Manufacture of IV nutrient reduced
HUNDREDS of patients across England and Wales dependent on intravenous nutrition are experiencing delays in deliveries after the medicines regulator found problems with the manufacturing process based in Runcorn.
Calea, which provides parenteral nutrition to patients for use at home, told the Press Association that several hundred people, including children, were experiencing delays after it changed the way it makes up the bags.
The company, at Cestrian Court on Eastgate Way in Manor Park, 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 said 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 it was ‘vital’ that patients could get their parenteral nutrition quickly.
A statement read: “The situation at the Calea UK site in Runcorn is improving. We are working closely with the company to safeguard the quality and safety of these important products, with MHRA inspectors monitoring changes to the production process, through correspondence and regular inspection visits.
“The issue arose following a routine MHRA inspection on June 24-26.
“Problems were identified with the design of the manufacturing process that did not meet the requirements of current guidance to ensure product safety published by the MHRA.
“Calea reduced output in order to make necessary changes. Whilst there is a backlog, progress is now being made to rectify the problem and increase supply as soon as possible.” ●