Personalised medicines Flashcards
What are personalised medicine?
Using the genetic profile to inform decisions made about an individual’s treatment plan
What is the aim of personalised medicine?
Maximum efficacy of treatment and significant reduction in the risk of undesirable side effects
What is the US definition of personalised medicine?
The application of genomic and molecular data to better target the delivery of health care, facilitate the discovery and clinical testing of new products, help determine a person’s predisposition to a particular disease or condition, and identify any targeted prevention strategies for that predisposition
Where are the highest concentrations of P450s found?
The liver and small intestine
How do P450s make molecules more soluble in water?
Add oxygen atoms to them
How many genes for human P450 enzymes have been found?
57
Which P450 is responsible for codeine metabolism?
CYP2D6
Which P450 is responsible for paracetamol toxicity?
CYP3A4
Which P450 metabolises warfarin?
CYP2C9
HER2 is overproduced in 25% of what?
Breast cancers
What is a ‘special’?
A non-licensed medicine manufactured to fulfil the prescriber’s requirements manufactured under a Special Manufacturing Licence (MS)
What conditions need to be met for a special?
Bona fide unsolicited order
In accordance with spec of prescriber
For use by prescribers individual patients on his direct responsibility
GMC rules allow prescribing of unlicensed medicines as long as what?
the licensed form is inappropriate for the patient
there is evidence the medication is safe and effective
Who is liable if an unlicensed medicine causes harm?
the prescriber/ pharmacist
Whos consent needs to be gained before a special is prescribed?
the patient
Why are pharmacists increasingly buying in specials rather than preparing them extemporaneously?
To ensure quality in the manufacturing process and to enhance patient safety
Which act is extemporaneous dispensing carried out under?
Section 10 exemption to Medicines Act 1968
Is product testing required for extemporaneous dispensing?
No as its made as a one-off
What are five important factors when making unlicsned medicines?
Risk assessment Record keeping and accountability Staff training Patient informaiton Equipment and facilities
Who is liable when using a licensed product within its license?
the manufacturer
Who is liable when using an unlicensed product ?
Prescriber and pharmacist
