Flashcards in Extemp Exam Deck (181)
What's the main aim of personalised medicine?
To ensure treatments meet the needs of INDIVIDUAL patients and to maximum efficacy of treatment, and significantly reduce the risk of undesirable side effects
Where are CYP450s found? What do they do?
Found on cells smooth endoplasmic reticulum
Highest conc in liver and small intestine
Add oxygen atoms to molecules, makes them more water soluble
10% of the population get little pain from codeine due to the enzyme _______
What two variants are being tested to determine more accurate dosing of warfarin based on a patients genotype?
Gene variations for the CYP2C9 enzyme that metabolises warfarin
And in the gene for the vitamin K epoxide reductase enzyme
How can we personalise the treatment of cancer with Trastuzumab (Herceptin)?
Drug binds to HER2 proteins, it's a monoclonal antibody
We can Test cancer patients to see if they have over production of HER2 BEFORE treating with this drug as these are the only patients who will benefit from it
Definition of a special?
A non-licensed medicine manufactured to fulfil the prescribers requirements
Manufactured under a 'Special Manufacturing License'
Definition of an import?
A product that has a product license in its country of origin
Definition of extemporaneous preparation?
Made under the supervision of a pharmacist under section 10 of the Medicines Act 1968
Which regulations exempt the need for a MA for a relevant medicinal product, which is supplied to fulfill a 'special need'?
HMR 2012 part 10: exception to requirements for a marketing authorisation
When can doctors give unlicensed medication?
If the licensed form is inappropriate for the patient
If there's evidence the unlicensed form is SAFE
As long as they monitor and follow it up
Remember doctors are liable if the unlicensed med causes harm
It's a legal requirements that specials products are _________ by the requesting pharmacist
Commissioned/ signed off
Any unlicensed meds must be made up in licensed premises, that is they've been inspected by the _____
E.g Registered pharmacies under supervision of a pharmacist
What are some of the risks associated with extemporaneous dispensing?
Feisty Cats Like Rapping Songs Quite Loudly
F= Failure of Formulation : eg microbiological contamination, bioequivalence issues, dose uniformity (overdose or underdose), issues with stability
C = Calculation errors
L = Labelling errors
R = Raw material contamination
S = Safety and efficacy unknown
Q = QA and GMP issues
L= lack of standards and specifications
In extemporaneous dispensing there's some risks to staff. What are these?
Liability, they have a lot of responsibility
May be exposed to harmful substances when crushing tablets or weighing and pouring etc
How can we minimise risk in extemporaneous dispensing?
Do risk assessments to ensure a safe outcomes
Record keeping to safeguard patients
Patient information- make sure pharmacy staff communicate with patients
Correct equipment and facilities available
How can we comply with quality requirements in extemp?
Make sure premises comply with GMP
Follow QA systems, eg following pharmacopeia monographs
Make sure batch testing systems are in place
Certificates of analysis for batchs
Yellow card ADR reporting schemes
When using a product within its licence, liability lies with the manufacturer if it all goes wrong. When using an unlicensed product, who does liability lie with?
The pharmacist AND the prescriber
What's an overall definition of specials and unlicensed medicines?
Medicinal products prescribed by doctors for specific indications for which a licensed product does not exist or is no longer available on the market.
Repackaged medicines are classed as specials/ unlicensed. Meds prepared by a manufacturer but aren't available in UK are also classed as this (unlicensed). What about medicines prepared for a specific patient, to use with doctors instructions?
This is classed as specials
Does a pharmacy require a specials manufacturing license?
No, all suppliers and manufacturers of specials must have one apart from pharmacies, as the law recognises that pharmacists should have the knowledge to safely prepare and supply medicines without a manufacturers license.
If a patient experiences an adverse effect for a product that has been prescribed within its terms of license, who can they prosecute?
Ie the ones who created the sPc
if it's a special/ unlicensed then the prescriber gets the blame
Specials don't need a Marketing authorisation, and can be given by a practitioner in the UK. Who may these practitioners be?
Nurse independent prescriber
Pharmacist IP or supplementary prescriber
Specials manufacturers can advertise their _______ but not their _______
Can advertise their services
But not their products!! Cannot advertise specials
HMR 2012 makes the exception that a pricelist of products they usually make can be published by manufacturers, can't include bespoke products in this!
What does be-spoke mean?
Custom made, completely tailored to an individual patient!
The HMR 2012 requires anyone selling or supplying an unlicensed medicines to keep a record of supply for _______?
What are transmissible spongiform encephalopathys?
Also known as prion diseases, caused by prions (infectious agents composed of proteins in a mis-folded form)
Progressive conditions effecting brains and nervous system
What are the TSE guidelines?
Unlicensed medicines for human use (transmissible spongiform encephalopathies) safety regulations 2003
All manufacturers, importers AND exporters MUST comply with these, otherwise the import is not allowed.
If an unlicensed medication is supplied and proves a risk of TSE, those who manufactured and imported the medication should be held liable as they should have checked TSE guidelines have been followed in the manufacture.
When do TSE guidelines NOT apply?
Don't apply to pharmacists making up unlicensed medicines in the pharmacy
What are chief pharmacists and superintendent pharmacists responsible for?
Responsible for making sure systems are in place to safeguard public health and the safety of patients being supplied unlicensed medication