In a letter to clinicians across the NHS, national patient safety director at NHS England and NHS Improvement, Dr Adrian Fowler, called on health professionals to review and risk assess all those patients affected, in order to help identify a “clear national picture” of where increased risk lies.
“It is important to us that we are assured that each patient has been risk assessed and a contingency plan put in place”
Dr Adrian Fowler
In a separate letter, patients were assured that nursing staff were being asked to ensure that they received all the support needed while the NHS dealt with a shortage of Calea’s parenteral nutrition (PN) bags.
The news comes after an inspection of Calea UK’s Runcorn site in June 2019, during which regulators said they found problems with the design of the manufacturing process for its PN bags.
During the inspection, carried out by the Medicines and Healthcare products Regulatory Agency (MHRA), it was identified that the process used by Calea did not meet the requirements of guidance published by the safety body in 2015.
In addition, it was flagged by the MHRA that Calea’s own routine monitoring, which was designed to detect microbial contamination in the production area and on production personnel, had identified bacteria which were known human pathogens.
In his letter to clinicians – not currently published on the MHRA’s website but seen by Nursing Times – Dr Fowler stressed that there was no evidence to indicate that Calea products manufactured and supplied to patients were contaminated.
However, he warned that the “environmental contamination, in combination with the inspection findings, presented a very serious risk to patients and required immediate action”.
“There needs to be clear communication to staff so nurses can give patients and their families reassurance”
As Calea has been directed to change its processes, a shortage of its product supply has occurred as a result.
NHS providers were first told by Calea that the supply issues would last four weeks, although Dr Fowler said it now “appears likely that the issues will last longer than initially anticipated”.
Dr Fowler 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.”
He stressed to clinicians the importance of reviewing all patients to “ensure that the available compounding slots are reserved for high-risk patients and that the details of these patients are clearly communicated with Calea”.
“It is important to us that we are assured that each patient has been risk assessed and a contingency plan put in place and to this end we would ask that you confirm this, so we have a clear national picture of where any remaining increased risk sits,” he said in the letter.
The document explained that the issue had been formally designated as an “emergency preparedness, resilience and response, at the highest level in view of the risk”.
To help manage the issue, he told staff that the Department of Health and Social Care (DHSC) had convened a National Actional Group to coordinate national management strategies.
The group is comprised of the DHSC, NHS England and NHS Improvement, MHRA, representatives from the Devolved Administrations and national clinical experts.
Because the issue was anticipated to be a “longer-term issue”, he said that several longer-term management strategies were currently being explored.
“Whilst there is a backlog, Calea are working to rectify the problem and increase supply as soon as possible”
The plan is that patients who would usually have the PN Calea bags would instead have temporary standard multi-chamber bags, which may mean that patients would have to have additional supplements.
Dr Fowler said one strategy being explored was to identify “nursing capacity” to “allow the delivery of extra infusions that may be required by patients on multi-chamber bags”.
Wendy Preston, head of nursing practice at the Royal College of Nursing, said that clear communication was needed for staff, so that nurses could give patients vital reassurance.
She said: “By raising the alarm this shortage should now get the urgent attention it deserves. The health service and the regulator must confirm how long is anticipates this situation will last.
“It is vital these types of products are regulated effectively and where standards fall below the requirement it can be detrimental to patient care,” she said.
“There needs to be clear communication to staff so nurses can give patients and their families the reassurance that they will receive the vital treatment they need.”
A spokesman for Calea said: “Following a routine MHRA inspection in June 2019, we were directed to change the process by which we add trace elements and vitamins to our parenteral nutrition bags, in order to align with latest standard industry practice.
“As a result, the time taken to produce bags has increased considerably and this has, unfortunately, affected the supply to patients,” he said.
“On July 22, Calea informed the NHS of a voluntary decision to impose a production capacity restriction in order to restore a reliable supply and simultaneously committed to review the situation in four weeks’ time.
“Supplying patients is Calea’s number one priority and we apologise to patients and their families for the distress caused,” he added.
“We are fully committed to working with the MHRA and the NHS Action Group to return to usual and reliable supply levels as quickly as possible during this challenging period.”
Meanwhile, an MHRA spokesman said: “It is vital that patients can get their parenteral nutrition quickly.”
He stressed that the agency was “working closely” with the company to safeguard the “quality and safety of these important products”.
“Calea reduced output in order to make necessary changes,” he said. “Whilst there is a backlog, Calea are working to rectify the problem and increase supply as soon as possible.”