FOI 2025/1220

1. Has your ICB developed any local planning documents, protocols or guidance specifically relating to managing pancreatic cancer enzyme replacement therapy (PERT) shortages, including but not limited to Creon, between January 2023 and present? Please respond with yes or no.

1a. If yes to question 1, please provide copies of all such documents, protocols or guidance.

2. Has your ICB procured any alternative PERT products from overseas suppliers between January 2023 and present? Please respond with yes or no.

If yes to question 2, please answer the following:

2a. Which countries were these products sourced from?

2b. How many ‘special order’ prescriptions for these products have been dispensed?

2c. What percentage of the local demand has been covered by these overseas products?

2d. How have many Trusts within your ICS have used these products?

3. Please provide details of:

3a. Any risk assessments conducted regarding PERT / Creon shortages and.

3b. Any monitoring systems put in place to track local supply levels, between January 2023 and present.

1.Yes

1a. The NHS Greater Manchester (NHS GM) Pathway for the Management of Patients Prescribed Pancreatic Enzyme Replacement Therapy (PERT) during the National Shortage is available at: https://gmmmg.nhs.uk/GM-pathway-for-Primary-Care-PERT-medicines-shortage-Approved-April-2025.pdf.

2. NHS GM did not implement a central procurement system for PERT. However, we cannot confirm whether alternative PERT products from overseas suppliers were procured locally, as this may have been managed by individual NHS trusts or community pharmacies.

For further information regarding local procurement activity, we recommend contacting relevant secondary care trusts or community pharmacy providers directly.

To assist you please find links to their details below:

Bolton NHS Foundation Trust – Freedom of information – Bolton NHS FT (boltonft.nhs.uk)

Northern Care Alliance NHS Foundation Trust – Freedom of Information Requests :: Northern Care Alliance

Manchester University NHS Foundation Trust – Freedom of Information – Manchester University NHS Foundation Trust (mft.nhs.uk)

Stockport NHS Foundation Trust – Freedom of Information – Stockport NHS Foundation Trust

Tameside and Glossop Integrated Care NHS Foundation Trust – Freedom of Information Requests :: Tameside and Glossop Integrated Care (tamesideandglossopicft.nhs.uk)

Wrightington, Wigan and Leigh Teaching Hospitals NHS Foundation Trust – WWL Teaching Hospitals NHS Foundation Trust | FOI Disclosure Log

Pharmacists (chemists) | Greater Manchester Integrated Care Partnership

3a. Risk assessments conducted regarding PERT / Creon shortages

Local Impact Assessment

In January 2025, a structured survey was conducted with both local secondary care trusts and community pharmacies to assess the impact of PERT shortages and to inform mitigation planning.

Secondary Care Trusts

Secondary care trusts were asked a series of questions to evaluate the impact of PERT shortage on hospital pharmacy supply and prescribing. These questions included:

• Whether hospital pharmacies were able to obtain licensed or unlicensed PERT stock.
• Which patient cohorts were currently being supplied with PERT.
• Whether current supply was sufficient to meet population-level demand, or if any challenges were being experienced.
• Whether there had been an increase in patients being referred from primary care for PERT supply.
• How emergency PERT prescription requests were being managed.

Community Pharmacies

A survey of community pharmacies explored their access to PERT stock and identified potential barriers. Key questions focused on:

• Access to licensed and unlicensed PERT.
• Supply challenges or disruptions.
• Instances where patients may have run out of medication.

Centralised Ordering Consideration

The option of introducing a centralised ordering process for PERT was explored, including engagement with Integrated Care Boards (ICBs) in other regions, such as Surrey, where this model had been piloted. Following local stakeholder engagement, it was agreed that centralised ordering would not be implemented at this stage due to:

• Low uptake of centralised systems in other regions.
• Contractual complexities with new suppliers.
• The risk of stock waste if unused.

Improving stock availability across primary and secondary care reduced the urgency for centralised ordering. While not currently being pursued, centralised ordering may be revisited should supply issues worsen.

Guidance and Mitigation Planning

One of the key outcomes of the assessment was the identified need for a clear, system-wide guidance document to support community pharmacies, GP practices, and patients in managing PERT shortages.

The guidance aims to minimise the risk of patients running out of PERT and ensure appropriate escalation in exceptional circumstances.

As a result, a comprehensive guidance document was developed and is now available on the GMMMG website. The guidance includes:

• Clear protocols for scenarios where licensed or unlicensed PERT is unavailable.
• Clarification of mitigation pathway for patients unable to access PERT through their usual community pharmacy.
• Clear procedures for emergency supply from secondary care trusts in exceptional cases.

3b. Monitoring systems put in place to track local supply levels, between January 2023 and present.

Monitoring Systems and Supplier Support

To support access and improve visibility of supply, the following mechanisms have been put in place:

Customer service helplines from the two main UK suppliers (details below) are included in the guidance document:

Viatris (Creon®):                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    

Phone: 0800 808 6410 (for patients and pharmacists)

Email: productenquiries@viatris.co.uk

Zentiva (Nutrizym®):

Phone: 0844 879 3188 (for pharmacists) and 0800 090 2408 (for patients)

Email ukcustomerservices@zentiva.com

Links to the Specialist Pharmacy Service (SPS) for:

• Real-time updates on stock availability.
• A dose conversion tool to support prescribing of suitable alternatives.

Manufacturer Updates:

In January 2025, manufacturers confirmed they were maintaining supply at 90–95% of average monthly demand and had implemented measures to improve long-term availability. From 1 March 2025, Alliance Healthcare UK became the sole distributor of Creon® to pharmacies, GPs, and hospitals across the UK, to support more efficient and consistent distribution.

Ongoing Monitoring

We remain committed to monitoring the PERT supply situation closely. Secondary care trusts and community pharmacies have been asked to notify us of any significant changes in referral patterns or emerging supply challenges.

A follow-up meeting is scheduled for July to review ongoing availability, assess any changes in demand, and determine whether additional measures are needed.