A Necessary Component for Care of Patients Treated

Editorial Integrated Pharmacy Services: A Necessary Component for Care of Patients Treated by Long-term Dialysis Related Article, p. 557

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nder the Medicare Modernization Act, prescription drug plans and Medicare Advantage plans are required to have continuous quality improvement programs related to medications, such as medication therapy management (MTM), to optimize prescription drug use, improve outcomes, and reduce adverse drug interactions.1 The systematic provision of medication management services includes identifying and resolving medication-related problems (MRPs). Risk factors for MRPs include having 3 or more concurrent disease states, having a medication regimen change at least 4 times during the past 12 months, taking 5 or more medications or 12 or more doses per day, having a history of noncompliance, taking drugs that require therapeutic monitoring, and having kidney disease or diabetes as a chronic condition.2 In the US health care system, MRPs cause significant morbidity, mortality, and cost. MRPs are implicated in 16.1% of all hospital admissions to an internal medicine ward.3 Of these, 58.9% of admissions definitely or possibly could be avoided. More than 18% of deaths of patients admitted to internal medicine wards can be ascribed to drugs, with adverse drug events contributing to more than 100,000 deaths each year.4,5 MRPs are estimated to cost the health care system more than $177 billion.6 The impact of MRPs on dialysis patients is similar to that on the general population. A pooled analysis of 7 studies examining MRPs in hemodialysis patients found more than 1,500 MRPs in nearly 400 patients.7 Another report involving patients with chronic kidney disease stage 5 demonstrated that medications are implicated in nearly 50% of hospitalizations; MRPs are considered the sole reason for admission 18% of time and considered a contributor but not the sole cause for the admission 29% of time.8 Possidente et al9 found that nearly 50% of MRPs identified in dialysis patients admitted to the hospital were preexisting, while another 50% occurred during hospitalization (26.7%) or at discharge (25.5%). This suggests that ⬎70% of MRPs could be addressed by integrated pharmacy services (IPS) and MTM at the dialysis unit during routine care (for in-center pre-existing MRPs) and at transition back to the dialysis unit (for discharge MRPs), which potentially could prevent readmission. A thorough review of MRPs in chronic kidney disease prevalence, their associated effects, and strategies to address them is provided elsewhere.10 Am J Kidney Dis. 2013;62(3):445-447

In this issue of AJKD, Weinhandl et al11 present an analysis of clinical outcomes in hemodialysis patients at a large US dialysis organization (DaVita) who received IPS from the organization’s mailorder pharmacy (DaVita Rx). Patients voluntarily enrolled in the IPS, which provided dispensed prescribed medications from a central location and delivered them by mail to the dialysis patient’s home or dialysis clinic. The IPS also included medication refill management, prior authorization assistance, and limited MTM services. Mortality, hospitalization, and days of hospitalization were compared between IPS enrollees (n ⫽ 8,864) and a propensity score–matched control cohort from the US Renal Data System (n ⫽ 43,013) between January 2006 and December 2008. The investigators present the results of both intention-to-treat and as-treated analyses. The intention-to-treat analyses followed up patients from the date of the first prescription fill on or after enrolling in IPS or from the index date (control patients) to the earliest of death, kidney transplantation, cessation of hemodialysis therapy, loss of Medicare as primary payer status, or maximal follow-up period of 30 months or December 31, 2008. The as-treated analyses also included end of the enrollment episode (ie, patients no longer enrolled in IPS) or the beginning of a new enrollment episode (ie, control patients who enrolled in IPS during the study period) to the list of dates on which follow-up may end. Overall, IPS was associated with lower rates of mortality and hospitalization and fewer hospital days. The association of IPS was greater in the as-treated analyses compared with the intention-to-treat analyses. Patients receiving IPS had statistically significant and sustained lower rates of mortality (21%), hospital admissions (7%), and hospital days (14%) during a 24-month period. The intention-to-treat analyses also showed that patients receiving IPS had significantly lower overall mortality (8% reduction), yet the association dissipated by follow-up month 19. The intention-to-treat analyses showed that IPS had positive Address correspondence to Harold J. Manley, PharmD, Medication Management & Pharmacovigilance, Dialysis Clinic, Inc, 1633 Church St, Nashville, TN 37203. E-mail: harold.manley@ dciinc.org © 2013 by the National Kidney Foundation, Inc. 0272-6386/$36.00 http://dx.doi.org/10.1053/j.ajkd.2013.06.004 445

