Patient safety definition

The subjects of data security and privacy are not considered by this paper, although they are cormnonly used as part of the patient safety definition when discussing regulation in an international or European forum. In the UK our view of patient safety does not include these facets. This exclusion is justified in Sec-... 

With the transfer of most biopharmaceutical INDs from CBER to CDER in 2003, there has been an increased tendency to apply the small-molecule paradigm for evaluation of QT liability to biopharmaceutical product candidates, and to request information on hERG assays or plans for definitive clinical QT studies. This does not seem reasonable based on the postmarketing safety data for biopharmaceuticals, nor on scientific grounds as discussed above. If these investigations become routinely required, they will only add significant time and costs to the process of biopharmaceutical product evaluation and have little ultimate impact on patient safety. 

To pretend that fraud does not exist is to condone it. To take no action when fraud is suspected or when blatant evidence is seen is not acceptable. The most vulnerable potential victims are the patients whichever definition of fraud is used, the fact that patients have been exploited remains. This exploitation occurs when ethics committee authorization is not sought or is forged, denying patients the protection of review of the safety and ethics of the study. It occurs when safety data are not recorded or when patients are treated with inappropriate drugs. It occurs when drugs are licensed or withdrawn from the market using fraudulent data. It occurs when there are incorrect details on their patient notes. 

This definition goes some way to differentiate patient safety from more general concerns about the quality of healthcare the focus is on the dark side of quality (Vincent, 1997), care that is actually harmful rather than just not of a good standard. Healthcare is, in many cases at least, inherently hazardous and the definition implicitly acknowledges this. The definition also refers to the amelioration of adverse outcomes or injuries, which broadens the definition beyond traditional safety concerns towards an area that would, in many industries, be called disaster management. In healthcare, amelioration firstly refers to the need for rapid medical intervention to deal with the immediate crisis, but also to the need to care for injured patients and to support the staff involved. 

Retrospective reviews of medical records aim to assess the nature, incidence and economic impact of adverse events and to provide some information on their causes. Adverse events are defined as an unintended injury caused by medical management rather than the disease process that results in some definite injury or, at the very least, spent on additional days in hospital (Box 4.1). Definitions are critical in patient safety and one has to be constantly aware of differences in terminology. For instance, a study by Andrews et al. (1997) in the United States showed a 17.7% rate of serious adverse events in a surgical unit, much higher than most other studies. However, their definition of adverse event was different from that usually employed and they used observation rather than record review, as most other studies do. These are not flaws the study is a good one. The point is... 

The patient safety indicators were developed with exemplary thoroughness and due attention to a number of key issues affecting the validity and usefulness of the indicators. The full list of indicators is shown in Box 6.2, and some examples of definitions and outstanding issues in Box 6.3. It is critical to appreciate that the indicators do not necessarily indicate unsafe care and still less specific errors the clinician panels rated only severe transfusion reaction and retained foreign body as very likely to be due to error. While this is important for individual cases however, it is less critical when aggregating data over time. Any organization would like to reduce these events and once they... 

BOX 6.3 Examples of AHRQ patient safety indicators PSI Name Definition... 

The best measures of harm that we have, and apossible measurement model for patient safety in general (Burke, 2003), are rates of healthcare acquired infections. Most of these infections are preventable and are measured using standardized and well-validated systems and definitions. In the United States, the Centre for Disease Control and Prevention has set out standard definitions, and hospitals have created epidemiology and infection control departments to independently monitor, report and reduce infections. 

Medical device manufacturers are required to report adverse events related to their devices as per 21 CFR 803 under the definition of MDR. Adverse events can be reported directly to device manufacturers or reported to the FDA. The MDR database is searchable and open to the public. In some instances, MDR can provide safety signals for devices that can provoke actions to ensure patient safety such as product recalls. 

Summarising the various concepts and definitions proposed, safety culture appears to be the broader, manifest concept behind the fiamewoik of safety climate. Safety cultme is the source for patterns of behaviour which can be observed, described and changed (Goodmaim 2004), whereas safely climate is the sum of behaviours and attitudes based on common assumptions and beliefs toward patient safety. Cox and Flin (1998) describe culture as an organisation s personality while climate is seen as the organisation s mood . 

Table 12.1 Patient Safety Culture composites and definitions...

Patient Safety Culture Composite Definition The extent to which. .. 

The book is composed of 11 chapters. Chapter 1 presents the various introductory aspects of patient safety including patient safety-related facts and figures, terms and definitions, and sources for obtaining useful information on patient safety. Chapter 2 reviews mathematical concepts considered useful to understand subsequent chapters and covers topics such as mode, median, mean deviation. Boolean algebra laws, probability definition and properties, Laplace transforms, and probability distributions. 

DEFINITION— includes all locations. Includes aU types of patient safety reports. 

Barriers to research include insufficient funding, lack of experts, legal constraints, complexity and fragmentation of the health care system, the culture of blame surrounding error and patient safety, lack of consensus in definitions, and lack of priority for patient safety in the health care arena as a whole (Cooper and others, 2001). 

In this glossary, we have collected terms and definitions used in the emerging field of safety science most of these terms are also used in this book. Some are technical and come from the various disciplines that comprise safety science. Many will be new to the health care professional who is learning about safety science in order to create a culture of safety. Other terms may be familiar from other contexts, but they are explained here as they relate to patient safety. This list is not meant to be comprehensive, and the definitions are not meant to be official. Rather, our intent is to provide helpful operational definitions, and we have based some of them on the use of these terms in the current literature on patient safety. When formal definitions do exist and are helpful, we have used them and provided their sources in the literature. 

Patient Safety Reporting System (PSRS) (6) A prototype blameless reporting system established in 2000 by NASA and the Veterans Administration. The PSRS emphasizes the reporting of near misses (see definition above). 

Definitions are provided to clarify language and obligations and should in no way limit the intent of the organization to respond to all events affecting patient safety. 

Patient safety is an increasingly important topic for all patients and for physicians and surgeons worldwide. A clear definition of patient safety remains elusive, and depends upon the perspective of whoever is defining it at the time (i.e. doctor, patient, government - regulatory body). A variety of factors contribute to patient safety and all play a role in patients receiving peritoneal dialysis (PD). 

The UK National Health Service definition can be found on the website http //www.npsa.nhs.uk/nrls/reporting/what-is-a-patient-safety-incident/. While the trend to include potentially harmful events is understandable, it is also rather unfortunate because the reporting of such events depends on how people have judged a situation rather than on what actually happened. 

In the Introduction to this paper, an issue was raised that the European and international definition of patient safety is somewhat wider than the UK definition, including privacy and security in its remit Two typical working definitions used in the UK patient safety community are ... 

In general, for smokers with cardiac disease, the benefits of nicotine replacement therapy outweigh the potential risks. In a safety and efficacy study that included veterans with cardiac disease, smoking concurrently with the nicotine patch was not associated with an increase in adverse events (Joseph et al. 1996). Although bupropion SR is generally well tolerated by smokers, it has not been adequately studied in persons with cardiac disease, and definitive conclusions regarding its safety in this patient population cannot currently be made (Society for Research on Nicotine and Tobacco 2003). 

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