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

Updated 26/07/2024

Serious Shortage Protocols were issued on the 24th May for both strengths of Creon® which limit the quantity pharmacies may dispense to one month’s supply.

Position Statement for Clinicians for Adult Patients – Pancreatic enzyme replacement therapy (PERT) shortage – advice for the management of adults with pancreatic exocrine insufficiency

NEW: Position Statement for Adult Patients – Pancreatic enzyme replacement therapy (PERT) shortage – advice for adults with pancreatic exocrine insufficiency

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

National Patient Safety Alert Reference Number: NatPSA/2024/007/DHSC

Date issued: 24 May 2024

This alert supersedes the Medicine Supply Notification (MSN/2024/054) issued on the 9th May 2024.

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

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 mid-August 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 to be 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 severity of symptoms (Note B)
    • where symptoms remain despite a dose of ≥10,000 units lipase/kg/day or 100,000 units lipase with a meal, whether other causes of the symptoms should be investigated (Note B)
    • prescribing medication to manage symptom control (Note B)

e. 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

f. immediately refer patients to a specialist for advice on alternative treatments if above options are not suitable

2. Pharmacists presented with repeat prescription for PERT should only supply the equivalent to one month’s supply in accordance with SSP060 and SSP061.

Note A: Supply of Creon 10,000 capsules should be reserved for patients unable to take Creon 25,000 capsules only. Where patients are prescribed Creon 10,000 due to swallowing difficulties, consider the suitability of prescribing Creon 25,000 capsules which may be opened and mixed (without crushing) with soft acidic food (e.g., apple sauce or yoghurt). It is very important granules are not chewed or mixed with hot food. Patients should be counselled on oral care, including rinsing the mouth after eating, and ensuring dentures are
cleaned regularly as granules can get stuck in the gums and under dentures and cause ulceration.

Note B: For advice on the use of reduced doses, optimisation of doses, and symptom control, please refer to the clinical advice in this position statement, endorsed by a number of professional bodies. Please note that medication prescribed for symptom control will not treat malabsorption and should not be considered as alternative to PERT.

The following specialist importers have confirmed they can source unlicensed PERT preparations (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 corresponding Summary of Product Characteristics for specific product information.

• Alium (PANCREAZE® Delayed-Release Capsules)
• Durbin (Zenpep® Delayed-Release Capsules)
• Mawdsleys (Creon®)
• Smartway (Creon®)
• Target (Creon®, PANCREAZE® Delayed-Release Capsules, Zenpep® Delayed-Release Capsules)

Please see full guidance in the alert.