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Integra(ng PDMP Data into the Clinical Workflow Dr. Jinhee Lee Public Health Advisor, Division of Pharmacologic Therapies Center, Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Dr. Michael O’Neil Drug Diversion and Substance Abuse Consultant South College School of Pharmacy RxSummit 2014
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Pdmp 3 lee oneil

May 07, 2015

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Page 1: Pdmp 3 lee oneil

Integra(ng  PDMP  Data  into  the  Clinical  Workflow  

Dr.  Jinhee  Lee  Public  Health  Advisor,  Division  of  Pharmacologic  Therapies  Center,  Center  for  Substance  Abuse  Treatment,  Substance  Abuse  and  Mental  Health  Services  

Dr.  Michael  O’Neil  Drug  Diversion  and  Substance  Abuse  Consultant  South  College  School  of  Pharmacy  

RxSummit    2014  

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Disclosure Statement

•  Jinhee  Lee  has  no  financial  rela/onships  with  proprietary  en//es  that  produce  health  care  goods  and  services.  

•  Michael  O’Neil  has  no  financial  rela/onships  with  proprietary  en//es  that  produce  health  care  goods  and  services.  

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Objectives

•  Define  current  tools  that  are  in  place  for  prescribers  and  dispensers  to                incorporate  PDMPs  through  electronic  health  informa/on  sources.  

•  Evaluate  effec/veness  of  current  PDMP  programs  to  op/mally  manage  pa/ents.  

•  Outline  opportuni/es  to  enhance  the  access  and  effec/veness  of  PDMP  programs.  

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Over  prescribing  for  various  reasons……..  

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Obj. 2 Evaluate effectiveness of current PDMP programs to optimally manage patients……………………

in the clinical environment.  

•  basic  clinical  applica/ons  

•  limita/ons  

•  prescriber  /  pharmacist  vs.  law  enforcement  approaches    

•  example  cases  

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Clarification of Acronyms

•  Controlled Substance Monitoring Database (CSMD)

•  Controlled Substance Monitoring Program (CSMP)

•  Controlled Substance Monitoring Program Database (CSMPD)

•  Prescription Monitoring Program (PMP)

•  Controlled Substance Database (CSD)

•  Prescription Drug Monitoring Program (PDMP)

CSMD=CSMP = CSMPD = PMP = CSD = PDMP

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Intent of PDMP

“Two intents depending on the origination of legislation and the state of origination”

•  Practitioner driven with specified allowances to law enforcement / health professional boards

•  Law enforcement driven with specified allowances for specific healthcare professionals

•  The differences are BIG!!!

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Use of the PDMP

•  The PDMP database is a tool and NOT definitive evidence of a crime!

•  The database should be used to pose further questions to the patients, prescribers or law enforcement.

•  “………then where does the crime come in?”

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Two Major components of the PDMP

1.        pa/ent  tracking  of  records  

 2.      prescriber  tracking  of  records  

 3.      surveillance  /  monitoring  /  Research  

•   review  for  today  is  on  pa/ent  data  

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Limitations

•  pa/ent  names-­‐spellings  •  addresses  •  date  of  birth    •  accurate  NDC  codes  •  accurate  prescribers  /  accurate  pa/ents….legal  ramifica/ons  •  lazy  pharmacists  /  techs  •  reversing  errors  (reversing  transac/ons)  •  current  state  interfaces………GeVng  beWer!  But…….  •  diagnosis  unknown  •  error  accountability?  •  federal  data…..  VA  Medical  Centers?  •  repor/ng  should  go  where?  •  Internet  capabili/es  /  servers  

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Basic Observations of the PDMP Report

•  early refills

•  multiple pharmacies – (be cautious, many patients swap pharmacies due to financial incentives for every prescription transferred)

•  ?multiple doctors (sometimes hard to tell) -cross cover prescribers -prescription renewals -is it the same address?

•  persistent or continued randomness of similar medications including escalating-deescalating doses, variation in products

•  Combinations (Soma, Oxys, Xanax)

Example: e.g. oxycodone, morphine, hydromorphone, oxymorphone (Indication?)

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Sometimes more importantly…..

What’s  not  on  the  report!  

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What’s Not on the Report

•  prescriber  verbal  changes  •  is  the  DEA  Valid?  •  fixed  errors  •  controlled  substances  NOT  picked  up  •  wrong  entries  •  federal  prescrip/ons  (VA  Medical  centers),  data  waived  

•  methadone  /  buprenorphine  under  federal  programs  

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Optimizing PDMP Report Reviews: Running the PDMP Report

•  In  todays  busy  medical  offices  and  community  pharmacies…..  unless  you  get  more  help…rarely  do  new  processes  actually  facilitate  workflow!  

•  Individual  prescribers  and  pharmacist  should  have  their  “own”  access  codes.  

•  Most  states  allow  sharing  of  access  codes  up  to  2-­‐3  individuals  (nurse  manager,  pharmacy  technician,  medical  assistant,  etc.)  

•  As  pa/ent  records  are  pulled  by  assistants  for  appointments  or  technicians  for  filling  prescrip/ons.  “Flags”  should  be  part  of  the  assistants  /  techs  workflow  that  prompts  running  the  PDMP.  

