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)

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2
Q

What is an adverse drug reaction?

A

a response to a drug that is noxious or unintended

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3
Q

What is pharmacovigilance?

A

Process of identifying and acting on safety issues

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4
Q

What are the four pieces of information you put on a yellow report form?

A

An identifiable patient, source, drug, suspect reaction

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5
Q

What is the misuse of drug regulations (2001)?

A

Series of requirements introduced for controlled drugs e.g. diamorphine

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