Preventing and
Resolving Medication-related
Problems in Individuals on
Dialysis
Wendy L. St. Peter, Pharm.D., FCCP, BCPS
Associate Professor, College of Pharmacy,
University of Minnesota
Investigator, United States Renal Data System
and Chronic Disease Research Group
Objectives
• Discuss common medication-related
problems (MRPs)
• Demonstrate the role of the pharmacist in
averting MRPs
• Discuss how medication-related disasters
can be avoided
• Understand medication-related issues
under Medicare Part D
Medication-Related Problems (MRP)
in Dialysis Patients
• Probability is high
– Average no. of drugs per day: 10-12
– Complex comorbidity
•
•
•
•
Several published papers on topic
Pooled analysis was done
MRPs were placed into 9 categories
1593 MRPs were identified in 395 patients
Manley HM, et al. Am J Kidney Dis 2005;46:669-680
Indication without
drug therapy
Subtherapeutic
dosage
Adverse drug
reaction
Failure to
receive drug
Drug without
indication
MedicationRelated
Problems
Manley HM, et al. Am J
Kidney Disease 2005;
46:669-680
Improper drug
selection
Overdosage
Drug interaction
Inappropriate
laboratory
monitoring
Frequency of MRPs
Manley HM, et al. Am J Kidney Dis 2005;46:669-680
Most Common MRPs
• Inappropriate laboratory monitoring
(23.5%)
• Indication without drug therapy (16.9%)
• Dosing errors accounted for 20.4% of
medication-related problems
– Subtherapeutic dosage: 11.2%
– Overdosage: 9.2%
Manley HM, et al. Am J Kidney Dis 2005;46:669-680
Reduce MRPs and Improve
Patient Outcomes and QOL
• Pharmacists uniquely
trained to detect and
manage MPRs
• All U.S. trained
pharmacists
graduate with 6+
years of training and
a Pharm.D. degree
Question
Under Medicare, which of the following
health care professionals is not considered
to be “part of the team” in the care of endstage renal disease patients?
a.
b.
c.
d.
e.
Nephrologist
Social Worker
Dietician
Nurse
Pharmacist
Pharmacist as a CKD Team Member
• Pharmacists are not officially listed as an
essential team member under the
Medicare ESRD Conditions of Coverage
• About 65% of Canadian nephrology
practices have access to a pharmacist and
multidisciplinary care is encouraged
• In U.S., CKD care is more fragmented
Mendelssohn DC et al. Am J Kidney Dis 2006;47:277-284.
Can Collaborative Team Care in
CKD Patients Make a
Difference?
Collaborative Multidisciplinary
Clinic (MDC) Care
• Canadian CKD clinic models have been
well-described in literature
• The Team: physician, nurse educator,
pharmacist, social worker, nutritionist
• Standardized philosophy
– Regular clinic visits with prespecified
education topics and management protocols
– Frequency of visits, lab tests based on GFR
Levin A, et al. Am J Kidney Dis 1997;29:533-540.
Curtis BM, et al. Nephrol Dial Transplant 2005;20:147-154.
Short-term Outcomes Better with
Collaborative MDC care
• Higher
– GFR
– Hb (10.2 ± 1.8 vs 9.0 ± 1.4)
– Albumin
– Calcium
• Similar
– Phosphorus
Curtis BM, et al. Nephrol Dial Transplant 2005;20:147-154.
Long-term Outcomes Better with
Collaborative MDC
Curtis BM, et al. Nephrol Dial Transplant 2005;20:147-154.
Why Is Collaborative Care
Beneficial?
• Nephrologist workforce shortages restrict care
delivery to growing number of CKD patients
• Need for dietary counseling, improved
medication management, medication adherence
in CKD patients
• Many of these tasks can be more efficiently and
effectively implemented by nurses, dieticians,
social workers and pharmacists
• Each team member brings strengths that
enhance patient care and outcomes
• Allows for provision of complex care
Avoiding Medication-Related
Disasters…
During a Disaster
Lessons from Katrina
• Unlabeled medications
confiscated at Superdome
• Refill policies of Medicaid,
commerical insurers,
Medicare Part D do not
allow extra refills to allow for
emergency supply
• Poor patient recall on
medication list and doses
Kleinpeter MA et al. Am J Med Sci 2006;332:259-263.
First Step
Patients need to carry a current
medicine list on their person
“My Medicine List”
http://www.mnpatientsafety.org/
http://www.mnpatientsafety.org/
My Medication List
• Download from:
http://www.mnpatientsafety.org/
• Order a vinyl sleeve to store and protect
the folded My Medicine List in a wallet or
purse
– Sleeves are 75 cents each
– To order contact Sarah Bohnet at (651) 6411121 or e-mail sbohnet@mnhospitals.org.