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Strategies to consider

•  The  most  important  factor…..train  your  staff  on  how  to  run  the  report.  If  you  don’t  know….  learn.  Designate  staff!  

•  Request  your  local/regional  professional  agencies  to  provide  CEs  as  part  of  PDMP  training.  

•  At  LEAST  login  to  the  PDMP  rou/nely.  

           -­‐forgoWen  or  expired  passwords  cost  significant    loss  of  /me  

             -­‐familiarity  with  PDMP  formaVng  helps!  

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Facilita(ng  Work  Flow  with  the  PDMP  Tool;  When  to  Run  the  Report  

•  State  mandated  reports  (chronic  opioids  or  benzodiazepines),  opioids  >  than  3  months  

•  Annually  with  chronic  controlled  substances?  

•  The  report  does  not  need  to  be  run  for  every  pa/ent!    

                               (unless  otherwise  mandated  by  the  state)  

•  Flags:  new  pa/ents,  unknown  pa/ents,  pa/ents  that  travel  long  distances,  unusual  cocktail  prescrip/ons.  

•  Recommended  to  go  back  At  LEAST  6months….1  year  is  usually  op/mal.  

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Case Points: Prescribers  /  pharmacists  should  not  spend  lots  of  /me  interpre/ng    “gray  areas”.  

•  Rarely  is  this  ever  about  1  or  2  prescrip/ons  

•  Occasionally  “extra  scripts”  

•  Den/sts,  ER  visits  

•  Frequently  there  are  “clinically  relevant”  jus/fica/ons.              Clinical  judgment  is  frequently  warranted  and  reports  should                be  confirmed  via  phone  calls,  emails,  etc.  

•  Prescribers  and  pharmacists  are  not  looking  for  subtle/es  

Everyone  is  looking  at  trends  or  paYerns  

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Evaluating the Printout

•  Pick  drug  

•  Note  QTY  

•  Note  Dates  

•  Note  Prescribers  

•  Note  addresses  

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State XXX= BOARD OF PHARMACY – PATIENT PROFILE Date 4/15/2012 Date of Birth 12-10-1966 Beginning Date: 04-01-11 =nbsp Ending Date: 04-15-12 First Name: MIKE Last Name: =OWEN

First  Name  

Address   Zip   Fill  date   Rx  no.   Product  Name   Strength   Qty   Doctor  Name  

Doctor  Dea   Pharm  Name  

Pharm  Dea   Ph  Zip  

MIKE   319  LOWER   25526   4/2/2011   11222   APAP/HYDRO   500MG-­‐10MG  

180   SMITH  JOE   DH0267890   TOM’S  PHARM  

GF1234567   25526  

MIKE   319  LOWER   25526   5/3/2011   19976   APAP/HYDRO   500MG-­‐10MG  

180   SMITH  JOE   DH0267890   TOM’S  PHARM  

GF1234567   25526  

MIKE   319  LOWER   25526   5/27/2011   23466   APAP/HYDRO   500MG-­‐10MG  

180   SMITH  JOE   DH0267890   TOM’S  PHARM  

GF1234567   25526  

MIKE   319  LOWER   25526   6/4/2011   31111   APAP/HYDRO   500MG-­‐10MG  

180   SMITH  JOE   DH0267890   TOM’S  PHARM  

GF1234567   25526  

Case  1  

1.  Early  Refill?  2.  How  many  days  of  medica/on?  3.  Change  of  prescriber?  

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Findings

•  Early  Refillers    (professional  judgment    vs.  negligence)  •  Dr.  Shoppers  •  Pa/ent  cocktails  •  Mul/ple  medica/ons  (polypharmacy)  •  Mul/ple  prescribers  •  Aberrant  paWerns  of  prescribing  medica/ons  •  Escala/on  of  doses  /  de-­‐escala/on  of  doses  •  Changes  in  medica/ons  •  Acute  medica/ons  and  Chronic  medica/ons  •  Disease  state  knowledge  

Frequently  requires  clinical  judgment……..  

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Clarification, Verification and Documentation of the Prescription or Whether to Even Prescribe

•  Calling the prescriber(s) - validating patient - validating prescription - quantity - validating indication

•  Questioning the patient - previous prescriptions - other practitioners - indication

•  Documentation of the query / discussion / intervention

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Findings and anomalies should lead to further questions by the prescriber, pharmacist (not technician), or investigator

•  When  was  last  refill  for  drug  X  

•  Have  you  had  any  other  scripts  for    drug  X?  •  Indica/ons    for  drug  X  /  Hx?  •  Do  the  other  Drs  Know?  •  Distance  Travelled?  •  What  other  medica/ons  do  you  take…….where  are  they  filled?  

•  OK  to  call  prescriber?  

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Key Considerations:

Prescribers  and  pharmacists  are  making  on  the  spot    real  /me  “clinical  decisions”  with  the  PDMP.  Law  enforcement  is  not.  

Law  Enforcement  is  usually  accessing  the  PDMP  AFTER  some  report,  probable  cause  or  inves/ga/on  of  diversion,  etc.  has  been  reported.  

Poor  PROFESSIONAL  judgment  by  a  prescriber  is  NOT  CRIMINAL!  

