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Use your pharmacists: lead
         screening, care
   management, PEP roles taken
         by pharmacists

Heather Huentelman, PharmD, AAHIVP, LCDR USPHS
       Director of HIV Center of Excellence (Acting)
   Nothing to disclose
   Jessica Leston
   RADM Scott Giberson, Rockville
   Lisa Neel, MPH, HIV Analyst, Rockville
   Brigg Reilley, MPH, HIV Epi, Albuquerque
   Scott Wiegand, Pharm D, Rosebud
   The IHS HIV/STD/HCV Pharmacy Workgroup




                                               3
   Define the different roles of pharmacist in HIV
    management
   “Increasing the number of HIV providers, as
    well as increasing knowledge among all
    health professionals about HIV risks and
    prevention is a critical need. This involves a
    wide range of health professionals in all
    health care settings including physicians,
    registered nurses, nurse practitioners,
    physician assistants, social workers,
    pharmacists, and dentists.”
   “There is also a need for ongoing support to
    maintain the necessary high levels of
    adherence to antiretroviral treatment.”
   STANDARD: Monitor proper dosing, drug
    interactions and drug utilization.
   MEASURE: Dosing order in chart matches
    provider’s order.
   MEASURE: Potential drug interactions are
    reviewed by the pharmacist and noted in the
    patient profile.
   MEASURE: Indications for drug utilized
    matches provider order.
   “All health care team members, including
    nurses, nurse practitioners, pharmacists,
    medication managers, and social workers,
    have integral roles in successful adherence
    programs”
   “Strategies to Improve adherence include
    multidisciplinary team approach”
    ◦ “Nurses, social workers, pharmacists, and
      medications managers”
   Treatment:
    ◦   Antiretroviral counseling: Initiation and change
    ◦   Adherence (including refill history)
    ◦   Medication reconciliation
    ◦   Drug interaction identification and management
    ◦   Side effect management
    ◦   HIV prophylaxis
    ◦   Laboratory assessments
    ◦   Vaccinations
   Alternate resource utilization
   Prevention
    ◦ Improve the management and control of STIs
        Promotion of safer sexual behaviors
    ◦ Post-exposure prophylaxis (PEP)
    ◦ Reduce mother-to-child transmission
   Screening
    ◦ Improve access to testing
        Walk-in STI testing
        Bundled STI screening versus HIV testing alone
   Facilities with pharmacists working in HIV
    ◦   PIMC
    ◦   Rosebud
    ◦   GIMC
    ◦   Ft Defiance
    ◦   Shiprock

   Any other sites here today with active
    pharmacy involvement in HIV?
   New Case Identification (iCare)
   Clinic multidisciplinary team
   HIV test interpretation
   Refill management
   Adherence clinic
   Alternate resource utilization
   HIV/HCV co-infection management
   Co-morbidity management
    ◦ Hyperlipidemia and Hypertension
   Post-exposure prophylaxis
   2004- HIV registry 235
   2012- HIV registry 442
    ◦ Active patients: 200

   Treatment with antiretrovirals
    ◦ FY2005         83 patients, 802 pt-mo
    ◦ FY2010         149 patients, 1446 pt-mo
   Clinic multidisciplinary team started 2004
    ◦ RN Case managers, Physician, Pharmacists, nursing
      assistant, and Patients
   Pharmacy recommendations
    ◦ Averaged 0.5 per patient per clinic
   Saved $3,467,208 in 5 years
   FY10 ARV expenditures $1.29 million net cost
    to PIMC less than $135,000
   90% of patients on ARVs were at goal
    ◦ VL <200 copies/ml or 1-2 log drop for new starts at
      end of the fiscal year
Figure 1: Total Antiretroviral (ARV) Cost Compared to Net Cost to PIMC

$1,400,000


$1,200,000
                    Grand Total ARV Cost
                    Net Cost to PIMC
$1,000,000


