Len 1 rannazzisi

Law Enforcement Track: Rx Drug Inves9ga9ons in the

21st Century

Presenter: Joseph T. Rannazzisi, JD, RPh, Deputy Assistant Administrator, Office of Diversion Control, United States Drug Enforcement AdministraEon (DEA)

Moderator: Dan Smoot, CEO, OperaEon UNITE

I have no financial rela.onships to disclose and

I will not discuss off-‐label use and/or inves.ga.onal drug use in my presenta.on

Disclosure Statement

U.S. Drug Enforcement Administra.on Office of Diversion Control

  Examine reasons for the increasing rate of diversion and abuse of prescrip.on narco.cs

  Evaluate effec.ve strategies for drug diversion inves.ga.ons

  Describe the opportuni.es for law enforcement agencies to collaborate with regulatory agencies during drug diversion inves.ga.ons

Goals and Objectives


Responding to America’s Prescription Drug Abuse Crisis

“When Two Addictions Collide”


In 2010, approximately 38,329 uninten9onal drug overdose deaths occurred in the United States, one death every 14 minutes.

Of this number, 22,134 of these deaths were aNributed to Prescrip9on Drugs (16,651 aNributed to opioid overdoses/ 75.2 %).

Prescrip9on drug abuse is the fastest growing drug problem in the United States.

Source: CDC Drug Overdose Deaths in the United States, 2010 (October 2012)


Consequences

U.S. Drug Overdose Deaths by Major Drug Type, 1999-2010

Source: CDC/NCHS, NVSS U.S. Drug Enforcement Administra.on

Office of Diversion Control

Drug-Induced Deaths vs. Other Injury Deaths, 1999–2009

Source: National Center for Health Statistics, Centers for Disease Control and Prevention. National Vital Statistics Reports Deaths: Final Data for the years 1999 to 2009 (January 2012).

Causes of death aGributable to drugs include accidental or inten.onal poisonings by drugs and deaths from medical condi.ons resul.ng from chronic drug use. Drug-‐induced causes exclude accidents, homicides, and other causes indirectly related to drug use. Not all injury cause categories are mutually exclusive.


2011 Current Users (Past Month) 2012

Source: 2011 & 2012 NSDUH

Prescription Drug Abuse

More Americans abuse prescription drugs than the number of:

Cocaine, Hallucinogen, Heroin, and Inhalant abusers


Scope and Extent of Problem: Past Month Illicit Drug Use among Persons

Aged 12 or Older

Source: 2004, 2007, 2008, 2009, 2010, 2011, 2012 National Survey on Drug Use and Health U.S. Drug Enforcement Administra.on Office of Diversion Control

Source: 2011 National Survey on Drug Use and Health


Percentage of Past Month Nonmedical Use of Psychotherapeutics by Age, 2003-2011

SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA)

Past Year Initiates 2012 – Ages 12 and Older


Emergency Room Data 2004-2010


SOURCE: The DAWN Report, Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, December 28, 2010

SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA)

Substances for Which Most Recent Treatment Was Received in the Past Year among Persons Aged 12 or Older: 2012

SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 03, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA)

Substances for Which Most Recent Treatment Was Received in the Past Year

among Persons Aged 12 or Older: 2002-2012

Number of Forensic Cases 2001-2011

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

50,000

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

240%

257%


322%

Poisoning Deaths: Opioid Analgesics

*2009 data approximated

*

Drug Overdose Mortality Rates per 100,000 People 1999

Source: Trust for America’s Health, www.healthyamericans.org. “Prescription Drug Abuse: Strategies to Stop the Epidemic (2013)” U.S. Drug Enforcement Administra.on


Source: Trust for America’s Health, www.healthyamericans.org. “Prescription Drug Abuse: Strategies to Stop the Epidemic (2013)”

Drug Overdose Mortality Rates per 100,000 People 2010


 Most severe in Southwest and Appalachian  In 2010, the top three states were West Virginia, New Mexico, and Kentucky; West Virginia: 28.9 deaths per 100,000 New Mexico: 23.8 deaths per 100,000 Kentucky: 23.6 deaths per 100,000  Lowest-North Dakota: 3.4 deaths per 100,000  Minnesota ranked 47th 7.3 deaths per 100,000

Where Prescription Painkiller Overdose Deaths Are The Highest

SOURCE: Trust for America’s Heath-Prescription Drug Abuse: Strategies To Stop The Epidemic; October 2013


Naloxone


Source: U.S. Census Bureau

Statistical Perspective


Why is the problem outpacing population growth?


In Florida two

Westchase teachers learn a lesson:

Say 'no' to mints in pill

bottles


The drug boGles were made more realis.c with labels that read in part: “Watson’s Whiz Kid Pharmacy. Take 1 tablet by mouth EVERY 5 MINUTES to cure FCAT jiGers. Repeated use may cause crah to spontaneously ooze from pores. No refills. Ms. Falcon’s

authoriza.on required.”

