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Pharmacy: The DEA Regulations Update - Joe Rannazzisi

Pharmacy: The DEA Regulations Update - Joe Rannazzisi

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Ph 4 rannizzisi Ph 4 rannizzisi Presentation Transcript

  • Joseph Rannazzisi Deputy Assistant Administrator Office of Diversion Control
  • I  have  no  financial  rela.onships  to  disclose     and   I  will  not  discuss  off-­‐label  use  and/or   inves.ga.onal  drug  use  in  my  presenta.on   Disclosure Statement U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • 1.  Iden.fy  the  legal  standard  for  dispensing   medica.ons  pursuant  to  a  valid  prescrip.on.     2.  Iden.fy  the  basis  and  effects  of  the  proposed   DEA  regula.ons.     3.  List  the  factors  the  pharmacist  should   consider  in  determining  whether  to  dispense   medica.on.     Learning Objectives U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  •   Iden.fy  the  legal  standard  for  dispensing   medica.ons  pursuant  to  a  valid  prescrip.on     Iden.fy  regula.ons  that  establish  prac..oners   legal  requirements  under  21  USC     List  the  factors  the  pharmacist  should  consider   prior  to  dispensing     Review  status  of  drug  disposal  legisla.on  and   regula.ons   Goals and Objectives U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • In  2010,  approximately  38,329  uninten7onal  drug   overdose  deaths  occurred  in  the  United  States,  one   death  every  14  minutes.     Of  this  number,  22,134  of  these  deaths  were   aFributed  to  Prescrip7on  Drugs  (16,651  aFributed   to  opioid  overdoses/  75.2  %).     Prescrip7on  drug  abuse  is  the  fastest  growing  drug   problem  in  the  United  States.   Source: CDC Drug Overdose Deaths in the United States, 2010 (October 2012) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Consequences
  • Although  more  men  die  from  drug  overdoses  than  woman,   the  percentage  increase  in  deaths  since  1999  is  greater     among    woman.    More  woman  have  died  each  year     from  drug  overdoses  than  from  motor  vehicle–related     injuries  since  2007.    Deaths  and  ED  visits  related  to  OPR   con.nue  to  increase  among  woman.  
  • U.S. Drug Overdose Deaths by Major Drug Type, 1999-2010 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Source: CDC/NCHS, NVSS
  • Drug-Induced Deaths vs. Other Injury Deaths (1999–2009) Source: National Center for Health Statistics, Centers for Disease Control and Prevention. National Vital Statistics Reports Deaths: Final Data for the years 1999 to 2009 (January 2012). Causes  of  death  aTributable  to  drugs  include  accidental  or  inten.onal  poisonings  by  drugs  and  deaths   from  medical  condi.ons  resul.ng  from  chronic  drug  use.    Drug-­‐induced  causes  exclude  accidents,   homicides,  and  other  causes  indirectly  related  to  drug  use.    Not  all  injury  cause  categories  are  mutually   exclusive.   U.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control        
  • 2011 Current Users (Past Month) 2012    Source:  2011  &  2012  NSDUH  
  • More Americans abuse prescription drugs than the number of: Cocaine, Hallucinogen, Heroin, and Inhalant abusers U.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control        
  • Source: 2004, 2007, 2008, 2009, 2010, 2011, 2012 National Survey on Drug Use and Health U.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control        
  • Source: 2011 National Survey on Drug Use and Health U.S.  Drug  Enforcement  Administra.on   Office  of  Diversion  Control         Percentage of Past Month Nonmedical Use of Psychotherapeutics by Age, 2003-2011
  • SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA) Past Year Initiates 2012 – Ages 12 and Older U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         SOURCE: The DAWN Report, Highlights of the 2009 Drug Abuse Warning Network (DAWN) Findings on Drug-Related Emergency Department Visits, December 28, 2010
  • SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA) Substances for Which Most Recent Treatment Was Received in the Past Year among Persons Aged 12 or Older: 2012
  • SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 03, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA) Substances for Which Most Recent Treatment Was Received in the Past Year among Persons Aged 12 or Older: 2002-2012
  • Questions to Discuss        According  to  the  Na.onal  Survey  on  Drug  Use  and      Health  (NSDUH),  in  2012  there  were  6.8  million    persons  aged  12  and  older  who  used  prescrip.on-­‐  type   psychotherapeu.c  drugs  non-­‐medically  in  the    last   month.  Which  class  of  pharmaceu.cal  had  the    highest   level  of  non-­‐medical  use?    A)  S.mulants    B)  Seda.ves    C)  Pain  relievers    D)  Tranquilizers     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Number of Forensic Cases 2001-2011 0   5,000   10,000   15,000   20,000   25,000   30,000   35,000   40,000   45,000   50,000   2001  2002  2003  2004  2005  2006  2007  2008  2009  2010  2011   240%     257%     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         322%    
  • Poisoning Deaths: Opioid Analgesics *2009  data  approximated   *  
  • Drug Overdose Mortality Rates per 100,000 People 1999 Source: Trust for America’s Health, www.healthyamericans.org. “Prescription Drug Abuse: Strategies to Stop the Epidemic (2013)” U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source: Trust for America’s Health, www.healthyamericans.org. “Prescription Drug Abuse: Strategies to Stop the Epidemic (2013)” Drug Overdose Mortality Rates per 100,000 People 2010 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  •  Most severe in Southwest and Appalachian  In 2010, the top three states were West Virginia, New Mexico, and Kentucky; West Virginia: 28.9 deaths per 100,000 New Mexico: 23.8 deaths per 100,000 Kentucky: 23.6 deaths per 100,000  Lowest-North Dakota: 3.4 deaths per 100,000  Minnesota ranked 47th 7.3 deaths per 100,000 Where Prescription Painkiller Overdose Deaths Are The Highest SOURCE: Trust for America’s Heath-Prescription Drug Abuse: Strategies To Stop The Epidemic; October 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Naloxone     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source:  U.S.  Census  Bureau   Statistical Perspective U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Why is the problem outpacing population growth? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Violence U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Prescription drug epidemic? How did we get to this point? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • 70s  Public  Service  Announcement  –  The  Magician  
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The 1960s/70s/80s Downers  -­‐  Barbiturates   Uppers  -­‐  Amphetamines   Meprobamate   Hydromorphone   “Ts  and  Blues”   “Fours  and  Doors”   Oxycodone/APAP   Methaqualone  
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         The 1990s
  • Hydrocodone AlprazolamOxycodone 30 mg Carisoprodol   OxyCon.n®  80mg   (Oxycodone  controlled-­‐release)   Commonly Abused Controlled Pharmaceuticals Oxymorphone   C-­‐IV  as  of  1/11/2012  
  • The Trinity C-­‐IV  as  of  1/11/2012   Hydrocodone   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         The HolyTrinity
  • Inadequate Pain Control U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • We  conclude  that  despite  widespread  use  of   narco.c  drugs  in  hospitals,  the  development  of   addic.on  is  rare  in  medical  pa.ents  with  no   history  of  addic.on.   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • 1.Temperature   2.Heart  Rate   3.Blood  Pressure   4.Respira.on     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         The Fifth Vital Sign? 5.Pain?  
