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Law	
  Enforcement	
  Track:	
  
Rx	
  Drug	
  Inves9ga9ons	
  in	
  the	
  
21st	
  Century	
  
Presenter:	
  Joseph	
  T...
I	
  have	
  no	
  financial	
  rela.onships	
  to	
  disclose	
  	
  
and	
  
I	
  will	
  not	
  discuss	
  off-­‐label	
 ...
  Examine	
  reasons	
  for	
  the	
  increasing	
  rate	
  of	
  diversion	
  and	
  abuse	
  of	
  
prescrip.on	
  narc...
Responding to America’s
Prescription Drug Abuse Crisis
“When Two Addictions Collide”
U.S.	
  Drug	
  Enforcement	
  Admini...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
In	
  2010,	
  approximately	
  38,329	
  uninten9onal	
  drug	
  
overdose	
  deaths	
  occurred	
  in	
  the	
  United	
...
U.S. Drug Overdose Deaths
by Major Drug Type, 1999-2010
Source: CDC/NCHS, NVSS
U.S.	
  Drug	
  Enforcement	
  Administra.o...
Drug-Induced Deaths vs.
Other Injury Deaths, 1999–2009
Source: National Center for Health Statistics, Centers for Disease ...
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 Inh...
Scope and Extent of Problem:
Past Month Illicit Drug Use among Persons
Aged 12 or Older
Source: 2004, 2007, 2008, 2009, 20...
Source: 2011 National Survey on
Drug Use and Health
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
Office	
  of	
  Diversi...
SOURCE: 2012 National Survey on Drug Use and
Health (NSDUH) published September 2013 by the
Dept of HHS/ Substance Abuse a...
Emergency Room Data 2004-2010
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	...
SOURCE: 2012 National Survey on
Drug Use and Health (NSDUH)
published September 2013 by the
Dept of HHS/ Substance Abuse a...
SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published
September 03, 2013 by the Dept of HHS/ Substance Abu...
Number of Forensic Cases
2001-2011
0	
  
5,000	
  
10,000	
  
15,000	
  
20,000	
  
25,000	
  
30,000	
  
35,000	
  
40,00...
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. “Presc...
Source: Trust for America’s Health,
www.healthyamericans.org. “Prescription Drug Abuse:
Strategies to Stop the Epidemic (2...
 Most severe in Southwest and Appalachian
 In 2010, the top three states were West Virginia,
New Mexico, and Kentucky;
W...
Naloxone	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Source:	
  U.S.	
  Census	
  Bureau	
  
Statistical Perspective
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	...
Why is the problem outpacing
population growth?
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversi...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
In Florida
two
Westchase
teachers
learn a
lesson:
Say 'no' to
mints in pill
bottles
U.S.	
  Drug	
  Enforcement	
  Adminis...
Violence
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Source: DEA Drug Theft & Loss Database as of 03/18/2014
Pharmacy Armed Robberies
Rankings by State
January 1 thru December...
Pharmacy Armed Robberies
Rankings by State
January 1 thru December 31, 2012 (780)
U.S.	
  Drug	
  Enforcement	
  Administr...
Source: DEA Drug Theft & Loss Database as of 03/18/2014
Pharmacy Armed Robberies
Rankings by State
January 1 thru December...
2011	
  
Violence Related to Controlled
Substance Pharmaceuticals
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
...
 Eyewitness	
  News	
  
	
  MEDFORD	
  (WABC)	
  -­‐-­‐	
  The	
  suspect	
  in	
  the	
  Father's	
  Day	
  massacre	
  a...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
2 killed, 2 wounded in pharmacy shooting; ex-Bean Station officer to be
charged
By News Sentinel staff Knoxville News Sent...
Drug Education
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Where do kids get their
information from?
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  ...
www.JustThinkTwice.com
DEA Web-based Resources
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversio...
www.GetSmartAboutDrugs.com
DEA Web-based Resources
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Dive...
DEA Web-based Resources
www.DEA.gov
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Contro...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Community	
  Coali.ons	
  and	
  
