ADVERSE EVENT REPORTING

Any undesirable clinical occurrence in a patient who has been administered a product—whether a medicinal product, medical device, or cosmetic—which does not necessarily have a causal relationship with its use.¹ In this context, the key consideration is the temporal association, without any suspicion of a causal relationship.

The World Health Organization (WHO) defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding, and prevention of adverse events or any other health problem associated with medicines or vaccines.²

The Pan American Health Organization (PAHO) defines technovigilance as a set of methods and observations used to detect adverse events during the use of a medical device that could harm the patient, the operator, or their surroundings. Problems, malfunctions, risks, or potential risks arising from the use of medical devices may be collectively referred to as adverse incidents.³

Cosmetovigilance is defined as the activity of collecting, assessing, and monitoring information concerning undesirable effects observed as a result of the normal or reasonably foreseeable use of cosmetic products, as well as implementing measures and disseminating information related to such effects.⁴