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Pharmacy: The DEA Regulations Update - Joe Rannazzisi
Citation preview
Joseph Rannazzisi Deputy Assistant Administrator Office of Diversion Control
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
1. Iden.fy the legal standard for dispensing medica.ons pursuant to a valid prescrip.on.
2. Iden.fy the basis and effects of the proposed DEA regula.ons.
3. List the factors the pharmacist should consider in determining whether to dispense medica.on.
Learning Objectives
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Drug Enforcement Administra.on Office of Diversion Control
Iden.fy the legal standard for dispensing medica.ons pursuant to a valid prescrip.on
Iden.fy regula.ons that establish prac..oners legal requirements under 21 USC
List the factors the pharmacist should consider prior to dispensing
Review status of drug disposal legisla.on and regula.ons
Goals and Objectives
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Drug Enforcement Administra.on Office of Diversion Control
In 2010, approximately 38,329 uninten7onal drug overdose deaths occurred in the United States, one death every 14 minutes.
Of this number, 22,134 of these deaths were aFributed to Prescrip7on Drugs (16,651 aFributed to opioid overdoses/ 75.2 %).
Prescrip7on 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
Although more men die from drug overdoses than woman, the percentage increase in deaths since 1999 is greater among woman. More woman have died each year
from drug overdoses than from motor vehicle–related injuries since 2007. Deaths and ED visits related to OPR
con.nue to increase among woman.
U.S. Drug Overdose Deaths by Major Drug Type, 1999-2010
U.S. Drug Enforcement Administra.on Office of Diversion Control
Source: CDC/NCHS, NVSS
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 aTributable 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
2011 Current Users (Past Month) 2012
Source: 2011 & 2012 NSDUH
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
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
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
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
Questions to Discuss According to the Na.onal Survey on Drug Use and
Health (NSDUH), in 2012 there were 6.8 million persons aged 12 and older who used prescrip.on-‐ type
psychotherapeu.c drugs non-‐medically in the last month. Which class of pharmaceu.cal had the highest level of non-‐medical use?
A) S.mulants B) Seda.ves C) Pain relievers D) Tranquilizers
U.S. Drug Enforcement Administra.on Office of Diversion Control
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%
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
Office of Diversion Control
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
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
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 of Diversion Control
Why is the problem outpacing population growth?
U.S. Drug Enforcement Administra.on Office of Diversion Control
Violence
U.S. Drug Enforcement Administra.on Office of Diversion Control
Prescription drug epidemic?
How did we get to this point?
U.S. Drug Enforcement Administra.on Office of Diversion Control
70s Public Service Announcement – The Magician
U.S. Drug Enforcement Administra.on Office of Diversion Control
The 1960s/70s/80s
Downers -‐ Barbiturates
Uppers -‐ Amphetamines
Meprobamate
Hydromorphone
“Ts and Blues”
“Fours and Doors”
Oxycodone/APAP
Methaqualone
U.S. Drug Enforcement Administra.on Office of Diversion Control
The 1990s
Hydrocodone
Alprazolam Oxycodone 30 mg
Carisoprodol
OxyCon.n® 80mg (Oxycodone controlled-‐release)
Commonly Abused Controlled Pharmaceuticals
Oxymorphone
C-‐IV as of 1/11/2012
The Trinity
C-‐IV as of 1/11/2012
Hydrocodone
U.S. Drug Enforcement Administra.on Office of Diversion Control
The HolyTrinity
Inadequate Pain Control
U.S. Drug Enforcement Administra.on Office of Diversion Control
We conclude that despite widespread use of narco.c drugs in hospitals, the development of addic.on is rare in medical pa.ents with no
history of addic.on.
U.S. Drug Enforcement Administra.on Office of Diversion Control
1.Temperature 2.Heart Rate 3.Blood Pressure 4.Respira.on
U.S. Drug Enforcement Administra.on Office of Diversion Control
The Fifth Vital Sign?
5.Pain?
U.S. Drug Enforcement Administra.on Office of Diversion Control
Now, Dr. Portenoy and other pain doctors who promoted the drugs say they erred by oversta.ng the drugs’
benefits and glossing over risks. “Did I teach about pain management, specifically about opioid therapy, in a way that reflects misinforma.on? We, against the standards of 2012, I guess I did,” Dr. Portenoy said in an interview with The Wall Street Journal. “We didn’t know then
what we know now.”