Advocacy	
  Groups	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
...
Education
 Pharmacists	
  
	
  Drug	
  Experts	
  in	
  the	
  health	
  care	
  
	
  delivery	
  system	
  
	
  Correspo...
Scheduled	
  PDACs	
  
16-­‐Knoxville,	
  TN	
  March	
  22-­‐23,	
  2014	
  
17-­‐St.	
  Louis,	
  MO	
  April	
  5-­‐6,	...
Law Enforcement Sponsored
Training
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control...
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 Abus...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Medicine Cabinets: Easy Access
More than half of teens (56%) indicate that it’s easy to get
prescription drugs from their ...
So Many Drugs in the
Household – Why?
Unreasonable quantities being
prescribed
Insurance rules
U.S.	
  Drug	
  Enforcement...
Law Enforcement
Law	
  enforcement	
  officers,	
  ac9ng	
  to	
  enforce	
  laws	
  regarding	
  the	
  
abandonment	
  of	...
April	
  26,	
  2014	
  
National Take Back Initiative
April 26, 2014
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
 ...
On September 30, 2010, approximately 122 tons
On April 30, 2011, approximately188 tons
On October 29, 2011, approximately ...
National Take Back Day: October 26, 2013
Total Weight Collected (pounds): 647,211 (324 Tons)
8,153	
  
10,880	
  
5,527	
 ...
Prescription drug
epidemic?
How did we get to this
point?
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
The 1960s/70s/80s
Downers	
  -­‐	
  Barbiturates	
  
Uppers	
  -­‐	
  Amphetamines	
  
Meprobamate	
  
Hydromorphone	
  
“...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
The
1990s
Hydrocodone
AlprazolamOxycodone 30 mg
Carisoprodol	
  
OxyCon.n	
  80mg	
  
Commonly Abused Controlled Pharmaceuticals
Oxy...
The Trinity
C-­‐IV	
  as	
  of	
  1/11/2012	
  
Hydrocodone	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Most commonly prescribed prescription
medicine?
Hydrocodone/acetaminophen
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  ...
Top Five Prescription Drugs Sold in the U.S.
(2008-2011)
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
...
State Ranking* - Hydrocodone
January – September 2013
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  D...
Approval of Single Entity
Extended Release Hydrocodone
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  ...
Source: Drug Enforcement Administration, Office of Diversion Control,
Pharmaceutical Investigations Section, Targeting and...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
OxyContin Change
New OxyContin® OP
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Oxycodone 15mg/30mg
Immediate Release
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Cont...
Opana ER (Schedule II)
 Opana	
  ER	
  -­‐	
  (Schedule	
  II)	
  
– Treats	
  constant,	
  around	
  the	
  clock,	
  mo...
Source: Drug Enforcement Administration, Office of Diversion Control,
Pharmaceutical Investigations Section, Targeting and...
Hydromorphone
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Source: Drug Enforcement Administration, Office of Diversion Control,
Pharmaceutical Investigations Section, Targeting and...
Opiates v. Heroin
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Circle of Addiction & the Next Generation
Hydrocodone	
  
Lorcet®	
  
$5-­‐$7/tab	
  
Oxycodone	
  
Combina.ons	
  
Percoc...
HEROIN CASES and EXHIBITS
National Forensic Laboratory Information System
Year	
   #	
  Exhibits	
   #	
  Cases	
  
2004	
...
Heroin	
  trafficking	
  organiza.ons	
  reloca.ng	
  to	
  areas	
  where	
  
prescrip.on	
  drug	
  abuse	
  is	
  on	
  t...
Where are the
Pharmaceuticals Coming
From?
 Friends	
  and	
  Family	
  for	
  Free	
  
 Medicine	
  Cabinet	
  
 Docto...
Methods of Diversion
 Practitioners / Pharmacists
–  Illegal distribution
–  Self abuse
–  Trading drugs for sex
 Employ...
Prescription Fraud
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Questions to Discuss
 	
  What	
  combina.on	
  of	
  drugs	
  is	
  referred	
  to	
  as	
  the	
  “trinity”?	
  
