A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

BACKGROUND: In response to a national call for re-evaluation of the use of race in clinical algorithms, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) established a Task Force to reassess inclusion of race in the estimation of glomerular filtration rate (GFR) in the United States and its implications for diagnosis and management of patients with, or at risk for, kidney diseases. PROCESS & DELIBERATIONS: The Task Force organized its activities over 10 months in phases to (1) clarify the problem and evidence regarding GFR estimating equations in the United States (described previously in an interim report), and, in this final report, (2) evaluate approaches to address use of race in GFR estimation, and (3) provide recommendations. We identified 26 approaches for the estimation of GFR that did or did not consider race and narrowed our focus, by consensus, to 5 of those approaches. We holistically evaluated each approach considering 6 attributes: assay availability and standardization; implementation; population diversity in equation development; performance compared with measured GFR; consequences to clinical care, population tracking, and research; and patient centeredness. To arrive at a unifying approach to estimate GFR, we integrated information and evidence from many sources in assessing strengths and weaknesses in attributes for each approach, recognizing the number of Black and non-Black adults affected. RECOMMENDATIONS: (1) For US adults (>85% of whom have normal kidney function), we recommend immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the United States because it does not include race in the calculation and reporting, included diversity in its development, is immediately available to all laboratories in the United States, and has acceptable performance characteristics and potential consequences that do not disproportionately affect any one group of individuals. (2) We recommend national efforts to facilitate increased, routine, and timely use of cystatin C, especially to confirm estimated GFR in adults who are at risk for or have chronic kidney disease, because combining filtration markers (creatinine and cystatin C) is more accurate and would support better clinical decisions than either marker alone. If ongoing evidence supports acceptable performance, the CKD-EPI eGFR-cystatin C (eGFRcys) and eGFR creatinine-cystatin C (eGFRcr-cys_R) refit without the race variables should be adopted to provide another first-line test, in addition to confirmatory testing. (3) Research on GFR estimation with new endogenous filtration markers and on interventions to eliminate race and ethnic disparities should be encouraged and funded. An investment in science is needed for newer approaches that generate accurate, unbiased, and precise GFR measurement and estimation without the inclusion of race, and that promote health equity and do not generate disparate care. IMPLEMENTATION: This unified approach, without specification of race, should be adopted across the United States. High-priority and multistakeholder efforts should implement this solution.

Reassessing the Inclusion of Race in Diagnosing Kidney Diseases: An Interim Report from the NKF-ASN Task Force.

For almost two decades, equations that use serum creatinine, age, sex, and race to eGFR have included "race" as Black or non-Black. Given considerable evidence of disparities in health and healthcare delivery in African American communities, some regard keeping a race term in GFR equations as a practice that differentially influences access to care and kidney transplantation. Others assert that race captures important non GFR determinants of serum creatinine and its removal from the calculation may perpetuate other disparities. The National Kidney Foundation (NKF) and American Society of Nephrology (ASN) established a task force in 2020 to reassess the inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and subsequent management of patients with, or at risk for, kidney diseases. This interim report details the process, initial assessment of evidence, and values defined regarding the use of race to estimate GFR. We organized activities in phases: (1) clarify the problem and examine evidence, (2) evaluate different approaches to address use of race in GFR estimation, and (3) make recommendations. In phase one, we constructed statements about the evidence and defined values regarding equity and disparities; race and racism; GFR measurement, estimation, and equation performance; laboratory standardization; and patient perspectives. We also identified several approaches to estimate GFR and a set of attributes to evaluate these approaches. Building on evidence and values, the attributes of alternative approaches to estimate GFR will be evaluated in the next phases and recommendations will be made.

A Unifying Approach for GFR Estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease.

