Pharmacovigilance – a process related to the detection, collection, evaluation, study, and prevention of adverse reactions, adverse events following immunization/tuberculin diagnostics, and any other issues associated with the safety and effectiveness of medicines, vaccines, and tuberculin.
What should be reported:
Adverse reactions
Other important safety information that must be reported (special situations):
· Lack of therapeutic effectiveness
· Use during pregnancy and breastfeeding
· Abuse/misuse
· Off-label use
· Occupational exposure to a medicinal product
· Drug–drug interactions
· Medical error (including potential and intercepted errors)
· Incorrect use
· Overdose
· Suspected transmission of infection through a medicinal product
Minimum information required (4 minimum reporting elements):
Identifiable Patient (initials, sex, age)
Identifiable Reporter (name and phone number)
Adverse reaction / special situation (symptoms, duration)
Suspected Product (name, batch/lot number)
Important!
If fewer than 4 minimum reporting elements are available and you only have information about the product and the adverse reaction, you still must forward such a report.
It is strictly forbidden to record patient identification data such as full name or home address.
You must clearly state exactly what the reporter said, without interpreting the information.
You must report cases regardless of:
· The seriousness of the adverse reaction/special situation
· Whether the adverse reaction/special situation is listed in the product information
· How long ago the adverse reaction/special situation occurred
Report all available information as soon as possible (within 24 hours)!
You can report the information by completing an Adverse Reaction Report Form or in free form by emailing: farmaconadzor@ventaltd.com.ua
By following these rules, you help keep medicines safe and effective!