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Title:Drug Trends - December 2012
Description:Drug Trends - December 2012
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Body:Joseph Rannazzisi Deputy Assistant Administrator DEA Office of Diversion Control Drug Trends Indianapolis, Indiana December 2012

Legend Drugs v. Controlled Substances

Prescription Requirements Schedule II Schedule III Schedule IV Schedule V

Written Yes Yes Yes Yes

Oral Emergency Only* Yes Yes Yes

Facsimile Yes** Yes Yes Yes

Refills No Yes# Yes# Yes#

Partial Fills Yes*** Yes Yes Yes

* 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.

Hydrocodone

Alprazolam

Oxycodone 30 mg

Carisoprodol OxyContin 80mg

Commonly Abused Controlled Pharmaceuticals Oxymorphone

C-IV as of 1/11/2012

. Industry is producing a wider variety of controlled substance pharmaceuticals . Use of Medicare / Medicaid or insurance to fund drug habits . Information / Electronic era - Web sites such as Erowid & Bluelight The Perfect Storm

Inadequate Pain Control

Direct to Patient Advertising

METHAMPHETAMINE: 502,000

ANY ILLICIT DRUG: 21.8 million (8.7% of population)

MARIJUANA: 16.7 million

COCAINE: 1.6 million

PSYCHOTHERAPEUTIC DRUGS: 7 million

HALLUCINOGENS: 1.3 million

2009 Current Users 2010 Source: 2009 & 2010 NSDUH METHAMPHETAMINE: 353,000

ANY ILLICIT DRUG: 22.6 million (8.9% of population)

MARIJUANA: 17.4 million

COCAINE: 1.5 million

PSYCHOTHERAPEUTIC DRUGS: 7 million

HALLUCINOGENS: 1.2 million

More Americans abuse prescription drugs than the number of: Cocaine, Hallucinogen, Heroin, and Inhalant abusers COMBINED!!! Prescription Drug Abuse

0

1000000

2000000

3000000

4000000

5000000

6000000

7000000

8000000

9000000

2004 2007 2008 2009 2010

4,300,000 5200000 4700000 5,300,000 5,100,000

1,600,000

1800000 1800000 2,000,000 2,200,000 1,200,000

1100000 900000

1,300,000 1,100,000 300,000

350000 230000

370,000 374,000

Stimulants Anti-Anxiety Narcotic Pain Relievers

Source: 2004, 2007, 2008, 2009, 2010 National Survey on Drug Use and Health Scope and Extent of Problem

Source: National Survey on Drug Use and Health 0

1

2

3

4

5

6

7

2003 2004 2005 2006 2007 2008 2009

12 to 17 18 to 25 26 and older

Percentage of Past Month Nonmedical Use of Psychotherapeutics by Age, 2003-2009

2006 estimated cost in the United States from nonmedical use of prescription opioids $53.4 BILLION . $42 billion - Lost productivity . $8.2 billion - Criminal justice costs . $2.2 billion - Treatment costs . $944 million - Medical complications Five drugs - OxyContin®, oxycodone, hydrocodone, propoxyphene, a nd methadone accounted for two-thirds of the economic burden Source: Clinical Journal of Pain, December 2010, University of Washington, Hansen RN; Oster, G; Edelberg, J; Woody, GE; and Sullivan, SD

Economic Impact - The Cascading Effect

0

500

1,000

1,500

2,000

2,500 2,426

2,004

1,238

937 798 637 624

337 252 140 45

Avg. 5,490 persons per day initiating with pain relievers

Past Year Initiates for Specific Drugs Persons Aged 12 or Older 2010

0

500

1,000

1,500

2,000

2,500 2,400 2,400

793 637

377

140

Psychotherapeutics Include: Pain Relievers, Tranquilizers, Stimulants, and Sedatives Source: 2010 NSDUH

Avg. 6,600 new initiates per day for psychotherapeutic drugs Numbers in the Thousands Gateway is gone

New Initiates 2010 - 12 years and older

. Increase of 98.4%: ER visits attributable to pharmaceuticals alone (i.e., with no other type of drug or alcohol) (627,291 to 1,244,679) - No Significant Change: ER visits attributable to cocaine, heroin, marijuana, or methamphetamine . Rx Drugs most frequently implicated: - Opiates/Opioids pain relievers . Oxycodone products 242.2% increase . Hydrocodone products 124.5% increase . Fentanyl products 117.5% increase - Insomnia or Anti-Anxiety medications . Zolpidem 154.9% increase . Alprazolam 148.3% increase . Clonazepam 114.8% increase - Carisoprodol 100.6% increase