So  prosecu/ons  are  very  difficult,  labor  intensive,  last  forever  and  costs  big  bucks…..open  have  minimum  outcome.  

State  professional  boards  MUST  step  up  enforcement  for  professional  “misbehaviors”,  poor  prac/ces  and  errors.  

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Complications and Barriers……

•  Corporate  policies  and  procedures  

•  Lack  of  training  is  big  across  the  board!  

•  Who  to  report  is  some/mes  confusing,  frustra/ng,  difficult  

•  Manpower  

•  $$$$$  

•  …and  we  haven’t  even  seen  the  lawyers  yet…..  

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Repor(ng  Clinical  Findings  

•  Law  Enforcement  

•  Prescribers  

•  Colleagues  

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Case  2  

First  Name   Address   Zip   Fill  date   Rx  no.   Product  Name   Strength   Qty   Doctor  Name   Doctor  Dea   Pharm  Name   Pharm  Dea   Ph  Zip  

MIKE   319  LOWER   25526   4/2/2011   11222   APAP/HYDRO   500MG-­‐10MG   180   SMITHJOE   0267890   TOM’S  PHARM   FT1234567  25526  

MIKE   319  LOWER   25526   4/9/11   19986   Oxymorphone  ER   20MG     60   SMITH  JOE   CS0267890   TOM’S  PHARM   FT1234567  25526  

MIKE   319  LOWER   25526   4/27/2011   23466   APAP/HYDRO   500MG-­‐10MG   180   SMITH  JOE   CS0267890   TOM’S  PHARM   FT1234567  25526  

MIKE   319  LOWER   25526   5/4/2011   31111   Oxycodone  ER   40  MG   45   SMITH  JOE   CS0267890   TOM’S  PHARM   FT1234567   25526  

MIKE   319  LOWER   25526   5/12/2011   44445   hydromorphone   4mg   80   JONES  BILL   CJ9839432   TOM’S  PHARM   FT1234567   25526  

MIKE   319  LOWER   25526   5/9/11   59986   Oxymorphone  ER   20MG     60   SMITH  JOE   CS0267890   TOM’S  PHARM   FT1234567   25526  

MIKE   319  LOWER   25526   5/23/2011   69976   APAP/HYDRO   500MG-­‐10MG   180   SMITH  JOE   CS0267890   TOM’S  PHARM   FT1234567  25526  

MIKE   319  LOWER   25526   5/27/2011   23466   Morphine  sulf  liq     10mg/5ml   100   SMITHJOE   CS0267890   TOM’S  PHARM   FT1234567  25526  

MIKE   319  LOWER   25526   5/4/2011   31111   Oxycodone  ER   40  MG   45   SMITH  JOE   CS0267890   TOM’S  PHARM   FT1234567   25526  

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Summary

•  PDMP  is  an  amazing  and  evolving  tool!  

•  The  PDMP  is  NOT  evidence  of  a  crime!  

•  Usually  involves  blatant,  repe//ve,  and  illegal  behaviors.  

•  Flags  and  strategies  can  be  ini/ated  that  help  minimize  interrup/on  of  clinician’s  work  flow.  

•  Enforcement  of  the  PDMP  is  also  s/ll  evolving  

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Integra/ng  PDMP  Data  Into  the  Clinical  Workflow  

Jinhee  Lee,  PharmD  Division  of  Pharmacologic  Therapies    Center  for  Substance  Abuse  Treatment  

Substance  Abuse  and  Mental  Health  Services  Administra/on  

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Status of State Prescription Drug Monitoring Programs (PDMPs)

AK

AL

AR

CA CO

ID

IL IN IA

MN

MO

MT

NE1

NV

ND

OH

OK

OR

TN

UT

WA

AZ

SD

NM

VA

WY MI

GA

KS

HI

TX

ME

MS

WI NY

PA

LA

KY NC

SC

FL

NH MA RI CT NJ DE MD

VT

WV

1  The  opera/on  of  Nebraska’s  Prescrip/on  Monitoring  Program  is  currently  being  facilitated  through  the  state’s  Health  Informa/on  Ini/a/ve.    Par/cipa/on  by  pa/ents,  physicians,  and  other  health  care  providers  is  voluntary.  2  The  Mayor  of  D.C.  has  approved  the  legisla/on  but  it  is  pending  a  30-­‐day  review  process  by  Congress.  

States with operational PDMPs

States with enacted PDMP legislation, but program not yet operational

States with legislation pending

© 2014 The National Alliance for Model State Drug Laws (NAMSDL). Headquarters Office: 215 Lincoln Ave. Suite 201, Santa Fe, NM. 87501. This information was compiled using legal databases, state agency websites and direct communications with state PDMP representatives.

D.C.2

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The  Story  So  Far  

Stakeholders

Organizations

White  House  Roundtable  on  

Health  IT    &  Prescrip(on  Drug  Abuse  June  3,  2011  

Federal & State Partners

State Participants

Action Plan

Slide  31  

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PDMP  Workflow  Today    and  in  the  Future  

•  PDMPs  today  –  primarily  standalone  

systems  –  Separated  from  rest  of  

health  IT  ecosystem    –  accessed  via  web  portals  –  Human-­‐centric  process  

•  PDMPs  tomorrow  –  Integrated  with  other  

health  IT  in  the  pa/ent  workflow  

–  Machine-­‐centric  process  

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Ac(on  Plan  Implementa(on  

•  SAMHSA  provided  funding  for  implementa/on  of  the  Ac/on  Plan  through  the  “Enhancing  Access  to  PDMPs  through  Health  IT  Project”.  

