89
Clinical Track Panel Discussion: Avoiding the Dangers of RumorBased Medicine Panelists: Stacey Worthy, JD, Associate A6orney, DCBA Law and Policy Dr. Seddon Savage, MD, MS, Chronic Pain and Recovery Center, Silver Hospital Joseph T. Rannazzisi, JD, RPh, Office of Diversion Control, United States Drug Enforcement AdministraLon Moderator: Michael C. Barnes, JD, Center for Lawful Access and Abuse Deterrence

Cl 2 worth savage_rannazzisi

  • Upload
    opunite

  • View
    244

  • Download
    1

Embed Size (px)

DESCRIPTION

 

Citation preview

Page 1: Cl 2 worth savage_rannazzisi

Clinical  Track  Panel  Discussion:  Avoiding  the  Dangers  of    Rumor-­‐Based  Medicine  

Panelists:  

Stacey  Worthy,  JD,  Associate  A6orney,  DCBA  Law  and  Policy  

Dr.  Seddon  Savage,  MD,  MS,  Chronic  Pain  and  Recovery  Center,    Silver  Hospital  

Joseph  T.  Rannazzisi,  JD,  RPh,  Office  of  Diversion  Control,  United  States  Drug  Enforcement  AdministraLon  

Moderator:  Michael  C.  Barnes,  JD,  Center  for  Lawful  Access  and  Abuse  Deterrence    

Page 2: Cl 2 worth savage_rannazzisi

Disclosures  

•  Stacey  Worthy  has  no  financial  rela3onship  with  proprietary  en33es  that  produce  health  care  goods  and  services.  

•  Seddon  Savage  has  no  financial  rela3onship  with  proprietary  en33es  that  produce  health  care  goods  and  services.  

•  Joseph  T.  Rannazzisi  has  no  financial  rela3onships  to  disclose  and  will  not  discuss  off-­‐label  use  and/or  inves3ga3onal  drug  use  in  his  presenta3on.  

Page 3: Cl 2 worth savage_rannazzisi

Learning  Objec3ves  

1.  Describe  factors  health  care  providers  must  consider  on  a  case-­‐by-­‐case  basis  before  prescribing  controlled  substances.    

2.  Iden3fy  reasonable  efforts  controlled  substance  prescribers  may  make  to  spot  signs  of  medica3on  diversion,  misuse,  or  abuse.    

3.  Explain  steps  a  prescriber  may  take  to  reduce  the  likelihood  of  liability  without  abandoning  a  pa3ent  with  a  substance  use  disorder.    

Page 4: Cl 2 worth savage_rannazzisi

Avoiding  the  Dangers  of    Rumor-­‐Based  Medicine  

Page 5: Cl 2 worth savage_rannazzisi

Stacey  Worthy  has  no  financial  rela3onship  with  proprietary  en33es  that  produce  health  care  

goods  and  services.    

Page 6: Cl 2 worth savage_rannazzisi

Preview  

•  Standards  of  care  •  Civil  and  criminal  ac3ons  

•  Trends    •  Recent  cases  •  How  to  avoid  liability  •  Conclusion  

Page 7: Cl 2 worth savage_rannazzisi

Standards  of  Care  

•  Physicians  have  a  legal  duty  to  abide  by  the  medical  standard  of  care  

•  What  happens  if  they  don’t?  –  Professional  Sanc3ons,  Civil  Liability,  &  Criminal  Liability    

•  No  universally  accepted  defini3on    –  Common:  medical  customs;  reasonable,  prudent  physician;  CSA  

•  Test  encompassing  all  standards:  –  Legi3mate  medical  purpose  – Within  the  usual  course  of  medical  prac3ce  –  Took  reasonable  steps  to  prevent  harm  

Page 8: Cl 2 worth savage_rannazzisi

Civil  &  Criminal  Ac3ons  

•  Medical  Malprac3ce  /  Negligence  (monetary)  •  Involuntary  manslaughter  (max.  4  years)    

