Effectiveness and Cost of Weekly Recombinant Tissue Plasminogen Activator Hemodialysis Catheter Locking Solution.

BACKGROUND AND OBJECTIVES: Evidence to guide hemodialysis catheter locking solutions is limited. We aimed to assess effectiveness and cost of recombinant tissue plasminogen activator (rt-PA) once per week as a locking solution, compared with thrice weekly citrate or heparin, in patients at high risk of complications. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We used a prospective design and pre-post comparison in three sites across Canada. Pre-post comparisons were conducted using multilevel mixed effects regression models accounting for cluster with site and potential enrollment of patients more than once. In the pre period, catheter malfunction was managed as per site-specific standard of care. The intervention in the post period was once weekly rt-PA as a locking solution (with citrate or heparin used for other sessions). The primary outcome was rate of rt-PA use for treatment of catheter malfunction. Secondary outcomes included rates of bacteremia, management of catheter malfunction, and cost. RESULTS: There were 374 patients (mean age 68 years; 52% men) corresponding to 506 enrollments. Mean length of enrollment was 200 days (SD 119) in the pre period and 187 days (SD 101) in the post period. There was a significant decline in rate of rt-PA use for treatment of catheter malfunction in the post compared with pre period (adjusted incidence rate ratio, 0.39; 95% confidence interval, 0.30 to 0.52); however, there was no difference in the rate of bacteremia, or catheter stripping or removal/replacement. The increase in mean total health care cost in the post period was CAD$962 per enrollment, largely related to costs of rt-PA as a locking solution. CONCLUSIONS: Once weekly rt-PA as a catheter locking solution was associated with a reduction in rt-PA use for treatment of catheter malfunction. Our results showing a reduction in rescue rt-PA use are consistent with a prior randomized trial, although we did not observe a reduction in bacteremia or catheter stripping/removal and did observe an increased incremental cost of this strategy primarily accounted for by the cost of the rt-PA.

Ambulatory Medication Reconciliation in Dialysis Patients: Benefits and Community Practitioners' Perspectives.

BACKGROUND: Ambulatory medication reconciliation can reduce the frequency of medication discrepancies and may also reduce adverse drug events. Patients receiving dialysis are at high risk for medication discrepancies because they typically have multiple comorbid conditions, are taking many medications, and are receiving care from many practitioners. Little is known about the potential benefits of ambulatory medication reconciliation for these patients. OBJECTIVES: To determine the number, type, and potential level of harm associated with medication discrepancies identified through ambulatory medication reconciliation and to ascertain the views of community pharmacists and family physicians about this service. METHODS: This retrospective cohort study involved patients initiating hemodialysis who received ambulatory medication reconciliation in a hospital renal program over the period July 2014 to July 2016. Discrepancies identified on the medication reconciliation forms for study patients were extracted and categorized by discrepancy type and potential level of harm. The level of harm was determined independently by a pharmacist and a nurse practitioner using a defined scoring system. In the event of disagreement, a nephrologist determined the final score. Surveys were sent to 52 community pharmacists and 44 family physicians involved in the care of study patients to collect their opinions and perspectives on ambulatory medication reconciliation. RESULTS: Ambulatory medication reconciliation was conducted 296 times for a total of 147 hemodialysis patients. The mean number of discrepancies identified per patient was 1.31 (standard deviation 2.00). Overall, 30% of these discrepancies were deemed to have the potential to cause moderate to severe patient discomfort or clinical deterioration. Survey results indicated that community practitioners found ambulatory medication reconciliation valuable for providing quality care to dialysis patients. CONCLUSIONS: This study has provided evidence that ambulatory medication reconciliation can increase patient safety and potentially prevent adverse events associated with medication discrepancies.