 $800,000


 $600,000


 $400,000


 $200,000


       $0
             2000    2001   2002       2003   2004   2005   2006   2007   2008   2009   2010
   Requires 95% adherence to prevent drug
    resistance
   Simplification of regimens has helped
    ◦ All first-line regimens are once daily except for one
    ◦ First-line regimens are one to four pills daily
   With good adherence, patient many never
    need to change medications
   Access to medications
   Side effects
   Drug interactions
   Active substance abuse
   Homeless
   Adherence assessment at each medical visit
    ◦ Self-report +/- refill history + lab results
   Separate adherence clinic:
    ◦ New starts- pharmacist protocol
    ◦ Med changes- provider/pharmacist recommended
    ◦ Med box fills
   Automatic refills (including mail order)
   Majority (if not all) of treatment failure is
    from nonadherence
   Patients need consistently reminded of drug
    interactions and food restrictions
   Side effects can be life altering and should be
    addressed even if someone is well controlled
How can a pharmacist be involved?
   PEP (post-exposure prophylaxis
    ◦ Occupational exposure
   nPEP (nonoccupational post-exposure prophylaxis)
    ◦ Support 3 drugs for known HIV+ source and 2
      drugs for unknown source
    ◦ Must be started within 72 hours of exposure
    ◦ Highly recommend consulting PEPLine
   PrEP (pre-exposure prophylaxis)
    ◦ Recommendation for use in MSM population
    ◦ Need to use with caution (TDF)
      Screening HBV, HIV x2, HIV VL?, SrCr, UA?, PO4?
    ◦ Able to replicate study conditions?
   Consider having pre-packaged PEP kits
    ◦ Recommend short supply 3-5 days
      Allows time for additional source patient testing
      Continued follow-up in population with high rate of
       discontinuation
      Reduce cost if discontinued or changed
    ◦ Include reference material
      Contain medication guide, follow-up for employee
   Many providers believe giving PEP is
    always the right answer
   Appropriate med choice
    ◦ Efavirenz
    ◦ Renal function
    ◦ Drug interactions
   PEPline
    ◦ Especially for nPEP
   Employees are more likely to have ADRs
   Most employees do not complete 28 days
   Continue meds past “PEP kit” as appropriate
   Coping with ADRs or changing if needed
   Follow-up testing
    ◦ Use EHR notifications
   PEP & nPEP guidelines expect update soon
    ◦ Make sure to update your policies
    ◦ Recommended antiretrovirals likely to change
   HCV
    ◦ Treat acute infection with peg-interferon alone?
Universal screening and pharmacy
   based HIV testing program
   Implement universal screening measures
   Increase overall number of patients ever
    tested for HIV
   Identify HIV infection as early as possible to
    increase survival and decrease transmission
   Link patients to appropriate care
   Implement Expedited Partner Therapy (EPT)
   Current progress:
    ◦ Proposal to adopt new HIV and STD screening
      measures approved by Medical Staff
    ◦ STD/HIV and EPT Protocol being developed based
      on CDC protocol and adapted to fit local needs
    ◦ Routine screening is being done at providers
      discretion until protocol is approved by P&T
    ◦ EPT and presumptive treatment of STDs per area
      guidelines with protocol to come
   Still to come:
    ◦ Nurses to be trained on how to offer “opt-out”
      testing and obtain informed consent per protocol
    ◦ Will use clinical reminder in EHR once a new Clinical
      Applications Coordinator is established
    ◦ Provider to attend HIV preceptorship training in
      Denver to become local HIV care provider
   Pharmacy testing goals:
    ◦   Provide increased access to HIV testing
    ◦   Reduce stigma attached to HIV testing
    ◦   Increase awareness of the need for HIV testing
    ◦   Incorporate HIV testing into other routine
        screenings and healthcare services in IHS
        pharmacies
   Pharmacy will provide private testing to any
    patient asking for an HIV test
   Testing will occur in private counseling rooms
   Tests done using either Insti (60 second) test
    or OraSure Rapid test (20 minutes)
   Results reported to patient according to
    patient preference (phone, in person, or
    patient call-in)
   Current Progress
    ◦ Pharmacists trained on testing procedures for both
      testing types
    ◦ Proposal for pharmacy testing model approved by
      medical staff
    ◦ Protocol developed, awaiting revision and P&T
      Committee approval
    ◦ Billing procedure is being explored but no model
      has been developed yet
QUESTIONS???
PIMC – HIV Center of Excellence

Heather Huentelman, PharmD
Heather.huentelman@ihs.gov
602-263-1200 x2002
602-723-3974




                                  3
                                  7
   Funding
    ◦ Minority AIDS Initiative (MAI) Grant
    ◦ Ryan White (direct or subcontractor) Grant
      Policy Notice 07-01
    ◦ ADAP
    ◦ Patient assistant programs
   Federal sites
    ◦ Interested in expanding HIV testing contact Lisa
      Neel or Brigg Reilley
    ◦ Other HIV initiates in pharmacy submit plans now
      for funding for 2014
   Urban
    ◦ Through a cooperative agreement
    ◦ Contact Phyllis Wolf
   Tribal
    ◦ Grant cycle $90,000/year up to 5 years
    ◦ Grants.gov released in early summer submit by
      Aug
   Get on IHS HIV list serve for other
    opportunities

