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Medicines Management Team Presentation on Specials/Unlicensed Medicines A Brief History of the Specials Authorisation Process February 2013 May 2019 PCA2013(P) 4 set Email authorisation out new process March 2015 process is for


  1. Medicines Management Team Presentation on Specials/Unlicensed Medicines

  2. A Brief History of the Specials Authorisation Process February 2013 May 2019 PCA2013(P) 4 set Email authorisation out new process March 2015 process is for reimbursement RC is brought in implemented as the of Specials. GK & to post to take new way to submit SN set up over authorisation authorisation authorisation requests to comply process for Fife, and clawback with GDPR. including "Fife process. List". January 2014 September 2015 contractors PCA2015(P) 17 warned that stipulates NHS Fife will authorisation must "claw back" be given on patient payment where by patient basis. authorisation Changes made to process has not process and Fife List been followed. is withdrawn.

  3. The Authorisation Process Today

  4. The Pharmacy Determines Whether Health Board Authorisation Is Required…

  5. Where Authorisation Is Required, An Authorisation Request Form Is Submitted By Email

  6. Things We Consider Before Authorising a Special/Unlicensed Medicine • Use of licensed alternatives should always be fully explored before an Are there licensed alternatives available (e.g. licensed liquids of similar drugs)? unlicensed medicine is considered. Could a licensed product be used off-label • Off-label use of a licensed product comes next in the MHRA (e.g. crushing tablets, opening capsules Hierarchy for the use of Unlicensed Medicines. etc.)? • This is especially important if it is the first prescription for the Would input from practice team be patient. It is much more difficult to switch patients from any drug appropriate, further discussion with the prescriber required? after it has been supplied previously. • The price of unlicensed medicine can vary immensely across different If prescribing the Special is to go ahead, is wholesalers. It is important to ensure that NHS Funds are being used the price acceptable or can it be sourced at a more reasonable price? in the most efficient way.

  7. Pharmacy feedback – since moving to email the health board takes longer to respond to special requests • The average response time to Special Authorisation Requests in January 2020 was 52 minutes with 100% of requests sent before 5pm receiving a response the same day. • We are mindful that many companies require the order to be placed by 3.30pm for next day delivery. We aim to have a response sent to the pharmacy before this time wherever possible. The best time for the pharmacy to check the inbox is through the day, 2pm – 3pm to avoid any delays with ordering.

  8. Pharmacy feedback – the price we submit is never authorised, can’t we just send the form in without a price since NHS Fife obviously has a table with what they’re willing to pay? • Of the 769 authorisation requests submitted in 2019: • 510 were approved at the price submitted • 215 were not given immediate approval either due to a licensed/off label product being advised instead, directing pharmacies to an NHS PPU or a lower price than the one submitted being authorised • The remaining 44 were “N/A” requests (licensed/7S/7U products or requests for authorisation to order from an NHS PPU.

  9. Pharmacy feedback – the price we submit is never authorised, can’t we just send the form in without a price since NHS Fife obviously has a table with what they’re willing to pay? • Of the 769 authorisation requests submitted in 2019: • 510 were approved at the price submitted 510 were approved at the price submitted These requests make up our “table” – in fact a huge spreadsheet that we use as our database to direct pharmacies to the most cost effective source and keep the amount that we authorise to every pharmacy fair. Prices for Specials are always changing, if pharmacies did not submit a price we would manually be tracking down sources and prices for 85 pharmacies submitting nearly 800 requests a year!

  10. Pharmacy feedback – the Specials team are really helpful but we miss speaking to them since it changed to email! We miss you too! We are looking in to different ways of keeping in touch – as ever we are only a phone call away if you need any help with Specials!

  11. Efficiencies on Special/Unlicensed Medicines Over The Years

  12. Some examples of savings made Pharmacies Requested We Advised

  13. With the cooperation of Community Pharmacies, NHS Fife avoided spending an additional £211,734 on Specials last year because of switches like these!

