Therapeutics and clinical risk management
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Ther Clin Risk Manag · Jan 2013
Evaluation of recombinant activated protein C for severe sepsis at a tertiary academic medical center.
Early clinical trials of recombinant human activated protein C (rhAPC) for severe sepsis excluded patients at high risk of bleeding. Recent literature suggests bleeding rates are higher in clinical practice and may be associated with worsened outcomes. Our objective was to evaluate baseline demographics; incidence, and risk factors for major bleeding; and mortality of patients receiving rhAPC for severe sepsis at our institution. ⋯ Patients receiving rhAPC at our institution had higher APACHE II scores, mortality, and major bleeding events than published postmarketing studies. Risk factors for major bleeding other than package-labeling contraindications and bleeding precautions were identified in our patient population.
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Ther Clin Risk Manag · Jan 2013
Pharmacokinetic drug interaction profile of omeprazole with adverse consequences and clinical risk management.
Omeprazole, a proton pump inhibitor (PPI), is widely used for the treatment of dyspepsia, peptic ulcer, gastroesophageal reflux disease, and functional dyspepsia. Polypharmacy is common in patients receiving omeprazole. Drug toxicity and treatment failure resulting from inappropriate combination therapy with omeprazole have been reported sporadically. Systematic review has not been available to address the pharmacokinetic drug-drug interaction (DDI) profile of omeprazole with adverse consequences, the factors determining the degree of DDI between omeprazole and comedication, and the corresponding clinical risk management. ⋯ Despite the fact that omeprazole is one of the most widely prescribed drugs internationally, clinical professionals should enhance clinical risk management on adverse DDIs associated with omeprazole and ensure safe combination use of omeprazole by rationally prescribing alternatives, checking the appropriateness of physician orders before dispensing, and performing therapeutic drug monitoring.
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Ther Clin Risk Manag · Jan 2013
Prescribing practice and evaluation of appropriateness of enteral nutrition in a university teaching hospital.
A retrospective utilization study was performed to evaluate utilization patterns for enteral nutrition in a university teaching hospital. ⋯ This utilization study indicates that continuous quality improvement is necessary and that a Drug and Therapeutics Committee can play an important role in promoting rational and safe use of enteral nutrition. Appropriateness of this therapy still needs to be improved, especially in addressing the issues of non-evidence-based combined use of multiple enteral nutrition formulas, the relatively high rate of concomitant use of enteral and parenteral nutrition, off-label use of diabetes-specific Fresubin Diabetes, insufficient use of Supportan in cancer patients, and unnecessary use of Supportan in intensive care patients not suffering from cancer.
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Ther Clin Risk Manag · Jan 2013
ReviewGuidelines for overcoming hospital managerial challenges: a systematic literature review.
The need to respond to accreditation institutes' and patients' requirements and to align health care results with increased medical knowledge is focusing greater attention on quality in health care. Different tools and techniques have been adopted to measure and manage quality, but clinical errors are still too numerous, suggesting that traditional quality improvement systems are unable to deal appropriately with hospital challenges. The purpose of this paper is to grasp the current tools, practices, and guidelines adopted in health care to improve quality and patient safety and create a base for future research on this young subject. ⋯ This research contributes to introducing a new theme in health care literature regarding the development of successful projects with both clinical risk management and health lean management objectives, and should address solutions for improving health care even in the current context of decreasing resources.
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Ther Clin Risk Manag · Jan 2013
ReviewBridging, switching or drug holidays - how to treat a patient who stops natalizumab?
Natalizumab (NAT) was the first monoclonal antibody to be approved for the treatment of relapsing-remitting multiple sclerosis (RRMS). While pivotal and postmarketing studies have showed considerable and sustained efficacy of NAT in RRMS, the increasing incidence of therapy-associated progressive multifocal leukoencephalopathy (PML), a brain infection caused by the John Cunningham virus (JCV), is a risk associated with long-term therapy. The risk for therapy-associated PML is highest in so-called "triple risk" patients. ⋯ The time interval between the discontinuation of NAT and the start of FTY might affect the recurrence of disease activity. Long-term data about the efficacy and safety of FTY treatment after cessation of NAT are urgently needed and should be further investigated. Prospective studies are warranted, to optimize treatment strategies for RRMS patients who discontinue NAT, especially because new therapies will be available in the very near future.