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RResearched esearched AAbuse, Diversion, andbuse, Diversion, andAAddictionddiction--RRelated elated SSurveillanceurveillance
Sidney H. Schnoll, M.D., Ph.D.Sidney H. Schnoll, M.D., Ph.D.
CONFIDENTIAL
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RADARSRADARS® System Need for Surveillance System
• Increasing reports of abuse and diversion of OxyContin®
• Lack of data to support or refute media reports
• National data sets (DAWN, NHSDA) reporting increasing problems with prescription opioids
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Narcotic Analgesics ED Mentions as a Percent of Total Drug Abuse Mentions
0%
2%
4%
6%
8%
10%
12%
1995 1996 1997 1998 1999 2000 2001 2002
Drug Abuse Warning Network (DAWN), 1995-2002
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National Household Survey of Drug AbuseAny Lifetime Use of Hydromorphone
200120001999Lifetime Drug Use Behaviors:
65.257.753.4% Needle Use
88.284.284.1% Nonmedical Use of Multiple Analgesics AND Cocaine or Heroin
94.088.895.4% Use of Cocaine or Heroin54.855.564.2% Use of Heroin92.287.795.4% Use of Cocaine
93.393.188.6%Nonmedical Use of Multiple (2 or more) Prescription Analgesics (not hydromorphone)
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RADARSRADARS® System Need for Surveillance System
• National data sets reported data 18-24 months after collection
• Those abusing and diverting were not necessarily patients
• Traditional drug safety/pharmacovigilance not the answer
• Needed rapid implementation
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RADARSRADARS® System Design Considerations
• Develop advisory board of experts in addiction, drug policy, law enforcement and epidemiology
• Use existing models if possible, i.e. tramadolindependent steering committee
• Expand and use different models as needed• Keep pipeline in mind
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RADARSRADARS® System External Advisory Board (EAB)
Edgar Adams, Ph.D. Harris InteractiveCmdr. John Burke NADDITheodore Cicero, Ph.D. Washington Univ.Richard Dart, M.D. Rocky Mountain PCCDanna Droz, R.Ph., J.D. NASCSAAnn Geller, M.D. Columbia UniversityJames Inciardi, Ph.D. Univ. of DelawareHerbert Kleber, M.D. Columbia UniversityAlvaro Muñoz, Ph.D. Johns Hopkins Univ.Mark Parrino, M.P.A. AATODEdward Senay, M.D. Univ. of ChicagoGeorge Woody, M.D. Univ. of Pennsylvania
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RADARSRADARS® System Goals
• Prospectively study the nature and extent of abuse of scheduled prescription opioid medications
• Suggest interventions to reduce diversion and abuse that are related to problems identified
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The RADARSThe RADARS® System DrugsSystem Drugs
1. buprenorphine2. fentanyl 3. hydrocodone 4. hydromorphone5. methadone6. morphine 7. oxycodone
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RADARS® SystemLevels of Activity
Other Purdue Signals
Signal Detection
Signal Verification
Focused Studies
Interventions
Outcomes
Relative Rate Determination
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Signal Detection Components Rationale
Serves as an early warning system
• Timely collection (quarterly)
• Geographically sensitive (3-digit ZIP code)– Calculation of local rates
• Useful for monitoring newly approved drugs
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Our Early Detection System in ActionThe RADARS® System Signal Detection Studies began picking up abuse and diversion of “generic OxyContin”
one week after launch.
4/53/30/04 5/30/04
4/12 4/19 4/26 5/3 5/10 5/17 5/24
Media Signal 5/21/04"Drug dealers in eastern Kentucky beat pharmacists to new form of OxyContin"
By ROGER ALFORDAssociated Press Writer
PCC Signal3 casesTEVA launches 80 mg
generic OxyContin
PCC Signal20 cases
(Wash, DC)Dealer attempted to
sell generic to undercoveragent (LE Drug Diversion Study)
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Signal Detection Studies
• Funded by Purdue Pharma L.P.
