Public Health England (PHE) and the Medicines and Healthcare Regulatory Agency (MHRA) have launched a joint investigation after the baby died at St Thomas’ Hospital in London from septicaemia blood poisoning on Sunday June 1.
The outbreak of septicaemia – caused by the bacteria Bacillus cereus – also sickened 18 other babies at six hospitals.
PHE director of health protection, Paul Cosford, said that the most likely cause of the infection was the contamination of the baby’s feed drip. “It’s an ongoing investigation but it [the contamination of feed with Bacillus cereus during its manufacture] is by far the most likely cause of this infection,” Cosford told BBC Radio 4’s Today programme.
“If that is definitely the cause, then there is clearly something that will have gone wrong in that manufacturing process and that is being investigated,” he said. Medicines are manufactured under the strictest precautions and hygiene rules.
‘Extremely unusual incident’
“This is an extremely unusual incident so, to that extent, there is reassurance,” added Cosford.
PHE confirmed 22 hospitals throughout the UK received the feed product, which is no longer being used. “This is a very short-life product and the regulator has put out an urgent recall to make sure there isn’t any more being used,” said Cosford. “We have notified every hospital across the country that if there are any more cases, we will find out about them quickly and they will be notified to us.”
Many of the babies affected had been born prematurely and were being cared for in neonatal intensive care units. They received the feed because they could not receive milk by mouth.
The feed linked to the blood poisoning was manufactured in the UK by the London-based firm ITH Pharma. The firm said in a statement: “ITH Pharma is very saddened to hear about the death of a baby in hospital, and that 14 others are ill with septicaemia.
‘Very saddened to hear about the death’
“ITH Pharma is a specialist manufacturer of parenteral nutrition, which is given to babies in neonatal intensive care units. The products in question, which are no longer in circulation, are made to order for individual patients on a daily basis, in response to bespoke orders from hospitals.
“We are co-operating fully with the MHRA in the investigation, and are doing everything we can to help them establish the facts in this case as quickly as possible.”
Professor Mike Catchpole, PHE incident director, said the bacteria was widely spread in the environment and the authorities were continuing to investigate potential sources of infection.
“However, all our investigations to date indicate that the likely source of the infection has been identified,” said Catchpole. “We have acted quickly to investigate this issue alongside the MHRA and we have taken action to ensure that the affected batches and any remaining stock of this medicine is not being used in hospitals.”
Adam Burgess, the MHRA’s manager at the Defective Medicines Reporting Centre, added: “We have sent inspectors to the manufacturer’s facility to carry out a detailed and rigorous inspection and we have ensured that the potentially affected medicine is recalled.”