Latest news with #PERT
Medscape
02-06-2025
- Business
- Medscape
UK Pharmacies Struggle with Severe Creon Shortage
Nearly all UK pharmacies are experiencing severe 'challenges' supplying pancreatic enzyme replacement therapy (PERT), the National Pharmacy Association (NPA) warned. A sample survey by the association found that 96% of pharmacies were struggling to obtain Creon (pancrelipase, Mylan). A further 89% reported difficulties supplying PERT alternatives. Patients Resorting to Extreme Measures The ongoing shortage has forced patients to take desperate action, according to the NPA, which said some are rationing existing medication supplies or skipping meals entirely. One pharmacist described it as the 'worst stock shortage' they had ever encountered. Patients report eating only one meal daily, contacting multiple pharmacies for supplies, or travelling more than 30 miles to obtain the medication. Critical Medication for Serious Conditions Creon is used to treat pancreatic exocrine insufficiency from a variety of causes, including pancreatic cancer, cystic fibrosis, and pancreatitis. The medication, derived from porcine pancreatin, contains lipase, protease, and amylase. It dissolves rapidly in the stomach to release its enzyme load in the small intestine, where its lipolytic, amylolytic, and proteolytic activity enable absorption of the products of pancreatic digestion. PERT medications need to be taken to facilitate digestion every time a patient eats. In clinical trials, treatment with Creon markedly improved stool consistency, abdominal pain, and stool frequency, independent of the underlying disease. The consequences of inadequate dosing can be severe. Patients may become too unwell for surgery, struggle with chemotherapy tolerance, or experience debilitating symptoms that diminish quality of life. Symptoms may include diarrhoea, flatulence, bloating, abdominal pain, unexplained weight loss, and oily, foul-smelling stools (steatorrhoea). Safety Concerns Olivier Picard, NPA chair, warned the shortage has 'profound effects' on patients who depend on the medication to survive and lead normal lives. 'It simply cannot be right that in the 21st century patients are skipping meals in order to ration their medication,' he said. Last week, the government extended the current Serious Shortage Protocol (SSP) for Creon until 21 November 2025. The protocol allows pharmacists to use professional judgement to decide whether it's 'reasonable and appropriate' to substitute a patient's prescription for an alternative agent for one dispensing month. It allows pharmacies to supply a reduced quantity of Creon capsules that might be in stock, without having to send a patient back to their GP to get a new prescription. Two SSPs for Creon 10,000 and 25,000 capsules have been in place since May 2024. However, the survey found that 81% of pharmacies felt the current arrangements for managing the shortage were inadequate. In particular, pharmacists were still obliged to refer patients back to prescribers when seeking PERT alternatives. Alternative PERT formulations Nutrizym and Pancrex are also now in short supply as manufacturers struggle to meet demand. GPs and pharmacies can order unlicensed Creon or other PERT products from overseas, but other countries have experienced similar shortages. Calls for Regulatory Change The NPA and Pancreatic Cancer UK issued a joint statement urging government action. They called for a national plan to address shortages and support patients with alternative care. Picard said that although the situation was complex and not the fault of the government, medicine shortages were all too common. 'Highly trained pharmacists should also be permitted to use their professional judgment to supply alternative medicines — where it is safe and appropriate — in the event of the prescribed version being unavailable.' Alfie Bailey-Bearfield, head of influencing and health improvement at Pancreatic Cancer UK, said that the findings were 'deeply worrying'. It was 'totally unacceptable' that cancer patients were still taking desperate measures that put their health, wellbeing, and eligibility for treatment at risk, when the charity had been raising concerns with Department of Health and Social Care (DHSC) officials and PERT suppliers for more than a year. 'This crisis continues to put people's health on the line, and they cannot afford to wait any longer,' he said. A DHSC spokesperson said that the supply issues with Creon were European-wide and caused by limited availability of raw ingredients along with manufacturing capacity constraints. 'We are working closely with industry and the NHS to mitigate the impact on patients and resolve the issues as quickly as possible,' the spokesperson said.
