Clinical Pharmacology- Use of medicine Flashcards
What is licensing of medicine in the UK done via?
MHRA
MHRA: Regulating medicine and medical devices
What are the 2 main functions of the MHRA?
- Ensures that human medicines meet acceptable standards on safety, quality and efficacy
- Ensures that the sometimes difficult balance between safety and effectiveness is achieved.
What is Pharmacovigilance?
The process involving detection, assessment, understanding and prevention of adverse drug reactions (ADRs).
What does pharmacovigilance provide?
Continual assessment of the risks and benefits of each drug resulting in the best drug therapy for the patient.
What is the main method for post-marketing surveillance of ADRs in the UK?
Yellow Card Scheme
Who can file a yellow card report?
Both healthcare professionals and the public can file a yellow card report
What does the yellow card scheme collect information on?
- Side effects
- Medical device adverse incidents.
- Defective medicines
- Counterfeit or fake medicines or medical devices.
- Safety concerns, e.g. for e-cigarettes or their refill containers (e-liquids).
What type of incidences should be reported via the yellow card scheme?
- Vomiting following administration of new vaccine
* Neutropenia following administration of well-established drug
What type of incidences shouldn’t be reported via the yellow card scheme?
• Sleep disturbance following administration of new drug
What is the GMC guidance on the administration of an unlicensed drug?
You may prescribe unlicensed medicines where, based on 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 the 2 classifications of medication?
Prescription only medicine (POM)
Over the Counter (OTC)
Who is Prescription only medicine (POM) written by before it can be sold or supplied?
An appropriate practitioner
What does it mean when a medication is reclassified from POM to P
It can be prescribed by: • doctor • dentist • supplementary prescriber • nurse independent prescriber • pharmacist independent prescriber
Who can over the counter medication be sold by and where?
A registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist
What medication can only be sold from a pharmacy?
Pharmacy (p) only medicine
