Ph 5 michel ward_warren


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Ph 5 michel ward_warren

  1. 1. Liabilities for Pharmacists April  23,  2014   Atlanta  Marrio2  Marquis   Troubles  Along  The  Way  
  2. 2. Disclosure Statements •  Alix  C.  Michel   •  David  J.  Ward   •  Michael  L.  Warren   The three faculty for this activity have disclosed no relevant, real or apparent personal or professional financial relationships.
  3. 3. Learning Objectives 1.  IdenGfy  current  liabiliGes  facing  pharmacists.     2.  Evaluate  cases  brought  against  a  pharmacist   to  show  best  pracGces.   3.  Establish  methods  for  improving  a   pharmacist’s  pracGce.    
  4. 4. Overview of Pharmacist Liabilities •  Pharmacy  Robberies   •  Criminal  Liability   •  Civil  Liability   •  CMS  Issues   •  Board  InvesGgaGons  
  5. 5. Troubles That Break Down Your Door Pharmacy Robberies •  Chain  Pharmacies  reported  517  armed   robberies  January  ‘12-­‐January  ’13   •  Retail  Pharmacies  reported  214  armed   robberies  January  ‘12-­‐January  ’13  
  6. 6. How Robberies Impact Pharmacies •  Psychological  impact   •  Loss  of  employees   •  Loss  of  business   •  Time  and  expense   – DEA,  police  and  insurance  invesGgaGon  and   reporGng  
  7. 7. What keeps pharmacists up at night Police Arrest Second Suspect In Pharmacy Robbery, Murder Sep 22, 2013 - Prosecutors to seek death penalty against ex-lawman in pharmacy slayings, robbery Sep 17, 2013 - Pharmacy Shooting: 2 people dead, 2 injured in shooting at East Tennessee pharmacy May 24, 2013 - WBIR-TV NY Pharmacy Robbery Leaves Suspect, ATF Agent Dead in Confused Shootout  Jan. 1, 2012 - WACB-TV    Suspect Arrested in New York Pharmacy Killings  June 22, 2011 - ABC News
  8. 8. “Hardening the Target” – Making the store less attractive •  Employees  trained  on  suspicious  persons  and   behaviors  and  what  to  do  if  a  robbery  occurs   •  Front  counter  easily  visible  from  the  outside   •  Video  surveillance  prominent   •  High  pharmacy  counter   •  Bullet  resistant  glass   •  Time  delay  safe  
  9. 9. “2nd level” Protection •  Tracking  devices   •  DNA  and  other  marking  technologies   •  Verified  alarms   •  Community  policing  –   – Know  the  police   – Share  informaGon     – Suspicious  person  alerts
  10. 10. Response to a Robbery
  11. 11. What to Do If Robber Enters Building •  Remain  as  calm  as  possible   •  Comply  but  don’t  volunteer   •  Make  sure  the  robber  understands  what  you   are  about  to  do   •  Observe   •  Do  not  a2empt  to  chase  or  apprehend  the   robber  
  12. 12. What to do after Robber has left •  Immediately  lock  all  doors   •  Call  police   •  Take  notes  on  what  happened   •  Preserve  evidence  
  13. 13. Mama Bear
  14. 14. Other Pharmacist’s Responses
  15. 15. Problems that Knock at Your Door Why pharmacist liability is so high •  Pharmacists  are  consistently  viewed  as  the  “last   line  of  defense”  in  making  sure  a  prescripGon  is   right  –  that  it  is  the  correct  drug,  that  dosage  is   correct  and  that  the  person  should  be  receiving   the  prescripGon    How  that  applies  to  prescrip/on  narco/cs    
  16. 16. Problems that Knock at Your Door The Corresponding Responsibility Doctrine •  The  United  States  Controlled  Substances  Act   (CSA)  is  the  statutory  basis  for  federal  oversight   of  controlled  substance  regulaGon  in  the  United   States.   •  The  CSA  provides  the  pharmacist  an  affirmaGve   obligaGon  to  only  fill  prescripGons  that  are   “issued  in  the  usual  course  of  professional   treatment,”  and  prescripGons  that  do  not  meet   this  requirement  are  considered  improper.  