Violence


Source: DEA Drug Theft & Loss Database as of 03/18/2014

Pharmacy Armed Robberies Rankings by State

January 1 thru December 31, 2011 (691)


Violence Related to Controlled Substance Pharmaceuticals


Eyewitness News

MEDFORD (WABC) -‐-‐ The suspect in the Father's Day massacre at a Long Island pharmacy pleaded guilty to murder charges Thursday. David Laffer has officially withdrawn his not guilty pleas to charges of first-‐degree murder and criminal use of a firearm and waived his right to appeal. Laffer killed four people at Haven Drugs in Medford before robbing the place of 10,000 hydrocodone pills.

Laffer's wife, Melinda Brady, also pleaded guilty to robbery charges. The judge announced his inten.on to sentence Laffer to the maximum of four life sentences with no parole, to be served consecu.vely, and Brady to 21 to 25 years in state prison. Formal sentencing for both husband and wife is scheduled for October 17.

Laffer and Brady were arrested June 22 in their suburban home a mile and a half from Haven Drugs, where authori.es say he opened fire on the vic.ms before jamming the backpack full of prescrip.on painkillers.


Couple pleads guilty in pharmacy murders

2 killed, 2 wounded in pharmacy shooting; ex-Bean Station officer to be charged

By News Sentinel staff Knoxville News Sentinel Posted May 23, 2013 at 12:28 p.m., updated May 23, 2013 at 9:52 p.m.


Drug Education


Where do kids get their information from?


www.JustThinkTwice.com

DEA Web-based Resources


www.GetSmartAboutDrugs.com DEA Web-based Resources


DEA Web-based Resources www.DEA.gov


Community Coali.ons and Advocacy Groups


Education

 Pharmacists

Drug Experts in the health care delivery system

Corresponding responsibility


Scheduled PDACs 16-‐Knoxville, TN March 22-‐23, 2014 17-‐St. Louis, MO April 5-‐6, 2014 18-‐Phoenix, AZ June 28-‐29, 2014 19-‐Philadelphia, PA July 12-‐13, 2014 20-‐Denver, CO Aug 2-‐3, 2014 21-‐Salt Lake City, UT Aug 23-‐24, 2014

FL

2

WA

UT

OR

CA NV

ID

MT

AZ

WY

CO

NM

ND

SD

TX

4

NE

KS

OK

MN

IA

MO

AR

LA

MI WI

IL IN

6 KY

TN MS AL GA

3

OH

1 WV VA

NC

SC

PA

NY

5 MA

ME

DC MD

NJ

CT

RI

DE

NH

VT

12B

12A

18

21 20

7

11

10

17

9

14

8

16 15

13

19

Completed PDACs

Scheduled PDACs

February 11, 2014

Completed PDACs AGendance 1-‐Cincinna., OH 9/17-‐18/11 75 2-‐WPB, FL 3/17-‐18/12 1,192 3-‐Atlanta, GA 6/2-‐3/12 328 4-‐Houston, TX 9/8-‐9/12 518 5-‐Long Island, NY 9/15-‐16/12 391 6-‐Indianapolis, IN 12/8-‐9/12 137 7-‐Albuquerque, NM 3/2-‐3/13 284 8-‐Detroit, MI 5/4-‐5/13 643 9-‐Chicago, IL 6/22-‐23/13 321 10-‐Portland, OR 7/13-‐14/13 242 11-‐Baton Rouge, LA 8/3-‐4/13 259 12A-‐San Diego, CA 8/16-‐17/13 353 12B-‐San Jose, CA 8/18-‐19/13 434 13-‐Boston, MA 9/21-‐22/13 275 14-‐Louisville, KY 11/16-‐17/13 149 15-‐CharloGe, NC 2/8-‐9/14 513 Total AGendance 6,114

Law Enforcement Sponsored Training


Health care professionals Community associations Schools

Most Frequent Method of Obtaining a Pharmaceutical

Controlled Substance for Non-Medical Use

Friends and Family…For Free!!


SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 3, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA)

Source Where Pain Relievers Were Obtained for Most Recent Nonmedical Use Among Past

Year Users Aged 12 or Older: 2011-2012

Medicine Cabinets: Easy Access

More than half of teens (56%) indicate that it’s easy to get prescription drugs from their parent’s medicine cabinet

Half of parents (495) say anyone can access their medicine cabinet

More than four in 10 teens (42%) who have misused or abused a prescription drug obtained it from their parent’s

medicine cabinet

Almost half (49%) of teens who misuse or abuse prescription medicines obtained them from a friend

Source: 2012 Partnership Attitude Tracking Study, published 4/23/13


So Many Drugs in the Household – Why?

Unreasonable quantities being prescribed

Insurance rules


Law Enforcement

Law enforcement officers, ac9ng to enforce laws regarding the abandonment of controlled substances, may receive controlled substances from ul9mate users.

Law enforcement must safeguard the controlled substances and ensure that they are destroyed properly.

Law enforcement must be present during the destruc9on of the controlled substances.


