Preventable adverse event defined

Because of the problems that resulted from self-regulation, another law, the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was approved in 2006. This law requires manufacturers, packers, or distributors of supplements to submit reports of serious adverse events to the FDA. Serious adverse events are defined as death, a life-threatening event, hospitalization, a persistent or significant disability or incapacity, congenital anomaly or birth defect, or an adverse event that requires medical or surgical intervention to prevent such outcomes based on reasonable medical judgment. If this requirement were enforced, and consumers cooperated, these reports would make it possible to identify trends in adverse effects and would help to alert the public to safety issues. 

The efficacy and safety parameters describe how and when the variables are going to be recorded, usually in relation to drug administration and follow-up periods. How adverse events are managed and recorded are particularly important to the sponsor and regulatory authorities. Protocol authors should ensure that the study defines the criteria for success or failure of treatment. End-points should be clear and defined. Since many clinical phenomena are open to interpretation, protocols should provide definitions of variables and time windows for their collection. If the assessments are purely subjective, then methods to prevent observer bias (so-called observer truing ) must be employed. Addressing these issues will improve the quality and meaningfulness of the results of the study. 

Adverse events occurred in 3.7% of hospitalizations and 27.6% were due to negligence (defined as care that fell below the standard expected of physicians in that community, and which might therefore lead to legal action). Almost half of adverse (47.7%) events were associated with an operation. The most common non-operative adverse events were adverse drug events, followed by diagnostic mishaps, therapeutic mishaps, procedure related events and others. Permanent disability resulted from 6.5% of adverse events and 13.6% involved the death of a patient. Extrapolations from this data suggested that approximately 100 000 deaths each year were associated with adverse events. Later analyses indicated that 69.6% of adverse events were potentially preventable. 

US that hard outcome measures are poor proxy measures, not only because they are uni-dimensional bnt also becanse they are not process measures - i.e. the processes that ensure safety and prevent nnsafe events from happening. In the widely known fiamewoik of Donabedian with its trio - structure, process and ontcome - risk is measnred in the ontcome categoiy whereas safety is a feature of stmcture and process. Therefore, defining safety as the inverse of risk makes it inverse to risk not only in a formal sense bnt also inverse in a qualitative sense. Hard ontcomes (adverse events snch as injnries, mortality, infections etc.) are therefore also poor safely indicators in the sense that they do not give any direction on how to improve safely. 

The United States Eood and Drug Administration (EDA) states that any serious adverse event should be reported to the EDA and defines such an event as any undesirable experience associated with the use of a medical product in a patient. The event is said to be serious when the patient outcome is death, life-threatening, hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), and other serious important medical events (e.g., allergic bronchospasm, serious blood dysaasias, or seizures or convulsions that do not result in hospitalization). 

Adverse drug events (ADEs), defined as any injury owing to a medication error, happen often. The Institute of Medicine has reported that at least 1.5 million preventable ADEs occur each year in hospitals and in people s homes. You can reduce your risk of having an ADE by having all your medications reviewed by your doctor or pharmacist. 

In 1997, Condado et al. was the first to investigate the effectiveness of ICB after PTCA in human coronary arteries. Twenty-one patients who underwent PTCA for unstable angina received ICB (gamma radiation) for prevention of restenosis, Immediate and six-month follow-up revealed improved freedom from major adverse cardiac event (MACE) defined as death, myocardial infarction or target lesion revascularization compared with several previously completed balloon angioplasty trials (20), More importantly, this trial demonstrated that ICB was a feasible technique for the prevention of restenosis without any unexpected acute complications in humans. 

One of the most important public health tasks in the immediate aftermath of a disaster is to conduct a rapid and comprehensive assessment of population health requirements. Responders should conduct a health assessment of the community as soon as possible within the first few days following the event (Connolly, 2005). This is a multifaceted process that consists of several key elements (1) data collection for assessment of needs, (2) identification of available resources that match to defined needs, (3) prevention of further adverse health effects associated with the event, (4) implementation of disease control strategies, (5) evaluation of the effectiveness of the application of these strategies, and (6) improvement in contingency planning for future disasters. 

As the described age-dependent chain of events can be deduced to well-defined biochemical lesions, the chances of developing a new drug strategy for counteracting or possibly even preventing the adverse consequences of the age-related decrease of the catecholaminergic tone in the brain are fair. 

Patient safety is a relatively new health care discipline that clearly emphasizes the reporting, analysis, and prevention of all types of medical errors that frequently result in adverse health care events. The Institute of Medicine in the United States defines patient safety as "the prevention of harm to patients" [1,2]. 

A medication error is an example of a preventable cause of an adverse drug event and is defined as any preventable event that may result in incorrect medication use or patient harm while the medication is in the control of a consumer, a healfh care professional, or a patient [4,5]. Medication-related errors result in deaths or serious injuries infrequently, but a sizable number of people each year are affecfed due to the widespread use of various types of drugs bofh oufside and wifhin the hospital environments [6]. 

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