	
  	
...
Doctor Shopping
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Prescription Drug Monitoring
Programs
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Cont...
Mandatory PDMP review before
prescribing CS?
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	...
Standard of Care
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
National Association of
Boards of Pharmacy
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
 ...
Diversion via the
Internet
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  ...
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
V
T N
H
CT
DE
WV
...
New Felony Offense Internet
Trafficking - 10/15/2008	
  
  21 USC 841(h)(1): It shall be unlawful for any
person to knowi...
Per Se Violations
 No in-person medical evaluation by
prescribing practitioner
 Online pharmacy not properly registered
...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Pain Clinics
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Explosion of South Florida
Pain Clinics
As	
  of	
  June	
  4,	
  2010,	
  Florida	
  has	
  received	
  1,118	
  applica....
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,...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Medical Care ?
 Many	
  of	
  these	
  clinics	
  are	
  prescrip.on/
dispensing	
  mills	
  
 Minimal	
  prac..oner/pa....
Increased Law Enforcement
Pressure
 Clinics	
  migra.ng	
  north	
  and	
  west	
  
 Funded	
  by	
  owners	
  in	
  Flo...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
WASHINGTON
OREGON
CALIFORNIA
NEVADA
IDAHO
MONTANA
WYOMING
UTAH
ARIZONA NEW MEXICO
COLORADO
TEXAS
OKLAHOMA
KANSAS
NEBRASKA
...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Drugs Prescribed
 A	
  ‘cocktail’	
  of	
  oxycodone	
  and	
  alprazolam	
  (Xanax)	
  
 An	
  average	
  ‘pa.ent’	
  r...
Average Charges for a Clinic Visit
 Price varies if medication is dispensed or if customers
receive prescriptions
 Some ...
Cost of Drugs
 According	
  to	
  medical	
  experts,	
  most	
  clinics	
  do	
  not	
  
require	
  sufficient	
  medical	...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
What’s the Profit?
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
What’s the Profit?
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
What’s the Profit?
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Florida
Pain
Clinic Raid
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
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  Control	
  	
  	
  	
  
U.S.	
  Drug	
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  Administra.on	
  
	
  Office	
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U.S.	
  Drug	
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  Administra.on	
  
	
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U.S.	
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U.S.	
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U.S.	
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U.S.	
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U.S.	
  Drug	
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U.S.	
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  Office	
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U.S.	
  Drug	
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  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
The	
  Controlled	
  Substances	
  Act	
  	
  
Foreign Mfr
Importer Manufacturer
Distri-
butor
Practitioner
Pharmacy
Hospital
Clinic
Patient
?
Law:	
  21	
  USC	
  822	
...
Closed System
of Distribution
Cyclic
Investigations
Security
Requirements
Recordkeeping
Requirements
ARCOS
Established
Quo...
150	
   U.S.	
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  Administra.on	
  
	
  Office	
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  Control	
  	
  	
  	
  
The Flow of Pharmaceuticals
PATIENTS
Hospitals NTPs
21 CFR 1306.04
Physicians
(Rx and drugs)
Pharmacies
QUOTASRaw Material...
Diversion via the
Internet
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  ...
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
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CT
DE
WV
...
Purchases of hydrocodone by Known and Suspected
Rogue Internet Pharmacies
January 1, 2006 – December 31, 2006
Date	
  Prep...
Checks and Balances of the CSA
and the Regulatory Scheme
  Distributors of controlled substances
“The registrant shall de...
DEA	
  Distributor	
  Ini9a9ve	
  
  Purpose and format:
  Educate and inform distributors/manufacturers of their due di...
Source:	
  www.kuow.org	
  ,	
  
01/30/2014	
  
John Gray, president and CEO of
Healthcare Distribution
Management Associa...
“At	
  the	
  .me	
  we	
  filled	
  these	
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  state	
  	
  
board	
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 ...
Misleading	
  Title?	
  
