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Changesinage-specificratesofdoctor-shoppingforopioidsfollowingintroductionofreformulatedOxyContin® tablets
H.Chilcoat,P.Coplan,N.Sessler,V.Harikrishnan
Purdue PharmaL.P.,Stamford, CT
BACKGROUND / METHODS(CONT.) / RESULTS(CONT.)■InAugust2010,PurduePharmaintroducedareformulatedextended-releaseoxycodone(OxyContin®)in / ■Doctorshoppingthreshold / Figure2. Changesinratesofdoctor-shoppingbyagegroup / Table3. ChangeinRatesofdoctor-shopping(95%CI)forOxyContinBeforeVersus
theUS,whichisintendedtodetercrushingandformsagelwhendissolvedtodeterabuse. / – Sumtotalnumberofuniqueprescribersandpharmaciesacrossalloverlapeventsinsix-monthperiod / beforeversusafterreformulationofOxyContin / AfterReformulationbyShoppingThreshold
■TheintroductionofreformulatedOxyContinhasresultedindeclinesinindicatorsofdiversion: / – Ifnumberofprescribers/pharmacies reachesaspecifiedthresholdthenpatientiscodedaspositivefor
• 60%reductioninreportsofdrugdiversionbylawenforcement / doctorshopping
• 80%reductioninprescriptionsforhighdosageOxyContinprescriptionsbypotentiallyproblematicprescribers
■Isthereasimilardeclineindiversionthrough“doctor-shopping”andhowdochangesinratesofdoctor-shoppingvarybyage?
DOCTOR-SHOPPING
■Obtainingprescriptionsfrommultipleprescribersand/orpharmacies:
• Forpersonalabuse
• Fordistributiontootherswhointendtoabusethedrugs
• Generallyinvolvesmultipleoverlappingprescriptionsfrommorethanoneprescriberandmultiplepharmacies(Cepedaetal.,2012,JournalofClinicalPharmacology)
– Initialthreshold=atleast2prescribersand3pharmacies(Cepedaetal.,2012,JournalofClinical
Pharmacology
– Allcombinationsofprescribersandpharmaciesexamined
■Doctorshoppingrate
– Numberofdoctorshoppers/numberofindividualswithaprescriptionofspecifiedproductinspecifiedtimeinterval
Figure1. Doctor-shoppingexampleofapatientwithtwooverlapeventsinvolvingprescriptionsfrom2uniqueprescribersand
3uniquepharmaciesinasix-monthperiod
OBJECTIVES
■Tocharacterizeandestimatechangesinage-specificratesofdoctor-shoppingforOxyContinandotheropioidsbeforeversusafterintroductionofOxyContinreformulatedwithabusedeterrentpropertiesinAug
2010
■Tocompareratesofdoctor-shoppingforOxyContinandothersingle-entity(SE)opioidproducts,oftenabusedthroughnon-oralroutes(eg,snortingandinjecting),andcombinationopioidproducts(withacetaminophen[APAP]),oftenabusedorallybyingestingintacttablets
■Toestimatechangesindoctorshoppingbyadditionalcharacteristicsassociatedwithabuse/diversion
– Cashpayment
RESULTS
Table1. IMS:RateofDoctor-shoppingforOxyContinbyTimePeriod
SUMMARY
■Declinesinratesofdoctor-shoppingfrom1yearbefore(July2009toJune2010)to2.5yearsafterreformulation(January2011toJune2013)wereoflargermagnitudeforOxyContinthanotheropioids.
■Factorsthathavebeenpreviouslyshowntobeassociatedwithdoctor-shoppingandabuse(Cepedaet
– Highdosagestrength
■Tocomparethemagnitudeinchangeofdoctor-shoppingratesformoreversuslesssensitivethresholdsdefiningdoctor-shopping
Pre-
Reformulation
Transition
Post-
Reformulation
Figure3. Changesinratesofdoctor-shoppingforOxycontinforoverlapeventsthat
al.,2012,JournalofClinicalPharmacology;Coplanetal.,2013,Pharmacoepidemiology andDrugSafety)
hadlargerdeclinesinratespost-reformulation
– 18-29yearsold
METHODS
NumberofOxyContin
PatientsIncludedinStudy
NumberofPatientswith
849,860 447,569 2,130,955
involveatleastonecashpayment,80mgdosagestrength,andbothcashpayment
and80mgdosagestrength:a)Allagesandb)18-29yearolds
– Cashpayment
– Highdosagestrength
■Theage-specificprofileofdoctor-shoppingratesofOxyContinwasconsistentwiththatofothersingle
■DataSource:IMSLRxdatabase
– Patientde-identifieddatafromsampleofIMSHealthretailuniverse
– Directfeedsfromretailpharmacies
– Encryptionalgorithmtode-identifyandassigneachpatientauniqueID
– Coversapproximately65%ofallretailprescriptionsfilledintheUS
– Morethan150millionuniquede-identifiedpatients
– Morethan1millionprescribers
■Estimatedratesofdoctorshoppinginsix-monthintervalsbeforeandafterintroductionofORF
– Pre-reformulation:July2009toJune2010
– Transition:JulytoDecember2010
– Post-reformulation: January2011toJune2013
■Foreachsix-monthcalendarperiod(January-June,July-December),identifyallpossible“overlap”eventsforOxyContinandcomparatorproducts:
– Startdateofeachprescriptionanddayssupply
– Overlappingprescriptionsaredeterminedbymultipleprescriptionsforthesamepatientwherenumberofdayssupplyoftheprescriptionsoverlapbyatleastoneday
– Comparators include: Immediate-release (IR) single entity (SE) oxycodone, IR oxycodone/APAP, IR
hydrocodone/APAP
■Foreachoverlapevent
– Countnumberofuniqueprescribers
– Countnumberofuniquepharmacies
2+Prescribers/ 2,087 977 2,606
3+Pharmacies
Doctor-shoppingrate 0.25% 0.22% 0.12%
Table2. ChangesinRatesofDoctor-shoppingforOxyContinandOpioidComparators
(atleast2prescribersand3pharmacies)
AllAges
18-29YearsOld
entityopioids(IRsingleentityoxycodone)beforereformulationbutwasmoresimilartoopioidcombinationproducts(hydrocodoneandoxycodonewithAPAP)afterreformulation
■Magnitudeofdeclineindoctor-shoppingratesincreasedasthresholdfordoctor-shoppingincreased
CONCLUSIONS
■Largerdeclinesforcharacteristicsassociatedwithabuseanddiversionsupportsconstructvalidityofchangesinratesofdoctor-shoppingforreformulatedOxyContin.
■Thereductionindoctor-shoppingsupportsthehypothesisthatthereformulationofOxyContindetersabuse.
DisclosureStatement
ThisstudywasfundedbyPurduePharmaandChilcoat,Coplan,Sessler,andHarikrishnanareemployeesof
PurduePharmaL.P.
PresentedattheCollegeonProblemsofDrugDependence77thAnnualScientificMeeting,Phoenix,AZ,June13-18,2015