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Technologies	
  in	
  Preven/ng	
  	
  
        Diversion	
  
          April	
  2	
  –	
  4,	
  2013	
  
        Omni	
  Orlando	
  Resort	
  	
  
         at	
  ChampionsGate	
  
Technologies	
  in	
  Preven@ng	
  Diversion	
  
Moderator:	
  Dr.	
  Sarah	
  Melton,	
  Associate	
  Professor	
  of	
  Pharmacy	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  Prac@ce,	
  GaHon	
  College	
  of	
  Pharmacy	
  Prac@ce	
  

Presenters:	
  	
  Janet	
  Hart,	
  Director,	
  Government	
  Affairs,	
  Rite	
  Aid	
  

	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  Dr.	
  Michael	
  O’Neil,	
  Drug	
  Diversion	
  Consultant	
  DEA	
  /BCI	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  Professor,	
  Dept.	
  of	
  Pharmacy	
  Prac@ce,	
  South	
  College	
  	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  	
  School	
  of	
  Pharmacy	
  
Learning	
  Objec@ves	
  
1.  Evaluate	
  the	
  impact	
  of	
  controlled	
  substance	
  diversion	
  in	
  the	
  
	
  	
  	
  	
  	
  	
  	
  hospital	
  seVng.	
  

2.  Iden@fy	
  primary	
  methods	
  of	
  diversion	
  in	
  the	
  pharmacy	
  and	
  	
  
	
  	
  	
  	
  	
  	
  	
  on	
  nursing	
  units.	
  

3.  Iden@fy	
  processes	
  to	
  maximize	
  the	
  use	
  of	
  technology	
  in	
  	
  
	
  	
  	
  	
  	
  	
  diversion	
  preven@on,	
  detec@on,	
  and	
  management.	
  
Disclosure	
  Statement	
  
•  Dr.	
  ONeil	
  is	
  a	
  consultant	
  for	
  the	
  DEA,	
  WV-­‐bureau	
  of	
  criminal	
  Inves@ga@on,	
  
   The	
  US	
  AHorneys	
  Office,	
  Na@onal	
  Associa@on	
  of	
  Dental	
  Boards	
  and	
  has	
  
   provided	
  con@nuing	
  educa@on	
  for	
  in	
  chronic	
  pain	
  management	
  and	
  
   prescrip@on	
  drug	
  diversion	
  for	
  Endo	
  Pharmaceu@cals.	
  

•  Janet	
  Hart	
  has	
  no	
  relevant	
  financial	
  rela@onships	
  with	
  commercial	
  
   interests	
  to	
  disclose	
  
Overview	
  
•  Ini@al	
  overview	
  of	
  employee	
  behaviors	
  and	
  
   tac@cs	
  in	
  community	
  and	
  hospital	
  sites	
  
•  Overview	
  of	
  technologies	
  used	
  to	
  combat	
  
   diversion	
  behaviors	
  	
  
•  Physician	
  Driven	
  Diversion	
  
•  “Customer”	
  oriented	
  diversion:	
  focus	
  on	
  
   robberies	
  and	
  burglaries	
  
Impact	
  of	
  Drug	
  Diversion	
  in	
  Hospital	
  
       Pharmacies	
  and	
  Nursing	
  Units	
  
•  Absolute	
  inventory	
  $	
  costs	
  
	
  	
  	
  	
  	
  -­‐controls	
  v.	
  non-­‐controls	
  

•  Costs	
  of	
  impairment	
  
	
  	
  	
  	
  -­‐pharmacist	
  /	
  techs	
  
	
  	
  	
  	
  	
  -­‐nurses	
  
	
  	
  	
  	
  	
  -­‐management	
  

•  Cost	
  to	
  the	
  pa@ent	
  
	
  	
  	
  	
  -­‐injury,	
  death	
  
Counterfeit	
  Drugs	
  
•  Actual	
  TRUE	
  incidence	
  and	
  cost	
  is	
  unknown	
  
•  Can	
  be	
  a	
  major	
  contributor	
  in	
  community	
  and	
  
   hospital	
  pharmacy	
  
Bevacizumab	
  (for	
  cancer	
  treatment)	
  United	
  States	
  of	
  America,	
  2012	
  

Affected	
  19	
  medical	
  prac@ces	
  in	
  the	
  USA.	
  The	
  drug	
  lacked	
  ac@ve	
  ingredient	
  1	
  


Sildenasil	
  (for	
  erec/le	
  dysfunc/on)	
  United	
  Kingdom,	
  2012	
  

Smuggled	
  into	
  the	
  UK.	
  Contained	
  undeclared	
  ac@ve	
  ingredients	
  with	
  possible	
  serious	
  health	
  risks	
  to	
  the	
  
consumer	
  	
  



(Source	
  -­‐	
  WHO	
  Fact	
  Sheet)	
  
Counterfeit	
  Drugs	
  
•  Accounts	
  for	
  about	
  1%	
  of	
  total	
  market	
  sales	
  of	
  
   medica@ons	
  

•  One	
  of	
  the	
  primary	
  reasons	
  corporate	
  
   pharmacies	
  do	
  not	
  allow	
  ‘drug	
  take-­‐backs’	
  
“Grazing”	
  
Grazing	
  “Behaviors”	
  
•  Overt	
  self-­‐medica@ng	
  

•  Staff	
  diagnosing	
  /	
  “encouraging”	
  each	
  other	
  
   “Knowledge	
  does	
  not	
  grant	
  privilege!”	
  

•  Blatant	
  theh	
  for	
  $,	
  sex	
  
Medica@on	
  Sources	
  
•    BoHles	
  in	
  the	
  pharmacy	
  
•    Pa@ent	
  boHles	
  
•    Pa@ent	
  carts	
  
•    Medica@on	
  drawers	
  
•    Stock	
  
•    Automated	
  dispensing	
  machines	
  
•    Trash	
  (broken,	
  spilled	
  medica@ons)	
  
Grazing	
  
•    sexual	
  enhancers	
  
•    an@depressants	
  
•    an@psycho@cs	
  
•    butalbital	
  	
  
•    an@eme@cs	
  (promethazine))	
  
•    tramadol	
  
•    muscle	
  relaxants	
  
•    aspirin,	
  ibuprofen	
  	
  
Pharmacy	
  Community	
  
•  Trash	
  
•  Inventory	
  altera@ons	
  
•  Overt	
  Theh	
  	
  
	
  	
  	
  	
  	
  	
  	
  1.	
  individual	
  pills	
  v.	
  boHles	
  
	
  	
  	
  	
  	
  	
  	
  2.	
  dilu@ons	
  
•  Inten@onal	
  miscounts	
  
•  Dropped	
  meds	
  /	
  broken	
  meds	
  
•  Forged	
  prescrip@ons	
  
•  Adding	
  “false”	
  refills	
  to	
  old	
  prescrip@ons	
  
•  Sharing	
  /	
  Borrowing	
  passwords	
  
Hospital	
  Pharmacy	
  
•    Grazing	
  
•    Overfill	
  
•    Waste	
  
•    returns	
  
Nursing	
  
•      Pa@ent	
  complains	
  of	
  lack	
  of	
  pain	
  relief	
  

•  	
  Highly	
  suspicious	
  behavior	
  by	
  the	
  staff	
  in	
  ques@on	
  sugges@ng	
  impairment.	
  	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  Increased	
  tardys,	
  change	
  in	
  appearance,	
  worsening	
  behavior,	
  increased	
  errors	
  	
  

•      	
  The	
  nurse	
  in	
  ques@on	
  was	
  "too	
  busy	
  or	
  forgot"	
  to	
  secure	
  a	
  witness	
  for	
  a	
  waste	
  

•  	
  The	
  controlled	
  substance	
  count	
  is	
  incorrect	
  when	
  the	
  nurse	
  in	
  ques@on	
  works,	
  	
  	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  ohen	
  repe@@vely	
  

•      	
  Suspected	
  forged	
  signatures	
  

•      	
  The	
  nurse	
  in	
  ques@on	
  states	
  "gave	
  access	
  code"	
  to	
  another	
  nurse	
  

•      The	
  frequently	
  forgets	
  to	
  document	
  in	
  the	
  pa@ent’s	
  record	
  