– High-­‐risk  ac3vity  without  due  cau3on  •  Second-­‐degree  murder  (min.  15  years)  

– Conscious  disregard  for  life  •  First-­‐degree  murder  (typically  life)  

–  Premedita3on    –  Felony-­‐murder  (death  while  commi`ng  a  felony,  irrespec3ve  of  malice)  

Page 9: Cl 2 worth savage_rannazzisi

Trends  

•  Aggressive  prosecu3on:  professional  sanc3ons  &  civil  suits  inadequate  for  par3cularly  egregious  offenders  

•  Tradi3onal  defenses  are  no  longer  reliable    – Contributory  negligence  (blaming  the  pa3ent)  

– Good  faith  /  trus3ng  the  pa3ent    – Lack  of  foreseeability  /  willful  ignorance  – Calculated  risk  

Page 10: Cl 2 worth savage_rannazzisi

Recent  Cases  

•  People  v.  Murray  (Los  Angeles,  2011)  –  Convicted  of  involuntary  manslaughter;  4  years  –  Administered  lethal  dosages  of  benzodiazepines  and  propofol  –  Ct.  rejected  pa3ent-­‐blaming  defense  –  Medical  board  revoked  license  post-­‐sentencing  in  2012  

•  Chua  v.  State  (Georgia  2011)  –  Medical  board  suspended  license;  civil  suit  for  malprac3ce  

sedled    –  Convicted  of  felony-­‐murder  for  death  of  pa3ent;  life  in  prison  –  Prescribed  oxycodone  &  distributed  methadone;  pa3ent’s  

medical  records  showed  padern  of  abuse;  ignored  warning  signs  –  Defense  of  willful  ignorance  didn’t  work  

Page 11: Cl 2 worth savage_rannazzisi

Recent  Cases  

•  People  v.  Rodriguez  (Florida  2013)  –  Pleaded  guilty  to  manslaughter  for  deaths  of  4  pa3ents;  27  

years    –  Medical  board  revoked  license  and  fined  him  $40K  –  Operated  a  “pill  mill”;  prescribed  oxycodone,  methadone,  and  

alprazolam  without  examining  his  pa3ents  –  Ct.  rejected  pa3ent-­‐blaming  defense  

•  People  v.  Klein  (Florida  2012)  (ongoing)  –  Charged  with  first-­‐degree  murder  –  Prescribed  single  prescrip3on  for  over  200  pills  without  

determining  legi3mate  medical  need;  pa3ent  died  the  next  day  –  Adempted  to  blame  the  pa3ent  

Page 12: Cl 2 worth savage_rannazzisi

Recent  Cases  

•  People  v.  Tseng  (Los  Angeles  2012)  (ongoing)  –  “Dr.  Feelgood”;  charged  with  second-­‐degree  murder    –  Responsible  for  8  pa3ents’  deaths;  prescribed  without  proper  exam  

–  “If  a  pa3ent  decides  to  take  a  month’s  supply  in  a  day,  then  there’s  nothing  I  can  do  about  that”  (pa3ent-­‐blaming  /  lack  of  foreseeability  /  willful  ignorance)    

–  Voluntarily  surrendered  license;  sedled  civil  case  •  William  Mar3n  Valuck  (Oklahoma,  2013)  (ongoing)  

–  Charged  with  first-­‐degree  murder  for  deaths  of  9  pa3ent  –  Each  had  been  prescribed  between  250  and  600  pills    –  Surrendered  license;  civil  suit  pending  

Page 13: Cl 2 worth savage_rannazzisi

How  to  avoid  liability  

•  Prescriber  educa3on  •  Follow  best  prac3ces  to  meet  the  standard  of  care  (Dr.  Savage  to  elaborate)  

Page 14: Cl 2 worth savage_rannazzisi

Conclusion  

•  Michael  C.  Barnes  &  Stacey  L.  Sklaver,  Ac=ve  Verifica=on  and  Vigilance:  A  Method  To  Avoid  Civil  and  Criminal  Liability  When  Prescribing  Controlled  Substances,  15  DEPAUL  J.  HEALTH  CARE  L.  93(2013).  

