Aseptics/ unlicensed medicines Flashcards
Which does the MHRA view as a higher risk medicine?
An extemporaneously dispensed medicine
An imported medicinal product licensed in the country of origin
Off label use in the UK/ EU licensed medicines
Least risk: 1) Off label use in the UK/ EU licensed medicines
2) An imported medicinal product licensed in the country of origin
Most risk: 3) An extemporaneously dispensed medicine
How long should records concerning unlicensed medicines be retained for?
5 years
What is the most common type of error to occur in aseptic units?
Labelling errors
A patient who can no longer swallow tablets of his medication and there is no licensed liquid in the UK. What is the safest, lowest risk treatment option out of the following:
> Unlicensed import licensed elsewhere in the EU
> Crush tablets at patients bedside immediately prior to administration
> extemporaneous preparation made in the Hospital Pharmacy
> Unlicensed import licensed outside the EU
> A UK manufactured special
A UK Manufactured Special
Most common source of contamination in an aseptic unit?
Personnel
Is alcohol effective against spores?
No- need a sporicidal as alcohol not always effective against bacterial/ fungal spores. Should wash hands with soap and water when coming into contact with someone with C.diff- soap is effective against the spores.
What is a COSHH assessment?
COSHH: Control of Substances Hazardous to Health Regulations
Required by law for the possession or use of hazardous chemicals in the workplace to protect staff working with these
The assessment must be completed before work begins and before a chemical is brought into the unit
Examples of what is in a COSHH risk assessment:
how the chemical is hazardous e.g. toxic, flammable
How to deal with the hazard e.g. how to mop up the spill, emergency first aid procedures, handling, storage
Who could be at risk e.g. pharmacy staff, nursing staff
I licensed unit holds a ‘Specials’ License granted by the MHRA. This allows the unit to manufacture products without a product license or marketing authorisation.
Licensed units can:
manufacture products and sell them to external customers
Assign extended expiry dates to products provided they’re supported with stability data
The chemo unit at Guy’s is an unlicensed unit. Can you think of what this means for their products?
This means they operate under an exemption from section ___ of the Medicines Act
Section 10
> Must dispense directly to named patients
Dispense against legal prescriptions
Must be under supervision of a pharmacit
Operate under a closed system
Assign aseptically prepared products a maximum of a 7 day expiry
Used licensed sterile products as ingredients
Whats the difference between the Orange Guide and the Yellow Guide both used by Aseptic units?
Orange guide: brings together all the main European and UK directives, regulations and legislation relating to the manufacture and distribution of medicines. It lays out a number of standards that Aseptic units must work at and it is compiled by the MHRA
The Yellow guide ‘Quality Assurance of Aseptic preparation services’ gives guidance on all aspects of the principles of GMP. A detailed guide to the operation and quality assurance of UK hospital aseptic preparation services.
What was the name of the report that defined a set of standards that aseptic units must work towards?
Farwell report 1995: Aseptic dispensing for NHS patients
What does the NPSA monitor and do?
Monitors patient safety incidents in the NHS
Issues alerts to avoid these from happening again
