Clinical therapeutics
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Clinical therapeutics · Sep 2015
ReviewGaps in Drug Dosing for Obese Children: A Systematic Review of Commonly Prescribed Emergency Care Medications.
Approximately 1 of 6 children in the United States is obese. This has important implications for drug dosing and safety because pharmacokinetic (PK) changes are known to occur in obesity due to altered body composition and physiologic mechanisms. Inappropriate drug dosing in an emergency setting can limit therapeutic efficacy and increase drug-related toxic effects for obese children. Few systematic reviews examining PK properties and drug dosing in obese children have been performed. ⋯ Insufficient information exists to guide dosing in obese children for any of the emergency care drugs reviewed. This knowledge gap is alarming, given the known PK changes that occur in the setting of obesity. Future clinical trials examining the PK properties of emergency care medications in obese children should be prioritized.
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Clinical therapeutics · Sep 2015
ReviewPediatric Obesity: Pharmacokinetics and Implications for Drug Dosing.
Clinicians are increasingly likely to have under their care obese children with diseases requiring pharmacotherapy. Optimal drug dosing for this population is unclear. Excess weight likely leads to alterations in pharmacokinetics. The purpose of this article was to describe the pharmacokinetics and pharmacodynamics in overweight and obese children and, where possible, provide recommendations for drug dosing. ⋯ Limitations to the available data include the inherent design constraints to case reports and retrospective cohort studies, as well as the small numbers of children in some of the studies. Use of normal-weight historical control subjects for obese children in the context of a pharmacokinetic study is not ideal. Although more information is becoming available, our understanding of the pharmacokinetics in obese children is still limited. When dosing information is not available for obese children, it may be necessary to extrapolate from available data in obese adults, but one should consider the effects of the child's age on pharmacokinetics.
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Clinical therapeutics · Sep 2015
ReviewExpedited Programs for Serious Conditions: An Update on Breakthrough Therapy Designation.
Our aim was to describe the regulatory pathways made available by the US Food and Drug Administration (FDA) to expedite the drug development and approval process, with a focus on the benefits and limitations of the Breakthrough Therapy Designation (BTD) pathway. ⋯ BTD has already had many positive and negative impacts on various stakeholders, including sponsors, investors, regulatory agencies, third-party payors, and patients. The ultimate goal of the BTD program is to identify promising drug candidates early in the clinical development timeline, expedite the development and review processes via intensive guidance from the FDA, and provide patients access to approved therapies as quickly as possible. With the first few batches of BTD product approvals, the FDA and other stakeholders have been working collaboratively to address the various expected and unexpected challenges that have arisen during the BTD process in order to refine and improve this already successful program.
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Clinical therapeutics · Sep 2015
Medication Extraction from Electronic Clinical Notes in an Integrated Health System: A Study on Aspirin Use in Patients with Nonvalvular Atrial Fibrillation.
The purpose of this study was to investigate whether aspirin use can be captured from the clinical notes in a nonvalvular atrial fibrillation population. ⋯ We developed and validated an NLP method specifically designed to identify low dose aspirin use status from the clinical notes with high accuracy. This method can be a valuable tool to supplement existing structured medication data.
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Trauma and complex cardiac surgery are associated with a high risk of bleeding complications. The difference in costs between patients who require bleeding control measures and those who do not is poorly understood. Our goal was to assess the cost of care and outcomes for patients in these settings. ⋯ Trauma and cardiac surgery patients who experienced bleeding and received allogeneic blood product transfusions had significantly worse outcomes, including longer LOS, greater inpatient mortality, and higher costs of care (even when excluding costs of agents used for bleeding control) than those who did not.