Download Post-Transplant Patient Education and Medication Adherence

4/28/2017
Post-Transplant Patient
Education and
Medication Adherence
Texas Kidney Foundation
Spring Symposium
April 28, 2017
Alex de la Vega, PharmD, BCPS
Diana Luong, PharmD, BCPS
Objectives
At the end of this presentation, you will be able to:
• Understand post-kidney transplant medication education and
counseling
• Discuss the importance of medication adherence and compliance
• List and describe risk factors and potential barriers to medication
nonadherence and noncompliance
• Identify various interventions and strategies to prevent
nonadherence
• Examine current and future Medicare immunosuppressant drug
coverage
Overview of Kidney
Transplantation
Management of Transplant
Patients
• Most patients with end-stage renal disease (ESRD) stem
from conditions such as:
• Immunosuppressive therapy is most important
component
• Complex regimen of drugs
• Lifelong immunosuppressive
• Primary cause of kidney transplant failures
• Diabetes (diabetic nephropathy)
• Hypertension (hypertensive nephrosclerosis)
• Glomerular disease
• Transplantation is the primary treatment option for most
ESRD patients
• Transplant patients live an average of 10 to 15 years longer
than patients on dialysis1
Lack of adherence to immunosuppressive
medications
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Patient Education Workflow
• Pre-transplant education
session
• Living donors
• Deceased donors
• Post transplant nurse
coordinators
•
•
•
•
•
•
Roles
Education booklet
Wound care
General info
Appointment follow up
Medication
delivery/pillbox
UNOS Bylaws: Transplant Clinical
Pharmacist2
• Inpatient pharmacist
counseling
• Importance of
medications
• Side effects
• Pain
• Expectations
• Duration of anti-infective
prophylaxis
• Medication reconciliation
• Discontinue ESRD meds
• i.e. phosphate binders,
Sensipar
Pre
Peri
Post
• Evaluates, screens and identifies medication related issues for
potential transplant recipients
• Educates transplant recipients and their family members on transplant
medications and adherence to medication regimen
Prepares and assists with discharge planning for all transplant recipients
Acts as liaison between patient and patients’ families and other health care team
members
regarding medication
issues
Evaluates transplant
recipient medication
regimens
Communicates all transplant recipient medication issues and concerns to
appropriate members of the transplant team
• Assists with designing, implementing, and monitoring of comprehensive care
plans with other team members (i.e. transplant coordinators, financial
coordinator, social worker, dietician, etc.
•
•
•
•
UNOS= United Network for Organ sharing
Typical Post-Transplant
Medication Regimen
• Anti-rejection medications
• Tacrolimus (Prograf)
• Mycophenolate mofetil (Cellcept)
• +/- Prednisone
• Anti-infective medications
• Antibacterial
• Sulfamethoxazole/Trimethoprim (Bactrim DS) or alternative if allergic
• Anti-viral
• Valganciclovir (Valcyte)
• Medications for other conditions and Supplements as
needed
• Anti-hypertensives
• Anti-hyperglycemics
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Transplant Patient Education
Transplant Patient Education
• Why patients need these medications
• Cytomegalovirus (CMV) 3
• BK virus (polyoma virus) 4
• Anti-rejection medications
• Lowers body’s natural defense (immune system) against illness and new
organ
• When the body’s immune system fights against organ/allograft, it is known
as rejection
• Thus, these medications stop the body from rejecting the new organ
• Anti-infective medications
• Anti-rejection medications increases risk of becoming sick from infections
due to the decrease in immune system
• Taking an antibacterial and antiviral can help prevent certain potential
infections
• Related to herpes virus
• Most people have previously been
exposed to CMV
• In immunocompromised patients,
latent virus may become active
• Most people have been previously
exposed
• Latent virus
• Symptoms are similar to the
common cold
• Can affect many organ systems
•
•
•
•
Eyes
Lungs
GI tract
Liver
• May increase risk of rejection
• Symptoms of nausea, vomiting, and
diarrhea, abdominal pain
Mycophenolate REMS program5
Missing
doses*
Intentional
Altering
doses*
Nonadherence6
Nonintentional
Forgetting
doses
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WHO classification of risk factors
for non-adherence8
Why is this so important?
