‘Specials’/Unlicensed Medicines Information Evening

1. ‘Specials’/Unlicensed Medicines Information Evening 6.45pm – Registration 7.00pm – Welcome & Introduction 7.05pm – Progress, Process + Paperwork – 1 year on 7.40pm – Discussion Groups 8.45pm – Evaluation & Close

2. Unlicensed Medicines: Process, Progress & Plans1 Year on Gillian Kerr Prescribing Support Pharmacist Sandra Notman Practice Pharmacist G&NEF CHP

3. Aims To provide an update on progress and compliance with the authorisation and reimbursement process within NHS Fife To reinforce the requirements of the NHS Fife authorisation and reimbursement process for unlicensed medicines. To discuss Out of Pocket Expense claims To provide a forum to share views, experiences and issues related to these preparations.

4. Thank You!

5. Progress?

6. Where are we now? • Use of the non-authorisation pathways to quickly obtain cost-effective preps e.g. NHS manufacturing units or Fife List recommendations • Authorisation requests no longer monthly • COA/COC/Invoices starting to come in • Specials reviews in GP practices to reduce inappropriate use

7. Still got a way to go...

8. Problems • Non-compliance with process: • 9 pharmacies have not submitted any authorisation requests • 42 pharmacies have not submitted any endorsed paperwork i.e. COA/COC/invoice • Claims paid to pharmacies do not match agreed prices • XP claims vary between pharmacies and suppliers

9. Claims Review – 10 pharmacies • 1 pharmacy - no specials issued • 2 pharmacies – correct claims and paperwork submitted • 7 pharmacies – errors in claims and some/ no paperwork submitted • 51 ‘specials’ items issued • 27 not obtained at the recommended price • £7,718 of unauthorised payments claimed • Overpayment of £2,663

10. NHS Fife Process • Clarify the process • Ensure prompt payment by following the required process • Ensure Health Board receipt of required information

11. Step 1 – Is a licensed product available? • MHRA and UKMI advice is to use a licensed product where one exists • Alternative – use a licensed product in an ‘off label’ way if appropriate e.g. Crush tablets, open capsules • Only where no suitable alternative exists should an unlicensed preparation be sourced. • Discuss with prescriber • E.g. • Folic acid 5mg/5ml oral solution – item listed in Part 7S but a licensed prep exists Lexpec syrup 2.5mg/5ml • Gabapentin 300mg/5ml suspn – a licensed liquid is available from Rosemont as 250mg/5ml • Advice available from specials pharmacists re crushing tablets etc.

12. Notify the Practice Pharmacist

13. Step 2 - Part 7S? • No need for authorisation from Health Board (except ‘urgent’ fee) • Price paid will be that stated in drug tariff • No endorsement of price required • No out of pocket expenses will be paid (included in tariff price) • E.g. • Omeprazole 20mg/5ml oral suspn 150ml £167.50

14. New! - Part 7U • Introduced 1st December 2013 • Limited list of reimbursable unlicensed products • i.e. Marketed products without formal marketing authorisation (not in ACBS list) but supplied from time to time on prescription • Price obtained for ‘known’ brand • Held in stock by large wholesaler • No XP payment will be allowed • E.g. • Magnaphate chewable 4mmol tabs • Magnaspartate 6.5g sachets • Vitamin D3 1,000u tabs (Colecalciferol) • Cod liver oil caps • Multivitamin 1 a day tabs • E45 dry scalp shampoo • Oilatum bath formula • etc

15. Step 3 - NHS Manufacturing Units? • Glasgow Pharmacy Production Unit, Western General Hospital, Tayside Pharmaceuticals • Also English sites e.g. Moorfields, Stockport, Torbay • Range of liquids, creams, eye drops etc • P&P only charged on small orders • No authorisation required (except ‘urgent’ fee) • Endorse COA/COC/invoice with ‘NMU01’ in place of authorisation name • E.g. • Topiramate 50mg/5ml x 400ml costs £62 • From another supplier, can cost £731.20 + £20 XP • i.e. Saves £689.20 per script.

16. Step 4 – Fife List item? • Collates relevant information into one document • Reduces the number of requests requiring authorisation

17. Step 4 – Fife List item? • NHS Fife Common Specials and Unlicensed Medicines • Preparation can be obtained from any supplier as long as the cost is less than or equal to the price stated • No authorisation required (except ‘urgent’ fee or excessive XP) • Endorse COA/COC/invoice with ‘FL01’ instead of authorisation name • E.g. • Acetylcysteine 600mg tablets £21 for 100 on Fife List • Some suppliers charge e.g. £83 for 100 – authorisation must be sought if this is the best price available • Saves £62 for each script

18. Step 5 – Seek Authorisation • If Steps 1 – 4 do not apply, authorisation must be sought from the Health Board using the ‘Authorisation Request Form’ • It must be completed in full • ‘Urgent’ requests for authorisation - all the relevant information must be provided • Need to get Name of Authorising Pharmacist and Date of Authorisation for endorsement purposes

19. Authorisation Form • Provides all the details required to make an informed decision • Captures data to guide future authorisation request advice • Provides details to allow follow up with the prescriber if appropriate

20. Prescription Endorsement • 7S prep – No endorsement required unless additional costs approved by HB e.g. ‘urgent’ fee • Non-7S preps: • Manufacturer with an MHRA specials license/ Imported specials • SP - Invoice price (Ex VAT) less any discount or rebate obtained in the purchase • XP - Additional charges in obtaining the item (hc/pp) • Send a copy of the invoice with paper copy of prescription • Extemp preps • EXT – Formula i.e. Ingredients & quantities

21. COA/COC/Invoice Endorsement • Pharmacy stamp • Date • Contractor’s initials • Invoice price (ex VAT) less discount • Additional charges • Prescriber’s details • Authorisation name/code • Date authorisation obtained

22. Endorsement Proforma • To ensure complete endorsement with correct information • Must be submitted with each COA/COC/invoice • COA/COC/invoice will be returned if not completed in full

23. Authorisation Codes • Obtained from an NHS manufacturing unit e.g. Glasgow or Tayside • NMU01 • Fife List item obtained at or below the price stated • FL01

24. Submission of Paperwork • At the end of each month: • All COA/COC/invoices from ‘specials’ supplied that month. • To: Pharmacy Services, Lynebank Hospital, Halbeath Road, Dunfermline, KY11 4UW • Please remove patient identifiable data

25. Out of Pocket Expenses

26. Considerations? • If the ‘special’ is delivered with your usual delivery, should we be expected to pay postage & packing? • If the ‘special’ has to be posted to you, as there is no wholesaler linked in, should postage & packing be paid? • Where an excessive charge is applied to one pharmacy but not another, should this be paid? • Please remember: ‘URGENT’ delivery charges must be authorised or they will not be paid

27. Feedback • Via email: Fife-UHB.SpecialsUnlicensedMedicines@nhs.net • By phone: 01383 565351 • Via Community Pharmacy Scotland website: www.communitypharmacyscotland.org.uk

30. Take Home Messages • All the supporting paperwork is available via links on the NHS Fife page of NHS Scotland Community Pharmacy website • Ensure everyone working with ‘specials’ in your pharmacy understands the process and the consequences of non-compliance • Think about the OOPE charges being applied – are they fair & necessary? • Refer to the relevant practice pharmacist for help • If in doubt, please ask!

31. Where are you?

32. Any Questions?

33. 40 mins Authorisation requests COA/COC/invoice endorsement 10 mins Answers 10 mins Discussion around OOPE Thoughts Ideas Other issues Discussion Groups – 1 Hour