Use of Medicine Flashcards
What does the MHRA or EMA do
Regulate and license all U.K medicine
Not influenced by cost
Safety standards and trials of evidence
Yellow card scheme reports
What does the SMC do
Provide advice to NHS Scotland regarding all licensed medicines
Cost effectiveness / QALT
Medicine has to be approved by SMC before it can be prescribed in the NHS
What are categories of medicine
Licensed
Off-label
Unlicensed
Specials
What is off-label
Prescribed outwit terms of marketing license
Liability increased if prescribed
What is unlicensed
No marketing license but can be brought in from another country
What is specials
Special formulation of an existing product
Unlicensed
How can medicine be classified
Prescription only
Over the counter general sale
Over the counter pharmacy
What is the yellow card scheme
Centre for reporting adverse drug reactions in Scotland
Run by the MHRA
What is the EMA
Same as MHRA but for Europe
What is ADTC
Develop regional formularies and implement SMC advice for regional areas
Look at good prescribing practice
OK
How do you report ADR
Yellow card scheme
What can SMC decide for drug
Approval
Approve for restricted use
Not recommended - individual patient treatment request can be made (IPTR)
What should be reported on yellow card scheme
Al suspected ADR for new medicines (black triangle)
All suspected ADR in children even if off-label
All suspected serious ADR for any medication
What do you write all prescription in
Black capital letter