April 26, 2014

National Take Back Initiative April 26, 2014


10:00 AM – 2:00 PM

On September 30, 2010, approximately 122 tons On April 30, 2011, approximately188 tons

On October 29, 2011, approximately 189 tons On April 28, 2012, approximately 276 tons

On September 29, 2012, approximately 244 tons On April 27, 2013, approximately 376 tons

On October 26 , 2013, approximately 324 tons


National Take Back Day: October 26, 2013 Total Weight Collected (pounds): 647,211 (324 Tons)

8,153

10,880

5,527

10,030

17,077 MA 2,171

RI

4,603CT

16,520

3,430 VT

5,343 NH

811 PR & VI

33,761 22,000

215

38,506

10,402

46,565

936

18,433

1,195

1,251

4,461

11,380

23,678

9,171

3,215

72,886

1,777

2,580 HI & GU

16,950

14,841NJ

2,541

18,008

1,420 4,123

41,501

38,493

10,303

14,508

5,766

4,587

2,763

19,901

7,004

9,737

6,194

908

20,072 4,977

9,425MD

974 DC

5,258 DE


Prescription drug epidemic?

How did we get to this point?


The 1960s/70s/80s

Downers -‐ Barbiturates

Uppers -‐ Amphetamines

Meprobamate

Hydromorphone

“Ts and Blues”

“Fours and Doors” Oxycodone/APAP

methaqualone


The 1990s

Hydrocodone

Alprazolam Oxycodone 30 mg

Carisoprodol

OxyCon.n 80mg

Commonly Abused Controlled Pharmaceuticals

Oxymorphone

C-‐IV as of 1/11/2012

The Trinity

C-‐IV as of 1/11/2012

Hydrocodone


Most commonly prescribed prescription medicine?

Hydrocodone/acetaminophen


Top Five Prescription Drugs Sold in the U.S. (2008-2011)


Source: IMS Health, Na.onal Prescrip.on Audit, Updated 02/24/14

Millions of Prescrip.ons

State Ranking* - Hydrocodone January – September 2013


Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014

Approval of Single Entity Extended Release Hydrocodone



State Ranking* - Oxycodone January – December 2013



OxyContin Change

New OxyContin® OP


Oxycodone 15mg/30mg Immediate Release


Opana ER (Schedule II)  Opana ER -‐ (Schedule II)

– Treats constant, around the clock, moderate to severe pain

– Becoming popular and is abused in similar fashion to oxycodone ; August 2010 (Los Angeles FD TDS)

– Slang: Blues, Mrs. O, Octagons, Stop Signs, Panda Bears

– Street: $10.00 – $80.00



State Ranking* - Oxymorphone January – December 2013


Hydromorphone



State Ranking* - Hydromorphone January – December 2013


Opiates v. Heroin


Circle of Addiction & the Next Generation

Hydrocodone Lorcet®

$5-‐$7/tab

Oxycodone Combina.ons

Percocet®

$7-‐$10/tab

OxyCon9n® $80/tab

Heroin $10/bag

Roxicodone® Oxycodone IR 15mg, 30mg $30-‐$40/tab


HEROIN CASES and EXHIBITS National Forensic Laboratory Information System

Year # Exhibits # Cases

2004 69,467 60,851

2005 73,569 64,471

2006 83,945 72,351

2007 82,408 69,850

2008 94,229 79,366

2009 107,272 87,249

2010 104,676 84,170

2011 109,049 86,513

2012 127,568 101,512

2013: Jan – Jun 69,574 55,325 U.S. Drug Enforcement Administra.on


Heroin trafficking organiza.ons reloca.ng to areas where prescrip.on drug abuse is on the rise

Heroin traffickers pave the way for increasing crime and violence

Law enforcement and prosecutors eventually figh.ng the problem on two fronts (prescrip.on opiate diversion and heroin distribu.on) further deple.ng resources

Communi.es suffer

Community Impact?


Where are the Pharmaceuticals Coming

From?  Friends and Family for Free

 Medicine Cabinet

 Doctor Shopping

 Internet

 Pain Clinics U.S. Drug Enforcement Administra.on


Methods of Diversion

 Practitioners / Pharmacists –  Illegal distribution –  Self abuse –  Trading drugs for sex

 Employee pilferage –  Hospitals –  Practitioners’ offices –  Nursing homes –  Retail pharmacies –  Manufacturing / distribution

facilities

 Pharmacy / Other Theft –  Armed robbery –  Burglary (Night Break-ins) –  In Transit Loss (Hijacking) –  Smurfing

 Patients / Drug Seekers –  Drug rings –  Doctor-shopping –  Forged / fraudulent / altered

prescriptions  The medicine cabinet / obituaries  The Internet  Pain Clinics


Prescription Fraud


Questions to Discuss

  What combina.on of drugs is referred to as the “trinity”?

A) Hydrocodone, alprazolam, and carisoprodol

B) Promethazine with codeine, methylphenidate and carisoprodol

C) Hydromorphone, carisoprodol and buprenorphine

D) Methadone, diazepam and tramadol


Doctor Shopping


Prescription Drug Monitoring Programs


Mandatory PDMP review before prescribing CS?