• Patients are on life-long immunosuppressive
regimens
• Non-adherence and non-compliance is associated
with a 60% increased risk of kidney transplant
failure7
•
•
•
•
Socio-economic factors
•
•
•
•
•
•
Age
Gender
Nationality
Live alone/with others
Employment status
Perceived adequacy of
one’s financial situation
• Level of education
Increase graft rejection episodes
Increase hospitalizations
Increase costs
Increase poor long-term kidney outcomes
Patient- / disease-related
factors
•
•
•
•
•
Health beliefs/behaviors
Vaccination status
Smoking history
Alcohol use
Depression
Treatment-related factors
• Patient symptoms
• Side effects of
medications
Health care
system/health care
worker factors
• Lack of health insurance
or health benefits
WHO = World Health Organization
▫ Positive
perception
of
treatment
benefits
▫ Age >
40
▫ Low
medication
side effects
▫ Female
▫
Caucasian
▫ Absence
of
psychiatri
c
illness
▫ Poorly
perceived
treatment
benefits
▫
Healthcare
coverage
▫ Available
Factors
affecting
ADHEREN
CE9
▫ Shorter
time
since
transplant
▫ Diabetes
transportat
ion
▫ Age <
25
▫ Males
▫ Noncaucasian
▫ Higher
▫ Good
social
support
▫ Lack of
education
medication
side
effects
▫ Complex
medical
regimens
Factors
affecting
NONADHEREN
CE9
▫ Patients
without
diabetes
Additional factors
▫Unemploym
ent
▫ Greater
distances to
travel
▫ Poor
transportatio
n
▫ Poor
social
support
• Influence of personal characteristics
• Predictor of health-related behavior
• Previous dialysis-dependent patients
• Perceived susceptibility to rejection
• Frequency of drug dosing
• Once vs Twice daily
▫ Increased
time period
since
transplant
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Measuring nonadherence
Patient Survey Responses
on Medication Nonadherence10
• Electronic medication monitoring9
• Gold standard
• Limitations:
• Lack of certainty that med or correct dose was taken
• Self-reporting
• Drug levels
• Compliant with medications prior to known lab draw
• However, patient may have missed a dose or two
• Difficult to quantify nonadherence
• Inconsistent methodology
• Honest disclosure of self reporting
Medication Adherence
Study,
duration
Number of
participants
Chisholm11 C: n = 12
(2001)
I: n = 12
21 months
Usual care (C)
vs intervention
(I)
ChisholmBurns 12
(2013)
15 months
C: n = 74
I: n = 76
Interventions
Results
Measurement
Results
Informational:
Pharmacy refill
verbal or written records
instructions
Mean
compliance
rates
Serum drug
concentrations
of IS
% patients within
target serum
levels
Behavioral:
Monthly face-toface sessions
with pharmacist
I: 96%
C: 82%
Informational:
non-adherence
consequences
Behavioral:
identify
tools/strategies
Patient
motivation
Measurement
Secondary Outcomes
Pharmacy refill
records
t-test
Adherence
score
6 months:
I: 0.89
C: 0.80
9 months:
I: 0.91
C: 0.81
I: 64%
C: 48%
Monthly
healthcare
screening
questionnaire
% patients
requiring
hospitalization
I: 23.9%
C: 57.3%
Overcoming barriers of
Nonadherence
A combination of interventions via team approach is the most helpful
long-term strategy
•
•
•
•
•
•
•
Pharmacist-led medication counseling
Individualized and patient-tailored education
Open-ended questions regarding adherence
Repetitive teaching
Medication scheduling
Weekly pillboxes
Refill reminders
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Transplant Patient Education
Other considerations
• Medication List
• Once vs Twice daily dosing
• Every patient should have an up-to-date medication list
that includes:
•
•
•
•
•
•
Names and doses of medications
How often
Indication
Name of prescriber
Allergies
Medication conditions
• Bring list to every clinic appointment
• Drug holidays
• Belatacept (Nulojix™)
• Steroid free protocols
• Calcineurin-inhibitor (CNI) minimization
• Valganciclovir (Valcyte®) mini-dosing13
• Generics vs Brand medications
• Pipeline transplant medications
• Novel technology: New ingestible sensor system14
• Medication Pillbox
Barriers to Medication Adherence
Disparities in Kidney Transplant
Outcomes
15
• Access to immunosuppressive agents
• Medicare benefits
• Financial
• Direct relationship between loss of insurance coverage
and allograft failure
Sociocultural
Socioeconomic
Geographic
Risk Factors for Worse Graft Function
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Disparities in Kidney Transplant
Outcomes15
• Immunological risk factors
Medicare Coverage of
Immunosuppressant drugs
• Non-immunological risk factors
 Comorbidities
 time on dialysis
 donor characteristics and organ characteristics
 socioeconomic status
 medication adherence
 access to care and health policies*
Medicare Part B History 17
Social Security Amendments of 1965
established Medicare and Medicaid
•>65 age, people with disabilities,
and poor families
92nd Congress: H.R. 1 as section 299I
of the Social Security Amendments of
1972 providing disease specific
Medicare benefits for eligible
patients with ESRD
•Part A and B coverage of the costs
of dialysis and renal transplantation
but not immunosuppressive drug
coverage
Medicare Part B History 17
Omnibus Budget Reconciliation Act
1986
•Authorized payment through Part B
benefits for immunosuppressive
medications for 1 year after a
Medicare covered renal transplant
1993-95 Medicare and
Medicaid services gradually
extended coverage
• 3 years after kidney
transplantation
2011-Present ??
