National Patient Safety Alert: Potential for inappropriate dosing of insulin when switching insulin degludec (Tresiba®) products

National Patient Safety Alert: Potential for inappropriate dosing of insulin when switching insulin degludec (Tresiba®) products

National Patient Safety Alert Reference Number: NatPSA/2023/016/DHSC

Date issued: 8th December 2023

Brief description of the problem

A Medicine Supply Notification issued on 24 May 2023, detailed a shortage of Tresiba® (insulin degludec) FlexTouch® 100units/ml solution for injection 3ml pre-filled pens. Advice on how to
manage this supply issue can be found on the Medicine Supply Tool.

The Medication Safety Officer (MSO) network has highlighted that in response to this shortage, some patients may have been switched to Tresiba® (insulin degludec) FlexTouch® 200units/ml solution for injection 3ml pre-filled pens. Tresiba® FlexTouch® pen delivery devices dial up in unit increments rather than volume.

However, a small number of patients have been incorrectly advised to administer half the number of units.

MSOs have highlighted five reports of patients being incorrectly advised to reduce the number of units of insulin to be administered. These reports suggest that errors have occurred at the
prescribing, dispensing and administration stages of the medicine journey. One case described a patient requiring treatment in hospital for diabetic ketoacidosis because of a reduced insulin dose.

Actions required

Actions to be completed as soon as possible and no later than 22nd December 2023.

All providers MUST ensure that patients who have been switched to Tresiba® (insulin degludec) FlexTouch® 200units/ml solution for injection 3ml prefilled pens are:

  • Made aware that Tresiba® FlexTouch® pen delivery devices dial up in unit increments rather than volume and no dose change is necessary.

Primary care providers should:

  • Continue to follow the advice in the Medicine Supply Notification.
  • When prescribing Tresiba® 100units/ml Penfill® cartridges, ensure the patient is also supplied with a compatible Novo Nordisk insulin delivery system and appropriate needles.
  • For a small cohort of patients unable to use Tresiba® 100units/ml Penfill® cartridges a switch to Tresiba® FlexTouch® 200units/ml prefilled pens may be necessary, clinicians should not adjust the dose of insulin.
  • Ensure all patients initiated on a new device are counselled on the change and provided with training on their use, including signposting to training videos, and the potential need for closer
    monitoring of blood glucose levels.

Secondary care providers should:

  • Avoid initiating patients on Tresiba® (insulin degludec) FlexTouch® 200units/ml prefilled pens due to supply constraints.
  • If unable to switch to Tresiba 100units/ml Penfill® cartridges, consider initiating a patient on an alternative long-acting insulin.

Please see full guidance in the alert.

Additional information

Supply Summary

Tresiba® FlexTouch® 100units/ml pre-filled pens are out of stock until December 2024. Prescribers should not initiate new patients on Tresiba® FlexTouch® 100units/ml pens during this time and should consider prescribing Tresiba® Penfill® cartridges with a NovoPen® 6 or Echo® Plus, which can support increased demand. Tresiba® FlexTouch® 200units/ml pre-filled pens are not able to support increased demand during the affected period and should not be prescribed as an alternative to Tresiba® FlexTouch® 100units/ml pens. Where switching to Tresiba® Penfill® cartridges is not considered suitable, due to a patient’s dexterity or ability to use the new device, seek advice from specialist diabetes teams on the use of an alternative insulin.

References:

  1. Tresiba® (insulin degludec) SmPC
  2. BNF insulin degludec
  3. BNF insulin preparations
  4. Novo Nordisk quick guide to using NovoPen® 6 or NovoPen Echo® Plus
  5. NICE guidance: Type 1 diabetes in adults (insulin therapy)
  6. Smart insulin pens – JDRF, the type 1 diabetes charity
  7. Novo Nordisk ‘Connected Pens’
  8. NovoPen® 6 and NovoPen Echo® Plus resources
  9. NHS England » Purchasing for safety

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