Nursing	
  Techniques	
  /	
  Solu@ons	
  
Stealing	
  pa@ent	
  dose	
  
•  Order	
  is	
  for	
  hydrocodone/APAP	
  1-­‐2	
  tablets	
  Q4-­‐6Hr	
  Prn	
  Pain	
  
	
  	
  	
  	
  	
  	
  Over	
  IM/IV	
  administra@on	
  

•  Subs@tu@ng	
  a	
  dose	
  	
  
	
  	
  	
  	
  	
  1.	
  oral	
  (capsule,	
  liquid)	
  
	
  	
  	
  	
  	
  2.	
  IV	
  	
  

•  Falsifying	
  waste	
  

•  New	
  and	
  used	
  patches	
  
	
  	
  	
  	
  	
  1.	
  replace	
  new	
  with	
  old	
  
	
  	
  	
  	
  	
  2.	
  reuse	
  old	
  patches	
  

•  WriHen	
  -­‐Verbal	
  /	
  telephone	
  orders	
  that	
  are	
  false	
  
Other	
  Sites	
  within	
  the	
  Ins@tu@on	
  
•  OR	
  /	
  OR	
  satellites	
  anesthesiologist,	
  
   anesthe@sts	
  

•  ERs	
  
The	
  Technology	
  -­‐	
  Basics	
  
•  Do	
  official	
  background	
  checks	
  regardless	
  if	
  you	
  know	
  the	
  candidate	
  or	
  
   their	
  families	
  

•  Call	
  at	
  least	
  2	
  previous	
  employers	
  

•  Random	
  drug	
  tes@ng	
  	
  (for	
  the	
  right	
  drugs)	
  

•  Do	
  not	
  allow	
  people	
  to	
  be	
  alone	
  in	
  pharmacy	
  

•  Double	
  sign	
  off	
  inventories	
  

•  No	
  coats,	
  purses,	
  backpacks,	
  etc.	
  in	
  pharmacy	
  area	
  

•  LIMIT	
  ACCESS!	
  
The	
  Technology	
  
•  Hospital	
  Pharmacy	
  
	
  	
  	
  -­‐	
  Point	
  of	
  entry	
  to	
  controlled	
  substances	
  
	
  	
  	
  -­‐	
  ID	
  badge	
  	
  swipes	
  
	
  	
  	
  -­‐	
  refractometer	
  drug	
  tes@ng	
  
	
  	
  	
  -­‐	
  IV	
  product	
  /	
  waste	
  tes@ng	
  and	
  QA	
  
Refractometer	
  
•  Very	
  accurate	
  tes@ng	
  

•  Provides	
  a	
  sense	
  of	
  “surveillance”	
  as	
  a	
  
   deterrent	
  	
  

•  IV	
  rooms,	
  nursing	
  units,	
  ORs,	
  satellite	
  
   pharmacies	
  
Tracking	
  doses,	
  nurses,	
  tendencies	
  
           Automated	
  dispensing	
  machines	
  

•  drug,	
  unit,	
  formula@on,	
  person,	
  place,	
  @me	
  
Tracking	
  doses,	
  nurses,	
  tendencies	
  
•  PaHerns	
  
	
  	
  	
  	
  	
  -­‐on	
  floor	
  sta@s@cal	
  comparisons,	
  signs	
  out	
  more	
  than	
  other	
  	
  	
  
	
  	
  	
  	
  	
  	
  	
  	
  	
  nurses	
  
	
  	
  	
  	
  	
  	
  	
  -­‐excessive	
  documen@ng	
  waste	
  
	
  	
  	
  	
  	
  	
  	
  -­‐uses	
  larger	
  vials	
  for	
  smaller	
  doses	
  
	
  	
  	
  	
  	
  	
  	
  -­‐mul@ple	
  breaks	
  
•  Medica@on	
  changes	
  	
  
•  Doses	
  given	
  	
  
	
  	
  	
  	
  	
  -­‐range	
  doses	
  
	
  	
  	
  	
  	
  	
  	
  -­‐range	
  schedule	
  (Q4-­‐6)	
  
	
  	
  	
  	
  	
  	
  -­‐PRNS	
  
•  Shih	
  /	
  nurse	
  comparisons	
  
•  Witness	
  end	
  of	
  shih	
  counts	
  
Counterfeit	
  –	
  Shipment	
  Tracking	
  
•  RFID	
  /	
  GPS	
  tracking	
  of	
  full	
  shipments	
  

•  RFID	
  /GPS	
  tracking	
  of	
  single	
  boHles	
  

“NYPD	
  Will	
  Implant	
  GPS	
  Chips	
  Into	
  Pill	
  Bo>les	
  To	
  
         Combat	
  PrescripBon	
  Drug	
  Abuse”	
  
Employee	
  Diversion(retail)	
  
•  Hydrocodone	
  is	
  the	
  number	
  1	
  prescribed	
  item	
  
   in	
  the	
  US	
  
•  Also	
  a	
  highly	
  diverted	
  item	
  
•  Abusers	
  typically	
  take	
  15	
  to	
  20	
  tablets	
  a	
  day	
  	
  
•  Reports	
  have	
  shown	
  abusers	
  taking	
  in	
  excess	
  
   of	
  100	
  tablets	
  a	
  day	
  for	
  personal	
  use	
  
•  Most	
  employee	
  diversion	
  is	
  for	
  self	
  use	
  and	
  
   profit	
  
Automated	
  Dispensing	
  Cabinets	
  
• Strict	
  control	
  to	
  
  inventory	
  access	
  
• Records	
  individual	
  
  operator’s	
  access	
  	
  
  to	
  system	
  
• Daily	
  discrepancy	
  
  reports	
  generated	
  
Biometric	
  Safe	
  
•  Bolted	
  to	
  the	
  floor	
  
•  Controlled	
  access	
  with	
  biometric	
  scan	
  
Analy@cs	
  
Predic/ve	
  indicators	
  
•  Cycle	
  count	
  
   adjustments	
  
•  Overriding	
  
   replenishment	
  	
  
   orders	
  
•  Ordering	
  from	
  the	
  
   outside	
  vendor	
  
•  Purchases	
  do	
  not	
  
   balance	
  dispensing	
  
Point	
  of	
  Sale	
  with	
  Remote	
  Monitoring	
  
•  Remote	
  video	
  monitoring	
  
•  Point	
  of	
  sale	
  data	
  is	
  available	
  
•  Transac@on	
  analysis	
  by	
  individual	
  
   user	
  
•  Excep@on	
  based	
  reports	
  	
  
   automa@cally	
  generated	
  	
  
   with	
  video	
  back	
  up	
  
Remote	
  Monitoring	
  
  Incident	
  Report	
  
Policies	
  and	
  Procedures	
  
Zero	
  tolerance	
  on	
  employee	
  
  pilferage	
  for	
  controlled	
  
            substances	
  
Prescrip@on	
  Drug	
  Abuse	
  Epidemic	
  
               25	
  
                                                                                            22.5	
  
               20	
  
Millions	
  




               15	
  


               10	
  


                 5	
  

                                         0.6	
               1	
            1.4	
  
                          0.3	
  
                 0	
  
                         Heroin	
     Inhalants	
     Hallucinogens	
     Cocaine	
     Legend	
  Drugs	
  
Drug	
  Fact	
  
Over	
  100	
  People	
  die	
  from	
  drug	
  overdoses	
  every	
  
                 day	
  in	
  the	
  United	
  States.	
  
Many	
  of	
  the	
  individuals	
  started	
  therapy	
  with	
  a	
  
               valid	
  prescrip/on	
  for	
  pain.	
  
