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<p>We are aware of supply issues with three pancreatic enzyme replacement therapies:
Creon 10,000 gastro-resistant capsules; Creon 25,000 gastro-resistant capsules; and
Nutrizym 22 gastro-resistant capsules. We understand that these are due to limited
availability of active pharmaceutical ingredients, and manufacturing constraints in
producing the volumes required to meet demand. The Department has issued guidance
to healthcare professionals regarding treatment of patients while there is a disruption
to the supply of these pancreatic enzyme replacement therapies. We are having regular
conversations with the suppliers of these products to ask that they expedite deliveries
and increase production forecasts, and to confirm that they are taking action to address
the root causes of the issues, to ensure continuity of supply. We are also working
with specialist importers to source unlicensed imports from abroad.</p><p>Whilst we
can’t always prevent supply issues, we have a range of well-established tools and
processes to mitigate risks to patients. These include close and regular engagement
with suppliers, use of alternative strengths or forms of a medicine to allow patients
to remain on the same product, expediting regulatory procedures, sourcing unlicensed
imports from abroad, adding products to the restricted exports and hoarding list,
use of Serious Shortage Protocols, and issuing National Health Service communications
to provide management advice and information on the issue to healthcare professionals,
so they can advise and support their patients.</p>
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