i am the face of addiction atlanta field division...10/4/2018 2 the csa: checks & balances u.s....
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10/4/2018
1
I AM THE FACE OF ADDICTION
Atlanta Field Division Diversion Outreach Program
STAYING COMPLIANT WITH DEA REGULATION: EXAMINING THE PHARMACIST’S RESPONSIBILITIES WHEN DISPENSING CONTROLLED
SUBSTANCES
LEARNING OBJECTIVES
U.S. Drug Enforcement Administration / Operations Division / Diversion Control Division
1. Recognize opioid prescribing which is outside of normal prescribing patterns
2. Detect various red flags for inappropriate prescribing of controlled substances
Atlanta Field Division
U.S. Drug Enforcement Administration /AFDDiversion Control Division
GEORGIA: Atlanta FD, Columbus RO, Macon RO, Savannah RO, Augusta POD and Rome POD
SOUTH CAROLINA: Columbia DO, Charleston RO, Florence RO and Greenville RO
NORTH CAROLINA: Charlotte DO, Greensboro RO, Raleigh RO, Wilmington RO, and Asheville POD
U.S. Drug Enforcement Administration / AFD Division / Diversion Control Division
ATLANTA FIELD DIVISION OFFICEDPM David M. Hargroder
GS Lydia Y. Bagley, GS Jason K. Allen75 Spring Street, SW, Suite #800Atlanta, Georgia 30303‐3308 Diversion Nr: (404) 893‐7165 Diversion Fax: (404) 893‐7095Registration Nr: (866) 533‐6983
SAVANNAH RESIDENT OFFICEGS George M. Taylor
56 Park of Commerce Blvd., Suite A Savannah, Georgia 31405‐7447 Diversion Nr: (912) 447‐4427 Diversion Fax: (912) 652‐4081Registration Nr: (866) 533‐6983
U.S. Drug Enforcement Administration / AFD Division / Diversion Control Division
COLUMBIA DISTRICT OFFICE GS Debra K. Black1835 Assembly Street, Suite #1229 Columbia, South Carolina 29201‐2453Diversion Nr: (803) 253‐3441 Diversion Fax: (803) 253‐3163Registration Nr: (888) 219‐8689
GREENSBORO RESIDENT OFFICE GS Byron K. Bruce, GS Stephanie A. Evans1801 Stanley Road, Suite #201 Greensboro, North Carolina 27407Diversion Nr: (336) 547‐4219 Diversion Fax: (336) 547‐4209Registration Nr: (888) 869‐9935
10/4/2018
2
THE CSA: CHECKS & BALANCES
U.S. Drug Enforcement Administration / Operations Division / Diversion Control Division
Cost of 30 second commercial during Super Bowl 50 = $5 million
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
Distributor
Pharmacy
Practitioner
Importer
Manufacturer
Hospital
Researcher Analytical Laboratory
Exporter
Narcotic Treatment Program
Teaching Institution Reverse Distributor
Mid-Level Practitioner
Canine Handler
The CSA’s Closed System of Distribution
CyclicInvestigations
SecurityRequirements
Record KeepingRequirements
ARCOS
EstablishedQuotas
Registration
EstablishedSchedules
10/4/2018
3
The Flow of Pharmaceuticals
PATIENTS
Hospitals NTPs
21 CFR 1306.04
Physicians(Rx and drugs)
Pharmacies
QUOTAS(Thebaine)Raw Material
Importers Imp - Manufacturers
21 USC 823(c)(1)21 USC 823(d)(1)21 CFR 1301.71
Dosage Form Manufacturers
Manufacturers
Dosage Form Manufacturers
21 USC 823(b)(1)21 USC 823(e)(1)21 CFR 1301.7121 CFR 1301.74
(Suspicious Orders)
Wholesalers - DistributorsSmaller Distributors
Prescriptions
Prescriptions
• Under USC 841(a)(1):
In order for a prescription to be valid, it must be issued for a legitimate medical purpose by a doctor acting in the usual course of his professional practice.
*Each bad prescription is a separate crime ofdistribution under 841(a)(1).
Prescriptions
Prescriptions must be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use and the name, address and registration number of the practitioner.