•  LinkedIn.com/in/staceyworthy  

•  Thank  you  

Page 15: Cl 2 worth savage_rannazzisi

A Clinician’s View of Professional Responsibilities

with Respect to Opioids

Seddon R. Savage MD, MS

Silver Hill Hospital Chronic Pain & Recovery Center and

Geisel School of Medicine at Dartmouth

Page 16: Cl 2 worth savage_rannazzisi

Enduring Responsibilities

•  To heal when possible &

to comfort always

•  Above all else do no harm Hippocrates

Page 17: Cl 2 worth savage_rannazzisi

AMA Code of Ethics A physician shall

•  Provide  competent  care  with  compassion  &  respect  for  human  dignity  &  rights  

•  Uphold  standards  of  professionalism,  be  honest  in  professional  interac3ons,  &  report  physicians  deficient  in  character  or  competence,  or  engaging  in  fraud  

•  Respect  the  rights  of  pa3ents,  colleagues,  &  other  health  professionals  &  safeguard  pa3ent  confidences  &  privacy  within  constraints  of  the  law  

•  Study,  apply,  &  advance  scien3fic  knowledge,  provide  relevant  informa3on  to  pa3ents,  colleagues,  &  the  public,  obtain  consulta3on,  &  refer  when  indicated  

•  Except  in  emergencies,  be  free  to  choose  whom  to  serve,  with  whom  to  associate,  &  the  environment  in  which  to  prac3ce  

•  Par3cipate  in  ac3vi3es  to  improve  the  community  &  beder  the  public  health  

•  While  caring  for  a  pa3ent,  regard  responsibility  to  the  pa3ent  as  paramount  

•  Support  access  to  medical  care  for  all  people  

(Paraphrased to shorten)

Page 18: Cl 2 worth savage_rannazzisi

Accountability Systems for Physician Practice

•  Professional –  Peer review –  Credentialing

•  Regulatory –  Boards of Medicine

•  Meeting professional standards of care •  Complying with AMA Code of Ethics (some states) •  Compliance with state regulations, including State CSAs (+/- with AGs)

–  DEA •  CS registration & administrative compliance

•  Civil –  Malpractice liability

Page 19: Cl 2 worth savage_rannazzisi

Accountability Systems for Physician Practice

•  Criminal –  Federal & State justice systems with respect to practice

related criminal behavior •  Financial fraud •  Some HIPAA violations •  Credentialing fraud •  Assaults •  Other

– DEA with respect to CSA breach of providing CS •  For no legitimate medical purpose •  Outside the course of usual medical practice

•  And then there is the Media…

Page 20: Cl 2 worth savage_rannazzisi

Opioids are Unique

•  Potent in healing. Potent in harm with misuse.

•  Require practice strategies not required of other medications

•  Relate to subjective patient domains that cannot be objectively measured – Pain

– Reward

Page 21: Cl 2 worth savage_rannazzisi

Professional Standards with Respect to Opioids

•  Continuously evolving

•  Differ between states and communities

•  Reasonable to consider FSMB guidelines as a practice standard –  Informed by diverse professional perspectives

–  Inform many state standards

– Detailed and proscriptive

Page 22: Cl 2 worth savage_rannazzisi

Model Guideline on Opioids in Treatment of Chronic Pain, 2013

•  Legitimate medical practice –  Sound clinical judgment –  Current best clinical practices –  Appropriately documented –  Of demonstrable benefit to the patient

•  Usual course of practice –  A legitimate physician-patient relationship exists –  Medications are appropriate to the diagnosis –  Care includes careful follow-up monitoring of