Standard of Care


National Association of Boards of Pharmacy


Diversion via the Internet


WA

OR ID

WY

ND

SD

MN

NE

WI MI

CO KS MO

IL IN UT

NV

CA

AZ NM OK

AR

LA

TN

KY

MS AL GA

SC

NC

OH

VA

PA

NY

ME

VT N

H

CT

DE WV

RI

MD

MA

Domestic ‘Rx’ Flow

MT MT

FL TX TX

2. Request goes through Website Server in San Antonio, TX

WS FL

IA IA NJ

1. Consumer in Montana orders hydrocodone on the Internet

C

3. Web Company (located in Miami, FL) adds request to queue for Physician approval

WC

4. Order is approved by Physician in New Jersey and returned to Web Company Dr.

S

6. Pharmacy in Iowa fills order and ships to Consumer via Shipper

Rx

5. Approved order then sent by Web Company to an affiliated Pharmacy

New Felony Offense Internet Trafficking - 10/15/2008

  21 USC 841(h)(1): It shall be unlawful for any person to knowingly or intentionally:

(A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by this title; or

(B) aid or abet any violation in (A)


Per Se Violations

 No in-person medical evaluation by prescribing practitioner

 Online pharmacy not properly registered with modified registration.

 Website fails to display required information


Pain Clinics


Explosion of South Florida Pain Clinics

As of June 4, 2010, Florida has received 1,118 applica.ons and has approved 1026 *As of May 14, 2010, Broward 142; Miami-‐Dade 79; Palm Beach 111 U.S. Drug Enforcement Administra.on


Hydrocodone Oxycodone

2002 9,376 8,288

2003 12,130 9,715

2004 16,401 13,492

2005 21,190 14,643

2006 24,984 17,927

2007 30,637 22,425

2008 33,731 28,756

2009 38,084 38,332

2010 39,444 48,210

2011 37,483 46,906

2012 35,140 42,869

2013* 26,844 31,897

NFLIS – Federal, State, and local cases reported

U.S. Drug Enforcement Administra.on Office of Diversion Control NFLIS Query Date: 02/24/14

Medical Care ?

 Many of these clinics are prescrip.on/dispensing mills

 Minimal prac..oner/pa.ent interac.on


Increased Law Enforcement Pressure

 Clinics migra.ng north and west

 Funded by owners in Florida


WASHINGTON

OREGON

CALIFORNIA

NEVADA IDAHO

MONTANA

WYOMING

UTAH

ARIZONA NEW MEXICO

COLORADO

TEXAS OKLAHOMA

KANSAS

NEBRASKA

SOUTH DAKOTA

NORTH DAKOTA

MINNESOTA

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.


Drugs Prescribed

 A ‘cocktail’ of oxycodone and alprazolam (Xanax)

 An average ‘pa.ent’ receives prescrip.ons or medica.ons in combina.on

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 or more; each subsequent visit may exceed $200

 Prescriptions average 120-180 30mg oxycodone tablets per visit


Cost of Drugs

 According to medical experts, most clinics do not require sufficient medical history and tests for proper prescribing of Schedule II substances

 Oxycodone 30mg immediate release tablets cost approximately $30.00 to $40.00 per tablet on the street depending on the sale loca.on in the U.S. ($1 per mg or more)


What’s the Profit?


Florida Pain

Clinic Raid


The Controlled Substances Act

Foreign Mfr Importer Manufacturer

Distri-butor

Practitioner Pharmacy Hospital Clinic

Patient

?

Law: 21 USC 822 (a) (1) Persons Required to Register: “Every person who manufactures or distributes any Controlled Substance or List I Chemical or who proposes to engage in ..”

Law: 21 USC 822 (a) (2) Persons Required to Register: “Every person who dispenses, or who proposes to dispense any controlled substance ...”

Closed System of Distribution

Cyclic Investigations

Security Requirements

Recordkeeping Requirements

ARCOS

Established Quotas

Registration

Established Schedules


150 U.S. Drug Enforcement Administra.on Office of Diversion Control

The Flow of Pharmaceuticals

PATIENTS

Hospitals NTPs

21 CFR 1306.04

Physicians (Rx and drugs)

Pharmacies

QUOTAS 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 1301.71 21 CFR 1301.74 (Suspicious Orders) Wholesalers - Distributors Smaller Distributors


Diversion via the Internet


WA

OR ID

WY

ND

SD

MN

NE

WI MI

CO KS MO

IL IN UT

NV

CA

AZ NM OK

AR

LA

TN

KY

MS AL GA

SC

NC

OH

VA

PA

NY

ME

VT N

H

CT

DE WV

RI

MD

MA

Domestic ‘Rx’ Flow

MT MT

FL TX TX

2. Request goes through Website Server in San Antonio, TX

WS FL

IA IA NJ

1. Consumer in Montana orders hydrocodone on the Internet

C

3. Web Company (located in Miami, FL) adds request to queue for Physician approval

WC

4. Order is approved by Physician in New Jersey and returned to Web Company Dr.

S

6. Pharmacy in Iowa fills order and ships to Consumer via Shipper

Rx

5. Approved order then sent by Web Company to an affiliated Pharmacy


Purchases of hydrocodone by Known and Suspected Rogue Internet Pharmacies

January 1, 2006 – December 31, 2006

Date Prepared: 03/07/2007 Source: ARCOS

98,566,711

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 the registrant suspicious orders of controlled substances…Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” (21 CFR §1301.74)


DEA Distributor Ini9a9ve   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 83 firms with 276 locations

Examples of civil action against distributors:

Cardinal Health , $34 million civil fine McKesson, $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 U.S. Drug Enforcement Administra.on


Source: www.kuow.org , 01/30/2014

John Gray, president and CEO of Healthcare Distribution Management Association, said suppliers used to have a more cooperative and collaborative relationship with the Drug Enforcement Agency. But things have changed, he said. “It’s all been dumped in our laps as wholesalers to make what I would consider to be law enforcement decisions as to whether or not a particular customer or account is or is not over what the DEA, in their own mind, thinks is a viable limit for Schedule II drugs they ought to be dispensing,” Gray said.


