‘‘Specials’/Unlicensed Medicines Specials’/Unlicensed Medicines Information EveningInformation Evening

6.45pm – Registration6.45pm – Registration

7.00pm – Welcome & Introduction7.00pm – Welcome & Introduction

7.05pm – Progress, Process + Paperwork – 7.05pm – Progress, Process + Paperwork – 1 year on1 year on

7.40pm – Discussion Groups7.40pm – Discussion Groups

8.45pm – Evaluation & Close8.45pm – Evaluation & Close

Unlicensed Medicines: Unlicensed Medicines: Process, Progress & PlansProcess, Progress & Plans

1 Year on1 Year on

Gillian KerrGillian KerrPrescribing Support PharmacistPrescribing Support Pharmacist

Sandra NotmanSandra NotmanPractice Pharmacist G&NEF CHPPractice Pharmacist G&NEF CHP

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.

Thank You!Thank You!

Progress?Progress?

Where are we now?Where are we now?

Use of the non-authorisation pathways to Use of the non-authorisation pathways to quickly obtain cost-effective preps e.g. quickly obtain cost-effective preps e.g. NHS manufacturing units or Fife List NHS manufacturing units or Fife List recommendationsrecommendations

Authorisation requests no longer monthlyAuthorisation requests no longer monthly COA/COC/Invoices starting to come inCOA/COC/Invoices starting to come in Specials reviews in GP practices to Specials reviews in GP practices to

reduce inappropriate usereduce inappropriate use

Still got a way to go...Still got a way to go...

ProblemsProblems

Non-compliance with process:Non-compliance with process: 9 pharmacies have not submitted any 9 pharmacies have not submitted any

authorisation requestsauthorisation requests 42 pharmacies have not submitted any 42 pharmacies have not submitted any

endorsed paperwork i.e. COA/COC/invoiceendorsed paperwork i.e. COA/COC/invoice Claims paid to pharmacies do not match Claims paid to pharmacies do not match

agreed pricesagreed prices XP claims vary between pharmacies and XP claims vary between pharmacies and

supplierssuppliers

Claims Review – 10 pharmaciesClaims Review – 10 pharmacies

1 pharmacy - no 1 pharmacy - no specials issuedspecials issued

2 pharmacies – 2 pharmacies – correct claims and correct claims and paperwork submittedpaperwork submitted

7 pharmacies – errors 7 pharmacies – errors in claims and some/ in claims and some/ no paperwork no paperwork submittedsubmitted

51 ‘specials’ items 51 ‘specials’ items issuedissued

27 not obtained at the 27 not obtained at the recommended pricerecommended price

£7,718 £7,718 of of unauthorised unauthorised payments claimedpayments claimed

Overpayment of Overpayment of £2,663£2,663

NHS Fife ProcessNHS Fife Process

Clarify the process Clarify the process

Ensure prompt Ensure prompt payment by following payment by following the required process the required process

Ensure Health Board Ensure Health Board receipt of required receipt of required informationinformation

Determining the Supply of a ‘Special’ Algorithm (Jan 14)

Is a special/ unlicensed medicine still required?

Arrange new prescription, supply alternative and discuss change with

patient/ carer.

Is the preparation listed in Part 7S or 7U of the Scottish Drug Tariff?

Order from supplier. No endorsement required.

No additional costs can be claimed No Health Board authorisation needed* *Urgent delivery costs – seek authorisation first

Is the preparation available from an NHS manufacturing unit? (e.g.

Tayside Pharmaceuticals, Glasgow Pharmacy Production Unit,

Moorfields)

Order from Tayside/ Glasgow. Endorse prescription with:

Invoice price Any additional cost incurred e.g.

out of pocket expenses No Health Board authorisation

needed* *Urgent delivery costs – seek authorisation

Is the preparation listed on the NHS Fife Common Specials &

Unlicensed Medicines List? (If YES but unable to source at

price stated or below, follow NO)

If able to source the preparation at or below the price stated on the Fife Common Specials & Unlicensed

Medicines List, order from supplier.

