AQW 15983/22-27

Mr Danny Donnelly
Alliance Party
East Antrim

Tabled Date: 01/10/2024
Answered On Date: 15/10/2024
Priority Written: No

Question:
To ask the Minister of Health to detail any action being taken to manage the supply issues of the pancreatic enzyme replacement therapy, Creon, for people with cystic fibrosis who require this treatment.

Answer:

The Department of Health and Social Care (DHSC) leads on the maintenance of supply chains to the UK, and works closely with the other devolved administrations, including my Department, the Medicines and Healthcare products Regulatory Agency (MHRA) and other operators within the supply chain. Through this engagement and UK-wide medicines shortages working groups, my Department is aware of ongoing supply disruptions affecting pancreatic enzyme replacement therapy (PERT) treatments, including Creon® preparations. The disruptions to Creon® preparations have been caused by limited availability of the active pharmaceutical ingredient and manufacturing constraints in meeting patient demand.

There are national and locally tried and tested mitigations that can be used during periods of supply disruption. Several of these steps have been taken in response to supply disruptions to Creon® and other PERT products.

A National Patient Safety Alert was issued by my Department on 24 May 2024, providing healthcare professionals with advice and actions to take to ensure patients can continue to access appropriate treatments. This alert has superseded previous guidance issued to healthcare professionals through Medicines Supply Notifications. Healthcare professionals can also register with the NHS Specialist Pharmacy Service (SPS) which provides up-to-date information on medicine shortages and their anticipated resupply.

Additionally, PERT products were added to the UK restricted export and hoarding list on 22 May 2024, and Serious Shortage Protocols (SSPs) have been issued to community pharmacists for Creon® 10,000 and 25,000 capsules.

My Department will continue to work closely with DHSC and the other devolved administrations on these UK-wide supply disruptions to help ensure patients and/ or their representatives can continue to have access to appropriate treatments.