The NHS has declared a national emergency over delays in deliveries of intravenous nutrition to hundreds of patients across England and Wales.
Patients dependent on them 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.
Cheshire-based company Calea said it was changing the way trace elements and vitamins are added 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”, national patient safety director Dr Aidan Fowler said in a letter to NHS Trusts and doctors.
The drips provide parenteral nutrition which 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), Fowler said the problem, initially thought to impact patients for four weeks, is likely to go on longer.
He said: “We realise that 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, which we know has already had significant impact.
“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.
“This is a difficult balance, but we are of the view that the manufacturing changes are necessary to ensure safe supply now and in the long-term.”
Writing to patients, Fowler said they will give affected people temporary standard, multi-chamber bags, which may mean they need additional supplements.
He said that, despite the “immediate and essential” changes, there is no risk to patients who used the products made before they were implemented.
Fowler said the NHS is working with the Department of Health and Social Care to identify where other suppliers may be able to increase their production and are sourcing additional products from abroad.
An NHS spokeswoman said: “The NHS is working hard to minimise disruption to patients and ensure they are kept up to date, while supporting Calea to find a solution to the issue.”