ph 4 rannizzisi

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


  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


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)


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


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.


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


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

Office of Diversion Control

Source: 2011 National Survey on Drug Use and Health


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

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

Past Year Initiates 2012 – Ages 12 and Older



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


Number of Forensic Cases 2001-2011

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

45,000

50,000

2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

240%

257%


322%

Poisoning Deaths: Opioid Analgesics

*2009 data approximated

*

Drug Overdose Mortality Rates per 100,000 People 1999

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


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

Drug Overdose Mortality Rates per 100,000 People 2010


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

Where Prescription Painkiller Overdose Deaths Are The Highest

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


Naloxone


Source: U.S. Census Bureau

Statistical Perspective


Why is the problem outpacing population growth?


Violence


Prescription drug epidemic?

How did we get to this point?


70s Public Service Announcement – The Magician

The 1960s/70s/80s

Downers -‐ Barbiturates

Uppers -‐ Amphetamines

Meprobamate

Hydromorphone

“Ts and Blues”

“Fours and Doors”

Oxycodone/APAP

Methaqualone


The 1990s

Hydrocodone

Alprazolam Oxycodone 30 mg

Carisoprodol

OxyCon.n® 80mg (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


The HolyTrinity

Inadequate Pain 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.


1.Temperature 2.Heart Rate 3.Blood Pressure 4.Respira.on


The Fifth Vital Sign?

5.Pain?


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


We will not arrest our way out of this problem!!!!!

Enforcement is just as important as….

Preven.on/Educa.on

Treatment


Drug Education


Education

  Children/Teens Informa.on from the Internet or their peers

Following parents


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


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.


Where do kids get their information from?


www.EROWID.org

www.EROWID.org

Community Coali.ons and Advocacy Groups


Education

  Physicians/Den.sts/Prac..oners

Prescribing habits

Mandatory opiate prescribing con.nuing educa.on?


Education

 Pharmacists

Drug Experts in the health care delivery system

Corresponding responsibility


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


CSA Registrant Population

March 20, 2014

Provisional registra7ons in effect at the 7me CSA was passed (rela7ve to the Harrison Narco7cs Act of 1914)


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


Closed System of Distribution

The Controlled Substances Act


The Flow of Pharmaceuticals

PATIENTS

Hospitals NTPs

21 CFR 1306.04

Physicians (Rx and drugs)

Pharmacies

QUOTAS Raw Material

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

Manufacturers

Manufacturers

Dosage Form Manufacturers

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


Diversion via the Internet


WA

OR ID

WY

ND

SD

MN

NE

WI MI

CO KS MO

IL IN UT

NV

CA

AZ NM OK

AR

LA

TN

KY

MS AL GA

SC

NC

OH

VA

PA

NY

ME

VT N

H

CT

DE WV

RI

MD

MA

Domestic ‘Rx’ Flow

MT MT

FL TX TX

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

WS FL

IA IA NJ

1. Consumer in Montana orders hydrocodone on the Internet

C

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

WC

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

S

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

Rx

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

Purchases of hydrocodone by Known and Suspected Rogue Internet Pharmacies

January 1, 2006 – December 31, 2006

Date Prepared: 03/07/2007 Source: ARCOS

98,566,711

Checks and Balances of the CSA and the Regulatory Scheme

  Distributors of controlled substances

“The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances…Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” (21 CFR §1301.74)


DEA Distributor 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


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

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


“At the .me we filled these orders, the pharmacies held valid state board of pharmacy and DEA licenses,” 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)


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


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


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


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

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

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

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

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


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

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

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

Pa.ent 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



Pharmacists – The Last Line of Defense

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

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



Pharmacists – The Last Line of Defense

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

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


The Last Line of Defense


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


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


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…


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;


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


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


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


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.


Violations?

What happens next…..


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


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


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


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

Memorandum of Agreement (MOA)

Order to Show Cause (OTSC)

 Civil Fines

 Criminal

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


How Do You Lose Your Registration?

The Order to Show Cause Process 21 USC § 824

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

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

program

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

* FY2014 as of April 10, 2014

Administrative Actions Initiated by DEA FY2007 thru 2014*


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



 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


Most Frequent Method of Obtaining a Pharmaceutical Controlled

Substance for Non-Medical Use

Friends and Family…For Free!!



First Specific Drug Associated with Initiation of Illicit Drug Use Among Past Year Illicit

Drug Initiates Aged 12 or Older: 2012


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

Past Year Users Aged 12 or Older: 2011-2012


  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


The Problem – Easy Access


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


So Many Drugs in the Household – Why?

 Unreasonable quan..es being prescribed

 Insurance rules


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


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.


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.


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.



