U.S. Drug Supply Chain Integrity: Protecting Patient Safety CDR Connie Jung, PharmD, PhD LCDR Eleni...

U.S. Drug Supply Chain Integrity:U.S. Drug Supply Chain Integrity: Protecting Patient SafetyProtecting Patient Safety

CDR Connie Jung, PharmD, PhDLCDR Eleni Anagnostiadis, RPhOffice of Drug Security, Integrity, and RecallsOffice of Compliance/Center for Drug Evaluation and ResearchU.S. Food and Drug Administration

USPHS Scientific and Training Symposium June 21, 2012

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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.

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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

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Finished dosage form or API

API and Inactive Ingredients

Patient

Intentional Adulteration

Counterfeit

Unknown threats

Terrorism

Globalization

Terrorism

Cargo theft

Diversion

Counterfeit

Unknown threats

ManufacturerImporter

Wholesaler

ManufacturerWholesalerPharmacy

Threats Throughout the Drug Supply ChainThreats Throughout the Drug Supply Chain

Globalization

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Distributor (Primary)Pharmacy

Manufacturer

Distributor (Secondary)Repackager

Complexity of the supply chain is increased by:

– Multiple participants

– Globalization of supply chains

– Criminal activities such as diversion, cargo theft, and counterfeiting

– Rules that vary by state

Example of vulnerabilities in the supply chain:

– Stolen products reintroduced

– Counterfeit/falsified drugs sold to suppliers

– Diverted drugs resold

– Other adulterated/misbranded drugs introduced

Supply Chain for Finished Drugs

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Distributor (Primary)Pharmacy

Manufacturer

Distributor (Secondary)Repackager

Complexity of the supply chain is increased by:

– Multiple participants

– Globalization of supply chains

– Criminal activities such as diversion, cargo theft, and counterfeiting

– Rules that vary by state

Example of vulnerabilities in the supply chain:

– Stolen products reintroduced

– Counterfeit/falsified drugs sold to suppliers

– Diverted drugs resold

– Other adulterated/misbranded drugs introduced

Supply Chain for Finished Drugs

Vulnerabilities/Threats

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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

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Compromised Integrity:Examples of Supply Chain Threats

• Counterfeit drugs

• Diverted drugs

• Cargo Theft/ Stolen drugs

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Recent Counterfeit Drugs

• Counterfeit Adderall

• Counterfeit Avastin

• Counterfeit Altuzan

CounterfeitCounterfeit

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95

116

21

27 30

58

32

54

31

56

6572

59

0

10

20

30

40

50

60

70

80

Number of cases

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

Year

Counterfeit Drug Cases Opened by FDA’s Office of Criminal Investigations per Fiscal Year

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Diverted DrugsDiverted 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 doctorsReselling of Rx drugs obtained by doctors

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Cargo Theft/Stolen Drugs Cargo Theft/Stolen Drugs

multiple adverse event reports of patients who suffered multiple adverse event reports of patients who suffered poor glycemic control after using a vial from a stolen lotpoor glycemic control after using a vial from a stolen lot

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• 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)

Internet – Illegitimate Drug Sellers Internet – Illegitimate Drug Sellers

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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

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FDA Supply Chain Security Initiatives

• Response to recent Counterfeit Avastin and Altuzan incidents

• Operation Pangea

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• 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

Letters from FDA

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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)

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Counterfeit Altuzan

• Altuzan® 400mg/16mL vial with lot number B6021

• Vial contains no active ingredient

• Writing is in English

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2323

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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• 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

Pharmacist’s RolePharmacist’s Role

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Resources

ODSIR Drug Integrity and Supply Chain Security www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/default.htm

Counterfeit Medicine

www.fda.gov/counterfeit

Buying Medicines Online

www.fda.gov/buyonline

Resources

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Thank you

CDR Connie Jung, RPh, PhDActing Associate Director for Policy and CommunicationsConnie.jung@fda.hhs.gov

LCDR Eleni Anagnostiadis, RPhDivision of Supply Chain IntegrityEleni.anagnostiadis@fda.hhs.gov

Office of Drug Security, Integrity & Recalls Center for Drug Evaluation and ResearchU.S. Food and Drug Administration

Thank You!