                              	
   	
   	
   	
  	
  
Drug	
  Fact	
  

•  For	
  every	
  death	
  there	
  are:	
  
   – 10	
  treatment	
  admissions	
  for	
  abuse	
  
   – 32	
  emergency	
  department	
  visits	
  for	
  misuse	
  
     or	
  abuse	
  
   – 130	
  people	
  who	
  abuse	
  or	
  are	
  dependent	
  
   – 825	
  non-­‐medical	
  users	
  
•  An	
  epidemic	
  
Drug	
  Fact	
  
•  Most	
  prescrip@on	
  pain	
  killers	
  are	
  
   prescribed	
  by	
  primary	
  care	
  and	
  
   internal	
  medicine	
  prescribers	
  
   – Not	
  specialists	
  
•  Roughly	
  20%	
  of	
  prescribers	
  prescribe	
  
   80%	
  of	
  ALL	
  prescrip@on	
  pain	
  killers	
  
Drug	
  Fact	
  
•  Enough	
  prescrip@on	
  pain	
  killers	
  were	
  
   prescribed	
  in	
  2011	
  to	
  medicate	
  every	
  
   American	
  adult	
  around	
  the	
  clock	
  for	
  
   a	
  month	
  
•  ¾	
  of	
  all	
  drug	
  overdose	
  deaths	
  in	
  the	
  
   US	
  are	
  due	
  to	
  prescrip@on	
  drugs	
  
Analy@cs	
  Suspicious	
  Ac@vity	
  
Prac@ce	
  of	
  pharmacy	
  is	
  changing	
  and	
  
pharmacists	
  must	
  be	
  more	
  aware	
  of	
  
the	
  poten@al	
  diversion	
  of	
  controlled	
  
substances	
  
•  Prescriber	
  
•  Pa@ent	
  
•  Pharmacy	
  
Pharmacist’s	
  Corresponding	
  
              Responsibili@es	
  (CSA)	
  
•  Must	
  consider	
  the	
  
   geographical	
  distance	
                                    PATIENT	
  

   between	
  the	
  doctor,	
  	
  the	
  
   pa@ent	
  	
  and	
  the	
  
   pharmacy	
  	
  
    –  Would	
  you	
  fill	
  a	
  
       prescrip@on	
  for	
  a	
  pa@ent	
  
       that	
  resides	
  in	
  Ohio,	
  
       prescribed	
  by	
  a	
  physician	
       PHARMACY	
                   PRESCRIBER	
  

       in	
  Florida	
  at	
  a	
  pharmacy	
  
       in	
  MassachuseHs?	
  
    –  NO	
  
Pill	
  Mill	
  Clinics	
  
•  Escalated	
  from	
  Florida	
  
•  LiHle	
  state	
  regulatory	
  oversight	
  
   – Doctor	
  dispensing	
  
   – Ques@onable	
  wholesalers	
  
Ten	
  Arrested	
  
In	
  Strike	
  Against	
  Florida	
  “Pill	
  Mill”	
  
The	
  Migra@on	
  
Suspicious	
  Ac/vity	
  
•  Pharmacists	
  play	
  an	
  important	
  role	
  in	
  the	
  
   diversion	
  of	
  controlled	
  substances	
  
    –  Pharmacist	
  can	
  iden@fy	
  suspicious	
  prescribers	
  
       (trends)	
  
    –  Pharmacist	
  can	
  iden@fy	
  suspicious	
  pa@ents	
  
       (PDMP)	
  
    –  Pharmacist	
  can	
  iden@fy	
  abuse	
  trends	
  
    –  Pharmacists	
  are	
  not	
  licensed	
  by	
  the	
  DEA/
       pharmacies	
  are	
  
    –  Pharmacists	
  need	
  help	
  and	
  guidance	
  
Report	
  Suspicious	
  Ac@vity	
  
•  Pharmacist	
  should	
  
   – Gather	
  informa@on	
  
      •  Prescriber	
  name	
  
          – Address	
  
          – DEA	
  
          – Descrip@on	
  of	
  	
  
            suspicious	
  ac@vity	
  

•  Pharmacist	
  should	
  report	
  trends	
  or	
  
   suspicious	
  ac@vity	
  
Pharmacy	
  Systemic	
  Approach	
  

Chain	
  data	
  
Top	
  Oxycodone	
  
                         Pharmacy	
  generated	
  data	
  
Stores	
                                 Prescriber	
  data	
  
                         Reported	
  
Top	
  Oxycodone	
  
Prescribers	
  
                         suspicious	
  
                                         Trends	
  
                                                               Store/Site	
  visit	
  
                         ac@vity	
  
Pa@ent	
  is	
  	
  
                         Distribu@on	
   Cash	
  vs.	
  TP	
  
                                                               Clinical	
  Protocol	
  
                                                                                        Edits	
  
iden@fied	
  from	
  
                         threshold	
              Oxy	
  vs.	
  CIIs	
              completed	
  by	
  
dispensing	
  data	
  
                         increase	
  requests	
                                     member	
  of	
  field	
   LeHer	
  to	
  
                                                  CII’s	
  vs.	
  all	
  RX’s	
  
                                                                                    management	
  or	
   Prescriber	
  
                                                                                    corporate	
              Edit	
  in	
  dispensing	
  
                                                                                                             system	
  to	
  
                                                                                                             prevent	
  control	
  
                                                                                                             prescrip@on	
  
                                                                                                             dispensing	
  for	
  
                                                                                                             select	
  prescribers	
  
Analysis	
  (Corporate)	
  
•  Top	
  oxycodone	
  and	
  hydrocodone	
  dispensing	
  
   pharmacies	
  
•  Top	
  oxycodone	
  and	
  hydrocodone	
  prescribers	
  
•  Reported	
  suspicious	
  ac@vity	
  of	
  prescribers	
  
•  Requests	
  for	
  distribu@on	
  threshold	
  increases	
  
•  Percentage	
  of	
  cash	
  versus	
  third	
  party	
  payer	
  for	
  
   controlled	
  substance	
  prescrip@ons	
  for	
  an	
  
   individual	
  prescriber	
  
•  Percentage	
  of	
  controlled	
  versus	
  non-­‐controlled	
  
   prescrip@ons	
  wriHen	
  by	
  a	
  prescriber	
  
Analy@cs	
  
•  Na@onal	
  Controlled	
  Substance	
  Ra@ng	
  
   Solu@on*	
  	
  
    – Na@onal	
  database	
  	
  
          •  Purchasing	
  data	
  
          •  Prescrip@on	
  data	
  
          •  Pa@ent	
  data	
  (de-­‐iden@fied)	
  
          •  Prescriber	
  reference	
  data	
  (specialty)	
  
    – Guide	
  to	
  iden@fying	
  suspicious	
  
      prescriber	
  ac@vity	
  
*Currently	
  under	
  development	
  
Na@onal	
  Dashboard	
  
•  The	
  Na@onal	
  Dashboard	
  will	
  be	
  color-­‐coded	
  
   based	
  on	
  the	
  metric	
  selected	
  
    –  Per	
  Capita	
  $	
  Spend	
  for	
  controlled	
  substances	
  
    –  Rx	
  Volume	
  
    –  Unit	
  Volume	
  (best	
  analysis	
  by	
  dosage	
  unit)	
  
    –  Change	
  in	
  Unit	
  Volume	
  (spike	
  in	
  dispensing	
  CDS)	
  
    –  #	
  of	
  Outlets	
  w/	
  High	
  Overall	
  Ra@ng	
  
    –  #	
  of	
  Prescribers	
  w/	
  High	
  Overall	
  Ra@ng	
  
•  Selec@ng	
  a	
  state	
  will	
  then	
  drop	
  color-­‐code	
  “pins”	
  	
  
   for	
  each	
  of	
  the	
  areas	
  within	
  a	
  state	
  	
  
   where	
  suspicious	
  ac@vity	
  may	
  be	
  iden@fied	
  
Na@onal	
  Dashboard	
  
Pharmacy	
  Clinic	
  Protocol 	
  	
  
•  Checklist	
  to	
  review	
  a	
  prescriber’s	
  office	
  
   –  Onsite	
  visit	
  (pictures	
  or	
  Google	
  maps)	
  
   –  Review	
  of	
  opera@ng	
  procedures	
  (security	
  guards)	
  
   –  Review	
  staff	
  and	
  creden@als	
  (sanc@ons)	
  
   –  Review	
  the	
  pa@ent	
  base	
  (similar	
  age)	
  
   –  Review	
  medica@ons	
  prescribed	
  (each	
  pa@ent	
  gets	
  
      same	
  medica@on	
  in	
  same	
  strength	
  and	
  quan@ty)	
  
       •  Oxycodone	
  30mg	
  #180	
  for	
  all	
  pa@ents	
  
Clinic	
  Protocol	
  
•  The	
  protocol	
  is	
  not	
  only	
  used	
  for	
  
   prescribers	
  of	
  opioids	
  such	
  as	
  
   oxycodone	
  and	
  hydrocodone	
  
   –  Buprenorphine	
  clinics	
  
       •  Review	
  of	
  DEA	
  license	
  to	
  determine	
  number	
  of	
  pa@ents	
  
          prescriber	
  can	
  treat	
  (30	
  versus	
  100	
  pa@ents)	
  
