O O XY X Y C C ONTIN ONTIN ® ® Diversion & Abuse Diversion & Abuse Drug Enforcement Administration Office of Diversion Control May 2003
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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
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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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Drug Enforcement Administration Diversion Control ProgramMAY 2003
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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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Drug Enforcement Administration Diversion Control ProgramMAY 2003
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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 ®
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Drug Enforcement Administration Diversion Control ProgramMAY 2003
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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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Drug Enforcement Administration Diversion Control ProgramMAY 2003
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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 ®
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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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Drug Enforcement Administration Diversion Control ProgramMAY 2003
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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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OO XYXYCCONTINONTIN ®® Action PlanAction Plan
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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Drug Enforcement Administration Diversion Control ProgramMAY 2003
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OO XYXYCCONTINONTIN ®® Action PlanAction Plan
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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Drug Enforcement Administration Diversion Control ProgramMAY 2003
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OO XYXYCCONTINONTIN ®® Action PlanAction Plan
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.