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Patients with chronic kidney disease (CKD) are at high risk for clinically significant medication therapy problems (MTPs) due primarily to the complex pharmacotherapy prescribed by numerous providers, and the significant changes in pharmacokinetic and pharmacodynamic properties of many medications due to their kidney disease. While MTPs are well recognized, pharmacists are not routinely involved in the health care teams that provide care for patients with CKD. The Advancing American Kidney Health initiative was announced in July 2019 and is poised to shift models of care in nephrology toward value‐based payment. This represents an opportunity for pharmacists to integrate into teams to improve quality of care and outcomes for patients with CKD. Pharmacists should engage in medication reconciliation, transitions of care, and medication‐focused kidney disease education programs within a comprehensive medication management (CMM) framework to optimize pharmacotherapy outcomes. To implement these services, pharmacists need to utilize certified pharmacy technicians, telehealth, interprofessional skills, and other tools in innovative ways. Current models of successful practice from Canada can serve as a template for United States‐based nephrology pharmacy practice. In this opinion paper, we characterize the current state of nephrology practice and identify significant opportunities for advancement. We propose metrics to evaluate pharmacy services and a framework for key stakeholder engagement which will be critical to advance the profession of pharmacy within nephrology. The Advancing American Kidney Health initiative offers a distinct opportunity to demonstrate the value of CMM provided by pharmacists in the nephrology arena to optimize patient care. [ABSTRACT FROM AUTHOR]

Intravenous iron formulations are a class of complex drugs that are commonly used to treat a wide variety of disease states associated with iron deficiency and anemia. Venofer® (iron-sucrose) is one of the most frequently used formulations, with more than 90% of dialysis patients in the United States receiving this formulation. Emerging data from global markets outside the United States, where many iron-sucrose similars or copies are available, have shown that these formulations may have safety and efficacy profiles that differ from the reference listed drug. This may be attributable to uncharacterized differences in physicochemical characteristics and/or differences in labile iron release. As bioequivalence evaluation guidance evolves, clinicians should be educated on these potential clinical issues before a switch to the generic formulation is made in the clinical setting. [ABSTRACT FROM AUTHOR]

Study Objective. To investigate the impact of a pharmaceutical care program managed by clinical pharmacists on drug use, drug costs, hospitalization rates, and drug-related problems (DRPs) in ambulatory patients undergoing hemodialysis. Design. Prospective, randomized, controlled, longitudinal, 2-year pilot study. Setting. Nonprofit university-affiliated dialysis clinic. Patients. One hundred four patients older than 18 years with end-stage renal disease (ESRD) who were undergoing a stable hemodialysis regimen for at least 3 months. Intervention. Patients were randomly assigned to receive either pharmaceutical care, consisting of one-on-one care, with in-depth drug therapy reviews conducted by a clinical pharmacist (57 patients), or standard of care, consisting of brief drug therapy reviews conducted by a nurse (47 patients). Measurements and Main Results. Baseline data on demographic and clinical characteristics were collected. Mean numbers of concomitant drugs, drug costs, hospitalization rates, and lengths of stay were compared between the groups. In the pharmaceutical care group, DRPs were identified and recorded. Baseline age, length of time receiving hemodialysis, and etiology of ESRD were not significantly different between the groups. Mean number of concomitant drugs at baseline was similar between the groups. At the end of the 2-year follow-up, pharmaceutical care was associated with a significant decrease of 14% fewer drugs compared with standard of care, as documented during each drug therapy review (p<0.05). There were significantly fewer all-cause hospitalizations among patients assigned to pharmaceutical care compared with those receiving standard of care (mean ± SD 1.8 ± 2.4 vs 3.1 ± 3 hospitalizations, p=0.02), and the cumulative time hospitalized was shorter in the pharmaceutical care group compared with the standard of care group (9.7 ± 14.7 vs 15.5 ± 16.3 days, p=0.06). During the study period, 530 DRPs were identified and resolved. Conclusion. Identification and resolution of DRPs through pharmaceutical care resulted in decreased drug use and costs for patients undergoing hemodialysis. Hospitalization rates were significantly lower in the pharmaceutical care group, with a trend toward shorter duration. Provision of pharmaceutical care is associated with tangible benefits on outcomes in ambulatory patients undergoing hemodialysis and should be considered in health care policy decisions. [ABSTRACT FROM AUTHOR]