       •  Review	
  the	
  number	
  pa@ents	
  under	
  treatment	
  or	
  care	
  
          by	
  the	
  prescriber	
  
   –  Weight	
  loss	
  clinics	
  
   –  ADHD	
  clinics 	
  	
  
Poten@al	
  Ac@on	
  Edit	
  in	
  Computer	
  
•  LeHer	
  sent	
  to	
  the	
  prescriber	
  sta@ng	
  this	
  
   pharmacy	
  will	
  no	
  longer	
  dispense	
  
   prescrip@ons	
  for	
  controlled	
  substances	
  under	
  
   his/her	
  DEA	
  registra@on	
  (2	
  days	
  prior	
  to	
  edit	
  in	
  
   the	
  dispensing	
  system)	
  
    –  LeHer	
  must	
  be	
  mailed	
  via	
  Cer@fied	
  Mail,	
  UPS,	
  
       FedEx,	
  or	
  any	
  other	
  provider	
  that	
  has	
  shipment	
  
       tracking	
  and	
  signature	
  required	
  to	
  assure	
  delivery	
  
•  “Corporate	
  policy	
  prohibits	
  dispensing	
  
   controlled	
  substance	
  prescrip4ons	
  	
  
   wri6en	
  by	
  this	
  prescriber”	
  
Suspicious	
  Prescriber	
  
•  Prescriber	
  
   –  Prescribed	
  695,811	
  total	
  dosage	
  units	
  of	
  oxycodone	
  
      containing	
  products	
  in	
  12	
  months	
  
        •  Prescribed	
  460,806	
  dosage	
  units	
  of	
  oxycodone	
  30	
  mg	
  tablets	
  
           in	
  12	
  months	
  
   –  Prescribed	
  to	
  several	
  members	
  of	
  the	
  same	
  family	
  at	
  
      the	
  same	
  address	
  with	
  same	
  diagnosis	
  
   –  Prescribed	
  the	
  same	
  combina@on	
  of	
  drugs	
  to	
  the	
  
      majority	
  of	
  pa@ents	
  
   –  Did	
  not	
  accept	
  Medicaid	
  pa@ents	
  and	
  did	
  not	
  accept	
  
      insurance	
  plans	
  for	
  office	
  visits	
  
   –  Ini@al	
  office	
  visit	
  per	
  pa@ent	
  was	
  $250.00	
  cash	
  only	
  
Systemic	
  Approach	
  

Store	
  generated	
  data	
  

Distribu@on	
   •  Pharmacy	
  Manager	
  requests	
  a	
  
threshold	
        threshold	
  increase	
  for	
  oxycodone	
  
increase	
  
request	
  
                   30mg	
  
                       –  “Pharmacy	
  200	
  feet	
  down	
  the	
  block	
  
                          is	
  no	
  longer	
  stocking	
  oxycodone	
  
                          30mg.	
  I’ve	
  lost	
  a	
  ton	
  of	
  business	
  so	
  I	
  
                          try	
  to	
  fill	
  in	
  the	
  gaps	
  and	
  aHract	
  new	
  
                          business	
  however	
  I	
  can”	
  
Systemic	
  Approach	
  

Prescriber	
  Data	
  

Trends	
                        •  Top	
  6	
  prescribers	
  were	
  prac@cing	
  in	
  
Cash	
  vs.	
  TP	
                Florida	
  (Store	
  is	
  in	
  New	
  England)	
  
                                •  Oxycodone	
  30mg	
  was	
  the	
  primary	
  
Oxy	
  vs.	
  CIIs	
               oxycodone	
  product	
  prescribed	
  
CII’s	
  vs.	
  all	
  RX’s	
   •  85%	
  of	
  these	
  prescrip@ons	
  were	
  for	
  
                           cash	
  payments	
  
                        •  67%	
  of	
  the	
  CII	
  prescrip@ons	
  were	
  for	
  
                           oxycodone	
  30mg	
  
                        •  78%	
  of	
  the	
  prescrip@ons	
  were	
  for	
  CIIs	
  
Systemic	
  Approach	
  

Store/Site	
  Visit	
  

Clinic	
  Protocol	
     •  Based	
  on	
  the	
  informa@on	
  from	
  
completed	
  by	
  
member	
  of	
              the	
  store	
  generated	
  data	
  and	
  
field	
                      the	
  prescriber	
  data	
  a	
  Store/Site	
  
management	
  
or	
  corporate.	
          visit	
  was	
  not	
  required	
  
                         •  The	
  request	
  for	
  a	
  threshold	
  
                            increase	
  was	
  denied	
  
Systemic	
  Approach	
  

Edits	
  
LeHer	
  to	
  
Prescriber.	
  
                               •  Based	
  on	
  prescriber	
  analysis	
  a	
  
Edit	
  in	
  dispensing	
  
                                  leHer	
  was	
  sent	
  to	
  suspicious	
  
system	
  to	
                    prescribers	
  
prevent	
  control	
  
prescrip@on	
                  •  A	
  message	
  is	
  ac@vated	
  in	
  the	
  
dispensing	
  for	
               dispensing	
  system:	
  “Corporate	
  
select	
  
prescribers.	
                    policy	
  prohibits	
  dispensing	
  
                                  controlled	
  substance	
  prescrip@ons	
  
                                  wriHen	
  by	
  this	
  prescriber”	
  
Addi@onal	
  Technology	
  Tools	
  
              (under	
  development)	
  
•  Poten@al	
  edit	
  through	
  “third	
  party	
  
   processor”	
  to	
  alert	
  for	
  suspicious	
  ac@vity	
  
   (may	
  include)	
  	
  
   –  Pa@ent	
  demographic	
  
   –  Prescriber	
  prac@ce	
  loca@on	
  
   –  Prescriber’s	
  scope	
  of	
  prac@ce	
  
   –  Medica@on	
  and/or	
  therapy	
  prescribed	
  
   –  Prescribing	
  paHerns	
  
      •  All	
  pa@ents	
  get	
  the	
  same	
  combina@on	
  	
  
         of	
  medica@ons	
  with	
  same	
  diagnosis	
  
Summary	
  
•  Pharmacies	
  should	
  consider	
  developing	
  a	
  
   comprehensive	
  analy@cal	
  approach	
  to	
  iden@fy	
  
   suspicious	
  prescriber	
  ac@vity. 	
  	
  
       –  This	
  approach	
  cannot	
  iden@fy	
  all	
  ac@vity	
  and	
  must	
  
          be	
  supplemented	
  by	
  the	
  pharmacists	
  in	
  stores	
  	
  
       –  Prescribers	
  are	
  reviewed	
  on	
  an	
  individual	
  basis	
  
          with	
  respect	
  to	
  their	
  scope	
  of	
  prac@ce	
  and	
  pa@ent	
  
          base	
  
       –  The	
  analy@cs	
  are	
  simply	
  an	
  added	
  tool.	
  
          Pharmacists	
  are	
  a	
  key	
  part	
  of	
  the	
  process	
  
Note:	
  This	
  list	
  is	
  not	
  inclusive	
  of	
  all	
  the	
  inves@ga@ve	
  techniques	
  we	
  rou@nely	
  conduct,	
  this	
  is	
  
intended	
  to	
  highlight	
  the	
  major	
  inves@ga@ve	
  steps.	
  