– SAMHSA  partnered  with  ONC,  ONDCP,  &  the  CDC.  

– ONC  has  management  oversight  of  the  effort.  

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•  Goal:  Increase  /mely  access  to  PDMP  data  in  an  effort  to  reduce  prescrip/on  drug  misuse  and  overdoses.  –  Explore  ways  to  use  HIT  to  link  prescribers  and  dispensers  with  the  valuable  data  in  PDMPs.  

– Main  issue:  How  to  make  this  informa/on  more  available  to  three  key  groups  of  clinical  decision  makers:    

Enhancing  Access  to  PDMPs  through  Health  IT  Project  

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Improve  clinician  workflow  by  connec(ng  PDMPs  to  health  IT  

Support  (mely  decision-­‐making  at  the  

point  of  care  

Establish  standards  for  facilita/ng  informa/on  

exchange  

Provide  recommenda/ons  and  pilot  input  

Test  the  feasibility  of  using  health  IT  to  enhance  PDMP  access  

Reduce  prescrip+on  drug  misuse  and  overdose  in  the  United  States  

Enhancing  Access  to  PDMPs  through  Health  IT  Project  

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Phase  1  Pilots:  Overview    

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Phase 2 Pilots - Overview State   End  User   Pilot  Summary  

Illinois  Emergency  Department  

•  Automated  query  via  intermediary  and  interstate  hub  to  PDMP  upon  pa/ent  admission  to  ED  

•  PDMP  data  integrated  into  EHR  as  a  PDF  via  a  Direct  message  

Indiana  Emergency  Department  

•  Automated  query  via  HIE  to  mul/ple  states’  PDMPs  upon  pa/ent  admission  to  ED  

•  Pa/ent  risk  score  and  PDMP  data  integrated  into  EHR  

Kansas   Providers   •  Unsolicited  report  of  at-­‐risk  pa/ents  sent  via  Direct  to  EHR-­‐integrated  mailboxes  

Michigan   Providers  •  Automated  query  via  e-­‐Prescribing  sopware  to  mul/ple  states’  PDMPs    and  result  integrated  in  pa/ent’s  medica/on  history  

Nebraska  Emergency  Department  

•  Automated  query  via  HIE  to  PDMP  upon  pa/ent  admission  to  ED  

•  Easy  access  to  PDMP  with  SSO  

•  PDMP  data  integrated  into  EHR  

Oklahoma  Emergency  Department  

•  Established  PDMP  access  directly  though  an  HIE  

•  Developed  a  SSO  from  the  EHR  through  the  HIE  to  the  PDMP  

•  Alert  flag  represen/ng  the  PDMP  data  

Tennessee   Pharmacy  •  Real-­‐/me  repor/ng  of  dispensing  controlled  substance  data  to  the  PDMP  using  an  exis/ng  network  

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•  Enhancing  Access”  Pilot  White  Papers:    Eight  papers  detailing  each  pilot’s  design,  technical  configura/on,  outcomes,  and  plans  for  expansion.    The  white  papers  also  highlight  various  personal  anecdotes  from  the  par/cipants  who  wrote  about  how  they  integrated  PDMP  data  into  their  clinical  workflow  and  the  success  it  had  on  their  prac/ce.  

•  The  Road  to  Connec+vity:    A  roadmap  for  connec/ng  to  PDMPs  through  health  IT.  

•  Work  Group  Recommenda+ons–Final  Report:    Stakeholders  iden/fied  challenges  and  recommended  solu/ons  to  increase  /mely  use  of  PDMP  data  by  clinicians.  More  than  94  people  across  53  organiza/ons  formed  work  groups  to  define  barriers  and  rapidly  finalize  recommenda/ons  to  address  the  problem.  

•  Videos:  Pilot  par/cipants  detail  their  individual  baWles  against  prescrip/on  drug  abuse,  recalling  the  advantages  of  their  state’s  PDMP  including  real-­‐/me  repor/ng  and  how  they  used  health  IT  to  connect  clinicians  to  this  important  database.  

•  PDMPConnect:  A  website  providing  a  forum  for  connec/ng  members  of  the  PDMP  community  to  share  valuable  experience,  informa/on,  and  resources  wherever  they  are.  

**All  resources  available  at:  www.healthit.gov/pdmp  

Enhancing  Access  to  PDMP  using  Health  IT    

Phases  1&2:  Resources  

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SAMHSA  -­‐  PDMP  EHR  Coopera(ve  Agreements  

•  FY  12  –  Provided  2  year  funding  for  9  states:  FL,  IN,  IL,  KS,  ME,  OH,  TX,  WA,  WV  

•  FY  13  –  Provides  2  year  funding  for  7  states:        KY,  MA,  ND,  NY,  RI,  SC,  WI  

–  Purpose:    1)  Improve  real-­‐/me  access  to  PDMP  data  by  integra/ng  

PDMPs  into  exis/ng  technologies  like  EHRs  (FY12,13)  2)    Strengthen  currently  opera/onal  state  PDMPs  by  

increasing  interoperability  between  states    (FY12)  3)    Evaluate  whether  these  enhancements  have  an  impact  on  

prescrip/on  drug  abuse  (FY12)  

Slide  39  

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PDMP  EHR  Coopera(ve  Agreement  State  Updates  

•  Illinois*    –  Currently  connected  to  Anderson  Hospital.    

