Special Unlicensed Medicine
SPECIALS/UNLICENSED MEDICINE PROCEDURE NHS FIFE
The Scottish Government published PCA(P)(2015)17 on September 1st 2015 as a national framework for the procurement of Specials/Unlicensed medicines - all community pharmacists must be aware of the associated responsibilities, risks and liabilities of procuring and dispensing an unlicensed medicine and ensure the clinical appropriateness of any product supplied.
- Every step should be taken to ensure that all licensed preparations and formulations have been fully explored, as well as “off-label” use of licensed products (e.g. opening capsules, dispersing tablets in water etc), before use of a Special/Unlicensed product is considered.
- Specials and Unlicensed products are not required to meet the same standards as licensed preparations.
- Pharmacists should always contact the prescriber and advise that they have prescribed an unlicensed medicine and to discuss alternatives.
- Both prescribers and pharmacists assume a greater responsibility and potential liability where unlicensed medicines are used.
Once it is certain that an unlicensed medicine is required as there are no other suitable alternatives, local and national NHS Pharmacy Production Units (NHS PPU) should be contacted in the first instance. (Glasgow Pharmacy Production Unit: 0141 451 5820, Tayside Pharmacy Production Unit: 01382 632 052). Where the item is available from an NHS Pharmacy Production Unit further authorisation is not required.
Where the item is not available from an NHS PPU; Parts 7S and 7U of the Scottish Drug Tariff should be checked for reimbursement arrangements. Part 7S and 7U of the Scottish Drug Tariff can be viewed by downloading Part 7 (choosing relevant month) and switching tabs at the bottom of the Excel document. If the item is contained in the Scottish Drug Tariff, authorisation is not required.
Where the item is neither contained in Part 7S or 7U of the Scottish Drug Tariff, nor available from an NHS Pharmacy Production Unit, authorisation must be sought from the prescribing Health Board. For prescriptions issued within NHS Fife, theSpecial/Unlicensed Medicines Authorisation Request From should be filled in and sent as an email attachment to Fife-UHB.SpecialsUnlicensedMedicines@nhs.net this form is also available as an Editable PDF.
- The Special/Unlicensed Medicines Authorisation Request Form must be sent from an “@nhs.net” email address to ensure encryption of confidential patient information
- Authorisation is valid for 12 months – unless otherwise advised.
- Reauthorisation is required where the item price increases by more than 20%
- Authorisation is given for each patient, not each drug. Authorisation should be sought for each new patient even if the drug has previously been authorised for another patient
- It is no longer a requirement to submit copies of COC/COA/Invoices to the Health Board
- The authorisation process is only for Special/unlicensed medicines only and does not relate to any other products e.g. high-cost licensed products, ACBS, foodstuffs, stoma products etc.
- All Special/Unlicensed Medicine prescriptions must be endorsed with a price using the “SP” endorsement both electronically as well as on the paper copy to ensure correct payment
- Email Authorisation Process Letter April 2019
- Specials FAQs - PCA(P)(2015)17 Annex B
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