A shortage of intravenous food supplies affecting hundreds of patients has been declared a national emergency by the NHS.
The situation has affected patients who cannot digest food normally and instead depend on intravenous food that bypasses the gastrointestinal tract, known as parenteral nutrition (PN). The NHS has been forced to try to procure supplies from abroad to address domestic shortages.
This was caused by a decrease in the output of PN manufacturer Cale, as a result of the medical regulator ordering it to take immediate steps to change its manufacturing process.
The Medicines and Healthcare Products Regulatory Agency (MHRA) identified problems in the manufacturing process during an inspection in June, while the company routinely monitored contamination in the form of bacteria known to human pathogens.
In a letter to Aidan Fowler, National Director of Patient Safety for NHS England and Improvement (NHSE / I), he said that the issue was formally flagged as an emergency incident under the Civil Cases Act "at the highest level given the risk within the NHSE / I. "
He added: "Calea has already written to you explaining that this deficiency is likely to last four weeks. However, working closely with Cale on this issue, it seems that the problems will take longer than originally anticipated. "
HSJ, who interrupted the story, said that some patients had withstood the long wait for delivery of their prescriptions, and some would go days without food. It reports that several patients, including one child, were admitted to the hospital because they were effectively starving for vital nutrients.
NHS provider CEO Chris Hopson said: "Obviously, this is a concern for all NHS trusts who care for patients who are dependent on IV nutrition. We are aware that trusts have developed local scarcity solutions, such as hospital pharmacies that produce patient food just in case. However, this is clearly not a viable, long-term solution. We know that NHS England and NHS Improvement are doing everything they can to solve the problem and ensure that patients do not have to suffer unnecessarily. "
The Ministry of Health and Welfare has convened a national action group involving experts from the NHSE, DHSC and MHRA to ensure that patients are treated appropriately.
Fowler described the PN market as "fragile and complex," but said the group worked with other suppliers to increase capacity and "work with MHRA to accelerate regulatory processes, including those needed to import supplies from global markets."
He said the regulator regularly visits Calea's manufacturing facility to perform inspections and advised him on how to protect the quality and safety of the product.
There is a certain amount of trust to review all patients and ensure that those at highest risk are given priority.
In a separate letter to patients, Fowler writes that temporary "standard" bags, unlike those tailored to the individual's needs, will be used where conventional PN cannot be delivered. He said additional supplements may need to be given.
He said that although the MHRA calls for urgent action based on "very serious risk to patients," there is no evidence to suggest contamination of PN produced before inspection by the regulator.
Fowler wrote, "We understand that the disorder poses a clinical risk, and we have carefully tried to balance the risk of contamination and sepsis with the risk of a supply disorder, which we know has already had a significant impact."
In a letter to patients, he wrote, "Be sure that we are doing absolutely everything we can to resolve this situation as quickly and safely as possible."
An NHS spokesman said: "The NHS is working hard to reduce disorders in patients and ensure they are up-to-date, while supporting Cale in finding a solution."