Pa@ent	
  Diversion	
  Behavior	
  
•  Armed	
  Robberies	
  rose	
  81%	
  from	
  2006	
  to	
  
   2010	
  
•  The	
  number	
  of	
  dosage	
  units	
  stolen	
  grew	
  from	
  
   706,000	
  to	
  1.3	
  million	
  
•  Haven	
  Drugs	
  –	
  Medford,	
  NY	
  a	
  pharmacist,	
  a	
  
   clerk	
  and	
  two	
  customers	
  killed	
  in	
  the	
  robbery	
  
•  Charlie’s	
  Family	
  Pharmacy	
  –	
  Seaford,	
  	
  
   NY	
  an	
  ATF	
  agent	
  and	
  robbery	
  suspect	
  	
  
   shot	
  and	
  killed	
  
Reason	
  Pharmacies	
  are	
  Targeted	
  
•  Easy	
  to	
  find	
  and	
  easy	
  access	
  
•  Open	
  extended	
  hours	
  
•  Typically	
  carry	
  larger	
  inventory	
  to	
  sa@sfy	
  demand	
  
•  Open	
  floor	
  design	
  to	
  facilitate	
  pa@ent	
  interac@on	
  
•  Limited	
  barriers	
  
•  Limited	
  training	
  for	
  employees	
  on	
  robbery	
  events	
  
•  Sa@sfy	
  addic@on	
  and	
  some	
  converted	
  	
  
   to	
  cash	
  
    –  $80/tablet	
  of	
  oxycodone	
  in	
  certain	
  markets	
  
Preven@on	
  Tips	
  -­‐	
  Training	
  
•  Understand	
  and	
  observe	
  behaviors	
  of	
  poten@al	
  robber	
  
    1.  Purposely	
  wearing	
  mul@ple	
  layers	
  to	
  cover	
  their	
  face	
  
    2.  Do	
  not	
  directly	
  look	
  at	
  cashier	
  or	
  other	
  associate	
  
    3.  They	
  do	
  not	
  acknowledge	
  your	
  gree@ng	
  or	
  comply	
  with	
  
        request	
  to	
  show	
  their	
  face	
  
    4.  They	
  walk	
  directly	
  and	
  with	
  purpose	
  to	
  the	
  pharmacy	
  
        counter	
  
•  Be	
  aware	
  of	
  your	
  surroundings	
  
•  Controlled	
  safes/cabinets	
  must	
  be	
  locked	
  when	
  not	
  in	
  
   use	
  
•  Keep	
  pharmacy	
  doors	
  locked	
  at	
  all	
  @mes	
  
•  Never	
  leave	
  the	
  pharmacy	
  area	
  unaHended	
  
Preven@on	
  Tips	
  -­‐	
  Training	
  
•  Wipe	
  counters	
  and	
  front	
  doors	
  
   – Finger	
  prints	
  
•  Stage	
  par@ally	
  filled	
  boHles	
  for	
  a	
  
   robbery	
  event	
  
•  Mark	
  your	
  boHles	
  
   – Provides	
  a	
  link	
  for	
  	
  
     law	
  enforcement	
  
   – Iden@fies	
  point	
  	
  
     of	
  origin	
  
During	
  an	
  Event	
  
•    Primary	
  concern	
  –	
  Safety	
  of	
  coworkers	
  and	
  customers	
  
•    Do	
  not	
  resist	
  
•    Remain	
  calm	
  –	
  no	
  sudden	
  movements	
  
•    Cooperate	
  and	
  follow	
  instruc@ons	
  given	
  by	
  the	
  robber	
  
      –  Do	
  exactly	
  what	
  you	
  are	
  told,	
  nothing	
  more,	
  nothing	
  less,	
  do	
  
         not	
  argue	
  
•  Make	
  mental	
  notes	
  of	
  the	
  robber	
  –	
  hair,	
  clothing,	
  
   shoes,	
  taHoos,	
  scars,	
  etc.	
  
•  Do	
  not	
  aHempt	
  to	
  apprehend	
  the	
  criminal	
  
•  Goal	
  is	
  to	
  get	
  the	
  robber	
  out	
  of	
  the	
  	
  
   building	
  quickly	
  
For@fica@on	
  Sugges@ons	
  Based	
  on	
  	
  
               Risk	
  Level	
  
•  Height	
  Strip	
  Cameras	
   •  Public	
  view	
  monitor	
  
•  Capture’s	
  height	
  of	
       at	
  the	
  pharmacy	
  
   robbery	
  suspect	
              drop	
  off	
  window	
  
•  BeHer	
  facial	
  image	
     •  In@mida@on	
  
Exterior	
  Ligh@ng	
  and	
  Cameras	
  
•  Increasing	
  the	
  foot	
  candles	
  of	
  exterior	
  ligh@ng	
  
•  Exterior	
  cameras	
  for	
  parking	
  lots	
  and	
  store	
  
   entrance	
  
    –  Some	
  suspects	
  do	
  not	
  wear	
  their	
  disguise	
  	
  
       in	
  the	
  car	
  or	
  parking	
  lots	
  
    –  Capture	
  car	
  make	
  and	
  model,	
  may	
  capture	
  	
  
       license	
  plates	
  
    –  Direc@on	
  the	
  suspected	
  	
  
       headed	
  
Robbery	
  Poster	
  
•  Overt	
  warning	
  to	
  
   the	
  suspect	
  and	
  
   customers	
  for	
  
   awareness	
  
•  Trained	
  associates	
  
Reward	
  Offers	
  


             Asking	
  concerned	
  
             ci@zens	
  for	
  their	
  
             help	
  to	
  resolve	
  a	
  
             crime.	
  
“Bait	
  BoHles”	
  
Tracking	
  Devices	
  
•  GPS	
  tracking	
  system	
  
•  Law	
  Enforcement	
  Tool	
  
•  Immediate	
  no@fica@on	
  of	
  robbery	
  events	
  to	
  a	
  
   mobile	
  device	
  and	
  law	
  enforcement	
  
•  Provides	
  law	
  enforcement	
  accurate	
  loca@on	
  
   data	
  on	
  the	
  suspect	
  
•  Aids	
  in	
  the	
  apprehension	
  of	
  the	
  robbery	
  
   suspect	
  and	
  recovery	
  of	
  stolen	
  drugs	
  
Tracking	
  Devices	
  
•    Hidden	
  within	
  the	
  inventory	
  
•    Fully	
  automa@c	
  
•    Updates	
  GPS	
  loca@on	
  every	
  6	
  to	
  8	
  seconds	
  
•    Track	
  via	
  secured	
  website	
  (law	
  enforcement)	
  
•    Device	
  is	
  silent	
  
•    Seamless	
  to	
  day	
  to	
  day	
  pharmacy	
  opera@ons	
  
•    Tip:	
  Give	
  staged	
  par@ally	
  filled	
  boHles	
  with	
  the	
  
     tracker	
  
Tracking	
  Points	
  
•  9:27	
  PM	
  –	
  Device	
  ac@ve	
  on	
  Server	
  
•  9:29	
  PM	
  –	
  Unit	
  gains	
  GPS	
  and	
  is	
  SW	
  on	
  Roosevelt	
  Blvd	
  	
  
•  9:33	
  PM	
  –	
  Subject	
  turns	
  leh	
  traveling	
  SE	
  on	
  Tyson	
  Ave	
  
•  9:34	
  PM	
  –	
  Vehicle	
  crosses	
  over	
  Frankford	
  Ave	
  s@ll	
  
   moving	
  SE	
  
•  9:36	
  PM	
  –	
  Subject	
  turns	
  right	
  on	
  to	
  Torresdale	
  Ave	
  
   traveling	
  SW	
  
•  9:39	
  PM	
  –	
  Subject’s	
  vehicle	
  is	
  stopped	
  by	
  Police	
  
Outcome	
  
•  Police	
  arrested	
  2	
  subjects	
  at	
  the	
  scene	
  
•  Recovered	
  weapons	
  and	
  evidence	
  of	
  the	
  event	
  
       –  Clothing	
  and	
  drugs	
  
•  They	
  were	
  connected	
  to	
  20+	
  open	
  cases	
  
   against	
  chain	
  and	
  independent	
  pharmacy	
  
   robberies	
  
This	
  list	
  of	
  suggested	
  tac@cs	
  is	
  not	
  all	
  inclusive.	
  All	
  factors	
  should	
  be	
  considered	
  
when	
  implemen@ng	
  any	
  tac@c	
  or	
  combina@on	
  of	
  tac@cs	
  including	
  threat	
  level,	
  
design	
  of	
  building,	
  method	
  of	
  robbers	
  in	
  the	
  geographic	
  area,	
  etc.	
  	
  
QUESTIONS	
  
•  Thank	
  you	
  

•  Dr.	
  Michael	
  O’Neil	
  
•  Janet	
  Hart	
  R.Ph.	
  

