Creon 10,000 and 25,000: Quantities to be dispensed limited to one month

Creon 10,000 and 25,000: Quantities to be dispensed limited to one month

The Department of Health and Social Care (DHSC) has introduced two new Serious Shortage Protocols (SSPs), SSP060 and SSP061, in response to the current shortage of pancreatic enzyme replacement therapies (PERTs). The SSPs relate to Creon 10,000 and Creon 25,000 capsules. They are valid from 24/05/2024 until 22/11/2024.

Both SSPs indicate that where supplies are available, but the prescription is for more than one month’s supply, the total quantity that may be supplied against the prescription is to be limited to the equivalent of one months’ supply of the prescribed medicine. They also place an obligation on the dispensing pharmacy professionals to make the patient/carer aware that in accordance with this SSP, no further supply can be made from the same prescription above the one-month quantity. In other words, the pharmacy must supply and claim for a maximum of one month’s supply, but cannot generate an “owing” for the patient to collect the balance the following month.

Background

As per Community Pharmacy England, 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. Alternatives such as Nutrizym 22 capsules and Pancreas V are either out of stock or not expected to support an uplift in demand.

  • 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 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.

Implications for Pharmacy Professionals in General Practice

Pharmacists and pharmacy technicians in general practice will likely get one or both of the following queries over the immediate future:

  • Requests for alternatives from frustrated patients who have not been able to obtain PERT from their pharmacy
  • Complaints over limitation of supply to one month by dispensing pharmacies.

As usual, exercising empathy and good consultation skills in this situation is paramount. It is vital to support frontline fellow professionals working in community pharmacy. At the same time, the following advice from Community Pharmacy England will go a long way in guiding clinicians to minimise the development of such problems:

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.

If you would like information on other SSPs, please click here.


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M Moyo

Founder of GP Pharmacy Club. Clinical Pharmacist working in GP Primary Care. Experienced community pharmacist. Independent Prescriber.

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