Sponsored	
  by	
  
Reps	
  from	
  TN,	
  
PA,	
  CO,	
  	
  and	
  GA	
  
This	
  bill	
  effec....
DEA Imposed Quotas on Wholesalers/
Distributors of Controlled Substances to
downstream customers?
NO!
U.S.	
  Drug	
  Enfo...
Checks and Balances
Under the CSA
•  Practitioners
“A prescription for a controlled substance to be
effective must be issu...
The Controlled Substances Act
Illegal Distribution
21 U.S.C. § 841 (a) Unlawful acts:
Except as authorized by this subchap...
The Last Line of Defense
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
...
Checks and Balances
Under the CSA
Pharmacists – The Last Line of Defense
“The responsibility for the proper prescribing an...
Checks and Balances Under the CSA
Pharmacists – The Last Line of Defense
“An order purporting to be a prescription issued ...
 When	
  prescrip.ons	
  are	
  clearly	
  not	
  
issued	
  for	
  legi.mate	
  medical	
  purposes,	
  a	
  
pharmacist	...
Corresponding Responsibility Cases
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control...
What	
  happens	
  next?	
  
You	
  aGempt	
  to	
  resolve…	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office...
Resolution is comprised of many
factors
Verifica.on	
  of	
  a	
  valid	
  prac..oner	
  DEA	
  number	
  	
  is	
  require...
Many	
  customers	
  receiving	
  the	
  same	
  combina.on	
  of	
  prescrip.ons;	
  cocktail	
  
Many	
  customers	
  re...
Customers	
  coming	
  into	
  the	
  pharmacy	
  in	
  groups,	
  each	
  with	
  the	
  same	
  
prescrip.ons	
  issued	...
AMA View on Corresponding
Responsibility
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  C...
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
Purchases of Oxycodone 30mg
 In	
  2009,	
  	
  44%	
  of	
  all	
  oxycodone	
  30mg	
  products	
  
were	
  distributed...
Remaining	
  States	
  
593,625,290	
  dosage	
  units	
   Florida	
  
94,923,484	
  dosage	
  units	
  
Source:	
  	
  AR...
Florida	
  
94,923,484	
  dosage	
  units	
  
New	
  York	
  
50,658,100	
  dosage	
  
units	
  
Remaining	
  States	
  
4...
Viola.ons?	
  
What	
  happens	
  next…..	
  
DEA Legal Recourse
 Administra.ve	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  Immediate	
  Suspension	
  Order	
  (IS...
How Do You Lose Your
Registration?
The	
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a)  Gr...
* FY2014 as of February 27, 2014
AdministrativeActions Initiated by DEA
FY2007thru2014*
U.S.	
  Drug	
  Enforcement	
  Adm...
Initiation of Investigation
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
 ...
ARCOS
PDMP	
  	
  
U.S.	
  Drug	
  Enforcement	
  Administra.on	
  
	
  Office	
  of	
  Diversion	
  Control	
  	
  	
  	
  
 Inves9ga9ng	
  Physicians	
  
• “Outside the Scope”
–  CFR and Case Law: “A prescription for a controlled
substance to be...
Standards	
  of	
  Care-­‐State	
  Boards	
  
U.S. Drug Enforcement Administration / Operations Division / Office of Diver...
Inves9ga9ng	
  Physicians	
  
Targeting sources:
–  Referrals from medical/pharmacy boards
–  Law enforcement agency partn...
Interviews of sources (patients, former employees)
–  Look for Patterns and RED FLAGS:
•  Relatively large quantities of c...
Dr.	
  	