  17. 17. •  The  pharmacist  must  exercise  sound   professional  judgment  regarding  the   validity  of  a  prescripGon  prior  to   dispensing.  The  pharmacist  should  not   assume  that  every  controlled  substance   prescripGon  is  improper,  but  rather  take   affirma8ve  steps  to  ensure  the   prescrip8on’s  validity
  18. 18. Source of Pharmacists’ Corresponding Responsibility •  (A)n  order  purporGng  to  be  a  Rx  issued  not  in  the   usual  course  of  professional  treatment  or  in   legiGmate  and  authorized  research  is  not  a  Rx  within   the  meaning  and  intent  of  secGon  309  of  the  Act  (21   U.S.C.  §  829)  and  the  person  knowingly  filling  such  a   purported  Rx,  as  well  as  the  person  issuing  it,  shall   be  subject  to  the  penal8es  provided  for  violaGons  of   the  provisions  of  law  relaGng  to  controlled   substances.                  21  C.F.R.  §  1306.04(a)  
  19. 19. Corresponding Responsibility Doctrine U.S. v. Hayes 1979 (Texas) •  Pharmacist  filled  34  prescripGons  for  Dilaudid  for   paGent  (3400  pills)  and  75  prescripGons  for   Preludin  in  month  1   •  101  prescripGons  for  Dilaudid  and  137   prescripGons  for  Preludin  in  month  2   •  Prescribing  Doctor  was  transient  alcoholic  that   lived  part-­‐Gme  with  pharmacist  
  20. 20. Corresponding Responsibility Doctrine U.S. v. Hayes 1979 (Texas) •  Pharmacist:  Cannot  have  a  "corresponding   responsibility"  to  that  of  a  pracGGoner   because  he  cannot  prescribe  at  all  but  only   dispense;  an  a2empt  by  regulaGon  to  impose   on  him  the  obligaGons  of  a  prescriber  must,   therefore,  be  ineffectual.  
  21. 21. •  Court:  Pharmacist  may  not  fill  a  wri2en   order  from  a  pracGGoner,  appearing  on  its   face  to  be  a  prescripGon,  if  he  knows  the   pracGGoner  issued  it  in  other  than  the   usual  course  of  medical  treatment.  The   regulaGon  gives  "fair  noGce  that  certain   conduct  is  proscribed.“  We  affirm  the   Convic8on.  
  22. 22. Corresponding Responsibility Doctrine U.S. v. Irwin 1981 (Texas) •  Delivery  of  Controlled  Substance   •  Delivery  of  controlled  substance  was  other   than  for  a  legiGmate  medical  purpose  and  in   the  usual  course  of  professional  pracGce   •  Conduct  was  knowing  and  intenGonal  
  23. 23. Corresponding Responsibility Doctrine Med. Shoppe-Jonesborough v. DEA 2008 The  regulaGon  requires  pharmacists  to  use   common  sense  and  professional  judgment,   which  includes  paying  a2enGon  to  the  number   of  prescrip8ons  issued,  the  number  of  dosage   units  prescribed,  the  dura8on  and  paNern  of   the  alleged  treatment,  the  number  of  doctors   wri8ng  prescrip8ons  and  whether  the  drugs   prescribed  have  a  
  24. 24. high  rate  of  abuse.  When  pharmacists'   suspicions  are  aroused  as  reasonable   professionals,  they  must  at  least  verify  the   prescrip8on's  propriety,  and  if  not  saGsfied   by  the  answer  they  must  refuse  to   dispense.  
  25. 25. Corresponding Responsibility Doctrine Holiday CVS 2012 FL ViolaGon  of  “corresponding  responsibility”  in   administraGve  cases  required     •  Delivery  of  controlled  substance   •  Red  flag  that  was  or  should  had  been   recognized   •  QuesGon  raised  by  the  red  flag  not  resolved   conclusively  prior  to  dispensing  
  26. 26. Corresponding Responsibility Doctrine Holiday CVS 2012 FL The  “irresolvable”  red  flags:   •  Prescriber  in  Fort  Lauderdale,  paGent  had  out   of  state  address,  and  paGent  paid  cash  for   oxycodone   •  Same  red  flags  +  prescripGon  filled  in  close   sequence  for  individuals  from  out  of  state  
  27. 27. Corresponding Responsibility Doctrine Holiday CVS 2012 FL The  “irresolvable”  red  flags:   •  Dispensing  oxycodone  30  mg  and  15  mg   products  to  the  same  paGent   •  Prescribers  whose  prescribing  pa2ern   suggests  a  one  size  fits  all  concept  
  28. 28. Corresponding Responsibility Doctrine Holiday CVS 2012 FL
  29. 29. Corresponding Responsibility Doctrine Top Rx Pharmacy (2013) ViolaGon  of  “corresponding  responsibility”  in   administraGve  case  required   •  Delivery  of  controlled  substance   •  A  red  flag  that  was  or  should  have  been   recognized   •  The  quesGon  raised  by  the  red  flag  is  not   resolved  conclusively    prior  to  dispensing  
  30. 30. Corresponding Responsibility Doctrine Top Rx Pharmacy (2013) Red  flags  based  on  state  law   •  Dispensing  is  unlawful  if  pharmacist  knows  or  should  know   that  the  prescripGon  was  issued  outside  a  valid  physician-­‐ paGent  relaGonship   •  Can  judge  validity  of  physician-­‐paGent  relaGonship  on   1.  Manner  in  which  prescripGons  are  received   2.  Number  of  prescripGons  for  controlled  substances  issued   by  the  pracGGoner   3.  Number  of  paGents  receiving  controlled  substances  
  31. 31. Corresponding Responsibility Doctrine Top Rx Pharmacy (2013) Red  flags  based  on  statements  made  by   pharmacy  employees:   “To  the  extent  [the]  statements  consGtuted  a  red  flag,   [the  pharmacy]  should  have  stopped  all  controlled   substances  dispensing  unGl  resolved.”  
