Contractor notification: Melatonin oral solution – retrospective price adjustment

Contractor notification: Melatonin oral solution – retrospective price adjustment

July 11, 2019

Following representation from PSNC the Department of Health and Social Care (DHSC) have retrospectively determined that from July 2019:

  • Melatonin 1mg/1ml oral solution sugar free (150ml) – is added to Part VIIIA of the Drug Tariff as a Category C line based on Colonis Pharma,
  • Melatonin 5mg/5ml oral solution and Melatonin 5mg/5ml oral suspension – are deleted from Part VIIIB.

Please note that payment for July’s prescriptions will reflect the above retrospective determination; not as per the published July Drug Tariff.

For information of the licensed indication and safety restrictions for Melatonin 1mg/ml Oral Solution contact Colonis: Email: medinfo@colonis.co.uk or Telephone: 01892 739 403

For more information on Melatonin 1mg/1ml oral solution sugar free see the product information leaflet here.


FAQs

Q. I have received a green paper FP10 prescription for ‘Melatonin 1mg/1ml oral solution sugar free x 150ml’ for a 12 year old child; can I supply the licensed product from Colonis Pharma Ltd

Melatonin 1mg/ml Oral Solution from Colonis Pharma Ltd is not licensed for use in children and adolescents aged 0 – 18 years. If there is uncertainty over the prescribers intentions, the prescriber should be contacted and the prescription amended accordingly, if needed. Should the prescriber wish you to dispense an unlicensed melatonin formulation, the prescription would need to be amended to specify ‘Melatonin 1mg/1ml oral solution (Special Order)’, for example and the prescription would need to be endorsed as per the specials endorsing guidance and submitted using in your red separator.

Q. I have received a prescription for ‘Melatonin 5mg/5ml oral solution sugar free’ from a patient that requires the unlicensed preparation. I contacted my specials supplier who have requested that I provide a letter from the prescriber documenting the special clinical need for the continued use of the unlicensed presentation as there is now a licensed preparation available. Is it standard practice for special suppliers to request this?

We are aware that some specials suppliers may ask for written notification from the prescriber which documents the special clinical need for the continued use of the unlicensed presentation.  This is in line with MHRA guidance note 14 which sates ‘Anyone supplying an unlicensed medicinal product, where an equivalent licensed medicinal product is available must be satisfied as to the existence of a special need for the unlicensed medicinal product. MHRA expects that documentary evidence of this special need should be obtained by manufacturers, importers or distributors and that this evidence should be made available on request of the Licensing Authority. This may take the form of a prescriber’s letter, however an alternative fully documented audit trail through the supply chain confirming special need may be acceptable.’

Q. I have received a green paper FP10 prescription for ‘Melatonin 5mg/5ml oral solution x 150ml’ and have dispensed the licensed ‘Melatonin 1mg/1ml oral solution sugar free x 150ml’ (as per MHRA guidelines) following direction from the prescriber, what will I be paid for?

A. All prescriptions for ‘Melatonin 5mg/5ml oral solution’ submitted in July’s prescription bundle, will be reimbursed the dm+d list price for ‘Melatonin 1mg/1ml oral solution sugar free’ which is currently £130.00 for a pack of 150ml manufactured by Colonis Pharma Ltd.

Q. I have received an EPS prescription for ‘Melatonin 5mg/5ml oral solution (Drug Tariff special order) x 150ml’ and have dispensed the licensed ‘Melatonin 1mg/1ml oral solution sugar free x 150ml’ (as per MHRA guidelines) following direction from the prescriber, what will I be paid for?

A. All prescriptions for ‘Melatonin 5mg/5ml oral solution’  submitted in July’s prescription bundle, will be reimbursed the dm+d list price for ‘Melatonin 1mg/1ml oral solution sugar free’ which is currently £130.00 for a pack of 150ml manufactured by Colonis Pharma Ltd.

Q. I have received a green paper FP10 prescription for ‘Melatonin 5mg/5ml oral suspension x 150ml’ and have dispensed the licensed ‘Melatonin 1mg/1ml oral solution sugar free x 150ml’ (as per MHRA guidelines) following direction from the prescriber, what will I be paid for?

A. If the pharmacy team has endorsed ‘Melatonin 1mg/1ml oral solution sugar free x 150m, Colonis Pharma Ltd’, they will be paid based on the dm+d list price of £130.00. If the prescription has not been endorsed, it will be referred back to the pharmacy for clarification.

Q. I have received an EPS prescription for ‘Melatonin 5mg/5ml oral suspension (Drug Tariff special order) x 150ml’ and have dispensed the licensed ‘Melatonin 1mg/1ml oral solution sugar free x 150ml’ (as per MHRA guidelines) following direction from the prescriber, what will I be paid for?

A. If the pharmacy team has endorsed ‘Melatonin 1mg/1ml oral solution sugar free x 150ml, Colonis Pharma Ltdl’, they will be paid based on the dm+d list price of £130.00. If the prescription has not been endorsed, it will be referred back to the pharmacy for clarification.

Q. Is the licensed Melatonin 1mg/1ml oral solution sugar free a special container?

A. No. This product is not a special container. Pharmacy teams are reminded that they are able to claim broken bulk on this product. For further information on broken bulk, visit psnc.org.uk/bb.



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