1. OVERVIEW OF THE DEA AS YOUR RESOURCEBy
Supervisory Diversion Investigator Tim Lenzi
DEA Chicago Office

2. The Purpose of the DEA
Enforcement of the Controlled Substances Act (CSA)
Diversion Investigators enforce the CSA for all legitimate handlers of controlled substances “Registrants”

3. Diversion Mission
Prevent, detect, and investigate the diversion of pharmaceutical controlled substances and listed chemicals
Ensure there is adequate supply of pharmaceutical controlled substances to meet legitimate medical, commercial, and scientific needs

4. CSA of 1970
Consolidated numerous Federal drug laws and international treaties USA was a party to
Provides civil and criminal penalties for abuse of controlled substances
Drug Scheduling, Registration System, and Record Keeping Regulations are major components – Prevent “Diversion” of legally manufactured controlled substances

5. Drug Scheduling Potential for Abuse (Physical and Psychological)
Accepted Medical Use
**Schedule I Controlled Substances have no accepted medical use in the USA
Marijuana, Heroin, LSD, GHB all in Schedule I
Temporary “emergency” scheduling of drugs into Schedule I for two years – K2, Spice, Bath Salts, Fentanyl analogues
Psychological dependence – need/craving for the drug compels abuser to continue use Physical dependence – repeated use requires continued administration of the drug to prevent withdrawal symptoms

6. Schedule II Accepted Medical Use
High Abuse Potential – physical and psychological dependence
OxyContin (Oxycodone), Morphine, Methadone, Hydromorphone (Dilaudid), Fentanyl
Cocaine, Ritalin, Methamphetamine, Adderall (IIN)
Hydrocodone Products as of 10/6/14 – Vicodin, Lortab, Norco

7. Schedule III Moderate physical and psychological dependence
Codeine based products (Tylenol w/Codeine)
Anabolic Steroids (IIIN)
Suboxone
Buprenorphine
Ketamine (IIIN)

8. Schedule IV Lower Abuse Potential
Valium, Xanax, Ativan (benzodiazepines)
Phenobarbital
Phentermine
Tramadol
Soma (Carisoprodol)
Benzos – depressants used as sedatives, reduce anxiety, widely abused

9. Schedule V Lowest Abuse Potential Lomotil Lyrica
Codeine based cough syrups –Phenergan w/Codeine

10. Registration System
Maintain closed system of distribution to prevent diversion of legally manufactured controlled substances that have legitimate medical use
Requires any legitimate handler of controlled substances to register with DEA – importers, exporters, manufacturers, researchers, distributors, pharmacies, narcotic treatment programs, practitioners, hospital/clinics, analytical labs, reverse distributors

11. Practitioner Registration
Title 21, United States Code (USC), Section 823(f) practitioners shall register with DEA to dispense controlled substances provided they are authorized to dispense controlled substances by the State in which they practice
Compliance with state laws/regulations is a prerequisite for registration with DEA
Illinois requires both a professional license and controlled substance license

12. Practitioner Registration
Title 21, Code of Federal Regulations (CFR), Section (a) Every person who manufactures, distributes, dispenses, imports or exports controlled substances shall obtain a registration unless exempted by law
Title 21, CFR, Section (a) separate registration required for each principal place of business or professional practice where controlled substances are manufactured, distributed, imported, exported, or dispensed by a person

13. Practitioner Registration
Title 21, CFR, Section (b)(3) practitioner registered at another location in the same State he practices may prescribe controlled substances at another office but not administer or dispense controlled substances at the non-registered office
Practitioner registration and state controlled substance license must be at same address (principal place of business or professional practice)
Must have separate registration at each location where controlled substances are administered or dispensed

14. Registration Fees Practitioner registration is for three years
Application Fee is $731.00
Practitioner with a government agency is exempt from registration fee
Must certify on the application (renewal too) that you are fee exempt

15. Exemption from Registration
Title 21, CFR, Section (c) allows for practitioner who is agent or employee of hospital to administer, dispense, or prescribe controlled substances using hospital’s registration
Practitioner must have state authorization
Hospital/Clinic registration must be used (not hospital out-patient pharmacy registration)
Hospital uses internal code number for each practitioner

16. Exemption from Registration
Controlled substance prescription can only be filled at the hospital/clinic pharmacy
Resident is not authorized to issue controlled substance prescriptions outside the scope of their residency because they are not licensed by the State as a practitioner
Hospital must maintain a current list of the internal codes for practitioners and residents

