SummaryPatients with ESRD undergoing dialysis have highly complex medication regimens and disproportionately higher total cost of care compared with the general Medicare population. As shown by several studies, dialysis-dependent patients are at especially high risk for medication-related problems. Providing medication reconciliation and therapy management services is critically important to avoid costs associated with medication-related problems, such as adverse drug events and hospitalizations in the ESRD population. The Medicare Modernization Act of 2003 included an unfunded mandate stipulating that medication therapy management be offered to high-risk patients enrolled in Medicare Part D. Medication management services are distinct from the dispensing of medications and involve a complete medication review for all disease states. The dialysis facility is a logical coordination center for medication management services, like medication therapy management, and it is likely the first health care facility that a patient will present to after a care transition. A dedicated and adequately trained clinician, such as a pharmacist, is needed to provide consistent, high-quality medication management services. Medication reconciliation and medication management services that could consistently and systematically identify and resolve medication-related problems would be likely to improve ESRD patient outcomes and reduce total cost of care. Herein, this work provides a review of available evidence and recommendations for optimal delivery of medication management services to ESRD patients in a dialysis facility-centered model.
Medication regimen simplification may improve adherence in end-stage kidney disease. The effect of nocturnal home hemodialysis (NHHD) on medication burden is unknown. A retrospective pilot study of NHHD patients was conducted. Medication information was collected at baseline, NHHD start, and at 3, 6, 12, 18, and 24 months. SF-36 scores were collected at baseline, 6, 12, and 24 months. The number of medications, pill burden, and number of administrations per day were determined. Medication Regimen Complexity Index was used at each time point as a comparator. Medications for anemia, mineral and bone disorders (MBD), cardiovascular (CV) disease, infection, and vitamins were analyzed for number of medications and pill burden. Thirty-five patients were included. Patients used 10.5 ± 4.4 medications at baseline and 11.8 ± 4.7 at the end of the study (P=NS). Regarding the number of medications, anemia medications, anti-infectives, and vitamins increased; MBD and CV medications decreased by the end of the study. Total pill burden did not change over 24 months, nor did anemia pill burden. Mineral bone disorder and CV pill burden decreased, and vitamins and anti-infective pill burden increased. Daily medication administration times decreased significantly from 5.0 ± 1.5 to 3.6 ± 1.5 by 24 months. Switching to NHHD was associated with a significant increase in Medication Regimen Complexity Index at 24 months (P<0.05). SF-36 scores increased significantly once patients began on NHHD. No measure of medication regimen complexity was correlated with the SF-36 score. Medication burden changes over time after starting NHHD. It is unknown what effect NHHD has on adherence or medication costs, and warrants further study in a prospective comparative investigation.
This study identified optimal daptomycin dosing for patients receiving thrice-weekly hemodialysis (HD). Twelve adult patients on HD received daptomycin at 6 mg/kg of body weight intravenously (i.v.) one time; plasma and dialysate samples were collected over 3 days. A 2-compartment model with separate HD and non-HD clearance terms was fit to the data. A series of 9,999-subject Monte Carlo simulations (MCS) was performed to identify HD dosing schemes providing efficacy and toxicity profiles comparable to those obtained for MCS employing the daptomycin population pharmacokinetic (PK) model derived from patients in the Staphylococcus aureus bacteremia-infective endocarditis (SAB-IE) study. For efficacy, we selected the HD dosing scheme which generated an area-under-the-curve (AUC) exposure profile comparable to that for the SAB-IE population model. For toxicity, we selected HD dosing schemes that minimized trough concentrations of >24. Daptomycin is a lipopeptide approved for the treatment of Staphylococcus aureus bacteremia and complicated skin and skin structure infections, both of which are common in patients receiving hemodialysis (HD) (1,4,(14)(15)(16)(17)(18). While the pharmacokinetic (PK) properties of daptomycin are well described for the general population, there are scant data for patients on HD (12, 13). An understanding of how PK changes during HD is essential to determining optimal dosing schemes for these patients. Furthermore, such dosage adjustments necessitate cognizance of interactions between antibiotic exposure, efficacy, and toxicity. Given the dearth of treatment options available against methicillin-resistant S. aureus (MRSA), it is imperative that daptomycin regimens be optimized for those on HD.The two objectives of this study were (i) to characterize the PK profile of daptomycin in patients receiving traditional thrice-weekly hemodialysis and (ii) to identify the optimal dosing scheme for daptomycin among patients on HD. With respect to the latter, the intent was to identify HD dosing schemes with efficacy and toxicity profiles comparable to those obtained from Monte Carlo simulations (MCS) employing the daptomycin population PK model derived from patients enrolled in the Staphylococcus aureus bacteremia-infective endocarditis (SAB-IE) clinical study for doses of 4 mg/kg of body weight given intravenously (i.v.) every 24 h (q24h) and 6 mg/kg given i.v. q24h (2, 7).Separate dosing schemes were developed for both FDAapproved daptomycin dosing regimens (4 mg/kg i.v. q24h and 6 mg/kg i.v. q24h) and for the two interdialytic periods (48 and 72 h). For efficacy, the primary exposure target was the area under the curve (AUC). Animal model data suggest that daptomycin is a concentration-dependent antibiotic, and the AUC/ MIC ratio is the pharmacodynamic (PD) parameter that best describes its activity (3,5,9,11). However, the AUC/MIC ratio associated with maximal effect has varied (3,5,9,11). Given the lack of a definitive AUC/MIC threshold, especially for patients with bloodstream infections, the ...
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