Pharmacovigilance and Adverse Drug Reactions (ADR) - A Guide PDF
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Instituto Arzobispo Loayza
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Summary
This document details pharmacovigilance, the science of detecting, evaluating, understanding, and preventing adverse effects of medications. It also outlines adverse drug reactions (ADR), their factors, and their classification, along with technovigilance and reporting procedures. The document is aimed at healthcare professionals.
Full Transcript
# **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.
