1. 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

2. 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

3. 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

4. Medication- Related Problems Indication without drug therapy Drug without indication Improper drug selection Subtherapeutic dosage Overdosage Drug interaction Adverse drug reaction Inappropriate laboratory monitoring Failure to receive drug Manley HM, et al. Am J Kidney Disease 2005; 46:669-680

5. Frequency of MRPs Manley HM, et al. Am J Kidney Dis 2005;46:669-680

6. 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

7. 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

8. 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.Nephrologist b.Social Worker c.Dietician d.Nurse e.Pharmacist

9. 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.

10. Can Collaborative Team Care in CKD Patients Make a Difference?

11. 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.

12. 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.

13. Long-term Outcomes Better with Collaborative MDC Curtis BM, et al. Nephrol Dial Transplant 2005;20:147-154.

14. Similar Findings from another Canadian MDC Goldstein M, et al. Am J Kidney Dis 2004; 44:706-714.

15. Mortality reduced with MDC Goldstein M, et al. Am J Kidney Dis 2004; 44:706-714.

16. 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

17. Avoiding Medication-Related Disasters… During a Disaster

18. 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.

19. First Step Patients need to carry a current medicine list on their person

20. “My Medicine List” http://www.mnpatientsafety.org/

22. 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 sbohnet@mnhospitals.org.sbohnet@mnhospitals.org

23. Medicare Part D and Implications for ESRD Patients

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. 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

33. Dual Eligible ESRD Patients 1999- 2003 (dialysis and transplant) USRDS ASN Presentation 2005

34. 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

35. 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

36. b. False, is correct answer

37. 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

38. 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)

39. 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

40. Medicare Prescription Drug Plan Finder: www.Medicare.gov WB a 65 year-old Transplant Patient

41. Medicare Prescription Drug Plan Finder: www.Medicare.gov

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

44. Medicare Prescription Drug Plan Finder: www.Medicare.gov

45. 1 This drug may be subject to prior authorization, step therapy or quantity limits. View plan details or contact the plan for more information.

46. 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

47. 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”

48. Number of Part D Covered Medications Includes diabetes supplies for administration of insulin Does not include Medicare Part B covered drugs 10-14 2005 American Society of Nephrology Meeting Medstat 2003 data, USRDS.org

49. Part D Medication Cost in EGHP Dialysis Patients All Ages *Includes diabetes supplies for administering insulin *Does not include Medicare Part B covered drugs Medstat 2003 data, USRDS.org

50. Drug Spending Much Higher if ESRD Patel D. J Am Soc Nephrol 17: 2546–2553, 2006.

51. ESRD patients reach “gap” more quickly

52. 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

53. Selecting the right doses, quantity and number of doses per time period

54. Lowest cost plan nearly $5000 per year, not including cost of ESAs, vitamin D or IV iron

55. 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