PCA (P) (2015)17 details the national framework for the procurement of Specials/Unlicensed medicines not listed in Scottish Drug Tariff Part 7S. It is important community pharmacists are aware of the associated responsibilities and risks of procuring and dispensing an unlicensed medicine and that they ensure the clinical appropriateness of any product supplied.
Prior to supply, all specials/unlicensed medicines, not listed in Scottish Drug Tariff Part 7S, must be authorised by NHS AA Specials. The authorisation process is only for unlicensed medicines and does not relate to any other products e.g. those categorised ACBS, foodstuffs, stoma products, high value licensed medicines.
The guide prices for commonly requested unlicensed medicines and the NHS AA Specials Authorisation Request Pro-Forma can be found here: Specials Authorisation Pro-Forma v9. Please use this information to procure and endorse unlicensed specials or imports. If you can obtain at the guide price or lower, you do not need to seek authorisation. If the guide price provided cannot be met, or if the drug prescribed is not on the pro-forma list, then authorisation from NHS AA is required. Authorisation request forms must be emailed from the pharmacy clinical mailbox to: aa-uhb.cpspecialsauthorisation@aapct.scot.nhs.uk
Specials authorisations operate between 08:30 and 16:30 Monday to Friday. Requests out with this time will be responded to on the next working day.
This email address can also be used for any general queries regarding the authorisation process or unlicensed medicines.
Key Points
- All communications must come from the Pharmacy Clinical mailbox (nhs.scot), not a personal email due to GDPR. Please ensure your email is correctly addressed.
- Authorisation is valid for 12 months ONLY
- If the item price varies by more than 20% within the 12 month period, reauthorisation is required
- Authorisation is required for each medicine, not each patient
- Do not submit copies of COC/COA/Invoices to NHS Ayrshire & Arran
Resources
- Generic Framework for Specials Authorisation Process across Scotland
(An authorisation is required for every individual medicine) – PCA(P)(2015)17 Annex A - Specials FAQs – PCA(P)(2015)17 Annex B
- MHRA Guidance note 14