- For patients aged 20 and younger misuse/abuse of pharmaceuticals increased 45.4% - For patients aged 20 and older the increase was 111% SOURCE: The DAWN Report, Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, December 28, 2010 Emergency Room Data 2004-2009

0

2500

5000

7500

10000

12500

15000

1999 2000 2001 2002 2003 2004 2005 2006 2007

4041 4419 5538

7475 8535

9876 10947

13755 14459

Poisoning Deaths: Opioid Analgesics Source: CDC/NCHS, National Vital Statistics System Poisoning Deaths

Number of Forensic Cases 2001-2010 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

NFLIS Estimated U.S. Law Enforcement Encounters Methadone Oxycodone Hydrocodone 253% 281% 331%

0

5,000

10,000

15,000

20,000

25,000

30,000

2004 2005 2006 2007 2008

Hydrocodone

Oxycodone

Cocaine

Methadone

Heroin

Source: American Association of Poison Control Centers (AAPCC) Annual Reports, 2004-2008 Number of U.S. Poison Case Mentions National Poison Data Center Number of U.S. Poison Exposure Case Mentions 2004 - 2008

% Learned a lot about risks of drugs from...

1998 2004 2005 2007 2008 2009

School 41 42 38 37 44 39*

Parents 26 28 28 29 35 31

TV Commercials 17 36 26 31 31 26*

The Internet 11 23 22 25 29 29

Websites like YouTube NA NA NA NA 14 17*

Source: Partnership for Drug Free America, March 2, 2010

* = Significant at the .05 level vs 2008

Sources of Information and Risks

Teens and Their Attitudes % Agree strongly/somewhat 2008 2009 2010

Prescription drugs are available everywhere 42 55 38

Its easy to get prescription drugs from parent's medicine cabinets 56 63 47

Most teens get prescription drugs from their own family's medicine cabinets 59 62 51

Most teens get prescription drugs from their friends 53 62 49

Parents are still not discussing the risks of abusing prescription and over-the-counter medicines SOURCE: 2010 Partnership Attitude and Tracking Study (PATS) Released Apr. 2011 Percent 2008 2009 2010

Beer/alcohol 79 79 81

Marijuana 79 79 77

Cocaine/crack 36 35 30

Prescription pain reliever w/o doctor's Rx 20 20 23

Any prescription drug used w/o doctor's Rx 21 20 22

Heroin 23 23 21

Ecstasy 21 20 21

Methamphetamine 23 21 21

Non-prescription cold/cough medicine to get high 15 14 15

Parents and Their Attitudes

We will not arrest our way out of this problem!!!!! . Enforcement is just as important as.... . Prevention/Education . Treatment

ONDCP Strategy "Epidemic: Responding To America's Prescription Drug Abuse Crisis" (Released in April 2011) Highlights: . Education . Healthcare Provider Education . Parent, Youth, and Patient Education . Tracking and Monitoring - Work with states to establish effective PDMPs - Support NASPER - Explore reimbursements to prescribers who check PDMPs before writing a prescription

ONDCP Strategy con't . Proper Medicine Disposal . Enforcement - Assist states address doctor shopping and pill mills - Increase HIDTA intelligence-gathering and investigation of prescription drug trafficking - Expand the use of PDMPs to identify criminal prescribers and clinics . Prescription Drug Abuse Plan Goals - 15% reduction in non-medical use of prescription-type psychotherapeutic drugs; - Write and disseminate a Model Pain Clinic Regulation Law within 12 months; - Implement REMS for long-acting and extended release opioids within 12 months

Most Frequent Method of Obtaining a Pharmaceutical Controlled Substance for Non Medical Use Friends and Family...For Free!!

The Medicine Cabinet and the Problem of Pharmaceutical Controlled Substance Disposal

So Many Drugs in the Household - Why? . Unreasonable quantities being prescribed . Insurance rules

Controlled Substances Act of 1970

. Legal foundation of federal government's authority for controlled substances and listed chemicals. . System of U.S. compliance with international treaties. . Established a "closed system" of distribution

The CSA's Closed System of Distribution Cyclic Investigations

Security Requirements

Record Keeping Requirements

ARCOS

Established Quotas

Registration

Established Schedules

How Do You Lose Your Registration?

