Patients without a vital IV diet threaten to drag the NHS to court

Patients affected by a shortage of tube feeding plan to bring the NHS to court, according to their lawyer.

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More than 40 people have ended up in hospital after a delay in the delivery of feeds for people who cannot eat solid food.

After an inspection earlier in the year, a manufacturer, Calea, was told that he had to change his production process from one day to the next and this disrupted the supply chain.

Patients waiting for liquid food are now considering suing the NHS, Calea, the Department of Health and the Medicines and Healthcare products Regulatory Agency (MHRA).

Lauren Mitchell, 21, from Stansted, said she felt sick, tired, and dizzy since her liquid food had been suspended and replaced with a generic food that wasn't tailored to her needs. It is not known whether Miss Mitchell is one of the patients considering legal action

Lauren Mitchell, 21, from Stansted, said she felt sick, tired, and dizzy since her liquid food had been suspended and replaced with a generic food that wasn't tailored to her needs. It is not known whether Miss Mitchell is one of the patients considering legal action

& # 39; These people feel abandoned, & # 39; said lawyer Dominic Thompson to the Health diary.

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Thompson said he talks to about 160 of the more than 500 patients affected by the deficit.

& # 39; Many have been left too weak to speak out, so we hope to act as a spearhead to ensure that maximum pressure is exerted so that this desperate situation is resolved as quickly as possible & # 39 ;, he added.

& # 39; What is frightening for people is that there is no end in sight.

& # 39; They were told that the problem would be resolved within four weeks, but now they are told that it might not be until the end of the year.

& # 39; This creates nightmare scenarios for hundreds of people and their families and answers are now needed. & # 39;

The feeds, known as total parenteral nutrition (TPN), are used by patients whose digestive system does not work well enough to eat normal food.

Laura Mitchell, a 21-year-old from Stansted in Essex, has been using TPN since she was seven years old and had to switch to a generic alternative after a production delay from Calea.

WHAT IS PARENTERAL FOOD?

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Parenteral nutrition, also known as intravenous nutrition, is food that people have injected directly into their veins.

It comes in the form of a liquid that contains water, proteins, carbohydrates, vitamins and minerals, fats and other vital nutrients.

Parenteral nutrition is given to bypass the digestive system in patients who cannot absorb nutrients from the gut properly.

Conditions that can cause this include short bowel syndrome, bowel obstruction, pancreatitis or a gastrointestinal fistula – a hole in an organ.

Parenteral nutrition can be given to people of any age, and some people only need a short time to get over a disease, while others may need to use it for years.

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Source: ESP

She was born with chronic bowel pseudo-obstruction, which means that her digestive muscles are unable to push food through her stomach.

The new feed that Miss Mitchell must use is not tailored to her specific needs and has made her nauseous, exhausted and dizzy.

& # 39; If diabetic insulin was removed, there would be a commotion & # 39 ;, she said the BBC.

& # 39; But because nobody knows what TPN is, nobody is bothered and nobody knows how serious this is.

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& # 39; This is our lives at stake here and we need answers and something needs to be done. & # 39;

The disruption of Calea's products began in June after an inspection by the MHRA – the British drug regulator – discovered that the production process did not meet the guidelines.

Calea was told to change the way it makes the products that provide people with nutrients by injecting them into their veins overnight.

As a result, it has since stopped delivering the bags to 511 patients who needed them the least.

Dominic Thompson & Co Solicitors said it will now investigate whether the MHRA was too fast to demand a process change overnight.

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And it would investigate why the Calea process was below the standard and whether the NHS and the Ministry of Health had sufficient back-up stocks.

The NHS stated this month that the problem was an emergency and began importing feeds from Germany and Norway.

Mr. Thompson stated that about 18 patients want to take legal action and another 24 consider doing so.

He added: & # 39; Our customers are angry about the lack of communication, and the whole system seems chaotic with TPN that is either not delivered, delivered at extremely irregular times, even in the middle of the night, and often in insufficient quantities.

& # 39; Some patients have reported receiving TPN bags and associated kits for other patients. & # 39;

Calea declined to comment.

An MHRA spokesperson told the HSJ that they were not aware of the legal threat, but added: & # 39; Our priority was always patient and product safety.

& # 39; We are very clear that the decisions we made were both urgent and necessary to protect patients. & # 39;

And a health ministry spokesperson said: “We still have to receive the letter, but we will consider all correspondence once it is received.

& # 39; We continue to work closely with the NHS, supplier and national experts to resolve this supply issue as quickly as possible and to ensure that affected patients continue to receive the nutrition they need. & # 39;

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MailOnline has contacted NHS England for comments.

WHY IS THERE A DEFICIENCY IN TPN?

In June, Calea, a company from Runcorn in Cheshire, was told that it did not meet the standards of the Regulatory Agency Medicines and Healthcare products (MHRA).

The MHRA discovered that the way the company added vitamins and elements to the bags was not in line with national requirements.

As a result, Calea had to immediately change the way it makes the food bags, what deliveries to & # 39; several hundred & # 39; patients in England and Wales.

Intravenous nutrition, also known as parenteral nutrition, is used by patients whose digestive system is not functioning properly.

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The MRHA, which controls all devices used by doctors in the UK, said that no defective items have been found so far and that the move was a precautionary measure.

A spokesperson said: & # 39; MHRA has conducted a routine inspection of the Calea UK site in Runcorn.

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& # 39; Problems were identified with the design of the production process that did not meet the guidelines previously published by MHRA.

& # 39; Calea has reduced their output while making the necessary changes to the production process.

& # 39; The MHRA monitors these changes through regular correspondence and weekly inspection visits.

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& # 39; The production changes are a precautionary measure, but a necessary measure to maintain product safety. & # 39;

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