Source: The Wall Street Journal, December 15-‐16, 2012
Direct to Consumer Advertising
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Drug Enforcement Administra.on Office of Diversion Control
We will not arrest our way out of this problem!!!!!
Enforcement is just as important as….
Preven.on/Educa.on
Treatment
U.S. Drug Enforcement Administra.on Office of Diversion Control
Drug Education
U.S. Drug Enforcement Administra.on Office of Diversion Control
Education
Children/Teens Informa.on from the Internet or their peers
Following parents
U.S. Drug Enforcement Administra.on Office of Diversion Control
Parents & Their Attitudes Parents are not discussing the risks of abusing prescription drugs
Source: 2011 Partnership Attitude Tracking Study U.S. Drug Enforcement Administra.on
Office of Diversion Control
Source of Concerns 1 in 5 parents (20 percent) report that they have given their teen a prescription drug that was not prescribed to them.
17 percent of parents do not throw away expired medications.
14 percent of parents say they themselves have misused or abused prescription drugs within the past year.
49 percent of parents say anyone can access their medicine cabinet.
SOURCE: 2012 Partnership Attitude Tracking Study Report; Partnership for a Drug-Free America and MetLife Foundation, published April 23, 2013.
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 Control
www.EROWID.org
www.EROWID.org
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
Community Coali.ons and Advocacy Groups
U.S. Drug Enforcement Administra.on Office of Diversion Control
Education
Physicians/Den.sts/Prac..oners
Prescribing habits
Mandatory opiate prescribing con.nuing educa.on?
U.S. Drug Enforcement Administra.on Office of Diversion Control
Education
Pharmacists
Drug Experts in the health care delivery system
Corresponding responsibility
U.S. Drug Enforcement Administra.on Office of Diversion Control
Scheduled PDACs 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
April 8, 2014
Completed PDACs ATendance 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-‐CharloTe, NC 2/8-‐9/14 513 16-‐Knoxville,TN 3/22-‐23/14 246 17-‐St. Louis, MO 4/5-‐6/14 224 Total ATendance 6,584
The Controlled Substances Act
U.S. Drug Enforcement Administra.on Office of Diversion Control
CSA Registrant Population
March 20, 2014
Provisional registra7ons in effect at the 7me CSA was passed (rela7ve to the Harrison Narco7cs Act of 1914)
U.S. Drug Enforcement Administra.on Office of Diversion Control
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 ...”
Cyclic Investigations
Security Requirements
Recordkeeping Requirements
ARCOS Reporting
Established Quotas
Registration
Established Schedules
U.S. Drug Enforcement Administra.on Office of Diversion Control
Closed System of Distribution
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Drug Enforcement Administra.on Office of Diversion Control
The Controlled Substances Act
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
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
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)
U.S. Drug Enforcement Administra.on Office of Diversion Control
DEA Distributor Ini7a7ve 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
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
“At the .me we filled these orders, the pharmacies held valid state board of pharmacy and DEA licenses,” BarreT 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 BarreT
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.
H.R. 4069: Ensuring Pa.ent Access and Effec.ve Drug Enforcement Act of 2013
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.
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
U.S. Drug Enforcement Administra.on Office of Diversion Control
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 maTer
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
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
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 wriTen 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
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
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 asking for drugs in street slang
Pa.ent directed prescribing
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
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
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
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
The Last Line of Defense
U.S. Drug Enforcement Administra.on Office of Diversion Control
Pharmacists
The $80 million settlement is the largest fine related to DEA’s strategy of cracking down on rampant prescription drug abuse by targeting large corporations
Walgreen “negligently allowed” prescription painkillers to be diverted for illegal black market sales
The license of a Florida facility used by Walgreen to distributed controlled substances was revoked for two years
U.S. Drug Enforcement Administra.on Office of Diversion Control
The $80 million settlement is the
largest fine paid by a pharmacy chain as related to DEA’s
strategy of cracking down on rampant prescription drug
abuse 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,
according to a new resolu.on by the American Medical Associa.on.
