I AM THE FACE OF ADDICTION Atlanta Field Division...10/4/2018 2 THE CSA: CHECKS & BALANCES U.S. Drug...

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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 /AFD Diversion 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 OFFICE DPM David M. Hargroder GS Lydia Y. Bagley, GS Jason K. Allen 75 Spring Street, SW, Suite #800 Atlanta, Georgia 30303‐3308 Diversion Nr: (404) 893‐7165 Diversion Fax: (404) 893‐7095 Registration Nr: (866) 533‐6983 SAVANNAH RESIDENT OFFICE GS George M. Taylor 56 Park of Commerce Blvd., Suite A Savannah, Georgia 31405‐7447 Diversion Nr: (912) 447‐4427 Diversion Fax: (912) 652‐4081 Registration Nr: (866) 533‐6983 U.S. Drug Enforcement Administration / AFD Division / Diversion Control Division COLUMBIA DISTRICT OFFICE GS Debra K. Black 1835 Assembly Street, Suite #1229 Columbia, South Carolina 29201‐2453 Diversion Nr: (803) 253‐3441 Diversion Fax: (803) 253‐3163 Registration Nr: (888) 219‐8689 GREENSBORO RESIDENT OFFICE GS Byron K. Bruce, GS Stephanie A. Evans 1801 Stanley Road, Suite #201 Greensboro, North Carolina 27407 Diversion Nr: (336) 547‐4219 Diversion Fax: (336) 547‐4209 Registration Nr: (888) 869‐9935

Transcript of I AM THE FACE OF ADDICTION Atlanta Field Division...10/4/2018 2 THE CSA: CHECKS & BALANCES U.S. Drug...

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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

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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

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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)

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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.

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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

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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

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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…

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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

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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

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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.

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

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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.

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.

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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 !!

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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 !!!!

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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)

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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

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WASHINGTON

OREGON

CALFORNIA

NEVADA

IDAHO

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WYOMING

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ARIZONA NEW MEXICO

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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.

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ILL.IND.

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PENN.

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MAINE

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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

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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