Preventing and Resolving Medication-related Problems in Individuals on Dialysis Wendy L. St. Peter, Pharm.D., FCCP, BCPS Associate Professor, College of

Preventing and Resolving Medication-related

Problems in Individuals on Dialysis

Wendy L. St. Peter, Pharm.D., FCCP, BCPSAssociate Professor, College of Pharmacy,

University of MinnesotaInvestigator, 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

Medication-Related

Problems

Indication without drug therapy

Drug withoutindication

Improper drugselection

Subtherapeuticdosage

Overdosage

Drug interactionAdverse drug

reaction

Inappropriatelaboratorymonitoring

Failure toreceive drug

Manley HM, et al. Am JKidney Disease 2005;46:669-680

Frequency of MRPs


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%


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 end-stage renal disease patients?

a. Nephrologistb. Social Workerc. Dieticiand. Nursee. 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) 641-

1121 or e-mail [email protected].

mailto:[email protected]

Medicare Part D and

Implications for ESRD Patients

Medicare pays for treatment of end-stage 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 end-stage 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 Medicare-approved 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

Patel D. J Am Soc Nephrol 17: 2546–2553, 2006.

*table excludes patients dually eligible for Medicare and Medicaid

ESRD Patients and Part D• Most dialysis patients can not join a Medicare

Advantage Part D plan (MAPD), only a stand-alone 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

• 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-of-pocket costs (Doughnut Hole or gap)

– 5% of the costs for covered drugs (or a co-payment of $2 or $5), whichever is more, for the remainder of the calendar year (Catastrophic Coverage)

How Medicare Part D Standard Plan Works in 2007

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 1999-2003 (dialysis and transplant)

Dual Eligible Patients (1999-2003)

100000

105000

110000

115000

120000

125000

1999 2000 2001 2002 2003

Year

Nu

mb

er

of

Pa

tie

nts

USRDS ASN Presentation 2005

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 DDialysis 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 DDialysis 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 DKidney 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




From 2006 to 2007, “Tier elevation” occurred for immunosuppressants (e.g. Cellcept)



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

•Includes diabetes supplies for administration of insulin•Does not include Medicare Part B covered drugs

0

10

20

30

40

50P

erce

nt

of

Pat

ien

ts

0 1-4 5-9 - 15+

Number of Medications

All

<65 years

> = 65 years

10-14

2005 American Society of Nephrology MeetingMedstat 2003 data, USRDS.org

Part D Medication Cost in EGHP Dialysis Patients All Ages

0

10

20

30

40

50

Per

cen

t o

f P

atie

nts

$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 genericNC = Not covered by Part DPart 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

Documents

Preventing and Resolving Medication-related Problems in Individuals on Dialysis Wendy L. St. Peter, Pharm.D., FCCP, BCPS Associate Professor, College of