Corresponding Responsibility
The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who dispenses the prescription order:
CFR 1306.04(a)
The person knowingly dispensing such prescription, as well as the person issuing it, will be subject to criminal and/or civil penalties.
Checks and Balances of the CSA and the Regulatory Scheme
Distributors of controlled substances
“The registrant shall design and operate a system to disclose to theregistrant suspicious orders of controlled substances…Suspicious ordersinclude orders of unusual size, orders deviating substantially from anormal pattern, and orders of unusual frequency.” (21 CFR §1301.74)
10/4/2018
4
Checks and Balances Under the CSA
Practitioners
“A prescription for a controlled substance to be effective must be issuedfor a legitimate medical purpose by an individual practitioner acting inthe usual course of professional practice.” (21 CFR §1306.04(a))
United States v Moore 423 US 122 (1975)
The Good Doctor
U.S. Drug Enforcement AdministrationOffice of Diversion Control
Checks and Balances Under the CSA
Pharmacists – The Last Line of Defense
“The responsibility for the proper prescribing and dispensing ofcontrolled substances is upon the practitioner, but a correspondingresponsibility rests with the pharmacist who fills the prescription.” (21CFR §1306.04(a))
System of Checks and Balances
The Last Line of Defense
Diversion Prevention Tips
Know the prescriber and his or her signature.
Know the prescriber’s DEA registration number.
“Communicate with other pharmacists”.
When in doubt about a physician, contact your local DEA or your State Medical Board.
Notify DEA upon discovery of thefts/losses of CS via phone call and form DEA-106.
10/4/2018
5
Notice of Inspection -Administrative Inspection
Warrant
Pharmacy Related Violations
Administrative/Civil OffensesPoor record keeping:
Lack of or “NO” Biennial Inventory
Lack of any Inventory Inventories that are Incomplete &
Inaccurate Failure to Maintain Complete
Records for minimum of (2) Two Years
Lack of receipts, invoices, returns, DEA 222 forms, theft/losses etc.
Failure to submit DEA-106 Theft and Loss within 1 business day
Having too much faith in other employees i.e. techs, fill-in RPh
Criminal “Red Flags”
Filling prescriptions that appear to be fraudulent or forged
Customers discuss street prices and drug effects with pharmacist
Pharmacist ignores warnings by other pharmacist about fraudulent prescriptions and/or known drug seekers
Sells mostly large volumes of highly abused controlled substances and cannot explain reasoning.
You shall not employ as an agent or employee who has access to controlled substances:
Any person who has been convicted of a felony offense related to controlled substance.
Any person who has been denied a DEA registration.
Any person who has had a DEA registration revoked.
Any person who has surrendered a DEA registration for cause.
Know Your Employees
What can happen when these checks and balances
collapse ?
The Growing Toll of Americas Opioid Epidemic
10/4/2018
6
Doctor Shopping
Doctor Shopping: What is it ?
Practiced by both Individual Patient Drug Seekers & Trafficking Organizations Target Physicians
• Obtain prescriptions from multiple physicians• Physicians who are willing to prescribe controlled
substances over an extended period of time with little or no follow-up
Target Pharmacies• Utilize multiple pharmacies to fill the orders to avoid
suspicion• Pharmacies known to dispense controlled substances
without asking questions are targeted
32
Doctor Shopping: What is it ?
Healy, according to prosecutors, is a most prolific drug dealer. In 2008 alone, he illegally distributed enough prescription drugs to constitute the federal government’s equivalent of more than 50 kilos of cocaine or 37,000 pounds of marijuana.
The Duarte physician ordered more Vicodinthan any doctor in the nation – 1 million pills in 2008. That’s 10 times the stockpile of an average pharmacy; more than his local CVS, Wal-Mart, Target, and City of Hope pharmacies combined.
Illinois Doctor Sentenced to Four Consecutive Life Sentences
Dr. Paul H. Volkman was sentenced in the Southern District of Ohio on February 14, 2012 to four consecutive life sentences and ordered to forfeit $1.2 million. Volkman was convicted on 12 counts of illegal distribution of controlled substances, four of which resulted in a death; one count of conspiracy to distribute controlled substances; four counts of maintaining a drug premise; and one count of possession of a firearm in furtherance of a drug trafficking crime.