  Bamdad,	
  Los	
  
Angeles	
  	
  
Fugitive Pill Mill Doctor (Dr. Robert Ignasiak) Who Faked Suicide Found
and ...
189	
  
Perfunctory	
  ini.al	
  physical	
  exam…return	
  visits	
  no	
  exam	
  
Physical	
  exam	
  included	
  needle	
  mar...
Rosen	
  was	
  a	
  68	
  yo	
  physician	
  who	
  had	
  a	
  prac.ce	
  that	
  was	
  focused	
  on	
  obesity.	
  He...
Customers	
  coming	
  into	
  the	
  pharmacy	
  in	
  groups,	
  each	
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  the	
  same	
  
prescrip.ons	
  issued	...
The	
  physician	
  issued	
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  to	
  a	
  pa.ent	
  known	
  to	
  be	
  delivering	
  the	
  drugs	
  to	
...
Pa.ents	
  receiving	
  the	
  same	
  combina.on	
  of	
  prescrip.ons;	
  cocktail	
  
Pa.ents	
  receiving	
  the	
  sa...
Initial verification/corroboration
–  Prescription Monitoring Programs-30 day look
–  Look for legitimate explanations of ...
Inves9ga9ng	
  Physicians	
  	
  
Considerations
–  DON’T TRICK THE DOCTOR
–  Intent: evidence of “outside the scope”
–  V...
Inves9ga9ng	
  Physicians	
  
Grand Jury Subpoenas
–  Banks- Laundering and asset identification
Expert Review
–  Establis...
Inves9ga9ng	
  Physicians	
  
Timing of search and arrests-considerations
–  Public safety
–  Rush to Indictment following...
Inves9ga9ng	
  Physicians	
  
Search warrants/affidavits
–  Get a go-by
–  Include: type of drugs, case law/statute of leg...
Inves9ga9ng	
  Physicians
Appropriate Jurisdiction:	
  Federal/State (Attorney General)/District Attorney’s
Office
–  Offe...
Inves9ga9ng	
  Pharmacies	
  
•  Corresponding Responsibility – Unlawful Distribution
Title 21 USC 841 (a)(1)/846
•  Evide...
Inves9ga9ng	
  Pharmacies	
  
•  Unlawful Distribution –Unlawful Distribution
Title 21 USC 841 (a)(1)/846
•  Evidence exis...
Inves9ga9ng	
  Pharmacies	
  
• Health Care Fraud –
•  31 U.S.C. 3729(a)(1)(A)(B): When a person knowingly makes a
false c...
Inves9ga9ng	
  Pharmacies	
  
•  Chain Pharmacies-
•  Pharmacy which has national exposure: CVS; Rite Aid;
Walgreens, etc....
Inves9ga9ng	
  Pharmacies	
  
• Sources of Information - Supplier/Distributor, Suspicious Order
Reports, Pharmacy Boards, ...
Inves9ga9ng	
  Pharmacies	
  
• Profiles - Check ARCOS, PDMP, NADDIS, NCIC, Pharmacy Board,
ChoicePoint, CLEAR, Police Dep...
Ringleader Robin
Steinke	
  
Pharmacist Jeff
Clawson	
  
CVS Pharmacy, Inc. Agrees to $11 Million Settlement
for Violation...
Inves9ga9ng	
  Pharmacies	
  
• Vehicle Stops - Stops of multiple customers may reveal drug prescription
information, doct...
Inves9ga9ng	
  Pharmacies	
  
• Video - Review any available video from inside pharmacy, consider
obtaining court order to...
Inves9ga9ng	
  Pharmacies	
  
• Criminal Actions - Determine if evidence exists to prove the following
statutes:
•  21 U.S...
Inves9ga9ng	
  Pharmacies	
  
• Administrative - Immediate Suspension Order/Order to Show
Cause- Determine if grounds exis...
• Other Administrative Actions - Determine if violations of Title 21 CFR
1300 to end:
•  Memorandum of Agreement (MOA) – S...
Inves9ga9ng	
  Pharmacies	
  
• Search Warrant - Handled the same as normal search warrants but are
usually executed witho...
Inves9ga9ng	
  Pharmacies	
  
