The Use of Medicines Flashcards
what does MHRA stand for?
Medicines and Healthcare Products Regulatory Agency
what does the MHRA do?
ensure human medicines meet acceptable standards on safety, quality and efficacy.
what does a product licence - marketing authorisation mean?
medicine meets the standards of safety, quality and efficacy
granted for periods of up to 5 years
variations common
what does SMC stand for?
Scottish Medicines COnsortium
what does the SMC do?
The SMC provides advice to NHS Scotland regarding all new licenced medicines, new formulations of
existing medicines and new indications for established products. They review medicines that have
received a licence from the MHRA or the EMA. Before a medicine can be routinely prescribed in
Scotland it has to be accepted by SMC.
when reviewing a new medicine, what does the SMC look at?
how well it works
which patients could benefit
whether it is as good as or better than the medicines currently used
value for money
if a drug is prescribed off-label what does this mean?
prescribed outwith the terms of marketing autorisation
if a drug is prescribed unlicensed what does this mean?
no marketing authorisation
if a drug is prescribed specials what does this mean?
special formulation of medicines made for clinical reasons when an existing formulation of an available licensed product is not suitable for a patient
what is the GMC guidance on unlicensed medicines?
You should usually prescribe licensed medicines in accordance with the terms of their licence.
However; you may prescribe unlicensed medicines where, on the basis of an assessment of the
individual patient, you conclude, for medical reasons, that it is necessary to do so to meet the specific
needs of the patient.
what are pharmacy medicines?
Pharmacy only medicines are sold for a registered pharmacy premises by a pharmacist or a person
acting under the supervision of a pharmacist. These medicines are not for public self-selection. There
are additional legal/professional considerations.
what are general sales list medicines?
These can be sold in registered pharmacies but also in other retail outlets. For example, paracetamol
in pack size 16 or 32.
what are prescription only medicines?
Prescription only medicines must be written by an appropriate practitioner before it can be sold or
supplied. Some medicines come under more than one category of classification e.g. formulation,
strength, quantity, indication or marketing authorisation. There are a number of medicines being
reclassified from POM to P to improve access to medicines with a safety net of pharmacists.
list examples of appropriate practitioners
doctor Dentist Supplementary prescriber Nurse independent prescriber Pharmacist independent prescriber EEA and Swiss doctors and dentists (limited) Community practitioner nurses (limited) Optometrist independent prescribers (limited)
what are the general prescription requirements?
- Name and address of patient
- Age of patient if under 12 years old
- Details of drug name, formulation, dose, frequency, and quantity to be dispensed
- Signed in indelible ink by appropriate practitioner
- Date
- Type of prescriber and address
