Therapeutics and clinical risk management
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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.
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Ther Clin Risk Manag · Jan 2013
ReviewGabapentin enacarbil extended release for the treatment of postherpetic neuralgia in adults.
The development of biomedical technology is allowing refinement of drug therapies in order to improve medication profiles and benefit patients. Gabapentin (Gp) is a medication licensed globally for various indications, including postherpetic neuralgia. It has a pharmacokinetic profile which has been suggested may limit its clinical effects and reduce medication compliance. ⋯ An absence of comparative data, however, limits the direct evaluation of the medication to both immediate release and other extended release preparations available on the market. Additionally, no data are currently available addressing efficacy, tolerability, or side effects with other first line treatments of postherpetic neuralgia. Additional experimental data should be sought to clarify the position of Gp enacarbil, both within postherpetic neuralgia treatment protocols and in relation to the increasing numbers of gabapentinoids available.