Tobacco regulatory science: research to inform regulatory action at the Food and Drug Administration's Center for Tobacco Products.

The U.S. Food and Drug Administration (FDA) promotes the development of regulatory science to ensure that a strong evidence base informs all of its regulatory activities related to the manufacture, marketing, and distribution of tobacco products as well as public education about tobacco product constituents and effects. Toward that end, the FDA's Center for Tobacco Products (CTP) provides funding for research studies with scientific aims that fall within its defined regulatory authority. However, given their traditional biomedical focus on basic and applied research, some researchers may not understand the principles of regulatory science or the types of studies CTP funds. The purpose of this paper is (1) to clarify the definition of regulatory science as a distinct scientific discipline, (2) to explore the role of tobacco regulatory science in order to help researchers understand the parameters and types of research that can be funded by CTP, and (3) to describe the types of research efforts that will inform the FDA's public health framework for tobacco product regulation.

Optimizing hemostatic practices: matching the appropriate hemostat to the clinical situation.

Achieving hemostasis is a critical focus of clinicians working in the surgical setting, given that uncontrolled surgical bleeding is associated with increased mortality rates and higher costs of care. As principal members of the surgical team, perioperative nurses are in an optimal position to plan and direct care during a bleeding event and throughout a patient's surgical stay. This supplement includes an assessment of the clinical and economic effects of surgical bleeding, a thorough review of available therapies, and a detailed comparison of these products to demonstrate which agents are best suited for a given clinical situation. By understanding the basic science of coagulation and hemostasis and current advances in topical hemostatic agents, including their safety, efficacy, and judicious use, perioperative nurses will be empowered to better assist the surgeon in optimizing patient outcomes.

Achieving hemostasis with topical hemostats: making clinically and economically appropriate decisions in the surgical and trauma settings.

Achieving hemostasis is a crucial focus of clinicians working in surgical and trauma settings. Topical hemostatic agents-including mechanical hemostats, active hemostats, flowable hemostats, and fibrin sealants-are frequently used in efforts to control bleeding, and new options such as hemostatic dressings, initially used in combat situations, are increasingly being used in civilian settings. To achieve successful hemostasis, a number of vital factors must be considered by surgeons and perioperative nurses, such as the size of the wound; bleeding severity; and the efficacy, possible adverse effects, and method of application of potential hemostatic agents. Understanding how and when to use each of the available hemostatic agents can greatly affect clinical outcomes and help to limit the overall cost of treatment.

Implementing methods to improve perioperative hemostasis in the surgical and trauma settings.

Achieving perioperative hemostasis is vital to surgical success. Inadequate control of bleeding is associated with serious adverse outcomes, including extended duration of surgery, unanticipated blood transfusions, shock, infection, impaired wound healing, longer hospital stays, and mortality. Appropriate clinical management of bleeding in the surgical and trauma settings requires careful collaborative planning and coordination by the entire perioperative team. Perioperative nurses, because of their strategic role in patient care, must be familiar with risk factors for excessive bleeding and the fundamental roles of hemostatic agents, environmental temperature, and blood transfusion in controlling bleeding in the surgical patient. Knowledge of the characteristics, safety, efficacy, and costs of available topical hemostatic agents promotes their appropriate selection in the OR. By incorporating evidence-based approaches into practice, perioperative nurses can support effective intraoperative hemostasis, thereby improving patient outcomes.