“At the .me we filled these orders, the pharmacies held valid state board of pharmacy and DEA licenses,” BarreG said in a call to investors on Friday. “Pharmaceu.cal distributors do not influence the manufacture of controlled medicines. We do not write prescrip.ons. We do not dispense controlled medicines, nor do we license pharmacies. Our role is, as a distributor, a cri.cal link in the supply chain between pharmaceu.cal

manufacturers and pharmacies. “ Cardinal CEO George BarreG

The Company called the DEA ac.on “a dras.c overreac.on” that would disrupt delivery of cri.cal medica.ons to

hospitals and pharmacies.

Misleading Title?

Sponsored by Reps from TN, PA, CO, and GA

This bill effec.vely eliminates the DEA’s administra.ve powers of the OTSC and ISO op.ons, and instead requires DEA to give no.ce and offer the registrant an opportunity to submit a correc.ve ac.on plan.

An ISO is issued to protect the public from imminent harm. By redefining an ISO and delaying it’s issuance, the bill would prevent the DEA from protec.ng the public when harm is imminent.

DEA conducts more 5,000 inspec.ons on registrants yearly and takes administra.ve ac.on on a very small percentage of those registrants inspected.

DEA Imposed Quotas on Wholesalers/Distributors of Controlled Substances to

downstream customers?

NO! U.S. Drug Enforcement Administra.on


Checks and Balances Under the CSA

•  Practitioners

“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.” (21 CFR §1306.04(a))

United States v Moore 423 US 122 (1975)


The Controlled Substances Act Illegal Distribution

21 U.S.C. § 841 (a) Unlawful acts:

Except as authorized by this subchapter, it shall be unlawful for any person to knowingly or intentionally

(1) to manufacture, distribute or dispense, or possess with intent to manufacture, distribute or dispense, a controlled substance; or


The Last Line of Defense



Pharmacists – The Last Line of Defense

“The responsibility for the proper prescribing and dispensing of controlled substances is upon the practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” (21 CFR §1306.04(a))

U.S v. Hayes 595 F. 2d 258 (5th Cir 1979) U.S. v. Leal 75 F. 3d 219 (6th Cir 1996) U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010) East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27, 2010)



Pharmacists – The Last Line of Defense

“An order purporting to be a prescription issued not in the course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the act (21 USC 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” (21 CFR §1306.04(a))

U.S v. Hayes 595 F. 2d 258 (5th Cir 1979) U.S. v. Leal 75 F. 3d 219 (6th Cir 1996) U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010) East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27, 2010)


When prescrip.ons are clearly not issued for legi.mate medical purposes, a pharmacist may not inten.onally close his eyes and thereby avoid [actual] knowledge of the real purpose of the prescrip.ons.

(Ralph J. Bertolino, 55 FR 4729, 4730 (1990)),

Corresponding Responsibility Cases


What happens next?

You aGempt to resolve…


Resolution is comprised of many factors

Verifica.on of a valid prac..oner DEA number is required! It is not, however, the end of the pharmacists duty. Invalid RX

Resolu.on cannot be based solely on pa.ent ID and prescriber verifica.on.

You must use your professional judgment, training and experience…we all make mistakes Knowledge and history with the pa.ent

Circumstances of prescrip.on presenta.on

Experience with the prescribing prac..oner It does not require a call to the prac..oner for every CS RX

This is not an all-‐inclusive list…


Many customers receiving the same combina.on of prescrip.ons; cocktail

Many customers receiving the same strength of controlled substances; no individualized dosing: mul.ple prescrip.ons for the strongest dose

Many customers paying cash for their prescrip.ons

Early refills

Many customers with the same diagnosis codes wriGen on their prescrip.ons;

Individuals driving long distances to visit physicians and/or to fill prescrip.ons;


Customers coming into the pharmacy in groups, each with the same prescrip.ons issued by the same physician; and

Customers with prescrip.ons for controlled substances wriGen by physicians not associated with pain management (i.e., pediatricians, gynecologists, ophthalmologists, etc.).

Overwhelming propor.on of prescrip.ons filled by pharmacy are controlled substances

Pharmacist did not reach out to other pharmacists to determine why they were not filling a par.cular doctors prescrip.on

Verifica.on of legi.macy not sa.sfied by a call to the doctors office


AMA View on Corresponding Responsibility


Inquiries by pharmacists with doctors regarding the ra.onale behind prescrip.ons, diagnoses and treatment plans are inappropriate.

These inquiries are “an interference with the prac.ce of medicine and unwarranted”.