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Now,  Dr.  Portenoy  and  other  pain  doctors  who  promoted   the  drugs  say  they  erred  by  oversta.ng  the  drugs’   benefits  and  glossing  over  risks.    “Did  I  teach  about  pain   management,  specifically  about  opioid  therapy,  in  a  way   that  reflects  misinforma.on?    We,  against  the  standards   of  2012,  I  guess  I  did,”  Dr.  Portenoy  said  in  an  interview   with  The  Wall  Street  Journal.  “We  didn’t  know  then   what  we  know  now.”   Source:  The  Wall  Street  Journal,  December  15-­‐16,  2012  
  • Direct to Consumer Advertising U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  •  We will not arrest our way out of this problem!!!!! Enforcement  is  just  as  important  as….   Preven.on/Educa.on   Treatment   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Drug Education U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Education    Children/Teens    Informa.on  from  the  Internet    or  their  peers    Following  parents     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Parents & Their Attitudes Parents are not discussing the risks of abusing prescription drugs Source: 2011 Partnership Attitude Tracking Study U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source of Concerns  1 in 5 parents (20 percent) report that they have given their teen a prescription drug that was not prescribed to them.  17 percent of parents do not throw away expired medications.  14 percent of parents say they themselves have misused or abused prescription drugs within the past year.  49 percent of parents say anyone can access their medicine cabinet. SOURCE: 2012 Partnership Attitude Tracking Study Report; Partnership for a Drug-Free America and MetLife Foundation, published April 23, 2013. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Where do kids get their information from?   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         www.EROWID.org  
  • www.EROWID.org  
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Community  Coali.ons  and   Advocacy  Groups   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Education      Physicians/Den.sts/Prac..oners        Prescribing  habits    Mandatory  opiate  prescribing    con.nuing  educa.on?   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Education  Pharmacists    Drug  Experts  in  the  health  care    delivery  system    Corresponding  responsibility   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Scheduled  PDACs   18-­‐Phoenix,  AZ  June  28-­‐29,  2014   19-­‐Philadelphia,  PA  July  12-­‐13,  2014   20-­‐Denver,  CO  Aug  2-­‐3,  2014   21-­‐Salt  Lake  City,  UT  Aug  23-­‐24,  2014                                            FL    2                  WA        UT        OR   CA    NV          ID        MT            AZ    WY    CO      NM ND SD                                TX                                                    4 NE KS                          OK   MN IA        MO AR LA MI WI      IL IN    6                    KY    TN      MS AL GA              3 OH            1  WV                        VA                      NC      SC PA                  NY                            5 MA ME DC   MD   NJ   CT   RI   DE   NH   VT   12 B 12A 18 21 20 7 11 10 17 9 14 8 16 15 13 19        Completed  PDACs                        Scheduled PDACs April  8,  2014   Completed  PDACs                            ATendance   1-­‐Cincinna.,  OH    9/17-­‐18/11                   75   2-­‐WPB,  FL    3/17-­‐18/12                               1,192   3-­‐Atlanta,  GA  6/2-­‐3/12                             328   4-­‐Houston,  TX  9/8-­‐9/12                         518   5-­‐Long  Island,  NY  9/15-­‐16/12               391   6-­‐Indianapolis,  IN    12/8-­‐9/12                                    137   7-­‐Albuquerque,  NM  3/2-­‐3/13                             284   8-­‐Detroit,  MI  5/4-­‐5/13                               643   9-­‐Chicago,  IL    6/22-­‐23/13                               321   10-­‐Portland,  OR  7/13-­‐14/13                     242   11-­‐Baton  Rouge,  LA    8/3-­‐4/13       259   12A-­‐San  Diego,  CA  8/16-­‐17/13             353   12B-­‐San  Jose,  CA  8/18-­‐19/13                 434   13-­‐Boston,  MA  9/21-­‐22/13                         275   14-­‐Louisville,  KY  11/16-­‐17/13                 149   15-­‐CharloTe,  NC  2/8-­‐9/14   513   16-­‐Knoxville,TN  3/22-­‐23/14   246   17-­‐St.  Louis,  MO  4/5-­‐6/14   224              Total  ATendance       6,584  
  • The Controlled Substances Act U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • CSA Registrant Population March  20,  2014   Provisional  registra7ons    in  effect  at  the   7me  CSA    was  passed  (rela7ve  to  the   Harrison  Narco7cs  Act  of  1914)   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Foreign Mfr Importer Manufacturer Distri- butor Practitioner Pharmacy Hospital Clinic Patient ? Law: 21 USC 822 (a) (1) Persons Required to Register: “Every person who manufactures or distributes any Controlled Substance or List I Chemical or who proposes to engage in ..” Law: 21 USC 822 (a) (2) Persons Required to Register: “Every person who dispenses, or who proposes to dispense any controlled substance ...”