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Use your Pharmacist Huentelman

  • 1. Use your pharmacists: lead screening, care management, PEP roles taken by pharmacists Heather Huentelman, PharmD, AAHIVP, LCDR USPHS Director of HIV Center of Excellence (Acting)
  • 2. Nothing to disclose
  • 3. Jessica Leston  RADM Scott Giberson, Rockville  Lisa Neel, MPH, HIV Analyst, Rockville  Brigg Reilley, MPH, HIV Epi, Albuquerque  Scott Wiegand, Pharm D, Rosebud  The IHS HIV/STD/HCV Pharmacy Workgroup 3
  • 4. Define the different roles of pharmacist in HIV management
  • 5.
  • 6. “Increasing the number of HIV providers, as well as increasing knowledge among all health professionals about HIV risks and prevention is a critical need. This involves a wide range of health professionals in all health care settings including physicians, registered nurses, nurse practitioners, physician assistants, social workers, pharmacists, and dentists.”  “There is also a need for ongoing support to maintain the necessary high levels of adherence to antiretroviral treatment.”
  • 7. STANDARD: Monitor proper dosing, drug interactions and drug utilization.  MEASURE: Dosing order in chart matches provider’s order.  MEASURE: Potential drug interactions are reviewed by the pharmacist and noted in the patient profile.  MEASURE: Indications for drug utilized matches provider order.
  • 8. “All health care team members, including nurses, nurse practitioners, pharmacists, medication managers, and social workers, have integral roles in successful adherence programs”  “Strategies to Improve adherence include multidisciplinary team approach” ◦ “Nurses, social workers, pharmacists, and medications managers”
  • 9.
  • 10. Treatment: ◦ Antiretroviral counseling: Initiation and change ◦ Adherence (including refill history) ◦ Medication reconciliation ◦ Drug interaction identification and management ◦ Side effect management ◦ HIV prophylaxis ◦ Laboratory assessments ◦ Vaccinations  Alternate resource utilization
  • 11. Prevention ◦ Improve the management and control of STIs  Promotion of safer sexual behaviors ◦ Post-exposure prophylaxis (PEP) ◦ Reduce mother-to-child transmission  Screening ◦ Improve access to testing  Walk-in STI testing  Bundled STI screening versus HIV testing alone
  • 12.
  • 13. Facilities with pharmacists working in HIV ◦ PIMC ◦ Rosebud ◦ GIMC ◦ Ft Defiance ◦ Shiprock  Any other sites here today with active pharmacy involvement in HIV?
  • 14. New Case Identification (iCare)  Clinic multidisciplinary team  HIV test interpretation  Refill management  Adherence clinic  Alternate resource utilization  HIV/HCV co-infection management  Co-morbidity management ◦ Hyperlipidemia and Hypertension  Post-exposure prophylaxis
  • 15. 2004- HIV registry 235  2012- HIV registry 442 ◦ Active patients: 200  Treatment with antiretrovirals ◦ FY2005 83 patients, 802 pt-mo ◦ FY2010 149 patients, 1446 pt-mo
  • 16. Clinic multidisciplinary team started 2004 ◦ RN Case managers, Physician, Pharmacists, nursing assistant, and Patients  Pharmacy recommendations ◦ Averaged 0.5 per patient per clinic  Saved $3,467,208 in 5 years  FY10 ARV expenditures $1.29 million net cost to PIMC less than $135,000  90% of patients on ARVs were at goal ◦ VL <200 copies/ml or 1-2 log drop for new starts at end of the fiscal year
  • 17. Figure 1: Total Antiretroviral (ARV) Cost Compared to Net Cost to PIMC $1,400,000 $1,200,000 Grand Total ARV Cost Net Cost to PIMC $1,000,000 $800,000 $600,000 $400,000 $200,000 $0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
  • 18. Requires 95% adherence to prevent drug resistance  Simplification of regimens has helped ◦ All first-line regimens are once daily except for one ◦ First-line regimens are one to four pills daily  With good adherence, patient many never need to change medications
  • 19. Access to medications  Side effects  Drug interactions  Active substance abuse  Homeless
  • 20. Adherence assessment at each medical visit ◦ Self-report +/- refill history + lab results  Separate adherence clinic: ◦ New starts- pharmacist protocol ◦ Med changes- provider/pharmacist recommended ◦ Med box fills  Automatic refills (including mail order)
