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® 10000 and Creon® 25000 capsules are in limited supply until 2026
- Supply disruption is due to limited availability of the active pharmaceutical ingredients and manufacturing constraints.
- Nutrizym® 22 capsules are out of stock until mid-August 2024
- Supply disruption is caused by a manufacturing issue and increased demand due to reduction in Creon® supply.
- Pancrex V® capsules and powder are available but are unable to support increased demand.
A National Patient Safety Alert (NPSA) has been issued for the Shortage of Pancreatic enzyme replacement therapy (PERT) alongside Serious Shortage Protocols (SSPs) for two pancreatic enzyme products; Creon® 25000 capsules and Creon® 10000 capsules.
Actions required for clinicians and prescribers from NPSA alert:
- Creon® 10000 capsules should be reserved for people unable to take Creon® 25000 capsules e.g. children and people who are unable to swallow larger capsules.
- Nutrizym® 22 should be prioritised for people who are unable to tolerate Creon preparation.
- Ensure prescriptions of PERT are for a maximum of 1 month supply. Typically for adults this will be a maximum of 500 Creon® 25000 or Nutrizym® 22 capsules per month. Issue as a single item on an EPS prescription not nominated to a pharmacy. Provide patients with a prescription token they can take to the pharmacy.
- 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.
- Prescribe unlicensed imports of PERT only where licensed alternatives are unavailable, working with local pharmacy teams to ensure orders are placed within appropriate time frames. Unlicenced imports include Creon®, Zenpep® and PANCREAZE® preparations. Where a prescriber wishes to prescribe an imported product, an FP10 paper prescription should be issued as ‘Specified imported product (Special Order)’ and endorsed by the pharmacy as a non-Part VIIIB special with the information in the “Advice to community pharmacy” section.
- 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.
- 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.
Advice for patients
- 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 prescription as soon as your previous one has been dispensed.
- 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.
- 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.
- 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.
- Some community pharmacies have online stock checking services, which may be helpful. Do call ahead to confirm stock before making a special visit to a pharmacy.
- To help the enzymes work best remember to take your PERT throughout your meals rather than all at the start, middle or end.
- As we are heading into the summer months 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.
- 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 1 month’s supply of PERT at a time.
- Please do not borrow or share medication with other patients or buy medication on the internet.
- Please let your GP know if you are not able to get a prescription filled and have only 10 days’ supply of PERT remaining.
Advice for pharmacies
- 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 2 weeks in advance of need.
- If patients ask to try a different pharmacy please return the prescription to the spine and give a printed token to the patient.
- The following specialist importers have confirmed they can source unlicensed PERT preparations if licensed products are unavailable (other companies may also be able to source supplies):
* PANCREAZE and Zenpep are available in different strengths, please check the strength supplied. The enzyme composition of unlicensed imports may differ from UK licensed products; please refer to corresponding Summary of Product Characteristics for specific product information.
- Please liaise with patients and prescribers where an unlicensed import product is required to fill a patient’s prescription. Where a prescriber wishes to prescribe a specially manufactured or imported product, an FP10 paper prescription should be issued as ‘Specified imported product (Special Order)’ and endorsed by the pharmacy as a non-Part VIIIB special with the following information:
- Amount dispensed over pack sized used
- Invoice price per pack size from which the order was supplied less any discount or rebate
- Medicines and Healthcare products Regulatory Agency (MHRA) license number of the supplier or importer
- Batch number of the product supplied
- ‘SP’
References
- National Patient Safety Alert for the shortage of PERT
- Serious Shortage Protocols for PERT
- National Position Statement: PERT Shortage
Document History
Version: V 1.0
Approval date: August 2024