Safety indicators using patient

Miller, M. R., Elixhauser, A., Zhan G., Meyer, G. S., Patient Safety Indicators Using Administrative Data to Identify Potential Patient Safety Concerns, Health Service Research, Vol. 36, No. 5, 2001, pp. 110-132. 

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. 

Azelastine nasal spray is indicated for children 5 years of age and older and is considered an alternative to intranasal corticosteroids in patients with persistent severe symptoms. Intranasal cromolyn, another commonly used agent in children, is indicated in patients 2 years of age and older and has an acceptable safety profile. However, limited efficacy and multiple daily administrations limit its use to mild and early rhinitis or for prophylaxis of a known imminent exposure. 

Supply on a particular patient basis encompasses various categories of unauthorised use of medicinal products. A product maybe imauthor-ised because it has been specially formulated for use it may be at the clinical trial stage of development, but be requested by doctors for use outside a trial it may have been authorised previously and then withdrawn from the market for commercial reasons, or because of safety, efficacy or quality concerns or it may be authorised currently, but for a different indication or patient population, or in a different country. 

The characteristics and performances referred to in sections 1, 2 and 3 above must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses that can occur during normal conditions of use. 

AT-III activity which was similar to that seen with the plasma-derived product. Clinical use of ATryn in patients who had surgical procedures indicated that it was well tolerated in all cases. Shortages in THROMBATE III supplier resulted in the use of ATryn on compassionate grounds when the plasma product was not available. No clinical evidence of thrombosis has been reported in any of these compassionate-use patients. The routine use of THROMBATE III as replacement therapy is not generally recommended due to the high cost, the risk of infection, and the need for frequent intravenous administration. The recombinant product derived from milk should have improved safety and reduced cost, resulting in a product that is suitable for chronic use. 

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... 

Patient safety indicators have typically been rmderstood as measures that produce irrformation on the number of urrsafe outcomes in healthcare. The indicator data typically collected and followed in healthcare deal with irrfectiorts associated with healthcare, such as mirrary irrfectiorrs from catheters and a central lirre due to bloodstream infectiorrs (EUNetPas 2010). In the light of recent system safety theories, this use of indicators seems rrarrow since it reflects the idea of patient safety as a lack of adverse events. 

Patient safety indicators are a set of quality measures that makes use of hospital inpatient data to provide a perspective on patient safety. The indicators highlight difficulties that patients face through contact with the health care system and that are likely amenable to prevention by implementing appropriate changes at system level. The difficulties or problems highlighted are commonly known as adverse events or complications. 

Chapter 3 presents introductory aspects of safety and human factors. Chapter 4 is devoted to methods considered useful to perform patient safety analysis. These methods include failure modes and effect analysis (FMEA), fault tree analysis (FTA), root cause analysis (RCA), hazard and operability analysis (HAZOP), six sigma methodology, preliminary hazard analysis (PFfA), interface safety analysis (ISA), and job safety analysis (JSA). Patient safety basics are presented in Chapter 5. This chapter covers such topics as patient safety goals, causes of patient injuries, patient safety culture, factors contributing to pahent safety culture, safe practices for better health care, and patient safety indicators and their selection. 

A Toolkit for Hospitals Improving Performance on the AHRQ Quality Indicators helps hospitals understand AHRQ s Qnality Indicators that use hospital administrative data to assess the quality of care provided, identify areas of concern in need of further investigation, and monitor progress over time. The toolkit is a general guide to using improvement methods and focuses on the 17 Patient Safety Indicators and the 28 Inpatient Quality Indicators to improve quality and patient safety. 

In general, drug-induced sleep disruption is not regarded as a serious safety risk when considering progression to a phase 1 clinical trial however, for certain indications and patient populations, dmg-induced sleep disruption may be an unacceptable adverse effect. In this context, it is useful to consider the benefit of studying dmg-induced effects on sleep in preclinical models. Given that all mammalian species have measurable sleep/wake cycles, there is the expectation that rodent or non-rodent species used in standard safety assessment studies can serve as... 

Rimonabant (382) was also included in a clinical study to assess the safety and efficacy of four novel compounds for the treatment of schizophrenia and psychoaffective disorder [378]. The other compounds included in the trial were a neurokinin NK3 antagonist, a serotonin 2A/2C antagonist and a neurotensin NTSl antagonist. Halopeiidol and placebo groups were used as controls in the study. Sixty-nine patients received (382) (20 mg once per day), which failed to demonstrate efficacy in this trial. The reasons for the lack of efficacy may be due to inadequate dosing or an indication that CBi antagonism is not appropriate in the treatment of this condition. 

The developments in the treatment of RA are tempered by the lack of evidence describing the long-term safety and efficacy of the BRMs. In addition, the cost associated with the medications can be a deterrent to use. Long-term data are needed to determine if patients receiving BRM therapy early in the course of disease have reduced disease activity, reduced joint deformities and disability, improved quality of life, and continued function as productive members of society. Cost analyses of long-term data may indicate that the increased expenses associated with BRMs are offset by the costs avoided for the treatment of advanced RA. 

The ocular hypotensive lipids in typical ophthalmology practice are considered first-line alternatives to topical P-blockers because of their superior efficacy and safety profiles. Many clinicians may choose to use the ocular hypotensive lipids as first-line agents, especially in patients that have an initial requirement to lower IOP by more than 25%, or in patients that have relative or absolute contraindications to topical P-blockers. However, latanoprost is currently the only ocular hypotensive lipid drug that has a Food and Drug Administration (FDA) indication for first-line therapy. Bimatoprost and travoprost are indicated by the FDA for patients who are intolerant of other IOP-lowering therapy or insufficiently responsive to another IOP-lowering medication.10,38... 

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