The AMA adopted the resolu.on at its 2013 annual mee.ng, calling such inquiries “an interference with the prac.ce of medicine and
unwarranted”.
Red Flag?
What happens next?
You aTempt to resolve…
U.S. Drug Enforcement Administra.on Office of Diversion Control
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 wriTen 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
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 wriTen 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 doctor’s 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
U.S. Drug Enforcement Administra.on Office of Diversion Control
Large-Scale Diversion
In 2009, the average purchase for all oxycodone products for all pharmacies in US – 63,294 d.u.
In 2010, the average was – 69,449 d.u.
In 2009, the average purchase for all oxycodone products for the top 100 pharmacies in Florida – 1,226,460 d.u.
In 2010, the average was – 1,261,908 d.u.
U.S. Drug Enforcement Administra.on Office of Diversion Control Source: DEA Automated Reports and Consolidated Orders System (ARCOS)
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 Source: DEA Automated Reports and Consolidated Orders System (ARCOS)
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
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
Paul Volkman, Chicago Doctor, Gets 4 Life Terms In Drug Overdose Case
ANDREW WELSH-‐HUGGINS 02/14/12 06:45 PM ET Associated Press COLUMBUS, Ohio — A Chicago doctor who prosecutors say dispensed more of the powerful painkiller oxycodone from 2003 to 2005 than any other physician in the country was sentenced Tuesday to four life terms in the overdose deaths of four pa.ents. Dr. Paul Volkman made weekly trips from Chicago to three loca.ons in Portsmouth in southern Ohio and one in Chillicothe in central Ohio before federal inves.gators shut down the opera.ons in 2006, prosecutors said. He was sentenced in federal court in Cincinna.. "This criminal conduct had devasta.ng consequences to the community Volkman was supposed to serve," Assistant U.S. ATorneys Adam Wright and Tim Oakley said in a court filing ahead of Tuesday's hearing. "Volkman's ac.ons created and prolonged debilita.ng addic.ons; distributed countless drugs to be sold on the street; and took the lives of numerous individuals who died just days azer visi.ng him," they said. The 64-‐year-‐old Volkman fired his aTorneys earlier this month and said he acted at all .mes as a doctor, not a drug dealer. "The typical drug dealer does not care how much drugs a client buys, how ozen he buys, or what he does with his drugs," Volkman said in a 28-‐page handwriTen court filing Monday, maintaining that he did all those things and more for his pa.ents.
U.S. Drug Enforcement Administra.on Office of Diversion Control
Violations?
What happens next…..
U.S. Drug Enforcement Administra.on Office of Diversion Control
The DEA Inspection
Investigators will identify themselves and produce their official credentials
Investigators will produce, either a
– Notice of Inspection – Administrative Inspection Warrant – Search Warrant
U.S. Drug Enforcement Administra.on Office of Diversion Control
Notice of Inspection
You may refuse the Notice of Inspection and require an Administrative Inspection Warrant or Search Warrant:
Explain the NOI and provide a copy Explain the purpose of the visit Request to inspect the registered location and the controlled substance records Receipt provided for records obtained Conducted between normal business hours
U.S. Drug Enforcement Administra.on Office of Diversion Control
Administrative Inspection Warrant
Reviewed by an Assistant United States Attorney Executed by a United States Magistrate Judge Served with a copy of the AIW Controlled substances records obtained and a receipt provided Conducted between normal business hours
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
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 April 10, 2014
Administrative Actions Initiated by DEA FY2007 thru 2014*
U.S. Drug Enforcement Administra.on Office of Diversion Control
Questions to Discuss
True or False…
For a controlled substance prescrip.on to be effec.ve, it must be, “issued for a legi.mate medical purpose by an individual prac..oner ac.ng in the usual course of professional prac.ce.”
A) True B) False
U.S. Drug Enforcement Administra.on Office of Diversion Control
Questions to Discuss
The ATorney General can immediately suspend a DEA registra.on based on the determina.on that the con.nued registra.on poses an imminent danger to public health or safety;
A) True B) False
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!!
