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Integrated care boards (ICBs) have until 31 January 2025 to implement a “local mitigation plan” to ensure patients can continue accessing their pancreatic enzyme replacement therapy (PERT) amid supply shortages, says the government.
A national patient safety alert (NPSA), published by NHS England and the Department of Health and Social Care (DHSC) on 18 December 2024, also advised pharmacy procurement teams at NHS trusts to use unlicensed imports where demand for PERT is greater than supply.
The alert follows an earlier NPSA, published in May 2024, which advised prescribers to limit prescriptions to one month’s supply for patients. The latest alert says clinicians should continue to prescribe in line with this advice.
The shortage affects three PERT products: Creon (Viatris) 10,000 and 25,000 capsules, Nutrizym 22 (Zentiva) capsules and Pancrex V (Essential Pharma) capsules and powder. These medicines are used to treat pancreatic exocrine insufficiency in patients with cystic fibrosis, pancreatic cancer and pancreatitis.
“The supply disruption of Creon capsules is due to limited availability of raw ingredients and manufacturing capacity constraints to produce volumes needed to meet demand,” the alert said.
“Production of Nutrizym 22 capsules has been increased and supplies are being released monthly, however this increase is unable to fully cover the gap in supply. There are intermittent deliveries of Pancrex V capsules and powder, but these are also unable to support an uplift.”
To reduce the impact of the shortages, the alert says that by the end of January 2024, ICBs “should put in place a local mitigation plan for instances when patients are unable to obtain stock from their community pharmacy or dispensing GP”.
ICBs have also been told to “cascade any local management plan to all community pharmacies and GP practices within the region, as well as local trust pharmacy teams”.
The alert adds that “several specialist importers have confirmed they can source unlicensed PERT” to support NHS trusts.
Although the shortage “is impacting primary care suppliers to a much greater extent than secondary care suppliers”, the alert says that this is then “increasing pressure on secondary care supplies” as some patients are being referred by primary care to secondary care to obtain their medicines.
Community pharmacies in Hampshire and Isle of Wight have been advised to order imports of Pangrol, an alternative brand to Creon that has been approved by University Hospital of Southampton for use, if a patient is due to run out of supplies in 14 days and Creon is unavailable.
A spokesperson for NHS Bristol, North Somerset and South Gloucestershire ICB said the board was “working with system colleagues across our ICS [integrated care system] to monitor the PERT shortage frequently”.
They added measures being taken included signposting clinicians to the Specialist Pharmacy Service website for stock updates; directing healthcare professionals and patients to customer support lines for the two main suppliers of PERT; and working closely with pharmacy teams and local community pharmacy colleagues to ensure a mitigation plan is in place.
A spokesperson for NHS Hereford and Worcestershire ICB said that “since the alert was published yesterday, we have had local discussions and will work with our community pharmacies, GP practices and provider trusts to ensure we have a local mitigation plan in place before the deadline of 31 January 2025”.
In October 2024, Pancreatic Cancer UK published a five point plan calling on the government to deliver a national action plan to address the shortages, including a national effort to import PERT into the UK.
This was followed by a survey conducted by the charity of 572 people in December 2024, which found that 71% are taking a lower dose of PERT than they need or have altered their diet owing to the shortages.