The Order to Show Cause Process 21 USC § 824 a) Grounds - 1. Falsification of Application 2. Felony Conviction 3. State License or Registration suspended, revoked or denied - no longer authorized by State law 4. Inconsistent with Public Interest 5. Excluded from participation in Title 42 USC § 1320a-7(a) program

b) AG discretion, may suspend any registration simultaneously with Order to Show Cause upon a finding of Imminent Danger to Public Health and Safety

Closed System . Under the CSA, Congress established a "closed system" of distribution to prevent the diversion of controlled substances. . All persons who lawfully handle controlled substances must be registered with DEA or exempt from registration. . Ultimate users are not required to register with DEA to possess controlled substances.

CSA Definitions . An "ultimate user" is a person who has lawfully obtained, and who possesses, a controlled substance for his own use or for the use of a member of his household or for an animal owned by him or by a member of his household. . To distribute means to deliver (other than by administering or dispensing) a controlled substance or a listed chemical. 21 U.S.C. 802

The Ultimate User and Drug Disposal

ONDCP Guidelines . ONDCP guidelines for the disposal of ultimate user medications, including dispensed controlled substances (2/20/07). . Advise public to flush medications only if the prescription label or accompanying patient information specifically states to do so. . ONDCP recommends a minimal deactivation procedure, and disposal in common household trash.

Law Enforcement Involvement . Law enforcement officers, acting to enforce laws regarding the abandonment of controlled substances, may receive controlled substances from ultimate users. . Law enforcement must safeguard the controlled substances and ensure that they are destroyed properly. . Law enforcement must be present during the destruction of the controlled substances.

Statute or Regulation Change? Law Enforcement Coordination/Involvement

Nationwide Take-back Initiative . On September 30, 2010, the American public turned in more than 245,000 lbs of prescription drugs for safe and proper disposal. More than 4,000 take back sites were available in all 50 states with approximately 3000 agencies participating in the initiative. . The second nationwide take-back event, on April 30, 2011 featured over 5200 collection sites with over 3800 Federal, state and local agencies involved in the initiative. This initiative took in approximately 188 tons of unwanted, unused or expired medication at collection sites throughout the U.S. This includes collections from Long Term Care Facilities that were not involved in the previous collection event. . The third nationwide take-back event, on October 29, 2011 featured over 5300 collection sites with over 3900 Federal, state and local agencies involved in the initiative. This initiative took in approximately 189 tons of unwanted, unused or expired medication at collection sites throughout the U.S. This includes collections from Long Term Care Facilities, tribal lands and military installations. Collections were greater than previous initiative dates despite the snow storm that crippled many parts of the northeast that limited access to collection sites.

39 DRUG ENFORCEMENT ADMINISTRATION | DIVERSION CONTROL PROGRAM

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 ultimate user to "deliver" a controlled substance "to another person for the purpose of disposal" in accordance with regulations issued by DEA . If the ultimate user dies while in lawful possession of the controlled substance, then any person lawfully entitled to dispose of the decedent's property may deliver the controlled substance to another person for the purpose of disposal. . DEA may also, by regulation, authorize long term care facilities (LTCFs) to dispose of controlled substances on behalf of ultimate users who reside or have resided at the LTCF. . DEA is working to promulgate regulations to implement this Act. DEA must consider: - Public health and safety - Ease and cost of program implementation - Participation by various communities - Diversion Control . Participation is voluntary. DEA may not require any person to establish or operate a delivery or disposal program.

Ultimate User Disposal . ANPRM published on January 21, 2009 in the Federal Register . "Disposal of Controlled Substances by Persons Not Registered With the Drug Enforcement Administration"

. Seeking options for the safe and responsible disposal of patient owned controlled substances consistent with CSA . Comment period ended March 23, 2009

Ultimate User Disposal . Solicited information on the disposal of cs dispensed to ultimate user from:  ultimate users  law enforcement  interest groups  long-term care facilities  hospices and in-home care groups  pharmacies  reverse distributor  state regulatory  agencies  other interested  parties 158 Comments Received

Secure and Responsible Drug Disposal Act Public Meeting - January 19-20 2011 . Many different views on how to proceed . Questions concerning who will fund

Other trends related to the medicine cabinet . Real estate . Trip to relatives/friends house . Easy access at home

Controlled and Legend Pharmaceuticals

Most commonly prescribed prescription medicine? Hydrocodone/acetaminophen

Top Five Prescription Drugs Sold in the U.S. (2006-2010) 0

20,000,000

40,000,000

60,000,000

80,000,000

100,000,000

120,000,000

140,000,000

2006 2007 2008 2009 2010

Hydrocodone/Apap

Lipitor

Amoxicillin

Lisinopril

Simvastatin

Levothyroxine

Azithromycin

131,200,000

(By Number of Prescriptions Sold) 112,400,000 119,200,000 124,100,000 128,200,000