Endorse prescription with: Invoice price, less any rebate Any additional cost incurred e.g.

out of pocket expenses No Health Board authorisation

needed* *Urgent delivery costs – seek authorisation

Phone around Specials manufacturers to source the most cost-effective supply of the preparation. Consider impact of shelf

life and handling charges/ P&P

Complete NHS Fife Special/ Unlicensed Medicine Authorisation Request Form

and fax to 01383 741395 for authorisation before placing order

Certificate of Analysis/ Conformity (or invoice if unavailable) to be: Stamped, dated and initialled. Endorsed with:

o Invoice price less any discount or rebate obtained o Prescriber’s details o ‘Authorised by’ Authorisation name & date of authorisation or o ‘Authorisation code’ ‘NMU01’ (Tayside/Western) or ‘FL01’ (Fife List) as appropriate

At the end of each month send to Pharmacy Services, Lynebank Hospital, Halbeath Road, Dunfermline, KY11 4UW.

Please remove all patient identifiable information before submitting to Pharmacy Services. Payment cannot be authorised if correctly endorsed paperwork is not received.

Prescription received for a ‘special’ or imported unlicensed medicine. Contact prescriber to discuss indication, continuing need for the preparation and associated cost.

Consider if a licensed alternative is available or can be used in an ‘off label’ way e.g. crush or disperse tablets in water? Open capsules? Refer to e.g. NEWT Guidelines for advice.

No

Yes

Yes

Yes

Yes

No

No

No

Authorisation obtained: Endorse prescription with:

Invoice price, less any rebate Any additional cost authorised

e.g. out of pocket expenses

Step 1Step 1 – Is a licensed product – Is a licensed product available?available?

MHRA and UKMI advice is to use a licensed product MHRA and UKMI advice is to use a licensed product where one existswhere one exists

Alternative – use a licensed product in an ‘off label’ way if Alternative – use a licensed product in an ‘off label’ way if appropriate e.g. Crush tablets, open capsulesappropriate e.g. Crush tablets, open capsules

Only where no suitable alternative exists should an Only where no suitable alternative exists should an unlicensed preparation be sourced.unlicensed preparation be sourced.

Discuss with prescriberDiscuss with prescriber E.g.E.g.

Folic acid 5mg/5ml oral solution – item listed in Part 7S but a Folic acid 5mg/5ml oral solution – item listed in Part 7S but a licensed prep exists Lexpec syrup 2.5mg/5mllicensed prep exists Lexpec syrup 2.5mg/5ml

Gabapentin 300mg/5ml suspn – a licensed liquid is available from Gabapentin 300mg/5ml suspn – a licensed liquid is available from Rosemont as 250mg/5mlRosemont as 250mg/5ml

Advice available from specials pharmacists re crushing tablets etc.Advice available from specials pharmacists re crushing tablets etc.

Notify the Practice PharmacistNotify the Practice Pharmacist

Step 2Step 2 - Part 7S? - Part 7S?

No need for authorisation from Health No need for authorisation from Health Board (except ‘urgent’ fee)Board (except ‘urgent’ fee)

Price paid will be that stated in drug tariffPrice paid will be that stated in drug tariff No endorsement of price requiredNo endorsement of price required No out of pocket expenses will be paid No out of pocket expenses will be paid

(included in tariff price)(included in tariff price) E.g.E.g.

Omeprazole 20mg/5ml oral suspn 150ml Omeprazole 20mg/5ml oral suspn 150ml £167.50£167.50

New!New! - Part 7U - Part 7U Introduced 1Introduced 1stst December 2013 December 2013 Limited list of reimbursable Limited list of reimbursable

unlicensed productsunlicensed products i.e. Marketed products without i.e. Marketed products without

formal marketing authorisation formal marketing authorisation (not in ACBS list) but supplied (not in ACBS list) but supplied from time to time on from time to time on prescriptionprescription

Price obtained for ‘known’ Price obtained for ‘known’ brandbrand

Held in stock by large Held in stock by large wholesalerwholesaler

No XP payment will be No XP payment will be allowedallowed

E.g.E.g. Magnaphate chewable Magnaphate chewable

4mmol tabs4mmol tabs Magnaspartate 6.5g Magnaspartate 6.5g

sachetssachets Vitamin D3 1,000u tabs Vitamin D3 1,000u tabs

(Colecalciferol)(Colecalciferol)

Cod liver oil capsCod liver oil caps Multivitamin 1 a day tabsMultivitamin 1 a day tabs E45 dry scalp shampooE45 dry scalp shampoo Oilatum bath formulaOilatum bath formula etcetc

Step 3 Step 3 - NHS Manufacturing - NHS Manufacturing Units?Units?