The Guardian
02-06-2025
- Business
- The Guardian
UK shortage of critical drug forcing pancreatic cancer patients to skip meals
People with pancreatic cancer are eating only one meal a day because of an acute shortage of a drug that helps them digest their food. Patients with cystic fibrosis and pancreatitis are also affected by the widespread scarcity of Creon, a form of pancreatic enzyme replacement therapy (PERT). People who rely on the drug have also been taking reduced doses to conserve their supplies and travelling more than 30 miles from their home to find it, pharmacists revealed today. Thousands of people with pancreatic cancer need to take PERT tablets and those hit by the shortage are suffering 'distress and frustration', the charity Pancreatic Cancer UK said. The difficulties the Creon shortage is causing patients emerged today in a survey of 300 pharmacies undertaken by the National Pharmacy Association. Almost all – 96% – are struggling to get enough of the medication to meet demand. 'As this distressing survey shows, ongoing supply problems with Creon have had a profound effect on the patients who depend on it to survive and lead a normal life', said Olivier Picard, the chair of the NPA. 'It simply cannot be right that in the 21st-century patients are skipping meals in order to ration their medication. 'Medicine shortages not only cause huge inconvenience but can risk serious patient safety issues, particularly in the case of PERTs, including Creon,' he added. Pancreatic cancer patients who either do not take a PERT or take too small a dose of it can become too sick to have surgery, which is the only potentially curative treatment for the condition, the NPA explained. They may also be less able to withstand the rigours of having chemotherapy and struggle to manage the symptoms of their condition, which can affect their quality of life. The Department of Health and Social Care (DHSC) said that the scarcity of Creon in the UK is part of a Europe-wide shortage linked to a lack of the ingredients used to make it and 'manufacturing capacity constraints'. Creon has been in short supply for at least a year. The DHSC last week extended the two serious shortage protocols that have already been in place for it since May last year, covering 10,000 and 25,000 capsule formulations of Creon, until 21 November this year. The protocols are official notifications of a medication being hard to obtain, which allow pharmacists to give patients a smaller quantity of a drug than they usually receive. Alfie Bailey-Bearfield, head of influencing and health improvement at Pancreatic Cancer UK, said: 'These deeply worrying findings echo the distress and frustration we are hearing from patients and their loved ones across the UK. 'Thousands of people affected by pancreatic cancer rely on taking PERT tablets every time they eat simply to digest their food and absorb nutrients, something most of us take for granted. 'It's totally unacceptable that they are taking desperate measures which put their health, wellbeing and their eligibility for treatment at risk,' he added. One pharmacist said the Creon scarcity was the 'worst stock shortage' they have ever dealt with. Pancreatic Cancer UK called on ministers to buy supplies of Creon directly from countries that have a surplus in order to tackle the shortage in Britain. A DHSC spokesperson said: 'We know how frustrating and distressing medicine supply issues can be for patients and the clinicians caring for them. 'The European-wide supply issues with Creon are caused by a limited availability of raw ingredients and manufacturing capacity constraints. 'We are working closely with industry and the NHS to mitigate the impact on patients and resolve the issues as quickly as possible.'
Sky News
28-02-2025
- Health
- Sky News
What does vital drug Creon do - and how is a shortage affecting patients?
Why you can trust Sky News Wes Streeting says he is "extremely sorry" patients who need medication for pancreatic insufficiency are being affected by shortages. The health secretary said global supply chain issues were proving "a hell of a challenge" and acknowledged there is "often a huge amount of anxiety as your prescription's coming up for renewal". Pancreatic Cancer UK has warned shortages of the drug Creon could last until at least 2026, affecting an estimated 61,152 people. But what is Creon, what does it treat and how is the shortage affecting people? What is Creon? Creon is the most popular brand of pancreatic enzyme replacement therapy (PERT), along with Nutrizym and Pancrex. PERT provides the enzymes people with exocrine pancreatic insufficiency (EPI) need to absorb nutrients, essentially allowing them to digest food, because their condition means their pancreas isn't able to break down proteins, fats and carbohydrates as it should. The medication comes in tablet form and can be taken with most food, including meals, snacks, and milky drinks. There is no set dose of PERT. Patients are encouraged to take as much as they feel they need to comfortably digest their food. This can be a lot, because Creon capsules can contain between 3,000 and 36,000 enzyme units, and healthy pancreas would normally make up to 720,000 units for a small meal, according to Pancreatic Cancer UK. Pancreatic cancer patient Dan Godley, 31, previously told Sky News he would take up to 15 tablets with one meal. 2:38 Who is affected by EPI and how? EPI can be brought on for no obvious reason, according to the NHS, but is also commonly caused by acute or chronic pancreatitis, pancreatic surgery, cystic fibrosis, pancreatic cancer, gastric-bypass surgery or coeliac disease. Less common causes include diabetes, untreated celiac disease, inflammatory bowel diseases and HIV. The symptoms of untreated EPI can be food not being absorbed properly and going "straight through" the small bowel into the colon, often causing diarrhoea, wind, cramps and bloating. This can lead to weight loss and in severe cases malnutrition, because the body is unable to get enough fat-soluble vitamins, and in some cases people may eat less than they need to avoid getting uncomfortable symptoms. It can also lead to low bone mass, weakness of the immune system, and increased risk of cardiovascular events like heart attacks and strokes. For children, it can also cause problems with growth. People with pancreatic cancer may become too unwell to have surgery - the only way to potentially cure the disease - and may be less able to tolerate treatments such as chemotherapy, according to Pancreatic Cancer UK. Why is there a shortage? The Department of Health and Social Care (DHSC) says the Creon shortage, which has been ongoing for more than a year, is down to supply issues caused by a limited availability of raw ingredients and manufacturing capacity constraints. Nutrizym has also suffered manufacturing issues and struggled with increased demand amid the Creon shortage, while Pancrex has also been unable to plug the gap. There have been calls for the government to address the shortage, including from the National Pharmacy Association. A DHSC spokesperson said the government was "working closely with industry, the NHS, manufacturers and other partners in the supply chain to resolve the impact of these supply issues as quickly as possible". Speaking to BBC Breakfast on Friday, Mr Streeting said there were "global supply chain issues" and the UK was working "actively to try and strengthen our supply chain resilience". "This is not easy," he said. "I just want to say to people who have been affected by these shortages, whether in Creon or other medications, I'm extremely sorry people have been in this position." He said there could be a "huge amount of anxiety" for people looking to renew their prescriptions, and said he had seen that in his constituency. Asked when the supply chain would improve, he said he didn't want to "over-promise and under-deliver" but added "I hope people will see progress over the course of this year". "What I can promise is that we are keeping a constant eye on medicine levels and where shortages are occurring, looking at where alternatives can be put in place for different types of medications, looking at how we can adjust frequency and volume for prescriptions." 'I'm always worried about next month's supply' A survey of 572 patients by Pancreatic Cancer UK in 2024 found 82% had struggled to obtain their usual PERT prescription on more than one occasion, almost one in five (19%) had frequently gone without taking PERT and 71% were taking a lower dose than they needed or had altered their diet. 73% of those surveyed said their ability to manage their symptoms had become more difficult. Michael Harvey, 72, from North Yorkshire, has been dependent on PERT since he had successful surgery after being diagnosed with pancreatic cancer in 2017. "There has been an erratic supply of PERT for the whole time I've been on them - over seven years - but it's never been as bad as it's been in the last year," he said. "It just seems to lurch from crisis to crisis. Every month we put in a repeat prescription with hope more than expectation. "I'm always worried where the next month's supply is coming from." He said he has typically only received 100 tablets at a time - a three- or four-day supply - rather than his full prescription of 800 tablets, leading him to try changing pharmacies, sometimes driving 20 miles to other towns. Emmerdale actor Tony Audenshaw's wife Ruth was diagnosed with pancreatic cancer in late 2015. She had surgery but the cancer returned and she died in April 2017 at the age of 43. Audenshaw said PERT provided Ruth with "a bit of normality" while she was ill, allowing her "really simple pleasures" like ice cream, which she loved. He said the fact some people are being denied a bit of extra quality of life is "a massive problem". What have suppliers said about the shortage? A spokesperson for Viatris, marketing authorisation holder and distributor of Creon in the UK, said: "We were notified by our third-party manufacturing partner, Abbott, of a global supply constraint of Creon. "This constrained supply is due to high global demand and reaching maximum manufacturing supply output." Some strengths of Creon are available in the UK, they said, adding: "Plans to reduce the constraints and increase capacity are under way. "During this supply constraint, we hope to be able to supply approximately 90-95% of the average monthly demand for Creon lipase units into the market each month, until this supply constraint is resolved." They said distribution of the drug will continue as shipments arrive and Viatris was in "daily" contact with the manufacturer. Viatris is also in regular contact with DHSC, patient association groups and healthcare professionals, they added. A spokesperson for Essential Pharma said: "We have been working hard with suppliers of raw materials and our manufacturing partners to increase supply of our product as quickly as possible, in order to help patients impacted by the shortages of the other products. "We are also working closely with the relevant authorities to support these efforts. "As soon as more Pancrex is available we will work to get supplies to patients through the usual channels as quickly as we can." A spokesperson for Zentiva, which makes Nutrizym, said: "Although supplies of Nutrizym 22 remain steady, stock is running out more quickly than usual, leading to temporary shortages. "Zentiva is working closely with DHSC to manage supplies and minimise disruption. However, the situation is expected to improve only when the market leader's product returns to full availability."
