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
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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.