Source: IMS Health

OXYCODONE

OxyContin ® (Schedule II) . 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 . Since 2002, use among 12th graders has remained between approximately 4% and 5%* * SOURCE: 2007 Monitoring the Future study released April 2008

OxyContin® v. Heroin

Circle of Addiction & the Next Generation Hydrocodone Oxycodone OxyContin® Heroin Roxicodone

OPANA ® ER (Oxymorphone Hydrochloride) Extended- Release Tablets - 5mg, 10mg, 20mg, and 40mg CII

0

100

200

300

400

H y d r o c o d o n e

O x y c o d o n e

M e t h a d o n e

2006 2007

Deaths/100,000 Prescriptions

Deaths/100,000 Prescriptions in Florida Source: FDLE and NPA Plus(tm)

WHY IS IT ALSO USED AS AN ANALGESIC?????? Cheapest narcotic pain reliever - synthetic Insurance companies What's the problem?

One Pill Can Kill

Fentanyl Hydromorphone Meperidine Morphine Codeine Propoxyphene Other Narcotics

 Fentanyl Patches  Fentanyl Citrate dispensed in a berry flavored lollipop-type unit  Fentanyl is 100 times more potent than morphine  Intended to be used for chronic cancer pain & only for people who are tolerant to prescription opioid (narcotic) pain medicines  Abused for its intense euphoric effects Actiq ® Fentanyl Fentora®

Alprazolam Xanax ® (Z-bars) C-IV

. Drug abusers often prefer alprazolam due to its rapid onset and longer duration of action . Alprazolam was ranked third in the number of prescriptions for controlled substances in 2003, 2004, 2005 and 2006* . For all sales of generic pharmaceuticals, alprazolam was ranked 7 th ** * Source IMS Health ** Source Verispan VONA

Alprazolam Clonazepam Diazepam Lorazepam Midazolam Triazolam Temazepam Flunitrazepam Benzodiazepines

Other Controlled Substances . Phentermine C-IV . Phendimetrazine C-III - Bontril® . Amphetamines - Adderall C-II - Methylphenidate C-II . Ritalin® . Concerta®

Ritalin® / Concerta® / Adderall  Used legitimately to treat ADHD  Used non-medically to get high and as an academic "performance- enhancer" to improve memory and improve concentration - gain the edge  Higher GPA  Higher SAT / ACT score  Get that scholarship

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

Where are the Pharmaceuticals Coming From? . Medicine Cabinet . Internet . Pain Clinics . Doctor Shoppers; RX Fraud; Practitioner Diversion

Prescription Fraud . Fake prescriptions - Highly organized - Use real physician name and DEA Registrant Number . Contact Information false or "fake office" - (change locations often to avoid detection) - Prescription printing services utilized . Not required to ask questions or verify information printed . Stolen prescriptions - Forged - "Smurfed" to a large number of different pharmacies

Doctor Shopping

Prescription Drug Monitoring Programs

Doctor Appointment Records

2012 Newsday

Diversion via the Internet

WA

OR ID

WY

ND

SD

MN

NE

WI MI

CO KS MO

IL IN UT NV

CA

AZ NM OK AR

LA

TN

KY

MS AL GA

SC

NC

OH

VA

PA

NY

ME

V T N H

CT

DE WV

RI

MD

MA

Domestic 'R x ' 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

What has been the reaction???? New Felony Offense Internet Trafficking  21 USC 841(h)(1): It shall be unlawful for any person to knowingly or intentionally: (A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by this title; or (B) aid or abet any violation in (A)

Per Se Violations No in-person medical evaluation by prescribing practitioner Online pharmacy not properly registered with modified registration.

Website fails to display required information Automatic Violation of the CSA if any of the following occurs:

Current CSA Registrant Population Total Population: 1,341,505

 Practitioner - 1,040,496  Mid-Level Practitioner - 170,115  Pharmacy - 65,946  Hospital/Clinic - 15,702  Manufacturer - 525  Distributor - 805  Researcher - 6,357  Analytical Labs - 1,504  NTP - 1,247  ADS Machine - 161

as of 1/21/2010

What took the place of Internet Medical Care and Internet CS pharmaceutical Distribution?

