• Clinicians criticise MHRA handling of IV feed supply issue
  • Patients being admitted for IV hydration and moved to off the shelf feed
  • MHRA insists it did not sign off Calea production during 2017 inspection

A regulator has defended its actions which caused delays to the supply of life-saving intravenous feed for hundreds of patients with HSJ learning some are now being admitted to hospital.

The Medicines and Healthcare products Regulatory Agency told HSJ it had to take action against a firm which manufactures parenteral nutrition feed for hundreds of patients across the country, after finding a bacterial contamination in the Runcorn-based firm Calea’s production process.

There is no suggestion however that any of the feed was contaminated as a result of the production process issues.

And initially the MHRA made no mention of contamination. It said it took action to bring Calea into line with their 2015 best practice standards. The regulator also insisted it did not sign off Calea’s production process during an earlier 2017 inspection.

It said the company had to take “full responsibility” for meeting its regulatory requirements. Part of the reason for its restrictions was Calea’s failure to achieve standards dating back to 2015.

Off the shelf

But the national body is now facing increasing criticism about its intervention from frontline staff.

Clinicians have told HSJ they have been forced to give patients sub-standard ‘off the shelf’ feed which is not a long-term solution for patients who require bespoke mixtures.

Patients and parents of children who rely on the IV feed to stay alive have reported having to miss several days of feed and being left feeling weak and dehydrated.

Sources told HSJ some patients who have gone without feed deliveries have been admitted to hospital for IV hydration. Other patients have been shifted to off the shelf feed rather than bespoke prescriptions, with no idea how long the situation will last, HSJ has been told.

Across the country, hundreds of patients, including children, have been hit by the delays, with hospital nutrition teams having to coordinate care for patients without any idea when and if supplies will reach previous levels.

Jim Stewart, clinical lead for adult nutrition at University Hospitals of Leicester, said on Twitter the MHRA had “known about problems for years and their precipitate late reaction [is] threatening patients health far more than the initial problems. Should’ve been controlled monitored improvement of production standards rather than national chaos endangering lives.”

Dr Stewart added: “The process has been an utter shambles and possibly endangered lives rather than protecting them.”

One doctor told HSJ they had been forced to admit a patient for hydration over two nights at a cost to the NHS of hundreds of pounds. They added this was being replicated across the country.

They said: “It has been a monumental cock up by those at the MHRA who think they understand the process but then realise their superficial understanding of the complexities has been beyond their comprehension. The whole process is creating such a mess.”

Another doctor, who has also admitted a patient after they presented at accident and emergency, told HSJ: “The MHRA caused this problem unnecessarily. It was heavy handed regulation and the impact on the patients and service has been far worse than the possible risk.”

Dietitian Catherine Collins said on Twitter: “Just because community-based PN is a well-honed specialist service doesn’t mean it’s robust enough to deal with supply chain issues at local level at short notice. Lack of insight of the process and infrastructure by MHRA and DHSC have created this debacle.”

She said the MHRA should have worked with Calea on its production issues and that communication had been “appalling”.

’It’s frankly terrifying’

Across the country patients are struggling to cope.

Catherine Lethbridge’s daughter has been dependent on total parenteral nutrition for seven years but some deliveries from Calea have not arrived.

She said: “Patients are, effectively, being starved. The only advice that has been given by either Calea or the hospital has been to run replacement saline fluid. Whilst this provides some hydration, fluid bags do not contain any calories, electrolytes or sugars and are an insufficient and unsustainable replacement.”

On social media parents have angrily criticised the response from Calea and the NHS. Many complained they cannot get clear information and are in the dark about what will happen in the longer term.

And some families have been advised to take their children to A&E if they go too long without feed, messages seen by HSJ reveal.

The parent of one patient said: “Can you imagine going without food for days on end, it’s frankly terrifying…within a couple of days [my daughter] will become extra dizzy , her blood pressure will drop to dangerous levels.”

Another patient, Katie Avery, said: “This is so bad they are leaving people without any alternatives. I went three days last week on sodium chloride which I was thankful for but it was hard and I felt extremely weak, light headed and poorly.”

’Duty bound’

The MHRA told HSJ in a statement that sterile manufacturing of IV feed was essential to avoid contamination which can lead to patient deaths.

It said: “The MHRA’s inspectors found evidence of serious failing in the processes Calea use to monitor and react to possible contamination in their sterile manufacturing areas.

“Although there is no evidence that any products were contaminated the risk to patient safety was real. Consequently, the MHRA was duty bound to act quickly and decisively to protect patients.”

In response to questions about why action wasn’t taken to enforce 2015 standards when Calea was inspected in 2017 the regulator said: “The MHRA did not ‘sign off’ these procedures in our 2017 inspection.

“All MHRA inspections are a sampling exercise. It is the responsibility of the company operating the facility to ensure that they are always operating in compliance with the regulation and with best practice which evolves over time as we learn more about potential issues that may arise in complex manufacturing processes.

“[Calea’s] management must take full responsibility for meeting regulatory requirements at all times and are accountable for the operations in their facility.”

It said the contamination had been referenced in response to requests for information but it has since published a full statement online.

A national action group involving NHS England, the MHRA, and the Department of Health and Social Care has been set up to try and resolve the supply shortage.