Pharmacology - Prescribing Flashcards
Who regulates which medications can be used in the UK?
MHRA - Medicines & Healthcare products Regulatory Agency
What licenses can the MHRA give out?
1) Clinical Trial Authorisation
2) Marketing Authorisation
3) Manufacturers or Wholesale dealer’s license
What is a “Marketing Authorisation”?
License given by the MHRA to a product once it meets their safety, quality and efficacy standards.
Lasts up to 5yrs
What are Manufacturer’s and wholesale dealer’s authorisation?
Licenses given by the MHRA to a company qualifying that their manufacture, distribution and supply of a product meets their safety & quality standards
Basically allows that company to make and sell a particular med
Who regulates what meds are used in scotland?
The Scottish Medicines Consortium (SMC)
What’s different about the SMC process to the MHRA process?
MHRA just review whether the med is safe for use.
The SMC compare it’s efficacy to existing meds & take into account value for money. Essentially dictating which meds should be used in scotland rather than just what’s available
Define off-label prescribing?
Prescribing a med with marketing authorisation but for something it’s not authorised for
Define unlicensed prescribing?
Prescribing a medication with no marketing authorisation
This includes “Specials”, special formulation made for clinical reasons when existing formulation of a licensed product isn’t suitable
Medications are grouped into 2 categories based on who can provide them, what are they?
POM - Prescription only meds
OTC - Over the counter
What are the different types of OTC drugs?
General Sale List - Can be sold outside pharmacies e.g. paracetamol in shops
Pharmacy only - Require a pharmacist i.e. not suitable for public selection
What formularies can you refer to when prescribing?
BNF
NHS Grampian Joint Formulary (takes into account SMC advice, local requests and funding)
What’s the proper name for a patien’ts Kardex?
Prescription &Administration Record (PAR)
When filling out a PAR, how do you prescribe combination medications e.g. Co-amilofruse?
They come in different strengths e.g. 2.5mg:20mg or 5:40 etc..
Make sure to put that strength in the “Medication/Form box”:
E.g. CO-AMILOFRUSE 2.5mg:20mg
When filling out a PAR, how do you prescribe combination inhalers?
They have different dose combinations marked with a number that denotes their steroid component e.g. Seretide 50, Seretide 100, Seretide 125 etc.
As well as different formulations (Accuhaler dry powder or Evohaler aerosol)
Make sure to put the strength in the “Medication/Form” box
And the formulation in the “Additional instructions” box
How do you prescribe a medicine in a liquid solution?
Note mg of active ingredient per ml
E.g. “Paracetamol 120mg/5ml”
What is pharmacovigilance?
- The process involving detection, assessment, understanding and prevention of adverse drug reactions (ADRs).
- Provides continual assessment of the risks and benefits of each drug resulting in the best drug therapy for the patient.
What is the main scheme used for pharmacovigilance?
The yellow card scheme
What information does the yellow card scheme collect?
- side effects
- medical device incidents
- defective medicines
- counterfeit/fake medicines
- safety concerns
would information should a yellow card scheme involve?
1-Side effects
2-Information about the person who had that side effect
3-The name of the medicine which is thought to have caused the side effecr
4-Your name and full address
what are some of the general rules regarding prescription?
Less than 1 g – write as mg
E.g. 500mg not 0.5g
Less than 1 mg – write as micrograms
E.g. 500 micrograms not 0.5mg
Do not use latin
What is important when prescribing warfarin?
IT HAS A SEPARATE CHART
