Pharmacovigilance and Adverse Drug Reactions (ADR) - A Guide PDF

# **Pharmacovigilance** The science and activities relating to the detection, evaluation, comprehension, and prevention of adverse effects of medications or any other problem related to them. * Perspectivas Políticas de la OMS sobre medicamentos (2004). ## Adverse Drug Reaction (ADR) An unexpecte...

# **Pharmacovigilance** The science and activities relating to the detection, evaluation, comprehension, and prevention of adverse effects of medications or any other problem related to them. * Perspectivas Políticas de la OMS sobre medicamentos (2004). ## Adverse Drug Reaction (ADR) An unexpected reaction to a medication that is harmful and unintentional. It happens when the medication is being used as recommended for diagnosis, prophylaxis, treatment or modification of physiological function. * (OMS 2001) ### **Factors that influence the appearance of ADR** * Factors that depend on the drug * Factors that depend on the patient * Extrinsic factors # **Technovigilance** A series of activities aimed at the prevention, detection, investigation and dissemination of information on IADM during its use. It can generate damage to the user, operator or the surrounding environment. * (OPS/OMS) # **Adverse Event Classification** * **Mild Adverse Events** When these do not modify the quality of life of the patient or their daily activities. * **Moderate Adverse Events** When these change the normal daily activities of the patient. * **Serious Adverse Events** When these endanger the life of the patient, cause hospitalization, or prolong their hospitalization. * (OPS/OMS) # **Reporting of Suspected Adverse Events** The text on this page is a form for reporting suspected adverse events and is a part of the image. * This form requires the patient's identification, data on the medical device, information on the suspected adverse event, and data on the reporter of the event.