• Studies conducted at major research organizations and universities under direction of Principal Investigators
• Data independently housed
• Data reports presented to the EAB and Purdue on a quarterly basis
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Denominator Candidates
Based on projected figures that have high error rate in low population areas
Provides estimate of those benefiting from medication
5. Patients dispensed medications
Bases calculation on injectable dosages of buprenorphine and fentanyl, assumes incorrect minimum dosage strength for oxycodone
Used by DEA and familiar to regulatory agencies
6. Dosage units
ConsPros
Harder to understand, not intuitive; New metric
Modifies DEA approach to correct for dosage units and delivery type
7. Minimum divertible dosage units
No adjustment for dosage strengthProvides closer estimate to drug available than prescriptions alone
4. Delivery units
No adjustment for potency; rate for high potency drugs will be over-estimated
Readily available; Easily understood
3. Kg distributed
One Rx ≠ One person; no adjustment for dosage strength, days of therapy, quantity, acute vs. chronic use
Readily available; Easily understood
2. Prescriptions filled
Uniform exposure assumedReadily available1. Population
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Comparison of Abuse Rates Using Different Denominators
Rates based on median rate of abuse according to denominator total exposure using Poison Control Center data from 1Q03
0
50
100
150
200
250
300
350
400
100,000Population
Prescriptions Delivery Units MinimumDivertable Units
Denominator
Rat
e
FentanylHydrocodoneHydromorphoneMethadoneMorphineOther oxycodoneOxyContin®
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CONFIDENTIAL16% of reporting zip codes with cases and > 100 Pts
med
ian
of ra
tes
per 1
00,0
00 P
ts
0 20 40 60
010
020
030
040
0
Oc
Fe
Hc
Hm
Me
Mo
oO
OcFe
Hc
Hm
Me
Mo
oO
OcFe
Hc
Hm
Me
Mo
oOKI
Div
PCC
Median National Rates by Signal Detection Study in ZIP Codes with Greater Than 100
Patients
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418: KY(1, 19.80)
248: WV(3, 37.17)
413: KY(1, 11.72)
408: KY(4, 42.82)
412: KY(2, 10.50)
2004Q1
808: CO(1, 45.17)
247: WV(4, 158.07)
246: VA(6, 206.75)
268: WV(1, 31.79)
048: ME(2, 33.05)
2004Q2
409: KY(6, 228.90)
408: KY(2, 47.13)
256: WV(4, 80.08)
412: KY(2, 35.64)
413: KY(2, 19.01)
2003Q4
409: KY(4, 241.57)
415:KY(2, 116.54)
408: KY(2, 59.83)
413: KY(1, 22.33)
418: KY(1, 20.99)
2003Q3
426: KY(1, 103.35)
229: VA(5, 511.45)
050: VT(1, 89.83)
408: KY(2, 61.23)
413: KY(1, 20.41)
2003Q2
426: KY(1, 110.31)
415: KY(2, 144.75)
416: KY(2, 98.10)
412: KY(2, 59.73)
408: KY(3, 71.07)
2003Q1
811: CO(1, 227.23)
403: KY(2, 327.43)
597: MT(2, 266.59)
246: VA(2, 263.20)
048: ME(1, 48.83)
2002Q4
3 Digit Zip Codes: state(Numerator, Denominator)
Quarter
5 Highest Rates of Abuse for Oxycodone Extended-Release and the Corresponding 3 Digit Zip Codes
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Drug Evaluation Network System(DENS)
Thomas McLellan, PhD, Principal InvestigatorTRI & University of Pennsylvania
Rationale• Collect data on abuse of prescription drugs by those
entering drug abuse treatment programs and track trends over time
Objectives• Gather data on prescription drug abuse in admissions
to treatment programs• Track trends in prescription drugs abused over timeDENS has lost federal funding – no further data will be collected. TRI is
not interested in collecting data for individual companies
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Law Enforcement Drug DiversionJames Inciardi, PhD, Principal Investigator
University of DelawareRationale• Monitor diversion of RADARS® System Drugs
compared to other drugs in a specific geographic locale
Objectives• Monitor the extent of diversion from a national
convenience sample of police diversion units • Identify “signal sites” for these drugs over time• Identify “epicenters of diversion” (3-digit zip code
locations where a signal is detected > 1Q per year)
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Key Informant NetworkTheodore Cicero, PhD, Principal Investigator
Washington UniversityRationale• Monitor an extensive network of specialists to
proactively seek out documented cases of abuse
Objectives• Use key informants to proactively count the cases of
abuse & addiction to RADARS® System Drugs in specific geographic locations
• Monitor the number of cases of abuse and addiction of the RADARS® System Drugs over time
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Poison Control Centers (PCCs)Richard Dart, MD, PhD, Principal Investigator
University of Colorado
Rationale• Monitor calls to PCCs regarding abuse of
RADARS® System Drugs
Objectives • Prospectively monitor exposure and
information calls• Monitor the changes in these calls over
time
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Opioid Abuse in Methadone Treatment Enrollees
Mark Parrino, MPA and Andrew Rosenblum, Ph.D.,Principal Investigators, AATOD and NDRI
Rationale• Collect admission data on new enrollees at 75
MTPs regarding abuse and addiction involving RADARS® System Drugs
Objectives• Monitor drugs used by new admissions• Monitor need for pain medication • Monitor trends over timePilot study completed February 2005. Full study implemented March 2005.
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Field ResearchStructured Interview Process
• Law Enforcement • Drug Treatment Center • Physician • Pharmacist • Other
– Indian Health Services – Hospital – Board of Pharmacy – State Agencies
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Limitations and Concerns
• Not 100% coverage for all studies• Not all sites report each quarter• No universally accepted method defined
for calculating rates/denominator issues• Potential double counting• No access to raw data• Adverse event reporting
RResearched esearched AAbuse, Diversion, andbuse, Diversion, andAAddictionddiction--RRelated elated SSurveillanceurveillance