Spontaaniraportteja

Spontaaniraportteja, also known as spontaneous reports, are unsolicited reports of adverse events or suspected adverse reactions to drugs, medical devices, or other health products. These reports are crucial for post-marketing surveillance, which is the ongoing monitoring of a product's safety and effectiveness after it has been approved for use. Spontaneous reports can come from various sources, including healthcare professionals, patients, and consumers. They are often submitted to regulatory authorities, such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in Europe, and are used to identify potential safety issues, assess the risk-benefit profile of a product, and inform decision-making processes. While spontaneous reports are valuable, they should be interpreted with caution, as they can be incomplete, biased, or subject to reporting delays. Therefore, they are typically used in conjunction with other data sources, such as clinical trials and observational studies, to gain a comprehensive understanding of a product's safety profile.