  • Cyclic Investigations Security Requirements Recordkeeping Requirements ARCOS Reporting Established Quotas Registration Established Schedules U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Closed System of Distribution
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The Controlled Substances Act U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The Flow of Pharmaceuticals PATIENTS Hospitals NTPs 21 CFR 1306.04 Physicians (Rx and drugs) Pharmacies QUOTASRaw Material Importers Imp - Manufacturers 21 USC 823(c)(1) 21 USC 823(d)(1) 21 CFR 1301.71 Dosage Form Manufacturers Manufacturers Dosage Form Manufacturers 21 USC 823(b)(1) 21 USC 823(e)(1) 21 CFR 1301.71 21 CFR 1301.74 (Suspicious Orders) Wholesalers - DistributorsSmaller Distributors U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Diversion via the Internet U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WA OR ID WY ND SD MN NE WI MI CO KS MO IL IN UT NV CA AZ NM OK AR LA TN KY MS AL GA SC NC OH VA PA NY ME V T N H CT DE WV RI MD MA Domestic ‘Rx’ Flow MTMT FL TX TX 2. Request goes through Website Server in San Antonio, TX WS FL IAIA NJ 1. Consumer in Montana orders hydrocodone on the Internet C 3. Web Company (located in Miami, FL) adds request to queue for Physician approval WC 4. Order is approved by Physician in New Jersey and returned to Web Company Dr. S 6. Pharmacy in Iowa fills order and ships to Consumer via Shipper Rx 5. Approved order then sent by Web Company to an affiliated Pharmacy
  • Purchases of hydrocodone by Known and Suspected Rogue Internet Pharmacies January 1, 2006 – December 31, 2006 Date  Prepared:      03/07/2007  Source:    ARCOS   98,566,711
  • Checks and Balances of the CSA and the Regulatory Scheme   Distributors of controlled substances “The registrant shall design and operate a system to disclose to the registrant suspicious orders of controlled substances…Suspicious orders include orders of unusual size, orders deviating substantially from a normal pattern, and orders of unusual frequency.” (21 CFR §1301.74) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • DEA  Distributor  Ini7a7ve     Purpose and format:   Educate and inform distributors/manufacturers of their due diligence responsibilities under the CSA by discussing their Suspicious Order Monitoring System, reviewing their ARCOS data for sales and purchases of Schedules II and III controlled substances, and discussing national trends involving the abuse of prescription controlled substances   August 2005 – Present: Briefings to 83 firms with 276 locations Examples of civil action against distributors: Cardinal Health , $34 million civil fine McKesson, $13.25 million civil fine Harvard, $6 million civil fine Examples of suspension, surrender or revocation of DEA registration Keysource, loss of DEA registration Sunrise, loss of DEA registration U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source:  www.kuow.org  ,   01/30/2014   John Gray, president and CEO of Healthcare Distribution Management Association, said suppliers used to have a more cooperative and collaborative relationship with the Drug Enforcement Agency. But things have changed, he said. “It’s all been dumped in our laps as wholesalers to make what I would consider to be law enforcement decisions as to whether or not a particular customer or account is or is not over what the DEA, in their own mind, thinks is a viable limit for Schedule II drugs they ought to be dispensing,” Gray said. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • “At  the  .me  we  filled  these  orders,  the  pharmacies  held  valid  state     board  of  pharmacy  and  DEA  licenses,”  BarreT  said  in  a  call  to  investors  on   Friday.  “Pharmaceu.cal  distributors  do  not  influence  the  manufacture  of   controlled  medicines.  We  do  not  write  prescrip.ons.  We  do  not  dispense   controlled  medicines,  nor  do  we  license  pharmacies.  Our  role  is,  as  a   distributor,  a  cri.cal  link  in  the  supply  chain  between  pharmaceu.cal   manufacturers  and  pharmacies.  “      Cardinal  CEO  George  BarreT   The  Company  called  the  DEA  ac.on    “a  dras.c  overreac.on”   that  would  disrupt  delivery  of  cri.cal  medica.ons  to     hospitals  and  pharmacies.  
  • H.R.  4069:  Ensuring  Pa.ent  Access  and     Effec.ve  Drug  Enforcement  Act  of  2013   This  bill  effec.vely  eliminates  the  DEA’s  administra.ve  powers  of  the  OTSC  and  ISO  op.ons,  and   instead  requires  DEA  to  give  no.ce  and  offer  the  registrant  an  opportunity  to  submit  a  correc.ve   ac.on  plan.   An  ISO  is  issued  to  protect  the  public  from  imminent  harm.    By  redefining  an  ISO  and  delaying   it’s  issuance,  the  bill  would  prevent  the  DEA  from  protec.ng  the  public  when  harm  is  imminent.   DEA  conducts  more  5,000  inspec.ons  on  registrants  yearly  and  takes  administra.ve  ac.on  on  a   very  small  percentage  of  those  registrants  inspected.  
  • Checks and Balances Under the CSA •  Practitioners “A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.” (21 CFR §1306.04 (a)) United States v Moore 423 US 122 (1975) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Perfunctory  ini.al  physical  exam…return  visits  no  exam   Physical  exam  included  needle  mark  checks…some  were  simulated   Pa.ent  received  quan.ty  of  drugs  requested…were  charged  based   on  quan.ty   Unsupervised  urinalysis  –  results  did  not  maTer   Accurate  records  not  kept  –  quan.ty  dispensed  not  recorded   Prac..oner  not  authorized  to  conduct  methadone  maintenance;   Pa.ent  directed  prescribing;     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Rosen  was  a  68  yo  physician  who  had  a  prac.ce  that  was  focused  on  obesity.  He   dispensed  large  quan..es  of  s.mulants  to  undercover  officers    outside  the   scope  and  not  for  a  legi.mate  purpose.       The  5th  circuit  had  to  address  whether  the  medica.on  was  dispensed  “for  a   legi.mate  medical  purpose  and  in  the  course  of  the  doctors  professional   prac.ce.”    In  its  analysis,  the  court  stated,  “We  are  however,  able  to  glean   from  reported  cases,  certain  recurring  concomitance  of  condemned   behavior,  examples  of  which  include  the  following:     An  inordinately  large  quan.ty  of  controlled  substances  prescribed   Large  numbers  of  prescrip.on  were  issued   No  physical  exam  given   The  physician  warned  the  pa.ent  to  fill  prescrip.ons  at  different    drug  stores   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Customers  coming  into  the  pharmacy  in  groups,  each  with  the  same   prescrip.ons  issued  by  the  same  physician;  and   Customers  with  prescrip.ons  for  controlled  substances  wriTen  by  physicians  not   associated  with  pain  management  (i.e.,  pediatricians,  gynecologists,   ophthalmologists,  etc.).   