•  Over  700  requests  per  week  to  IL  PMP  •  Requests  triggered  upon  pa/ent  presenta/on  or  admission  to  ER.  •  PMP  report  returned  and  presented  on  select  worksta/ons  in  the  ER  and  immediate  care  

loca/ons  

–  Plans  to  integrate  with  a  EMR  sopware  company  that  is  used  by  many  opioid  treatment  programs.  

•  Tes/ng  to  begin  within  the  next  30  days  

–  Plans  to  bring  another  hospital  online  within  the  quarter  –  Within  the  next  6  months,  three  hospitals  fully  implemented  and  five  

hospitals  in  the  tes/ng  stage  

•  West  Virginia  –  Planning  with  a  clinic,  hospital  and  the  West  Virginia  Health  Informa/on  

Network  con/nues.    

Slide  40  

*Murzynski,  Stanley.  “Illinois  PMP  SAMHSA  Grantee  Mee/ng  on  Data  Integra/on.”  PowerPoint  presenta/on.  SAMHSA,  Rockville,  MD.  19  Feb  2014.  

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PDMP  EHR  Coopera(ve  Agreement  State  Updates  (cont)  

•  Kansas*  –  Integra/on  at  Via  Chris/  Hospital  fully  func/onal  

•  K-­‐TRACS  is  integrated  into  the  physician’s  workflow  •  VC  currently  has  267  users  +  

–  Integra/on  with  LACIE  (Lewis  And  Clark  Informa/on  Exchange)  •  Tes/ng  successfully  completed  •  Hospital  pilot  an/cipated  by  end  of  this  month  •  An/cipate  3-­‐4K  users  in  the  KC  metro  

–  Integra/on  with  major  pharmacy  chain  

•  Ohio**  –  Currently  integrated  into  the  EMR  of  22  hospitals  and  6  primary  care  

prac/ces  –  Plans  to  expand  and  integrate  into  over  200  community  pharmacies,  

addi/onal  hospitals,  and  15  ambulatory  clinics  

Slide  41  

*Singleton,  Marty.  “Kansas  PDMP  Status  Update.”  PowerPoint  presenta/on.  SAMHSA,  Rockville,  MD.  19  Feb  2014.  **Garner,  Chad.  “Bringing  Ohio’s  PMP  Into  the  Clinician  Workflow.”  PowerPoint  presenta/on.  CADCA,  Na/onal  Harbor,  MD.  4  Feb  2014.  

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Now  and  Then  

Enhancing  Access  to  PDMPs  using  Health  IT  project  –  Phases  1  &  2      •  September  2011  -­‐  March  2013  •  Pilots  demonstrated  proof  of  concept.    •  Various  non-­‐standard  approaches  were  also  used  that  need  to  be  refined  or  harmonized  

with  the  exis/ng  porzolio  of  standards  and  implementa/on  specifica/ons.    •  Abbreviated  S&I  Ini/a/ve  (Jan  –  March  2013)  

  Did  not  iden/fy,  evaluate  and  harmonize  standards  for  the  exchange  of  informa/on  from  PDMP  to  EHRs  or  HIEs.  

  Valuable  feedback  from  stakeholders  but  only  iden/fied  where  standards  were  needed  and  the  poten/al  standards  that  could  be  used.  

PDMP  &  Health  IT  Integra>on  Ini>a>ve  –  Phase  3  •  November  2013  –  TBD  •  Full  S&I  Framework  Ini/a/ve    •  Assess  the  current  PDMP  infrastructure  and  available  standards  that  could  be  

harmonized  to  allow  interoperable  communica/ons  between  PDMPs  and  health  IT  systems.    

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PDMP  Ecosystem  

Pharmacy

PMPi / RxCheck PDMP

Other  State  PDMPs  

NCPDP  Script  

PDMP

Por

tal

Switches

NCPDP  Telecom  

ASAP  

Pharmacy Benefits Mgmt

Provider  

EHR System

NIEM-­‐PMP   NIEM-­‐PMP  

Provider  

EHR System

Provider  

EHR System Data  Out  

Needs  for  standards  (data  format  and  content;  transport  and  security  protocols)  

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PDMP  Interoperability  Challenges  

•  One  of  the  current  technical  barriers  to  interoperability  is  the  lack  of  standard  methods  to  exchange  and  integrate  the  prescrip/on  drug  data  available  in  PDMPs  into  health  IT  systems.    

–  Lack  of  common  technical  standards  and  vocabularies  to  enable  PDMPs  to  share  computable  informa/on  with  the  EHR  that  providers  can  use  to  support  clinical  decision-­‐making.    

•  To  achieve  interoperability,  consistent  and  standardized  electronic  methods  need  to  be  established  to  enable  seamless  data  transmission  between  PDMPs  and  health  IT  systems.  

