Policies and laws_for_pharmacists_final_rev
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Pharmacy Track, National Rx Drug Abuse Summit, April 2-4, 2013. Policies and Laws for Pharmacists presentation by Dr. Lynn Rafferty and Joel Thornbury

Pharmacy Track, National Rx Drug Abuse Summit, April 2-4, 2013. Policies and Laws for Pharmacists presentation by Dr. Lynn Rafferty and Joel Thornbury

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Policies and laws_for_pharmacists_final_rev Policies and laws_for_pharmacists_final_rev Presentation Transcript

  • Policies  and  Laws  for  Pharmacists   Dr.  Lynn  Rafferty,  Pharm.  D,  MBA,  N.D.,   CNC,  CNHP.   Assistant  Professor  at  The  College  of   Medicine,  Nova  Southeaster  University   Joel  Thornbury   President,  Kentucky  Board  of  Pharmacy    
  • Learning  ObjecKves  1.  Describe  the  relaKonship  between  federal   law,  state  law  and  other  regulatory   requirements  pertaining  to  diversion.  2.  Outline  the  variables  to  consider  when   construcKng  a  strategy  for  diversion   prevenKon,  detecKon  and  remediaKon.  3.  Formulate  an  effecKve  plan  of  acKon  when   diversion  is  discovered  or  suspected.  
  • Disclosure  Statement  •  Lynn  Lafferty  has  no  financial  relaKonships   with  proprietary  enKKes  that  produces  health   care  goods  and  services.    •  Joel  Thornbury  has  no  financial  relaKonships   with  proprietary  enKKes  that  produces  health   care  goods  and  services.     View slide
  • Florida  Law  and  the  PracKce  of   Pharmacy   Lynn  Lafferty,  Pharm.D.,  N.D.   Assistant  Professor     College  of  Osteopathic  Medicine   Nova  Southeastern  University   *SPECIAL  THANKS  Dr.  James  Hall,     Broward  Task  Force   View slide
  • Federal  Laws  •  Title  21  United  States  Code  (21  U.S.C.)  801-­‐971  and  the   DEA  regulaKons,  Title  21,  Code  of  Federal  RegulaKons   (21  C.F.R.),  Parts  1300  to  End.     –  On  line  Pharmacists  Manuel   –  Sec$on  1306.06  Persons  en$tled  to  fill  prescrip$ons  “A  prescripKon  for  a  controlled  substance  may  only  be  filled  by  a  pharmacist,  acKng  in  the  usual  course  of  his  professional  pracKce  and  either  registered  individually  or  employed  in  a  registered  pharmacy,  a  registered  central  fill  pharmacy,  or  registered  insKtuKonal  pracKKoner.”   –   
  • Florida  State  Law  •  Title  XLVI,  Chapter  893  •  A  pharmacist,  in  good  faith  and  in  the  course   of  professional  pracKce  only,  may  dispense   controlled  substances  upon  a  wriaen  or  oral   prescripKon  of  a  pracKKoner,  under  the   following  condiKons:    
  • Prescription Drug-Related Deaths in Florida: 2011 5,489 individuals died with one or more prescription drugs in their system. The drugs were at both lethal and non-lethal levels.Source:    Florida  Department  of  Law  Enforcement:                      Florida  Medical  Examiners  Commission  Report  2011
  • Physician  Dispensing  •  Physicians  ordering  and  dispensing   prescripKon  medicaKons   –  Used  to  be  limited  to  emergency  supply  and   samples   –  Large  problems  with  limited  benefits  to  paKents.  
  • Physician  Dispensing  Pros  •  Improved  paKent  access  to  medicaKons  •  PaKent  convenience  •  Generic    and  therapeuKc  subsKtuKons  due  to   the  physician’s  enhanced  awareness  of   medicaKon  costs  •  Possible  improved  paKent  adherence  with   medicaKon  regimens  
  • Physician  Dispensing  Cons  •  Conflict  of  Interest   –  Large  Problem  with  narcoKc  dispensing  •  Serious  medicaKon  safety  concerns   –  loss  of  a  crucial  second  check  by  a  pharmacist  and  use   of  sofware  to  detect  prescribing  errors  and  ,     –  lack  of  regulatory  oversight   •   lax  procedures  for  medicaKon  labeling   •  record-­‐keeping   •  storage   •  supervision  of  the  dispenser  
  • Top 25 Dispensing Practitioners of Oxycodone in the U.S. (All in Florida) October2008 – March 2009ARCOS
  • Florida 9,201,731Dose Units
  • 5,233,785Dose Units
  • Number  of  Oxycodone  Reports  Detected         among  Decedents  in  Broward  County:  2007-­‐2011   250   225   236   200   NUMBER  of   171   Oxycodone   174   OCCURRENCES   150   Including     “Present”    &  “Cause  of  Death”   Broward   100   119   50   0   2007   2008   2009   2010   2011    SOURCE:  Florida  Medical  Examiners  Commission  Report  2011  
  • Number  of  Alprazolam  Reports  Detected     among  Decedents  in  Broward  County:  2007-­‐  2011   300   245   235   250   NUMBER  of   203   Alprazolam   200   OCCURRENCES   Including     199   “Present”    &   150   133  “Cause  of  Death”   100   Broward   50   0   2007   2008   2009   2010   2011    SOURCE:  Florida  Medical  Examiners  Commission  Report  2011  
