The use of medicines - clinical pharmacology Flashcards
What does the MHRA ensure?
human medicines meet acceptable safety, quality and efficacy standards
safety and effectiveness balance
MHRA product
clinical trial authorisation
product license - marketing authorisation
MHRA company
company licenses
manufacturers and wholesalers
Marketing authorisation
ensures medicine meets standards
How long does an MHRA product license last?
5 years
SMC role
advice to NHS Scotland about new licensed meds
review medications given license by MHRA or EMA
Before a new medication is prescribed in Scotland who has to approve it?
SMC
SMC looks at what 4 things before approving a drug for use?
how well it works
which patients could benefit
whether it is as good or better than current drugs
value for money
off label
prescribed outwith terms of marketing authorisation
unlicensed
no marketing authorisation
specials
special formulations for clinical reasons when existing formulation is unsuitable for patient - unlicensed
POM
prescription only medicines - practitioner
Who can prescribe POM?
doctor, dentist, nurse prescriber etc
OTC
pharmacy
general sales list
General prescriptions requirements - primary care
name and address age - under 12 drug name, dose, frequency, formulation, quantity signature by practitioner date of signature type of prescriber and address