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45  

•  A  collabora/ve  community  of  par/cipants  from  the  public  and  private  sectors  who  are  focused  on  providing  the  tools,  services  and  guidance  to  facilitate  the  func/onal  exchange  of  health  informa/on.    

•  Creates  a  open  and  transparent  process  where  healthcare  stakeholders  can  focus  on  solving  real-­‐world  interoperability  challenges.    

•  Is  a  consensus-­‐driven,  coordinated,  incremental  standards  process.    

Each  S&I  Ini/a/ve  focuses  on  narrowly-­‐defined,  broadly  applicable  challenge,  tackled  through  a  rigorous  development  cycle,  and  provides  input  to  Federal  Advisory  CommiWees  for  considera/on.  

The Standards & Interoperability (S&I) Framework:

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ONC Standards and Interoperability (S&I) Framework Lifecycle

Our Missions »  Promote a sustainable ecosystem that drives increasing interoperability and standards adoption. »  Create a collaborative, coordinated, incremental standards process that is led by the industry in solving

real world problems. »  Leverage “government as a platform” – provide tools, coordination, and harmonization that will support

interested parties as they develop solutions to interoperability and standards adoption.

46  

Tools and Services

Use Case Development

and Functional Requirements

Standards Development Support

Certification and Testing

Harmonization of Core Concepts

Implementation Specifications

Pilot Demonstration Projects

Reference Implementation

Architecture Refinement and Management

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PDMP  &  Health  IT  Integra(on  Ini(a(ve  Purpose  &  Goals  

•  The  purpose  of  this  ini/a/ve  is  to  bring  together  the  PDMP  and  health  IT  communi/es  to  standardize  the  data  format,  and  transport  and  security  protocols  to  exchange  pa/ent  informa/on  between  PDMPs  and  health  IT  systems  (e.g.,  EHRs  pharmacy  systems).  

•  The  specific  goals  are:  –  Iden/fy  exis/ng  connec/ons  that  consume  PDMP.  –  Iden/fy,  evaluate,  and  harmonize  the  data  format(s)  sent  from  PDMPs  to  EHRs.  –  Evaluate  and  select  transport  protocol(s)  systems  support.  –  Evaluate  and  select  security  protocol(s)  systems  support.  –  Map  selected  health  IT  standards  to  standards  already  in  use  for  PDMP-­‐to-­‐PDMP  

interstate  exchange.  

•  The  results  of  this  work  would  enable  health  care  providers  to  make  more  informed  clinical  decisions  though  /mely  and  convenient  access  to  PDMP  data  in  an  effort  to  reduce  prescrip/on  drug  misuse  and  overdose  in  the  United  States.    

47  

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PDMP  &  Health  IT  Integra(on  Ini(a(ve  Stakeholder  Community  

10%  

15%  

6%  

13%  

11%  

45%  

HIT/EHR,  Vendors/PHR  and  Associa/ons  Provider/Provider  Organiza/ons  

SDOs/Analy/cs/Research  

Federal/State/Local  Agencies  

Other  

State  PDMP/PMP/Or  Affiliate  

48  

•  This  is  an  open  government  ini/a/ve.  To  succeed,  the  S&I  Framework  works  with  a  set  of  mo/vated  organiza/ons  and  individuals  who  share  the  mission  and  goals  of  care  delivery  transforma/on  through  improved  interoperability.    

Stakeholder  Par(cipa(on  by  Industry  (n=190)  

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Phase   Planned  Ac(vi(es    Pre-­‐Discovery   •  Development  of  Ini/a/ve  Background  

•  Development  of  Ini/a/ve  Charter  •  Defini/on  of  Goals  &  Ini/a/ve  Outcomes  

Discovery     •  Crea/on/Valida/on  of  Use  Cases,  User  Stories  &  Func/onal  Requirements  •  Iden/fica/on  of  interoperability  gaps,  barriers,  obstacles  and  costs  •  Review  of  Vocabulary  

Implementa(on   •  Crea/on  of  aligned  specifica/on    •  Documenta/on  of  relevant  specifica/ons  and  reference  implementa/ons  such  as  

guides,  design  documents,  etc.  •  Valida/on  of  Vocabulary  •  Development  of  tes/ng  tools  and  reference  implementa/on  tools  

Pilot   •  Valida/on  of  aligned  specifica/ons,  tes/ng  tools,  and  reference  implementa/on  tools  •  Revision  of  documenta/on  and  tools  

Evalua(on   •  Measurement  of  ini/a/ve  success  against  goals  and  outcomes  •  Iden/fica/on  of  best  prac/ces  and  lessons  learned  from  pilots  for  wider  scale  

deployment  •  Iden/fica/on  of  hard  and  sop  policy  tools  that  could  be  considered  for  wider  scale  

deployments  

S&I  Framework  Phases  &    PDMP  &  Health  IT  Integra/on  Ac/vi/es  

49  

We are Here

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50  

•  1.0  Preface  and  Introduc(on  •  2.0  Ini(a(ve  Overview  

–  2.1  Ini/a/ve  Challenge  Statement**  

•  3.0  Use  Case  Scope  –  3.1  Background**  –  3.2  In  Scope  –  3.2  Out  of  Scope  –  3.3  Communi/es  of  Interest  (Stakeholders)