Purchases of Oxycodone 30mg

 In 2009, 44% of all oxycodone 30mg products were distributed to Florida

 In 2010, 43% of all oxycodone 30mg products were distributed to Florida


Remaining States 593,625,290 dosage units Florida

94,923,484 dosage units

Source: ARCOS Date Prepared: 01/30/2014 U.S. Drug Enforcement Administra.on


Florida 94,923,484 dosage units

New York 50,658,100 dosage

units

Remaining States 486,977,390 dosage units

California 55,989,800 dosage

units

Source: ARCOS Date Prepared: 01/30/2014 U.S. Drug Enforcement Administra.on


Viola.ons?

What happens next…..

DEA Legal Recourse  Administra.ve Immediate Suspension Order (ISO)

Memorandum of Agreement (MOA)

Order to Show Cause (OTSC)

 Civil Fines

 Criminal

Tac.cal Diversion Squads U.S. Drug Enforcement Administra.on


How Do You Lose Your Registration?

The Order to Show Cause Process 21 USC § 824

a)  Grounds – 1.  Falsifica.on of Applica.on 2.  Felony Convic.on 3.  State License or Registra.on suspended, revoked or denied –

no longer authorized by State law 4.  Inconsistent with Public Interest 5.  Excluded from par.cipa.on in Title 42 USC § 1320a-‐7(a)

program

b) AG discre.on, may suspend any registra.on simultaneously with Order to Show Cause upon a finding of Imminent Danger to Public Health and Safety

* FY2014 as of February 27, 2014

Administrative Actions Initiated by DEA FY2007 thru 2014*


Initiation of Investigation


ARCOS

PDMP


Inves9ga9ng Physicians

• “Outside the Scope” – CFR and Case Law: “A prescription for a controlled

substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.”

–  “In accordance with the standard of medical practice generally recognized and accepted in the US.”

Once outside the scope => 21 USC 841

U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control

Legal Basis

Standards of Care-‐State Boards



Targeting sources:

– Referrals from medical/pharmacy boards – Law enforcement agency partners – Confidential Sources – Liaison:

•  Hospitals (ER staff) •  Medical examiners •  Treatment /Rehab facilities •  Pharmacies (PICs and security staff)

– Choicepoint and other commercially available databases


Targeting/Evaluation

Interviews of sources (patients, former employees) –  Look for Patterns and RED FLAGS:

•  Relatively large quantities of controlled substances •  Little or no medical exam or diagnostic exams •  Cash-only practice •  No referrals to specialist for treatment or evaluation •  Pain “cocktails” •  Patients live long distances from practice •  Long lines of waiting patients •  Patients show indications of addiction •  Directed patients to specific pharmacies


Evaluation/Red Flags Inves9ga9ng Physicians

Dr. Bamdad, Los Angeles

Fugitive Pill Mill Doctor (Dr. Robert Ignasiak) Who Faked Suicide Found and Arrested in South Florida

Perfunctory ini.al physical exam…return visits no exam

Physical exam included needle mark checks…some were simulated

Pa.ent received quan.ty of drugs requested…were charged based on quan.ty

Unsupervised urinalysis – results did not maGer

Accurate records not kept – quan.ty dispensed not recorded

Prac..oner not authorized to conduct methadone maintenance;

Pa.ent directed prescribing; U.S. Drug Enforcement Administra.on


Rosen was a 68 yo physician who had a prac.ce that was focused on obesity. He dispensed large quan..es of s.mulants to undercover officers outside the scope and not for a legi.mate purpose.

The 5th circuit had to address whether the medica.on was dispensed “for a legi.mate medical purpose and in the course of the doctors professional prac.ce.” In its analysis, the court stated, “We are however, able to glean from reported cases, certain recurring concomitance of condemned behavior, examples of which include the following:

An inordinately large quan.ty of controlled substances prescribed

Large numbers of prescrip.on were issued

No physical exam given

The physician warned the pa.ent to fill prescrip.ons at different drug stores


Customers coming into the pharmacy in groups, each with the same prescrip.ons issued by the same physician; and

Customers with prescrip.ons for controlled substances wriGen by physicians not associated with pain management (i.e., pediatricians, gynecologists, ophthalmologists, etc.).

Overwhelming propor.on of prescrip.ons filled by pharmacy are controlled substances

Pharmacist did not reach out to other pharmacists to determine why they were not filling a par.cular doctors prescrip.on

Verifica.on of legi.macy not sa.sfied by a call to the doctors office


The physician issued prescrip.ons to a pa.ent known to be delivering the drugs to others

The physician prescribed controlled drugs at intervals inconsistent with legi.mate medical treatment

The physician involved used street slang rather than medical terminology for the drugs prescribed

There was no logical rela.onship between the drug prescribed and treatment of the condi.on allegedly exis.ng

The physician wrote more than one prescrip.on on occasions in order to spread them out


Pa.ents receiving the same combina.on of prescrip.ons; cocktail

Pa.ents receiving the same strength of controlled substances; no individualized dosing: mul.ple prescrip.ons for the strongest dose

Majority of pa.ents paying cash for their prescrip.ons

Pa.ent directed prescribing; pa.ent asks for drugs in street slang

Early refills

No specialized training in pain management;

Individuals driving long distances to visit physicians and/or to fill prescrip.ons

