Cancer patients at risk due to drug shortages

Charities warn that tens of thousands of pancreatic cancer and cystic fibrosis patients in the UK are at risk of drug shortages.

More than 60,000 people across the UK with pancreatic cancer, cystic fibrosis (CF) and chronic pancreatitis require pancreatic enzyme replacement therapy (PERT) to stay healthy. The prescription drugs are used to treat people who cannot digest food normally because their pancreas does not produce enough enzymes.

Pancreatic cancer survivors rely on the drugs to eat and digest their food, as their bodies would not be able to break down fat without them. For CF patients, the drugs are essential to control symptoms such as bloating and diarrhea, and to absorb fats, oils, fat-soluble vitamins and certain medications such as Kaftrio.

Shortages began in late 2003 and one of the most common PERT drugs, also called Creon, was placed on the UK’s Serious Shortage Protocol (SSP) list in May. SSPs allow pharmacists to limit supplies to one month and also offer alternative medicines without having to send patients back to their GP for a new prescription.

According to Community Pharmacy England, there will likely be disruptions in the supply of 25,000 and 10,000 Creon tablets until at least November, and possibly until 2026.

Aid organizations said more and more people were being forced to change their diets due to shortages. Others had to desperately run from pharmacy to pharmacy to find the vital medicines that would make their everyday lives easier.

Iain Rowland, from Misterton in Nottinghamshire, was diagnosed with pancreatic cancer in the spring of 2003. His disease was caught early enough to receive the only potentially curative treatment: surgery. His case is incredibly rare, with only 7 percent of pancreatic cancer patients surviving beyond five years. Yet 20 years later, he is frustrated and concerned about ongoing shortages of Creon across the UK.

“I would take one or two 25,000 tablets before each meal, depending on the fat content,” said the 79-year-old I“About three months ago I went to my pharmacy with my repeat prescription and was told they were out of Creon. So they gave me the 10,000s so I would need 3 or 4 of them instead to get the same dose.

“Without them, I get stomach cramps and diarrhea. Even when I take them, I have to be careful and sometimes increase the amount of Creon I need. I thought it would be a short-term problem, but the next month they told me they had no Creon at all, so they suggested I go to different pharmacies and find out who had it in stock.”

He has been symptom-free since being treated with Creon during the Whipple operation – which involves removing the head of the pancreas, the first section of the small intestine, the gallbladder and the bile duct – but he is worried that the terrible symptoms he suffered from before could return if he cannot find enough tablets in the coming months.

Mr Rowland said: “I was offered other medication as an alternative but the pharmacist said they couldn’t prescribe it until it was prescribed. I then went to my GP who said they couldn’t prescribe it until the pharmacist could prescribe it. I asked where the wall was because I wanted to bang my head against it.

“I told them it sounded like nobody cared what had caused it because the medical centre called me later that day and I explained that I was lost without those pills. So the staff called around and eventually got me the medication from a village pharmacy somewhere. However, I had to change my diet to almost completely fat free and it was very difficult. I have already lost 6.5 kilos in the last few weeks. My life has been turned upside down, it is so frustrating.

“I probably have a month’s supply now, but if I don’t get more, I’ll be eating every day now knowing I’ll be sitting on the toilet all day the next day. That’s the biggest concern.”

Adam McCusker from Dyfed in Wales suffers from cystic fibrosis and needs the 25,000 capsules, but has had to take the smaller dose since the beginning of the year.

“I’ve had to go from taking 5 tablets to 15 to 20 tablets per meal – there are only 100 tablets in each container, so it’s not enough for two or three days and then I have to go back to the pharmacy. I’m missing food to have just one main meal in the evening. I’m missing work because I hardly get out of the house. I’m struggling to keep my energy up because you need food for energy,” he said. I.

“When you don’t have energy, it has a negative impact on your health. On my chest, it all has a negative impact on the little pill that they can’t produce enough of.

“I don’t tolerate the 10,000s well. I have trouble digesting food and have thin, greasy stools. That’s not nice. I have to plan whether there is a toilet nearby. My stomach gets bigger, I can also get constipated, which leads to further complications and I could end up in hospital – that’s very stressful.”

Mr McClusker, 41, said painful stomach cramps required him to go to the toilet regularly, even on the way to hospital, which is an hour away from his home.

“I have to weigh up what I eat and limit my choices. With Creon it’s all about the fat content of each meal, so it’s hard to find the right dose for that meal or snack, but I still can’t get the dose right. It’s about what I can tolerate in terms of pain, so I’m losing the battle with this Creon issue at the moment. It’s so, so difficult.

“There is a limited supply of Kreon, so I only eat one main meal a day, which is in the evening. So I know I’m home if I feel unwell. I can’t sleep because of the symptoms, so I’m even more tired and then I disturb my girlfriend by keeping her awake. It affects everyone.”

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A spokesperson for the Cystic Fibrosis Trust said: “This is a serious problem for people with CF who have pancreatic insufficiency and require enzymes. It is vital that they have access to these products. This has caused considerable worry and stress for those affected, as they have sometimes had to visit several pharmacies to find Creon, a vital medicine for many people with CF.

“We were very concerned when we heard that in some cases people were being forced to change their diets due to shortages. We are working with all stakeholders to highlight the importance of Creon and to try to reduce the impact of these issues on people with CF.”

Alfie Bailey-Bearfield, head of campaigns, health improvement and policy at Pancreatic Cancer UK, said: “People with pancreatic cancer rely on this vital medicine to digest food, maintain a healthy weight and ultimately live well.

“Lack of adequate nutrition can have a significant impact on people’s symptom control, their quality of life in everyday life and their ability to tolerate pancreatic cancer treatments such as chemotherapy or surgery. We have raised this situation with the UK Government and it is urgent that this issue is resolved as soon as possible.”

The charity said that while it cannot help people access PERT, it can provide information for those who run out of the drug and advice on how to manage their symptoms.

Janet Morrison, chief executive of Community Pharmacy England, said problems with medicines supplies had worsened in recent months and were significantly impacting both patients and local pharmacies.

“The results of our recent survey show that almost all pharmacy owners report a significant increase in supply chain problems. Pharmacists are increasingly concerned about the impact on patients,” she said.

“Supply issues also place additional operational and financial pressure on pharmacies. Teams spend hours each week sourcing medicines, taking time away from vital patient services. Pharmacies often have to supply medicines at a financial loss because the acquisition costs are too high and/or the costs are not adequately reimbursed by the NHS. This exacerbates the long-standing funding issues they face.

“Drug supply problems are harming pharmacies and the patients they serve in communities with alarming rates. The Government and the NHS must act now to stabilise the market, address supply shortages and improve patient access to vital medicines.”

Officials said supply problems with Kreon are affecting countries across Europe, due to limited availability of raw materials and capacity constraints in producing the quantities needed to meet demand.

This is causing supply issues for alternative PERT brands due to a resulting increase in demand. Manufacturers have indicated that they expect regular monthly deliveries of Creon for the remainder of the year.

A Department of Health and Social Care spokesman said: “We have inherited ongoing global supply issues that continue to impact the availability of medicines, including Creon.

“We know how distressing this can be for patients and we are working closely with industry, the NHS and others in the supply chain to reduce the risk to patients and ensure alternative products are available until their usual treatments are back in stock.”