ITH Pharma linked to the death of a baby

The manufacturer of a hospital feed "strongly linked" to the death of one baby and illness of 17 others has said it is "saddened" by what has happened. ITH Pharma managing director Karen Hamling said it was co-operating fully with an inquiry by health officials.

The baby died from blood poisoning at St Thomas' Hospital in south London from suspected contaminated drip food. Public Health England said babies at six hospitals developed septicaemia from the Bacillus cereus bacterium.

 

Last December, four newborn babies died in a hospital in Chambéry, south-east France. They were in the neonatal intensive care unit, premature and weak, and fed not by mouth but through an intravenous drip. It took weeks before it was established that the nutritional liquid in the drip was to blame. It was infected with bacteria. In January, the French authorities suspended the licence of the company making the product, Marette Laboratories, for six months.

 

The contrast with events in England in the past few days, where 18 babies have developed septicemia from a similarly infected drip, could not be greater. ITH Pharma, which dispatched the contaminated feed to 22 hospitals, has not stopped production. The only disruption has been the arrival of inspectors from the Medicines and Healthcare Products Regulatory Authority (MHRA) on Wednesday, followed by a small group of journalists on Thursday to hear a prepared statement from managing director Karen Hamling. She was clearly disturbed by what she described as the "tragic events that have occurred over the past few days" and the media attention. Currently though, the company's licence remains unrestricted.

 

It appears that the disaster in the UK was handled efficiently and that the problem has been resolved swiftly, unlike the incident in France. The first baby developed symptoms of septicaemia – blood poisoning – on Friday at Chelsea and Westminster hospital. Other cases there and in other premature baby units were reported to Public Health England over the weekend. It was quickly clear from the number and dispersal of cases that this was not any hospital's fault. The trail led back to ITH Pharma, which was told by the MHRA at 5pm on Monday that sick babies appeared to have been given its products, which are not standardised but made up on the day to suit the needs of the individuals. One ingredient, produced by a supplier to ITH, was common to all the cases. That ingredient was contaminated with Bacillus cereus, which is commonly in the soil and vegetation and can cause gut problems, but in this case caused life-threatening septicaemia because it went straight into the bloodstream.

 

In France, the bug was not easily identified. Scientists spoke of a new type of enterobacteria. But the reason for the closure of the lab appeared to have more to do with the spacing of the deaths. This was not a single batch from a single day's production, using ingredients of which anything left is routinely destroyed, which ITH Pharma says was the situation in Britain. Hamling stressed the company's track record. In the past 12 months it had supplied 800,000 products of this kind to patients, she said. She spoke of "exemplary ratings" from regulators for the quality and safety of the manufacturing process. The MHRA's inspectors presumably agree, or they would not allow production to continue.

 

Nonetheless, there are unanswered questions. If the incident had not led to the very emotive illness of so many newborn babies, not to mention a death, these might be passed over. When the same bacterium infected a liquid called Viaspan, used in the transportation of donor organs, in 2012, there was interest, but not the forensic media attention these cases will get. As it is, the company and the inspectors will need to explain further. They have so far refused to say what the "ingredient" is and which company supplied it. It is also still unclear how the ingredient came to be contaminated and what measures are being put in place to prevent that happening again. ITH Pharma is continuing to use the same supplier. The nutritional product is made in aseptic conditions, which means that the environment is strictly controlled to keep out bacteria and other micro-organisms. Workers in what are called the Clean Rooms are not allowed to wear jewellery or make-up. Bacteria monitors are installed, made by the British company Cherwell, which are checked every day, but they did not show up any problem on Tuesday 27 May, the day the contaminated product was made.

 

Source: Medicines and Healthcare Products Regulatory Agency

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