Program Description

Location

  • Located within the outpatient Gastroenterology/Hepatology Clinic at Eskenazi Health
  • Clinic is already well equipped with all necessary supplies and space
  • Clinic Hours: 8:00 AM- 4PM on Monday-Friday
  • Eskenazi Hospital is an urban hospital that has provided care to Indianapolis-area residents for more than 150 years
  • Public transportation can be easily utilized to access clinic

(1)


Staff

  • One full time pharmacist (1 FTE)
  • Utilize current clinic administrative staff
    • Responsibilities including scheduling, reminder calls/ texts/ emails, prior authorizations, and other administrative tasks necessary
  • Utilize 1-2 pharmacy students on rotations

Referral Process

  • Encourage Eskenazi Health Gastroenterology/Hepatology practitioners to refer patients meeting the following criteria:
      • Any Hepatitis C patient
      • Highly motivated patients
      • Gastroenterology/Hepatology patients that need further education or assistance in pharmacy services
      • Treatment is recommended for all patients with chronic HCV infection, except those with short life expectancies that cannot be remediated by treating HCV, by transplantation, or by other directed therapy2
    • Clinic will prioritize patients based upon clinical judgement
    • Referral forms can be filled out electronically by providers and submitted through EPIC
    • Providers can select can select the GI Clinic pharmacist and the reason for referral on the electronic form
    • Once the referral form is submitted, the existing administrative team at the Gastroenterology/Hepatitis clinic will schedule the visit with the pharmacist

Billing Process

  • Facility fee code G0463 ($96.25 per visit)
  • As alternative billing method if not able to utilize facility fee: Incident-To 99211 Code ($18.93)

Length of Patient Visits

  • We will visit with patients initially and at least every four weeks. Frequency may differ depending on personalized medication regimen chosen (0,4,8,12 week visits)
  • Phone call recommended 2 weeks after therapy initiated to monitor patient compliance and possible adverse reactions they are experiencing
  • Most treatments regimens are 12 weeks in length
  • Initial visits will be 30 minutes in length
  • Follow-up visits will be 30 minutes in length

Pharmacist-Patient Interaction

  • Newly diagnosed patient:
      • Patient will be referred to clinic from a Gastroenterology/Hepatitis provider
      • Pharmacist will discuss disease diagnosis with patient
      • Pharmacist will order a genotyping test
      • Collaboratively determine goals of treatment
      • Initiate lifestyle modifications
      • Assess drug options with patient
      • Begin a personalized treatment plan
  • Follow up:
      • Verify what medications the patient is taking and how they are taking them
      • Assess viral load and disease progression
      • Monitor for medication adverse reactions, and lifestyle modifications
      • Adjust medications according to CDTM if warranted
      • Review and reassess goals with patient


Visit Documentation

  • Documentation of all visits will be done on Eskenazi electronic medical record (EPIC)
  • Referring providers will be able to stay informed on patient progression through EMR
  • Notes on all patients seen that day will be updated and available for provider review at the end of each clinic day

No-Show Plan and Non-Compliance Plan:

  • We will explain the no-show policy at initial visit
  • Due to the highly expensive nature of these medications and average treatment length of 12 weeks, the policy will be strictly enforced
  • Patients will receive a reminder call/text/email (patient preference) 2 days prior to appointment
  • If patient fails to show up, arrives more than 15 minutes late, or cancels less than 24 hours in advance for scheduled appointment, patient is considered a no-show, and appointment will need to be re-scheduled
  • A courtesy call will be made for no show patients
  • After 2 no-shows within a year, the patient will be dismissed from our clinic
  • We hope to work with highly motivated patients, but we will monitor for compliance. If we suspect any issues, we will try to figure out underlying causes. 

Data Measures

  • Retrospective data (initial patient viral load) will be utilized to access our success
  • Treatment Responses
    • Rapid virologic response (RVR) at week 4
    • Early virologic response (EVR) at week 12
    • End of treatment response (ETR): undetectable viral load at end of therapy
    • Sustained virologic response (SVR): undetectable viral load at end of therapy and 24 weeks after treatment
      • SVR = cure
    • Relapse: initial response but viral load detectable at conclusion of therapy
    • Nonresponder: detectable viral load after 24 weeks of therapy
    • Null responder: viral load never decreases > 2 logs after 24 weeks of therapy
    • Partial responder: > 2 log reduction in viral load but detectable viral load after 24 weeks of therapy
  • Time to treat
  • Vaccination status
  • Patient compliance
  • Patient satisfaction
  • Ease of access to medications
  • Quality of life
  • Health care team satisfaction
  • Hospital admissions

Virologic Responses:3


Interventions

  • Drug-Interaction Screening
  • Medication Reconciliation including G3 note or Epic Charting
  • Insurance inquiry for medication selection, contacting insurance to confirm
  • Vaccination recommendations and reconciliations
  • HCV education and medication scripting including G3 note
  • Assistance in medication dosing, selection, titration, ordering (changed dosage form to be more tolerable)
  • Assistance with PAs/facilitation with nursing PA coordinator or MDs unsure of rejection reason
  • Recommendation for NS5A resistance testing for HCV treatment selection
  • Contacted pharmacy to begin refills, clarify quantity dispensed, determine copay/coverage

CDTM Protocol

  • Ability to recommend and adjust hepatitis C medications and gastroenterology medications based on current guidelines and physician recommendations  
  • Ability to recommend lifestyle modifications
  • Pharmacist can order genotyping test and monitor the viral load
  • Pharmacist can order NS5A resistance testing
  • Ultimately, the pharmacist has the ability to use his/her best clinical judgement for any decision making within their scope of practice

1. 2014 Monumental celebration. The Shiel Sexton blog. http://www.shielsexton.com/2014-monumental-celebration. November 11, 2014. Accessed: February 15, 2017.
2. American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (IDSA) Recommendations for Testing, Managing, and Treating Hepatitis C : http://www.hcvguidelines.org/full-report/initial-treatment-hcv-infection
3. Ramers CB. Initital evaluation of persons with chronic hepatits C. Hepatitis C Online. http://www.hepatitisc.uw.edu. March 27, 2014. Accessed: February 15, 2017.