Medicare Part D
and
Implications for ESRD Patients
Medicare pays for treatment of endstage renal disease (ESRD)
• Most patients who develop ESRD are
eligible for Medicare benefits
– Dialysis
– Kidney transplantation
• Medicare coverage generally starts the
fourth month after ESRD is determined
– Exception: Patients who receive training for
home dialysis are eligible for Medicare benefits
at the start of ESRD
Medicare pays for treatment of endstage renal disease (ESRD)
• If ESRD patient is covered by an employer
group health plan (EGHP)
– EGHP will be primary payer for total of 33
months from start of ESRD
– Medicare coverage will start in the fourth month
as secondary payer
– Coordination period lasts for 30 months
– Then, Medicare becomes the primary payer,
EGHP becomes secondary payer
Kidney Transplants and Medicare
• Medicare coverage can start the month
patient is admitted to a Medicareapproved hospital for a kidney transplant
• Medicare coverage lasts for 36 months
after a successful transplant; but after 36
months…
– In general, no more Medicare benefits
– EGHP, other health plans, Medicaid or other
assistance programs need to cover costs
Medicare Prescription Drug
Coverage
• Began January 1, 2006
• Available for all people with Medicare
– Part A, Part B, or both
• ~86% (279,350) dialysis and 58%
(74,315) transplant patients receive
Medicare benefits
• >353,000 ESRD (dialysis + transplant)
patients were eligible for Part D coverage
in 2006
Prescription Coverage Comparison:
With ESRD versus Without ESRD
*table excludes patients dually eligible for Medicare and Medicaid
Patel D. J Am Soc Nephrol 17: 2546–2553,
2006.
ESRD Patients and Part D
• Most dialysis patients can not join a Medicare
Advantage Part D plan (MAPD), only a standalone Prescription Drug Plan (PDP)
• “Successful” kidney transplant patients can
join MAPD or PDP
• It is not clear just how many dialysis or kidney
transplant patients have signed up for Part D
• It is clear that there have been significant
issues for those that have signed up
How Medicare Part D Standard
Plan Works in 2007
• After patient pay $265 yearly deductible, they
pay
– 25% of the yearly costs for covered drugs from
$265 to $2,400. Part D pays 75%.
– 100% of costs for covered drugs from $2401 to
$5,451.25. i.e. they pay up to $3,850 in out-ofpocket costs (Doughnut Hole or gap)
– 5% of the costs for covered drugs (or a copayment of $2 or $5), whichever is more, for the
remainder of the calendar year (Catastrophic
Coverage)
Medicare Part D Covered Drugs
Must cover “all or substantially all”
•
•
•
•
•
•
Cancer medicines
HIV/AIDS drugs
Anti-depressants
Anti-psychotics
Anti-convulsants
Immunosuppressants (unless covered by Part B)
Note: May not cover every brand name
or all doses
Standard Part D Excluded Drugs
•
•
•
•
•
•
•
•
Anorexia, weight loss, weight gain
Fertility drugs
Cosmetic purposes, like hair growth
Cold and cough medicines
Non-prescription or over-the-counter (OTC)
Barbiturates (e.g. Seconal®, Nembutal®)
Benzodiazepines (e.g. Restoril®, Ativan®)
Vitamins and minerals
– Except prenatal vitamins, fluoride preparations and,
– Oral active Vit D: Zemplar, Hectorol, Rocaltrol are
covered
Note: “Enhanced” plans may cover
excluded drugs
Dual Eligible ESRD Patients 19992003 (dialysis and transplant)
Number of Patients
Dual Eligible Patients (1999-2003)
125000
120000
115000
110000
105000
100000
1999
2000
2001
2002
Year
USRDS ASN Presentation 2005
2003
Issues with Dual Eligible ESRD
Patients
• Automatically enrolled in Medicare Part D
Plans
• Some kidney-specific medications that were
covered by state Medicaid programs in the
past, were not covered by various Part D plans
• Some patients have unintentionally enrolled in
plans with premiums
• Co-payment amounts often more than what
these patients paid through state Medicaid
programs
Question
Assuming a dialysis patient is covered by
Medicare Part A or B, then Part D will
primarily pay for erythropoietin-stimulating
agents (ESAs).