No records/pa.ent contracts/ urinalysis U.S. Drug Enforcement Administra.on


Initial verification/corroboration –  Prescription Monitoring Programs-30 day look –  Look for legitimate explanations of activity –  Physical surveillance-Video

•  Patient traffic inside/outside clinic •  Staff removing records/bags from office •  MD/staff visiting banks

–  Database checks; prior/related investigations –  Crosscheck with other agencies for related information

•  Professional state licensing boards-Discipline/on-going investigations


Initial Evaluation Inves9ga9ng Physicians


Considerations –  DON’T TRICK THE DOCTOR –  Intent: evidence of “outside the scope” –  Video/Audio recording crucial –  Pain mention- not always a show stopper –  MRI/Medical records- creating/patterns of use –  Frequency of visits-multiple undercovers –  Street slang/prices/conversation –  Meet other patients in clinic –  Medication prescribed for others not present –  ASK: specific drugs/increase doses/multiple scripts


Undercover Process


Grand Jury Subpoenas – Banks- Laundering and asset identification

Expert Review –  Establish Probable Cause for Search warrant/Administrative

action –  PMP records –  Reports: Undercover, Interviews of patients/employees –  UC video/audio –  Opinion: “Extreme departure” from standards –  Sources: Professional boards/associations, teaching universities.


Investigative Process


Timing of search and arrests-considerations –  Public safety –  Rush to Indictment following arrest-be prepared –  Loss of assets –  High profile defendant-Press/political interests –  Immediate suspension of DEA registration/state licensing action

Processing medical records –  Know what you’re looking for

Expert Review of seized medical records Patient and employee interviews


Search Warrants


Search warrants/affidavits

–  Get a go-by –  Include: type of drugs, case law/statute of legitimate prescribing,

medical standards, how target violated standard, expert opinion, specific records to seize, how to conduct search

–  Special masters not usually required in fed cases –  Plan how to process and store records –  Request computer forensic/doc exploitation teams –  Electronic scanning/prosecution preference


Search Warrant Mechanics


Appropriate Jurisdiction: Federal/State (Attorney General)/District Attorney’s Office

–  Offenses/charging/burdens/sentences all vary

Death enhancements –  Medical examiner investigation –  Cause of death/documentation –  Multiple Expert opinions

Other enhancements - Distances/under age 21

Charging: UC counts/Relative conduct at sentencing –  Medical fraud considerations

Asset Forfeiture - Criminal/civil/administrative


Prosecution

Inves9ga9ng Pharmacies

•  Corresponding Responsibility – Unlawful Distribution

Title 21 USC 841 (a)(1)/846 •  Evidence exists that pharmacist/owner delivered drugs to (an)

individual (s) pursuant to (an) unlawful order(s) (prescription). A “rogue” physician is typically involved.

•  Pharmacist knew or should have known that the prescription was illegal (issued outside the course of a professional practice.)

Examples: Prescription was issued in the course of an UC operation in exchange for cash; rx has obvious inadequacies, excessive dosages or quantities, refills at an uncommonly high rate or indications of customer misuse of the drug.

•  Use of Expert Witness – Pharmacists or Doctors are usually called upon to examine prescriptions and pharmacy records to aid in determining if the pharmacist exercised corresponding responsibility.

201 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control

Legal Basis


•  Unlawful Distribution –Unlawful Distribution Title 21 USC 841 (a)(1)/846

•  Evidence exists that pharmacist delivered a drug without a lawful order (issued outside the course of a professional practice).

•  Atypical to this case is the lack of physician involvement. For example, UC operation details the pharmacist delivering drugs to CS/UC in exchange for cash, and solicits CS/UC for fraudulent rxs to cover up the diversion of drugs from the pharmacy. (See Tampa case S/S Pharmacy, Federal register notice dated 9/19/2013).

202

Legal Basis



• Health Care Fraud –

•  31 U.S.C. 3729(a)(1)(A)(B): When a person knowingly makes a false claim to receive payment from the government.

•  There must be evidence that the pharmacist filled a prescription and billed medical insurance providers knowing the prescriptions were not written for a legitimate medical purpose.

203

Legal Basis



•  Chain Pharmacies-

•  Pharmacy which has national exposure: CVS; Rite Aid; Walgreens, etc.

•  Typically targeted for civil prosecution (fines).

•  Must be coordinated with DEA HQS ODG prior field contact with US Attorney.

•  Targeted pharmacy has numerous CSA violations (21 CFR 1300 to end) which led to facilitation of drug diversion.

204

Legal Basis



• Sources of Information - Supplier/Distributor, Suspicious Order

Reports, Pharmacy Boards, Medical Examiners, Police Departments,

Tips from citizens, ARCOS, PDMP

• Spin-off cases – Medical Doctor, distributor investigations

• Informants - Included in routine narcotics debriefings. Cooperating

defendants/individuals.

• Government Agencies - Joint investigations with agencies such as FBI,

HHS, FDA, Homeland Security, Medical/Pharmacy Boards, etc.

• Drug Overdose Investigation - Check of Police Report of OD

deaths in area to compare to pharmacy prescription history.

