VIGILANCES Flashcards
What is the definition of risk in the context of health vigilance?
Da nger or inconvenience to which one is exposed, potential harm or adverse event
The principle of health safety aims to ensure patient safety and reduce the risk of adverse events.
Define the term ‘vigilance’ as it relates to health.
A permanent watch aimed at reporting, managing, and investigating adverse events related to therapeutic products
Includes traceability of products and responses to health alerts.
What are the key principles of the health vigilance system?
Rapid alert capability, strong scientific expertise, transparency in decision-making, independence from economic interests, legal autonomy
What is the role of the ARS and ANSM as per the 2016 health system modernization law?
Responsible for the organization and territorial coverage of health vigilance
What are the different types of vigilance to know?
- Pharmacovigilance
- Hemovigilance
- Materiovigilance
- Reactovigilance
- Toxicovigilance
- Infectiovigilance
- Biovigilance
- Cosmetovigilance
- Radiovigilance
- Nutrivigilance
- Tatouvigilance
True or False: The declaration of adverse events is optional in health vigilance.
False
It is mandatory to report any adverse events or incidents.
What is pharmacovigilance?
Surveillance, evaluation, prevention, and management of adverse effects resulting from medication use
What constitutes an adverse event in pharmacovigilance?
Any harmful manifestation occurring in a person treated with a medication, whether or not it is suspected to be related
Define ‘materiovigilance’.
Surveillance of incidents or accidents related to the use of medical devices
What does hemovigilance monitor?
Procedures for surveillance, evaluation, and prevention of incidents and adverse effects occurring in blood donors and recipients
What is the role of addictovigilance?
Surveillance of cases of abuse and dependence on psychoactive substances excluding tobacco and alcohol
What is toxicovigilance?
Monitoring of substances that may have toxic effects on humans, whether acute or chronic
What does biovigilance involve?
Monitoring risks associated with the therapeutic use of elements and products derived from the human body
What is identity vigilance?
A systematic approach to ensuring patient identity throughout their healthcare journey
Fill in the blank: The obligation to report adverse events is known as _______.
[the obligation of declaration/signalement]
What is the significance of the method ALARM in analyzing adverse effects?
A systemic method for analyzing causes and consequences to identify root causes of errors
What is the purpose of the regulatory framework for health vigilance?
To ensure compliance with norms and regulations in health establishments
What are the consequences of non-compliance with health vigilance norms?
Sanctions can be imposed on the establishment or manufacturer responsible
What is the main goal of health vigilance?
To alert and respond to health risks and minimize consequences
What are the responsibilities of health professionals in vigilance?
To report any adverse events or incidents they observe
True or False: The ANSM is one of the most important agencies in health vigilance.
True
What is the primary focus of identito vigilance?
Managing medication errors and ensuring patient identification
What is the purpose of the creation of regional support structures (SRA)?
To provide expertise and support for care quality management
What does the term ‘mesusage’ refer to?
Non-compliant use of a medication contrary to its authorization
