Patients dependent on intravenous nutrition experiencing delays in deliveries
Patients across England and Wales dependent on intravenous nutrition are experiencing delays in deliveries after the medicines regulator found problems with the manufacturing process.
Calea, which provides parenteral nutrition to patients for use at home, told the Health Service Journal (HSJ) that several hundred people were experiencing delays after it changed the way it makes up the bags.
The company, based in Runcorn, Cheshire, was told its manufacturing process did not meet requirements set by the Medicines and Healthcare products Regulatory Agency (MHRA).
Parenteral nutrition is a formulation that bypasses the gut and provides nutrients directly into a person’s blood.
It is used when patients cannot absorb nutrients properly through their gut, which can be caused by intestinal failure.
A spokesman for Calea told the HSJ they had been directed to change the way they add trace elements and vitamins to the bags.
He added: “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.”
A spokesman for the regulator 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.
“No defective products have been identified to date.
“MHRA continues to work closely with the company as they prioritise the necessary work to return to full capacity.
“We are also working closely with the DHSC (Department of Health and Social Care) who are urgently reviewing the supply situation.”
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