Florida Pain Clinics

U.S. v. Moore 423 US 122 (1975)

Increased Law Enforcement Pressure . Clinics migrating north and west . Funded by owners in Florida

Why Florida? . No PDMP . Law Enforcement v. Regulatory Boards

Medical Care ? . Many of these clinics are prescription/dispensing mills. . Minimal practitioner/patient interaction

Explosion of South Florida Pain Clinics As of June 4, 2010, Florida has received 1,118 applications and has approved 1026 *As of May 14, 2010, Broward 142; Miami-Dade 79; Palm Beach 111

'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

WASHINGTON

OREGON

CALFORNIA

NEVADA

IDAHO

MONTANA

WYOMING

UTAH

ARIZONA NEW MEXICO

COLORADO

TEXAS

OKLAHOMA

KANSAS

NEBRASKA

SOUTH DAKOTA

NORTH DAKOTA

MINNOSOTA

IOWA

MISSOURI

ARKANSAS

LOUIS.

MISS. ALA.

GEORGIA

FLA.

WISC. MICH.

ILL. IND.

OHIO

PENN.

N.Y.

MAINE

R.I.

CONN.

N.J.

N.H.

VT.

MASS.

W.V.

DEL.

MD.

S.C.

VIRGINIA

N.C.

KENTUCKY

TENN.

(MIAMI)

Drugs Prescribed . A 'cocktail' of oxycodone and alprazolam (Xanax ® ) . An average 'patient' receives prescriptions or medications in combination Schedule II Schedule III Schedule IV

Oxycodone 15mg, 30mg Vicodin (Hydrocodone) Xanax (Alprazolam)

Roxicodone 15mg, 30mg Lorcet Valium (Diazepam)

Percocet Lortab

Percodan Tylenol #3 (codeine)

Demerol Tylenol #4 (codeine)

Methadone

Average Charges for a Clinic Visit . Price varies if medication is dispensed or if customers receive prescriptions . Some clinics advertise in alternative newspapers citing discounts for new patients such as 'buy one get one free' or "50% off with this ad" . Typically, initial office visit is $250; each subsequent visit is $150 to $200 . Average 120-180 30mg oxycodone tablets per visit

Cost of Drugs . The 'cocktail' prescriptions go for $650 to $1,000 . According to medical experts, most clinics do not require sufficient medical history and tests for proper prescribing of Schedule II substances . Each oxycodone 30mg tablet costs $1.75 to $2.50 at the clinics - On the street in Florida, that pill can be re-sold for $7 to $15 - Outside of Florida, it can be re-sold for $25 to $30 ($1 per mg)

What's the Profit? . May 20, 2010, Tampa, Florida owner/operator of pain clinic dispensing oxycodone . $5,822,604.00 cash seized

What's the Profit? . One case in Florida owner/operator of pain clinic allegedly generated $40 million in drug proceeds . Houston investigation $41.5 million in assets

What's the Profit? . Another case in Florida - pain clinic operation paid his doctors (in 2009): - $861,550 - $989,975 - $1,031,975 - $1,049,032 - $1,225,775

Operation Pill Nation This operation involved the mobilization of eleven Tactical Diversion Squads from across the United States to marshal with the Miami TDS and other state and local agencies in a concerted effort to attack and dismantle the hundreds of rogue pain clinics that continue to plague South Florida. . On February 23, 2011, as part of Operation Pill Nation DEA conducted a coordinated effort with more than 500 state and local law enforcement officers in a massive takedown which included: - 21 search warrants executed at clinics, residences, and other locations in south Florida; - 25 arrested on various federal and state drug and money laundering charges, of which 5 were medical doctors and 5 were pain clinic owners; - Seizure of approximately $7 million in assets. ($3 million dollars in US currency, a variety of other real property, jewelry, and assets including 62 vehicles, some of which were exotic cars; and - Immediate Suspension Orders issued against 14 DEA registrations, 1 Order to Show Cause issued against 3 DEA registrations, and the surrender of 7 DEA registrations.

Operation Pill Nation con't As of April 2011, Operation Pill Nation has resulted in: . The surrender of 83 DEA registrations (71 physicians, 8 pharmacies and 4 wholesale distributors); - 1 wholesale distributor's civil fine was $8 million . Immediate Suspension Orders issued against 63 DEA registrations (33 physicians, 1 distributor); . Orders to Show Cause issued against 6 DEA registrations; . 38 clinics closed; . 32 arrests (12 physicians, 5 clinic owners and 15 clinic employees) . Seizure of more than $16.4 million in assets ($11.9 million in US currency and approximately $4.5 million in vehicles, jewelry, real property, and other assets).

