- NHS has begun importing IV food from European suppliers
- Hundreds of patients are suffering delays in feed supplies
- MHRA accused of “reprehensible” actions causing a crisis
Senior clinicians have called for a review into how hundreds of patients have been left without intravenous food after action by the medical regulator severely curtailed its supply.
The NHS has been forced to import feed from European suppliers after the Medicines and Healthcare products Regulatory Agency imposed restrictions on IV feed manufacturer Calea following an inspection which it said had revealed a contamination risk and that its production processes did not meet required standards.
However, in posts to a closed Facebook group, seen by HSJ, a Calea spokeswoman told patients the claims of contamination were unfounded and the MHRA had not previously raised concerns in earlier inspections.
NHS England has declared a national emergency over the feed shortage. As part of its response, it is importing IV feed bags for patients who require what is known as total parenteral nutrition from countries including Norway and Germany. This will be paid for by Calea.
More than 500 patients across the UK have been switched from specialised to ‘off the shelf’ feed. Doctors have warned this is not a long-term solution, as off the shelf feed does not provide vital nutrients and electrolytes, such as potassium.
Meanwhile, dozens of patients have been admitted to hospital because of concerns for their health and around 40 patients have had their discharge delayed because their feed supplies cannot be guaranteed.
HSJ understands the NHS and Calea are now expecting the supply disruption to last until the end of 2019.
On Facebook, a Calea spokeswoman told patients: “Our previous process had been shared and reviewed with MHRA inspectors since the 2015 [production process] guidelines were issued; no expressions of concern were received and no further requests made to reassess our practices including during a December 2017 inspection.”
She added: “The supply issues we are facing are not related in any way to contamination”.
The MHRA told HSJ the changes it required were essential to protect patients.
Trevor Smith, president of the British Association for Parenteral and Enteral Nutrition and a gastroenterologist at University Hospital Southampton FT, told HSJ there needed to be a review of what had happened.
He said: “I think that needs to be some reflection about what’s happened and what collectively we might do to mitigate that risk in the future. Within that I think there needs to be a review of the aseptic compounding market because one of the challenges that’s come out of this is that the whole system is working at 100 per cent capacity. There’s no reserve.”
He added: “The issue for many clinicians is that there wasn’t any apparent forward planning or mitigation plan around what would happen when they were closed down and that’s why we’ve fallen into this kind of crisis.”
University Hospitals of Leicester clinical lead for adult nutrition Jim Stewart, told HSJ the MHRA needed to be held to account. He added: “The MHRA need to understand what the consequence of their decision has been. It was precipitous action and the resulting consequences was absolutely predictable. They knew they had issues with Calea for years and to take this action and cut off supply was reprehensible.
“I think there definitely needs to be a retrospective review by the government into what happened here. Because this is a genuinely life-threatening situation and it’s adults and children. I would say it’s only because of the goodwill of people at the very sharp end working very hard that has averted an absolute disaster.”
He said off the shelf bags were a “sticking plaster” although he added NHS England now seemed to recognise the level of crisis and were working hard to resolve it.
Catherine Collins, a dietitian at Surrey and Sussex Healthcare Trust, told HSJ that, in her opinion, there should be an inquiry saying the home TPN service had been damaged by MHRA involvement.
She said: “I hope there will be an inquiry into the poor handling of this situation. I would hope it would examine why contingency planning was not considered in anticipation of significant distribution problems, and hope that it will be possible to have full and frank disclosure from both MHRA and Calea on the matter, the latter without fear of such disclosures compromising their status as one of two major PN suppliers to UK patients. As a dietitian I am absolutely certain that the extent of this crisis could have been attenuated if MHRA had sought advice from DHSC and professional bodies in confidence before enforcing guidance.”
NHS England confirmed to HSJ that its incident management response is now coordinating the distribution of additional nutrients to patients, who will be expected to self-administer these in addition to using the off the shelf feed bags. It is also asking hospitals to send weekly updates on their local situation and patients affected.
One patient, who asked to remain anonymous, said she had been left housebound because of delays in TPN feed. She told HSJ: “I am TPN dependent and my last prescription of TPN was on the 20 July. I was then left for 18 days on IV fluids. I was then sent five off the shelf bags that made me feel so ill.”
HSJ asked the Department of Health and Social Care whether it would commission an inquiry into the disruption but it did not provide a substantive response to the question. It said it was working with the NHS to resolve the supply disruption “as quickly as possible”.
In a statement, Calea said it “was directed by the MHRA to make an immediate change to the process by which we add trace elements and vitamins to our parenteral nutrition bags and we complied with the instruction. As a result, the time taken to produce bags has increased considerably and this has, unfortunately, affected the supply to patients.
“The MHRA stated there was no evidence to indicate that any of the Calea products manufactured and supplied to patients were contaminated. Approximately 2.8 million products were aseptically manufactured by Calea for patients and hospitals in the intervening 2015-2019 period.”
A spokesman for the MHRA insisted that its restrictions on Calea “were both urgent and necessary to protect patients” adding: “At all times our priority is patient and product safety. In view of the potential supply disruption we agreed that FK Calea could take a phased but controlled transition to the new manufacturing processes.”
He added that MHRA was working with European regulators to assure the TPN products entering the UK including checking the inspection history of the facilities supplying the feed.
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