A pharmaceutical company has been fined more than a million pounds after pleading guilty to offences relating to the supply of intravenous feed to babies in 2014.
At Southwark Crown Court on Friday, 29 April, ITH Pharma, based at Premier Park, NW10, were fined £1.2 million after previously pleading guilty to one count of failing to make a suitable and sufficient risk assessment and two counts of supplying a medicinal product not of the nature or quality specified in the prescription.
The latter counts relate to 19 babies who received Total Parental Nutrition (TPN) in 2014.
Detective Chief Inspector Richard Leonard, who led the investigation, said: “This has been a lengthy and complex investigation and our thoughts today remain with the families of all those affected. “We commend their bravery and dignity in coming to court and reliving their most difficult moments. We hope they can take some comfort in the fact the criminal proceedings have now concluded.
“This outcome was only possible thanks to the tireless work of a dedicated team of officers, particularly DS Simon Dawes who must be commended for his efforts.” Following a referral by the Coroner for Inner South London in September 2014, the Met’s Specialist Crime Command began an investigation.
The team worked closely with the Medicines and Healthcare products Regulatory Agency (MHRA), Public Health England (PHE) and the CPS, engaging with experts in the field of aseptic microbiology. Thousands of documents were examined which ultimately led to ITH Pharma pleading guilty to offences under the Health and Safety at Work Act and the Medicines Act.
Yousef Al-Kharboush died aged 9 days old, on June 1 2014, from sepsis, after being infused with ITH Pharma’s Total Parenteral Nutrition (TPN) at St Thomas’ Hospital in central London. Southwark Crown Court heard on Thursday (April 28) that he was one of 19 infants at nine hospitals in England who fell ill after being infected with Bacillus Cereus bacteraemia from a contaminated batch of the fluid.
The TPN was administered directly into their bloodstream because they were unable to feed on their own between May 27 and June 2, 2014. Prosecutor Mark Heywood QC said: “The prosecution case is very firmly that Yousef’s death was the result of the way this company was carrying out the manufacturing activity and in particular the lack of a risk assessment.”
Mr Heywood said: “The defendant company, which was then, and still is, involved in the manufacture and supply of medical nutritional products to hospitals, including for administration to infants who were unwell, supplied one large batch of such products, which was contaminated with a pathogen, a bacterium which was dangerous to health and life particularly if allowed to enter the bloodstream.”
One of the Medicines Act charges relates to Yousef, while the second covers the 18 other babies who fell ill, as well as four more who were prescribed TPN but never given it. “Some became ill, some very ill, and the prosecution case is that among that number, one of the babies who died, died, says the prosecution, as a result of the infection that followed the administration,” the prosecutor said.
Statement from company
Karen Hamling, the managing director, said at the time that she was deeply saddened by the events “as a mother, as a pharmacist, as someone who has worked for 30 years in healthcare, inside and outside the NHS.”
She added: “We have instituted a recall of the limited number of batches which could potentially have been affected and all stock has been removed from circulation. Given this action, there is no reason for patients, their families or healthcare professionals to be concerned.
“From investigations carried out so far, it would appear the potential contamination is linked to a sourced single raw material ingredient.”
The company declined to elaborate on the type of ingredient or how it got into the nutritional product, which is made in an aseptic environment, where the air is constantly monitored for bacterial infection.
It would not say where the contaminated ingredient came from or when it became infected with Bacillus cereus, which is found in the soil and food. The company is understood to be continuing to use the same supplier.
The babies were vulnerable because they were underweight and sickly and the feed went directly into their bloodstream. Because of the contamination, they developed septicaemia. Strong antibiotics cleared the infection in most.
The feed, known technically as parenteral nutrition, contains formulated nourishment and is made to order for babies. Hospitals are supplied with it on the day they request it and it has a shelf life of seven days.
The Met said in a statement: “The families have been notified of this investigation by the forces concerned.
“The current focus of this investigation is on the production of intravenous feeds. We are not investigating the health trusts.”
ITH Pharma supplies aseptically manufactured specials. A special is an unlicensed medicinal product that is defined as, a product that has been specifically and specially manufactured to the unsolicited order of a doctor, dentist, nurse independent prescriber, pharmacist independent prescriber or supplementary prescriber for a patient for whose treatment that person is directly responsible in order to fulfil the special needs of that patient (“the Special”).
Aseptically manufactured specials are inherently a high risk product made under license granted by the MHRA, that by definition do not undergo terminal sterilisation and whilst manufactured through a process which has undergone a regulatory approved risk assessment, do not go through a formal licensing procedure to assess the safety, quality and efficacy of the product itself as would be the case with a licensed product.