BACKGROUND: In response to a national call for re-evaluation of the use of race in clinical algorithms, the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN) established a Task Force to reassess inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and management of patients with, or at risk for, kidney diseases. PROCESS DELIBERATIONS: The Task Force organized its activities over 10 months in phases to ( 1 ) clarify the problem and evidence regarding eGFR equations in the United States (described previously in an interim report), and, in this final report, ( 2 ) evaluate approaches to address use of race in GFR estimation, and ( 3 ) provide recommendations. We identified 26 approaches for the estimation of GFR that did or did not consider race and narrowed our focus, by consensus, to five of those approaches. We holistically evaluated each approach considering six attributes: assay availability and standardization; implementation; population diversity in equation development; performance compared with measured GFR; consequences to clinical care, population tracking, and research; and patient centeredness. To arrive at a unifying approach to estimate GFR, we integrated information and evidence from many sources in assessing strengths and weaknesses in attributes for each approach, recognizing the number of Black and non-Black adults affected. RECOMMENDATIONS: ( 1 ) For US adults (>85% of whom have normal kidney function), we recommend immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the United States because it does not include race in the calculation and reporting, included diversity in its development, is immediately available to all laboratories in the United States, and has acceptable performance characteristics and potential consequences that do not disproportionately affect any one group of individuals. ( 2 ) We recommend national efforts to facilitate increased, routine, and timely use of cystatin C, especially to confirm eGFR in adults who are at risk for or have CKD, because combining filtration markers (creatinine and cystatin C) is more accurate and would support better clinical decisions than either marker alone. If ongoing evidence supports acceptable performance, the CKD-EPI eGFR-cystatin C (eGFRcys) and eGFR creatinine-cystatin C (eGFRcr-cys_R) refit without the race variables should be adopted to provide another first-line test, in addition to confirmatory testing. ( 3 ) Research on GFR estimation with new endogenous filtration markers and on interventions to eliminate race and ethnic disparities should be encouraged and funded. An investment in science is needed for newer approaches that generate accurate, unbiased, and precise GFR measurement and estimation without the inclusion of race, and that promote health equity and do not generate disparate care. IMPLEMENTATION: This unified approach, without specification of race, should be adopted across the United States. High-priority and multistakeholder efforts should implement this solution.

Reassessing the Inclusion of Race in Diagnosing Kidney Diseases: An Interim Report From the NKF-ASN Task Force.

For almost 2 decades, equations that use serum creatinine, age, sex, and race to estimate glomerular filtration rate (GFR) have included "race" as Black or non-Black. Given considerable evidence of disparities in health and health care delivery in African American communities, some regard keeping a race term in GFR equations as a practice that differentially influences access to care and kidney transplantation. Others assert that race captures important non-GFR determinants of serum creatinine and its removal from the calculation may perpetuate other disparities. The National Kidney Foundation (NKF) and American Society of Nephrology (ASN) established a task force in 2020 to reassess the inclusion of race in the estimation of GFR in the United States and its implications for diagnosis and subsequent management of patients with, or at risk for, kidney diseases. This interim report details the process, initial assessment of evidence, and values defined regarding the use of race to estimate GFR. We organized activities in phases: (1) clarify the problem and examine evidence, (2) evaluate different approaches to address use of race in GFR estimation, and (3) make recommendations. In phase 1, we constructed statements about the evidence and defined values regarding equity and disparities; race and racism; GFR measurement, estimation, and equation performance; laboratory standardization; and patient perspectives. We also identified several approaches to estimate GFR and a set of attributes to evaluate these approaches. Building on evidence and values, the attributes of alternative approaches to estimate GFR will be evaluated in the next phases and recommendations will be made.

Reducing potentially preventable health events among patients with asthma through multi-state, multi-center quality improvement program.

INTRODUCTION: Enhancing Care for Patients with Asthma is a multi-state, multi-center quality improvement program developed to augment guideline-based practice among health care providers through Plan-Do-Study-Act cycle. This study examined the association between the implementation of the guideline-based quality improvement program and subsequent changes in asthma-related emergency room visits and hospitalizations. METHODS: This retrospective, interrupted time-series study used administrative claims data from a private insurer that provided coverage to patients receiving care from participating health centers (15 centers in New Mexico, Oklahoma, Texas, and Illinois). The 12-month implementation period started in January 2013 for centers in Cohort 1 and October 2013 for centers in Cohort 2. The claims of 1,828 patients with asthma from January 2012 to May 2015 were analyzed. The data included 12-month pre-program implementation, 12-month program implementation, and 5-month post-program completion periods. RESULTS: The average number of asthma-related emergency room visits and hospitalizations decreased from 2.22 to 1.38 and 1.97 to 1.04 per 100 patients per month, respectively, in the 12-month pre-implementation period as compared to 12-month implementation period. The results of three-level generalized linear mixed models found that during the 12-month implementation period, patients had 37.7% and 47.1% lower rates of emergency room visits and hospitalizations, respectively, compared to the 12-month pre-implementation period (p < 0.001 in both comparisons). CONCLUSIONS: Enhancing Care for Patients with Asthma is an effective quality improvement program that was successfully executed in diverse geographical states and associated with reductions in potentially preventable health events. The findings support the widespread use of the program in other settings.