From 2003 to 2005, Volkman illegally distributed over 2.5 million dosage units of Schedule II drugs, primarily oxycodone, outside the course of professional practice which resulted in the death of four people. Of the approximate one million practitioner registrants in the United States in 2004, Volkman ranked first in purchases of oxycodone.
Pharmacy Run Sheets…
10/4/2018
7
Doctor Appointment Records
Established & Operational PMPs -51 Juridictions(49 States, D.C. and St. Louis County)
Source: The National Alliance for Model State Drug Laws (NAMSDL), www.namsdl.com. “Established & Operational PMPs – Map ( July 21, 2017)”
Red Flags
Customers receiving the same combination of prescriptions
Customers receiving the same strength of controlled substances;
Customers paying cash for their prescriptions;
Customers with the same diagnosis codes written on their prescriptions; individuals driving long distances to visit physicians and/or to fill prescriptions;
Customers coming into the pharmacy in groups, each with the same prescriptions issued by the same physician; and customers with prescriptions for controlled substances written by physicians not associated with pain management (i.e., pediatricians, gynecologists, ophthalmologists, etc.).
Potential Red Flags
ROGUE PAIN CLINICS & “PILL
MILLS”
U.S. Drug Enforcement Administration / Operations Division / Diversion Control Division
10/4/2018
8
The Walking DEAD
Normal Practitioner / Patient Relationship
Practitioners
“A prescription for a controlled substance to beeffective must be issued for a legitimate medicalpurpose by an individual practitioner acting in theusual course of professional practice.” (21 CFR §1306.04(a))
United States v Moore 423 US 122 (1975)
The Florida “Migration”: Was this Normal ??
Vast majority of the patients visiting Florida pain clinics came from out-of-state:
Georgia Kentucky Tennessee OhioMassachusetts New Jersey North Carolina South Carolina VirginiaWest Virginia
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Massachusetts General
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Rhode Island
Hospital
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Yale-New Haven Hospital
10/4/2018
9
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
New York Presbyterian Hospital
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Newark Beth-Israel Hospital
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
University of Pennsylvania
Hospital
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Johns Hopkins University Hospital
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Georgetown University Medical Center
INOVA
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Wake Forrest BaptistMedical Center
10/4/2018
10
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Medical University
of South Carolina
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Emory UniversityHospital
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
(MIAMI)
Mayo Clinic of Jacksonville
“short waits or we will pay you”
“earn $$$ for patient referals” (sic)
Either they don’t have any business or the “patients” aren’t seeing the doctor for very long.
10/4/2018
11
No Insurance Accepted
What does a Rogue Pain Clinic Look Like? First, you need to get in line ….
64 Pharmaceutical Investigations (ODP)
A long line …..
65
When you get in, make sure you follow the Instructions !!
66
10/4/2018
12
All the Instructions
67
And more instructions !!!!
68 Pharmaceutical Investigations (ODP)
You may get searched & have
to give up your weapons !!!
69
Clinic Owner’s Weapons
70
All of your weapons !!!!!!
71
Including the knives !!!!
10/4/2018
13
Finally, get your script (s) !!
73
But, only after you pay for them !!!
74
75
Make sure you pack them properly for the trip home (which is often out of state)
Drugs Prescribed
A ‘cocktail’ of oxycodone and alprazolam (Xanax®)
An average ‘patient’ receives prescriptions or medications in combination
Schedule II Schedule III Schedule IV
Oxycodone 15mg, 30mg Vicodin (Hydrocodone) Xanax (Alprazolam)
Roxicodone 15mg, 30mg Lorcet Valium (Diazepam)
Percocet Lortab
Percodan Tylenol #3 (codeine)
Demerol Tylenol #4 (codeine)
Methadone
Average Charges for a Clinic Visit
Price varies if medication is dispensed or if customers receive prescriptions
Some clinics advertise in alternative newspapers citing discounts for new patients such as 'buy one get one free‘ or “50% off with this ad”
Typically, initial office visit is $250; each subsequent visit is $150 to $200
Average 120-180 30mg oxycodone tablets per visit
Cost of Drugs
The ‘cocktail’ prescriptions go for $650 to $1,000
According to medical experts, most clinics do not require sufficient medical history and tests for proper prescribing of Schedule II substances
Each oxycodone 30mg tablet costs the clinics $1.75 to $2.50 each
On the street in Florida, that pill can be re-sold for $7 to $15
Outside of Florida, it can be re-sold for $25 to $30 ($1 per mg)
10/4/2018
14
Why is this happening?
