Personalised and bespoke medicines Flashcards
What is the aim of personalised medicine?
Aim is maximum efficacy of treatment and significant reduction in the risk of undesirable side effects.
What is the definition of personalised medicine in the US Genomics and Personalised Medicine Act 2008?
Personalised medicine is 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.
Which CYP enzyme acts on half of all known drugs?
CYP3A4
Genotyping has found gene variants in what enzymes that metabolise warfarin? what has been the outcome of this?
CYP2C9
Vitamin K epoxide reductase gene variant
Has led to commercially available testing that enables more accurate dosing based on algorithms that take into account the age, gender, weight and genotype of an individual.
When are specials appropriate?
Dosage form is inappropriate Discontinued/withdrawn products Compassionate use products Off label use Bespoke dispensing of medicines in specialised unit dose systems to enable patients to adhere to their medication e.g. patient with an excipient allergy
Define ‘special’
A special can be defined as a non-licensed medicine manufactured to fulfil the prescribers requirements, if it is in the best interest of the patient.
What license is required to manufacture a special?
Special Manufacturing license (MS) issued by the MHRA
An imported MP with a licence in the country of origin but not in the UK is a special - true/false?
True
Do specials require a MA?
NO - HMR 2012 Part 10 states that specials are an exception to the requirement of an MA
The HMR 2012 Part 10 - exempts the need for MA for a relevant medicinal product which is supplied to fulfil a special need providing that certain conditions are met. What are these conditions?
- in response to a bona fide unsolicited order
- formulated in accordance with the specification of a doctor/dentist/supplementary prescriber
- for use by prescribers individual patients on his direct responsibility
Who holds responsibility for unlicensed medicines?
A pharmacist shares with the prescriber accountability for supplying a special to a patient
Patient consent is not needed when prescribing an unlicensed medicine…true or false?
FALSE
If requesting a special from a specials manufacturer who holds responsibility for the quality of the medicine?
The requesting pharmacist retains responsibility for the formulation NOT the manufacturer
In the medicines act 1968 ‘Section 10 exemption’ what does it state regarding the requirements of extemporaneous dispensing?
Must be carried out in a registered pharmacy and under supervision of a pharmacist.
Made as a one off- no requirement for product testing
Extemporaneously prepared medicines must undergo product testing - true/false
false