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Technologies in preventing_diversion-ne_wweb

  • 1. Technologies  in  Preven/ng     Diversion   April  2  –  4,  2013   Omni  Orlando  Resort     at  ChampionsGate  
  • 2. Technologies  in  Preven@ng  Diversion   Moderator:  Dr.  Sarah  Melton,  Associate  Professor  of  Pharmacy                                                Prac@ce,  GaHon  College  of  Pharmacy  Prac@ce   Presenters:    Janet  Hart,  Director,  Government  Affairs,  Rite  Aid                                              Dr.  Michael  O’Neil,  Drug  Diversion  Consultant  DEA  /BCI                                                Professor,  Dept.  of  Pharmacy  Prac@ce,  South  College                                                  School  of  Pharmacy  
  • 3. Learning  Objec@ves   1.  Evaluate  the  impact  of  controlled  substance  diversion  in  the                hospital  seVng.   2.  Iden@fy  primary  methods  of  diversion  in  the  pharmacy  and                  on  nursing  units.   3.  Iden@fy  processes  to  maximize  the  use  of  technology  in                diversion  preven@on,  detec@on,  and  management.  
  • 4. Disclosure  Statement   •  Dr.  ONeil  is  a  consultant  for  the  DEA,  WV-­‐bureau  of  criminal  Inves@ga@on,   The  US  AHorneys  Office,  Na@onal  Associa@on  of  Dental  Boards  and  has   provided  con@nuing  educa@on  for  in  chronic  pain  management  and   prescrip@on  drug  diversion  for  Endo  Pharmaceu@cals.   •  Janet  Hart  has  no  relevant  financial  rela@onships  with  commercial   interests  to  disclose  
  • 5. Overview   •  Ini@al  overview  of  employee  behaviors  and   tac@cs  in  community  and  hospital  sites   •  Overview  of  technologies  used  to  combat   diversion  behaviors     •  Physician  Driven  Diversion   •  “Customer”  oriented  diversion:  focus  on   robberies  and  burglaries  
  • 6. Impact  of  Drug  Diversion  in  Hospital   Pharmacies  and  Nursing  Units   •  Absolute  inventory  $  costs            -­‐controls  v.  non-­‐controls   •  Costs  of  impairment          -­‐pharmacist  /  techs            -­‐nurses            -­‐management   •  Cost  to  the  pa@ent          -­‐injury,  death  
  • 7. Counterfeit  Drugs   •  Actual  TRUE  incidence  and  cost  is  unknown   •  Can  be  a  major  contributor  in  community  and   hospital  pharmacy   Bevacizumab  (for  cancer  treatment)  United  States  of  America,  2012   Affected  19  medical  prac@ces  in  the  USA.  The  drug  lacked  ac@ve  ingredient  1   Sildenasil  (for  erec/le  dysfunc/on)  United  Kingdom,  2012   Smuggled  into  the  UK.  Contained  undeclared  ac@ve  ingredients  with  possible  serious  health  risks  to  the   consumer     (Source  -­‐  WHO  Fact  Sheet)  
  • 8. Counterfeit  Drugs   •  Accounts  for  about  1%  of  total  market  sales  of   medica@ons   •  One  of  the  primary  reasons  corporate   pharmacies  do  not  allow  ‘drug  take-­‐backs’  
  • 10. Grazing  “Behaviors”   •  Overt  self-­‐medica@ng   •  Staff  diagnosing  /  “encouraging”  each  other   “Knowledge  does  not  grant  privilege!”   •  Blatant  theh  for  $,  sex  
  • 11. Medica@on  Sources   •  BoHles  in  the  pharmacy   •  Pa@ent  boHles   •  Pa@ent  carts   •  Medica@on  drawers   •  Stock   •  Automated  dispensing  machines   •  Trash  (broken,  spilled  medica@ons)  
  • 12. Grazing   •  sexual  enhancers   •  an@depressants   •  an@psycho@cs   •  butalbital     •  an@eme@cs  (promethazine))   •  tramadol   •  muscle  relaxants   •  aspirin,  ibuprofen    
  • 13. Pharmacy  Community   •  Trash   •  Inventory  altera@ons   •  Overt  Theh                  1.  individual  pills  v.  boHles                2.  dilu@ons   •  Inten@onal  miscounts   •  Dropped  meds  /  broken  meds   •  Forged  prescrip@ons   •  Adding  “false”  refills  to  old  prescrip@ons   •  Sharing  /  Borrowing  passwords  
  • 14. Hospital  Pharmacy   •  Grazing   •  Overfill   •  Waste   •  returns  
  • 15. Nursing   •  Pa@ent  complains  of  lack  of  pain  relief   •   Highly  suspicious  behavior  by  the  staff  in  ques@on  sugges@ng  impairment.                        Increased  tardys,  change  in  appearance,  worsening  behavior,  increased  errors     •   The  nurse  in  ques@on  was  "too  busy  or  forgot"  to  secure  a  witness  for  a  waste   •   The  controlled  substance  count  is  incorrect  when  the  nurse  in  ques@on  works,                        ohen  repe@@vely   •   Suspected  forged  signatures   •   The  nurse  in  ques@on  states  "gave  access  code"  to  another  nurse   •  The  frequently  forgets  to  document  in  the  pa@ent’s  record  
  • 16. Nursing  Techniques  /  Solu@ons   Stealing  pa@ent  dose   •  Order  is  for  hydrocodone/APAP  1-­‐2  tablets  Q4-­‐6Hr  Prn  Pain              Over  IM/IV  administra@on   •  Subs@tu@ng  a  dose              1.  oral  (capsule,  liquid)            2.  IV     •  Falsifying  waste   •  New  and  used  patches            1.  replace  new  with  old            2.  reuse  old  patches   •  WriHen  -­‐Verbal  /  telephone  orders  that  are  false  
  • 17. Other  Sites  within  the  Ins@tu@on   •  OR  /  OR  satellites  anesthesiologist,   anesthe@sts   •  ERs  
  • 18. The  Technology  -­‐  Basics   •  Do  official  background  checks  regardless  if  you  know  the  candidate  or   their  families   •  Call  at  least  2  previous  employers   •  Random  drug  tes@ng    (for  the  right  drugs)   •  Do  not  allow  people  to  be  alone  in  pharmacy   •  Double  sign  off  inventories   •  No  coats,  purses,  backpacks,  etc.  in  pharmacy  area   •  LIMIT  ACCESS!  
  • 19. The  Technology   •  Hospital  Pharmacy        -­‐  Point  of  entry  to  controlled  substances        -­‐  ID  badge    swipes        -­‐  refractometer  drug  tes@ng        -­‐  IV  product  /  waste  tes@ng  and  QA  
  • 20. Refractometer   •  Very  accurate  tes@ng   •  Provides  a  sense  of  “surveillance”  as  a   deterrent     •  IV  rooms,  nursing  units,  ORs,  satellite   pharmacies  
  • 21. Tracking  doses,  nurses,  tendencies   Automated  dispensing  machines   •  drug,  unit,  formula@on,  person,  place,  @me  
  • 22. Tracking  doses,  nurses,  tendencies   •  PaHerns            -­‐on  floor  sta@s@cal  comparisons,  signs  out  more  than  other                        nurses                -­‐excessive  documen@ng  waste                -­‐uses  larger  vials  for  smaller  doses                -­‐mul@ple  breaks   •  Medica@on  changes     •  Doses  given              -­‐range  doses                -­‐range  schedule  (Q4-­‐6)              -­‐PRNS   •  Shih  /  nurse  comparisons   •  Witness  end  of  shih  counts  
  • 23. Counterfeit  –  Shipment  Tracking   •  RFID  /  GPS  tracking  of  full  shipments   •  RFID  /GPS  tracking  of  single  boHles   “NYPD  Will  Implant  GPS  Chips  Into  Pill  Bo>les  To   Combat  PrescripBon  Drug  Abuse”  
  • 24. Employee  Diversion(retail)   •  Hydrocodone  is  the  number  1  prescribed  item   in  the  US   •  Also  a  highly  diverted  item   •  Abusers  typically  take  15  to  20  tablets  a  day     •  Reports  have  shown  abusers  taking  in  excess   of  100  tablets  a  day  for  personal  use   •  Most  employee  diversion  is  for  self  use  and   profit  
  • 25. Automated  Dispensing  Cabinets   • Strict  control  to   inventory  access   • Records  individual   operator’s  access     to  system   • Daily  discrepancy   reports  generated  