U.S. Drug Enforcement Administra.on Office of Diversion Control
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)
First Specific Drug Associated with Initiation of Illicit Drug Use Among Past Year Illicit
Drug Initiates Aged 12 or Older: 2012
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
Questions to Discuss
According to the Na.onal Survey on Drug Use and Health (NSDUH), in 2012, par.cipants iden.fied the most frequent method of obtaining a prescrip.on-‐type psychotherapeu.c drug that they most recently non-‐medically used as:
A) Internet B) From a friend or rela.ve for free C) Purchased from a friend or rela.ve D) Purchased from stranger/drug dealer
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Drug Enforcement Administra.on Office of Diversion Control
The Problem – Easy Access
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 prescrip.on 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 prescrip.on drug obtained it from their parent’s medicine cabinet
Almost half (49%) of teens who misuse or abuse prescrip.on 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
So Many Drugs in the Household – Why?
Unreasonable quan..es being prescribed
Insurance rules
U.S. Drug Enforcement Administra.on Office of Diversion Control
So Why is this important to me (Pharmacist, Physician, Dentist, Nurse etc.)
Under the current law, receiving a controlled substance from a ul.mate user is a viola.on of the CSA
U.S. Drug Enforcement Administra.on Office of Diversion Control
Ultimate User Disposal of Medicines National Take-Back Events: Take-back events are a good way to remove expired, unwanted, or unused medicines from the home.
Law Enforcement Collection Bins: Collection bins installed by our Law Enforcement Partners are a good way to remove expired, unwanted, or unused medicines from the home.
Disposal in Household Trash: Mix medicines (do not crush tablets or capsules) with substances such as kitty litter or used coffee grounds and place the mixture in a container such as a sealed plastic bag and throw the container in your household trash.
Disposal by Flushing: Some medicines have specific disposal instructions that indicate they should be flushed down the sink or toilet when they are no longer needed.
U.S. Drug Enforcement Administra.on Office of Diversion Control
ONDCP Guidelines ONDCP guidelines for the disposal of ul.mate user medica.ons, including dispensed controlled substances (2/20/07).
Advise public to flush medica.ons only if the prescrip.on label or accompanying pa.ent informa.on specifically states to do so.
ONDCP recommends a minimal deac.va.on procedure, and disposal in common household trash.
U.S. Drug Enforcement Administra.on Office of Diversion Control
Law Enforcement
Law enforcement officers, ac7ng to enforce laws regarding the abandonment of controlled substances, may receive controlled substances from ul7mate users.
Law enforcement must safeguard the controlled substances and ensure that they are destroyed properly.
Law enforcement must be present during the destruc7on of the controlled substances.
U.S. Drug Enforcement Administra.on Office of Diversion Control
Questions to Discuss
Prior to passage of the Secure and Drug Disposal Act of 2010 and its implemen.ng regula.ons, ul.mate users could dispose of controlled substances in the following manner:
A) Wrap in coffee grinds and dispose in trash B) Give to a pharmacist for disposal C) Give to a law enforcement agency for disposal D) a and c
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
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
National Take Back Day October 26, 2013
4,114 Agencies; 5,683 Sites 647,211 Pounds Collected (324 Tons)
DRUG ENFORCEMENT ADMINISTRATION
DIVERSION CONTROL PROGRAM
U.S. Drug Enforcement Administra.on Office of Diversion Control
National Take Back Day: October 26, 2013 Total Law Enforcement Participation: 4,114
78
77
51 68
152MA
32 RI
46 CT
135 29VT
79 NH
14 PR & VI
204 70
6
135 29
191
12
98
17
21
53
128
143
62
38
258
15
1 HI 115
222 NJ
38
140
22 65
199
246
63
20
31
134
33
71
65
18
140 68 46 MD
7 DC
28 DE
36
65
U.S. Drug Enforcement Administra.on Office of Diversion Control
National Take Back Day: October 26, 2013 Total Collection Sites: 5,683
97
134
79 95
157MA
39 RI
78CT
165
60 VT 85
NH
19 PR & VI
243 88
6
158 37
284
17
134
21
24
59
168
234
77
69
425
22
12 HI
164
232 NJ
57
185
20 84
293
368
91
86
36
24
35
190
51
99
84
23
200 132 101 MD
11 DC
31 DE
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
U.S. Drug Enforcement Administra.on Office of Diversion Control
Secure and Responsible Drug Disposal Act of 2010
Enacted in October 2010 (Pub. L. 111-‐273, codified at 21 U.S.C. 822(g) and 823(b)(3)) Act allows an ul.mate user to “deliver” a controlled substance “to another person for the purpose of disposal” in accordance with regula.ons issued by DEA If the ul.mate user dies while in lawful possession of the controlled substance, then any person lawfully en.tled to dispose of the decedent’s property may deliver the controlled substance to another person for the purpose of disposal. DEA may also, by regula.on, authorize long term care facili.es (LTCFs) to dispose of controlled substances on behalf of ul.mate users who reside or have resided at the LTCF. DEA is working to promulgate regula.ons to implement this Act. DEA must consider:
– Public health and safety – Ease and cost of program implementa.on – Par.cipa.on by various communi.es – Diversion Control
Par.cipa.on is voluntary. DEA may not require any person to establish or operate a delivery or disposal program.