Risks associated with continuation of potentially inappropriate antihypertensive medications in older adults receiving hemodialysis.

BACKGROUND AND OBJECTIVES: After dialysis initiation, older adults may experience orthostatic or post-dialysis hypotension. Some orthostasis-causing antihypertensives (i.e., central alpha agonists and alpha blockers), are considered potentially inappropriate medications (PIMs) for older adults because they carry more risk than benefit. We sought to (1) describe antihypertensive PIM prescribing patterns before and after dialysis initiation and (2) ascertain the potential risk of adverse outcomes when these medications are continued after dialysis initiation. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Using United States Renal Data System data, we evaluated monthly prevalence of antihypertensive PIM claims in the period before and after dialysis initiation among older adults aged ≥66 years initiating in-center hemodialysis in the US between 2013 and 2014. Patients with an antihypertensive PIM prescription at hemodialysis initiation and who survived for 120 days were classified as 'continuers' or 'discontinuers' based on presence or absence of a refill within the 120 days after initiation. We compared rates of hospitalization and risk of death across these groups from day 121 through 24 months after dialysis initiation. RESULTS: Our study included 30,760 total patients, of whom 5981 (19%) patients had an antihypertensive PIM claim at dialysis initiation and survived ≥120 days. Most [65% (n = 3920)] were continuers. Those who continued (versus discontinued) were more likely to be black race (26% versus 21%), have dual Medicare-Medicaid coverage (31% versus 27%), have more medications on average (12 versus 9) and have no functional limitations (84% versus 80%). Continuers experienced fewer all-cause hospitalizations and deaths, but neither were statistically significant after adjustment (Hospitalization: RR 0.93, 95% CI 0.86, 1.00; Death: HR 0.89, 95% CI: 0.78-1.02). CONCLUSIONS: Nearly one in five older adults had an antihypertensive PIM at dialysis initiation. Among those who survived ≥120 days, continuation of an antihypertensive PIM was not associated with increased risk of all-cause hospitalization or mortality.

Enhancing guideline-based asthma care processes through a multi-state, multi-center quality improvement program.

OBJECTIVE: This study investigated the effectiveness of Enhancing Care for Patients with Asthma (ECPA)-a collaborative quality improvement program implemented in 65 community health centers that serve asthma patients in four states-on clinic-based asthma performance measures consistent with national guidelines. METHODS: This study utilized a pretest-posttest quasi-experimental design. Six clinic-based performance measures of each center were collected from a retrospective chart review at time points: before the ECPA implementation; at the end of the 12-month long ECPA program; and 6 months after program completion. The effectiveness of the ECPA was assessed using generalized linear mixed models with a Poisson distribution and log link by evaluating the change in each measure from baseline to program completion, from baseline to 6-month post-program completion and from program completion to 6-month post-program completion. RESULTS: The ECPA implementation was positively associated with improvement in all measures from baseline to program completion: documentation of asthma severity (rate ratio (RR) 1.314; 95% confidence interval (CI) 1.206, 1.432); Asthma Control Test (RR 3.625; 95% CI 3.185, 4.124); pulmonary function testing (RR 1.771; 95% CI 1.527, 2.054), asthma education (RR 2.246; 95% CI 2.018, 2.501), asthma action plan (RR 2.335; 95% CI 2.070, 2.634) and controller medication (RR 1.961; 95% CI 1.504,2.556). Improvement was sustained for all six measures at the 6-month post-program completion time point. CONCLUSION: This study demonstrated the favorable effect of the ECPA program on evidence-based asthma quality measures. This program could be considered a model worth replication on a broader scale.

