Adverse events

Adverse Events refer to any undesirable experiences associated with the use of a medical product in a patient. The concept of adverse events is critical in pharmacovigilance, clinical trials, and patient safety initiatives.

Definition

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the product.

Classification

Adverse events can be classified into two broad categories: serious adverse events and non-serious adverse events. Serious adverse events are those that result in death, are life-threatening, require hospitalization or prolongation of existing hospitalization, result in disability or incapacity, or are a congenital anomaly or birth defect. Non-serious adverse events are any other events that do not meet the definition of a serious adverse event.

Reporting

The reporting of adverse events is a key component of pharmacovigilance and provides the data necessary for the understanding of the risk-benefit profile of drugs. In many countries, healthcare professionals are required to report suspected adverse events to the national health authority. In addition, many pharmaceutical companies have systems in place to capture all adverse events reported to them by healthcare professionals and patients.

Prevention and Management

Prevention and management of adverse events involve a range of activities, including patient education, monitoring of patients, and use of strategies to mitigate risk. The choice of strategy depends on the nature of the adverse event, the drug involved, and the patient's individual risk factors.

See Also

• Pharmacovigilance
• Clinical trials
• Patient safety
• Serious adverse events
• Non-serious adverse events

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