**    

•  4.0  Value  Statement**  

•  5.0  Use  Case  Assump(ons  

•  6.0  Pre-­‐Condi(ons  •  7.0  Post  Condi(ons  •  8.0  Actors  and  Roles  •  9.0  Use  Case  Diagram  

PDMP  &  Health  IT  Integra(on  Ini(a(ve  Use  Case  Outline  

•  10.0 Scenario: Workflow –  10.1 User Story 1, 2, x, … –  10.2 Activity Diagram

o  10.2.1 Base Flow o  10.2.2 Alternate Flow (if needed)

–  10.3 Functional Requirements o  10.3.1 Information Interchange

Requirements o  10.3.2 System Requirements

–  10.4 Sequence Diagram

•  11.0 Dataset Requirements

•  12.0 Risks, Issues and Obstacles •  Appendices

–  Privacy and Security Considerations –  Related Use Cases –  Previous Work Efforts –  References

** Leverage content from Charter

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While it is understood that there are various workflows that can take place when a Healthcare Professional queries a PDMP (see full context diagram), for the purposes of this use case, we will be focusing on the transactions originating from the HIT to the next end point, which would be the PDMP, a Hub, or HIE/Pharmacy Intermediary

•  Scenario  #1  –  HIT  to  In-­‐State  PDMP  

•  Scenario  #2  –  HIT  to  Hub  

•  Scenario  #3  –  HIT  to  HIE/Pharmacy  Intermediary  

EHR  or  Pharmacy  System  

EHR  or  Pharmacy  System  

Hub  

EHR  or  Pharmacy  System  

HIE/  Pharmacy  

Intermediary  

51  

PDMP  &  Health  IT  Integra(on  Ini(a(ve  Use  Case  Scenarios  -­‐  examples  

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SDO  Ballo(ng,  RI  &  Pilots*  

Standards  &  Harmoniza(on  Process  

The  Harmoniza/on  Process  provides  detailed  analysis  of  candidate  standards  to  determine  “fitness  for  use”  

in  support  of  Ini/a/ve  func/onal  requirements.    

The  resul/ng  technical  design,  gap  analysis    and  harmoniza/on  ac/vi/es  lead  to  the  evalua/on  and  selec/on  of  drap  standards.    These  standards  are  

then  used  to  develop  the  real  world  implementa/on  guidance  via  an  Implementa/on  Guide  or  Technical  Specifica/on  which  are  then  validated  through  Reference    Implementa/on  (RI)  and  Pilots.    

The  documented  gap  mi/ga/on  and  lessons  learned  from  the  RI  and  Pilot  efforts  are  then  incorporated  into  an  SDO-­‐balloted  ar/fact  to  be  proposed  as  implementa/on  guidance  for  Recommenda/on.  

*Depending  on  the  ini>a>ve  the  SDO  Ballo>ng,  RI  &  Pilot  ac>vi>es  may  occur  prior  to  the  recommending  a  harmonized  standard,  this  also  means  that  ongoing  pilots  can  provide  feedback  to  draK  standards  or  specifica>ons;  May  not  be  

applicable  to  the  PDMP  &  HIT  Integra>on  Ini>a>ve  Leveraged  from  previous  S&I  Ini+a+ves  

52

Implementa(on  Guidance  for  Real-­‐World  Implementers  

Drar  Harmonized  Profile/Standard  

Evalua/on    and  Selec/on    of  Standards  

Valida/on  of  Standard  

Harmonized  Profile/Standard  for  Recommenda(on  

Use  Case  Requirements  

Candidate  Standards  

Technical  Design  

Standards  &  Technical  Gap  

Analysis  

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Standardiza(on  Development  &  Harmoniza(on:  Workflow  

Outputs  

1.  Validate  candidate  standards  list  

2.  Map  UCR  to  candidate  standards    

3.  Analyze  mapped  standards  per  HITSC  criteria  to  narrow  down  any  conflic(ng    standards  resul/ng  from  the  UCR-­‐Standards  mapping  

4.  Perform  technical  feasibility  of  analysis

5.  Review  with  community  

Use  Case  Requirements  Crosswalk  

1.  Develop  gap  mi/ga/on  plan  

2.  Drap  Solu/on    diagram  

3.  Validate  solu/on  plan  

2.  Confirm  data  model  approach  

4.  Modify/harmonize  exis/ng  standard(s)  to  produce  final  standards  

5.  Achieve  community  consensus  or  agreement  

Final  standards  

1.  Using  final  standards,  develop  Implementa/on  Guide  document  

2.  Document  IG  Conformance  Statements  in  RTM  

3.  Develop  Examples  to  inform  implementers  

4.  Validate  examples  5.  Achieve  community  

consensus  or  agreement  

Implementa(on  Guide  

1.  Survey  SDO  or  standards  organiza/on  op/ons  

2.  Select  ballo/ng  approach  

3.  Align  /meline  with  ballot  cycles  

4.  Submit  documents  informing  SDO  of  intent  to  ballot  

5.  Submit  content  to  SDO  

6.  Conduct  ballo/ng  cycle  &  reconcilia/on  per  SDO  guidelines  

Balloted  standards  

Evaluate  Standards  

Plan  for  Solu(on  and  Final  standards  

Develop  Implementa(on  

Guide  *SDO  Ballo(ng  

53

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Harmoniza/on  Timeline  Week  