a. True
b. False
b. False, is correct answer
Part B versus Part D
Dialysis Issues
• Part B covers separately reimbursable
medications given during or at dialysis
session
– Erythropoietin stimulating agents (ESAs)
– IV active vitamin D agents (calcitriol,
paricalcitol, doxercalciferol)
– IV iron products (iron sucrose, ferric gluconate,
iron dextran)
– IV antibiotics
Part B versus Part D
Dialysis Issues (continued)
• Part D will cover most oral medications
• Part D will not cover
– Kidney-related vitamins (Nephrocap,
Nephrovite, etc…)
– Benzodiazepines (anxiety, restless leg
syndrome)
Part B versus Part D
Kidney Transplant Issues
• If patient has a “Medicare-covered transplant” (MCT)
– Immunosuppressants are covered under Part B for at least
36 months
– After 36 months Part B will continue to pay if patient is
eligible for continued Medicare coverage (age or disability)
• If patient did not have a “MCT”, but becomes eligible
for Medicare, then immunosuppressants covered
under Part D
• Part D formularies are required to have
“Substantially all” immunosuppressants
Medicare Prescription Drug Plan Finder:
www.Medicare.gov
WB a 65 year-old Transplant Patient
Medicare Prescription Drug Plan Finder:
www.Medicare.gov
Medicare Prescription Drug Plan Finder:
www.Medicare.gov
Medicare Prescription Drug Plan Finder:
www.Medicare.gov
From 2006 to 2007, “Tier elevation” occurred for immunosuppressants (e.g. Cellcept)
Medicare Prescription Drug Plan Finder:
www.Medicare.gov
Medicare Prescription Drug Plan
Finder: www.Medicare.gov
1 This
drug may be subject to prior authorization, step therapy or quantity limits.
View plan details or contact the plan for more information.
Consequences of “Tier Elevation”
• Patients “stretch out” their doses
– Possible consequence: Transplant rejection
• Wasted nephrologist, social worker time
dealing with barriers
– Prior authorization
– Step-therapy
– Quantity limits
• Patient assistant programs during “gap”
– Not much help available for those that have
some income or assets
More Dialysis-Specific Issues
• Many commonly used dialysis-related
drugs are $$
• How many Part D medications are
dialysis patients taking?
• What % of dialysis patients will reach
Part D “doughnut hole”
• What % of patients will reach
“catastrophic coverage”
Number of Part D Covered
Medications
Percent of Patients
50
40
30
All
<65 years
> = 65 years
20
10
0
0
1-4
5-9
10-14
15+
Number of Medications
•Includes diabetes supplies for administration of insulin
•Does not include Medicare Part B covered drugs
2005 American Society of Nephrology Meeting
Medstat 2003 data, USRDS.org
Part D Medication Cost in EGHP
Dialysis Patients All Ages
Percent of Patients
50
40
30
20
10
0
$0-2250
$2250-5100
>$5100
Annual Medication Cost
*Includes diabetes supplies for administering insulin
*Does not include Medicare Part B covered drugs
Medstat 2003 data, USRDS.org
Drug Spending Much Higher
if ESRD
Patel D. J Am Soc Nephrol 17: 2546–2553, 2006.
ESRD patients reach “gap”
more quickly
Case Study: Person on Dialysis
• Nephrocaps® 1 every day (NC)
• Renagel® 800mg 2 tabs with
meals and snacks
• Sensipar® 30mg 1 every day
• Cardiazem CD® 240 mg 1
every day (G)
• Prinivil® 10 mg 1 every day (G)
• Zocor® 80 mg 1 every day
• Glucotrol® 10 mg 1 two times a
day (G)
• Aspirin EC 325mg 1 every day
(G, NC)
• Darvocet-N 100® 1 every 8
hours as needed for pain for 3
days only (G)
• Ativan® 0.5mg 1 every 8 hours
as needed for anxiety (G, NC)
• Ambien® 5mg 1 every bedtime
• Epogen® 3,000 IU every
dialysis (Part B, NC)
• Venofer® 100mg IV every other
week at dialysis (Part B, NC)
• Zemplar® 5mcg IV every
dialysis (Part B, NC)
G = Available in generic
NC = Not covered by Part D
Part B = Covered by Medicare Part B
Selecting the right doses, quantity and
number of doses per time period
Lowest cost plan
nearly $5000 per
year, not including
cost of ESAs,
vitamin D or IV iron
Key Points
• Medication-related problems are rampant
in ESRD patients
• Collaborative CKD care may improve
medication related outcomes
• Simple medication card may prevent
medication-related disasters
• Medicare Part D opens new possibilities
for MRPs