Overwhelming  propor.on  of  prescrip.ons  filled  by  pharmacy  are  controlled   substances   Pharmacist  did  not  reach  out  to  other  pharmacists  to  determine  why  they  were   not  filling  a  par.cular  doctors  prescrip.on   Verifica.on  of  legi.macy  not  sa.sfied  by  a  call  to  the  doctors  office   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The  physician  issued  prescrip.ons  to  a  pa.ent  known  to  be  delivering  the  drugs  to   others   The  physician  prescribed  controlled  drugs  at  intervals  inconsistent  with  legi.mate   medical  treatment   The  physician  involved  used  street  slang  rather  than  medical  terminology  for  the  drugs   prescribed   There  was  no  logical  rela.onship  between  the  drug  prescribed  and  treatment  of  the   condi.on  allegedly  exis.ng   The  physician  wrote  more  than  one  prescrip.on  on  occasions  in  order  to  spread  them   out   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Pa.ents  receiving  the  same  combina.on  of  prescrip.ons;  cocktail   Pa.ents  receiving  the  same  strength  of  controlled  substances;  no  individualized   dosing:  mul.ple  prescrip.ons  for  the  strongest  dose   Majority  of  pa.ents  paying  cash  for  their  prescrip.ons   Pa.ent  asking  for  drugs  in  street  slang   Pa.ent  directed  prescribing   Early  refills   No  specialized  training  in  pain  management;   Individuals  driving  long  distances  to  visit  physicians  and/or  to  fill  prescrip.ons   No  records/pa.ent  contracts/  urinalysis     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The Controlled Substances Act Illegal Distribution 21 U.S.C. § 841 (a) Unlawful acts: Except as authorized by this subchapter, it shall be unlawful for any person to knowingly or intentionally (1) to manufacture, distribute or dispense, or possess with intent to manufacture, distribute or dispense, a controlled substance; or U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Checks and Balances Under the CSA Pharmacists – The Last Line of Defense “The responsibility for the proper prescribing and dispensing of controlled substances is upon the practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription.” (21 CFR §1306.04(a)) U.S v. Hayes 595 F. 2d 258 (5th Cir 1979) U.S. v. Leal 75 F. 3d 219 (6th Cir 1996) U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010) East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27, 2010) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Checks and Balances Under the CSA Pharmacists – The Last Line of Defense “An order purporting to be a prescription issued not in the course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the act (21 USC 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.” (21 CFR §1306.04(a)) U.S v. Hayes 595 F. 2d 258 (5th Cir 1979) U.S. v. Leal 75 F. 3d 219 (6th Cir 1996) U.S. v. Birbragher 603 F. 3d 478 (8th Cir 2010) East Main Street Pharmacy 75 Fed. Reg. 66149 (Oct. 27, 2010) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The Last Line of Defense U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Pharmacists
  •   The $80 million settlement is the largest fine related to DEA’s strategy of cracking down on rampant prescription drug abuse by targeting large corporations   Walgreen “negligently allowed” prescription painkillers to be diverted for illegal black market sales   The license of a Florida facility used by Walgreen to distributed controlled substances was revoked for two years U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The $80 million settlement is the largest fine paid by a pharmacy chain as related to DEA’s strategy of cracking down on rampant prescription drug abuse U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Inquiries  by  pharmacists  with  doctors  regarding  the  ra.onale  behind       prescrip.ons,  diagnoses    and  treatment  plans  are  inappropriate,   according  to  a  new  resolu.on  by  the  American  Medical  Associa.on.     The  AMA  adopted  the  resolu.on  at  its  2013  annual  mee.ng,  calling   such  inquiries  “an  interference  with  the  prac.ce  of  medicine  and   unwarranted”.  
  • Red Flag? What  happens  next?   You  aTempt  to  resolve…   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Many  customers  receiving  the  same  combina.on  of  prescrip.ons;  cocktail   Many  customers  receiving  the  same  strength  of  controlled  substances;  no   individualized  dosing:  mul.ple  prescrip.ons  for  the  strongest  dose   Many  customers  paying  cash  for  their  prescrip.ons   Early  refills   Many  customers  with  the  same  diagnosis  codes  wriTen  on  their  prescrip.ons;   Individuals  driving  long  distances  to  visit  physicians  and/or  to  fill  prescrip.ons;     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Customers  coming  into  the  pharmacy  in  groups,  each  with  the  same   prescrip.ons  issued  by  the  same  physician;  and   Customers  with  prescrip.ons  for  controlled  substances  wriTen  by  physicians  not   associated  with  pain  management  (i.e.,  pediatricians,  gynecologists,   ophthalmologists,  etc.).   Overwhelming  propor.on  of  prescrip.ons  filled  by  pharmacy  are  controlled   substances   Pharmacist  did  not  reach  out  to  other  pharmacists  to  determine  why  they  were   not  filling  a  par.cular  doctor’s  prescrip.on   Verifica.on  of  legi.macy  not  sa.sfied  by  a  call  to  the  doctors  office   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Large-Scale Diversion  In  2009,  the  average  purchase  for  all  oxycodone  products  for   all  pharmacies  in  US  –  63,294  d.u.    In  2010,  the  average  was  –  69,449  d.u.    In  2009,  the  average  purchase  for  all  oxycodone  products  for   the  top  100  pharmacies  in  Florida  –  1,226,460  d.u.    In  2010,  the  average  was  –  1,261,908  d.u.   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        Source:  DEA  Automated  Reports  and  Consolidated  Orders  System  (ARCOS)  
  • Purchases of Oxycodone 30mg  In  2009,    44%  of  all  oxycodone  30mg  products   were  distributed  to  Florida    In  2010,    43%  of  all  oxycodone  30mg  products   were  distributed  to  Florida   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        Source:  DEA  Automated  Reports  and  Consolidated  Orders  System  (ARCOS)  
