Nội dung text 24. SCOPE, DEFINITION AND AIMS OF PHARMACOVIGILANCE.pdf
PHARMD GURU Page 1 The word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. DEFINITION: Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. SCOPE: Pharmacovigilance conducting advanced drug monitoring study based Adverse drug reactions, adverse events report of new drugs include: 1) Medication errors and irrational use of medicines. 2) Herbal, traditional and complimentary medicines. 3) Substandard medicines and counterfeit medicines. 4) Blood products, biologicals, medical devices and vaccines ADR Pharmacovigilance main aim is to give clear information regarding drug safety and its Risk or benefits of drugs to the patients. Patients are main end users of medicine. Patient information leaflet relating to medicine to be provided to the patient to increase the advantages of the medication and to reduce the risk associated with them. It is essential for Risk Minimization by making an early detection and preventing the progression of the adverse effects. AIMS OF PHARMACOVIGILANCE: Events such as the thalidomide tragedy highlight the extreme importance of effective drug monitoring systems for all medicines. The principal aims of pharmacovigilance programs are: 1) To improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions. 2) To improve public health and safety in relation to the use of medicines. SCOPE, DEFINITION AND AIMS OF PHARMACOVIGILANCE