Glasgow Pharmacy Production Unit, Western General Glasgow Pharmacy Production Unit, Western General Hospital, Tayside PharmaceuticalsHospital, Tayside Pharmaceuticals

Also English sites e.g. Moorfields, Stockport, TorbayAlso English sites e.g. Moorfields, Stockport, Torbay Range of liquids, creams, eye drops etcRange of liquids, creams, eye drops etc P&P only charged on small ordersP&P only charged on small orders No authorisation required (except ‘urgent’ fee)No authorisation required (except ‘urgent’ fee) Endorse COA/COC/invoice with ‘NMU01’ in place of Endorse COA/COC/invoice with ‘NMU01’ in place of

authorisation nameauthorisation name E.g.E.g.

Topiramate 50mg/5ml x 400ml costs £62Topiramate 50mg/5ml x 400ml costs £62 From another supplier, can cost £731.20 + £20 XPFrom another supplier, can cost £731.20 + £20 XP i.e. Saves £689.20 per script.i.e. Saves £689.20 per script.

Step 4Step 4 – Fife List item? – Fife List item?

Collates relevant Collates relevant information into one information into one documentdocument

Reduces the number Reduces the number of requests requiring of requests requiring authorisationauthorisation

Step 4Step 4 – Fife List item? – Fife List item?

NHS Fife Common Specials and Unlicensed MedicinesNHS Fife Common Specials and Unlicensed Medicines Preparation can be obtained from any supplier Preparation can be obtained from any supplier as long as long

as the cost is less than or equal to the price statedas the cost is less than or equal to the price stated No authorisation required (except ‘urgent’ fee or No authorisation required (except ‘urgent’ fee or

excessive XP)excessive XP) Endorse COA/COC/invoice with ‘FL01’ instead of Endorse COA/COC/invoice with ‘FL01’ instead of

authorisation nameauthorisation name E.g.E.g.

Acetylcysteine 600mg tablets £21 for 100 on Fife ListAcetylcysteine 600mg tablets £21 for 100 on Fife List Some suppliers charge e.g. £83 for 100 – authorisation must be Some suppliers charge e.g. £83 for 100 – authorisation must be

sought if this is the best price availablesought if this is the best price available Saves £62 for each scriptSaves £62 for each script

Step 5Step 5 – Seek Authorisation – Seek Authorisation

If Steps 1 – 4 do not apply, authorisation must be sought If Steps 1 – 4 do not apply, authorisation must be sought from the Health Board using the ‘Authorisation Request from the Health Board using the ‘Authorisation Request Form’Form’

It must be completed in fullIt must be completed in full ‘‘Urgent’ requests for authorisation - all the relevant Urgent’ requests for authorisation - all the relevant

information must be providedinformation must be provided Need to get Name of Authorising Pharmacist and Date of Need to get Name of Authorising Pharmacist and Date of

Authorisation for endorsement purposesAuthorisation for endorsement purposes

Authorisation FormAuthorisation Form

Provides all the details Provides all the details required to make an required to make an informed decisioninformed decision

Captures data to guide Captures data to guide future authorisation future authorisation request advicerequest advice

Provides details to allow Provides details to allow follow up with the follow up with the prescriber if appropriateprescriber if appropriate

Prescription EndorsementPrescription Endorsement

7S prep – No endorsement required unless 7S prep – No endorsement required unless additional costs approved by HB e.g. ‘urgent’ feeadditional costs approved by HB e.g. ‘urgent’ fee

Non-7S preps:Non-7S preps: Manufacturer with an MHRA specials license/ Manufacturer with an MHRA specials license/

Imported specialsImported specials• SP - Invoice price (Ex VAT) less any discount or rebate SP - Invoice price (Ex VAT) less any discount or rebate

obtained in the purchase obtained in the purchase • XP - Additional charges in obtaining the item (hc/pp)XP - Additional charges in obtaining the item (hc/pp)• Send a copy of the invoice with paper copy of prescriptionSend a copy of the invoice with paper copy of prescription

Extemp prepsExtemp preps• EXT – Formula i.e. Ingredients & quantitiesEXT – Formula i.e. Ingredients & quantities

COA/COC/Invoice EndorsementCOA/COC/Invoice Endorsement

Pharmacy stampPharmacy stamp DateDate Contractor’s initialsContractor’s initials Invoice price (ex VAT) less discountInvoice price (ex VAT) less discount Additional chargesAdditional charges Prescriber’s detailsPrescriber’s details Authorisation name/codeAuthorisation name/code Date authorisation obtainedDate authorisation obtained

