Patients who can’t eat solid foods have told how they are fearing for their lives amid the national shortage of intravenous fluids.
‘Concerning’ bacteria was found at the manufacturing site of a large-scale company, and as a result, it had to immediately change the way it makes the feeding bags.
Production has slowed causing delays or cancellations of deliveries to ‘several hundred’ patients in England and Wales.
It’s left scores of patients who rely on the bags of liquid feeling sick, dizzy and tired.
For the time being, they are using alternatives provided by the hospital which are not tailored to their own needs.
The NHS earlier this week declared the issue as a ‘national emergency’, as ‘several hundred’ patients in England and Wales have seen their deliveries disrupted.
Lauren Mitchell, 21, from Stansted, said she was feeling sick since her liquid food was suspended amid a national shortage of intravenous fluids
Keith Millen, 48, whose supply also stopped, said he was ‘petrified’ for his life. He is pictured holding a supply of intravenous nutrition at his home in Bridgend
Intravenous nutrition, also known as total parenteral nutrition (TPN), is used by patients whose digestive systems don’t work properly.
The injected TPN contains all the nutrients a person needs to survive, including fats, protein, carbohydrates, sugars and vitamins and minerals.
Lauren Mitchell, 21, from Stansted, Essex, told BBC News she had used TPN since she was seven years old.
She was born with chronic intestinal pseudo-obstruction, whereby her digestive system muscles aren’t able to push food through to the stomach.
WHAT IS PARENTERAL NUTRITION?
Parenteral nutrition, also known as intravenous nutrition, is feed which people have injected directly into their veins.
It comes in the form of a fluid which contains water, protein, carbohydrates, vitamins and minerals, fats and other vital nutrients.
Parenteral nutrition is given to bypass the digestive system in patients who cannot properly absorb nutrients from gut.
Conditions which may cause this include short bowel syndrome, a bowel obstruction, pancreatitis or a gastrointestinal fistula – a hole in an organ.
Parenteral nutrition may be given to people of any age, and some people only need it for a short time to get over an illness, while others may have to keep using it for years.
Six weeks ago, the delivery of her TPN was late, and then she stopped being supplied TPN at all. Her TPN is manufactured by the company Calea.
In June, the medicines safety body – the Medicines and Healthcare Regulatory Agency – inspected the manufacturing site in Runcorn, Cheshire.
The MHRA found bacterial contamination in the production area which presented a potential risk to patients.
The bacteria, Bacillus cereus, ‘are known human pathogens, which is of particular concern for the many vulnerable patients receiving parenteral nutrition’, the MHRA said in a statement.
No contaminated bags were discovered but the MHRA, but the company has been ordered to change its manufacturing process, which in turn has slowed output.
Calea sources said it had stopped supplying 511 of its patients, chosen based on the level of medical reliance on the pouches.
Two weeks ago, Ms Mitchell’s account with Calea was ‘suspended’, and she has since been receiving an ‘off the shelf’ alternative like hundreds of other patients.
These bags of liquid feed are not tailored for her specific dietary needs, which vary between patients.
The alternative bag has resulted in Ms Mitchell feeling regularly tired, nauseous and dizzy.
Ms Mitchell, who said the problem was a ‘national crisis’, said: ‘My life is in a lot of danger right now.
‘If diabetics’ insulin was taken away, then there would be uproar – but because no-one knows what TPN is, no-one’s bothered and no-one knows how serious this is.
‘This is our lives on the line here and we need answers and something to be done about it.’
Mr Millen has been left feeling exhausted after being given an alternative (pictured) to his usual TPN supply
According to the Calea source, normal service of production would not resume until ‘towards the end of the year’.
The news is ‘petrifying’ for Keith Millen, 48 from Bridgend, who was also using TPN until Calea production slowed.
He has a fistula which means food ‘pours straight out’ of his digestive system.
He told BBC News: ‘For 10 days I had nothing, all I had to go on were litre bags of saline [salt water].
‘There was nothing, no explanation.’
‘It’s petrifying, it’s so scary… I’ll die, I know it sounds dramatic but they’re playing around with what I need to survive.’
Mr Millen has been left feeling exhausted and all he could do was sleep.
His doctors eventually managed to get him on the limited list of patients Calea is still manufacturing the nutrition replacement bags for.
Letters shared by NHS England with the Health Service Journal reveal the issue has become a national emergency.
Dr Aidan Fowler, national patient safety director, said the issue had been ‘formally designated’ an emergency incident under the Civil Contingencies Act.
The HSJ claim the NHS is considering importing supplies from other countries because the need for TPN is so serious.
A Calea representative said: ‘Following a routine MHRA inspection in June 2019, we were directed to change the process by which we add trace elements and vitamins to our parenteral nutrition bags, in order to align with latest standard industry practice.
‘As a result, the time taken to produce bags has increased considerably and this has, unfortunately, affected the supply to patients.
‘Calea recently informed the NHS Action Group of a voluntary decision to impose a production capacity restriction in order to restore a reliable supply.
‘Supplying patients is Calea’s number one priority and we apologise to patients and their families for the distress caused. We are fully committed to working with the MHRA and the NHS Action Group to return to usual and reliable supply levels as quickly as possible.’
WHY IS THERE A SHORTAGE OF TPN?
In June, Calea, a firm based in Runcorn in Cheshire, was told it wasn’t meeting standards set by the Medicines and Healthcare products Regulatory Agency (MHRA).
The MHRA had found the way the company was adding vitamins and elements to the bags was not in line with national requirements.
As well as this, bacteria of the type Bacillus cereus/thuringiensis/mycoides were recovered in a sample.
The equipment used for identification is not sufficiently sensitive to identify the exact type of bacteria.
Even though this contamination was found in the production area, it is important to add that we found no evidence to indicate that the products manufactured and supplied to patients during this period were contaminated.
As a result of the findings, Calea had to immediately change the way it makes the feeding bags, which has delayed the deliveries to ‘several hundred’ patients in England and Wales.
Intravenous nutrition, also known as parenteral nutrition, is used by patients whose digestive systems don’t work properly.
The MRHA, which regulates all devices used by doctors in the UK, said no defective items had been found so far and that the move was a precaution.
A spokesperson said: ‘MHRA performed a routine inspection of the Calea UK site in Runcorn.
‘Problems were identified with the design of the manufacturing process that did not meet the requirements of guidance previously published by MHRA.
‘Calea have reduced their output while they make necessary changes to the manufacturing process.
‘The MHRA are supervising these changes through regular correspondence and weekly inspection visits.
The changes to production are a precautionary, but necessary, measure to ensure product safety is maintained.’