National Patient Safety Alert - 2024/007 - Shortage of Pancreatic Enzyme Replacement Therapy (PERT)

Oct 5, 2026

Uploaded by dhado

National Patient Safety Alert NatPSA/2024/007/DHSC addresses limited availability of pancreatic enzyme replacement therapy (PERT) and supersedes Medicine Supply Notification MSN/2024/054. It explains the disruption affecting Creon® (limited until 2026) and Nutrizym® 22 (out of stock until mid-August 2024), notes clinical use in pancreatic exocrine insufficiency, and states there is no clinical alternative to PERT. The alert sets time-limited actions for clinicians and pharmacists, including prescribing limits, prioritisation between strengths, dose optimisation considerations, and appropriate use of unlicensed imports with specialist referral when needed.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages3

Reading Time8 min

AccessFree to download

Explanation of identified safety issue

Actions required

Additional information

Chief Medical Officer Directorate Pharmacy and Medicines Division T: 0131-244-2528 E: [irene.fazakerley@gov.scot](irene.fazakerley@gov.scot) 􀀅􀀇􀀈􀀉 IMMEDIATE MESSAGE TO: Medical Directors NHS Boards Directors of Pharmacy 24 May 2024 Dear Healthcare Professional, NATIONAL PATIENT SAFETY ALERT/2024/007/DHSC SHORTAGE OF PANCREATIC ENZYME REPLACEMENT THERAPY (PERT) This National Patient Safety Alert supersedes the Medicine Supply Notification (MSN/2024/054) which was issued on 09 May 2024.There are limited supplies of pancreatic enzyme replacement therapies (PERT) . The Alert provides background and clinical information and actions for providers for onward transmission as below : Please could all Directors of Pharmacy please forward this alert to:- ● Chief Pharmacists ● Hospital Pharmacists ● Community Pharmacists Please could Medical Directors arrange to forward this alert on to:- ● General Practitoners ● Dispensing Doctors ● Respiratory Services ● Dietetics ● Hepatobiliary Services ● Cancer Services ● Relevant Clinics Private Healthcare providers Thank you for your co-operation. Yours sincerely IRENE FAZAKERLEY Medicines Policy Team Shortage of Pancreatic enzyme replacement therapy (PERT) | Date of issue: | 24-May-24 | Reference no: | NatPSA/2024/007/DHSC | | --- | --- | --- | --- | | This alert is for action by: All organisations involved in prescribing and dispensing pancreatic enzyme replacement therapy (PERT) . | | | | | This is a safety critical and complex National Patient Safety Alert. Implementation should be co-ordinated by an executive lead (or equivalent role in organisations without executive boards) and supported by clinical leaders in community pharmacy, GP practices and clinical leaders in pharmacy, dietetics, respiratory , hepatobiliary and cancer services. | | | | | Explanation of identified safety issue: | | --- | | This alert supersedes the Medicine Supply Notification (MSN/2024/054) issued on the 9th May 2024.
There are limited supplies of pancreatic enzyme replacement therapies (PERT) .
• Creon® 10,000 and 25,000 capsules are in limited supply until 2026.
• Nutrizym® 22 capsules are out of stock until midAugust 2024.
• Pancrex V® capsules and powder remain available but are unable to support an increase in demand.
The supply disruption of Creon® capsules is due to limited availability of active pharmaceutical ingredients and manufacturing constraints to produce the volumes required to meet demand.
The supply disruption for Nutrizym® 22 capsules has been caused by a manufacturing issue and increased demand because of the Creon® supply issue.
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.
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 tobe completed 10/06/2024
To remain in place only until the supply issues have resolved (see SPS Medicine Supply Tool):
1. Clinicians should:
a. prescribe a maximum of one month’s supply of PERT for all patients at a time.
b. prioritise available Creon 10,000 capsules for patients unable to take Creon 25,000 capsules only. Note A
c. prioritise remaining stock of Nutrizym® 22 capsules for patients unable to tolerate Creon capsules.
d. where PERT is prescribed for indications other than cystic fibrosis, clinicians and prescribers should consider:
• prescribing a proton pump inhibitor or H2 receptor antagonist to optimise efficacy Note B
• if a dose reduction may be suitable for patients based on se

FAQs

What does the national patient safety alert NatPSA/2024/007/DHSC cover?

It covers a shortage of pancreatic enzyme replacement therapy (PERT), including background on the supply disruption and actions for prescribing and dispensing during the period of limited supplies.

Which PERT products are affected and what are the key supply constraints?

Creon® 10,000 and 25,000 capsules are in limited supply until 2026, while Nutrizym® 22 capsules are out of stock until mid-August 2024. Pancrex V® capsules and powder remain available but cannot support increased demand.

What immediate prescribing and dispensing actions are required for clinicians and pharmacists?

Clinicians should prescribe a maximum one month’s supply at a time and prioritise available Creon 10,000 for patients unable to take Creon 25,000, and reserve Nutrizym® 22 for patients who cannot tolerate Creon. Pharmacists should supply only the equivalent of one month’s supply for repeat prescriptions in line with specified safety guidance.

Oct 5, 2026

Uploaded by dhado