Emergency over delays in IV nutrition

The NHS has declared a national emergency over delays in deliveries of intravenous nutrition to hundreds of patients across Wales and England.

Patients dependent on parenteral nutrition for use at home, including children, are experiencing delays after the medicines regulator found problems with the ways the bags were manufactured at the end of June.

Calea, based in Runcorn, Cheshire, said it was changing the way it adds trace elements and vitamins to the bags after failing to meet requirements set by the Medicines and Healthcare products Regulatory Agency (MHRA).

The resulting delays have been formally declared an emergency “at the highest level in view of the risk within NHSE/I”, national patient safety director Dr Aidan Fowler said.

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.

In letters first seen by the Health Service Journal (HSJ), Dr Fowler said the problem, initially thought to impact on patients for four weeks, is now likely to go on longer.

In a letter to trusts and doctors, he said: “We realise the disruption presents a clinical risk and have been careful to try and balance the risk of contamination and sepsis against the risk of supply disruption.

“MHRA have been working closely with Calea to monitor the implementation of interim changes to the manufacturing process while a long-term solution is being developed which will increase production while maintaining the safety of the product.”