  • Remaining  States   593,625,290  dosage  units   Florida   94,923,484  dosage  units   Source:    ARCOS     Date  Prepared:      01/30/2014   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Florida   94,923,484  dosage  units   New  York   50,658,100  dosage   units   Remaining  States   486,977,390  dosage  units   California   55,989,800  dosage   units   Source:    ARCOS     Date  Prepared:      01/30/2014   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Paul  Volkman,  Chicago  Doctor,  Gets  4  Life  Terms   In  Drug  Overdose  Case     ANDREW  WELSH-­‐HUGGINS      02/14/12  06:45  PM  ET  Associated  Press         COLUMBUS,  Ohio  —  A  Chicago  doctor  who  prosecutors  say  dispensed  more  of  the  powerful  painkiller  oxycodone  from  2003   to  2005  than  any  other  physician  in  the  country  was  sentenced  Tuesday  to  four  life  terms  in  the  overdose  deaths  of  four   pa.ents.   Dr.  Paul  Volkman  made  weekly  trips  from  Chicago  to  three  loca.ons  in  Portsmouth  in  southern  Ohio  and  one  in  Chillicothe  in   central  Ohio  before  federal  inves.gators  shut  down  the  opera.ons  in  2006,  prosecutors  said.  He  was  sentenced  in  federal   court  in  Cincinna..   "This  criminal  conduct  had  devasta.ng  consequences  to  the  community  Volkman  was  supposed  to  serve,"  Assistant  U.S.   ATorneys  Adam  Wright  and  Tim  Oakley  said  in  a  court  filing  ahead  of  Tuesday's  hearing.   "Volkman's  ac.ons  created  and  prolonged  debilita.ng  addic.ons;  distributed  countless  drugs  to  be  sold  on  the  street;  and   took  the  lives  of  numerous  individuals  who  died  just  days  azer  visi.ng  him,"  they  said.   The  64-­‐year-­‐old  Volkman  fired  his  aTorneys  earlier  this  month  and  said  he  acted  at  all  .mes  as  a  doctor,  not  a  drug  dealer.   "The  typical  drug  dealer  does  not  care  how  much  drugs  a  client  buys,  how  ozen  he  buys,  or  what  he  does  with  his  drugs,"   Volkman  said  in  a  28-­‐page  handwriTen  court  filing  Monday,  maintaining  that  he  did  all  those  things  and  more  for  his   pa.ents.   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Violations? What  happens  next…..   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The DEA Inspection  Investigators will identify themselves and produce their official credentials  Investigators will produce, either a – Notice of Inspection – Administrative Inspection Warrant – Search Warrant U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Notice of Inspection  You may refuse the Notice of Inspection and require an Administrative Inspection Warrant or Search Warrant: Explain the NOI and provide a copy Explain the purpose of the visit Request to inspect the registered location and the controlled substance records Receipt provided for records obtained Conducted between normal business hours   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Administrative Inspection Warrant  Reviewed by an Assistant United States Attorney  Executed by a United States Magistrate Judge  Served with a copy of the AIW  Controlled substances records obtained and a receipt provided  Conducted between normal business hours U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • DEA Legal Recourse  Administra.ve                        Immediate  Suspension  Order  (ISO)                        Memorandum  of  Agreement  (MOA)                        Order  to  Show  Cause  (OTSC)    Civil                        Fines    Criminal                        Tac.cal  Diversion  Squads     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • How Do You Lose Your Registration? The  Order  to  Show  Cause  Process    21  USC  §  824   a)  Grounds  –     1.  Falsifica.on  of  Applica.on   2.  Felony  Convic.on   3.  State  License  or  Registra.on  suspended,  revoked  or  denied  –   no  longer  authorized  by  State  law   4.  Inconsistent  with  Public  Interest   5.  Excluded  from  par.cipa.on  in  Title  42  USC  §  1320a-­‐7(a)   program   b)        AG  discre.on,  may  suspend  any  registra.on  simultaneously   with  Order  to  Show  Cause  upon  a  finding  of  Imminent  Danger  to   Public  Health  and  Safety    
  • * FY2014 as of April 10, 2014 AdministrativeActions Initiated by DEA FY2007thru2014* U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Questions to Discuss        True  or  False…        For  a  controlled  substance  prescrip.on  to  be   effec.ve,  it  must  be,  “issued  for  a  legi.mate   medical  purpose  by  an  individual  prac..oner  ac.ng   in  the  usual  course  of  professional  prac.ce.”    A)  True    B)  False   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Questions to Discuss  The  ATorney  General  can  immediately  suspend  a   DEA  registra.on  based  on  the  determina.on  that   the  con.nued  registra.on  poses  an  imminent   danger  to  public  health  or  safety;    A)  True    B)  False     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Most Frequent Method of Obtaining a Pharmaceutical Controlled Substance for Non-Medical Use Friends  and  Family…For  Free!!     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 03, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA) First Specific Drug Associated with Initiation of Illicit Drug Use Among Past Year Illicit Drug Initiates Aged 12 or Older: 2012
  • SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 3, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA) Source Where Pain Relievers Were Obtained for Most Recent Nonmedical Use Among Past Year Users Aged 12 or Older: 2011-2012
  • Questions to Discuss    According  to  the  Na.onal  Survey  on  Drug  Use  and  Health   (NSDUH),  in  2012,  par.cipants  iden.fied  the  most  frequent   method  of  obtaining  a  prescrip.on-­‐type  psychotherapeu.c   drug  that  they  most  recently  non-­‐medically  used  as:          A)    Internet          B)    From  a  friend  or  rela.ve  for  free          C)    Purchased  from  a  friend  or  rela.ve          D)    Purchased  from  stranger/drug  dealer   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The Problem – Easy Access U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Medicine Cabinets: Easy Access  More  than  half  of  teens  (56%)  indicate  that  it’s  easy  to  get   prescrip.on  drugs  from  their  parent’s  medicine  cabinet    Half  of  parents  (495)  say  anyone  can  access  their  medicine   cabinet    More  than  four  in  10  teens  (42%)  who  have  misused  or  abused   a  prescrip.on  drug  obtained  it  from  their  parent’s  medicine   cabinet    Almost  half  (49%)  of  teens  who  misuse  or  abuse  prescrip.on   medicines  obtained  them  from  a  friend   Source: 2012 Partnership Attitude Tracking Study, published 4/23/13 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • So Many Drugs in the Household – Why?    Unreasonable  quan..es  being  prescribed    Insurance  rules   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  •  So  Why  is  this  important  to  me   (Pharmacist, Physician, Dentist, Nurse etc.)  