  • 26. Biometric  Safe   •  Bolted  to  the  floor   •  Controlled  access  with  biometric  scan  
  • 27. Analy@cs   Predic/ve  indicators   •  Cycle  count   adjustments   •  Overriding   replenishment     orders   •  Ordering  from  the   outside  vendor   •  Purchases  do  not   balance  dispensing  
  • 28. Point  of  Sale  with  Remote  Monitoring   •  Remote  video  monitoring   •  Point  of  sale  data  is  available   •  Transac@on  analysis  by  individual   user   •  Excep@on  based  reports     automa@cally  generated     with  video  back  up  
  • 29. Remote  Monitoring   Incident  Report  
  • 30. Policies  and  Procedures   Zero  tolerance  on  employee   pilferage  for  controlled   substances  
  • 31. Prescrip@on  Drug  Abuse  Epidemic   25   22.5   20   Millions   15   10   5   0.6   1   1.4   0.3   0   Heroin   Inhalants   Hallucinogens   Cocaine   Legend  Drugs  
  • 32. Drug  Fact   Over  100  People  die  from  drug  overdoses  every   day  in  the  United  States.   Many  of  the  individuals  started  therapy  with  a   valid  prescrip/on  for  pain.            
  • 33. Drug  Fact   •  For  every  death  there  are:   – 10  treatment  admissions  for  abuse   – 32  emergency  department  visits  for  misuse   or  abuse   – 130  people  who  abuse  or  are  dependent   – 825  non-­‐medical  users   •  An  epidemic  
  • 34. Drug  Fact   •  Most  prescrip@on  pain  killers  are   prescribed  by  primary  care  and   internal  medicine  prescribers   – Not  specialists   •  Roughly  20%  of  prescribers  prescribe   80%  of  ALL  prescrip@on  pain  killers  
  • 35. Drug  Fact   •  Enough  prescrip@on  pain  killers  were   prescribed  in  2011  to  medicate  every   American  adult  around  the  clock  for   a  month   •  ¾  of  all  drug  overdose  deaths  in  the   US  are  due  to  prescrip@on  drugs  
  • 36. Analy@cs  Suspicious  Ac@vity   Prac@ce  of  pharmacy  is  changing  and   pharmacists  must  be  more  aware  of   the  poten@al  diversion  of  controlled   substances   •  Prescriber   •  Pa@ent   •  Pharmacy  
  • 37. Pharmacist’s  Corresponding   Responsibili@es  (CSA)   •  Must  consider  the   geographical  distance   PATIENT   between  the  doctor,    the   pa@ent    and  the   pharmacy     –  Would  you  fill  a   prescrip@on  for  a  pa@ent   that  resides  in  Ohio,   prescribed  by  a  physician   PHARMACY   PRESCRIBER   in  Florida  at  a  pharmacy   in  MassachuseHs?   –  NO  
  • 38. Pill  Mill  Clinics   •  Escalated  from  Florida   •  LiHle  state  regulatory  oversight   – Doctor  dispensing   – Ques@onable  wholesalers  
  • 39. Ten  Arrested   In  Strike  Against  Florida  “Pill  Mill”  
  • 41. Suspicious  Ac/vity   •  Pharmacists  play  an  important  role  in  the   diversion  of  controlled  substances   –  Pharmacist  can  iden@fy  suspicious  prescribers   (trends)   –  Pharmacist  can  iden@fy  suspicious  pa@ents   (PDMP)   –  Pharmacist  can  iden@fy  abuse  trends   –  Pharmacists  are  not  licensed  by  the  DEA/ pharmacies  are   –  Pharmacists  need  help  and  guidance  
  • 42. Report  Suspicious  Ac@vity   •  Pharmacist  should   – Gather  informa@on   •  Prescriber  name   – Address   – DEA   – Descrip@on  of     suspicious  ac@vity   •  Pharmacist  should  report  trends  or   suspicious  ac@vity  
  • 43. Pharmacy  Systemic  Approach   Chain  data   Top  Oxycodone   Pharmacy  generated  data   Stores   Prescriber  data   Reported   Top  Oxycodone   Prescribers   suspicious   Trends   Store/Site  visit   ac@vity   Pa@ent  is     Distribu@on   Cash  vs.  TP   Clinical  Protocol   Edits   iden@fied  from   threshold   Oxy  vs.  CIIs   completed  by   dispensing  data   increase  requests   member  of  field   LeHer  to   CII’s  vs.  all  RX’s   management  or   Prescriber   corporate   Edit  in  dispensing   system  to   prevent  control   prescrip@on   dispensing  for   select  prescribers  
  • 44. Analysis  (Corporate)   •  Top  oxycodone  and  hydrocodone  dispensing   pharmacies   •  Top  oxycodone  and  hydrocodone  prescribers   •  Reported  suspicious  ac@vity  of  prescribers   •  Requests  for  distribu@on  threshold  increases   •  Percentage  of  cash  versus  third  party  payer  for   controlled  substance  prescrip@ons  for  an   individual  prescriber   •  Percentage  of  controlled  versus  non-­‐controlled   prescrip@ons  wriHen  by  a  prescriber  
  • 45. Analy@cs   •  Na@onal  Controlled  Substance  Ra@ng   Solu@on*     – Na@onal  database     •  Purchasing  data   •  Prescrip@on  data   •  Pa@ent  data  (de-­‐iden@fied)   •  Prescriber  reference  data  (specialty)   – Guide  to  iden@fying  suspicious   prescriber  ac@vity   *Currently  under  development  
  • 46. Na@onal  Dashboard   •  The  Na@onal  Dashboard  will  be  color-­‐coded   based  on  the  metric  selected   –  Per  Capita  $  Spend  for  controlled  substances   –  Rx  Volume   –  Unit  Volume  (best  analysis  by  dosage  unit)   –  Change  in  Unit  Volume  (spike  in  dispensing  CDS)   –  #  of  Outlets  w/  High  Overall  Ra@ng   –  #  of  Prescribers  w/  High  Overall  Ra@ng   •  Selec@ng  a  state  will  then  drop  color-­‐code  “pins”     for  each  of  the  areas  within  a  state     where  suspicious  ac@vity  may  be  iden@fied  
  • 48. Pharmacy  Clinic  Protocol     •  Checklist  to  review  a  prescriber’s  office   –  Onsite  visit  (pictures  or  Google  maps)   –  Review  of  opera@ng  procedures  (security  guards)   –  Review  staff  and  creden@als  (sanc@ons)   –  Review  the  pa@ent  base  (similar  age)   –  Review  medica@ons  prescribed  (each  pa@ent  gets   same  medica@on  in  same  strength  and  quan@ty)   •  Oxycodone  30mg  #180  for  all  pa@ents  
  • 49. Clinic  Protocol   •  The  protocol  is  not  only  used  for   prescribers  of  opioids  such  as   oxycodone  and  hydrocodone   –  Buprenorphine  clinics   •  Review  of  DEA  license  to  determine  number  of  pa@ents   prescriber  can  treat  (30  versus  100  pa@ents)   •  Review  the  number  pa@ents  under  treatment  or  care   by  the  prescriber   –  Weight  loss  clinics   –  ADHD  clinics    
  • 50. Poten@al  Ac@on  Edit  in  Computer   •  LeHer  sent  to  the  prescriber  sta@ng  this   pharmacy  will  no  longer  dispense   prescrip@ons  for  controlled  substances  under   his/her  DEA  registra@on  (2  days  prior  to  edit  in   the  dispensing  system)   –  LeHer  must  be  mailed  via  Cer@fied  Mail,  UPS,   FedEx,  or  any  other  provider  that  has  shipment   tracking  and  signature  required  to  assure  delivery   •  “Corporate  policy  prohibits  dispensing   controlled  substance  prescrip4ons     wri6en  by  this  prescriber”  
  • 51. Suspicious  Prescriber   •  Prescriber   –  Prescribed  695,811  total  dosage  units  of  oxycodone   containing  products  in  12  months   •  Prescribed  460,806  dosage  units  of  oxycodone  30  mg  tablets   in  12  months   –  Prescribed  to  several  members  of  the  same  family  at   the  same  address  with  same  diagnosis   –  Prescribed  the  same  combina@on  of  drugs  to  the   majority  of  pa@ents   –  Did  not  accept  Medicaid  pa@ents  and  did  not  accept   insurance  plans  for  office  visits   –  Ini@al  office  visit  per  pa@ent  was  $250.00  cash  only  
