Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the effectiveness of the Serious Shortage Protocols in place for Creon 10,000 and 25,000 capsules limiting prescriptions to one months’ supply; and what steps he is taking to ensure children with cystic fibrosis have access to that medication.

The Department has been working with suppliers to address current supply issues with pancreatic enzyme replacement therapy (PERT), including Creon, to help ensure patients, including children with cystic fibrosis, have access to this medicine. The supply issues are impacting countries throughout Europe and have been caused by limited availability of raw ingredients and manufacturing capacity constraints to produce volumes needed to meet demand.

The supplier of Creon has advised that there are regular deliveries of Creon 25000 and Creon 10000 scheduled for the remainder of the year in reduced quantities. Serious Shortage Protocols are in place for Creon 10000 and 25000 capsules, which pharmacists can use to restrict supply to one month at a time, to ensure more patients have access to it whilst stock is limited.

We have issued comprehensive guidance to healthcare professionals about these supply issues, which provides advice on how to manage patients whilst there is disruption to supply. In this guidance clinicians are asked to prioritise available stock of Creon 10000 for patients unable to take Creon 25000, to help ensure Creon 10000 remains available for those on lower doses or unable to swallow larger capsules, such as children with cystic fibrosis. This guidance is being kept under review and updates will be made as necessary.

The Department is continuing to work with all suppliers of PERT to help resolve the wider supply issues in the short and longer term. This includes asking that they expedite deliveries, source stock from other markets, and increase production.

The issues are mainly impacting Creon 25000 and Creon 10000 presentations, however there was a recent short term supply issue with Creon Micro, which is used in children. This issue was a result of an increased demand due to the issues with other PERT presentations and a delay in the resupply date. The Department worked quickly to issue communications to health care professionals with management advice to ensure patients who needed Creon Micro had access to it. The supply issue with Creon Micro is now resolved.