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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Clozapine, sold under the brand name Clozaril among others, is a psychiatric medication and was the first atypical antipsychotic to be discovered. [6] It is primarily used to treat people with schizophrenia and schizoaffective disorder who have had an inadequate response to two other antipsychotics, or who have been unable to tolerate other drugs due to extrapyramidal side effects.
In public surveys, a significant majority of those surveyed believe that health care providers should be required to report all serious medical errors publicly. [ 179 ] [ 180 ] However, reviews of the medical literature show little effect of publicly reported performance data on patient safety or the quality of care. [ 181 ]
The report was based upon analysis of multiple studies by a variety of organizations and concluded that between 44,000 to 98,000 people die each year as a result of preventable medical errors. For comparison, fewer than 50,000 people died of Alzheimer's disease and 17,000 died of illicit drug use in the same year. [1]
Variations in healthcare provider training & experience [45] [52] and failure to acknowledge the prevalence and seriousness of medical errors also increase the risk. [53] [54] The so-called July effect occurs when new residents arrive at teaching hospitals, causing an increase in medication errors according to a study of data from 1979 to 2006.
Many different professionals (physicians, clinical pharmacists, nurses, medical laboratory scientists, etc.) are involved with the various elements of drug concentration monitoring, which is a truly multidisciplinary process. Because failure to properly carry out any one of the components can severely affect the usefulness of using drug ...
Examples range from simple devices such as tongue depressors, medical thermometers, and disposable gloves to advanced devices such as medical robots, cardiac pacemakers, and neuroprosthetics. This modern concept of monitoring and safety of medical devices which is known materiovigilance was quite documented in Unani System of medicine.
The FDA can require a pharmaceutical company to place a boxed warning. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of preventable, serious or even life-threatening adverse effects .