Pharmacovigilance + Pharmacogenetics Flashcards
Define pharmacovigilance
The science and activities relating to detection, assessment, understanding + prevention of adverse effects or any other possible drug related problem
(Testing the safety of drugs)
What is an adverse drug event?
An injury that occurs during treatment + is no necessarily caused by the drug itself
What is an adverse drug reaction?
A response to a drug which is noxious + unintended + occurs at doses normally used in man
Limitations of early phase trails
Challenges of causality assessment of adverse drug reactions
Clinical relevance of pharmacogenomics + effects of efficacy and toxicity
Example of type A adverse drug reactions
- bleeding after anticoagulant
- hypoglycaemia from insulin
Example of type B adverse drug reaction
- Urticaria from aspirin
- exanthema from antibiotics
What are the types of adverse drug reactions?
ABCDE
- Augmented
- Bizarre
- Chronic
- Delayed
- End of Treatment
Outline type A adverse drug reactions
Augmented
- dose dependent
- frequent + predicable
- explained by pharmacological drug effect
Outline type B adverse drug reactions
Bizarre
- dose independent
- rare + unpredictable
- not explained by pharmacologic dug effect
Outline type C adverse drug reactions
Chronic
- dose + time dependent
- rare
- long term exposure
Outline type D adverse drug reactions
Delayed
- time dependent
- very rare
Outline type E adverse drug reactions
End of treatment
- time dependent
- rare
- relapse after stopping therapy
What are the four mechanism of actions of an adverse drug reaction?
- exaggerated response
- desired pharmacological effect at alternative site
- additional pharmacological effect
- triggering an immunological response e.g. anaphylaxis
