Pharmacovigilance dictionary


Adverse reaction / suspicious adverse reaction: An unexpected negative reaction of the human body when using the drug in the dosage indicated in its product information.
Unexpected adverse reaction: Adverse drug reaction which did not mention in the product information.
Serious adverse reaction: An adverse reaction which results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly/birth defect.
Pharmacovigilance: the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem.
Risk: Any undesirable type of risk to the patient's health and public health associated with the quality, safety and effectiveness of the medicinal product.
Healthcare professional: Reporter of a suspicious adverse drug reactions; medically qualified persons, such as physicians, dentists, pharmacists, nurses and coroners, or as otherwise specified by local regulations.
Signal: Information arising from one or multiple sources, including observations and experiments, which suggests a new potentially causal association, or a new aspect of a known association between an intervention and an event or set of related events, either adverse or beneficial, that is judged to be of sufficient likelihood to justify verificatory action
AEC: The Analytical Expertise Center of the Ministry of Health of the Republic of Azerbaijan - is the National Pharmacovigilance Center of the Republic of Azerbaijan.
Reporting form: Format and content for the reporting of one or several suspected adverse reactions to a medicinal product that occur in a single patient at a specific point of time 
Patient: Person, who experiencing suspicious adverse drug reaction.
Risk-benefit balance: An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health.