Overview of Personalised & Bespoke Medicines Flashcards
(31 cards)
What do Regional Pharmaceutical Quality Assurance Pharmacists do?
- Develop medicines
- Test medicines & environments
- > Chemical
- > Microbiological
- > Cleanroom Air Quality
- Audit and Inspection
What is the main problem with modern medicine?
Many medicines do not work effectively for a large number of the patients that they are supposed to treat
How does personalised & bespoke medicine aim to improve the main problem with modern medicine?
- Correct diagnosis required
- Right dose in Right place
- Right patient
- Right time (cell cycle, circadian rhythm etc.)
- Reduced cost, time and complications
Why are there differences between people when taking medicines?
- We are all different
- Genetic differences (e.g. metabolic profiles)
- Traditional pharmacology tends to use the ‘one disease, one drug’ approach
- Recognition of individual differences is growing thanks to the human genome project
How is genetics being utilised in medicine?
- Diagnosis
- Treatment
- Determine which drugs may be the most effective for an individual
- How likely it is for a cancer to return
- Disease susceptibility
What terms are commonly used to describe tests to see which drug is the most suitable for a patient?
- Companion diagnostics
- Theranostics
- Therapy genetics
What is the DEFINITION of Personalised Medicine? (According to the USA)
The application of genomic and molecular data to better target the delivery of health care and help determine a person’s predisposition to a particular disease or condition and identify any targeted prevention strategies for that predisposition.
What is the INTENTION of Personalised Medicine?
To ensure treatments meet the needs (medical, biological and biomolecular) of the individual patient.
What is the AIM of Personalised Medicine?
Maximum efficacy of treatment and significant reduction in the risk of undesirable side effects
What is the main group of enzymes responsible for unique responses to drugs?
CYP450s
What are some examples of ‘specials’?
Calculated cytotoxic chemotherapy
Parenteral Nutrition
Modified antibiotic therapy regimens
Who are ‘Specials’ for?
Often for the most vunerable patients
- Premature babies who can’t tolerate the normal doses
- Intensive care patients with specific IV needs
- Patients who can’t swallow (e.g. stroke or elderly)
- Cancer patients
- Dermatology patients (e.g. who are allergic to a specific excipient)
- Acute eye infections that need antibiotic eye drops
What is the definition of a ‘Special’?
A non-licensed medicine manufactured to fulfil the prescriber’s requirements
- Manufactured under a Special Manufacturing Licence (MS)
When the pharmacist is presented with a prescription for a ‘Special’ what options are available to get it?
Either:
- Make the product
- Purchase from a ‘Specials’ manufacturer
‘Specials’ Definitions:
- What is an ‘Import’?
Product with product license in a country of origin (not in the country of use)
‘Specials’ Definitions:
- What is an ‘Extemporaneous preparation’?
a product made under the supervision of a pharmacist
- (under section 10 exemption of Medicines Act 1968)
‘Specials’ Definitions:
- What is a ‘Ward based manipulation’?
Crushing, dispersing, dissolving, cutting etc
Which piece of legislation states that a licensed medicine should be used wherever possible?
MHRA Guidance Note 14
- The supply of unlicensed relevant medicinal products for individual patients
What do the Humans Medicines Regulations 2012 state with regards to ‘Specials’?
Part 10
- Exception to requirement for marketing authorisation
Exempts the need for a marketing authorisation for a relevant medicinal product which is supplied to fill a special need
Which conditions need to be met in order to supply a special under the Humans Medicines Regulations 2012 exemption?
- In response to a bona fide unsolicited order
- Formulated in accordance with the specification of a doctor, dentist or supplementary prescriber
- For use by prescriber’s individual patients on his direct responsibility
The GMC rules allow prescribing of unlicensed medicines as long as the licensed form is…
- Inappropriate for the patient
- There is evidence that the medicine is safe and effective
- They must also monitor and follow up patients
Who holds responsibility for deciding whether a patient has ‘special needs’ which a licensed product cannot meet?
The prescriber on advice of the pharmacist
Legally, products are commissioned by who?
The Pharmacist
Who holds responsibility for the formulation?
The Requesting Pharmacist (NOT the manufacturer!)