•  Patient’s response to treatment •  Safe use of the prescribed medication

–  Therapy adjusted as indicated

Page 23: Cl 2 worth savage_rannazzisi

Model Guideline on Opioids in Treatment of Chronic Pain, 2013

•  Comprehensive pain assessment & indication for opioids

•  Screen for risk (interview/screening tool, records, PDMP)

•  Multidimensional treatment plan, adjusted to risk

•  Clear goals of treatment & initiate opioids as a trial

•  Written informed consent & treatment plan

•  Monitor regularly & adjust plan

•  Periodic drug screens & address findings

•  Consultation & referral when appropriate

•  Discontinue opioids if indicated, but not care http://www.fsmb.org/pdf/pain_policy_july2013.pdf

Page 24: Cl 2 worth savage_rannazzisi

Systems Challenges with Respect to Opioids

•  Ethically must have systems capacity to prescribe opioids when indicated –  In a manner that addresses pain and deters harm

•  Meeting practice standards requires a prepared office system – Challenging for small practices but doable – Opioid clinics or specialists within practice systems may

be helpful

Page 25: Cl 2 worth savage_rannazzisi

Special Clinical Challenges with Respect to Opioids

•  Perceived tension between “comfort always” & “do no harm”

•  Hijacked (addicted) brain may result in conflict – Patient seeking care in their best interest

– Patient seeking drugs to satisfy the beast

•  Profiteers may exploit compassionate physicians

•  Experts manage complex high risk patients

Page 26: Cl 2 worth savage_rannazzisi

Questions

•  Should a physician prescribing opioids in the course of usual practice for a legitimate medical purpose, acting with due diligence within the standards of practice be subject to criminal prosecution due to a patients actions? Eg (overdose or sale of opioids)

•  When do violations of professional standards become criminal acts?

Page 27: Cl 2 worth savage_rannazzisi

Opioid Medications

Harm Healing

Page 28: Cl 2 worth savage_rannazzisi

Joseph Rannazzisi Deputy Assistant Administrator Office of Diversion Control

Page 29: Cl 2 worth savage_rannazzisi

I  have  no  financial  rela3onships  to  disclose    and  

I  will  not  discuss  off-­‐label  use  and/or  inves3ga3onal  drug  use  in  my  presenta3on  

Disclosure Statement

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 30: Cl 2 worth savage_rannazzisi

  Factors  to  be  considered  prior  to  prescribing  a  controlled  substance  

  Discuss  legal  obliga3ons  of  the  DEA  registrant    Discuss  poten3al  Red  Flags  and  the  process  of  

reconciling    

  Iden3fy  methods  of  pharmaceu3cal  diversion    and  discuss  how  a  health  care  prac33oner  can  prevent  diversion    

Goals and Objectives

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 31: Cl 2 worth savage_rannazzisi

Inadequate Pain Control

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 32: Cl 2 worth savage_rannazzisi

We  conclude  that  despite  widespread  use  of  narco3c  drugs  in  hospitals,  the  development  of  addic3on  is  rare  in  medical  pa3ents  with  no  

history  of  addic3on.  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 33: Cl 2 worth savage_rannazzisi

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

Source: CDC/NCHS, NVSS U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 34: Cl 2 worth savage_rannazzisi

Source: 2004, 2007, 2008, 2009, 2010, 2011, 2012 National Survey on Drug Use and Health U.S.  Drug  Enforcement  Administra3on  

Office  of  Diversion  Control        

Page 35: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 36: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 37: Cl 2 worth savage_rannazzisi

The Trinity

C-­‐IV  as  of  1/11/2012  

Hydrocodone  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 38: Cl 2 worth savage_rannazzisi

The Controlled Substances Act

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 39: Cl 2 worth savage_rannazzisi

CSA Registrant Population

March  20,  2014  

Provisional  registraEons    in  effect  at  the  Eme  CSA    was  passed  (relaEve  to  the  Harrison  NarcoEcs  Act  of  1914)  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 40: Cl 2 worth savage_rannazzisi

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 ...”

