Prescribing - The use of medicines Flashcards
What is the licensing regulation for medicines in the UK?
MHRA
medical and healthcare products regulatory agency
what is the purpose of the MHRA?
assesses that medicine meet acceptable standards on safety, efficacy and quality
ensures the balance between safety and effectiveness is met
what is the difference between licences, unlicensed, off-label and specials?
licensed - accepted for use of a drug for a specific condition in a specific group of patients
unlicensed - not licensed for the use of the drug
off-label - licensed but prescribed outwit the terms of authorisation
specials - special formulation made for clinical reasons when existing formulation is unsuitable for the patient
what are:
- OTC
- GSL
- P
- POM
- controlled
OTC = over the counter
GSL = general sales list
P - pharmacy sales only
POM = prescription only medications
controlled = risk of misuse so the development, marketing, sales, import/export and prescription is monitored very carefully and can only be prescribed in certain circumstances/individuals
how would you report an ADR?
via yellow card scheme
what is the purpose of the yellow card scheme?
used for reporting;
- ADR’s
- fake medicines
- defective medicine
- safety concerns
can you prescribe an unlicensed drug?
yes only if it is necessary to meet the needs of the patient