Florida Pain Clinic Raid

The Flow of Pharmaceuticals

PATIENTS

Hospitals NTPs

21 CFR 1306.04

Physicians (Rx and drugs) Pharmacies

QUOTAS (Thebaine) Raw Material Importers Imp - Manufacturers

21 USC 823(c)(1) 21 USC 823(d)(1) 21 CFR 1301.71 Dosage Form Manufacturers

Manufacturers

Dosage Form Manufacturers 21 USC 823(b)(1) 21 USC 823(e)(1) 21 CFR 1301.71 21 CFR 1301.74 (Suspicious Orders) Wholesalers - Distributors Smaller Distributors

Manufacturers DEA Registrants who are authorized to produce and distribute controlled substances. (1330 firms including all manufacturers and wholesale distributors)

Wholesale Distributors DEA Registrants who are authorized to distribute controlled substances.

Brick and Mortar Pharmacies DEA Registrants who are authorized to dispense controlled substances to individual customers. (66,000 registered pharmacies)

Drug Seekers

Manufacturers [Re-packagers/Re-labelers] DEA Registrants who are authorized to package bulk dosage units into consumer-use size packagers and distribute to pharmacies.

Flow of Controlled Substances

Practitioners DEA Registered doctors, nurse practitioners, PAs etc,,, who are authorized to issue prescriptions for controlled substances

Drugs Dispensed.

Rogue Pain Clinic/Pharmacy Scheme Rogue Clinics/ Practitioners

Prescription Issued to Drug Seeker

1 Practitioner in Ohio Purchased 465,200 units - 2.2% 97 Practitioners in Florida Purchased 20,760,567 units

1 Practitioner in North Carolina Purchased 153,200 units - 0.7%

Source: ARCOS Date Prepared: 01/12/2010 Top 100 Practitioner Purchasers of Oxycodone Nationwide January 1, 2009 - September 30, 2009 1 Practitioner in California Purchased 130,000 units - 0.6%

June 2010 DEA takes action against four wholesale distributors supplying doctors who were dispensing from rogue pain clinics.

21 CFR § 1306.04

. To be effective, a prescription for a controlled substance must be issued - for a legitimate medical purpose by an individual practitioner - who is acting in the usual course of his professional practice

21 CFR §1306.04

The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner , but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual 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.

. Effective October 1, 2010 - Pain clinics are banned from advertizing that they sell narcotics - They can only dispense 72-hour supply of narcotics . Violation is a 3 rd degree felony - Increased training for physicians will be required . Effective July 1, 2012, a physician cannot practice at a pain clinic if: - Has not completed a pain medicine fellowship, or - Has not completed a pain medicine residency, or - Grandfather physicians currently practicing in clinics prior to July 1, 2012 and complying with Board rules - State Department of Health will now be able to pass on any information in the PDMP database to law enforcement - Prohibits the registration of pain clinics unless they are owned by physicians or licensed by non-physicians as a health care clinic . Will deny any registration if doctor's DEA registration was ever revoked . Will deny if applicant has ever been convicted of a felony drug offense State of Florida Legislative Actions

Florida HB 7095: "Pill Mill Crackdown" Effective July 1, 2011

 Clinics must turn over their supply of C-II and C-III controlled substances  Clinics are no longer able to dispense these drugs  Clinics cannot have ANY affiliation with a doctor that has lost a DEA number

 Pharmacies must report all prescription fraud: failure to do so can result in a 1º misd.  3 rd degree felony for burglary structure or conveyance where there is theft of controlled substance  Amends PDMP from 15 day reporting to 7 day reporting

Clinic response to the Florida legislation prohibiting the sale of CS from pain clinics?

Buy Pharmacies!!

Pharmacy Applications for Registration

2008 2009 2010 2011 (as of 9/22/11

Registered Pharmacies in US 65,065 65,991 1.4% 66,766 1.2% 66,934 .03% Registered Pharmacies in FL 4,343 4,403 4,741 4,809 New Applications in US (Independent Pharmacies) 2,230 2,192 <1.73%> 2,010 <8.3%> 1,840 <8.5%> New Applications in FL (Independent Pharmacies) 271 250 <7.7%> 388 55.2% 290 <25.25%> New Applications in Miami area (Independent Pharmacies) 130 79 <39.2%> 118 49.4% 126 6.8% New Applications in Ft. Lauderdale area (Independent Pharmacies) 37 52 40.5% 81 55.8% 58 <28.4%>

Questions

Thank You!