Target  Date  (2014)  

All  Hands  WG  Mee(ng  Tasks  Review  &  Comments  from  Community  via  Wiki  

page  due  following  Monday  @  12  noon  

1   3/25  Harmoniza(on  Kick-­‐Off  &  Process  Overview  

Introduce:    Overview  of  UCR-­‐Standards  Mapping  Review:  N/A  

2   4/1   Introduce:  Candidate  Standards  List  &  UCR-­‐Standards  Mapping   Review:  Candidate  Standards  List  

3   4/8  Finalize:  Candidate  Standards  List  Review:  UCR-­‐Standards  Mapping  

Review:  UCR-­‐Standards  Mapping  

4   4/15   Review:  UCR-­‐Standards  Mapping   Review:  UCR-­‐Standards  Mapping  

5   4/22  Finalize:  Outcome  of  UCR-­‐Standards  Mapping  Introduce:  Gap  Mi(ga(on  Plan  

Review:  Gap  Mi(ga(on  Plan  

6   4/29  Finalize:  Gap  Mi(ga(on  Plan  Introduce:  HITSC  Evalua(on  

Review:  HITSC  Evalua(on  

7   5/6   Review:  HITSC  Evalua(on   Review:  HITSC  Evalua(on  

8   5/13  Finalize:  Full  Review  of  HITSC  Evalua(on,  Total  Ra(ngs,  List  of  Final  Standards  for  Solu(on  Plan  Introduce:  Solu(on  Plan  

Review:  Solu(on  Plan  

9   5/20   Review:  Solu(on  Plan   Review:  Solu(on  Plan  

10   5/27  Finalize:  Solu(on  Plan  Introduce:  Implementa(on  Guide  (IG)  Template  

Review:  Implementa(on  Guide  Template  

11-­‐15   6/3  –  7/1   Review:  Implementa(on  Guide   Review:  Implementa(on  Guide  

16-­‐17   7/8  –  7/15   End-­‐to-­‐End  Community  Review  of    Implementa(on  Guide   End-­‐to-­‐End  Review  of  Implementa(on  Guide  

18   7/22   Consensus  Vote  

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PDMP Project Timeline

Kick-­‐off    (11/14)  

Pre-­‐Discovery,  Call  for  Par/cipa/on  

Jan  14  June  14  

Discovery

Ini(a(ve  End  

55  

Nov  13   July  14  Mar  14  

Implementation Pilot

User  Stories,  Use  Cases,  Func/onal  Requirements  

Standards  Gap  Analysis  

Harmonized  Specifica/ons  

Technology  Evalua/ons   Reference  Model  Implementa/on  &  Valida/on  

Use  Case  Kick  Off   Use  Case  Consensus  

Standards  and  Harmoniza(on  Kick  Off  

Pilot  Kick  Off  

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Join  us!    

•  The PDMP & Health IT Integration Initiative is open for anyone to join

•  This community meets each week on Tuesday from 12:00-1:30 pm ET by webinar and teleconference.

•  We use Wiki pages to facilitate discussion. Information on how to join the Community can be found on the PDMP & Health IT Integration Initiative: •  http://wiki.siframework.org/PDMP+%26+Health+IT+Integration

+Homepage

•  In order to ensure the success of our initiative and the subsequent pilots, we encourage broad and diverse participation from the community.

•  This is your chance to have an impact on the creation and implementation of pilots that will use selected standards in transactions between PDMPs and Health IT systems.

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PDMP  &  Health  IT  Integra(on  Ini(a(ve  Resources  

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•  Initiative Wiki Homepage –  http://wiki.siframework.org/PDMP+%26+Health+IT+Integration

+Homepage •  Become a Community Member

–  http://wiki.siframework.org/PDMP+%26+Health+IT+Integration+Join+the+Initiative

•  Project Charter –  http://wiki.siframework.org/PDMP+%26+Health+IT+Integration

+Charter+and+Members •  Standards and Interoperability(S&I) Framework

–  http://wiki.siframework.org/Introduction+and+Overview •  S & I Calendar of Events –  http://wiki.siframework.org/Calendar

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PDMP  &  Health  IT  Integra(on  Ini(a(ve  Support  Leads  

•  For questions, please feel free to contact our support team: –  Initiative Coordinators:

•  Johnathon Coleman [email protected] •  Sherry Green [email protected]

–  ONC Leads: •  Jennifer Frazier [email protected] •  Helen Caton-Peters [email protected]

–  SAMHSA Leads: •  Jinhee Lee [email protected] •  Kate Tipping [email protected]

–  Support Team: •  Project Management:

–  Jamie Parker [email protected] –  Ali Khan [email protected] (Support)

•  Use Case Development: –  Presha Patel [email protected] –  Ahsin Azim [email protected] (Support)

•  Vocabulary and Terminology Subject Matter Expert: –  Mark Roche [email protected]

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Thank  you!  

Jinhee  Lee,  PharmD  [email protected]  

The findings and conclusions in this report are those of the author and do not necessarily represent the views of the Substance Abuse and Mental Health Services Administration.

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