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ADHERENCE: Focus on Hepatitis C. Background. Hepatitis C diagnosis: 5.4% of Veterans in VA care 1.6% of general US population Majority infected during Vietnam era Cirrhosis develops over 20-30 years 1-5% die from liver cancer or cirrhosis. - PowerPoint PPT Presentation
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Medication Use CrisisSponsored by the VA Medication Reconciliation Initiative
In conjunction with VHA Program Offices, DoD and IHS
Pam Belperio, PharmD, BCPS National Public Health Clinical PharmacistOffice of Public Health/Population Health
Jennifer Kryskalla, PharmD, BCPSPGY2 Pharmacy Resident
VA Sierra Pacific Network (VISN 21)
ADHERENCE: Focus on Hepatitis C
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Background• Hepatitis C diagnosis:
– 5.4% of Veterans in VA care– 1.6% of general US population
• Majority infected during Vietnam era– Cirrhosis develops over 20-30 years– 1-5% die from liver cancer or cirrhosis
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
• Remove the virus from the blood = CURE
• Prevent further damage to the liver
• Reduce chance of liver cancer
• Decrease the possibility of other Hep C complications
What is the reason to use medications in Hepatitis C?
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
• Drugs are taken for a limited period of time• Two new drugs approved in 2011: Direct
Acting Antivirals (DAAs)• Once chronically infected with hepatitis C the
only way to get rid of it is with medication• New drugs offer cure rates of up to 40%-
80% in combination– Peginterferon + Ribavirin + DAA
(boceprevir or telaprevir)
How is Hepatitis C treated?
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Drug Specific Factors Affecting Adherence to DAAs
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Boceprevir Telaprevir
Pill burden: 12/day Pill burden: 6/day
Three times a day (specifically every 7-9 hours)
Three times a day (specifically every 7-9 hours)
Must be taken with food Must be taken with high fat food
Dysgeusia Rash/puritis
Burdensome Adverse Effects (98% of pts will experience
Burdensome Adverse Effects (98% of pts will experience
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Consequence of Inappropriate Dosing = Resistance and Treatment Failure
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Time
Drug
Con
cent
ratio
n
IC 90
IC 50
Area of Potential
Replication
Inadequate drug levels will lead to viral breakthrough
Missed Dose
Inadequate Dose
Cmax
Cmin
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Complicated Course:Boceprevir Therapy Algorithm
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Barriers to Adherence• Low level of health literacy/numeracy• Cognitive impairment• Psychosocial Issues (homeless, depression, low social
support)• Polypharmacy• Active Substance Use/Abuse• Stigma• Difficulty taking medications (swallowing pills, schedules)• Complex regimens (pill burden, frequency, food
requirements) • Adverse drug effects
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
A Problem as Old as Medicine Itself…
“Keep watch also on the fault of patients which makes them lie about taking of things prescribed”
» Hippocrates circa 500 B.C
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Non-AdherenceHospitalization Risk
**
*
*** *
*
*
*
0
5
10
15
20
25
30
351-19
20-39
40-59
60-79
80-100
Hosp
italiz
ation
Risk
(%)
% Adherence
Sokol MC, McGuigan KA, Verbrugge RR, et al. Impact of medication adherence on hospitalization risk and health care cost. Med Care. 2005 43:521-30
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Methods of Estimating Adherence
• Directly observing therapy
• Measures of drug levels/biological markers in blood
• Record opening of a pill bottle electronically
• Patient interviews
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Calculations Used to Estimate Adherence
Proportion (%) of dayscovered (PDC)
Medication possessionratio (MPR)
Continuous measure ofmedication gaps (CMG)
X100Total days' supplyTotal study period days
Days' supply: Study period days
Total days of treatment gapsTotal days to end of obs. period
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Development of a Novel Medication Possession Ratio (MPR)
• Complex Running calculation
• Accounts for both stockpiling and gaps in therapy
• Resets when necessary
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MPR Example
Sum of Day’s Supply Received Sum of Day’s Elapsed =MPR
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
MPR Example
Sum of Day’s Supply Received Sum of Day’s Elapsed
Past 2 Years
=MPR
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
MPR Example
Sum of Day’s Supply Received Sum of Day’s Elapsed
Past 2 Years
Rx release date + days supplyRx release date + days supply
=MPR