Phosphate-Binder Use in US Dialysis Patients: Prevalence, Costs, Evidence, and Policies.

Medicare costs for phosphate binders for US dialysis patients and patients with chronic kidney disease enrolled in Medicare Part D exceeded $1.5 billion in 2015. Previous data have shown that Part D costs for mineral and bone disorder medications increased faster than costs for all Part D medications for dialysis patients. Despite extensive use of phosphate binders and escalating costs, conclusive evidence is lacking that they improve important clinical end points in dialysis patients or non-dialysis-dependent patients with chronic kidney disease. Using dialysis patient data from the US Renal Data System and laboratory information from the Centers for Medicare & Medicaid Services (CMS) CROWNWeb data, we update information on trends in phosphate-binder use, calcium and phosphorus values, and costs for Medicare-covered dialysis patients. We discuss these results in the context of evidence from clinical trials, meta-analyses, and observational studies evaluating phosphate-binder efficacy, safety, comparative effectiveness, and cost-effectiveness. Based on our analysis, we note a need for US Food and Drug Administration guidance regarding clinical evaluation of new phosphate binders, and we suggest that it would be in CMS' best interest to fund a clinical trial to assess whether lower versus higher phosphate concentrations improve hard clinical outcomes, and if so, whether particular phosphate binders are superior to placebo or other binders in improving these outcomes.

Drug Therapy Problem Severity Following Hospitalization and Association With 30-Day Clinical Outcomes.

BACKGROUND: Improved understanding of how drug therapy problems (DTPs) contribute to rehospitalization is needed. OBJECTIVE: The primary objectives were to assess the association of DTP likelihood of harm (LoH) severity score, as measured by comprehensive medication management (CMM) pharmacist after hospital discharge, with 30-day risk of hospital readmission, observation visit, or emergency department visit, and to determine whether resolution of DTPs reduces 30-day risk. Secondary objectives were to determine if any eventswere associated with DTPs and preventability of events. METHODS: Data were collected for 365 patients who received CMM following hospitalization and had at least 1 DTP identified. Retrospective chart reviews were completed for 80 patients with subsequent events to assess associationg with a DTP and its preventability. RESULTS: For each 1-point increment in maximum LoH score, there was 10% higher risk of the composite end point (hazard ratio [HR]=1.10; 95% CI:0.97-1.26; P=0.13). When DTPs were resolved by the CMM pharmacist, the association was attenuated, with a HR of 1.15 (95% CI:0.96-1.38; P=0.12) when the DTP was unresolved and HR of 1.09 (95% CI:0.96-1.25; P=0.52) when resolved; for hospital readmission alone, the corresponding HRs were 1.23 (95% CI:1.00-1.53; P=0.05) and 1.05 (95% CI:0.87-1.27; P=0.60). Of 80 subsequent events, 44 were associated with a medication; 22 were considered preventable. Conclusion and Relevance: The LoH severity score was associated with risk of 30-day events. The strength of association was attenuated when DTPs were resolved by the CMM pharmacist. However, because of statistical uncertainty, larger studies are needed to confirm these patterns.

Prevalence, treatment patterns, and healthcare resource utilization in Medicare and commercially insured non-dialysis-dependent chronic kidney disease patients with and without anemia in the United States.

