Clinical Pharmacology- Use of medicine Flashcards
(25 cards)
What does MHRA stand for?
Medicines & Healthcare products Regulatory Agency
What is the function of the MHRA?
Regulates which medications can be used in the UK
What licences can the MHRA give out?
- Clinical Trial Authorisation
- Marketing Authorisation
- Manufacturers or Wholesale dealer’s license
What is marketing authorisation?
License given by the MHRA to a product once it meets their safety, quality and efficacy standards.
When is marketing authorisation given by the MHRA?
Licence given when it meets their safety, quality and efficacy standards.
How long does marketing authorisation last?
5 years
What is the 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
What do the Scottish Medicines Consortium (SMC) do?
Regulates what meds are used in Scotland
What’s different about the SMC process to the MHRA process?
- MHRA just review whether the med is safe for use.
* SMC- Essentially dictating which meds should be used in scotland rather than just what’s available
What is off-label prescribing?
Prescribing a med with marketing authorisation but for something it’s not authorised for
What is unlicensed prescribing?
Prescribing a medication with no marketing authorisation
What are the groups of medications based on?
Who can provide them
What are the 2 groups of medications?
POM-Pharmacy Only Medication
OTC-Over The Counter medication
What are the 2 forms of over the counter medication?
- General Sale List
* Pharmacy only
Where can general sales list drugs be sold?
Can be sold outside pharmacies e.g. paracetamol in shops
What is the problem with pharmacy only drugs?
Require a pharmacist i.e. not suitable for public selection
What formularies can be referred to when prescribing?
- BNF
* NHS Grampian Joint Formulary
What is the formal name for a patients Kardex?
Prescription & Administration Record (PAR)
What is pharmacovigilance?
Detection, assessment, understanding and prevention of adverse drug reactions (ADRs)
What is the yellow card scheme?
Main method for post-marketing surveillance of ADRs
Who can file a yellow card report?
The public and healthcare professionals
What do yellow cards collection information of?
- Side effects
- Medical device adverse incidents.
- Defective medicines
- Counterfeit or fake medicines or medical devices.
- Safety concerns
What type of incidences should be reported via yellow card scheme?
- Vomiting following administration of new vaccine
* Neutropenia following administration of well-established drug
What type of incidences should not be reported via yellow card scheme?
Sleep disturbance following administration of new drug