• Arrests/Indictments
• Seized Assets
• Civil Fines
•  Civil fines are payable to the Depart...
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Len 1 rannazzisi

  1. 1. 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  
  2. 2. 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        
  3. 3.   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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  4. 4. Responding to America’s Prescription Drug Abuse Crisis “When Two Addictions Collide” U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  5. 5. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  6. 6. 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) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Consequences
  7. 7. 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        
  8. 8. 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.   U.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control        
  9. 9. 2011 Current Users (Past Month) 2012    Source:  2011  &  2012  NSDUH  
  10. 10. Prescription Drug Abuse More Americans abuse prescription drugs than the number of: Cocaine, Hallucinogen, Heroin, and Inhalant abusers U.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control        
  11. 11. 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 HealthU.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control        
  12. 12. Source: 2011 National Survey on Drug Use and Health U.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control         Percentage of Past Month Nonmedical Use of Psychotherapeutics by Age, 2003-2011
  13. 13. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  14. 14. Emergency Room Data 2004-2010 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         SOURCE: The DAWN Report, Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, December 28, 2010
  15. 15. 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
  16. 16. 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
  17. 17. 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%     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         322%    
  18. 18. Poisoning Deaths: Opioid Analgesics *2009  data  approximated   *  
  19. 19. 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    Office  of  Diversion  Control        
  20. 20. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  21. 21.  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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  22. 22. Naloxone     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  23. 23. Source:  U.S.  Census  Bureau   Statistical Perspective U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  24. 24. Why is the problem outpacing population growth? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  25. 25. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  26. 26. In Florida two Westchase teachers learn a lesson: Say 'no' to mints in pill bottles U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         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.”  
  27. 27. Violence U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  28. 28. Source: DEA Drug Theft & Loss Database as of 03/18/2014 Pharmacy Armed Robberies Rankings by State January 1 thru December 31, 2011 (691) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  29. 29. Pharmacy Armed Robberies Rankings by State January 1 thru December 31, 2012 (780) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Source: DEA Drug Theft & Loss Database as of 03/18/2014
  30. 30. Source: DEA Drug Theft & Loss Database as of 03/18/2014 Pharmacy Armed Robberies Rankings by State January 1 thru December 31, 2013 (692) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  31. 31. 2011  
  32. 32. Violence Related to Controlled Substance Pharmaceuticals U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  33. 33.  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.   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Couple pleads guilty in pharmacy murders
  34. 34. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  35. 35. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  36. 36. Drug Education U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  37. 37. Where do kids get their information from? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  38. 38. www.JustThinkTwice.com DEA Web-based Resources U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  39. 39. www.GetSmartAboutDrugs.com DEA Web-based Resources U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  40. 40. DEA Web-based Resources www.DEA.gov U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  41. 41. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  42. 42. Community  Coali.ons  and   Advocacy  Groups   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  43. 43. Education  Pharmacists    Drug  Experts  in  the  health  care    delivery  system    Corresponding  responsibility   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  44. 44. 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   12 B 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  
  45. 45. Law Enforcement Sponsored Training U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Health care professionals Community associations
  46. 46. Most Frequent Method of Obtaining a Pharmaceutical Controlled Substance for Non- Medical Use Friends and Family…For Free!! U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  47. 47. 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
  48. 48. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  49. 49. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  50. 50. So Many Drugs in the Household – Why? Unreasonable quantities being prescribed Insurance rules U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  51. 51. 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.       U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  52. 52. April  26,  2014   National Take Back Initiative April 26, 2014 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         10:00  AM  –  2:00  PM  
  53. 53. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  54. 54. 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   4,603 CT   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     14,841 NJ   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   9,425 MD   974   DC   5,258   DE   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  55. 55. Prescription drug epidemic? How did we get to this point? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  56. 56. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  57. 57. The 1960s/70s/80s Downers  -­‐  Barbiturates   Uppers  -­‐  Amphetamines   Meprobamate   Hydromorphone   “Ts  and  Blues”   “Fours  and  Doors”   Oxycodone/APAP   methaqualone  
  58. 58. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         The 1990s
  59. 59. Hydrocodone AlprazolamOxycodone 30 mg Carisoprodol   OxyCon.n  80mg   Commonly Abused Controlled Pharmaceuticals Oxymorphone   C-­‐IV  as  of  1/11/2012  