Its All About Profit
• One case in Florida - owner/operator of pain clinic allegedly generated $40 million in drug proceeds
• Houston investigation - $41.5 million in assets
Who is Applying?
An individual who is tied to Organized CrimeAn individual who works at Boston MarketAn individual whose father owns a pain clinicAn individual whose mother works at a pain clinicAn individual whose father is a doctor at a pain clinicAn individual who is a bartender/exotic dancerAn individual who is a truck driverAn individual who is retired from the dry wall businessAn individual who is a secretary at a pain clinicAn individual who runs a lawn care business
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
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WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
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MAINE
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CONN.
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N.H.
VT.
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W.V.
DEL.
MD.
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VIRGINIA
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KENTUCKY
TENN.
WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
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TEXAS
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NORTH DAKOTA
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IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
10/4/2018
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WASHINGTON
OREGON
CALFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
SOUTH DAKOTA
NORTH DAKOTA
MINNOSOTA
IOWA
MISSOURI
ARKANSAS
LOUIS.
MISS.ALA.
GEORGIA
FLA.
WISC. MICH.
ILL.IND.
OHIO
PENN.
N.Y.
MAINE
R.I.
CONN.
N.J.
N.H.
VT.
MASS.
W.V.
DEL.
MD.
S.C.
VIRGINIA
N.C.
KENTUCKY
TENN.
Realignment of DEA’s Diversion Control Efforts
In October 2008, the then Acting Administrator authorized a two-pronged reorganization of the DEA Diversion Control Program.
The first prong involved a substantial expansion in the number of Tactical Diversion Squads (TDS) and their deployment throughout the United States.
The second prong of the reorganization plan called for a renewed focus on DEA’s regulatory oversight of more than 1.4 million DEA registrants.
U.S. Drug Enforcement Administration Operations Division / Diversion Control Division
First Prong: Increased Enforcement Efforts
Currently 77 operational Tactical Diversion Squads (TDS) throughout the United States with more planned.
These TDS enforcement groups incorporate the skill sets of DEA Special Agents, Diversion Investigators, other federal law enforcement, and state and local Task Force Officers.
Second Prong: Renewed Focus on Regulatory Oversight
Increased regulatory efforts throughout the U.S. (to include increases in frequency of inspections)
Investigating/inspecting all new and renewal pharmacy applications.
Investigating/inspecting existing pharmacies registrations
DEA Distributor Initiative
Purpose and format:
Educate and inform distributors/manufacturers of their due diligence responsibilities under the CSA by discussing their Suspicious Order Monitoring System, reviewing their ARCOS data for sales and purchases of Schedules II and III controlled substances, and discussing national trends involving the abuse of prescription controlled substances
August 2005 – Present:
Briefings to firms
Examples of civil action against distributors: Cardinal Health , $34 million civil fineMcKesson, $13.25 million civil fine Harvard, $6 million civil fine
Examples of suspension, surrender or revocation of DEA registration Keysource, loss of DEA registration Sunrise, loss of DEA registration
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U.S. Drug Enforcement Administration / Operations Division / Diversion Control Division
The $80 million settlement is the largest fine paid by a pharmacy
chain as related to DEA’s strategy of cracking down on
rampant prescription drug abuse
We will not arrest our way out of this problem!!!!!
Enforcement is just as important as….Prevention/Education
Treatment
U.S. Drug Enforcement Administration / Operations Division / Diversion Control Division
www.deadiversion.usdoj.gov
10/4/2018
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U.S. Drug Enforcement Administration / Diversion Control Division
COLUMBIA DISTRICT OFFICE
GS Debra K. Black1835 Assembly Street, Suite #1229 Columbia, South Carolina 29201‐2453Office: (803) 253‐3441 Fax: (803) 253‐3163Registration: (888) 219‐8689
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