 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


April 26, 2014

National Take Back Initiative April 26, 2014


10:00 AM – 2:00 PM

 On September 30, 2010, approximately 122 tons

 On April 30, 2011, approximately188 tons

 On October 29, 2011, approximately 189 tons

 On April 28, 2012, approximately 276 tons

 On September 29, 2012, approximately 244 tons

 On April 27, 2013, approximately 376 tons

 On October 26 , 2013, approximately 324 tons


National Take Back Day October 26, 2013

4,114 Agencies; 5,683 Sites 647,211 Pounds Collected (324 Tons)

DRUG ENFORCEMENT ADMINISTRATION

DIVERSION CONTROL PROGRAM


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


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


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


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.


No.ce of Proposed Rulemaking


Pharmaceuticals


* 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


Opioids


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


Most commonly prescribed prescription medicine?

Hydrocodone/acetaminophen


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


State Ranking* - Hydrocodone January – September 2013


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

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.


  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


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


Approval of Single Entity Extended Release Hydrocodone



State Ranking* - Oxycodone January – December 2012



State Ranking* - Oxycodone January – December 2013


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.



OxyContin® Change (Oxycodone controlled-release)

New OxyContin® OP (oxycodone-controlled release)


Oxycodone 15mg/30mg Immediate Release


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



State Ranking* - Oxymorphone January – December 2013


Hydromorphone



State Ranking* - Hydromorphone January – December 2013


Opiates v. Heroin


Poppy

Codeine

Hydrocodone

Morphine

Hydromorphone

Thebaine

Oxycodone

Hydrocodone

Somniferum


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


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



Past Month and Past Year Heroin Use Among Persons Aged 12 or Older: 2002-2012


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


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


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?


Methods of Diversion


Source: DEA

Where are the Pharmaceuticals Coming From?

 Friends and Family for Free

 Medicine Cabinet

 Doctor Shopping

 Internet

 Pain Clinics


Prescription Fraud



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

A) Hydrocodone, alprazolam, and carisoprodol

B) Promethazine with codeine, methylphenidate and carisoprodol

C) Hydromorphone, carisoprodol and buprenorphine

D) Methadone, diazepam and tramadol


Doctor Shopping


Prescription Drug Monitoring Programs


Mandatory PDMP review before prescribing CS?


Standard of Care


National Association of Boards of Pharmacy


Diversion via the Internet


WA

OR ID

WY

ND

SD

MN

NE

WI MI

CO KS MO

IL IN UT

NV

CA

AZ NM OK

AR

LA

TN

KY

MS AL GA

SC

NC

OH

VA

PA

NY

ME

VT N

H

CT

DE WV

RI

MD

MA

Domestic ‘Rx’ Flow

MT MT

FL TX TX

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

WS FL

IA IA NJ

1. Consumer in Montana orders hydrocodone on the Internet

C

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

WC

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

S

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

Rx

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

New Felony Offense Internet Trafficking - 10/15/2008

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

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

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


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


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


As of 03/21/14

Pain Clinics


Explosion of South Florida Pain Clinics

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


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


NFLIS Query Date: 02/24/14

Medical Care ?

 Many of these clinics are prescrip.on/dispensing mills

 Minimal prac..oner/pa.ent interac.on


Increased Law Enforcement Pressure

 Clinics migra.ng north and west

 Funded by owners in Florida


WASHINGTON

OREGON

CALIFORNIA

NEVADA IDAHO

MONTANA

WYOMING

UTAH

ARIZONA NEW MEXICO

COLORADO

TEXAS OKLAHOMA

KANSAS

NEBRASKA

SOUTH DAKOTA

NORTH DAKOTA

MINNESOTA

IOWA

MISSOURI

ARKANSAS

LOUIS.

MISS. ALA.

GEORGIA

FLA.

WISC. MICH.

ILL. IND.

OHIO

PENN.

N.Y.

MAINE

R.I.

CONN.

N.J.

N.H.

VT.

MASS.

W.V.

DEL.

MD.

S.C.

VIRGINIA

N.C. KENTUCKY

TENN.


‘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

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.


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.


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.


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.


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.


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)


Drugs Prescribed

 A ‘cocktail’ of oxycodone and alprazolam (Xanax®)

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

Schedule II Schedule III Schedule IV

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

Roxicodone 15mg, 30mg Lorcet Valium (Diazepam)

Percocet Lortab

Percodan Tylenol #3 (codeine)

Demerol Tylenol #4 (codeine)

Methadone


Average Charges for a Clinic Visit

 Price varies if medication is dispensed or if customers receive prescriptions

 Some clinics advertise in alternative newspapers citing discounts for new patients such as 'buy one get one free‘ or “50% off with this ad”

 Typically, initial office visit is $250 or more; each subsequent visit may exceed $200

 Prescriptions average 120-180 30mg oxycodone tablets per visit


Cost of Drugs

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

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


What’s the Profit?


The Last Line of Defense


Pharmacist

Thank You!


ph 4 rannizzisi

Health & Medicine