Pancreatic Enzyme Replacement Therapy (PERT)

This document summarises the current challenges with Pancreatic Enzyme Replacement Therapy supply (PERT) and provides advice and actions for prescribers, patients and community pharmacy.

Summary of current issues:

There are limited supplies of pancreatic enzyme replacement therapies in the UK:

  • Creon® 10,000 capsules, Creon® 25,000 capsules and Creon® Micro Pancreatin 60.12mg gastro-resistant granules are available currently but in limited, capped quantities until 2026:
    • Supply disruption is due to limited availability of the active pharmaceutical ingredients and manufacturing constraints.
  • Nutrizym® 22 capsules are intermittently available but are unable to support increased demand:
    • Supply disruption is caused by a manufacturing issue and increased demand due to reduction in Creon® supply.
  • Pancrex® V capsules and powder are subject to supply disruption:
    • Supply disruption is caused by increased demand due to reduction in Creon® preparation supply.

    Two National Patient Safety Alerts (NPSA) have been issued for the Shortage of Pancreatic enzyme replacement therapy (PERT) in May 2024 and December 2024, alongside Serious Shortage Protocols (SSPs) for two pancreatic enzyme products; Creon® 25,000 capsules and Creon® 10,000 capsules.

    The current status of pancreatic enzyme supplies can be checked on the SPS website.

    • Creon® 10,000 capsules should be reserved for people unable to take Creon® 25,000 capsules e.g. infants and people who are unable to swallow larger capsules or unable to open them.
    • Nutrizym® 22 should be prioritised for people who are unable to tolerate Creon® preparations. Please note Nutrizym® 22 is not suitable for children aged 15 years and under with cystic fibrosis.
    • Creon® Micro Pancreatin 60.12mg gastro-resistant granules should be prioritised for children and people with swallowing difficulties. 
    • Pancrex® V Powder should be prioritised for patients with enteral feeding tubes, this is not an appropriate product for patients to take orally in most cases.
    • Ensure prescriptions of PERT are for a maximum of 1 month supply.  Typically for adults this will be a maximum of 500 Creon® 25,000 or Nutrizym® 22 capsules per month. Issue as a single item on an EPS prescription or provide patients with a prescription token. 
    • Issue repeat prescriptions ahead of patients need; patients are being advised to order their next prescription as soon as their previous one is dispensed.  Please make sure that GP practice prescription management teams are aware of this deviation from usual practice. Do not post-date prescriptions, use the pharmacy text box to explain why an early prescription is being submitted.
    • Patients must not be left without any PERT. This can lead to hypoglycaemia, severe bowel symptoms, poor absorption of other medications and weight loss.

    The Specialist Pharmacy Service (SPS) have created an interactive tool to find alternatives to a patient’s current PERT.

    Where PERT is prescribed to adults for indications other than cystic fibrosis, clinicians and prescribers should consider the following, described in more detail in the national position statement:

    • prescribing a proton pump inhibitor or H2 receptor antagonist to reduce acid degradation of PERT and optimise efficacy, for patients with no contraindications.
    • where symptoms remain despite a dose of more than 10,000 units of lipase per kg per day or 100,000 units lipase with a meal, whether other causes of the symptoms should be investigated.
    • prescribing medication to manage symptom control, noting that this will not treat malabsorption and is not an alternative to PERT.
    • Contact patient’s specialists via advice and guidance if additional support is required on managing non-CF patients during the shortage.

    Creon Support Line

    As part of the actions taken to mitigate the impact of the shortage on patients and healthcare professional, Viatris™ UK has initiated a free Creon® customer service line dedicated to patients and healthcare professional affected by the Creon® supply constraint. The service aims to provide information on the nearest pharmacies which have recently received supply. Consider recommending the service to patients who are trying to find pharmacies with available stock.

    The Creon® customer service line can be reached via 0800 808 6410. Operators will respond from UK and handle enquiries in real time. The service will be active from Monday to Friday from 9:00 to 17:00.

    Unlicensed imports

    • Unlicensed imports of PERT should only be prescribed where licensed alternatives are unavailable, working with local pharmacy teams to ensure orders are placed within appropriate time frames.
    • If community pharmacies are unable to access Creon® preparations and patients are due to run out of their medication please prescribe imported Pangrol® gastro resistant capsules.
    • Pangrol® is an unlicensed imported pancreatic enzyme preparation available in equivalent strengths to Creon® which is currently available at a significantly lower cost to the NHS compared to alternative unlicensed imports.  
    • Community pharmacies cannot issue Pangrol® imports against a prescription for Creon®, therefore prescriptions for Pangrol® should be issued on an FP10 paper prescription and should detail:
      • Pangrol® 10,000/25,000* gastro resistant capsules (Imported) *(delete as appropriate)
      • Special Order
      • Dosage instructions for patient
      • Quantity (Pangrol® comes in 200 capsule packs)
    • Patients should be informed of the rationale for the use of an unlicensed imported product and adequate justification provided. This should also be documented in the patient’s medical record as per GMC requirements.

    We understand the anxiety the current supply issues are causing and are working to help everyone who needs pancreatic enzymes (PERT) to get the medications they need.