  60. 60. The Trinity C-­‐IV  as  of  1/11/2012   Hydrocodone   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  61. 61. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  62. 62. Most commonly prescribed prescription medicine? Hydrocodone/acetaminophen U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  63. 63. Top Five Prescription Drugs Sold in the U.S. (2008-2011) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Source:  IMS    Health,  Na.onal  Prescrip.on  Audit,  Updated  02/24/14      Millions  of   Prescrip.ons  
  64. 64. State Ranking* - Hydrocodone January – September 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014
  65. 65. Approval of Single Entity Extended Release Hydrocodone U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  66. 66. Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014 State Ranking* - Oxycodone January – December 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  67. 67. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         OxyContin Change
  68. 68. New OxyContin® OP U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  69. 69. Oxycodone 15mg/30mg Immediate Release U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  70. 70. 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     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  71. 71. Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014 State Ranking* - Oxymorphone January – December 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  72. 72. Hydromorphone U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  73. 73. Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014 State Ranking* - Hydromorphone January – December 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  74. 74. Opiates v. Heroin U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  75. 75. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  76. 76. 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    Office  of  Diversion  Control        
  77. 77. 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? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  78. 78. Where are the Pharmaceuticals Coming From?  Friends  and  Family  for  Free    Medicine  Cabinet    Doctor  Shopping    Internet    Pain  Clinics   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  79. 79. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  80. 80. Prescription Fraud U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  81. 81. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  82. 82. Doctor Shopping U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  83. 83. Prescription Drug Monitoring Programs U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  84. 84. Mandatory PDMP review before prescribing CS? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  85. 85. Standard of Care U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  86. 86. National Association of Boards of Pharmacy U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  87. 87. Diversion via the Internet U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  88. 88. 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 V T N H CT DE WV RI MD MA Domestic ‘Rx’ Flow MTMT FL TX TX 2. Request goes through Website Server in San Antonio, TX WS FL IAIA 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
  89. 89. 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) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  90. 90. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  91. 91. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  92. 92. Pain Clinics U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  93. 93. 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    Office  of  Diversion  Control        
  94. 94. 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  
  95. 95. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  96. 96. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  97. 97. Medical Care ?  Many  of  these  clinics  are  prescrip.on/ dispensing  mills    Minimal  prac..oner/pa.ent  interac.on   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  98. 98. Increased Law Enforcement Pressure  Clinics  migra.ng  north  and  west    Funded  by  owners  in  Florida   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  99. 99. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  100. 100. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  101. 101. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  102. 102. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  103. 103. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  104. 104. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  105. 105. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  106. 106. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  107. 107. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  108. 108. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  109. 109. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  110. 110. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  111. 111. 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)   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  112. 112. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  113. 113. What’s the Profit? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  114. 114. What’s the Profit? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  115. 115. What’s the Profit? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  116. 116. Florida Pain Clinic Raid U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  117. 117. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  118. 118. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  119. 119. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  120. 120. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  121. 121. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  122. 122. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  123. 123. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  124. 124. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  125. 125. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  126. 126. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  127. 127. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  128. 128. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  129. 129. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  130. 130. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  131. 131. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  132. 132. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  133. 133. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  134. 134. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  135. 135. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  136. 136. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  137. 137. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  138. 138. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  139. 139. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  140. 140. The  Controlled  Substances  Act    
  141. 141. 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  ...”  
