Michigan Department 0f Community Health, Office of Drug Control Policy The Michigan Association of Community Mental Health March 27, 2009 NationalNational TrendsTrends andand DeterrentDeterrent StrategiesStrategies ForFor PrescriptionPrescription andand OTCOTC DrugDrug AbuseAbuse Joseph Rannazzisi Deputy Assistant Administrator Office of Diversion Control Drug Enforcement Administration IntroductionIntroduction BackgroundBackground andand StatisticsStatistics RegulatoryRegulatory ControlControl MethodsMethods ofof DiversionDiversion InternetInternet DiversionDiversion CommonlyCommonly DivertedDiverted PharmaceuticalsPharmaceuticals Steroids/Steroids/hGHhGH DietaryDietary SupplementsSupplements SalviaSalvia DivinorumDivinorum TheThe 19601960’’ss Marijuana Seconal LSD Dexedrine Meprobamate TheThe 19701970’’ss Heroin T’s and Blues 4’s and Doors (Talwin and Pyrabenzamine) TheThe 19801980’’ss Tylenol w/Codeine and Doriden Hydromorphone Cocaine TheThe 19901990’’ss Oxycodone Methamphetamine 20002000 Hydrocodone Ketamine Alprazolam Flunitrazapam MDMA (Rohypnol) Scope and Extent of Problem 2004 2007 0.30.3 millionmillion 0.35 million SedativesSedatives 1.21.2 millionmillion 1.11.1 millionmillion StimulantsStimulants 1.61.6 millionmillion 1.81.8 millionmillion Anti-Anxiety Medication 4.44.4 millionmillion 5.25.2 millionmillion NarcoticNarcotic PainPain RelieversRelievers Source: 2004 and 2007 National Survey on Drug Use and Health TeensTeens andand TheirTheir AttitudesAttitudes 1 in 5 teens report abusing Rx medications to get high 2 in 5 teens believe that Rx meds are “much safer” than illegal drugs 31% teens believe there’s “nothing wrong” with using Rx meds without a prescription “once in a while” Nearly 3 in 10 teens believe Rx pain relievers Partnership for a Drug Free America Study are not addictive RegulatoryRegulatory ControlControl Controlled Substances Act of 1970 • Established a “closed system” of distribution • Five “schedules” of controlled substances • Created the Compliance Program (1971) to monitor the legitimate manufacture and distribution of controlled substances • Clearly differentiated controlled substances from other “legend” drugs handled under the FDCA • Authorized DEA to register dispensers, practitioners and pharmacies • CSA/Regulations address creation, signature, retention of prescription/records PrescriptionPrescription RequirementsRequirements Schedule II Schedule III Schedule IV Schedule V Written Yes Yes Yes Yes Oral Emergency Yes Yes Yes Only* Facsimile Yes** Yes Yes Yes Refills No Yes# Yes# Yes# Partial Fills Yes*** Yes Yes Yes * Must be reduced in writing, and followed by sign, hard copy of the prescription. ** A signed, hard copy of the prescription must be presented before the medication is dispensed. *** 72 hour time limitation. # With medical authorization, up to 5 in 6 months. PrescriptionPrescription DrugDrug MonitoringMonitoring ProgramsPrograms BenefitsBenefits TheThe PDMPPDMP databasedatabase allowsallows investigatorsinvestigators toto obtainobtain pharmacypharmacy datadata fromfrom multiplemultiple locationslocations withoutwithout havinghaving toto visitvisit eacheach andand everyevery pharmacy.pharmacy. DeterDeter andand identifyidentify illegalillegal activityactivity suchsuch asas prescriptionprescription forgery,forgery, indiscriminateindiscriminate prescribingprescribing andand "doctor"doctor shopping."shopping." PatientPatient specificspecific drugdrug informationinformation uponupon requestrequest ofof thethe patientpatient’’ss physicianphysician oror pharmacist.pharmacist. NotificationNotification ofof physiciansphysicians whenwhen theirtheir patientspatients areare seeingseeing multiplemultiple prescribersprescribers forfor thethe samesame classclass ofof drugs.drugs. AssistsAssists healthcarehealthcare professionalsprofessionals inin managingmanaging patientpatient care.care. PMPPMP asas anan InvestigativeInvestigative ToolTool Date filled Patient name Drug name Patient Prescriber address Info. 03/10//2008 “A” APAP/Hydrocod NY, NY Auburndale, one Barbituate FL 03/10/2008 “B” APAP/Hydrocod Cherryhill, NJ Auburndale, one Barbituate FL 03/10/2008 “C” APAP/Hydrocod Edmond, WA Auburndale, one Barbituate FL 03/12/2008 “D” APAP/Hydrocod Walladlade MI Auburndale, one Barbituate FL 03/13/200 “E” APAP/Hydrocod Roanoke, VA Auburndale, one Barbituate FL 03/13/2008 “F” APAP/Hydrocod Hurst, TX Auburndale, one Barbituate FL 03/13/2008 “G” APAP/Hydrocod Pompano Auburndale, one Barbituate Beach, FL FL 21 CFR 1306.04 ToTo bebe effective,effective, aa prescriptionprescription forfor aa controlledcontrolled substancesubstance mustmust bebe issuedissued forfor aa legitimatelegitimate medicalmedical purposepurpose byby anan individualindividual practitionerpractitioner