Endorsement ProformaEndorsement Proforma

To ensure complete To ensure complete endorsement with endorsement with correct informationcorrect information

Must be submitted Must be submitted with each with each COA/COC/invoiceCOA/COC/invoice

COA/COC/invoice will COA/COC/invoice will be returned if not be returned if not completed in fullcompleted in full

Specials Invoice Proforma Month: Pharmacy Name & Address

PPD Code: Initials:

Prescriber's details Authorised by or Authorisation code &date

Authorised until*:

Invoice Cost - less any discount or rebate obtained

Handling Charge: P&P:

* if price increases, re-authorisation required.

If any of the above information is not supplied, the paperwork will be sent back to the pharmacy for completion.

Authorisation CodesAuthorisation Codes

Obtained from an Obtained from an NHS manufacturing NHS manufacturing unit unit e.g. Glasgow or e.g. Glasgow or TaysideTayside

NMU01NMU01

Fife List Fife List item obtained item obtained at or below the price at or below the price statedstated

FL01FL01

Submission of PaperworkSubmission of Paperwork

At the end of At the end of eacheach month: month: All COA/COC/invoices from ‘specials’ All COA/COC/invoices from ‘specials’

supplied that month.supplied that month.

To: Pharmacy Services, Lynebank To: Pharmacy Services, Lynebank Hospital, Halbeath Road, Dunfermline, Hospital, Halbeath Road, Dunfermline, KY11 4UWKY11 4UW

Please remove patient identifiable dataPlease remove patient identifiable data

Out of Pocket ExpensesOut of Pocket Expenses

Supplier Pharmacy A Pharmacy B Pharmacy C

AAH £20 £20 £20

Alcura £9.99 £9.99 £20

Dales £9.99 £20 £20

IDIS No charge £8.50 £20

Martindale £14.45 £14.45 £14.45

Pharmanord £10.50 £10.50 £10.50

Quantum £11.99 £11.99 £11.99

Rosemont £6.50 £11.50 £20

Considerations?Considerations?

If the ‘special’ is delivered with your usual If the ‘special’ is delivered with your usual delivery, should we be expected to pay postage delivery, should we be expected to pay postage & packing?& packing?

If the ‘special’ has to be posted to you, as there If the ‘special’ has to be posted to you, as there is no wholesaler linked in, should postage & is no wholesaler linked in, should postage & packing be paid?packing be paid?

Where an excessive charge is applied to one Where an excessive charge is applied to one pharmacy but not another, should this be paid?pharmacy but not another, should this be paid?

Please remember: ‘URGENT’ delivery charges Please remember: ‘URGENT’ delivery charges mustmust be authorised or they be authorised or they will not will not be paidbe paid

FeedbackFeedback

Via email:Via email:

Fife-UHB.SpecialsUnlicensedMedicines@nhs.netFife-UHB.SpecialsUnlicensedMedicines@nhs.net

By phone: By phone: 01383 56535101383 565351

Via Community Pharmacy Scotland Via Community Pharmacy Scotland website:website:

www.communitypharmacyscotland.org.uk

Take Home MessagesTake Home Messages

All the supporting paperwork is available via links All the supporting paperwork is available via links on the NHS Fife page of NHS Scotland on the NHS Fife page of NHS Scotland Community Pharmacy websiteCommunity Pharmacy website

Ensure Ensure everyoneeveryone working with ‘specials’ in your working with ‘specials’ in your pharmacy understands the process and the pharmacy understands the process and the consequences of non-complianceconsequences of non-compliance

Think about the OOPE charges being applied – Think about the OOPE charges being applied – are they fair & necessary?are they fair & necessary?

Refer to the relevant practice pharmacist for help Refer to the relevant practice pharmacist for help If in doubt, If in doubt, please ask!please ask!

Where are you?Where are you?

Any Questions?Any Questions?

Discussion Groups – 1 HourDiscussion Groups – 1 Hour

40 mins40 mins

Authorisation requestsAuthorisation requests

COA/COC/invoice COA/COC/invoice endorsementendorsement

10 mins10 mins

AnswersAnswers

10 mins10 mins

Discussion around OOPEDiscussion around OOPE ThoughtsThoughts IdeasIdeas Other issuesOther issues