BACKGROUND: Anemia is common in non-dialysis-dependent chronic kidney disease (NDD-CKD) patients, but detailed information on prevalence and treatment is lacking. METHODS: We evaluated anemia prevalence and treatment using two datasets: the Medicare 20% random sample (ages 66-85 years), and the Truven Health MarketScan database (ages 18-63 years). We selected stage 3-5 NDD-CKD patients with and without anemia from both databases during 2011-2013. We evaluated anemia prevalence and treatment (erythropoietin stimulating agents [ESAs], intravenous [IV] iron, red blood cell [RBC] transfusions) following anemia diagnosis during a 1-year baseline period, and healthcare utilization during a 1-year follow-up period. We used Poisson regression models to compare healthcare utilization in patients with and without anemia, adjusting for demographics, baseline comorbid conditions, inflammatory conditions, and CKD stage. RESULTS: We identified 218,079 older and 56,188 younger stage 3-5 NDD-CKD patients. Anemia prevalence increased with age in both datasets; was higher in women, black patients (Medicare only), and patients with comorbid conditions; and rose sharply with increasing CKD stage. Of 15,716 younger anemic patients, 11.7%, 10.8%, and 9.4% were treated with RBC transfusion, ESAs, and IV iron, respectively. Corresponding proportions of 109,251 older anemic patients were 22.2%, 12.7%, and 6.7%. Regardless of age, anemic patients were more likely than non-anemic patients to use healthcare resources, including hospitalizations and emergency department, hematologist, nephrologist, and outpatient visits. Anemic NDD-CKD patients were more likely to be treated with RBC transfusion than with ESAs or IV iron. CONCLUSION: More research is necessary to determine best approaches to anemia management in CKD.

Management of Polypharmacy in Dialysis Patients.

Most patients receiving dialysis have other common chronic conditions in addition to end-stage renal disease, including hypertension, diabetes, cardiovascular disease, and mineral and bone disorder, all of which require long-term medication management. Dialysis patients take an average of 10-12 prescribed and over-the-counter medications from an average of 4.7 prescribers, and an average of 19 pills per day. Thus, reducing polypharmacy is not adequate as a medication therapy goal for these patients. Instead, the dialysis community should focus on ensuring that all patients receive medications that are appropriate, effective, safe and convenient. Barriers to this include a fragmented health care system with inadequate communication between multiple prescribers and pharmacies, and frequent care transitions between ambulatory care sites (dialysis centre, ambulatory primary care practice, ambulatory specialty practice) and the hospital, skilled nursing facility or long-term care facility. Three distinct processes are necessary to prevent and solve the resultant medication-related problems (and reduce polypharmacy). These are medication reconciliation (creating an accurate medication list that reflects all medications the patients is taking and how they are being taken), medication review (evaluating the list for appropriateness, effectiveness, safety and convenience in conjunction with the patient's health status), and ongoing patient-centred medication therapy management (e.g., developing treatment plans centred on each patient's medication-related goals). A team approach including pharmacists as part of the dialysis team with the dialysis facility as the primary medication home is needed.

Parathyroid hormone change after cinacalcet initiation and one-year clinical outcome risk: a retrospective cohort study.

BACKGROUND: Cinacalcet reduces parathyroid hormone (PTH) levels in patients receiving hemodialysis, but no non-experimental studies have evaluated the association between changes in PTH levels following cinacalcet initiation and clinical outcomes. We assessed whether short-term change in PTH levels after first cinacalcet prescription could serve as a surrogate marker for improvements in longer-term clinical outcomes. METHODS: United States Renal Data System data were linked with data from a large dialysis organization. We created a point prevalent cohort of adult hemodialysis patients with Medicare as primary payer who initiated cinacalcet November 1, 2004-February 1, 2007, and were on cinacalcet for ≥ 40 days. We grouped patients into quartiles of PTH change after first cinacalcet prescription. We used Cox proportional hazard modeling to evaluate associations between short-term PTH change and time to first composite event (hospitalization for cardiovascular events or mortality) within 1 year. Overall models and models stratified by baseline PTH levels were adjusted for several patient-related factors. RESULTS: For 2485 of 3467 included patients (72%), PTH levels decreased after first cinacalcet prescription; for 982 (28%), levels increased or were unchanged. Several characteristics differed between PTH change groups, including age and mineral-and-bone-disorder laboratory values. In adjusted models, we did not identify an association between greater short-term PTH reduction and lower composite event rates within 1 year, overall or in models stratified by baseline PTH levels. CONCLUSIONS: Short-term change in PTH levels after first cinacalcet prescription does not appear to be a useful surrogate for longer-term improvements in cardiovascular or survival risk.

Predialysis systolic BP variability and outcomes in hemodialysis patients.

