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VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that occur after administration of vaccines to ascertain whether the risk–benefit ratio is high enough to justify continued use of any particular vaccine.
A 2001 study estimated that 1% of hospital admissions result in an adverse event due to negligence. [23] Identification or errors may be a challenge in these studies, and mistakes may be more common than reported as these studies identify only mistakes that led to measurable adverse events occurring soon after the errors.
Generally, any event which causes death, permanent damage, birth defects, or requires hospitalization is considered a serious adverse event. [4] The results of trials are often included in the labelling of the medication to provide information both for patients and the prescribing physicians.
An adverse event can also be declared in the normal treatment of a patient which is suspected of being caused by the medication being taken or a medical device used in the treatment of the patient. In Australia, 'Adverse EVENT' refers generically to medical errors of all kinds, surgical, medical or nursing related.
The NOAEL could be defined as "the highest experimental point that is without adverse effect," meaning that under laboratory conditions, it is the level where there are no side-effects. It either does not provide the effects of drug with respect to duration and dose, or it does not address the interpretation of risk based on toxicologically ...
Temporal relationship is said to exist when an adverse event occurs when a patient is taking a given drug. Although a temporal relationship is absolutely necessary in order to establish a causal relationship between the drug and the AE, a temporal relationship does not necessarily in and of itself prove that the event was caused by the drug.
After an adverse event occurs, each country has its own way of dealing with the incident. In Canada, a quality improvement review is primarily used. A quality improvement review is an evaluation that is completed after an adverse event occurs with the intention to both fix the problem as well as prevent it from happening again. [41]
An adverse event (AE) refers to any unexpected and inappropriate occurrence at the time a drug is used, whether or not the event is associated with the administration of the drug. [1]: 1.2 Adverse Event (AE) An ADR is a special type of AE in which a causative relationship can be shown. [3] ADRs are only one type of medication-related harm.