U.S. Drug Enforcement Administra.on Office of Diversion Control
No.ce of Proposed Rulemaking
U.S. Drug Enforcement Administra.on Office of Diversion Control
Pharmaceuticals
U.S. Drug Enforcement Administra.on Office of Diversion Control
* Must be reduced in writing, and followed by sign, hard copy of the prescription. ** A signed, hard copy of the prescription must be presented before the medication is dispensed. *** 72 hour time limitation. # With medical authorization, up to 5 in 6 months. U.S. Drug Enforcement Administra.on
Office of Diversion Control
Opioids
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Rates of Opioid Overdose Deaths, Sales, and Treatment Admissions, 1999-‐2010
Source: National Vital Statistics System (NVSS), DEA’s Automation of Reports and Consolidated Orders System, SAMHSA’s Treatment Episode Data Set U.S. Drug Enforcement Administra.on
Office of Diversion Control
Most commonly prescribed prescription medicine?
Hydrocodone/acetaminophen
U.S. Drug Enforcement Administra.on Office of Diversion Control
Source: IMS Health, Na.onal Prescrip.on Audit Updated March 22, 2013
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
Top 25 U.S. Pharmaceuticals by Dispensed Prescriptions*
Source: IMS Health, Na.onal Prescrip.on Audit Updated March 22, 2013
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
Hydrocodone Combinations CSA defines hydrocodone substance as Schedule II, while its combina.on products as Schedule III.
DEA has received a pe..on to reschedule CIII hydrocodone combina.on products to CII.
In 2004, DEA completed an ini.al review forwarded the data to DHHS with a request for scien.fic and medical evalua.on and scheduling recommenda.on.
In 2008, HHS provided a scien.fic and medical evalua.on
In 2009, DEA sent addi.onal data to FDA/HHS and requested a scien.fic and medical evalua.on.
U.S. Drug Enforcement Administra.on Office of Diversion Control
DEA receives a pe..on from an interested party (proceedings may also be ini.ated at the request of the AG or Secretary of HHS)
Pe..on is reviewed and accepted
DEA conducts ini.al 8-‐factor analysis review
Documents and material gathered during the ini.al review and analysis of pe..on is sent to HHS/FDA with a request for a scien.fic and medical evalua.on and a recommenda.on as to whether the drug should be controlled
The recommenda.on and review document is received back from HHS/FDA
U.S. Drug Enforcement Administra.on Office of Diversion Control
Schedule II The drug or other substance has a high poten.al for abuse The drug or other substance has a currently accepted medical use
in treatment in the United States or a currently accepted medical use with severe restric.ons
Abuse of the drug or other substance may lead to severe psychological or physical dependence
Schedule III The drug or other substance has a poten.al for abuse less than
the drugs or other substances in schedules I or II The drug or other substance has a currently accepted medical use
in treatment in the United States Abuse of the drug or other substance may lead to moderate or
low physical dependence or high psychological dependence 21 USC 812(b)(2),(3) U.S. Drug Enforcement Administra.on
Office of Diversion Control
Approval of Single Entity Extended Release Hydrocodone
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
State Ranking* - Oxycodone January – December 2012
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
State Ranking* - Oxycodone January – December 2013
U.S. Drug Enforcement Administra.on Office of Diversion Control
OxyContin® (Schedule II) (Oxycodone controlled-release)
Controlled- release formulation of Schedule II oxycodone – The controlled release method of delivery allows for a longer duration of
drug action so it contains much larger doses of oxycodone – Abusers easily compromise the controlled release formulation by
crushing the tablets for a powerful morphine-like high – Street Slang: “Hillbilly Heroin” – 10, 15, 20, 30, 40, 60, 80mg available
Effects: – Similar to morphine in effects and potential for abuse/ dependence
Street price: Approx. $80 per 80mg tablet
New formulation: Introduced into the marketplace in 2010 that is more difficult to circumvent for insufflation (snorting) or injection. Does nothing to prevent oral abuse.
