Licencing, Adverse drug reactions and Advertising Flashcards
1
Q
Which organisation controls the applications for marketing authorisation and yellow card scheme?
A
The comission on human medicines (CHM)
2
Q
What is an adverse drug reaction?
A
a response to a drug that is noxious or unintended
3
Q
What is pharmacovigilance?
A
Process of identifying and acting on safety issues
4
Q
What are the four pieces of information you put on a yellow report form?
A
An identifiable patient, source, drug, suspect reaction
5
Q
What is the misuse of drug regulations (2001)?
A
Series of requirements introduced for controlled drugs e.g. diamorphine