Page 41: Cl 2 worth savage_rannazzisi

Cyclic Investigations

Security Requirements

Recordkeeping Requirements

ARCOS Reporting

Established Quotas

Registration

Established Schedules

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Closed System of Distribution

Page 42: Cl 2 worth savage_rannazzisi

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 43: Cl 2 worth savage_rannazzisi

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 44: Cl 2 worth savage_rannazzisi

The Controlled Substances Act

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 45: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 46: Cl 2 worth savage_rannazzisi

Diversion via the Internet

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 47: Cl 2 worth savage_rannazzisi

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

Page 48: Cl 2 worth savage_rannazzisi

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

Page 49: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

What has been the reaction????

Page 50: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 51: Cl 2 worth savage_rannazzisi

Problem Solved, Right?

Wrong!!!!!  

The  Emergence  of  Rogue  Pain  Clinics…  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 52: Cl 2 worth savage_rannazzisi

Pain Clinics

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 53: Cl 2 worth savage_rannazzisi

Explosion of South Florida Pain Clinics

As  of  June  4,  2010,  Florida  has  received  1,118  applica3ons  and  has  approved  1026  *As  of  May  14,  2010,  Broward  142;  Miami-­‐Dade  79;  Palm  Beach  111    U.S.  Drug  Enforcement  Administra3on  

 Office  of  Diversion  Control        

Page 54: Cl 2 worth savage_rannazzisi

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 55: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        NFLIS  Query  Date:  02/24/14  

Page 56: Cl 2 worth savage_rannazzisi

Medical Care ?

 Many  of  these  clinics  are  prescrip3on/dispensing  mills  

 Minimal  prac33oner/pa3ent  interac3on  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 57: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 58: Cl 2 worth savage_rannazzisi

DEA  Distributor  IniEaEve    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  Administra3on  

 Office  of  Diversion  Control        

Page 59: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 60: Cl 2 worth savage_rannazzisi
Page 61: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 62: Cl 2 worth savage_rannazzisi

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 63: Cl 2 worth savage_rannazzisi

Perfunctory  ini3al  physical  exam…return  visits  no  exam  

Physical  exam  included  needle  mark  checks…some  were  simulated  

Pa3ent  received  quan3ty  of  drugs  requested…were  charged  based  on  quan3ty  

Unsupervised  urinalysis  –  results  did  not  mader  

Accurate  records  not  kept  –  quan3ty  dispensed  not  recorded  

Prac33oner  not  authorized  to  conduct  methadone  maintenance;  

Pa3ent  directed  prescribing;    U.S.  Drug  Enforcement  Administra3on  

 Office  of  Diversion  Control        

Page 64: Cl 2 worth savage_rannazzisi

Rosen  was  a  68  yo  physician  who  had  a  prac3ce  that  was  focused  on  obesity.  He  dispensed  large  quan33es  of  s3mulants  to  undercover  officers    outside  the  scope  and  not  for  a  legi3mate  purpose.      

The  5th  circuit  had  to  address  whether  the  medica3on  was  dispensed  “for  a  legi3mate  medical  purpose  and  in  the  course  of  the  doctors  professional  prac3ce.”    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  quan3ty  of  controlled  substances  prescribed  

Large  numbers  of  prescrip3on  were  issued  

No  physical  exam  given  

The  physician  warned  the  pa3ent  to  fill  prescrip3ons  at  different    drug  stores  U.S.  Drug  Enforcement  Administra3on  

 Office  of  Diversion  Control        

Page 65: Cl 2 worth savage_rannazzisi

Customers  coming  into  the  pharmacy  in  groups,  each  with  the  same  prescrip3ons  issued  by  the  same  physician;  and  

Customers  with  prescrip3ons  for  controlled  substances  wriden  by  physicians  not  associated  with  pain  management  (i.e.,  pediatricians,  gynecologists,  ophthalmologists,  etc.).  

