Pharmacovigilance and Pharmaceutical products

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science of collecting, detecting, evaluating, monitoring and preventing adverse drug reactions. As such, pharmacovigilance focuses primarily on adverse drug reactions, or ADRs, which are defined as any response to a medicinal product that is harmful and unintended, including lack of efficacy (the requirement that this definition applies only to doses normally used for the prophylaxis, diagnosis or therapy of a disease, or for the modification of the function of a physiological disorder was excluded in the last amendment of the relevant legislation). Medication errors, such as overdose, misuse and abuse of a medicinal product, as well as exposure to a medicinal product during pregnancy and lactation, are also of interest, even without an adverse event, as they may result in an adverse drug reaction.

 

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