Mark W. Caverly, Chief Liaison and Policy Section

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1 DEA Issues: An Update Harold Rogers National Prescription Drug Monitoring Meeting Meeting September 24 25, 2009 Mark W. Caverly, Chief Liaison and Policy Section

2 Prescription Drug Abuse

3 Prescription Drug Abuse 2008 National Survey on Drug Use and Health estimates there are 6.2 million Americans who are current nonmedical users of psychotherapeutic drugs More than the number of those abusing Cocaine, hallucinogens, and heroin COMBINED Non-medical use of prescription drugs ranks second only to marijuana as the most prevalent category of drug abuse

4 Pharmaceutical vs. Street Drugs Perception Safer to use: o Consistent Purity o Quality drugs o it s just a prescription drug Low or no acquisition cost: o Medicaid/Medicare o Worker s Comp o Private Insurance Less legal risk than illicit drugs

5 Scope and Extent of Problem million 1.2 million 0.35 million 1.0 million Sedatives Stimulants 1.6 million 1.8 million Tranquilizers 4.8 million 4.4 million Narcotic Pain Relievers Source: 2004 and 2008 National Survey on Drug Use and Health

6 Teens and Their Attitudes 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 Source: Partnership for Drug Free America Nearly 3 in 10 teens believe Rx pain relievers are not addictive

7 Controlled Substance Statistics

8 DEA Office of Diversion Control Mission To prevent, detect, and investigate the diversion of controlled substances from legitimate sources while Ensuring an adequate and uninterrupted supply for legitimate medical and scientific purposes

9 CSA Registrant Population Current Number of ,319,822 Current Number of DEA Registrants 08/19/2009 Provisional registrations in effect at the time CSA was passed (relative to the Harrison Narcotics Act of 1914) 480,

10 CSA Registrant Population as of 8/19/2009 Total Population: 1,319,822 Practitioner - 1,035,006 Mid-Level Practitioner - 162,038 Pharmacy (all) - 64,874 Pharmacy (chain) - 35,431 Hospital/Clinic - 15,584 Manufacturer Distributor Researcher - 5,840 Analytical Labs - 1,460 Importer Exporter NTP - 1,147

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18 Oxycodone Initial Aggregate g Quotas 80,000 70,000 60,000 50,000 40,000 30,000 20,000 10, % increase Kilograms

19 Hydrocodone Initial Aggregate g Quotas 60,000 50, % increase ,000 30,000 20,000 Kilograms 10,

20 Methadone Initial Aggregate g Quotas 25,000 20, % increase ,000 10,000 Kilograms ,

21 Number of Prescriptions Dispensed 140,000, ,000, ,000,000 80,000,000 60,000, Oxycodone Hydrocodone 40,000,000 Methadone 20,000, Source: IMS Health

22 Controlled Substances in the Supply Chain Total Dosage Units Dispensed: * Hydrocodone ,095,956, ,566,819,000 8,379,694, Oxycodone 2,731,493,000 3,074,906,000 3,390,531,000 Hydromorphone 144,183, ,964, ,495,000 Fentanyl 88,031,000 92,015,000 92,849,000 Methadone 495,398, ,071, ,447,000 Alprazolam 2,380,649,000 2,506,545,000 2,579,181,000 IMS Health, IMS National Prescription Audit PlusTM, Years 2006 & Extended Units, Extracted 01/30/2009 *2008 is projected based on three quarters worth of data (as of 1/30/2009)

23 National Forensic Laboratory System

24 National Forensic Laboratory Information System National Forensic Laboratory System Started in 1997 Collects results from state t and local l forensic labs nation-wide o 42 state systems o 92 local laboratories o 1t territorial i llab Reports include data from STRIDE

25 NFLIS National Data Narcotic Analgesics Number Percent Hydrocodone 36, % Oxycodone 32, % Methadone 8, % Morphine 5, % Buprenorphine 4, % Codeine 3, % Hydromorphone , % 1.84% Propoxyphene 1, % Dihydrocodeine , % 1.19%

26 NFLIS Narcotic Analgesics 2008 Regional Distribution Hydrocodone Oxycodone Methadone 15 Morphine West Midwest Northeast South

27 NFLIS National Data Benzodiazepines Number Percent Alprazolam 31, % 62% Clonazepam 7, % Diazepam 6, % Lorazepam 1, % Temazepam % Chlordiazepoxide % Ti Triazolam % 0.11% Midazolam % Fluniztrazepam 6 001% 0.01%

28 NFLIS Benzodiazepine 2008 Regional Distribution Alprazolam Clonazepam Diazepam Lorazepam 10 0 West Midwest Northeast South

29 Electronic Prescriptions for Controlled Substances

30 Electronic Prescriptions for Controlled Substances NPRM Published on June 27, 2008 in the Federal Register Proposal to provide DEA registered practitioners and pharmacies with the ability to electronically create, transmit, receive, and archive C II-V controlled substance prescriptions.