CONTEXTE: Le bilan comparatif des médicaments en soins ambulatoires peut réduire les divergences au chapitre des médicaments et les événements indésirables liés aux médicaments. Les divergences relatives aux médicaments représentent un risque élevé pour les patients dialysés, car ils souffrent normalement de multiples troubles comorbides, ils prennent souvent de nombreux médicaments et ils sont soignés par bon nombre de praticiens. Peu d'information existe sur les possibles avantages du bilan comparatif des médicaments en soins ambulatoires pour ces patients. OBJECTIFS: Déterminer le nombre et la catégorie des divergences concernant les médicaments constatées lors d'un bilan comparatif des médicaments en soins ambulatoires ainsi que la gravité potentielle des préjudices consécutifs. De plus, établir la position des pharmaciens communautaires et des médecins de famille sur cette modalité du bilan comparatif des médicaments. MÉTHODES: La présente étude de cohorte rétrospective a été menée auprès de patients amorçant un traitement par hémodialyse pour qui un bilan comparatif des médicaments en soins ambulatoires a été réalisé dans le cadre d'un programme hospitalier des maladies du rein, entre juillet 2014 et juillet 2016. Les divergences trouvées dans les formulaires de bilan comparatif des médicaments ont été classées par catégorie et selon la gravité potentielle des préjudices. Le niveau du préjudice a été déterminé de manière indépendante par un pharmacien et un membre du personnel infirmier praticien à l'aide d'un système de notation défini. En cas de désaccord, le score final était établi par un néphrologue. Des sondages ont été envoyés à 52 pharmaciens communautaires et à 44 médecins de famille prodiguant des soins aux participants afin qu'ils expriment leurs opinions et leurs points de vue sur le bilan comparatif des médicaments en soins ambulatoires. RÉSULTATS: En tout, 296 bilans comparatifs des médicaments en soins ambulatoires ont été effectués auprès de 147 patients hémodialysés. Le nombre moyen de divergences constatées par patient était de 1,31 (écart-type de 2,00). Dans l'ensemble, 30 % de ces divergences ont été considérées comme une source potentielle d'un inconfort allant de modéré à grave ou de dégradation clinique. Selon les résultats du sondage, les praticiens communautaires ont jugé le bilan comparatif des médicaments en soins ambulatoires utile à la prestation de soins de qualité aux patients dialysés. CONCLUSIONS: D'après les résultats de l'étude, le bilan comparatif des médicaments en soins ambulatoires augmenterait la sécurité des patients et pourrait prévenir les événements indésirables liés aux divergences relatives aux médicaments.

Comparison of intensive versus standard hemodialysis central venous catheter dysfunction protocol using rt-PA: a quality assurance initiative.

PURPOSE: Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA) are used to treat and prevent clotting of hemodialysis (HD) catheters during HD treatments and the interdialytic period. However, evidence to guide the use of rt-PA for catheter dysfunction is limited. METHODS: We evaluated outcomes using two catheter dysfunction protocols in a cohort of consecutive prevalent dialysis patients (Jan 2013 to Sep 2014) undergoing HD with a tunneled catheter. In the intensive protocol, rt-PA was administered to all catheters based on blood flow and/or line reversal. In the standard protocol, rt-PA administration was based only on blood flow. The primary outcome was the rate of rt-PA use for catheter malfunction (rt-PA treatment days/1000 total line days; [TLD]). Secondary outcomes included the cost of rt-PA/TLD and the rate of catheter-related bacteremia. RESULTS: There were 26 and 35 patients managed by the intensive and standard protocols, respectively. The rate of rt-PA use was 52/1000 TLD (intensive) versus 39/1000 TLD (standard) (rate ratio 1.30, 95% CI 1.12-1.52 CI, p<0.001). The rate of bacteremia was 0.43 and 0.22/1000 TLD for the intensive and standard protocols, respectively (p = 0.491). The cost of rt-PA was CDN $5.58 and CDN $6.15 per TLD for the intensive protocol and standard protocol groups (p<0.001). CONCLUSIONS: Managing catheter dysfunction based on line reversal and blood flow as opposed to only blood flow was associated with a higher rate of rt-PA use, but at a reduced overall cost.

An evaluation of oral dabigatran etexilate pharmacokinetics and pharmacodynamics in hemodialysis.

Dabigatran etexilate represents a possible improved alternative to warfarin for anticoagulation in hemodialysis patients with atrial fibrillation (AF). The objective was to determine dabigatran plasma concentrations and anticoagulant effects following administration of a single 110 mg oral dose of dabigatran etexilate to 10 adult patients immediately prior to starting hemodialysis. Mass spectrometry and the Hemoclot® assay were used, respectively, to determine free (unconjugated) dabigatran concentrations and thrombin time (TT) in plasma samples collected intermittently over 48 hours. The median time (tmax ) to reach the maximum plasma-free dabigatran concentration (Cmax ) was 2 hours (range 1-3 hours). The mean free dabigatran Cmax was 95.5 ± 33.4 ng/mL. The mean elimination half-lives on and off hemodialysis were, respectively, 2.6 ± 1.3 and 30.2 ± 7.8 hours. Hemodialysis effectively removed dabigatran with an extraction ratio of 0.63 ± 0.07. The maximal TT ratio was 2.1 and the TT ratio demonstrated a strong linear dependence on free dabigatran concentration (r(2) = 0.741). A 110 mg oral dabigatran dose prior to hemodialysis was rapidly absorbed and achieved therapeutic concentrations. Hemodialysis effectively removed dabigatran from the plasma and may be an effective means of accelerating the elimination of dabigatran in circumstances of excessive anticoagulation.