Pharmacovigilance system : A system organized by holders of registration certificates and national authorized bodies to carry out tasks and responsibilities for pharmacovigilance, designed to monitor the safety of medicines, timely detection of all changes in assessing the benefit ratio -Risk of medicines, development and implementation of measures to ensure the use of medicines when the excess of benefits over risk.
Quality control and assurance : Monitoring, evaluation, ensuring the effectiveness and compliance with the established requirements of the structural elements and processes of the pharmacovigilance system.
Adverse reaction : An unintended adverse reaction in the body associated with the use of a drug and suggesting at least a possible relationship with the use of a suspected drug. NOTE Adverse reactions may occur with the use of the drug in accordance with the approved instructions for medical use, in violation of the instructions for medical use or as a result of exposure associated with the occupation. Use cases not in accordance with the instructions for medical use include off-label use, overdose, abuse, misuse and medical errors.
Adverse event : Any adverse change in the health status of the patient or subject of the clinical trial / trial to whom the drug / study drug was prescribed, regardless of the causal connection with its use. NOTE An adverse event can be any unfavorable and unintentional change (for example, a deviation of a laboratory indicator from the norm), a symptom or disease, the time of occurrence of which does not exclude a causal relationship with the use of the drug, regardless of the presence or absence of the relationship with the use of the funds.
Unexpected adverse reaction : An undesirable reaction, the nature, severity or outcome of which does not match the information in the current instructions for medical use of the medicine or in the researcher's brochure for unregistered medicine. < / p>
Misuse : Intentional and improper use of a medicinal product that does not comply with that approved in the instructions for medical use.
Serious adverse reaction : An undesirable reaction that leads to death, poses a threat to life, requires hospitalization of the patient or its extension, leads to persistent or severe disability or disability, to congenital abnormalities or malformations, requires medical intervention to prevent the development of these conditions.
Medication error : Any unintentional mistake by a healthcare worker, patient, or consumer in prescribing, dispensing, dosing, or administering / taking a medication.
Overdose : The use of the drug at one time or during the day in an amount that exceeds the recommended maximum daily dose in accordance with the approved instructions for medical use. The cumulative effect associated with an overdose is also taken into account.
Off-label use : Intentional use of a medicinal product for medical purposes not in accordance with the instructions for medical use.
Risks related to use of a medicinal product : Any risk associated with the quality, safety or effectiveness of the drug in relation to the health of patients or the public, or any risk leading to undesirable environmental impact.
Spontaneous report : Voluntary transmission of data by a health professional or consumer to an authorized body, holder of a registration certificate or other authorized organization (for example, the World Health Organization, regional pharmacovigilance centers, poison control centers), which contain a description of one or more adverse reactions in a patient who has taken one or more drugs, and which were not obtained during clinical research or any other method of organized data collection.
Risk-benefit balance : Evaluation of the positive therapeutic effects of the drug in relation to the risks associated with its use