This study highlights the valuable role of mental health nurses in frontline emergency mental health care in particular mental health nurses skills in conducting a risk assessment in an emergency.
The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision‐making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice.
It has been suggested that the 'low-cost' model of air travel generates excessive levels of stress and fatigue amongst flight crew. Pilots were interviewed at a UK-registered low-cost carrier (LCC). Most said they felt stressed and fatigued. Despite its subjectivity the pilots' testimony suggests that stress and fatigue are issues that merit close attention-not least because events like the September 11 th , 2001 terrorist attacks, 2003 Gulf War and coterminous severe acute respiratory syndrome (SARS) outbreak have exacerbated economic pressures within the industry. Flight crews have insights and ideas that may benefit commercial aviation. It is they, and not legislators or civil servants, who deliver the product. It is suggested that a commitment to risk communication (as defined by Irwin and Wynne), which emphasises continuous dialogic risk assessment and the systematic and routinised exploitation of 'user knowledge' may enhance flight safety.
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