Pharmacology - use of medicines Flashcards
- Licensing regulations for Medicines
- Legal Categories of medicine
- Formularies – National and Local
- Use of evidence based guidelines
- IV Guidelines
.
A license from what body must be obtained before it can be used to treat people
MHRA (Medicines and Healthcare products Regulatory Agency)
What is pharmacovigilance
Process involving detection, assessment, understanding and prevention of adverse drug reactions
Basically the process of picking up problems with drugs once they have been licensed for use (i.e. after the trial phase has finished) since not all effects of a medication will be discovered in trials
What is the yellow card scheme
main method for post-marketing surveillance of ADRs in the UK.
The yellow card scheme collects information on suspected problems involving what (5)
Side effects
Medical device incidents;
Incidents involving defective medicines;
Counterfeit or fake medicines or medical devices;
Safety concerns
Who can file a yellow card report
Anyone
Healthcare professionals should report all suspected adverse reactions involving (3)
New drugs
Children
Serious ADRs for established drugs
What 4 pieces of info to include on a yellow card report
Side-effects;
information about the person experiencing the side-effect;
the name of the medicine;
your name and full address.
Legal categories of medicines
Unlicensed
Off-label - licensed but prescribed outwith terms of authorisation
Specials - special formulations made when existing formulation of an available licensed product unsuitable for patient = unlicensed
What is the GMC guidance on use of unlicensed medicines
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.
Carefully consider treatment that you prescribe and justify your decisions
Human Medicines Regulations 2012 – separated medications for human use into 3 classes:
Prescription-only medicines (POM)
Over the counter (OTC)
- what are the 2 subdivisions of OTC?
Pharmacy (P) medicines
General Sales List (GSL) medicines
With regards to General Sales List drugs:
A. Their sale is restricted to pharmacies
B. They can be bought in some supermarkets
C. They require a prescription written by an appropriate practitioner before they can be supplied by a pharmacist
D. Include controlled drugs
E. Can only be bought by someone over the age of 16
E
What are P only medicines
Sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist.
What are the key details of a prescription
Name and address of patient;
Age of patient if under 12 years old;
Details of drug name, formulation, dose, frequency and quantity
Signature of appropriate practitioner;
Date on which is signed;
Type of prescriber and address
If less than 1g, use what unit?
If less than 1mg, use what unit?
mg (miligrams)
micrograms (do not abbreviate)