Manley and Barton-Pai

but nonsignificant associations with reduced hospitalization rates and days. The report by Weinhandl et al11 is important to the dialysis community because it is another study illustrating the benefits of IPS. Pai et al12 reported a 2-year randomized controlled trial in hemodialysis patients (n ⫽ 104) comparing in-depth bimonthly medication management services provided by a clinical pharmacist to standard of care (brief medication therapy reviews conducted by a nurse): patients who received clinical IPS had fewer hospitalizations (1.8 ⫾ 2.4 vs 3.1 ⫾ 3; P ⫽ 0.02) and a trend toward reduced lengths of stay (9.7 ⫾ 14.7 vs 15.5 ⫾ 16.3 days; P ⫽ 0.06).12 In 2009, Medicare expenditures for end-stage renal disease (ESRD) were $20.8 billion in total, with ⬎$11 billion due to hospitalizations.13 Total costs of care for dialysis-dependent patients are disproportionately higher than their age-matched general population counterparts and continue to increase.14 Of late, increased concerns over medication use, cost, and associated outcomes in ESRD have entered public debate. Patients with ESRD treated by dialysis have highly complex medication regimens and disproportionately higher total costs of care compared to the general Medicare population.14 In 2010, total per-beneficiaryper-year costs for Medicare Parts D and B drugs and related supplies in hemodialysis patients were $15,311 and $7,728 for patients with and without the lowincome subsidy, respectively.14 Clinical outcomes remain poor and the lack of optimization of medication therapy may be one factor. Medication management services have been shown to improve clinical outcomes meaningfully in patients with diabetes and hypertension.15,16 These models are rooted in the contribution of a dedicated and adequately trained clinician, such as a pharmacist. In these practice models, the interaction with the pharmacist appears to be effective when it takes place in the clinic, as well as in the community (eg, retail) pharmacy setting.17 Despite the benefits of medication management, prescription drug plans define their own criteria for MTM enrollment and delivery, which results in highly variable MTM service provision. Only 12% of eligible patients currently receive MTM in the current model.18 Dialysis patients may have limited use of MTM services as a result of factors such as limited time and ability to access services due to their time commitment for dialysis treatment, lack of priority within the Part D prescription drug plans to include ESRD as an eligibility criterion, and the assumption that medication management services are provided at the dialysis clinic. Thus, the need to provide consistent comprehensive medication management services to dialysis-dependent patients is imperative. 446

The dialysis facility is a logical coordination center for medication management services like MTM and likely is the first health care facility a patient will present to after a transition in care. This suggests that complete computer-based algorithmic designs to address MRPs are not likely to be successful. Some form of person-to-person contact (eg, telehealth or telephone) is needed to provide consistent highquality medication management services. On April 15, 2008, the ESRD Conditions Final Rule updated Medicare’s health and safety conditions for covering ESRD and modernized the Centers for Medicare & Medicaid Services (CMS) standards for delivering safe high-quality care to patients on dialysis therapy.19 Language to include pharmacists in the conditions for coverage for consideration for ESRD by the health care community was in the draft document. Despite evidence of the need and the clinical outcome improvements in patients with ESRD who received care from a pharmacist, this language was not included in the Final Rule. Nonetheless, IPS, both dispensing and clinical services, will expand within ESRD care. Dispensingrelated IPS is already occurring to some, albeit minimal, degree in all dialysis patients as a result of changes to the ESRD prospective payment system to include ESRD-related medications in the composite rate.20 Providing ESRD-related medications not administered in the clinic requires dispensing the medication to patients so they can take it home. To meet this need, dialysis organizations either opened or contracted with a dispensing pharmacy to provide medications. Presently, only injectable ESRD drugs and their oral equivalents are included in the bundled composite rate. Expanding dispensing-related IPS will occur when the oral dialysis-related medications that do not have injectable equivalents (oral phosphate binders, cinacalcet, etc) are included in the bundled payment, which currently is scheduled to begin in 2016. The expansion of nondispensing clinical IPS (ie, MTM) is expected with the development of ESRD Seamless Care Organizations through the CMS Comprehensive ESRD Care Initiative. As part of this initiative, the CMS will test the clinical and financial impact of comprehensive medical management and care coordination. The CMS expects applicant organizations to provide MTM services to ESRD beneficiaries. In summary, dialysis patients have complex medication regimens and are at the highest risk of MRPs, which contribute to adverse patient outcomes and high cost. Expanding dispensing and clinical IPS in this population will result in improved patient outcomes and reduce the total cost of care. Am J Kidney Dis. 2013;62(3):445-447

Editorial

Harold J. Manley, PharmD Dialysis Clinic, Incorporated Nashville, Tennessee Amy Barton-Pai, PharmD Albany College of Pharmacy and Health Sciences Albany, New York

ACKNOWLEDGEMENTS Support: None. Financial Disclosure: Dr Manley is employed by Dialysis Clinic, Inc. Dr Barton-Pai declares that she has no relevant financial interests.