  14. Overall Spend on Specials – 2014 - 2019 £1,100,000.00 £1,007,220 £1,000,000.00 £900,000.00 £800,000.00 £700,000.00 £600,000.00 £460,603 £500,000.00 £400,000.00 £300,000.00 £200,000.00 £100,000.00 £0.00 2014/2015 2015/2016 2016/2017 2017/2018 2018/2019

  15. The Scottish Government Process – Clawbacks on Specials

  16. When the Scottish Government authorisation process is not followed, the Health Board should take steps to recover the unauthorised payments. From 2014 to 2019 this amounted to… £420,556

  17. Despite an increase in compliance with the authorisation part of the Scottish Government process, the number of claw back letters issued continues to rise… 800 700 600 500 400 300 200 100 0 2014 2015 2016 2017 2018

  18. How Can We Tackle The Issue Of Clawbacks? Let’s take a look at the numbers… Special should have been ordered from NHS Manufacturing Unit Authorisation granted but reimbursement was over the authorised price Authorisation not sought but lower price would have been authorised Authorisation not sought & alternative would have been advised Prescription hand endorsed ND but electronic claim was made Types of Clawback Letters sent from January to April 2019

  19. How Can We Tackle The Issue Of Clawbacks? Let’s take a look at the numbers … Authorisation not sought Special should have been ordered from NHS Special should have been ordered from NHS Manufacturing Unit Manufacturing Unit Authorisation granted but reimbursement was Authorisation granted but reimbursement was over the authorised price over the authorised price Authorisation not sought but lower price would Authorisation not sought but lower price would have been authorised have been authorised Authorisation not sought & alternative would Authorisation not sought & alternative would have been advised have been advised Prescription hand endorsed ND but electronic Prescription hand endorsed ND but electronic claim was made claim was made Types of Clawback Letters sent from January to April 2019

  20. How Can We Tackle The Issue Of Clawbacks? Let’s take a look at the numbers… Special should have been ordered from NHS Special should have been ordered from NHS Manufacturing Unit Manufacturing Unit Authorisation granted but reimbursement was Authorisation granted but reimbursement was over the authorised price over the authorised price Authorisation not sought but lower price would Authorisation not sought but lower price would have been authorised have been authorised Authorisation not sought & alternative would Authorisation not sought & alternative would have been advised have been advised Prescription hand endorsed ND but electronic Prescription hand endorsed ND but electronic claim was made claim was made Types of Clawback Letters sent from January to April 2019

  21. Let’s take a look at endorsing Special should have been ordered from NHS Manufacturing Unit Authorisation granted but reimbursement was over the authorised price Paper copy included endorsed price but it was higher Paper copy included endorsed price but it was higher than was/would have been authorised than was/would have been authorised Authorisation not sought but lower price would have been authorised Paper copy did not include endorsed price Paper copy did not include endorsed price Authorisation not sought & alternative would have been advised Prescription hand endorsed ND but electronic claim was made Level of endorsing from the same sample, January – April 2019

  22. 2020 – The Year of Endorsing!

  23. Special should have been ordered from NHS Manufacturing Unit Authorisation granted but reimbursement was over the authorised price Authorisation not sought but lower price would have been authorised Authorisation not sought & alternative would have been advised Prescription hand endorsed ND but electronic claim was made

  24. How can we improve authorisation compliance and awareness of the “SP” endorsement? It looks like this item does not have valid It looks like this item may not have authorisation. It could be that been endorsed appropriately, authorisation has not been sought or a leading to an overpayment. previously valid authorisation has If continuing to supply this item expired. make sure to use the “SP” If continuing to supply this item please endorsement both electronically submit an authorisation request form to and on the paper copy. More Fife-UHB.specialsunlicensedmedicines@nhs.net information on endorsing can be for the next dispensing. found on the Community Pharmacy Scotland website.

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