31 Electronic Prescriptions for Controlled Substances Comment period ended d 9/25/08. More than 230 comments received. Processes and procedures proposed include: o Initial identity verification o Two-factor authentication o Use of HHS transmission standards o No alteration of prescription during transmission

32 Electronic Prescriptions for Controlled Substances Final Rule has been drafted d with HHS and input from other federal agencies Informal review completed Next steps DOJ review, submission to OMB OMB has 90 days to review prior to publication in the Federal Register

33 Disposal of Controlled Substances

34 ONDCP Guidelines ONDCP guidelines for the disposal of ultimate user medications, including dispensed controlled substances (Feb. 20, 2007). Advise public to flush medications only if the prescription label l or accompanying patient t information specifically states to do so. ONDCP recommends a minimal deactivation procedure, and disposal in common household trash.

35 CSA Definitions An ultimate user is a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household h or for an animal owned by him or by a member of his household. To distribute means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. 21 U.S.C. 802

36 Registration Requirement Ultimate users are not permitted to distribute controlled substances without being separately registered. Because of registration requirement, it is unlawful for ultimate users to give their controlled substances to pharmacies, reverse distributors, etc. for destruction.

37 ANRPM Ultimate User Disposal ANPRM published on January 21, 2009 in the Federal Register Entitled Disposal p of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration Seeking options for the safe and responsible disposal of patient owned controlled substances consistent with CSA Comment period ended March 23, 2009

38 ANPRM Ultimate User Disposal Solicited information on the disposal of cs dispensed d to ultimate t user from: ultimate users law enforcement interest groups long-term care facilities hospices and in-home care groups 158 Comments Received pharmacies reverse distributor state regulatory agencies other interested parties

39 Law Enforcement Involvement Law enforcement officers, acting to enforce laws regarding controlled substances, may receive controlled substances from ultimate users. Must safeguard the controlled substances and ensure that they are destroyed properly. Law enforcement must be present during the destruction of the controlled substances.

40 Controlled Substance Waste Proper Disposal DEA does not specify the manner of destruction No CSA definition of waste No distinction between expired, contaminated controlled substances and saleable product Accountability required of all controlled substances

41 Safe Disposal Act of 2009 House Resolution 1191 Introduced on 2/25/2009 by Rep Inslee (WA) Amend the CSA to allow states to operate dth t t t t t disposal programs Direct the Attorney General to create 5 models the to create for implementation Companion Senate Bill 1336 Introduced on 6/24/2009 by Sen Murray (WA)

42 Secure and Responsible Drug Disposal Act of 2009 House Resolution 1359 Introduced on 3/5/2009 by Rep. Stupak (MI) Amend the CSA to permit ultimate user to dth t t t deliver drugs for destruction Grants the Attorney General discretion to the General to promulgate regulations Companion Senate Bill 1292 Introduced on 6/18/2009 by Sen Klobuchar (MN) and Sen Grassley (IA)

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44 Internet Legislation & Implementing Regulations

45 An Internet Pharmacy

46 Ryan Haight Online Pharmacy Consumer Protection Act Amends the CSA adding new provisions to prevent the illegal distribution of controlled substances by Internet Enacted on 10/15/08, effective on 4/13/09 As of 9/8/2009, only 6 pharmacies had requested modification to online pharmacy

47 Ryan Haight Online Pharmacy Consumer Protection Act New DEA registration requirements for all Internet pharmacies o Modification of existing Retail Pharmacy registration Reporting requirements o Monthly basis o All controlled substances dispensed (total of each) o Thresholds 100 or more cs prescriptions 5,000 or more total dosage units Disclosure requirements on home page o Identify servicing pharmacies, pharmacist in charge, and physicians

48 Comments / Questions?

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