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
Recognise importance of genetic polymorphism affecting harmcokinetics and dynamics
What is in place for reporting adverse drug reactions
Yellow card scheme
- all suspected ADR in new products (including minor)
- serious/unusual reactions to established products
What is the difference between type A and B adverse drug reactions?
Augmented:
- dose dependent
- frequent + predictable
- explained by pharmacologic drug effect
.
Bizarre:
- dose independent
- rare + unpredictable
- not explained by pharmacologic drug effect
Who do adverse drug reactions do to be reported to?
MHRA
What are the 4 Ps of pharmcogenomics?
- Prediction + Prevention
- precise
- personalised
- participatory