REFERENCES 1. Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Public Law 108-173, HR1 (December 8, 2003). http://www.gpo.gov/fdsys/pkg/PLAW-108publ173/pdf/PLAW108publ173.pdf. Accessed April 4, 2013. 2. Manley HJ, McClaran ML, Overbay DK, et al. Factors associated with medication-related problems in ambulatory hemodialysis patients. Am J Kidney Dis. 2003;41(2):386-393. 3. Nelson KM, Talbert RL. Drug-related hospital admissions. Pharmacotherapy. 1996;16:701-707. 4. Ebbesen J, Buajordet I, Erikssen J, et al. Drug-related deaths in a department of internal medicine. Arch Intern Med. 2001;161: 2317-2323. 5. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200-1205. 6. Ernst FR, Grizzle AJ. Drug-related morbidity and mortality: updating the cost-of-illness model. J Am Pharm Assoc. 2001;41: 192-199. 7. Manley HJ, Cannella CL, Bailie GR, et al. Medication related problems in ambulatory hemodialysis patients: a pooled analysis of published reports. Am J Kidney Dis. 2005;46:669-680. 8. Harchowal JT. Drug-related problems on a renal unit. Br J Renal Med. 1997;2:22-24. 9. Possidente CJ, Bailie GR, Hood VL. Disruptions in drug therapy in long-term dialysis patients who require hospitalization. Am J Health Syst Pharm. 1999;56:1961-1964.

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10. Cardone KE, Bacchus S, Assimon MM, Pai AB, Manley HJ. Medication-related problems in CKD. Adv Chronic Kidney Dis. 2010;17(5):404-412. 11. Weinhandl ED, Arneson TJ, St. Peter WL. Clinical outcomes associated with receipt of integrated pharmacy services: A quality improvement report. Am J Kidney Dis. 2013;62(3):557567. 12. Pai AB, Depczynski JC, Martinez I, Boyd A, Khan N, Manley HJ. Reduced drug use hospitalization rates in patients undergoing hemodialysis who received pharmaceutical care—a 2 year randomized, controlled study. Pharmacotherapy. 2009;29(12): 1433-1440. 13. Collins AJ, Foley RN, Chavers B. United States Renal Data System 2011 annual data report: atlas of chronic kidney disease and end-stage renal disease in the United States. Am J Kidney Dis. 2012;59(1)(suppl 1):e1-e420. 14. Collins AJ, Foley RN, Herzog C, et al. US Renal Data System 2012 annual data report. Am J Kidney Dis. 2013; 61(1)(suppl 1):e1-e480. 15. Carter BL, Rogers M, Daly J, Zheng S, James PA. The potency of team-based interventions for hypertension. Arch Intern Med. 2009;169(19):1748-1755. 16. Cranor CW, Bunting BA, Christensen DB. The Asheville Project: long-term clinical and economic outcomes of a community pharmacy diabetes care program. J Am Pharm Assoc. 2003; 43(2):173-184. 17. Cutrona SL, Choudhry NK, Fischer MA, et al. Modes of delivery for interventions to improve cardiovascular medication adherence. Am J Manag Care. 2010;16(12):929-942. 18. Giberson S, Yoder S, Lee MP. Improving Patient and Health System Outcomes Through Advanced Pharmacy Practice. A Report to the U.S. Surgeon General. Office of the Chief Pharmacist. Rockville, MD, US Public Health Service; 2011. 19. Medicare and Medicaid Programs. Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule. http://www.cms.gov/Regulations-and-Guidance/Legislation/ CFCsAndCoPs/downloads//esrdfinalrule0415.pdf. Accessed April 4, 2013. 20. Centers for Medicare & Medicaid Services: End stage renal disease (ESRD) payment. http://www.cms.gov/ESRDPayment/. Accessed April 4, 2013.

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