BP variability (BPV) is an important predictor of outcomes in the general population, but its association with clinical outcomes in hemodialysis patients is not clear. We identified 11,291 patients starting dialysis in 2003-2008 and followed them through December 31, 2008 (median=22 months). Predialysis systolic BPV was assessed over monthly intervals. Outcomes included factors associated with BPV, mortality (all-cause and cardiovascular), and first cardiovascular event (cardiovascular death or hospitalization). Patients' mean age was 62 years, 55% of patients were men, and 58% of patients were white. Modifiable factors associated with higher BPV included obesity, higher calcium-phosphate product levels, and lower hemoglobin concentration; factors associated with lower BPV included greater fluid removal, achievement of prescribed dry weight during dialysis, higher hemoglobin concentration, and antihypertensive regimens without ß-blockers or renin-angiotensin system blocking agents. In total, 3200 deaths occurred, including 1592 cardiovascular deaths. After adjustment for demographics, comorbidities, and clinical factors, higher predialysis BPV was associated with increased risk of all-cause mortality (hazard ratio [HR], 1.18; 95% confidence interval [95% CI] per 1 SD increase in BPV, 1.13 to 1.22), cardiovascular mortality (HR, 1.18; 95% CI, 1.12 to 1.24), and first cardiovascular event (HR, 1.11; 95% CI, 1.07 to 1.15). Results were similar when BPV was categorized in tertiles and patients were stratified by baseline systolic BP. In summary, predialysis systolic BPV is an important, potentially modifiable risk factor for death and cardiovascular outcomes in incident hemodialysis patients. Studies of BP management in dialysis patients should focus on both absolute BP and BPV.

Comparative effectiveness of calcium acetate and sevelamer on clinical outcomes in elderly hemodialysis patients enrolled in Medicare part D.

BACKGROUND: Phosphate binders are an important therapeutic option for managing hyperphosphatemia in hemodialysis patients. Whether sevelamer confers a survival advantage over calcium acetate is unclear. STUDY DESIGN: Observational cohort study using US Renal Data System (USRDS) data linked to Medicare Part D prescription drug data. SETTING & PARTICIPANTS: Medicare-enrolled elderly incident hemodialysis patients initiating calcium acetate or sevelamer therapy between July 1, 2006, and March 31, 2011. PREDICTOR: Prescription for sevelamer (hydrochloride or carbonate) or calcium acetate. OUTCOMES & MEASUREMENTS: All-cause and cardiovascular-related mortality, hospital admissions and hospital days assessed from Medicare Parts A, B, and D claims and other USRDS data. RESULTS: The sevelamer and calcium-acetate groups included 16,916 and 18,335 patients, respectively. After multivariable adjustment, all-cause (21.9 vs 21.8 deaths/100 patient-years; adjusted HR, 0.97; 95% CI, 0.94-1.03) and cardiovascular (8.7 vs 8.6 deaths/100 patient-years; HR, 0.99; 95% CI, 0.93-1.04) mortality did not differ significantly between the sevelamer and calcium-acetate (referent) groups. Mortality results in propensity score-matched cohorts showed significantly lower risk of death in sevelamer- than in calcium-acetate-treated patients (HR, 0.94; 95% CI, 0.91-0.98). Mortality results from additional analyses including only patients with low-income subsidy status were consistent with results from analyses including patients with and without low-income subsidy status. There were no significant differences between the sevelamer and calcium-acetate groups for all-cause and cardiovascular-related first hospitalization, multiple hospitalizations, and hospital days. LIMITATIONS: Results may not be applicable to younger patients; information about laboratory data and over-the-counter calcium-containing binders was lacking. CONCLUSIONS: Relative to treatment with calcium acetate, treatment with sevelamer was associated with similar or slightly lower risk of death and similar risk of hospitalization in elderly incident hemodialysis patients.

Utilization and costs of medications associated with CKD mineral and bone disorder in dialysis patients enrolled in Medicare Part D.