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
MPR Example
Sum of Day’s Supply Received Sum of Day’s Elapsed
Past 2 Years
Rx release date + days supplyRx release date + days supply
=MPR
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
MPR ExampleSum of Day’s Supply Received
Sum of Day’s ElapsedPast 2 Years
Rx release date + days supplyRx release date + days supply
=MPR
Rx release date + days supply
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
MPR Validation• VISN 21
• Prescriptions for all diabetes, hypertension and hyperlipidemia medication
• Laboratory results – Before starting the medication– Last result while on medication
• MPR associated with lab result
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Hypertension and Diabetes Outcomes using MPR
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Uses for MPR
• Provides an accurate way to measure adherence with respect to outcomes
• This calculation can be used by providers to estimate a patients adherence
• Help identify adherence rate required to maximize benefit of medication
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Adherence important for DAAs• Adherence strictly
measured in Clinical Trials– Patients allowed a 7-9
hour dosing window– Lower SVR if outside
of dosing interval – Lower SVR if dose or
treatment duration <80%
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Boceprevir Adherence and Response
VETERANS ADMINISTRATION PATIENT CARE SERVICES 24
NationNumber
with Boceprevir
MPR < 0.80
MPR 0.80-0.94
MPR ≥ 0.95
Number with
TelaprevirMPR < 0.80
MPR 0.80-0.94
MPR ≥ 0.95
1,682 6% 14% 80% 381 8% 18% 74%
MPR Report from VA HCV Clinical Case Registry (CCR)
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VISN Number with Boceprevir MPR < 0.80 MPR 0.80-
0.94MPR ≥
0.95Number with
TelaprevirMPR < 0.80
MPR 0.80-0.94 MPR ≥ 0.95
1 104 <1% 18% 81% 42 10% 12% 79%2 13 0% 23% 77% 1 0% 0% 100%3 53 0% 13% 87% 17 0% 24% 76%4 117 7% 15% 78% 11 9% 18% 73%5 35 29% 11% 60% 14 7% 43% 50%6 85 0% 15% 85% 25 0% 12% 88%7 81 6% 10% 84% 13 15% 8% 77%8 150 2% 5% 93% 2 0% 0% 100%9 125 8% 14% 78% 20 20% 50% 30%
10 25 12% 12% 76% 9 0% 0% 100%11 47 4% 6% 89% 22 0% 9% 91%12 73 1% 11% 88% 14 21% 14% 64%15 81 2% 20% 78% 28 0% 39% 61%16 165 5% 10% 85% 21 24% 10% 67%17 49 2% 6% 92% 2 0% 50% 50%18 74 4% 7% 89% 1 0% 100% 0%19 39 8% 28% 64% 25 4% 0% 96%20 45 7% 20% 73% 27 0% 7% 93%21 168 6% 27% 67% 30 13% 23% 63%22 81 6% 14% 80% 17 6% 18% 76%23 75 20% 19% 61% 40 10% 18% 73%
VETERANS ADMINISTRATION PATIENT CARE SERVICES
HEPATITIS C INTERACTIVE REPORT
Hepatitis C DAA Dashboard Report
VISN 21 Dashboard
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Interactive Report
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Step 1: Select a site
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Step 2: Select a drug
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Step 3: Select therapy status
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Main Report
Scroll to the right for more information
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Main Report- Continued
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Drill down for more data
Click “+” to the left of the patient’s name34
Monitoring safety & efficacy
Scroll to the right for more information
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Monitoring safety & efficacy
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Monitoring medication adherence
Adherence• Calculated Medication Possession Ratio (MPR)• MPR < 90% is shown as red
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Monitoring medication adherence
Days OverdueCalculated using last fill date and days supplied
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Monitoring medication adherence
Patient Instructions included- show dose reductions39
VETERANS ADMINISTRATION PATIENT CARE SERVICES
HEPATITIS C INTERACTIVE REPORT
Hepatitis C Clinical Case Registry (CCR)
VETERANS ADMINISTRATION PATIENT CARE SERVICES
VA HCV Clinical Case Registry (CCR)
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Clinical Reports• BMI by Range• Clinic Follow-up • Combined Meds and Labs • Current Inpatient List• Diagnoses • Liver Score by Range
• MELD, MELD-Na, APRI, FIB-4• Patient Medication History • Procedures • Registry Lab Tests By Range • Registry Medications• Renal Function by Range
Administrative Reports• General Utilization and
Demographics• Inpatient Utilization• Lab Utilization• List of Registry Patients • Outpatient Utilization• Pharmacy Prescription
Utilization • Radiology Utilization
Hepatitis C CCR Reports
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Description of Clinical Reports Useful for Managing Treatment• Clinic Follow-up
– Identify pts seen/not seen in specified date range; provides date last seen• Diagnoses
– Identify Pts with particular diagnoses• List of Registry Patients
