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Originator: National Patient Safety Alert - DHSC

Issue date: 24-May-2024 14:41:42

This alert has been issued to:
  • Care Trusts
  • Mental Health Trusts
  • Specialists Trusts
  • Learning Disabilities Trusts
  • Mental Health & Social Care Trusts
  • Ambulance Trusts
  • Mental Health & Learning Disabilities Trusts
  • Acute Trusts
  • Community Trusts

  • Other contacts
  • Independent Healthcare Providers (registered with CAS)
  • Clinical Commissioning Groups
  • Social Care Providers (registered with CAS)
  • Special Health Authorities
  • Territorial CMOs in Northern Ireland, Scotland & Wales
  • GP - Locum
  • NHS 111 and Out of hours providers
  • GP Practices
  • Integrated Care Boards
  • DHSC Supply Disruption - Medicines
  • Community Pharmacy
  • Primary Care Networks
  • GP Practices 1

Action category: Action

Title: Shortage of Pancreatic enzyme replacement therapy (PERT)

Broadcast content:

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).

·       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.

This National Patient Safety Alert provides further background, clinical information and actions for providers.

Additional information: NHS England regions: please cascade this alert to community pharmacy.

Alert reference: NatPSA/2024/007/DHSC

Action underway deadline: 29-May-2024

Action complete deadline: 10-Jun-2024


Contact our helpdesk

Email: safetyalerts@mhra.gov.uk

Medicines and Healthcare products Regulatory Agency