Wednesday 4 June 2014

Following the emergence of the outbreak of what transpired to be Bacillus cereus in parenteral feed, Public Health England released the following press release.

For immediate release

Wednesday 4 June, 2014

Investigation into Bacillus cereus infections

Public Health England (PHE) and the Medicines and Healthcare products Regulatory Agency (MHRA) can confirm they are investigating 15 cases of blood poisoning (septicaemia) caused by a bacteria known as Bacillus cereus. The affected babies were in neonatal intensive care units at a small number of hospitals in England.

Many of the babies were premature and very vulnerable and one baby has sadly died but 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 a particular form of intravenous liquid called parenteral nutrition which was given to the babies. This contains a variety of nutrients that are delivered directly into the babies’ bloodstream when they have problems ingesting food via their mouth. This batch of product is manufactured by ITH Pharma Limited.  

Because this type of nutrition is given into the bloodstream of vulnerable babies and adults it is manufactured under strictly controlled aseptic conditions. Investigations with the company have identified an incident that might have caused the contamination. Investigations into this by the MHRA 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 02/06/14). The MHRA has issued a Class 1 drug alert to support the manufacturer’s recall of the product this afternoon.

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.

Bacillus cereus is a bacteria found widely in the environment in dust, soil and vegetation. Most surfaces would be likely to test positive for the presence of the bacteria. Bacillus cereus produces very hardy spores and in the right conditions these will grow. The spores can produce a toxin which causes illness.

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.”

Adam Burgess, the MHRA’s manager of the Defective Medicines Reporting Centre, said:

“Patient safety is our top priority and we are working alongside PHE to establish what has happened. 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.”

I was called upon by the BBC news channel to undertake a live news interview where I explained the origins of the organism. Essentially we are dealing with an environmental spore forming Gram positive rod that apparently got into the feed being given to these very unwell premature babies. The feed was being given straight into the blood stream as they children were apparently not able to ingest or digest in the normal manner. The actions of the MHRA, PHE and the company involved limited the outbreak and protected many more patients. One should not comment too much more whilst the investigation is being carried out as speculation is not helpful at this time. We must of course recognise the tragedy of the situation where a child has lost their life – our thoughts go out to the childs family and loved ones. One does also have to remember that we are dealing with very unwell children and indeed only modern medical technology was sustaining their lives. It is good to see that the surviving children are responding well to the antibiotics being administered.

I was also interviewed on several radio stations re-iterating the points above getting out to LBC radio, BBC Radio Asia  and across the BBC regional radio news network, where interviews were carried on BBC Radio Humberside, BBC Radio York, BBC Radio Devon, BBC Radio Somerset, BBC Radio Wiltshire, BBC Radio Norfolk, BBC Three Counties Radio (covering Bedfordshire, Hertfordshire and Buckinghamshire) and BBC Radio Kent.

The following comment was then released by the Science Media Centre :

Prof Mark Fielder, Professor of Medical Microbiology, Kingston University, said:

“The recent Bacillus cereus outbreak linked to parenteral feed has left 14 premature babies with septicaemia and sadly one other has lost their life. There is an ongoing investigation to establish exactly how this feed might have become contaminated and in the meantime there has been a product recall to prevent any further infection. Public Health England and the MHRA have acted quickly to both identify the organism responsible and to put measures in place to protect the public. The occurrence of a further three cases, whilst distressing, was to some extent expected as patients who might have earlier received contaminated material develop symptoms. It remains the case that the outbreak is likely to have been contained and very few (if any) further cases will be seen.”

Since this comment went out we have seen three more babies become infected, which is not completely unexpected but nonetheless sad. Why not completely unexpected? Well although the infected material was withdrawn some feed may have been still in the ‘system’ or small amounts delivered to patients so it may have a taken a while for infections to become apparent. Sadly one more baby died but as I understand it this child had other unrelated complications. It would appear that to date no further loss of life has occurred and that this outbreak is now controlled.