Public Health England (PHE) and the Medicines and Healthcare products Regulatory Agency (MHRA) are investigating 15 cases of septicaemia caused by the bacteria Bacillus cereus. The affected babies were in neonatal intensive care units at a small number of hospitals in England. One baby has died, while the others are responding to antibiotic treatment.
Investigations are ongoing but so far indications show that the cases have been strongly linked with a number of batches of intravenous liquid administered for parenteral nutrition. The batch of product is manufactured by ITH Pharma Limited. Investigations with the company have identified an incident that might have caused the contamination. However, further investigations are ongoing and inspectors from the MHRA are visiting the manufacturing plant.
The product has a short shelf life and, although it is unlikely that any stock from the day of contamination incident remains (it expired on 2 June 2014), the MHRA has issued a Class 1 drug alert to support the manufacturer’s recall of the product. Although the affected product was only issued to a limited number of neonatal units an alert has been issued to all neonatology units across the UK to make them aware of the incident. Doctors have been given advice on what steps they need to take to identify any potential cases of infection and how to dispose of affected stock.
Professor Mike Catchpole, PHE incident director, said: "This is a very unfortunate incident and PHE have been working closely with the MHRA to investigate how these babies could have become infected. Given that the bacteria is widely spread in the environment we are continuing to investigate any other potential sources of infection. However, all our investigations to date indicate that the likely source of the infection has been identified. 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."
