efficacy and safety of mineralocorticoid receptor antagonist therapy in heart failure with reduced ejection fraction

CoNCluSIoNS: The present review highlights the benefit of MRAs across the spectrum of HFrEF despite a higher incidence of hyperkalemia. Therefore, MRA therapy should not be withheld from appropriately selected patients with HFrEF because the risk of adverse events does not appear to exceed the overall benefit in mortality reduction

Enhancing safety with potassium phosphates injection

Abstract The (ISMP Canada, 2006, April 25) for the purpose of enhancing safety with potassium phosphates injection

Reliability testing of a case- leveling framework for assigning level of difficulty of pharmacist's initial patient medication assessments

J o u r n a l o f t h e A m e r i c a n P h a r m a c i s t s A s s o c i a t i o n Intervention: Individual medication assessments, monitoring, and followup by pharmacists. A case-leveling framework was developed with three levels of complexity (graded as I, II, or III) including specific descriptors and practicebased examples. Reliability was assessed between two standardized assessors and between one assessor and project pharmacists. Project pharmacist feedback was elicited through an e-mail survey. Reliability is reported using the kappa statistic. Main outcome measures: Reliability of a case-leveling framework and helpfulness of the framework as reported by pharmacists. Results: 53 patient cases were evaluated for interrater reliability between standardized assessors. The mean (± SD) case level assigned was 1.8 ± 0.68, and the kappa was 0.62 (95% CI 0.44-0.79), indicating a substantial strength of agreement between raters. For the second reliability test, 52 cases were rated, with a level of agreement between project pharmacists and the external assessor of 0.46 (95% CI 0.27-0.65), indicating moderate agreement. Feedback resulted in slight revisions to the original framework. Conclusion: The case-leveling framework was a reliable method and can be used to determine the level of difficulty of patient cases in primary care

Illustration of the Impact of Unmeasured Confounding Within an Economic Evaluation Based on Nonrandomized Data

Background: Propensity score (PS) methods are frequently used within economic evaluations based on nonrandomized data to adjust for measured confounders, but many researchers omit the fact that they cannot adjust for unmeasured confounders. Objective: To illustrate how confounding due to unmeasured confounders can bias an economic evaluation despite PS matching. Methods: We used data from a previously published nonrandomized study to select a prematched population consisting of 121 patients (46.5%) who received endovascular aneurysm repair (EVAR) and 139 patients (53.5%) who received open surgical repair (OSR), in which sufficient data regarding eight measured confounders were available. One-to-one PS matching was used within this population to select two PS-matched subpopulations. The Matched PS-Smoking Excluded Subpopulation was selected by matching patients using a PS model that omitted patients’ smoking status (one of the measured confounders), whereas the Matched PS-Smoking Included Subpopulation was selected by matching patients using a PS model that included all eight measured confounders. Incremental cost-effectiveness ratios (ICERs) were assessed within both subpopulations. Results: Both subpopulations were composed of two different sets of 164 patients. Balance within the Matched PS-Smoking Excluded Subpopulation was achieved on all confounders except for patients’ smoking status, whereas balance within the Matched PS-Smoking Included Subpopulation was achieved on all confounders. Results indicated that the ICER of EVAR over OSR differed between both subpopulations; the ICER was estimated at $157,909 per life-year gained (LYG) within the Matched PS-Smoking Excluded Subpopulation, while it was estimated at$235,074 per LYG within the Matched PS-Smoking Included Subpopulation. Discussion: Although effective in controlling for measured confounding, PS matching may not adjust for unmeasured confounders that may bias the results of an economic evaluation based on nonrandomized data

Hospital-acquired acute hyponatremia and reports of pediatric deaths

Abstract Information from four voluntary reports of hospital-acquired acute hyponatremia leading to the death of otherwise healthy children is highlighted. In this column, we present two cases and information from a recent ISMP Canada Safety Bulletin, as well as two cases reported to ISMP United States. Information is shared to enhance health care practitioners' awareness of the potential for acute hyponatremia and to provide an overview of some of the potential underlying factors. Hospital-acquired acute hyponatremia and reports of pediatric deaths Four pediatric deaths due to acute hyponatremia associated with intravenous (IV) administration of hypotonic solutions, three in a postsurgical setting and the other in a medical setting were voluntarily reported (two to the Institute for Safe Medication Practices Canada [ISMP Canada] and two to the Institute for Safe Medication Practices [ISMP] in the United States). Acute hyponatremia is defined as a decline in serum sodium to less than 130 mmol/L within a 48-hour period. This abrupt change can lead to cerebral edema as a result of electrolyte-free water moving into the brain cells. Acute hyponatremia can be fatal for both children and adults. However, children are more vulnerable to the effects of fluid and electrolyte imbalance. The early signs of acute hyponatremia and rising intracranial pressure are often nonspecific and include nausea, vomiting, headache, and decreasing level of consciousness. Information from the voluntary incident reports is shared here to enhance health care practitioners' awareness of the potential for acute hyponatremia and to provide an overview of some of the potential underlying factors. Incident reports received by ISMP Canad