Under  the  current  law,  receiving  a  controlled   substance  from  a  ul.mate  user  is  a  viola.on  of  the   CSA   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Ultimate User Disposal of Medicines National Take-Back Events: Take-back events are a good way to remove expired, unwanted, or unused medicines from the home. Law Enforcement Collection Bins: Collection bins installed by our Law Enforcement Partners are a good way to remove expired, unwanted, or unused medicines from the home. Disposal in Household Trash: Mix medicines (do not crush tablets or capsules) with substances such as kitty litter or used coffee grounds and place the mixture in a container such as a sealed plastic bag and throw the container in your household trash. Disposal by Flushing: Some medicines have specific disposal instructions that indicate they should be flushed down the sink or toilet when they are no longer needed. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • ONDCP Guidelines  ONDCP  guidelines  for  the  disposal  of  ul.mate  user   medica.ons,  including  dispensed  controlled  substances   (2/20/07).    Advise  public  to  flush  medica.ons  only  if  the   prescrip.on  label  or  accompanying  pa.ent  informa.on   specifically  states  to  do  so.        ONDCP  recommends  a  minimal  deac.va.on  procedure,   and  disposal  in  common  household  trash.       U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Law Enforcement Law  enforcement  officers,  ac7ng  to  enforce  laws  regarding  the   abandonment  of  controlled  substances,  may  receive  controlled   substances  from  ul7mate  users.   Law  enforcement  must  safeguard  the  controlled  substances  and   ensure  that  they  are  destroyed  properly.   Law  enforcement  must  be  present  during  the  destruc7on  of  the   controlled  substances.       U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Questions to Discuss  Prior  to  passage  of  the  Secure  and  Drug  Disposal  Act  of   2010  and  its  implemen.ng  regula.ons,  ul.mate  users  could   dispose  of  controlled  substances  in  the  following  manner:          A)    Wrap  in  coffee  grinds  and  dispose  in  trash          B)    Give  to  a  pharmacist  for  disposal          C)    Give  to  a  law  enforcement  agency  for  disposal            D)    a  and  c   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • April  26,  2014   National Take Back Initiative April 26, 2014 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         10:00  AM  –  2:00  PM  
  •  On  September  30,  2010,  approximately  122  tons      On  April  30,  2011,  approximately188  tons    On  October  29,  2011,  approximately  189  tons      On  April  28,  2012,  approximately  276  tons    On  September  29,  2012,  approximately  244  tons    On  April  27,  2013,  approximately  376  tons    On  October  26  ,  2013,  approximately  324  tons   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • National Take Back Day October 26, 2013 4,114 Agencies; 5,683 Sites 647,211 Pounds Collected (324 Tons) DRUG  ENFORCEMENT   ADMINISTRATION     DIVERSION  CONTROL  PROGRAM       U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • National Take Back Day: October 26, 2013 Total Law Enforcement Participation: 4,114 78   77   51   68   152 MA   32   RI   46   CT   135   29 VT   79   NH   14   PR  &  VI   204   70   6   135   29   191   12   98   17   21   53   128   143   62   38   258   15   1  HI   115   222   NJ   38   140   22   65   199   246   63   20   31   134   33   71   65   18   140  68   46   MD   7     DC   28   DE   36   65   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • National Take Back Day: October 26, 2013 Total Collection Sites: 5,683 97   134   79   95   157 MA   39   RI   78 CT   165   60   VT   85   NH   19   PR  &  VI   243   88   6   158   37   284   17   134   21   24   59   168   234   77   69   425   22   12   HI   164   232   NJ   57   185   20   84   293   368   91   86   36   24   35   190   51   99   84   23   200  132   101   MD   11   DC   31   DE   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • National Take Back Day: October 26, 2013 Total Weight Collected (pounds): 647,211 (324 Tons) 8,153   10,880   5,527   10,030   17,077     MA   2,171   RI   4,603 CT   16,520   3,430   VT   5,343     NH   811   PR  &  VI   33,761   22,000   215   38,506   10,402   46,565   936   18,433   1,195   1,251   4,461   11,380   23,678   9,171   3,215   72,886   1,777   2,580     HI  &  GU    16,950     14,841 NJ   2,541   18,008   1,420   4,123   41,501   38,493   10,303   14,508   5,766   4,587   2,763   19,901   7,004   9,737   6,194   908   20,072   4,977   9,425 MD   974   DC   5,258   DE   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Secure  and  Responsible  Drug   Disposal  Act  of  2010    Enacted  in  October  2010  (Pub.  L.  111-­‐273,  codified  at  21  U.S.C.  822(g)  and  823(b)(3))    Act  allows  an  ul.mate  user  to  “deliver”  a  controlled  substance  “to  another  person   for  the  purpose  of  disposal”  in  accordance  with  regula.ons  issued  by  DEA    If  the  ul.mate  user  dies  while  in  lawful  possession  of  the  controlled  substance,  then   any  person  lawfully  en.tled  to  dispose  of  the  decedent’s  property  may  deliver  the   controlled  substance  to  another  person  for  the  purpose  of  disposal.        DEA  may  also,  by  regula.on,  authorize  long  term  care  facili.es  (LTCFs)  to  dispose  of   controlled  substances  on  behalf  of  ul.mate  users  who  reside  or  have  resided  at  the   LTCF.      DEA  is  working  to  promulgate  regula.ons  to  implement  this  Act.    DEA  must  consider:   –  Public  health  and  safety   –  Ease  and  cost  of  program  implementa.on   –  Par.cipa.on  by  various  communi.es     –  Diversion  Control    Par.cipa.on  is  voluntary.    DEA  may  not  require  any  person  to  establish  or  operate  a   delivery  or  disposal  program.       U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • No.ce  of  Proposed  Rulemaking   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Pharmaceuticals U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • * Must be reduced in writing, and followed by sign, hard copy of the prescription. ** A signed, hard copy of the prescription must be presented before the medication is dispensed. *** 72 hour time limitation. # With medical authorization, up to 5 in 6 months. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Opioids U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Rates  of  Opioid  Overdose  Deaths,  Sales,   and  Treatment  Admissions,  1999-­‐2010   Source: National Vital Statistics System (NVSS), DEA’s Automation of Reports and Consolidated Orders System, SAMHSA’s Treatment Episode Data Set U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Most commonly prescribed prescription medicine? Hydrocodone/acetaminophen U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Source:  IMS  Health,  Na.onal  Prescrip.on  Audit   Updated  March  22,  2013  