  • 21. Majority (if not all) of treatment failure is from nonadherence  Patients need consistently reminded of drug interactions and food restrictions  Side effects can be life altering and should be addressed even if someone is well controlled
  • 22. How can a pharmacist be involved?
  • 23. PEP (post-exposure prophylaxis ◦ Occupational exposure  nPEP (nonoccupational post-exposure prophylaxis) ◦ Support 3 drugs for known HIV+ source and 2 drugs for unknown source ◦ Must be started within 72 hours of exposure ◦ Highly recommend consulting PEPLine  PrEP (pre-exposure prophylaxis) ◦ Recommendation for use in MSM population ◦ Need to use with caution (TDF)  Screening HBV, HIV x2, HIV VL?, SrCr, UA?, PO4? ◦ Able to replicate study conditions?
  • 24. Consider having pre-packaged PEP kits ◦ Recommend short supply 3-5 days  Allows time for additional source patient testing  Continued follow-up in population with high rate of discontinuation  Reduce cost if discontinued or changed ◦ Include reference material  Contain medication guide, follow-up for employee
  • 25. Many providers believe giving PEP is always the right answer  Appropriate med choice ◦ Efavirenz ◦ Renal function ◦ Drug interactions  PEPline ◦ Especially for nPEP
  • 26. Employees are more likely to have ADRs  Most employees do not complete 28 days  Continue meds past “PEP kit” as appropriate  Coping with ADRs or changing if needed  Follow-up testing ◦ Use EHR notifications
  • 27. PEP & nPEP guidelines expect update soon ◦ Make sure to update your policies ◦ Recommended antiretrovirals likely to change  HCV ◦ Treat acute infection with peg-interferon alone?
  • 28.
  • 29. Universal screening and pharmacy based HIV testing program
  • 30. Implement universal screening measures  Increase overall number of patients ever tested for HIV  Identify HIV infection as early as possible to increase survival and decrease transmission  Link patients to appropriate care  Implement Expedited Partner Therapy (EPT)
  • 31. Current progress: ◦ Proposal to adopt new HIV and STD screening measures approved by Medical Staff ◦ STD/HIV and EPT Protocol being developed based on CDC protocol and adapted to fit local needs ◦ Routine screening is being done at providers discretion until protocol is approved by P&T ◦ EPT and presumptive treatment of STDs per area guidelines with protocol to come
  • 32. Still to come: ◦ Nurses to be trained on how to offer “opt-out” testing and obtain informed consent per protocol ◦ Will use clinical reminder in EHR once a new Clinical Applications Coordinator is established ◦ Provider to attend HIV preceptorship training in Denver to become local HIV care provider
  • 33. Pharmacy testing goals: ◦ Provide increased access to HIV testing ◦ Reduce stigma attached to HIV testing ◦ Increase awareness of the need for HIV testing ◦ Incorporate HIV testing into other routine screenings and healthcare services in IHS pharmacies
  • 34. Pharmacy will provide private testing to any patient asking for an HIV test  Testing will occur in private counseling rooms  Tests done using either Insti (60 second) test or OraSure Rapid test (20 minutes)  Results reported to patient according to patient preference (phone, in person, or patient call-in)
  • 35. Current Progress ◦ Pharmacists trained on testing procedures for both testing types ◦ Proposal for pharmacy testing model approved by medical staff ◦ Protocol developed, awaiting revision and P&T Committee approval ◦ Billing procedure is being explored but no model has been developed yet
  • 37. PIMC – HIV Center of Excellence Heather Huentelman, PharmD Heather.huentelman@ihs.gov 602-263-1200 x2002 602-723-3974 3 7
  • 38. Funding ◦ Minority AIDS Initiative (MAI) Grant ◦ Ryan White (direct or subcontractor) Grant  Policy Notice 07-01 ◦ ADAP ◦ Patient assistant programs
  • 39. Federal sites ◦ Interested in expanding HIV testing contact Lisa Neel or Brigg Reilley ◦ Other HIV initiates in pharmacy submit plans now for funding for 2014  Urban ◦ Through a cooperative agreement ◦ Contact Phyllis Wolf  Tribal ◦ Grant cycle $90,000/year up to 5 years ◦ Grants.gov released in early summer submit by Aug  Get on IHS HIV list serve for other opportunities

Notas do Editor

  1. Need updated info for FY2008 and change formatThe net cost of antiretrovirals was the entire amount until FY2006