Unlicensed medicines could lead to more baby deaths in England, the coroner has warned
More babies in England could die from problems caused by unlicensed medicines if healthcare providers are not obliged to report problems, a coroner has warned.
The conclusions were drawn at the end of an inquest after three babies died as a result of receiving contaminated food.
The babies all received hospital care after being born prematurely and died after receiving total parenteral nutrition (TPN) contaminated with Bacillus cereus, Southwark Crown Court heard.
Three-month-old Aviva Otte, one-month-old Oscar Barker and nine-day-old Yousef Al-Kharboush received critical nutrition through TPN. Aviva’s mother, Jedidajah Otte, is a Guardian journalist.
Otte has previously spoken about how she faced a “stubborn refusal” from doctors and nurses at St Thomas’ hospital in London to tell her what was wrong with Aviva’s health.
Aviva died in January 2014 at St Thomas’ and received TPN “provided and compounded” by the NHS under a section 10 exemption, according to a Preventing Future Deaths (PFD) report by senior coroner Dr Julian Morris.
The exemption under the Medicines Act 1968 allows organizations to legally produce tailor-made medicines without a license for specific patients experiencing niche problems.
Yousef, who also died at St Thomas’ in June 2014, and Oscar, who died the same month at Addenbrooke’s Hospital in Cambridge, received TPN produced by a “commercial supplier” – ITH Pharma, a licensed supplier and not subject to Article 10 exemption.
In his report, Morris highlighted his concerns about the obligations that section 10 has placed on exempt entities to report ‘adverse events’. He said: “There is no requirement for a section 10 exempt entity to report its findings to the MHRA (Medicines and Healthcare products Regulatory Agency) or indeed to other trusts or the industry generally if an adverse event occurs.
“Current reporting structures (for a section 10 entity) include reporting to the NHSE and the CQC, but the threshold or need for such reporting appears unclear and is essentially a matter for the trust.
“There may be times when Section 10 entities reach conclusions that would assist the wider industry and assist both other trusts and commercial organizations in assessing their own risks and improving the provision of very specific medications to a group of vulnerable patients .”
He also wrote that Bacillus cereus was resistant to some cleaning methods and that ‘sporocides’ might be needed to achieve decontamination. “This was information and a conclusion reached by the trust in early 2014 and therefore before the outbreak in May-June 2014,” Morris said.
There was a risk that deaths could occur in the future unless action was taken on the concerns raised.
Recipients must respond to the report by January 8.
ITH Pharma was fined £1.2 million by a Crown Court in 2022 after providing TPN, which infected 19 premature babies in nine hospitals in 2014. The company pleaded guilty to one regulatory offense of failing to have an appropriate and sufficient risk assessment under the Occupational Health and Safety Management Regulations 1999, and two offenses under the Medicines Act 1968 , where a medicine was supplied on May 27, 2014 that was not of the nature or quality specified in the prescription
A spokesperson for ITH Pharma said: “Any information shared with ITH and the MHRA as a result of a previous outbreak in the NHS five months prior to the ITH incident could have been of real value in taking steps to address future potential prevent incidents.
“We are proud to be working with and supporting the NHS and, importantly, patients in this vital work of specialist nutrition systems. We extend our deepest condolences to all the families affected by the events of 10 years ago.
“We have done everything possible to help the senior coroner ensure that this investigation examines the full picture of both outbreaks in 2014 and we hope these findings will provide answers for families.”