  32. 32. Corresponding Responsibility Doctrine Top Rx Pharmacy (2013) Conclusively  resolving  red  flags   •  Judged  using  “reasonable  pharmacist   standard”   •  Steps  necessary  to  resolve  red  flags  are   influenced  by  circumstances  giving  rise  to  the   red  flags.  
  33. 33. What are “Red Flags”? •  PrescripGons  for  controlled  substances  from   mulGple  doctors   •  PaGent  receives  more  than  one  controlled   substance  to  treat  the  same  indicaGon   •  PaGent  has  prescripGons  for  large  quanGGes/ doses  of  controlled  substances  
  34. 34. What are “Red Flags”? •  PaGent  seeks  early  refills   •  PaGent  travels  long  distance   •  Prescribing  physician  located  at  great  distance   •  PaGent  receives  opiate,  benzodiazepine  and   carisopridol  (cocktail)  
  35. 35. What are “Red Flags”? •  Filling  mulGple  prescripGons  for  strongest   formulaGon   •  PaGents  travelling  in  groups   •  Large  porGons  of  prescripGons  for  controlled   substances  issued  by  one  prescriber   •  Large  percentage  of  prescripGons  paid  for  in   cash.  
  36. 36. What are “Red Flags”? •  Failing  to  call  other  pharmacists  to  inquire  as   to  why  they  refuse  to  fill  prescripGons  filled  by   a  parGcular  prescriber   •  Cash  payments  in  combinaGon  with  other  red   flags   •  Drug  is  inconsistent  with  prescriber  area  of   pracGce    
  37. 37. What are “Red Flags”? •  PaGent  refers  to  drug  in  street  slang   •  MulGple  people  from  same  address  receive   controlled  substances   •  Family  members  receive  controlled  substances   from  same  prescriber   •  State  board  or  law  enforcement  acGon  against   prescriber   •  Lack  of  valid  doctor-­‐paGent  relaGonship  
  38. 38. How to Resolve Red Flags •  Use  PDMP   •  Talk  to  paGents  you  know   •  Extensively  talk  to  paGents  you  don’t  know   •  Contact  the  Prescriber   •  Document  all  communicaGon  with  Prescriber   •  Verify  Prescriber  DEA  number  
  39. 39. How to Resolve Red Flags •  Talk  with  other  pharmacists   •  Use  your  insGncts   •  If  not  comfortable,  refuse  to  fill  the   prescripGon  
  40. 40. NBC News 10/23/13
  42. 42. Other Problems
  43. 43. Inadequate  Supply  of Pain Meds to Meet the Medical Needs of the Community   Pharmacies Wholesalers     DEA      blame   blame  
  44. 44. One Response
  45. 45. Possible  “red  flags”  that  could  lead  to  the   prescripGon  being  denied  include:   • A  pain  medicaGon  not  previously  filled  at   Walgreens   • A  new  doctor  wriGng  a  prescripGon  for  the  same   pain  medicaGon   • A  doctor  wriGng  a  prescripGon  who  is  not  in  a   “reasonable  geographic  locaGon”  near  the   pharmacy.  
  46. 46. • A  paGent  paying  for  a  prescripGon  in  cash   • A  paGent  seeking  an  early  refill  of  a   prescripGon   • A  paGent  seeking  an  “excessive”  number  of   pills   • A  paGent  taking  the  same  pain  medicaGon  for   more  than  6  months  
  47. 47. Viscous cycle Prescribers fearful of liability Wholesalers fearful of DEA Pharmacies fearful of being cut-off
  48. 48. What’s old is new again…  1914 1940 1970 2001 2010 ? The Harrison Act and Restricted Access Death bed or Combat The pendulum shifts The 5th Vital sign, “non-addictive” Oxycontin CDC declares an epidemic History doesn’t repeat itself, but it rhymes - Mark Twain Congress declares a pain free decade.