whowho isis actingacting inin thethe usualusual coursecourse ofof hishis professionalprofessional practicepractice MethodsMethods ofof DiversionDiversion PharmacyPharmacy // OtherOther TheftTheft PractitionersPractitioners // PharmacistsPharmacists ArmedArmed robberyrobbery BurglaryBurglary (Night(Night BreakBreak--ins)ins) IllegalIllegal distributiondistribution InIn--TransitTransit LossLoss (Hijacking)(Hijacking) SelfSelf abuseabuse SmurfingSmurfing TradingTrading drugsdrugs forfor sexsex PatientsPatients EmployeeEmployee pilferagepilferage DrugDrug ringsrings HospitalsHospitals DoctorDoctor--shoppingshopping PractitionersPractitioners’’ officesoffices ForgedForged // fraudulentfraudulent // NursingNursing homeshomes alteredaltered prescriptionsprescriptions RetailRetail pharmaciespharmacies InternetInternet availabilityavailability ManufacturingManufacturing // distributiondistribution facilitiesfacilities InternetInternet DiversionDiversion RogueRogue InternetInternet PharmacyPharmacy ChecksChecks andand BalancesBalances Physician Pharmacist Patient OrderingOrdering fromfrom aa RogueRogue SiteSite (Historically)(Historically) buy hydrocodone http://www.drug-prices-and-information.com Order hydrocodone online from our U.S. based licensed pharmacy. No prior prescription needed. No consultation fees. OnlineOnline PharmacyPharmacy ConsultationsConsultations EasyEasy toto obtainobtain ConvenientConvenient ProblemsProblems withwith OnlineOnline ConsultationsConsultations AccordingAccording toto AMA,AMA, thisthis methodmethod ofof providingproviding patientspatients withwith prescriptionprescription medicationmedication fallsfalls wellwell belowbelow thethe acceptedaccepted standardstandard ofof medmedicalical carecare FormsForms askask forfor minimalminimal informationinformation NoNo mechanismmechanism toto determinedetermine ifif questionsquestions answeredanswered correctlycorrectly oror truthfullytruthfully NoNo explanationexplanation ofof riskrisk associatedassociated withwith drugdrug NoNo medicalmedical assessmentassessment atat allall NoNo followfollow upup ComponentsComponents necessarynecessary forfor DomesticDomestic RogueRogue InternetInternet OperationOperation ¾ WebWeb BrokerBroker // FacilitatorFacilitator (optional)(optional) ¾ PractitionerPractitioner ¾ PharmacyPharmacy ¾ ****AllAll membersmembers ofof schemescheme areare complicitcomplicit therebythereby eliminatingeliminating allall checkschecks andand balancesbalances ¾ SourceSource ofof SupplySupply C Consumer Dr. Doctor Rx Internet Pharmacy DomesticDomestic ‘‘RR ’’ FlowFlow WC Web Company 1. Consumer in Montana xx WS Website Server orders hydrocodone 6. Pharmacy in Iowa S Shipper on the Internet fills order and ships to C Consumer via Shipper WA ME 4. Order is MTMMT ND MN V approved by T N MA H Physician in OR NY RI New Jersey WI ID SD Rx and returned MI CTT to Web WY PA Company IAIA NJ Dr. NE OH DE NV IL IN UT WV MD CO VA 5. Approved CA KS MO KYY order NC TNS then sent by Web OK SC AZ NM AR Company GA to an MS AL affiliated Pharmacy TX TX LA FL FL WS 2. Request goes WC 3. Web Company through Website (located in Miami, FL) Server in adds request to queue San Antonio, TX for Physician approval HowHow Regulatory/CriminalRegulatory/Criminal EnforcementEnforcement andand LegislationLegislation ChangedChanged thethe LandscapeLandscape CutCut offoff thethe SupplySupply SeekSeek administrativeadministrative actionaction againstagainst DEADEA registrantsregistrants foundfound toto bebe contributingcontributing toto thethe illegalillegal distributiondistribution ofof controlledcontrolled substancessubstances overover thethe InternetInternet OrdersOrders ToTo ShowShow CauseCause ImmediateImmediate SuspensionsSuspensions TheThe DirtyDirty DozenDozen PHARMACIES CLOSED IN 2007 Total 2006 following Baywatch / Lightning Strike Dosage Units 1. 15,596,380 2. 9,082,010 3. 9,081,976 4. 4,733,290 5. 4,220,840 6. 4,564,480 7. 1,988,600 8. 1,656,450 9. 2,731,420 10. 1,962,620 11. 793,350 12. 1,051,500 TOTAL DOSAGE UNITS 57,462,916 ManufacturersManufacturersManufacturers Flow of Controlled Substances DEA Registrants who are authorized to DEA ReRegistrantsgistrants who are authorized to produce and distribute controlled substances. Rogue Internet Pharmacy pproduceroduce and distribute controlled substances. Typical Internet Diversion (1330 firms including all manufacturers (1(1330330 ffirmsirms includinincludingg all manumanufacturersfacturers Communications and wholesale distributors) Scheme and wholesale distributors)distributors) Wholesale Distributors ManufacturersManufacturersManufacturers Wholesale Distributors [Re-packagers/Re-labelers] DEA Registrants who are authorized to [Re-packagers/Re-labelers][Re-packagers/Re-labelers]