diversion & abuse

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OO X YX YCC ONTINONTIN ® ® D iv e r s io n & A b u s eD iv e r s io n & A b u s e

Drug Enforcement AdministrationOffice of Diversion ControlMay 2003



Drug Enforcement Administration Diversion Control ProgramMAY 2003

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§ OxyContin ® isa controlledrelease form ofSchedule IIoxycodone

§ Legitimately usedas a medicationto treat moderateto severe pain

§ Manufactured intablet form and

intended for oralingestion

§ Controlledrelease allowsfor longerduration ofdrug action

Manufactured by Purdue Pharma

O X YC O N T I N ®




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Non-Medical Use of O XYCONTIN ®

221,000

399,000

957,000

0

100,000

200,000300,000

400,000

500,000

600,000

700,000

800,000

900,000

1,000,000

1999 2000 2001Source: 2001 National Household Survey on Drug AbuseDept of HHS / Substance Abuse and Mental Health Services Adminis tration (SAMHSA)

Persons Reporting At Least OneNon-Medical Use of OxyContin ®

During Their Lifetime




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l The controlled release method of delivery usedin OxyContin ® allows for a longer duration ofdrug action, and consequently, it containsmuch larger doses of the active ingredient

l OxyContin ® is a single-entity oxycodoneproduct ~ most other oxycodone productscontain aspirin or acetaminophen (‘ combination oxycodone ’)

l OxyContin ® is highly-addictive ~ Abusers caneasily compromise the controlled releaseformulation for a powerful morphine-like high

O X YC O N T I N ®




4

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000

9,000

Jan-Jun1997

Jul-Dec1997

Jan-Jun1998

Jul-Dec1998

Jan-Jun1999

Jul-Dec1999

Jan-Jun2000

Jul-Dec2000

Jan-Jun2001

Jul-Dec2001

Jan-Jun2002

Emergency Department (ED) Mentions ofSingle-Entity and Combination Oxycodone

S i n g l eS i n g l e -- E n t i t yE n t i t y O x y c o d o n eO x y c o d o n e

C o m b i n at io n O x y c o d o n e

Source: ED Trends from the Drug Abuse Warning Network, Final Estimates 1994-2001ED Trends From Dawn, Preliminary Estimates January-June 2002

Dept of HHS / Substance Abuse and Mental Health Services Adminis tration (SAMHSA)




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l Addiction, crime,and fatal overdoseshave all beenreported as a result

of OxyContin ®

abusel The FDA has

approved a newpackage insert forOxyContin ® with a“Black Box” warningthat includes:

O X YC O N T I N ®



D E A 's N at io n a lD E A 's N a t io n a lOO X YX YCC ONTI NONTI N

®®

A c t io n P lanA c t io n P lanInitiated Spring 2001




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1. Enforcement & Intelligence

• Coordinated operations have beeninitiated in DEA field offices to targetindividuals and organizations involved inthe diversion and abuse of OxyContin ® .

This includes coordination with federal,state, and local agencies.

OO XYXYCCONTINONTIN ®® Action PlanAction Plan




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2. Regulatory & Administrative• DEA is utilizing the full range of its regulatory and

administrative authority in pursuing action that willmake it more difficult for abusers to obtainOxyContin

®. DEA is working closely with the FDA

to strongly urge the rapid reformulation ofOxyContin

®by Purdue Pharma, to the extent that it

is technically possible, in order to reduce the abuseof the product, particularly by injection.




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3. Industry Cooperation• DEA continues to stress the importance of voluntary

cooperation from industry in adhering to the spiritand substance of existing law and regulation. Theagency is increasing its cooperative efforts with alllevels of industry in order to stem the abuse anddiversion of OxyContin

®. As the sole manufacturer

of OxyContin ® , the cooperation of Purdue Pharma isintegral to the success of DEA ’s Action Plan.




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4. Awareness / Education / OutreachInitiatives

• An aggressive, national outreach effort is beingmade to educate the public, schools, the healthcareindustry, and state and local governments on thedangers related to the abuse of OxyContin

®. DEA is

also pursuing federal legislative initiatives to assiststates with funding for prescription data collectionand analysis.

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