Patient safety history

It is also necessary to consider the regulatory status of excipients and any country-specific requirements or constraints. The U.S. and Japanese regulatory agencies publish lists of excipients used in medicinal pro-ducts. The materials listed in these compendia can generally be considered suitable for administration by the route for which they are already being used. For materials with no history of previous use, evidence must be provided that they do not compromise patient safety nor induce any other undesirable effects. 

Two small comparative trials in HP-negative patients with histories of NSAID-related ulcer complications suggested that a standard dosage of a PPI and a nonselective NSAID have a GI safety profile similar to that observed with a selective COX-2 inhibitor. However, the comparative benefits and cost effectiveness of these regimens remain controversial. Cotherapy with a PPI and a selective COX-2 inhibitor should be considered in patients with multiple or life-threatening risk factors. ... 

As has been mentioned, the patient is often an unreliable witness concerning previous experience in industry. However, a solution to this problem lies in new developments allied to the availability of computers in the doctor s surgery. In France and in the United Kingdom experiments have taken place with smart cards , small plastic cards with a memory chip embedded in them. A patient s history can be recorded on the card and, when he goes to the surgery, he will present his card to the doctor, who will read it from his compute, update it as necessary during the visit, and return it to the patient If such a card carried an internationally coded job history as well as the medical facts, this would be a major contribution to chemical safety. 

HIT can enhance patient safety in three ways it can help prevent medical errors and adverse events it can initiate rapid responses to any event and it can enable the tracking of events, if they occur, and provide feedback on them to learn from [30]. But it is the first of these which is of most interest when it comes to proactively reducing the risk of harm. If we can identify the conditions in which dangerous scenarios occur we have a vital window of opportunity to intervene in the natural history of a hazard (see Sect. 2.6). 

The nature of the book, xi Inspiration, acknowledgements and thanks, xiii SECTION ONE The Evolution of Patient Safety Chapter 1 Medical harm a brief history, 3 Chapter 2 The emergence of patient safety, 14 Chapter 3 Integrating safety and quality, 31 SECTION TWO The Hazards of Healthcare Chapter 4 The nature and scale of error and harm, 49 Chapter 5 Reporting and learning systems, 75 Chapter 6 Measuring safety, 96... 

Leape, L. L., Scope of Problem and History of Patient Safety, Obstetrics and Gynecology Clinics of North America, Vol. 35, 2008, pp. 1-10. 

The history of organized patient safety activities is conflicted, driven in the context of widely published deaths and injuries, and influenced by managed care and the threat of government intervention, associated with the ill-fated initiative of the Clinton administration. 

Study history to ensure that patient safety continues to improve over time. 

The United States Department of Health and Human Services established the Health Insurance Portability and Accountability Act (HIPAA) in 1996, which, in part, protects the privacy and security of private health information. Dental care and history is considered private health information and is, therefore, protected by HIPAA regulations. Dental practices must adhere to strict guidelines to maintain patient confidentiality and improve patient safety. 

The history of safety in the modem times may be traced back to 1868, when a patent for a barrier safeguard was awarded in the United States [1]. In 1893, the U.S. Congress passed the Railway Safety Act and, in 1912, the cooperative Safety Congress met for the first time in Milwaukee, Wisconsin [1-3]. Today, the field of safety has developed into many areas, including workplace safety, patient safety, robot safety, and software safety. 

Consider technology and the human interface when designing processes. Study history to ensure that patient safety continues to improve over time. Statistics can help measure the impact of interventions or innovations. Continuous improvement processes shift focus from an individual to a team. 

Recent data suggest that COX-2 inhibitors, including rofe-coxib, valdecoxib, and celecoxib, may increase the risk for MI and stroke.47 There is also some evidence that the non-selective NSAIDs may increase the risk for cardiovascular events.47,48 Rofecoxib was withdrawn from the market in late 2004 because of safety concerns. The FDA requested the withdrawal of valdecoxib from the market in 2005. The FDA also asked the manufacturers of celecoxib and non-selective NSAIDs (prescription and over-the-counter) to include information about the potential adverse cardiovascular effects of these drugs in their product labeling. The cardiovascular risk with COX-2 inhibitors and NSAIDs may be greatest in patients with a history of, or with risk factors for, cardiovascular disease. The American Heart Association recommends that the use of COX-2 inhibitors be limited to low-dose, short-term therapy in patients for whom there is no appropriate alternative.48 Patients with cardiovascular disease should consult a clinician before using over-the-counter NSAIDs. 

Lubiprostone is contraindicated in patients with a history of mechanical gastrointestinal obstruction. Safety has not been established in pregnant women animal studies indicated the potential to cause fetal loss. Women who could become pregnant should have a negative pregnancy test result prior to beginning therapy with lubiprostone. 

Assess for the safety of others and potential for violence. If accompanied by friends or family with whom the patient is living, ask them to remove from the home all guns, caustic chemicals, medications, and objects the person might use to harm self or others. Risk factors for suicide include severity of depression, feelings of hopelessness, comorbid personality disorder, and a history of a previous suicide attempt.19... 

HRT, but they are less efficacious than hormonal therapies. Alternative treatments should be chosen based on the efficacy and safety profile of the treatment and the patient s past medical history and current medications. 

The exact role of rituximab in RA is not clearly defined, but it is indicated for patients with moderate to severe RA with a history of inadequate response to DMARDs and other BRMs. Rituximab carries a black-box warning of fatal infusion reactions and severe mucocutaneous reactions even though these events did not occur during the RA clinical trials. The benefits of rituximab must be tempered against the safety concerns reported with use of rituximab in the oncology setting. 

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