  • Number  of  Emergency  Departments  Reports        by  Drug  in  Broward  &  Palm  Beach  Coun$es,  FL:        2008,,2009   and  2010   6,000# of ED Report Estimates 5,560 5,500 5,000 Cocaine   4,479 4,500 4,081 4,000 3,500 3,299 3,000 2,913 3,110 2,351 2,900 2,500 2,274 NMU  Benzodiazepines   2,000 2008 2009 2010 Note:     Cocaine   visits   had   sta$s$cally   significant   decreases   from   2008   to   2009.   Prescrip$on   Opioid   nonmedical   use   visits   had   sta$s$cally   significant   increases   from   2008   to   2010.     No   sta$s$cally   significant  changes  were  noted  for  2008  or  2009  compared  with  2010  for  Benzodiazepines.     SOURCE: US Dept. HHS-SAMHSA, CBHSQ: DAWN Emergency Dept. Estimates 2008-2009.
  • Number  of  Emergency  Departments  Reports        by  Drug  in  Broward  &  Palm  Beach  Coun$es,  FL:        2008,,2009   and  2010   6,000# of ED Report Estimates 5,560 5,500 5,000 Cocaine   4,479 4,500 4,081 4,000 3,500 3,299 2,928 2,913 3,249 3,000 2,500 2,351 2,870 Marijuana   2,000 2008 2009 2010 Note:     Cocaine   visits   had   sta$s$cally   significant   decreases   from   2008   to   2009.   Prescrip$on   Opioid   nonmedical   use   visits   had   sta$s$cally   significant   increases   from   2008   to   2010.     No   sta$s$cally   significant  changes  were  noted  for  2008  or  2009  compared  with  2010  for  Marijuana.     SOURCE: US Dept. HHS-SAMHSA, CBHSQ: DAWN Emergency Dept. Estimates 2008-2009.
  • Number  of  Heroin-­‐related  Deaths     in  Florida:  2000  –2011   400 12    ??   20 Florida#  Lethal  Heroin  Deaths   350 Miami-Dade 300 Broward 250 200 150 100 62   50 15   0 3   SOURCE: Florida Medical Examiners Commission Reports 2000-2011
  • Sun  SenKnel  February  19,  2013  •  “Heroin  taking  oxys  place  for  more  addicts”   –  Heroin  increasing     –  Lost  opportunity  to  get  people  into  treatment  
  • Number  of  Primary  Heroin  Treatment  Admissions   Miami-­‐Dade  and  Broward  Coun$es,  FL:  2009-­‐2012   350   Broward   316  #  of  primary  Treatment  Admissions   Miami-­‐Dade   308   300   250   227   200   183   150   156   169   150   105   100   50   0        2009        2010        2011      2012*          2009        2010        2011    2012* 1   2   3   4   5   6   7   8     *  2012  Admissions  based  on  2  x‘s  1st  Half  2012   SOURCE:  Florida  Department  of  Children  and  Families  
  • FL  House  Bill  7095   EffecKve  July  1,  2011  •  PracKoners  no  longer  authorized  to  dispense  Schedule  II  or  III   controlled  substances.   –  Except:  Emergency  72  hr.  supply,  correcKons,  hospice,  clinical  trials,  surgical   procedures,  and  methadone  clinics  •  Standards  Made  Clear   –  Complete  medical  history   –  Wriaen  individualized  RX  plan   –  Wriaen  controlled  substance    agreement   –  Reg.  follow-­‐up  plan  •  Must  designate  themselves  as  a  controlled  substance   prescribing  pracKKoner  •  Counterfeit-­‐proof  Rx  pad  
  • Pharmacist  •  Number  one  most  respected  professional  •  Most  Accessible   –  More  paKent  contacts  than  any  other  health  care   professional  •  Has  access  to  paKent,  doctor  and  informaKon  •  CriKcized  not  taking  a  strong  role  in  addicKon   medicine  
  • Knowledge,  Aktudes  and  PracKces  of  Pharmacists  Concerning  PrescripKon  Drug  Abuse,  Lafferty,  Hunter  and  Marsh  •  454  Pharmacists  QuesKoned  •  65%  Retail,  16.5%  Hospital,  9%  Mail  order  •  68%  B.S.,  25%  Pharm.D.  •  65%  Male  and  35%  Female  •  65%  over  45  years  old  
  • Results  •  Knowledge   –  Most  did  not  answer  the  addicKon  quesKons   correctly   •  Only  28%  knew  the  standard  of  care   •  Less  than  half  said  they  knew  about  intervenKon  and   treatment  •  EducaKon   –  Almost  30%  had  no  substance  abuse  educaKon   –  67.5%  had  less  than  2  hours  
  • Treatment  and  IntervenKon  •  Although  most  had  not  intervened,  the  more   educaKon  they  had  the  more  confident  they   were  to  do  intervenKon  •  They  were  also  more  likely  to  call  the  physician   to  speak  about  a  problem.  
  • EducaKon  Needed  •  Pharmacists  can  help  by:   –  Calling  doctors  when  they  believe  there  is  a   problem   –  Speaking  to  alternaKves  to  paKent   –  Checking  and  making  sure  they  are  not  using   mulKple  pharmacies  and  doctors   –  Intervening  
  • Discussion  •  Pharmacists  Role   –  CerKficaKon  program   –  EducaKon  needed  to  have  a  greater  role   –  Pain  pharmacy  •  Society  at  Large   –  Oxycodone  vs.  Heroin    
  • Abuse…a  problem….Hello?   Yes,    Kentucky  Pharmacy  is  Here!!   April  2  –  4,  2013   Omni  Orlando  Resort     at  ChampionsGate  
  • Topics  for  Discussion  •  1.  Describe  what  SS-­‐HB1  has  done  to  affect  the   Profession  and  help  reduce  diversion.  •  2.  Provide  an  update  on  issues  we  faced  and  what  Bill   has  just  passed  and  signed  to  correct  issues.  •  3.  Formulate  an  effecKve  plan  of  acKon  when   diversion  is  discovered  or  suspected.