  • Top Five Prescription Drugs Sold in the U.S. (2008-2011) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        Source:  IMS    Health,  Na.onal  Prescrip.on  Audit,  Updated  02/24/14      Millions  of   Prescrip.ons  
  • Top 25 U.S. Pharmaceuticals by Dispensed Prescriptions* Source:  IMS  Health,  Na.onal   Prescrip.on  Audit  Updated  March   22,  2013   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • State Ranking* - Hydrocodone January – September 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014
  • Hydrocodone Combinations CSA  defines  hydrocodone  substance  as  Schedule  II,  while   its  combina.on  products  as  Schedule  III.   DEA  has  received  a  pe..on  to  reschedule  CIII   hydrocodone  combina.on  products  to  CII.     In  2004,  DEA  completed  an  ini.al  review  forwarded  the   data  to  DHHS  with  a  request  for  scien.fic  and  medical   evalua.on  and  scheduling  recommenda.on.     In  2008,  HHS  provided  a  scien.fic  and  medical  evalua.on     In  2009,  DEA  sent  addi.onal  data  to  FDA/HHS  and   requested  a  scien.fic  and  medical  evalua.on.     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  •   DEA  receives  a  pe..on  from  an  interested  party  (proceedings  may   also  be  ini.ated  at  the  request  of  the  AG  or  Secretary  of  HHS)     Pe..on  is  reviewed  and  accepted     DEA  conducts  ini.al  8-­‐factor  analysis  review     Documents  and  material  gathered  during  the  ini.al  review  and   analysis  of  pe..on  is  sent  to  HHS/FDA  with  a  request  for  a  scien.fic   and  medical    evalua.on  and  a  recommenda.on  as  to  whether  the   drug  should  be  controlled     The  recommenda.on  and  review  document  is  received  back  from   HHS/FDA       U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Schedule II   The  drug  or  other  substance  has  a  high  poten.al  for  abuse       The  drug  or  other  substance  has  a  currently  accepted  medical  use   in  treatment  in  the  United  States    or  a  currently  accepted  medical   use  with  severe  restric.ons     Abuse  of  the  drug  or  other  substance  may  lead  to  severe   psychological  or  physical  dependence   Schedule III   The  drug  or  other  substance  has  a  poten.al  for  abuse  less  than   the  drugs  or  other  substances  in  schedules  I  or  II       The  drug  or  other  substance  has  a  currently  accepted  medical  use   in  treatment  in  the  United  States       Abuse  of  the  drug  or  other  substance  may  lead  to  moderate  or   low  physical  dependence  or  high  psychological  dependence   21  USC  812(b)(2),(3)   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Approval of Single Entity Extended Release Hydrocodone U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014 State Ranking* - Oxycodone January – December 2012 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014 State Ranking* - Oxycodone January – December 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • OxyContin® (Schedule II) (Oxycodone controlled-release)  Controlled- release formulation of Schedule II oxycodone –  The controlled release method of delivery allows for a longer duration of drug action so it contains much larger doses of oxycodone –  Abusers easily compromise the controlled release formulation by crushing the tablets for a powerful morphine-like high –  Street Slang: “Hillbilly Heroin” –  10, 15, 20, 30, 40, 60, 80mg available  Effects: –  Similar to morphine in effects and potential for abuse/ dependence  Street price: Approx. $80 per 80mg tablet  New formulation: Introduced into the marketplace in 2010 that is more difficult to circumvent for insufflation (snorting) or injection. Does nothing to prevent oral abuse. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         OxyContin® Change (Oxycodone controlled-release)
  • New OxyContin® OP (oxycodone-controlled release) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Oxycodone 15mg/30mg Immediate Release U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Opana ER (Schedule II) (Oxymorphone extended release)  Opana  ER®  -­‐  (Schedule  II)   –  Treats  constant,  around  the  clock,  moderate  to   severe  pain   –  Becoming  popular  and  is  abused  in  similar   fashion  to  oxycodone  ;  August  2010  (Los   Angeles  FD  TDS)   –  Slang:  Blues,  Mrs.  O,  Octagons,  Stop  Signs,   Panda  Bears   –  Street:    $10.00  –  $80.00     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014 State Ranking* - Oxymorphone January – December 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Hydromorphone U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Source: Drug Enforcement Administration, Office of Diversion Control, Pharmaceutical Investigations Section, Targeting and Analysis Unit Most current ARCOS information as of March 18, 2014 State Ranking* - Hydromorphone January – December 2013 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Opiates v. Heroin U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Poppy   Codeine   Hydrocodone   Morphine   Hydromorphone   Thebaine   Oxycodone          Hydrocodone   Somniferum   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S. Rates of Opioid Overdose Deaths, Sales, and Treatment Admissions, 1999-2010 Source: National Vital Statistics System (NVSS), DEA’s Automation of Reports and Consolidated Orders System, SAMHSA’s Treatment Episode Data Set U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Hydrocodone   Lorcet®   $5-­‐$7/tab   Oxycodone   Combina.ons   Percocet®   $7-­‐$10/tab   OxyCon7n®   $80/tab   Heroin              $10/bag   Roxicodone®   Oxycodone  IR   15mg,  30mg   $30-­‐$40/tab   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • SOURCE: 2012 National Survey on Drug Use and Health (NSDUH) published September 03, 2013 by the Dept of HHS/ Substance Abuse and Mental Health Services Administration (SAMHSA) Past Month and Past Year Heroin Use Among Persons Aged 12 or Older: 2002-2012 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • HEROIN CASES and EXHIBITS National Forensic Laboratory Information System Year   #  Exhibits   #  Cases   2004   69,467   60,851   2005   73,569   64,471   2006   83,945   72,351   2007   82,408   69,850   2008   94,229   79,366   2009   107,272   87,249   2010   104,676   84,170   2011   109,049   86,513   2012   127,568   101,512   2013:  Jan  –  Jun   69,574   55,325   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Percent   Source: SAMSHA Treatment Episode Data Set, 1998-2008 released July 15, 2010 Substance Abuse Treatment Admissions within Specific Age Groups That Reported Any Pain Reliever Abuse: 1998-2008 Up  more  than  fourfold   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Heroin  trafficking  organiza.ons  reloca.ng  to  areas  where   prescrip.on  drug  abuse  is  on  the  rise   Heroin  traffickers  pave  the  way  for  increasing  crime  and   violence   Law  enforcement  and  prosecutors  eventually  figh.ng  the   problem  on  two  fronts  (prescrip.on  opiate  diversion  and   heroin  distribu.on)  further  deple.ng  resources   Communi.es  suffer   Community Impact? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Methods of Diversion U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Source:  DEA  