Overwhelming  propor3on  of  prescrip3ons  filled  by  pharmacy  are  controlled  substances  

Pharmacist  did  not  reach  out  to  other  pharmacists  to  determine  why  they  were  not  filling  a  par3cular  doctors  prescrip3on  

Verifica3on  of  legi3macy  not  sa3sfied  by  a  call  to  the  doctors  office  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 66: Cl 2 worth savage_rannazzisi

The  physician  issued  prescrip3ons  to  a  pa3ent  known  to  be  delivering  the  drugs  to  others  

The  physician  prescribed  controlled  drugs  at  intervals  inconsistent  with  legi3mate  medical  treatment  

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

There  was  no  logical  rela3onship  between  the  drug  prescribed  and  treatment  of  the  condi3on  allegedly  exis3ng  

The  physician  wrote  more  than  one  prescrip3on  on  occasions  in  order  to  spread  them  out  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 67: Cl 2 worth savage_rannazzisi

Pa3ents  receiving  the  same  combina3on  of  prescrip3ons;  cocktail  

Pa3ents  receiving  the  same  strength  of  controlled  substances;  no  individualized  dosing:  mul3ple  prescrip3ons  for  the  strongest  dose  

Majority  of  pa3ents  paying  cash  for  their  prescrip3ons  

Pa3ent  asking  for  drugs  in  street  slang  

Pa3ent  directed  prescribing  

Early  refills  

No  specialized  training  in  pain  management;  

Individuals  driving  long  distances  to  visit  physicians  and/or  to  fill  prescrip3ons  

No  records/pa3ent  contracts/  urinalysis     U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 68: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 69: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 70: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 71: Cl 2 worth savage_rannazzisi

The Last Line of Defense

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

THE  PHARMACIST  

Page 72: Cl 2 worth savage_rannazzisi

  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  Administra3on    Office  of  Diversion  Control        

Page 73: Cl 2 worth savage_rannazzisi

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  Administra3on  

 Office  of  Diversion  Control        

Page 74: Cl 2 worth savage_rannazzisi

Inquiries  by  pharmacists  with  doctors  regarding  the  ra3onale  behind      prescrip3ons,  diagnoses    and  treatment  plans  are  inappropriate,  

according  to  a  new  resolu3on  by  the  American  Medical  Associa3on.    

The  AMA  adopted  the  resolu3on  at  its  2013  annual  mee3ng,  calling  such  inquiries  “an  interference  with  the  prac3ce  of  medicine  and  

unwarranted”.  

Page 75: Cl 2 worth savage_rannazzisi

Red Flag?

What  happens  next?  

You  adempt  to  resolve…  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 76: Cl 2 worth savage_rannazzisi

Many  customers  receiving  the  same  combina3on  of  prescrip3ons;  cocktail  

Many  customers  receiving  the  same  strength  of  controlled  substances;  no  individualized  dosing:  mul3ple  prescrip3ons  for  the  strongest  dose  

Many  customers  paying  cash  for  their  prescrip3ons  

Early  refills  

Many  customers  with  the  same  diagnosis  codes  wriden  on  their  prescrip3ons;  

Individuals  driving  long  distances  to  visit  physicians  and/or  to  fill  prescrip3ons;    

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 77: Cl 2 worth savage_rannazzisi

Customers  coming  into  the  pharmacy  in  groups,  each  with  the  same  prescrip3ons  issued  by  the  same  physician;  and  

Customers  with  prescrip3ons  for  controlled  substances  wriden  by  physicians  not  associated  with  pain  management  (i.e.,  pediatricians,  gynecologists,  ophthalmologists,  etc.).  