  • 52. Systemic  Approach   Store  generated  data   Distribu@on   •  Pharmacy  Manager  requests  a   threshold   threshold  increase  for  oxycodone   increase   request   30mg   –  “Pharmacy  200  feet  down  the  block   is  no  longer  stocking  oxycodone   30mg.  I’ve  lost  a  ton  of  business  so  I   try  to  fill  in  the  gaps  and  aHract  new   business  however  I  can”  
  • 53. Systemic  Approach   Prescriber  Data   Trends   •  Top  6  prescribers  were  prac@cing  in   Cash  vs.  TP   Florida  (Store  is  in  New  England)   •  Oxycodone  30mg  was  the  primary   Oxy  vs.  CIIs   oxycodone  product  prescribed   CII’s  vs.  all  RX’s   •  85%  of  these  prescrip@ons  were  for   cash  payments   •  67%  of  the  CII  prescrip@ons  were  for   oxycodone  30mg   •  78%  of  the  prescrip@ons  were  for  CIIs  
  • 54. Systemic  Approach   Store/Site  Visit   Clinic  Protocol   •  Based  on  the  informa@on  from   completed  by   member  of   the  store  generated  data  and   field   the  prescriber  data  a  Store/Site   management   or  corporate.   visit  was  not  required   •  The  request  for  a  threshold   increase  was  denied  
  • 55. Systemic  Approach   Edits   LeHer  to   Prescriber.   •  Based  on  prescriber  analysis  a   Edit  in  dispensing   leHer  was  sent  to  suspicious   system  to   prescribers   prevent  control   prescrip@on   •  A  message  is  ac@vated  in  the   dispensing  for   dispensing  system:  “Corporate   select   prescribers.   policy  prohibits  dispensing   controlled  substance  prescrip@ons   wriHen  by  this  prescriber”  
  • 56. Addi@onal  Technology  Tools   (under  development)   •  Poten@al  edit  through  “third  party   processor”  to  alert  for  suspicious  ac@vity   (may  include)     –  Pa@ent  demographic   –  Prescriber  prac@ce  loca@on   –  Prescriber’s  scope  of  prac@ce   –  Medica@on  and/or  therapy  prescribed   –  Prescribing  paHerns   •  All  pa@ents  get  the  same  combina@on     of  medica@ons  with  same  diagnosis  
  • 57. Summary   •  Pharmacies  should  consider  developing  a   comprehensive  analy@cal  approach  to  iden@fy   suspicious  prescriber  ac@vity.     –  This  approach  cannot  iden@fy  all  ac@vity  and  must   be  supplemented  by  the  pharmacists  in  stores     –  Prescribers  are  reviewed  on  an  individual  basis   with  respect  to  their  scope  of  prac@ce  and  pa@ent   base   –  The  analy@cs  are  simply  an  added  tool.   Pharmacists  are  a  key  part  of  the  process   Note:  This  list  is  not  inclusive  of  all  the  inves@ga@ve  techniques  we  rou@nely  conduct,  this  is   intended  to  highlight  the  major  inves@ga@ve  steps.  
  • 58. Pa@ent  Diversion  Behavior   •  Armed  Robberies  rose  81%  from  2006  to   2010   •  The  number  of  dosage  units  stolen  grew  from   706,000  to  1.3  million   •  Haven  Drugs  –  Medford,  NY  a  pharmacist,  a   clerk  and  two  customers  killed  in  the  robbery   •  Charlie’s  Family  Pharmacy  –  Seaford,     NY  an  ATF  agent  and  robbery  suspect     shot  and  killed  
  • 59. Reason  Pharmacies  are  Targeted   •  Easy  to  find  and  easy  access   •  Open  extended  hours   •  Typically  carry  larger  inventory  to  sa@sfy  demand   •  Open  floor  design  to  facilitate  pa@ent  interac@on   •  Limited  barriers   •  Limited  training  for  employees  on  robbery  events   •  Sa@sfy  addic@on  and  some  converted     to  cash   –  $80/tablet  of  oxycodone  in  certain  markets  
  • 60. Preven@on  Tips  -­‐  Training   •  Understand  and  observe  behaviors  of  poten@al  robber   1.  Purposely  wearing  mul@ple  layers  to  cover  their  face   2.  Do  not  directly  look  at  cashier  or  other  associate   3.  They  do  not  acknowledge  your  gree@ng  or  comply  with   request  to  show  their  face   4.  They  walk  directly  and  with  purpose  to  the  pharmacy   counter   •  Be  aware  of  your  surroundings   •  Controlled  safes/cabinets  must  be  locked  when  not  in   use   •  Keep  pharmacy  doors  locked  at  all  @mes   •  Never  leave  the  pharmacy  area  unaHended  
  • 61. Preven@on  Tips  -­‐  Training   •  Wipe  counters  and  front  doors   – Finger  prints   •  Stage  par@ally  filled  boHles  for  a   robbery  event   •  Mark  your  boHles   – Provides  a  link  for     law  enforcement   – Iden@fies  point     of  origin  
  • 62. During  an  Event   •  Primary  concern  –  Safety  of  coworkers  and  customers   •  Do  not  resist   •  Remain  calm  –  no  sudden  movements   •  Cooperate  and  follow  instruc@ons  given  by  the  robber   –  Do  exactly  what  you  are  told,  nothing  more,  nothing  less,  do   not  argue   •  Make  mental  notes  of  the  robber  –  hair,  clothing,   shoes,  taHoos,  scars,  etc.   •  Do  not  aHempt  to  apprehend  the  criminal   •  Goal  is  to  get  the  robber  out  of  the     building  quickly  
  • 63. For@fica@on  Sugges@ons  Based  on     Risk  Level   •  Height  Strip  Cameras   •  Public  view  monitor   •  Capture’s  height  of   at  the  pharmacy   robbery  suspect   drop  off  window   •  BeHer  facial  image   •  In@mida@on  
  • 64. Exterior  Ligh@ng  and  Cameras   •  Increasing  the  foot  candles  of  exterior  ligh@ng   •  Exterior  cameras  for  parking  lots  and  store   entrance   –  Some  suspects  do  not  wear  their  disguise     in  the  car  or  parking  lots   –  Capture  car  make  and  model,  may  capture     license  plates   –  Direc@on  the  suspected     headed  
  • 65. Robbery  Poster   •  Overt  warning  to   the  suspect  and   customers  for   awareness   •  Trained  associates  
  • 66. Reward  Offers   Asking  concerned   ci@zens  for  their   help  to  resolve  a   crime.  
  • 68. Tracking  Devices   •  GPS  tracking  system   •  Law  Enforcement  Tool   •  Immediate  no@fica@on  of  robbery  events  to  a   mobile  device  and  law  enforcement   •  Provides  law  enforcement  accurate  loca@on   data  on  the  suspect   •  Aids  in  the  apprehension  of  the  robbery   suspect  and  recovery  of  stolen  drugs  
  • 69. Tracking  Devices   •  Hidden  within  the  inventory   •  Fully  automa@c   •  Updates  GPS  loca@on  every  6  to  8  seconds   •  Track  via  secured  website  (law  enforcement)   •  Device  is  silent   •  Seamless  to  day  to  day  pharmacy  opera@ons   •  Tip:  Give  staged  par@ally  filled  boHles  with  the   tracker  
  • 70. Tracking  Points   •  9:27  PM  –  Device  ac@ve  on  Server   •  9:29  PM  –  Unit  gains  GPS  and  is  SW  on  Roosevelt  Blvd     •  9:33  PM  –  Subject  turns  leh  traveling  SE  on  Tyson  Ave   •  9:34  PM  –  Vehicle  crosses  over  Frankford  Ave  s@ll   moving  SE   •  9:36  PM  –  Subject  turns  right  on  to  Torresdale  Ave   traveling  SW   •  9:39  PM  –  Subject’s  vehicle  is  stopped  by  Police  
  • 71. Outcome   •  Police  arrested  2  subjects  at  the  scene   •  Recovered  weapons  and  evidence  of  the  event   –  Clothing  and  drugs   •  They  were  connected  to  20+  open  cases   against  chain  and  independent  pharmacy   robberies   This  list  of  suggested  tac@cs  is  not  all  inclusive.  All  factors  should  be  considered   when  implemen@ng  any  tac@c  or  combina@on  of  tac@cs  including  threat  level,   design  of  building,  method  of  robbers  in  the  geographic  area,  etc.    
  • 72. QUESTIONS   •  Thank  you   •  Dr.  Michael  O’Neil   •  Janet  Hart  R.Ph.