- Hundreds of patients affected by delays in deliveries of intravenous nutrition
- MHRA imposed restrictions on manufacturer immediately after inspection
- Clinicians warn patients may need to be admitted to hospital, rather than stay at home, if delays continue
Hundreds of patients, including children, dependent on intravenous nutrition to keep them alive are experiencing delays in vital deliveries, because of restrictions placed on the manufacturer by the medical devices regulator.
Some people may have to be admitted to hospital, rather than remain at their home, because of the move; while staff have had to hand deliver emergency supplies to vulnerable patients from hospital stocks.
Runcorn-based firm Calea manufactures the feed, known as total parenteral nutrition. It told HSJ the problem was affecting several hundred patients, including children, and would take weeks to resolve. Those affected are mainly living and using the product at home.
Following an inspection by the Medicines and Healthcare products Regulatory Agency earlier this month, the company had restrictions imposed on its production process which significantly slowed it down.
In the past two weeks, it has alerted hospitals and patients that it can no longer guarantee deliveries, with some recipients now reporting having no deliveries and only a small supply of feed left.
“A very thin line”
James Stewart, gastroenterologist and clinical lead for intestinal failure at University Hospitals of Leicester Trust, told HSJ he was very worried for patients.
He said: “The real life impact of this is that if this carries on we are going to have to admit some of these patients because we simply can’t keep them hydrated and nourished with these sporadic supplies that we are getting.
“Families are distraught. It’s not just a question of a lack of manufacturing but a lack of transparency for them going forward.”
He said staff were making daily phone calls to patients to make sure they had enough feed. Some required bespoke prescriptions and couldn’t be given “off the shelf” solutions, he said. Up to nine Leicester Hospitals patients depend on bespoke feed from Calea.
Dr Stewart added: “This is being replicated around the country. It really is having a nationwide effect. I am very worried about it.
“There are patients who are on this PN daily not just for nutrition but hydration and we can’t afford them to be missing days. We are walking a very thin line.”
Another gastroenterologist told HSJ his trust had become increasingly concerned about the supply of TPN feed to patients in the community, and that some were running out of supplies.
Many families have expressed their fears on social media with parents saying their disabled children lacked supplies of feed after today.
Lotta Hartley said her son had had no deliveries on Friday or Monday. “No intraveneous nutrition delivered to my young son who cannot eat or drink and no warning from Calea. Shocking to hear people being admitted to hospital all over the country for this reason,” she said.
Alison Rushton, whose daughter Jess is dependent on the feeds, told HSJ: “We should have received a delivery of seven bags [on Tuesday last week], we got zero. A lot of people are affected.”
The delivery for her daughter arrived three days late, and local NHS organisation filled the gap by providing feeds.
Elsewhere nutritional teams from Newcastle upon Tyne Hospitals Foundation Trust hand delivered feeds to one woman while one child was admitted for fluids after his feed delivery was missed.
HSJ understands a letter to NHS trusts from NHS England and Calea warned supplies would be affected and warned there may be a longer term problem if the company cannot reverse its delays.
A Calea spokesman said: “Following a routine MHRA inspection, we have been 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 and although we are working as quickly and safely as possible to meet demand, we are sorry that our deliveries have been delayed.”
The MHRA imposed the requirements on Calea immediately after its inspection. A spokesman for the medical devices regulator said production processes did not meet requirements.
He said: “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. No defective products have been identified to date.”
The Department of Health and Social Care has convened a working group with NHS England and the MHRA and experts to manage communications to the health system.
A spokeswoman said the department was working to “resolve this supply issue as quickly as possible”.
She added: “It is vital that patients have access to the medicines and medical products they need and Calea’s parenteral nutrition is no exception.”
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- THE NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST
- UNIVERSITY HOSPITALS OF LEICESTER NHS TRUST