End-stage renal disease and initiation of hemodialysis (HD) adversely affect health-related quality of life (HRQOL). There are currently no data evaluating the effect of pharmaceutical care (PC) on HRQOL in HD patients. HD patients were randomized to receive PC; one-on-one, in-depth medication reviews conducted by a clinical pharmacist or Standard of Care (SOC); and brief medication reviews conducted by dialysis nurses. The renal quality of life profile (RQLP) was administered at baseline and then at 1 and 2 years after study initiation. The RQLP is a 43-item questionnaire that has 5 dimensions: Eating/Drinking, Physical Activities, Leisure Time, Psychosocial Activities, and Impact of Treatment, where increasing scores reflect worsening of HRQOL. A total of 107 patients were enrolled (SOC: n=46; PC: n=61). Besides gender, there were no differences in the demographics or the baseline total RQLP scores. The mean±SD total RQLP scores at Year 1 were significantly worse in SOC compared with PC (88±31 vs. 71±34, respectively; P=0.03). Significant worsening of Eating and Drinking (5.9±3.3 vs. 4.4±3.1, respectively; P=0.04), Physical Activities (37±13.6 vs. 30±16.3, respectively; P=0.04), and Leisure Time scores (8.3±3.4 vs. 5.9±3.6, respectively; P=0.03) was also observed in the SOC group. After 2 years, only the SOC patients had worsening of Leisure Time (7.5±3.0 vs. 5.2±3.9, respectively; P=0.04). No other parameters were different between the groups after 2 years. These data indicate that patients who have clinical care provided by pharmacists do not have worsened HRQOL after 1 year and are able to maintain HRQOL for an additional year. [ABSTRACT FROM AUTHOR]

Study Objective. To compare non-transferrin-bound iron and markers of oxidative stress after single intravenous doses of iron dextran, sodium ferric gluconate, and iron sucrose. Design. Prospective, open-label, crossover study. Setting. University-affiliated general clinical research center. Patients. Twelve ambulatory patients undergoing hemodialysis. Intervention. Patients received 100 mg of intravenous iron dextran, sodium ferric gluconate, and iron sucrose in random sequence, with a 2-week washout period between treatments. Measurements and Main Results. Serum samples for transferrin saturation, non-transferrin-bound iron, and malondialdehyde (MDA; marker of lipid peroxidation) were obtained before (baseline) and 30, 60, 120, and 3(,0 minutes and 2 weeks after each iron infusion. A serum sample for heme-oxygenase-1 (HO-1) RNA was obtained at baseline and 360 minutes after infusion. Non-transferrin-bound iron values were significantly higher 30 minutes after administration of sodium ferric gluconate and iron sucrose compared with iron dextran (mean ± SEM 10.1 ± 2.2, 3.8 ± 0.8, and 0.23 ± 0.1 µM, respectively, p<0.001 for sodium ferric gluconate vs iron dextran, p=0.002 for iron sucrose vs iron dextran). A significant positive correlation was noted between transferrin saturation and the presence of non-transferrin-bound iron for sodium ferric gluconate and iron sucrose (r²=0.37 and 0.45, respectively, p<0.001) but not for iron dextran (r² = 0.09). After sodium ferric gluconate, significantly more samples showed increases in MDA levels from baseline compared with iron sucrose and iron dextran (p=0.006); these increased levels were associated with the presence of non-transferrin-bound iron, baseline transferrin saturation above 30%, baseline transferrin levels below 180 mg/dl, and ferritin levels above 500 ng/ml (p<0.05). However, only a transferrin level below 180 mg/dl was independently associated (odds ratio 4.8, 95% confidence interval 1.2-15.3). Conclusion. Iron sucrose and sodium ferric gluconate were associated with greater non-transferrin-bound iron appearance compared with iron dextran. However, only sodium ferric gluconate showed significant increases in lipid peroxidation. The relationship between non-transferrin-bound iron from intravenous iron and oxidative stress warrants further exploration. [ABSTRACT FROM AUTHOR]

Cardiac implantable electronic device (CIED) leads can cause central venous stenosis (CVS). In addition, these devices can get infected. Both are critically important considerations in patients with chronic kidney disease (CKD) for at least two reasons: (i) central veins serve as the final pathway should these patients need an arteriovenous access to provide dialysis therapy; and (ii) the presence of renal failure increases the risk of CIED infection. In this analysis, we investigated the prevalence as well as the degree of chronic kidney disease in patients harboring a CIED. Patients undergoing CIED removal were evaluated from 2001 to 2011. The patients were categorized into CKD stage I-V based on National Kidney Foundation-Dialysis Outcomes Quality Initiative guidelines. A total of 503 patients underwent CIED removal. Demographic characteristics revealed that 30% had hypertension, 44% were diabetics, 77% had coronary artery disease, and 84% suffered from congestive heart failure. Ninety percent (452/503) of the patients had CKD (stage I = I9 [4.2%], stage II = 189 [41.8%], stage III A = 96 [21.2%], stage III B = 59 [13.0%], stage IV = 45 [9.9%], and stage V = 44 [9.7%]). Overall, 148 (32.7%) patients (stage III B, stage IV, and stage V) of 452 had advanced renal failure. The results of this study reveal that one-third of CIED patients undergoing device removal have advanced chronic kidney disease. [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to an article about the correlation between the renal quality of life profile and short form-36 in a U.S. hemodialysis population.