  142. 142. Closed System of Distribution Cyclic Investigations Security Requirements Recordkeeping Requirements ARCOS Established Quotas Registration Established Schedules U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  143. 143. 150   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  144. 144. The Flow of Pharmaceuticals PATIENTS Hospitals NTPs 21 CFR 1306.04 Physicians (Rx and drugs) Pharmacies QUOTASRaw 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 - DistributorsSmaller Distributors U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  145. 145. Diversion via the Internet U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  146. 146. 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 V T N H CT DE WV RI MD MA Domestic ‘Rx’ Flow MTMT FL TX TX 2. Request goes through Website Server in San Antonio, TX WS FL IAIA 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  147. 147. 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
  148. 148. 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) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  149. 149. 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    Office  of  Diversion  Control        
  150. 150. 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. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  151. 151. “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.  
  152. 152. 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.  
  153. 153. DEA Imposed Quotas on Wholesalers/ Distributors of Controlled Substances to downstream customers? NO! U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  154. 154. 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) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  155. 155. 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 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  156. 156. The Last Line of Defense U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  157. 157. Checks and Balances Under the CSA 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) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  158. 158. Checks and Balances Under the CSA 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) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  159. 159.  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)),    
  160. 160. Corresponding Responsibility Cases U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  161. 161. What  happens  next?   You  aGempt  to  resolve…   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  162. 162. 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…   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  163. 163. 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;     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  164. 164. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  165. 165. AMA View on Corresponding Responsibility U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         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”.  
  166. 166. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  167. 167. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  168. 168. 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    Office  of  Diversion  Control        
  169. 169. 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    Office  of  Diversion  Control        
  170. 170. Viola.ons?   What  happens  next…..  
  171. 171. 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    Office  of  Diversion  Control        
  172. 172. 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    
  173. 173. * FY2014 as of February 27, 2014 AdministrativeActions Initiated by DEA FY2007thru2014* U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  174. 174. Initiation of Investigation U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  175. 175. ARCOS PDMP     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  176. 176.  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
  177. 177. Standards  of  Care-­‐State  Boards   U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  178. 178. Inves9ga9ng  Physicians   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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Targeting/Evaluation
  179. 179. 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Evaluation/Red Flags Inves9ga9ng  Physicians  
  180. 180. Dr.    Bamdad,  Los   Angeles     Fugitive Pill Mill Doctor (Dr. Robert Ignasiak) Who Faked Suicide Found and Arrested in South Florida
  181. 181. 189  
  182. 182. 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    Office  of  Diversion  Control        
  183. 183. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  184. 184. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  185. 185. 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   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  186. 186. 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    Office  of  Diversion  Control        
  187. 187. 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Initial Evaluation Inves9ga9ng  Physicians  
  188. 188. 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Undercover Process
  189. 189. Inves9ga9ng  Physicians   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. U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Investigative Process
  190. 190. Inves9ga9ng  Physicians   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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Search Warrants
  191. 191. Inves9ga9ng  Physicians   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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Search Warrant Mechanics
  192. 192. Inves9ga9ng  Physicians 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control Prosecution  
  193. 193. 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  
  194. 194. Inves9ga9ng  Pharmacies   •  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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  195. 195. Inves9ga9ng  Pharmacies   • 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  196. 196. Inves9ga9ng  Pharmacies   •  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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  197. 197. Inves9ga9ng  Pharmacies   • 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
  198. 198. Inves9ga9ng  Pharmacies   • 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  199. 199. 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    
  200. 200. Inves9ga9ng  Pharmacies   • 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  201. 201. Inves9ga9ng  Pharmacies   • 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.) U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  202. 202. Inves9ga9ng  Pharmacies   • 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  203. 203. Inves9ga9ng  Pharmacies   • 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.) U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  204. 204. • 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 Inves9ga9ng  Pharmacies   213   Review Case to determine applicable Administration, Civil or Criminal Actions (cont’d.) U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  205. 205. Inves9ga9ng  Pharmacies   • 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control
  206. 206. Inves9ga9ng  Pharmacies   • 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 U.S. Drug Enforcement Administration / Operations Division / Office of Diversion Control

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