– all patients confirmed in the registry• Patient Medication History
– fill dates, type (original/refill), method of pick-up, days supply for selected pts • Procedures
– MRI, US, biopsy…• Registry Lab Tests By Range
– Find pts who fall within a specified lab result range (HCV RNA >100)• Registry Medications
– Pts receiving registry medications (summary =count by medication; complete= lists pts by medication combination)
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Combined Medication and Lab report (CM&L)
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Configuration
Meds date range
Medication selection
Lab date range
Lab selection
Utilization date range
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Answer Simple Complex QuestionsOf patients in the registry, which ones
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• Did / Did not have… (med, lab, procedure)• During date range…(ever, defined by you)
…are potentially eligible for treatment…ever had PegIFN in the past, when? (trx-experienced)…have never received PegIFN? (trx-naïve)…on treatment never had an HCV RNA PCR?…had Liver Bx in last 6 months? …who had RBV in last 3 months had Hgb <10 in last 3 months? …who had RBV and ESA in last 6 mos had Hgb >11 on most recent test?…treatment-experienced, with advanced liver disease
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Clinic Follow-upIdentify pts seen/not seen in a particular clinic during a specified date range; provides date last seen; can select any clinic or group of clinics. Option to include only patients with specific diagnoses
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Pharmacy Medication History
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Registry Lab Tests By Range
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Measuring and Managing Medication: Uses of the Local Clinical Case Registry for HCV
• Identify patients on treatment• Medication review• Medication Monitoring• Patient management
– Toxicity, response
• Adherence to guidelines• Continuity of care• Screening• Treatment outcomes
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Reminder Dialog for Hepatitis C[ ] HCV Treatment Nonpharmacologic intervention[ ] Adherence Assessed [ ] Knowledge of regimen(dose,frequency,food
requirements)assessed [text box][ ] Refill records reviewed [text box]
[ ] Adherence discrepancies exist based on refill records [ ] Patient verbally confirms remaining supplies which
correlate with current wk of tx [ ] Adherence discrepancies exist based on pt supplies [ ] Report of missed doses [text box] [ ] Other adherence issues identified:[textbox][ ] Medication Education Provided: [text box][ ] Medication reconciliation performed [ ] Copy provided for patient [ ] Non-VA medication updated in CPRS [ ] OTC medications documented [text box]
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Intranet Site for Providers: vaww.hepatitis.va.gov
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Patient Website: www.hepatitis.va.gov
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Patient EngagementTable of Contents
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Targeted Patient Specific Materials
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Medication Treatment Planning
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• HCV Specialists PACT communication
• Hepatitis C Treatment Classes • Improving Local Care Processes
– Multidisciplinary team managing treatment– Patient Provider Communication
VETERANS ADMINISTRATION PATIENT CARE SERVICES
Medication Adherence/Management Checklist
Knows name/indication/dose/frequency Understands duration to take medication Understands risk of side effects/what to do if they occur
Understands their disease Understands treatment options Aware of benefit/risk of medication Partnered in treatment decision Agreement and able to follow treatment plan
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Strategies to Improve Adherence in Hepatitis C
VETERANS ADMINISTRATION PATIENT CARE SERVICES
• New triple therapy improves chances of success– Recognize that adherence to regimens will be challenging but is
CRUCIAL to success• MPR can be used estimate adherence• Interactive dashboard for specific patient level data• CCR offers customizable reports at the patient level and
for the population of a local facility• Reminder Dialog to document interventions related to
adherence /medication reconciliation • Targeted material to engage the patient• Communication
SummaryOptimizing Medication Management
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VETERANS ADMINISTRATION PATIENT CARE SERVICES
Questions?
Please use the Q&A Function on Live Meeting
OR
Email: Rosemary.Grealish@VA.gov
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