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Ongoing Supply Issues with Pancreatic Enzyme Replacement Therapy (PERT) Preparations

Cegedim Healthcare Solutions has been notified that a National Patient Safety Alert (NPSA) relating to the shortage of Pancreatic enzyme replacement therapy (PERT) was issued on 18 December 2024 (Reference no: NatPSA/2024/013/DHSC):

https://www.cas.mhra.gov.uk/ViewandAcknowledgment/ViewAttachment.aspx?Attachment_id=104186

The alert is for action by all organisations involved in prescribing, dispensing and oversight of PERT and details actions for clinicians and prescribers of PERT to be completed by 31/01/2025 and to remain in place only until supply issues have resolved. It specifies that Creon® will remain in limited supply until 2026 and alternatives such as Nutrizym® 22 capsules and Pancrex V® capsules and powder are intermittently available but are unable to fully cover the gap in supply.

Due to these ongoing supply issues, unlicensed imports of PERT may be prescribed and dispensed. Examples of such preparations listed in the NHS dictionary of medicines and devices (dm+d) include:

  • Creon® 10000 gastro-resistant capsules (Imported)
  • Creon® 25000 gastro-resistant capsules (Imported)
  • Pancreaze®Delayed-Release capsules (Imported)
  • Pangrol® 10,000 capsules (Imported)
  • Pangrol® 25,000 capsules (Imported)

Please note: the enzyme composition of unlicensed imports may differ from UK licensed products

If an unlicensed PERT product is required, a prescription will need to be issued correctly with ‘(Imported)’ included as part of the drug name field. This will ensure pharmacies are reimbursed for supplying the unlicensed product (provided the prescription is endorsed accordingly).

Further details on the supply of unlicensed PERT preparations are available within an article published on 03 February 2025 by Community Pharmacy England:

https://cpe.org.uk/our-news/supply-of-unlicensed-pert-preparations/

Other related guidance specific to the four home nations that the UK comprises may additionally be available. Users may check with their National Leads to confirm the availability of such national guidance specifically applicable to their own country.

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