  • Where are the Pharmaceuticals Coming From?  Friends  and  Family  for  Free    Medicine  Cabinet    Doctor  Shopping    Internet    Pain  Clinics   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Prescription Fraud U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Questions to Discuss    What  combina.on  of  drugs  is  referred  to  as  the  “trinity”?        A)    Hydrocodone,  alprazolam,  and  carisoprodol        B)    Promethazine  with  codeine,  methylphenidate  and                  carisoprodol        C)    Hydromorphone,  carisoprodol  and  buprenorphine        D)    Methadone,  diazepam  and  tramadol   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Doctor Shopping U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Prescription Drug Monitoring Programs U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Mandatory PDMP review before prescribing CS? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Standard of Care U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • National Association of Boards of Pharmacy U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Diversion via the Internet U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WA OR ID WY ND SD MN NE WI MI CO KS MO IL IN UT NV CA AZ NM OK AR LA TN KY MS AL GA SC NC OH VA PA NY ME V T N H CT DE WV RI MD MA Domestic ‘Rx’ Flow MTMT FL TX TX 2. Request goes through Website Server in San Antonio, TX WS FL IAIA NJ 1. Consumer in Montana orders hydrocodone on the Internet C 3. Web Company (located in Miami, FL) adds request to queue for Physician approval WC 4. Order is approved by Physician in New Jersey and returned to Web Company Dr. S 6. Pharmacy in Iowa fills order and ships to Consumer via Shipper Rx 5. Approved order then sent by Web Company to an affiliated Pharmacy
  • New Felony Offense Internet Trafficking - 10/15/2008     21 USC 841(h)(1): It shall be unlawful for any person to knowingly or intentionally: (A) deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized by this title; or (B) aid or abet any violation in (A) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         What has been the reaction????
  • Per Se Violations  No in-person medical evaluation by prescribing practitioner  Online pharmacy not properly registered with modified registration.  Website fails to display required information U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Current CSA Registrant Population Total Population: 1,523,995   Practitioner 1,177,455   Mid-Level Practitioner 246,543   Pharmacy 69,807   Hospital/Clinic 16,047   Teaching Institution 312   Manufacturer 543   Distributor 839   Researcher 7,346   Analytical Labs 1,524   NTP 1,365   Importer/Exporter 476   ADS Machine 755   Chemicals 1,005 U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         As  of  03/21/14  
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Pain Clinics U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Explosion of South Florida Pain Clinics As  of  June  4,  2010,  Florida  has  received  1,118  applica.ons  and  has  approved  1026   *As  of  May  14,  2010,  Broward  142;  Miami-­‐Dade  79;  Palm  Beach  111     U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Hydrocodone Oxycodone 2002 9,376 8,288 2003 12,130 9,715 2004 16,401 13,492 2005 21,190 14,643 2006 24,984 17,927 2007 30,637 22,425 2008 33,731 28,756 2009 38,084 38,332 2010 39,444 48,210 2011 37,483 46,906 2012 35,140 42,869 2013* 26,844 31,897 NFLIS – Federal, State, and local cases reported U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         NFLIS  Query  Date:  02/24/14  
  • Medical Care ?  Many  of  these  clinics  are  prescrip.on/ dispensing  mills    Minimal  prac..oner/pa.ent  interac.on   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Increased Law Enforcement Pressure  Clinics  migra.ng  north  and  west    Funded  by  owners  in  Florida   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • ‘The Florida Migration’  Vast majority of ‘patients’ visiting Florida “pain clinics”come from out-of-state: –  Georgia –  Kentucky –  Tennessee –  Ohio –  Massachusetts –  New Jersey –  North and South Carolina –  Virginia –  West Virginia U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT.. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT.. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • WASHINGTON OREGON CALIFORNIA NEVADA IDAHO MONTANA WYOMING UTAH ARIZONA NEW MEXICO COLORADO TEXAS OKLAHOMA KANSAS NEBRASKA SOUTH DAKOTA NORTH DAKOTA MINNESOTA IOWA MISSOURI ARKANSAS LOUIS. MISS. ALA. GEORGIA FLA. WISC. MICH. ILL. IND. OHIO PENN. N.Y. MAINE R.I. CONN. N.J. N.H. VT. MASS. W.V. DEL. MD. S.C. VIRGINIA N.C. KENTUCKY TENN. (MIAMI) U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Drugs Prescribed  A  ‘cocktail’  of  oxycodone  and  alprazolam  (Xanax®)    An  average  ‘pa.ent’  receives  prescrip.ons  or   medica.ons  in  combina.on   Schedule  II   Schedule  III   Schedule  IV   Oxycodone  15mg,  30mg   Vicodin  (Hydrocodone)   Xanax  (Alprazolam)   Roxicodone  15mg,  30mg     Lorcet   Valium  (Diazepam)   Percocet   Lortab   Percodan   Tylenol  #3  (codeine)   Demerol   Tylenol  #4  (codeine)   Methadone   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Average Charges for a Clinic Visit  Price varies if medication is dispensed or if customers receive prescriptions  Some clinics advertise in alternative newspapers citing discounts for new patients such as 'buy one get one free‘ or “50% off with this ad”  Typically, initial office visit is $250 or more; each subsequent visit may exceed $200  Prescriptions average 120-180 30mg oxycodone tablets per visit U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • Cost of Drugs  According  to  medical  experts,  most  clinics  do  not   require  sufficient  medical  history  and  tests  for  proper   prescribing  of  Schedule  II  substances    Oxycodone  30mg  immediate  release  tablets  cost     approximately  $30.00  to  $40.00  per  tablet  on  the  street   depending  on  the  sale  loca.on  in  the  U.S.  ($1  per  mg  or   more)   U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • What’s the Profit? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • What’s the Profit? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • What’s the Profit? U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control        
  • The Last Line of Defense U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control         Pharmacist
  • Thank You! U.S.  Drug  Enforcement  Administra.on    Office  of  Diversion  Control