Pharmacovigilance activities contribute to the protection and promotion of public health through preventing harm caused by medicines as well as by enabling the safe and effective use of medicines. Pharmacovigilance activities are performed by regulators and pharmaceutical companies, including risk management planning, collecting and managing suspected adverse reaction (ADR) reports, signal detection and management, and post-authorisations studies that enable the generation of new information about marketed medicines. Regulators have several tools for taking action when new information based on pharmacovigilance data emerges. Regulatory actions are aimed at informing prescribers, healthcare providers or patients of new information on the quality, safety or efficacy of a medicine, to advise them to modify their behaviour or how to use medicines in order to prevent or minimise adverse events, to restrict to the use of medicines when the benefit-risk profile of a product is no longer positive for a certain patient population, or a combination of these actions.
The PRAC Impact Strategy describes the conceptual approach, principles and stakeholders, as well as the processes for prioritisation and conduct of impact research implemented by the EU Medicines Regulatory Network (EMRN) to systematically investigate how pharmacovigilance activities and major regulatory actions translate into measurable positive health outcomes (e.g. through reduction of harm from adverse reactions) and to determine potential unintended consequences in daily healthcare that may counteract risk minimisation efforts.
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