Heart failure is well recognized as a major public health concern not only due to severe and frequent adverse health outcomes but also related to the major financial burden this syndrome presents with advancing age in Western societies. Despite the dire need for more efficacious therapies and better application of existing advances, treatment gaps persist, and outcomes in heart failure remain poor, with continually high mortality and morbidity. Treatment guidelines provide one strategy for advancing quality of care in patients with heart failure. This approach, with well-known potential strengths and weaknesses, has both adherents and detractors. Heart failure treatment guidelines have been in sharp focus recently due to updates that address the United States Food and Drug Administration (FDA) approval in 2015 of two new pharmacologic therapies for heart failure with reduced ejection fraction: sacubitril-valsartan and ivabradine. Our commentary will revisit issues in guideline methodology and discuss these in the context of the updates addressing the FDA approval of new pharmacologic agents for heart failure with reduced ejection fraction.
Discussion | The observed decreases in RBC and plasma transfusions from 2011 to 2014 may reflect evidence demonstrating the safety of restricting RBC transfusions, patient blood management programs, conservation initiatives (eg, cell salvage, pharmacotherapy, improved surgical techniques), advocacy from medical organizations, and publication of transfusion guidelines. 1 No decrease in RBC transfusion was seen in children or platelet transfusion overall, areas for which there is limited evidence to guide clinical practice. 1,3 This study has limitations inherent to any retrospective analysis of administrative data. The ICD-9-CM coding is carried out primarily for billing purposes and it is not possible to verify its accuracy, but National Inpatient Sample coding has been validated in other studies. The laboratory data supporting indication for transfusion was unknown. This study was also limited to inpatient transfusions, which might not be generalizable to outpatient settings. Except for the a priori hypothesis for admission type, subgroup analyses were not prespecified and significant interactions should be considered exploratory and tentative.These data confirm and build upon previous descriptive studies. A statistical brief suggested RBC transfusions may be declining in the United States, but this study excluded children and did not examine trends in plasma or platelet transfusion. 2 Preliminary data by the AABB (formerly the American Association of Blood Banks) and the US Centers for Disease Control and Prevention that focused on number of units of blood collected also suggested a decrease in the total number of RBC units transfused that may have begun as early as 2008. [4][5][6] However, in this study the percentage of hospitalized patients receiving RBC transfusions did not decrease until 2011.
Precision medicine customizes drug treatment to an individual's disease and genetics in order to optimize therapeutic benefit and minimize risk. Surprisingly, drug dosing is generally not discussed as a component of precision medicine. Because dosing regimens are an independent factor modulating efficacy and toxicity, consideration should be given to the clinical significance of precision drug dosing (PDD) in patient care. Pharmacists routinely face dilemmas when they are asked for dosing recommendations for patients with characteristics that fall outside of those represented in the drug label (eg, morbid obesity, pregnancy, frailty, neonatal patients, or elderly patients). The necessary data and technology now exist to create and implement PDD software for high priority drug‐disease targets in order to assist pharmacists and prescribers in choosing the safest and most effective dose for every patient. Within 5 to 10 years, we believe this software will be available. This study discusses how pharmacists can participate in leading the implementation of these PDD tools to achieve effective and routine clinical use.
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