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Patients on pancreatic enzyme replacement therapy (PERT) should only be given a one-month supply of medicines at a time because of stock shortages, clinicians have been told.
In a national patient safety alert (NPSA), published on 24 May 2024, the Department of Health and Social Care warned that Nutrizym 22 capsules (Zentiva) will be out of stock until mid-August 2024 and that there will be limited supplies of Creon 10,000 capsules and 25,000 capsules (Viatris) until 2026.
Alongside the NPSA, the government has issued two serious shortage protocols for Creon 10,000 capsules and 25,000 capsules, enabling clinicians and pharmacists to supply a maximum of one month’s supply of PERT to patients at a time, even if the prescription is for longer.
Pancrex V capsules (Essential Pharmaceuticals) and powder remain available; however, the NPSA advised that current supplies will not be able to meet any increase in demand.
It said that the disruption in supply of Creon capsules was owing to “limited availability of active pharmaceutical ingredients”, as well as manufacturing constraints to meet demand, which has contributed to supply disruption for Nutrizym.
The NPSA also included a list of specialist importers, which have confirmed they would be able to supply unlicensed PERT preparations, but said that lead times may vary.
Commenting on the Creon shortages, Amanda Bevan, divisional pharmacist at University Hospital Southampton NHS Foundation Trust, said: “It’s a significant problem for patients.
“There’s no contingency stock in the system; the 25,000 strengths seem to be going out to pharmacies as soon as it is received by the wholesalers and there are currently no 10,000 strengths in the supply chain at all.
“The alternative (Nutrizym 22) is also out of stock. As it only accounts for 5% of the UK market, stock was quickly exhausted,” she added.
“Secondary care teams are receiving calls daily from patients who are running out because their community pharmacy is unable to fulfil a prescription,” said Bevan.
PERT is indicated for the treatment of pancreatic exocrine insufficiency, such as in cystic fibrosis, pancreatic cancer and pancreatitis. At present, there is no clinical alternative to PERT.
A joint position statement on supply issues with PERT products was published at the end of March 2024 by gastroenterology and cystic fibrosis organisations — the Nutrition Interest Group of the Pancreatic Society of Great Britain and Ireland, the Cystic Fibrosis Specialist Group, the Gastroenterology Specialist Group, and the British Dietetic Association.
The statement document, designed for adult patients, includes conversion charts and clinical management suggestions for prescribers and dietitians, as well as specific advice for patients divided into four phases, depending on their supply status and symptoms.
Katie Noon, acting chief executive officer at charity Guts UK, which has endorsed the joint position statement, said: “For those with pancreatitis and pancreatic exocrine insufficiency, taking PERT can reduce people’s level of abdominal pain and prevent unpleasant digestive symptoms.
“Not having PERT available results in weight loss, muscle loss, malnutrition and digestive symptoms, such as diarrhoea, abdominal pain and bloating,” she added.
“Without access to PERT, people’s symptoms can be seriously impacted — both physically and psychologically. Absence of PERT can have a devastating impact on people’s lives,” said Noon.
In May 2024, a survey carried out by Community Pharmacy England found that more than 90% of pharmacists said medicines shortages have got worse over the past year.
The survey of more than 2,000 community pharmacy staff members and owners of more than 6,000 pharmacy premises also revealed that medicines supply problems were affecting 99% of community pharmacies at least weekly, with 72% of pharmacies experiencing multiple shortages each day.
