pharmacovigilance Flashcards
1
Q
What is pharmacovigilance?
A
DUAP
- The science and activities relating to the detection, assessment, understanding and prevention of adverse effects of pharmaceutical product.
- Before medicine authorised, safety and efficacy limited to results from clinical trials and may not reveal all the possible side effects/hazard. After authorisation of medicine certain new side effects/hazard may arise, due to not being under the controlled conditions where its being administered to large numbers of patients over a longer period time.
2
Q
why is it important? pharmacovigilance Importance (AEE, PASS)
A
- Aids with post authorisation safety study.
- enhance patient care and patient safety by monitoring medicine throughout the entire drug development and manufacturing lifecycle and its use in healthcare practice.
- Effective assessment of the risk-benefit profile of medicines.