BACKGROUND: Information is limited regarding utilization patterns and costs for chronic kidney disease-mineral and bone disorder (CKD-MBD) medications in Medicare Part D-enrolled dialysis patients. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Annual cohorts of dialysis patients, 2007-2010. PREDICTORS: Cohort year, low-income subsidy status, and dialysis provider. OUTCOMES: Utilization and costs of prescription phosphate binders, oral and intravenous vitamin D analogues, and cinacalcet. MEASUREMENTS: Using logistic regression, we calculated adjusted odds of medication use for low-income subsidy versus non-low-income subsidy patients and for patients from various dialysis organizations, and we report per-member-per-month and average out-of-pocket costs. RESULTS: Phosphate binders (∼83%) and intravenous vitamin D (77.5%-79.3%) were the most commonly used CKD-MBD medications in 2007 through 2010. The adjusted odds of prescription phosphate-binder, intravenous vitamin D, and cinacalcet use were significantly higher for low-income subsidy than for non-low-income subsidy patients. Total Part D versus CKD-MBD Part D medication costs increased 22% versus 36% from 2007 to 2010. For Part D-enrolled dialysis patients, CKD-MBD medications represented ∼50% of overall net Part D costs in 2010. LIMITATIONS: Inability to describe utilization and costs of calcium carbonate, an over-the-counter agent not covered under Medicare Part D; inability to reliably identify prescriptions filled through a non-Part D reimbursement or payment mechanism; findings may not apply to dialysis patients without Medicare Part D benefits or with Medicare Advantage plans, or to pediatric dialysis patients; could identify only prescription drugs dispensed in the outpatient setting; inability to adjust for MBD laboratory values. CONCLUSIONS: Part D net costs for CKD-MBD medications increased at a faster rate than costs for all Part D medications in dialysis patients despite relatively stable use within medication classes. In a bundled environment, there may be incentives to shift to generic phosphate binders and reduce cinacalcet use.

Type 2 Diabetes and Chronic Kidney Disease: An Opportunity for Pharmacists to Improve Outcomes.

Chronic kidney disease (CKD) is an important contributor to end-stage kidney disease, cardiovascular disease, and death in people with type 2 diabetes (T2D), but current evidence suggests that diagnosis and treatment are often not optimized. This review examines gaps in care for patients with CKD and how pharmacist interventions can mitigate these gaps. We conducted a PubMed search for published articles reporting on real-world CKD management practice and compared the findings with current recommendations. We find that adherence to guidelines on screening for CKD in patients with T2D is poor with particularly low rates of testing for albuminuria. When CKD is diagnosed, the prescription of recommended heart-kidney protective therapies is underutilized, possibly due to issues around treatment complexity and safety concerns. Cost and access are barriers to the prescription of newer therapies and treatment is dependent on racial, ethnic, and socioeconomic factors. Rates of nephrologist referrals for difficult cases are low in part due to limitations of information and communication between specialties. We believe that pharmacists can play a vital role in improving outcomes for patients with CKD and T2D and support the cost-effective use of healthcare resources through the provision of comprehensive medication management as part of a multidisciplinary team. The Advancing Kidney Health through Optimal Medication Management initiative supports the involvement of pharmacists across healthcare systems to ensure that comprehensive medication management can be optimally implemented.

New models of chronic kidney disease care including pharmacists: improving medication reconciliation and medication management.

PURPOSE OF REVIEW: Patients with chronic kidney disease (CKD) are complex, have many medication-related problems (MRPs) and high rates of medication nonadherence, and are less adherent to some medications than patients with higher levels of kidney function. Nonadherence in CKD patients increases the odds of uncontrolled hypertension, which can increase the risk of CKD progression. This review discusses reasons for gaps in medication-related care for CKD patients, pharmacy services to reduce these gaps and successful models that incorporate pharmacist care. RECENT FINDINGS: Pharmacists are currently being trained to deliver patient-centred care, including identification and management of MRPs and helping patients overcome barriers to improve medication adherence. A growing body of evidence indicates that pharmacist services for CKD patients, including medication reconciliation and medication therapy management, positively affect clinical and cost outcomes, including lower rates of decline in glomerular filtration rates, reduced mortality and fewer hospitalizations and hospital days, but more robust research is needed. Team-based models including pharmacists exist today and are being studied in a wide range of innovative care and reimbursement models. SUMMARY: Opportunities are growing to include pharmacists as integral members of CKD and dialysis healthcare teams to reduce MRPs, increase medication adherence and improve patient outcomes.