• Comprehensive
Immunosuppressive Drug
Coverage for Kidney
Transplant Patients Act
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Current Medicare Part B after kidney
transplant
Current Medicare Part B after kidney
transplant
You have Part
A
Qualify for
Medicare
based on age
and disability
You have Part
A
Transplant in
Medicarecovered
facility
Entitled to
Medicare
soley because
of ESRD
ISD
covered
for a
lifetime
Transplant in
medicare
covered
facility
ISD
covered for
a limited
time
ISD= immunosuppressive drugs
Medicare Part B 16
Part B Premiums
• The standard Part B premium amount in 2017 is
$134 (or higher depending on your income)
• If you pay your Part B premium through your
monthly Social Security benefit, you’ll pay less
($109 on average).
Part B deductible & coinsurance
• You pay $183 per year for your Part B deductible
• After your deductible is met, you typically pay 20%
coinsurance
Medicare Part B: What does this
all mean?
Immunosuppressive
drug
AKA
30-d AWP $
Based on
avg. dose
Annual AWP
$
20%
Tacrolimus
FK
856
10,272
$2,054.00
Mycophenolate
Mofetil
MM
F
942
11,304
$2,260.00
Prednisone
Pred
3
36
$7.00
$4,321 total per person
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Medicare Part D 17
• The Medicare Prescription Drug, Improvement, and Modernization Act of
2003(PL108–173) authorized Medicare Part D to cover the cost of prescription
drugs for Medicare beneficiaries.
Medicare Part D Gap 17
Gap
for the
remain
der of
the
year
• Part D went into effect in 2006 and has been administered by private health
plans.
• In situations where a beneficiary receives a transplant prior to enrolling in
Medicare, immunosuppressive drugs are not covered by Part B but will be
covered under Part D
Total costs reach
About ~ $ 3,000
Annual
deductib
le &
monthly
premiu
m
copayments
Future
• Comprehensive Immunosuppressive Drug Coverage
for Kidney Transplant Patients Act “Immuno Bill”
• Affordable Care Act
• Assistance Programs
Immuno Bill 18
• S.1454/H.R. 2969 was first introduced in 2011
(112th congress)
• Proposed to amend Medicare to extend ISD
coverage beyond 36 mo
• Would allow individuals to be eligible for Medicare
Part B solely for the purpose of drug coverage
• Has “died” in the senate finance committee twice
• Recently re-introduced in House 9/22/16 and the
Senate 11/30/16
 H.R. 6139 and S.3487
 Bill was not enacted
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Immuno Bill
Immuno Bill 17
• A no brainer ?
• Cost of transplant vs dialysis
• Why the hesitation ?
Kidney transplant3
= $ 32,914
PD3=
 The financial health of Medicare programs will be partly determined by cost savings associated
with the ACA over the next decade
 Political pressure/lobbyists from industry has opposed any shifting of payment away from
dialysis to transplant antirejection drugs
 Additional expenditures and disease-specific ESRD entitlement have been questioned by some
policymakers when other disease-specific programs lack similar benefits
$66,751
HD3= $87,561
ACA = Affordable Care Act
Economic Impact of ESRD care and ISD
coverage
17
Medicare Part D
~ $305 million
ESRD = End Stage Renal Disease
Medicare Part B
~ $460 million
Source: GAO analysis of Centers for Medicare & Medicaid Services and RED BOOK data. | GAO-16-594
10
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Total Medicare ESRD Expenditures, by modality, 2004-2014
Data Source: USRDS ESRD Database. Total Medicare costs from claims data for period prevalent ESRD
patients. Abbreviation: ESRD, end-stage renal disease.
