1. Series Of Fortunate Events - Specials Delivery! Fraser Notman Prescribing Support Pharmacist Rebecca Creighton Prescribing Support Technician

2. Aims  To give an overview of the National Generic Framework and provide clarification on the process.  To highlight the common pitfalls and how to avoid them.  To discuss changes to the NHS Fife paperwork; the new Authorisation Request Form, The Fife List.

3. A Quick History  In 2013 the Scottish Government released a PCA which stipulated that all Specials not listed in part 7S of the Drug Tariff must be authorised by the Health Board prior to procurement.  Individual Health Boards created and implemented processes to allow for this, however compliance was an issue and the differing procedures across the Health Boards caused some confusion, particularly for Locum staff.  Part 7S of the Scottish Drug Tariff was created to regulate the price of the most common Specials and Unlicensed Medicines. All lines in Part 7S and 7U are inclusive of delivery therefore no additional claims should be made. No endorsement is required for these items.

4. Part 7S  Part 7S of the Drug Tariff can be viewed by downloading Part 7 and switching tabs at the bottom of the page:

5. Reimbursement of Items Not Listed in 7S  All ‘Specials’ not listed in part 7S MUST be endorsed with a price in order to receive correct payment. Some of the most commonly prescribed Specials in Fife Health Board include:  Diltiazem 2% Cream  Levomepromazine 6mg Tablets  Liothyronine 5mcg Tablets  Various strengths of Melatonin Capsules/Tablets  Metolazone 2mg & 5mg Tablets.  Although receiving prescriptions for these items can be a common occurrence, it’s important to remember to endorse them with a price attach an invoice to the prescription for verification by PSD.

6. Where We Are Now  In September 2015, the National Generic Framework was rolled out across Scotland. It offered a standardised process across all Health Boards and included a flowchart and FAQs to reduce confusion and aid compliance. This is the process we use today.

7. Where We Are Now -The National Generic Framework Flowchart

8. So What’s Changed?

9. The £30 Fixed Handling Fee  The Scottish Government has agreed to pay a fixed handling fee of £30 for each ‘Special’ that is not listed in Part 7S of the Scottish Drug Tariff. This should be claimed using the endorsement ‘HC 3000’.

10. Certificate of Analysis & Certificate of Conformity  It is no longer a requirement to submit copies of COAs or COCs to NHS Fife Pharmacy services. These should still be kept on the premises for your own record.

11. But What About the ‘Fife List’? X

12. Withdrawal of the ‘Fife List’  In order to bring NHS Fife in line with the National Generic Framework, the ‘Fife List’ will officially be withdrawn at the end of May.  The National Generic Framework stipulates that authorisations are patient-based, not drug-based.  Pharmacies will be required to submit an authorisation request form and provide CHI numbers for every patient on a Special/Unlicensed Medicine.

13. When Is Authorisation Required?  The Special is not listed in part 7S of the Scottish Drug Tariff.  The Special cannot be obtained from an NHS manufacturing unit.  The Special has a currently valid authorisation however the cost has increased by 20% or more.  The product was last authorised for the patient a year or more ago (or sooner if stated at the time of authorisation).

14. When Is Authorisation Not Required?  The product is listed in Part 7S of the Scottish Drug Tariff.  The preparation will be ordered from an NHS manufacturing unit within Scotland/England/Wales. Examples include The Western, Tayside, Oxford Pharmacy Store (with the exception of urgent fees).

15. However! This doesn’t automatically mean that prescribing the Special is appropriate!  Whether authorisation is required or not, the prescriber should always be contacted to highlight that an unlicensed medicine has been prescribed. It is beneficial both to the pharmacy and the practice to discuss indication, continuing need for the preparation and associated cost.  Licensed alternatives and off-label use of licensed products should be fully explored before a ‘Special’ is considered.

16. Common Pitfalls and Good to Know!  Not all items ordered through Specials companies are ‘Specials’. If the item is listed in the BNF and has a product license authorisation is not required. However these items can usually be ordered directly from the manufacturer to avoid/reduce delivery costs.

17. Common Pitfalls and Good to Know!  If a product is licensed in the UK but no stock can be obtained, authorisation should be sought before placing an order for an unlicensed import. An example of this is Sucralfate (Antepsin).

18. Common Pitfalls and Good to Know!  Guidance on the electronic and paper endorsing of Specials can be found on the Community Pharmacy Scotland Website:

19. New Authorisation Request Form

20. So What’s Different?

21. New Section – Has the Special Previously Been Prescribed For The Patient?  There is a new section which asks if this Special has previously been prescribed for the patient. It is much easier to intervene and discuss alternatives before a patient starts treatment. This information helps us determine when to intervene and which course of action should be taken.

22. New Information – Western & Tayside Phone Numbers  We have added the Western and Tayside Manufacturing Unit phone numbers to the form. Specials should always be ordered from an NHS Manufacturing Unit where available. Remember, items ordered from an NHS MU do not require authorisation.

23. Clarity on Cost  The Scottish Government £30 fixed handling fee should not be included on the form when requesting authorisation, this money comes out of a separate budget. We have reworded the form to make it clear that only additional costs set by the supplier should be included.  We have requested that the total cost for the prescribed quantity should be given, rather than pack size costs. This helps us keep an accurate record of the authorised price.

24. Removal of the ‘Urgent’ Section  The ‘Urgent?’ box has been removed. If the 24 hour response period is not suitable please call the number at the top of the form. This number will connect directly to a member of the Prescribing Support Team.

25. Risks and Responsibilities  We have added a section to the form to remind staff of the risks of unlicensed medicines and the shared responsibilities of the Pharmacist and GP. Please take a little time to read over this now and again.

26. We are the Prescribing Support Team for a reason..

27. Here’s How We Can Help  It’s okay to be unsure about whether you require authorisation or not, it’s important that both pharmacy contractors and NHS Fife are confident that the expected payment will be made. If you’re ever unsure about the process or a particular drug please don’t hesitate to get in touch!

28. Here’s How We Can Help  We can offer advice on which tablets can be crushed, capsules opened and other off-label methods of administration. As well as being the preferred choice to prescribing a Special, these will usually be stocked items which will save the patient waiting for their medication to be delivered and save the pharmacy a lot of stress when it comes to ordering and endorsing!

29. Why We Appreciate You Working With Us  When we ask that you discuss a licensed alternative with the GP, you are helping to improve patient safety. Our goal is to have as few Specials prescribed in NHS Fife as possible. We appreciate the time that goes in to these discussions to help achieve this.

30. Why We Appreciate You Working With Us  From April 2015 to March 2016, a total of £26,386 was recorded as ‘one-off savings’ when we suggested alternative products/suppliers when processing Specials authorisation requests. Many of these items would have been for long-term use so the actual savings are in fact much higher than this! We appreciate your co-operation, every penny saved really adds up and helps fund other NHS Fife services.

31. Thank You! Thank you for coming along tonight! We hope that you will come away feeling confident with the ‘Specials’ process and supported by NHS Fife Pharmacy Services.

32. Are There Any Questions?

33. Take Home Messages  The current process for the procurement of Specials is the ‘National Generic Framework’  The ‘Fife List’ will officially be withdrawn at the end of May and an authorisation request must be submitted for each patient who is prescribed a ‘Special’. Please ensure everyone working with ‘Specials’ in your pharmacy is aware of this and the consequences of non-compliance.  All ‘Specials’ not listed in Part 7S of the Drug Tariff must be endorsed with a price.  If in doubt, please ask!

34. Contact Details Rebecca Creighton – 01383 565 397 Fife-UHB.SpecialsUnlicensedMedicines@nhs.net