Overwhelming  propor3on  of  prescrip3ons  filled  by  pharmacy  are  controlled  substances  

Pharmacist  did  not  reach  out  to  other  pharmacists  to  determine  why  they  were  not  filling  a  par3cular  doctors  prescrip3on  

Verifica3on  of  legi3macy  not  sa3sfied  by  a  call  to  the  doctors  office  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 78: Cl 2 worth savage_rannazzisi

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 79: Cl 2 worth savage_rannazzisi

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  Administra3on    Office  of  Diversion  Control        

Page 80: Cl 2 worth savage_rannazzisi

Remaining  States  593,625,290  dosage  units   Florida  

94,923,484  dosage  units  

Source:    ARCOS    Date  Prepared:      01/30/2014   U.S.  Drug  Enforcement  Administra3on  

 Office  of  Diversion  Control        

Page 81: Cl 2 worth savage_rannazzisi

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  Administra3on  

 Office  of  Diversion  Control        

Page 82: Cl 2 worth savage_rannazzisi

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  pa3ents.  Dr.  Paul  Volkman  made  weekly  trips  from  Chicago  to  three  loca3ons  in  Portsmouth  in  southern  Ohio  and  one  in  Chillicothe  in  central  Ohio  before  federal  inves3gators  shut  down  the  opera3ons  in  2006,  prosecutors  said.  He  was  sentenced  in  federal  court  in  Cincinna3.  "This  criminal  conduct  had  devasta3ng  consequences  to  the  community  Volkman  was  supposed  to  serve,"  Assistant  U.S.  Adorneys  Adam  Wright  and  Tim  Oakley  said  in  a  court  filing  ahead  of  Tuesday's  hearing.  "Volkman's  ac3ons  created  and  prolonged  debilita3ng  addic3ons;  distributed  countless  drugs  to  be  sold  on  the  street;  and  took  the  lives  of  numerous  individuals  who  died  just  days  azer  visi3ng  him,"  they  said.  The  64-­‐year-­‐old  Volkman  fired  his  adorneys  earlier  this  month  and  said  he  acted  at  all  3mes  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  handwriden  court  filing  Monday,  maintaining  that  he  did  all  those  things  and  more  for  his  pa3ents.  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 83: Cl 2 worth savage_rannazzisi

Violations?

What  happens  next…..  

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 84: Cl 2 worth savage_rannazzisi

DEA Legal Recourse  Administra3ve                        Immediate  Suspension  Order  (ISO)  

                     Memorandum  of  Agreement  (MOA)  

                     Order  to  Show  Cause  (OTSC)  

 Civil                        Fines  

 Criminal  

                     Tac3cal  Diversion  Squads    U.S.  Drug  Enforcement  Administra3on  

 Office  of  Diversion  Control        

Page 85: Cl 2 worth savage_rannazzisi

How Do You Lose Your Registration?

The  Order  to  Show  Cause  Process    21  USC  §  824  

a)  Grounds  –    1.  Falsifica3on  of  Applica3on  2.  Felony  Convic3on  3.  State  License  or  Registra3on  suspended,  revoked  or  denied  –  

no  longer  authorized  by  State  law  4.  Inconsistent  with  Public  Interest  5.  Excluded  from  par3cipa3on  in  Title  42  USC  §  1320a-­‐7(a)  

program  

b)        AG  discre3on,  may  suspend  any  registra3on  simultaneously  with  Order  to  Show  Cause  upon  a  finding  of  Imminent  Danger  to  Public  Health  and  Safety    

Page 86: Cl 2 worth savage_rannazzisi

* FY2014 as of February 27, 2014

Administrative Actions Initiated by DEA FY2007 thru 2014*

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control        

Page 87: Cl 2 worth savage_rannazzisi
Page 88: Cl 2 worth savage_rannazzisi
Page 89: Cl 2 worth savage_rannazzisi

Thank You!

U.S.  Drug  Enforcement  Administra3on    Office  of  Diversion  Control