteration, cargo theft, counterfeiting, diversion,
other
– Focus on life-cycle of the product from drug components
through to the finished dosage from delivered to the patient
• New and coordinated approaches, policies and enforcement
strategies
Recalls
Drug
Shortages
Imports
Exports
Drug Supply
Chain Integrity
16
FDA Supply Chain Security Initiatives
• Response to recent Counterfeit Avastin
and Altuzan incidents
• Operation Pangea
17
18
Letters from FDA
• Sent to medical
practices in the U.S.
• Warned against the use
of counterfeit Avastin
• Risks of purchasing
from foreign sources
• Quality Specialty
Products (QSP)
• Volunteer Distribution
• Report adverse events
to MedWatch
19
Avastin
.
• Authentic Avastin marketed by
Genentech was not subject to
counterfeiting
• Only FDA-approved Avastin for
use in U.S
• Considered as safe and effective
for intended uses
• Patients that received
Genentech Avastin did not need
to be concerned
• Counterfeit was a fake of foreign
approved version
(Images from Genentech)
20
Counterfeit Altuzan
• Altuzan® 400mg/16mL vial with lot
number B6021
• Vial contains no active ingredient
• Writing is in English
21
22
Global Collaborations – tackling internet
 Operation Pangea IV
-
INTERPOL led global operation targeting internet
websites supplying illegal and dangerous drugs;
- 81 countries participated
- 13,500 websites shutdown
- Approximately 8,000 packages seized
- 2.4 million illicit counterfeit pills confiscated
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Pharmacist’s Role
• Minimize the risk of and exposure to counterfeit medical products
–
Know who you are doing business with
• Be vigilant
– Inspect the product and packaging
– Consider counterfeits if patient complains of:
• New/unusual side effects; lack of therapeutic effect; abnormal taste or smell;
pain, burning, or redness at injection site
• Counseling patients about counterfeit medical products
– Encourage patients to shop only at pharmacies licensed by the state board of pharmacy
– Tell patient if you dispense a drug that may look different from their previously dispensed
drug
– If cost is an issue, counsel on assistance program and generics, rather than buying online
– Explain the dangers of buying drug online
• Report Suspect Counterfeit medical products to
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Resources
Resources
ODSIR Drug Integrity and Supply Chain Security
www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSec
urity/default.htm
Counterfeit Medicine
www.fda.gov/counterfeit
Buying Medicines Online
www.fda.gov/buyonline
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hank you
Thank You!
CDR Connie Jung, RPh, PhD
Acting Associate Director for Policy and Communications
Connie.jung@fda.hhs.gov
LCDR Eleni Anagnostiadis, RPh
Division of Supply Chain Integrity
Eleni.anagnostiadis@fda.hhs.gov
Office of Drug Security, Integrity & Recalls
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
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