Choose a product taking account of clinical suitability, quality, licensed status and cost.
When choosing between available medicines:
- use a licensed medicine within the terms of its product licence if suitable for the patient
- if not, use a licensed medicine outside its product licence, ‘off-label’
- if licensed medicines are unsuitable, consider using an unlicensed ‘Special’
Using a licensed medicine ‘off-label’ is preferred to using an unlicensed medicine . This is because licensed medicines have been evaluated by the MHRA for safety, quality, and efficacy but unlicensed medicines have not.
If you need to use a licensed medicine ‘off-label’ or an unlicensed medicine, the prescriber has extra responsibilities. Consult GMC guidance for further information.
Medicines suitable for adults with swallowing difficulties lists licensed and ‘off-label’ options in some therapeutic classes. The BNF lists licensed options.
Licensed medicines
Medicines used as licensed
The Summary of Product Characteristics (SmPC) for a medicine provides information on licensed uses.
Sometimes the SmPC will say how to give a medicine to people with swallowing difficulties. For example, edoxaban tablets are licensed to be crushed and given with water or apple puree.
Try to use the SmPC for the patient’s brand of medicine, as sometimes information differs between brands.
Medicines used ‘off-label’
Using a medicine differently than described in the SmPC is considered outside the licence or ‘off-label‘.
Crushing tablets and opening capsules can be the best option for a patient even if it is not included in the SmPC. However, not all tablets can be crushed or capsules opened safely. See step 5.
For carers or care home staff to administer medicines in an ‘off-label’ way, the prescriber must make a written direction. Instructions must be included in the patient’s Medication Administration Record (MAR) chart and care plan.
Unlicensed medicines
Unlicensed medicines include special-order medicines (‘Specials’) and medicines imported from abroad which do not have a UK licence. This means their quality and safety have not been assessed by the MHRA.
You can use an unlicensed medicine when licensed medicines, including ‘off-label’ use, cannot meet a patient’s clinical needs. The MHRA acknowledges use of licensed medicines ‘off-label’ is preferable to the use of unassessed, unlicensed medicines.
Unlicensed medicines may be difficult to obtain. Some must be ordered far in advance of when they are needed.
‘Special order’ medicines
‘Specials’ can be very expensive. The cost to the NHS of ‘Specials’ listed in Part VIIIB of the Drug Tariff or Part 7S of the Scottish Drug Tariff is fixed but the cost of others is unregulated.