17. Mid Level Practitioners
Nurse Practitioner In IL may prescribe, administer and dispense Schedule IIN, III, IIIN, IV, V controlled substances but only prescribe Schedule II controlled substances for thirty days
Optometrist in IL may Schedule III, IV, V controlled substances and only prescribe Schedule II Hydrocodone
Physician Assistant In IL may prescribe, administer and dispense Schedule IIN, III, IIIN, IV, V controlled substances but only prescribe Schedule II controlled substances for thirty days

18. Mid Level Practitioners
DEA registration must match the drug Schedules allowed by IL
Title 21, CFR, Section (e) requires mid level practitioners to maintain readily retrievable State authorization documents including protocols, practice guidelines, and practice agreements

19. Drug Abuse Treatment Act (DATA) Waived Practitioners
Title 21, CFR, Section allows practitioner registrant to dispense or prescribe Schedule III, IV, or V controlled substances approved by FDA for treating addiction without obtaining a separate registration
Practitioner gets a special designation on their registration after completing Substance Abuse Mental Health Services Administration (SAMHSA) Committee on Substance Abuse Treatment (CSAT) requirements
Practitioner can treat up to 275 patients for substance abuse

20. Record Keeping
Follow controlled substances from manufacture, distribution, and dispensing to ultimate user
Record keeping regulations part of the closed system to prevent diversion
CSA requires registrant to maintain controlled substance records for two years
State of IL requires five years for controlled substance records
BOB/COB for inventories CFR = Code of Federal Regulations

21. Prescriptions
Controlled Substance Prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice - Title 21, CFR, Section (a) **corresponding responsibility rests with the pharmacist who fills the prescription
Must have doctor-patient relationship **exam and diagnosis** (NOT A REGULATION)

22. Prescriptions
Nexus between controlled drug prescribed and patient’s medical condition
No limits on amounts or types of controlled drugs prescribed for patients
Can’t issue a prescription to obtain controlled drugs to supply yourself for dispensing to patients – Title 21, CFR, Section (b)
Can’t issue a prescription for dispensing narcotic drugs in any schedule for “detoxification” or “maintenance treatment” – Title 21, CFR, Section (c) *unless FDA approved drug and doctor meets requirements

23. Prescriptions Must have patient’s name and address
Drug name, strength and dosage form, quantity prescribed, and directions for use
Practitioner’s name, address, and registration number (DOC!!!!!!! don’t pre-print your DEA# on your RX pad) *Registrants can verify registration number of another registrant on-line*
Must be dated and signed on the day issued

24. Tim’s Tips Know your employees
Watch out for “doctor shoppers” – dictate what drugs they need, tell you what their condition is, want to pay cash, don’t want to have insurance company pay for prescription
Pharmaceutical drug abuser knows that specific drug has purity and consistency, same strength, and lack of adulteration – Vicodin ES or Dilaudid versus street cut Heroin

25. Pharmaceutical Drug Abuse
“Kiddie Dope” – Street drugs more dangerous
It won’t hurt you, it was made by a company so it’s safe
You won’t get addicted to these drugs like those “bad” street drugs
Oh Really????????????

26. Legacy – Celebrity Deaths
Marilyn Monroe – Nembutal, Chloral Hydrate
Elvis Presley – Stimulants, Barbiturates, Opiates
Judy Garland – Amphetamines, Barbiturates
Howard Hughes – Codeine, Valium
Michael Jackson - Lorazepam with Propofol
Jeff Conaway – Opiates
Heath Ledger – Oxycodone
Prince - Fentanyl

27. Center for Disease Control Overdose Deaths

28. Illinois Prescription Monitoring Program (PMP)
All practitioners in IL must register with the PMP
Pharmacies enter in all controlled substance prescriptions filled
Practitioners can check to see if a patient is prescribed controlled substances by another practitioner
Practitioners can check their DEA registration number for controlled substance prescriptions issued

29. Information Resources for Registrants
DEA Chicago Office Telephone Number – ask for Diversion Investigator on Duty or Registration Dept.
deadiversion.usdoj.gov
idfpr.com – State of IL Website that has information on practitioner licenses and history of disciplinary action for practitioners, license applications
ilpmp.org – State of IL Prescription Monitoring Program (PMP)
samhsa.gov– substance abuse resources