National Patient Safety Alert: Shortage of Pancreatic enzyme replacement therapy (PERT) – Additional actions

National Patient Safety Alert: Shortage of Pancreatic enzyme replacement therapy (PERT) – Additional actions

National Patient Safety Alert Reference Number: NatPSA/2024/013/DHSC

Date issued: 18 Dec 2024

Explanation of identified safety issue

This alert contains actions which are in addition to those outlined in the National Patient Safety Alert (NatPSA/2024/007/DHSC) issued on 24th May 2024.

There are limited supplies of pancreatic enzyme replacement therapies (PERT).

• Creon® 10,000 and 25,000 capsules remain in limited supply until 2026.
• Nutrizym® 22 capsules and Pancrex V® capsules and powder are intermittently available but are unable to fully cover the gap in supply.

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.
There are regular deliveries to wholesalers, two to three times each month, of both strengths to allow for equitable distribution. However, the volumes are insufficient to meet full demand. Therefore out of stock periods continue between each delivery.

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.

Unlicensed imports of Creon® capsules and alternative brands of PERT may be sourced, lead times vary.

Information relating to imports is available below and on the SPS Medicines Supply Tool which also details any changes to resupply dates, updates to this communication and an up-to-date supply overview.

Actions required

Actions for clinicians and prescribers of PERT to be completed 31/01/2025

To remain in place only until the supply issues have resolved (see SPS Medicine Supply Tool)

1. Clinicians should continue to follow the actions set out in the National Patient Safety Alert (NatPSA/2024/007/DHSC) issued on 24th May 2024.
2. NHS provider trust pharmacy procurement teams should ensure that where quantities greater than current demand are required, unlicensed imports should be considered. NOTE A
3. To ensure that patients are not left without PERT, Integrated Care Boards (ICBs) should:
   1. put in place a local mitigation plan for instances when patients are unable to obtain stock from their community pharmacy or dispensing GP.
   2. cascade any local management plan to all community pharmacies and GP practices within the region, as well as local trust pharmacy teams. NOTE B

Clinical Information

PERT is indicated for the treatment of pancreatic exocrine insufficiency such as in cystic fibrosis, pancreatic cancer and pancreatitis. There is no clinical alternative to PERT. Each preparation contains different amounts of pancreatic enzymes. Many patients adjust their dose according to symptom management, but all patients should be counselled to re-titrate the dose if problems with digestion or weight loss occur.

For updates on stock availability, optimisation of doses and symptom control, as well as information on switching between products and available unlicensed preparations, please refer to the SPS webpage ‘prescribing and ordering available pancreatic enzyme replacement therapies’.

Note A: The supply issue is impacting primary care suppliers to a much greater extent than secondary care suppliers due to the supply channels available to each sector. This is increasing pressure on secondary care supplies as some patients unable to obtain stock locally are being referred to local secondary care supplier. Several specialist importers have confirmed they can source unlicensed PERT; please note there may be other companies that can also source supplies. The enzyme composition of unlicensed imports may differ from UK licensed products; please refer to the datasheet accompanying these products.

For a list of specialist importers and for guidance on ordering and prescribing unlicensed imports see here.

Note B: Many ICB regions have escalation processes in place for when patients are unable to access PERT from their community pharmacy or GP. Examples of local regional mitigation plans produced by ICBs include:

• Centralised ordering process for unlicenced imports to support local community pharmacies. For example, see Community Pharmacy Hampshire & Isle of Wight
• Collaboration between community pharmacies, GPs and local trusts to create an emergency pathway to access PERT

Please see full guidance in the alert.