The use of Medicines Flashcards
Who can license a drug?
EMA - European medicine authority
MHRA - Medicines and Healthcare products Regulatory Agency (for UK)
Who needs to authorise a clinical trial?
MHRA - clinical trial authorisation.
What happens after a clinical trial?
The results are sent to MHRA for detailed assessment - then they give it a marketing authorisation.
What is pharmacovigilance?
the practice of monitoring the effects of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously unreported adverse reactions.
Because theres no way all of the adverse drug reactions/side effects will be picked up during the clinical trial. + Theres not much trial info for children and the elderly as they’re usually not involved in trials.
How are adverse drug reactions reported in the UK?
MHRA - Yellow card scheme.
What adverse reactions should healthcare professionals report?
Reactions to:
- new drug on the market
- black triangle drug
- reactions in children
- serious reactions to established drugs and vaccines
What are off-labelled/unlicensed?
the medicine isn’t licensed for treatment of your condition.
the medicine will have a licence to treat another condition and will have undergone clinical trials for this.
What is a specials medicine?
a category of unlicensed medicines that are manufactured or procured specifically to meet the special clinical needs of an individual patient.
Can you prescribe unlicensed medicines?
Yes - if its necessary to do so. You must be able to justify your decisions.
What are the classifications of medicines?
Prescription only medicines
Over the counter
Pharmacy
General sales list
Where can general sales list medicines be sold?
In pharmacies and other retail outlets.
Where can pharmacy only drugs be sold?
From a registered pharmacy from a pharmacist
Not for self selection
Can be sold without a prescription but need to be sold under the supervision of a pharmacist.
What are controlled drugs?
A drug associated with dependence and can be used in an abusive manner.
