Lecture 6 -Pharmacovigilance And Pharmacogenetics Flashcards
What is pharmacovigilance?
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problem
What is the point of pharmacovigilance?
Enhance patient care and saftey in relation to use of medicines
What is the MHRA?
Agency for the department of health and social care that’s responsible for ensuring that medicines and medical devices work and are acceptably safe
What are ADRs?
Adverse drug reactions
A repsonse to a drug which is noxious and unintended and which occurs at doses normally used in man (a causal link)
What is the relationship of Thalidomide and ADRs?
Was used as a sedative and hypnotic
Was used with pregnant women when we didn’t know it was extremely Tetragenic
Dad to babies being born with phocomelia or limb malformation
What is thalidomide used for today?
Cancer
Leprosy treatments
What is an adverse drug event?
An injury that occurs during treatment and is not necessarily a caused by the drug itself
Adverse drug reaction is caused by the drug itself
What are augmented drug reactions/events?
Dose dependant
E.g bleeding after anticoagulants
What are bizarre drug reaction/events?
Dose independant
Urticaria from aspirin(not sure how it happens)
What are the 4 different types of mechanism of action for an adverse drug reaction?
-Exaggerated response
-Desired pharmacological effect at an alternate/different site (GTN headache)
-additional secondary pharmacological effect
-Triggering an immunological response (anaphylaxis)
Why are clinical trials limited in terms of assessing adverse drug reactions/longn term side effects?
Hard to identify reactions that are low frequency
Just might not see it in a trial population
What is the yellow card scheme?
Where all suspected ADRs including minor ones and reactions to vaccines are reported to the MHRA
What is pharmacogentics?
How a persons genetics afffects their ability to metabolise and respond to drugs
What is pharmacogenomics?
The study of how populations enter genomes affect their ability to respond to drugs (not just individual genes)
What is precision medicine?
When an indivudals genome is assessed along with other clinical and diagnostic information and then drugs are given to that patient on that basis
