OVERVIEW OF THE DEA AS YOUR RESOURCE By Supervisory Diversion Investigator Tim Lenzi DEA Chicago Office 312-886-2674

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”

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

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

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

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

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

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

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

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

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

Practitioner Registration Title 21, Code of Federal Regulations (CFR), Section 1301.11(a) Every person who manufactures, distributes, dispenses, imports or exports controlled substances shall obtain a registration unless exempted by law Title 21, CFR, Section 1301.12(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

Practitioner Registration Title 21, CFR, Section 1301.12(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

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

Exemption from Registration Title 21, CFR, Section 1301. 22(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

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

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

Mid Level Practitioners DEA registration must match the drug Schedules allowed by IL Title 21, CFR, Section 1304.03(e) requires mid level practitioners to maintain readily retrievable State authorization documents including protocols, practice guidelines, and practice agreements

Drug Abuse Treatment Act (DATA) Waived Practitioners Title 21, CFR, Section 1301.28 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

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

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, Section1306.04(a) **corresponding responsibility rests with the pharmacist who fills the prescription Must have doctor-patient relationship **exam and diagnosis** (NOT A REGULATION)

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 1306.04(b) Can’t issue a prescription for dispensing narcotic drugs in any schedule for “detoxification” or “maintenance treatment” – Title 21, CFR, Section1306.04(c) *unless FDA approved drug and doctor meets requirements

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

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

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????????????

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

Center for Disease Control Overdose Deaths

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

Information Resources for Registrants DEA Chicago Office Telephone Number 312-353-7875 – 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