Total Medicare ESRD expenditures per person per year, by modality, 2004-2014
Data Source: USRDS ESRD Database; Reference Tables K.7, K.8, & K.9.Period
prevalent ESRD patients; includes all claims with Medicare as primary payer
only. Abbreviation: ESRD, end-stage renal disease.
Medication Assistance Programs
Medication Assistance Programs
• Texas Kidney Healthcare
• Rx Assist, RxHope, Together Rx Access Card
• AZ&Me Prescription Savings Program
• VALCYTE® (valganciclovir): co-pay card
• Social worker/case manager
• Drug assistance programs
• Pre-transplant screening (financial)
11
References:
1.
Wolfe RA, Ashby VB, Milford EL, et al. Comparison of mortality in all patients on dialysis, patients on
dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. Dec 2 1999;
341(23): 1725-1730
2.
The United Network of Organ Sharing Bylaws. Attachment 1 to Appendix B of the UNOS Bylaws;
Designated Transplant Program Criteria. UNOS-Appendix B-Attachment I--XIII-93 June 28-29, 2011
3.
De Keyzer, Kristel et al. Human Cytomegalovirus and Kidney Transplantation: A Clinician's Update.
American Journal of Kidney Diseases , Volume 58 , Issue 1 , 118 - 126
4.
National Kidney Foundation. https://www.kidney.org/atoz/content/bk-virus-what-transplant-patientsneed-know. Accessed on February 2, 2017
5.
Mycophenolate REMS: Risks of First Trimester Pregnancy Loss and Congenital Malformations.
https://www.mycophenolaterems.com/REMSMaterials.aspx. Accesssed on February 5, 2017
6.
Johnson MJ. The Medication Adherence Model: a guide for assessing medication taking. Res Theory Nurs
Pract 2002; 3: 179-192
7.
Pinksy BW, Takemoto SK, Lentine KL et al. Transplant outcomes and economic costs associated with
patient noncompliance to immunosuppression. Am J Woodward RS, Schnitzler MA, LTransplant 2009; 11:
2597-2606
8.
De Geest S, Sabate E. Adherence to long-term therapies: Evidence for action. Eur J Cardiovadsc Nurs 2:
323, 2003
9.
Prendergast MB, Gaston RS. Optimizing Medication Adherence: An Ongoing Opportunity to Improve
Outcomes After Kidney Transplantation. Clin J Am Soc Nephrol 2010; 5: 1305-1311
10. Muduma G, Shupo FC, Dam S, et al. Patient survey to identify reasons for non-adherence and elicitation of
quality of life concepts associated with immunosuppressant therapy in kidney transplant recipients.
Patient Preference and Adherence 2016; 10: 27-36
11. Chisholm MA, Mulloy LL, Jagadeesan M et al. Impacte of clinical pharmacy services on renal transplant
patients’ compliance with immunosuppressive medications. Clin Transplant 2001; 5: 330-336
12. Chisholm-Burns MA, Spivey CA, Graff Zivin J et al. Improving outcomes of renal transplant recipients with
behavioral adherence contracts: a randomized controlled trial. Am J Transplant 2013; 9: 2364-2373
13. Luan FL, Kommareddi M, Ojo AO. Impact of cytomegalovirus disease in D+/R- kidney transplant patients
receiving 6 months low-dose valganciclovir prophylaxis. Am J Transplant. 2011;11:1936-1942. (B)
14. Eisenberger U, Wuthrich RP, Bock A, et al. Medication Adherence Assessment: High Accuracy of the New
Ingestible Sensor System in Kidney Transplants. Transplantation 2013; 96: 245-250
15. Gordon EJ, Ladner DP, Caicedo JC, et al. Disparities in Kidney Transplant Outcomes: A Review. Semin
Nephrol. 2010 January ; 30(1): 81. doi:10.1016/j.semnephrol.2009.10.009.
16. Medicare.gov Part B costs 2017. https://www.medicare.gov/your-medicare-costs/part-b-costs/part-bcosts.html. Accessed January 29, 2017.
17. Tanriover B, Stone PW, Mohan S, et al. Future of Medicare Immunosuppressive Drug Coverage for Kidney
Transplant Recipients in the United States. Clin J Am Soc Nephrol. 2013;8: 1258–1266.
18. S. 3487 — 114th Congress: Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant
Patients Act of 2016.”www.GovTrack.us. 2016. February 27,
2017<https://www.govtrack.us/congress/bills/114/s3487