  49. 49. But Wait…What a Generation of Doctors Learned Was Wrong. PBS  special,  5/2/13  
  50. 50. Troubles With Your License Board Investigations
  51. 51. TRENTON — The licenses of three New Jersey pharmacists have been suspended following their arrests last month and allegations that they participated in an illegal prescription drug ring, state authorities said today. The suspensions — handed down against Daniel Podell, 87, of Clark; Howard Hirsh, 61, of Cranbury; and Lawrence Zaslow, 59, of Cherry Hill — will remain in effect until further action by the state Board of Pharmacy and the resolution of the criminal charges. Authorities allege several pain management clinics in Florida provided prescriptions for painkillers such as oxycodone, hydromorphone and morphine sulfate to patients who had no medical need for them.
  52. 52. More Legal Troubles
  53. 53. Huntington Beach Pharmacy Shutdown, connected to Dr. Tseng
  54. 54. Emerging Trends Walgreens Loses $1.4M for Sharing Patient’s Private Medical Info Walgreens  pharmacist  whose  husband  was  the   ex-­‐boyfriend  of  customer  at  the  pharmacy   suspected  ex  of  giving  her  husband  a  sexually   transmi2ed  disease,  so  she  used  her  authority  at   the  pharmacy  to  access  ex’s  medical  records.   She  shared  ex’s  sensiGve  medical  details  with   her  husband,  who  later  sent  ex  a  text  message   indicaGng  he  knew  the  records’  contents.  
  55. 55. Even  though  ex  called  the  pharmacy  to   complain,  pharmacist  was  allowed  to  access   the  informa8on  a  second  8me.  The  suit   accused  Walgreens  of  negligence  in  its   supervision  of  pharmacist,  though  the   company  fought  back  by  arguing  that   pharmacist’s  illegal  acts  weren’t  associated   with  her  employer-­‐authorized  conduct.  A   judge  disagreed  and  sent  the  quesGon  to  a   jury,  which  found  the  company  liable  for  80%   of  the  damages  owed  to  ex.  Walgreens   indicated  it  would  appeal  the  decision.       (Indiana)  
  56. 56. Prescriber Education •  In  April  2011,  FDA  announced  the  elements  of  a   Risk  EvaluaGon  and  MiGgaGon  Strategy  (REMS)   to  ensure  that  the  benefits  of  extended-­‐release   and  long-­‐acGng  (ER/LA)  opioid  analgesics   outweigh  the  risks.     •  As  part  of  the  REMS,  all  ER/LA  opioid  analgesic   companies  must  provide:  
  57. 57. •   EducaGon  for  prescribers  of  these   medicaGons,  which  will  be  provided   through  accredited  conGnuing  educaGon   (CE)  acGviGes  supported  by  independent   educaGonal  grants  from  ER/LA  opioid   analgesic  companies.     •   InformaGon  that  prescribers  can  use   when  counseling  paGents  about  the  risks   and  benefits  of  ER/LA  opioid  analgesic   use.    
  58. 58. TIRF REMS Access Program •  The  Transmucosal  Immediate  Release  Fentanyl  (TIRF)   Risk  EvaluaGon  and  MiGgaGon  Strategy  (REMS)  program   is  an  FDA-­‐required  program  designed  to  ensure   informed  risk-­‐benefit  decisions  before  and  during   treatment,  to  ensure  appropriate  use  of  TIRF  medicines.     •  The  purpose  of  the  TIRF  REMS  Access  program  is  to   miGgate  the  risk  of  misuse,  abuse,  addicGon,  overdose   and  serious  complicaGons  due  to  medicaGon  errors  with   the  use  of  TIRF  medicines.   •  You  must  enroll  in  the  TIRF  REMS  Access  program  to   prescribe,  dispense,  or  distribute  TIRF  medicines  
  59. 59.
  60. 60. Questions? Alix  C.  Michel   (423)  602-­‐9522   David  J.  Ward   (423)  602-­‐9523   Michael  L.  Warren,  ARM,  OHST,  CCLS Risk   Manager,  Pharmacists  Mutual  Insurance   (800)  247-­‐5930  ext.  7229    
  61. 61. Disclaimer This  presenta8on  is  provided  with  the   understanding  that  the  presenters  are  not   rendering  legal  advice  or  services.    Laws  are   constantly  changing,  and  each  federal  law,  state   law,  and  regula8on  should  be  checked  by  legal   counsel  for  the  most  current  version.    We  make  no   claims,  promises,  or  guarantees  about  the   accuracy,  completeness,  or  adequacy  of  the   informa8on  contained  in  this  presenta8on.    Do   not  act  upon  this  informa8on  without  seeking  the   advice  of  an  aNorney.      
  62. 62. This  outline  is  intended  to  be   informa8onal.    It  does  not  provide  legal   advice.    Neither  your  aNendance  nor  the   presenters  answering  a  specific  audience   member  ques8on  creates  an  aNorney-­‐ client  rela8onship.