    • Please place your repeat prescription request as soon as your previous one has been dispensed. 
    • Check with your GP practice that this prescription request is not being automatically rejected as some automated systems reject prescriptions if they are put in too soon; if you are using the NHS app or a computerised system at your surgery, you should get a notification if the prescription is rejected.
    • Your GP should provide your prescription as a single item on a prescription; this allows you to take the prescription token to different pharmacies if there is available stock.
    • If your pharmacy let you know your PERT is out of stock, please ask them to order it anyway so the order is logged and will be filled when the next shipment of PERT arrives in the UK. 
    • Call ahead to confirm stock before making a special visit to a pharmacy. Some community pharmacies have online stock checking services, which may be helpful. 
    • Please let your GP know if you are not able to get a prescription filled and have only 10 days’ supply of PERT remaining. There is a process available to access imported medication.  You may be prescribed a different product which is equivalent to your usual PERT.  Please talk to your community pharmacist if you have any questions.
    • To help the enzymes work best remember to take your PERT throughout your meals rather than all at the start, middle or end. 
    • Please remember to store your enzyme products below 25 degrees; if the products get too hot the enzymes are destroyed and won’t work. This cannot be reversed. In periods of prolonged extreme heat store your PERT in a fridge. 
    • Ensure that you use your PERT before it goes out of date. If you store PERT in different places (e.g. at work), make sure you rotate your supplies to prevent any wastage.
    • Please don’t stockpile medications; this makes supply issues worse for everyone.  GPs have been advised by the Department for Health to issue prescriptions for one month’s supply of PERT at a time. 
    • Please do not borrow or share medication with other patients or buy medication on the internet.

    Creon Support Line

    As part of the actions taken to mitigate the impact of the shortage, Viatris™ UK has initiated a free Creon® customer service line. The service aims to provide up to date information on the pharmacies which have recently received a supply.

    The Creon® customer service line can be reached via 0800 808 6410. Operators will respond from the UK and handle enquiries in real time. The service will be active from Monday to Friday from 9:00 to 17:00.

    Please reassure patients that supplies of pancreatic enzymes are continuing to reach the UK and that Creon® and Nutrizym® products have not been discontinued.  The current stock issues will be intermittently continuing, but pancreatic enzymes are still available to prescribe.

    Pharmacies presented with repeat prescription for Creon® preparations should only supply the equivalent to one month’s supply in accordance with SSP060 and SSP061 and endorse as directed by the SSP.

    If the patient’s PERT preparation is showing as out of stock, please order to add onto the back-order list. Patients are being advised to submit requests as soon as their previous prescription has been dispensed.

    If the patient asks to try a different pharmacy, please return the prescription to the spine and give a printed token to the patient.

    Creon Support Line

    As part of the actions taken to mitigate the impact of the shortage on patients and healthcare professional, Viatris™ UK has initiated a free Creon® customer service line dedicated to patients and healthcare professional affected by Creon® supply constraint. The service aims to provide information on the nearest pharmacies which have recently received supply. Consider recommending the service to patients who wish to try visiting alternative pharmacies to find available stock.

    The Creon® customer service line can be reached via 0800 808 6410. Operators will respond from UK and handle enquiries in real time. The service will be active from Monday to Friday from 9:00 to 17:00.

    Unlicensed imports

    If patients are due to run out of PERT in the next 10 days and UK Creon® is not available via usual wholesale routes, consider ordering an imported alternative and requesting a new prescription to ensure all costs are covered.

    Oxford Pharmacy Stores (OPS) have confirmed they have stock of Pangrol® 10,000 and 25,000 capsules which can be ordered for next day delivery to community pharmacies across the UK. Pangrol® is an unlicensed imported pancreatic enzyme preparation available in equivalent strengths to Creon®. When ordered via OPS it is available at a significantly lower cost to the NHS compared to alternative unlicensed imports. You will need an account with OPS, if you do not have one already, email ops.orders@oxfordhealth.nhs.uk to set one up (this may take up to 3 days).

    The Specialist Pharmacy Service Medicines Supply Tool (registration required) contains a list of alternative specialist importers and guidance on ordering and prescribing unlicensed imports

    Please liaise with patients and prescribers where an unlicensed import product is required to fill a patient’s prescription. Where a prescriber needs to prescribe a specially manufactured or imported product, an FP10 paper prescription should be requested. The prescription should detail the imported product:

    • Pangrol® 10,000 or 25,000 gastro resistant capsules (Imported)

    When dispensing please print and include the relevant Patient Information Leaflet (PIL):

    Patients with swallowing difficulties who will need to open the Pangrol® capsules should be directed to the relevant section of the PIL. Pangrol® capsules can be carefully opened over a suitable container by pulling them apart and the contents swallowed with a little liquid immediately and without chewing. This advice differs to the advice for Creon®.

    Prescriptions should be endorsed as a non-Part VIIIB special as per NHS BSA guidance, ensuring the following information is included:

    • Amount dispensed over pack size (200) used
    • Invoice price per pack size from which the order was supplied less any discount or rebate; make sure to include delivery cost
    • Manufacturers’/importers’ (Target Healthcare) MHRA licence number: MS43086/ WDA(H)43086
    • Batch number of the product supplied
    • SP

    References

    V1.1 approved by Integrated Medicines Optimisation Committee (IMOC) on January 2025 (Acknowledgement Surrey Heartlands ICB)