What Triggers a Pharmacy Investigation

205 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control


• Profiles - Check ARCOS, PDMP, NADDIS, NCIC, Pharmacy Board,

ChoicePoint, CLEAR, Police Department activity reports.

• Industry reports - DEA-106s, DEA-41s, Check distributor customer

report.

• Surveillance - Observation of pharmacy activity, focus on video

recordings of suspicious individuals, vehicles (out of state plates),

parking lot hand exchanges, volume of customers in parking lot waiting to enter facility.

• Customer base – Review PMP data, identify primary source physicians and patient profiles (age, types of drugs, distance from residence, etc)

206

Conduct Background Investigation


Ringleader Robin Steinke

Pharmacist Jeff Clawson

CVS Pharmacy, Inc. Agrees to $11 Million Settlement for Violations of the Controlled Substances Act

Large National Chain Pharmacy First Ever DEA Registration Revocation

TDS Dismantles Oxycodone Trafficking Group and Arrests Pharmacist

PlaNe Valley Pharmacy in Brighton, Colorado

Sanford, FL, CVS


• Vehicle Stops - Stops of multiple customers may reveal drug prescription information, doctor information, drug type, drug quantities, patient information, develop confidential informants. Criminal checks based on vehicle registrations. Travel from afar? Follow to storage sites. Organized vehicle stops with Police.

• Undercover Operations - Undercover buys may reveal pharmacy illegal procedures, CSA violations, pharmacy/tech/owner conspiratorial members. Consensual phone calls by informant(s) to pharmacist.

• Trash searches - May produce evidence for search warrants. May also identify information regarding additional warehouses, banking information, additional addresses, discarded scripts, etc.

209

Evidence Gathering Techniques



• Video - Review any available video from inside pharmacy, consider obtaining court order to bug pharmacy.

• Financial Check - Conduct financial investigation on pharmacist to uncover unusual large cash deposits, bank accounts, associated assets.

•  Purpose of investigative methods will aid in establishing probable cause for a search warrant and identify conspirators.

210

Evidence Gathering Techniques (cont’d.)



• Criminal Actions - Determine if evidence exists to prove the following statutes:

•  21 U.S.C. 841(a)(1) – Illegal Distribution

•  21 U.S. C. 843(a)(3) – To acquire or obtain possession of a controlled substance by misrepresentation, fraud, forgery, deception or subterfuge

• Civil Actions - Determine if there is a preponderance of evidence indicating a violation of the following statutes:

•  21 U.S.C. 842(a)(1) – Dispensing outside the course of normal practice

•  21 U.S. C. 842(a)(5) – Violation of CSA, recordkeeping and reporting requirements (Title 21 CFR 1300 to end).

211

Review Case to determine applicable Administration, Civil or Criminal Actions



• Administrative - Immediate Suspension Order/Order to Show Cause- Determine if grounds exists under the following factors:

• (1) The recommendation of the appropriate State licensing board or professional disciplinary authority: license revocation/suspension; admin findings relating to drug violations, etc.

• (2) The applicant's experience in dispensing, or conducting research with respect to controlled substances: unlawful drug distribution; health care fraud conviction, etc.

• (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.

• (4) Compliance with applicable State, Federal, or local laws relating to controlled substances.

• (5) Such other conduct which may threaten the public health and safety.

• *Need one or more factor to recommend OTSC/ISO action.

212

Review Case to determine applicable Administration, Civil or Criminal Actions (cont’d.)


• Other Administrative Actions - Determine if violations of Title 21 CFR 1300 to end:

•  Memorandum of Agreement (MOA) – Specifies terms of registrant’s future compliance. Violation of terms is grounds for an OTSC.

•  Letter of Admonition (LOA) – Notifies the registrant in writing of CSA violations and requires that he/she remedies same.

•  Investigative Warning – Investigator advises registrant of CSA violations and requires that he/she remedies same. Note: Controlled Substance Act of 1970 outlines regulations for registrants regarding the proper handling of controlled substances. Violations of this act are usually remedied through civil/administrative actions


213

Review Case to determine applicable Administration, Civil or Criminal Actions (cont’d.)



• Search Warrant - Handled the same as normal search warrants but are usually executed without force.

• Administrative Inspection Warrant (AIW) - •  Issued by a Federal Magistrate.

•  Limited to records required to be kept under 21 CFR 1300 to end. Examples: Order Forms, Invoices, prescriptions, inventories, etc.

•  Has to be conducted during business hours in a professional manner.

•  Notice of Inspection (DEA Form – 82) – •  Issued by assigned Agent/Investigator/TFO (deputized)

•  Limited to required records relating to 21 CFR 1300 to end.

•  Only copies can be taken without consent.

214

Methods of obtaining pharmacy documentary evidence



• Arrests/Indictments

• Seized Assets

• Civil Fines •  Civil fines are payable to the Department of Justice and are not subject

to asset sharing

• Registration Revocation/Suspension Orders •  Issued by Office of Chief Counsel (CCD)

• Other Administrative Actions

• Sentencing •  Sentencing is enhanced if wrongful death is proven and Schedule II

narcotics are involved and quantified.

215

Investigative Outcomes


Len 1 rannazzisi

Health & Medicine

Transcript of Len 1 rannazzisi