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Drug Enforcement Administra.on Office of Diversion Control
OxyContin® Change (Oxycodone controlled-release)
New OxyContin® OP (oxycodone-controlled release)
U.S. Drug Enforcement Administra.on Office of Diversion Control
Oxycodone 15mg/30mg Immediate Release
U.S. Drug Enforcement Administra.on Office of Diversion Control
Opana ER (Schedule II) (Oxymorphone extended release)
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
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
Hydromorphone
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
State Ranking* - Hydromorphone January – December 2013
U.S. Drug Enforcement Administra.on Office of Diversion Control
Opiates v. Heroin
U.S. Drug Enforcement Administra.on Office of Diversion Control
Poppy
Codeine
Hydrocodone
Morphine
Hydromorphone
Thebaine
Oxycodone
Hydrocodone
Somniferum
U.S. Drug Enforcement Administra.on Office of Diversion Control
U.S. Rates of Opioid Overdose Deaths, Sales, and Treatment Admissions, 1999-2010
Source: National Vital Statistics System (NVSS), DEA’s Automation of Reports and Consolidated Orders System, SAMHSA’s Treatment Episode Data Set
U.S. Drug Enforcement Administra.on Office of Diversion Control
Hydrocodone Lorcet®
$5-‐$7/tab
Oxycodone Combina.ons
Percocet®
$7-‐$10/tab
OxyCon7n® $80/tab
Heroin $10/bag
Roxicodone® Oxycodone IR 15mg, 30mg $30-‐$40/tab
U.S. Drug Enforcement Administra.on Office of Diversion Control
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)
Past Month and Past Year Heroin Use Among Persons Aged 12 or Older: 2002-2012
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
Percen
t
Source: SAMSHA Treatment Episode Data Set, 1998-2008 released July 15, 2010
Substance Abuse Treatment Admissions within Specific Age Groups That Reported
Any Pain Reliever Abuse: 1998-2008
Up more than fourfold
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
Methods of Diversion
U.S. Drug Enforcement Administra.on Office of Diversion Control
Source: DEA
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
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”?
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
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 Control
Mandatory PDMP review before prescribing CS?
U.S. Drug Enforcement Administra.on Office of Diversion Control
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 Control
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
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)
U.S. Drug Enforcement Administra.on Office of Diversion Control
What has been the reaction????
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
Current CSA Registrant Population Total Population: 1,523,995 Practitioner 1,177,455 Mid-Level Practitioner 246,543 Pharmacy 69,807 Hospital/Clinic 16,047 Teaching Institution 312 Manufacturer 543 Distributor 839 Researcher 7,346 Analytical Labs 1,524 NTP 1,365 Importer/Exporter 476 ADS Machine 755 Chemicals 1,005
U.S. Drug Enforcement Administra.on Office of Diversion Control
As of 03/21/14
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.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
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
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
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
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
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
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
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
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
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
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
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
‘The Florida Migration’
Vast majority of ‘patients’ visiting Florida “pain clinics”come from out-of-state:
– Georgia – Kentucky – Tennessee – Ohio – Massachusetts – New Jersey – North and South Carolina – Virginia – West Virginia
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
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
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
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
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
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
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
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
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
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
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
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.
(MIAMI)
U.S. Drug Enforcement Administra.on Office of Diversion Control
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
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
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
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
The Last Line of Defense
U.S. Drug Enforcement Administra.on Office of Diversion Control
Pharmacist
Thank You!
U.S. Drug Enforcement Administra.on Office of Diversion Control