More children in England could die from unlicensed medicines unless healthcare providers are forced to report the problems, a coroner has warned.
This warning follows an investigation into the tragic deaths of three newborn babies due to contaminated feed given to them in hospitals.
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The babies, who were all being cared for in hospital after being born prematurely, died after receiving total parenteral nutrition (TPN) contaminated with a botulism bug.
Children are given TPN when they cannot eat on their own.
Three-month-old Aviva Oti, one-month-old Oscar Parker and nine-day-old Yousef Al-Kharboush were provided with critical nutrition through TPN.
An inquest at Southwark Coroner's Court included Bacillus cereus contamination in every cause of death.
Read more about Bacillus cereus
Bacillus cereus is a deadly bacteria that infects around 20-30 newborns a year in England, Wales and Northern Ireland.
Aviva died in January 2014 at St Thomas' Hospital in central London and received combination TPN by the NHS, under a Section 10 exception, according to a Preventing Future Deaths (PFD) report prepared by chief coroner Dr Julian Morris.
An exemption under the Medicines Act 1968 allows organizations to legally produce personalized medicines without a license for specific patients with specialist problems.
Youssef, who also died at St Thomas' Hospital in June 2014 from sepsis, and Oscar, who died at Addenbrooke's Hospital in Cambridge in the same month, received TPN produced by the “commercial provider”, ITH Pharma.
Because ITH is a licensed provider, it is not subject to the Section 10 exemption.
In his report on the PFD, Dr Morris highlighted concerns about the obligations that Article 10 exempt entities are under to report “adverse events”.
He said: “There is no requirement on a section 10 exempt entity to report any of its findings to the MHRA or indeed to other trusts or the industry generally in the event of an adverse event.
“Current reporting structures (for a Section 10 entity) include reporting to the NHSE and CQC, but the threshold or necessity for such reporting appears unclear and, in essence, is up to the Trust.
“There may be times when Section 10 entities reach conclusions that will help the wider industry and both trusts and other commercial organizations to assess their own risks and improve the provision of very specific medicines to groups of patients at risk.
“The same may also be true for commercial organizations but they have the MHRA’s power to control and implement withdrawals and procedures and disseminate information more widely.”
The chief coroner also wrote that Bacillus cereus is resistant to some cleaning methods and that “sporecides” may be needed to achieve decontamination.
“This was information and conclusion reached by the Foundation in early 2014, and therefore before the outbreak in May/June 2014,” Dr Morris said.
“These results have not been passed on either within Section 10 other TPN multiplexing units or the broader market.
“The worst experience a parent can go through”: A heartbreaking statement from Yousef Al-Kharboush’s mother
Ganda Al-Kharboush – who moved with her husband from Saudi Arabia to study a doctorate in dentistry – gave birth to her twin children by emergency caesarean section at 32 weeks, after it became clear that one of them was not growing properly.
Both were placed in intensive care at St. Thomas Hospital and were fed intravenously, meaning they were given a liquid mixture of nutrients directly into their bloodstream, a common practice when newborns cannot eat on their own.
While Abdel-Ilah was not affected, Youssef developed fatal blood poisoning due to feed contaminated with Bacillus cereus bacteria.
In a statement read to the court, Ganda said she noticed something was wrong when she went to express milk for her baby on May 30, 2014.
She spoke to the nurse after she noticed that “Youssef was not as loud as usual” and that “his breathing was not regular.”
Ganda was told that Joseph “was not coping as well as he had been” and was given a scan.
She added: “Shortly after the examination, Youssef stopped breathing. I was in a state of shock and suddenly there was activity around Youssef.”
Ganda watched his condition deteriorate in the following days, adding: “It was very difficult to see our son in pain. I felt useless and could not do anything for him.
“It's the worst experience a parent can have.”
Youssef appeared to be improving after being given antibiotics and was taken to see his twin, but “this will be the only time” he will see his brother, the court heard.
Ganda later noticed that he had no color and spots on his chest.
“I wanted to stop his pain,” she said.
“I took him in my arms while he was connected to a ventilator.”
Youssef died on June 1.
“Subsequently, the Medicines and Healthcare Products Regulatory Agency (MHRA) provided further advice on the use of sporicides in 2015.”
He said there was a risk of future deaths unless action was taken in relation to the concerns highlighted.
Recipients must respond to the report by January 8 of next year.
ITH Pharma was fined £1.2m by the Crown Court in 2022 after introducing TPN that infected 19 children at nine hospitals in 2014.
The company pleaded guilty to one regulatory offense of failing to carry out a suitable and adequate risk assessment, under the Management of Health and Safety at Work Regulations 1999.
She also pleaded guilty to two regulatory offenses under the Medicines Act 1968 of supplying a medicinal product on 27 May 2014 that was not of the nature or quality specified in the prescription.
“Our deepest condolences to all the affected families.”
Regarding the PFD report, an ITH Pharma spokesperson said: “We welcome Chief Investigator Morris’s report on Preventing Future Deaths, which recognizes the importance of information sharing and learning across this specialist industry.
“Any information shared with ITH and the MHRA as a result of a previous outbreak in the NHS five months before the ITH incident would have been of real value in taking steps to prevent potential future incidents.
“We are proud to work with and support the NHS and, most importantly, patients in this vital work for specialist nutrition systems.
“We offer our deepest condolences to all the families affected by the events that occurred 10 years ago.
“We have done everything we can to assist the chief coroner in ensuring these investigations examine the full picture of both outbreaks in 2014, and we hope these findings will provide the families with answers.”
