Therapeutics and clinical risk management
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Ther Clin Risk Manag · Jan 2012
The changing landscape of opioid prescribing: long-acting and extended-release opioid class-wide Risk Evaluation and Mitigation Strategy.
Prescriptions for opioid analgesics to manage moderate-to-severe chronic noncancer pain have increased markedly over the last decade, as have postmarketing reports of adverse events associated with opioids. As an unintentional consequence of greater prescription opioid utilization, there has been the parallel increase in misuse, abuse, and overdose, which are serious risks associated with all opioid analgesics. In response to these concerns, the Food and Drug Administration announced the requirement for a class-wide Risk Evaluation and Mitigation Strategy (REMS) for long-acting and extended-release (ER) opioid analgesics in April 2011. ⋯ Support from primary care will be necessary for the success of this REMS, as these clinicians are the predominant providers of care and the main prescribers of opioid analgesics for patients with chronic pain. Although currently voluntary, future policy will likely dictate that providers undergo mandatory training to continue prescribing medications within this class. This article outlines the elements of the class-wide REMS for ER opioids and clarifies the impact on primary care providers with regard to training, patient education, and clinical practice.
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Ther Clin Risk Manag · Jan 2015
Fluid accumulation threshold measured by acute body weight change after admission in general surgical intensive care units: how much should be concerning?
The objective of this study (ClinicalTrials.gov: NCT01351506) was to identify the threshold level of fluid accumulation measured by acute body weight (BW) change during the first week in a general surgical intensive care unit (ICU), which is associated with ICU mortality and other adverse outcomes. ⋯ Fluid accumulation, measured as acute BW change of more than the threshold of 5% during the first week of ICU admission, is associated with adverse outcomes of higher ICU mortality, especially in the patients without RRT, with reintubation within 72 hours, with RRT requirement, with vasopressor requirement, and with delirium. Some of these effects were higher in postoperative patients. This threshold value might be an indicator for caution during fluid management in surgical ICU.
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Ther Clin Risk Manag · Jan 2015
Vasopressors in septic shock: a systematic review and network meta-analysis.
Vasopressor agents are often prescribed in septic shock. However, their effects remain controversial. We conducted a systematic review and Bayesian network meta-analysis to compare the effects among different types of vasopressor agents. ⋯ In terms of survival, NE may be superior to DA. Otherwise, there is insufficient evidence to suggest that any other vasopressor agent or vasopressor combination is superior to another. When compared to DA, NE is associated with decreased heart rate, cardiac index, and cardiovascular adverse events, as well as increased SVRI. The effects of vasopressor agents or vasopressor combinations on mortality in patients with septic shock require further investigation.
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Ther Clin Risk Manag · Jan 2015
Effect of fluid loading on left ventricular volume and stroke volume variability in patients with end-stage renal disease: a pilot study.
The aim of this study was to investigate fluid loading-induced changes in left ventricular end-diastolic volume (LVEDV) and stroke volume variability (SVV) in patients with end-stage renal disease (ESRD) using real-time three-dimensional transesophageal echocardiography and the Vigileo-FloTrac system. ⋯ Our preliminary data suggest that fluid responsiveness can be assessed not by LVEDV but also by SVV due to underlying cardiovascular pathophysiology in patients with ESRD.
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Dexmedetomidine undoubtedly is a useful sedative in the intensive care setting because it has a minimal effect on the respiratory system. Dexmedetomidine infusions lasting more than 24 hours have not been approved since the first approval was acquired in the US in 1999. However, in 2008, dexmedetomidine infusions for prolonged use were approved in Colombia and in the Dominican Republic, and the number of countries that have granted approval for prolonged use has been increasing every year. ⋯ However, dexmedetomidine seems to be effective in managing extubation, reducing the use of conventional sedatives, and as an alternative for inducing sedation in patients for whom traditional sedatives induce inadequate sedation. Prolonged dexmedetomidine infusion has not been reported to have any serious adverse effects. Dexmedetomidine appears to be an alternative long-term sedative, but further studies are needed to establish its efficacy and safety.