UK authorities charge firm over poor parenteral nutrition used in babies
The offences include seven counts of supplying a medicinal product that were not of the nature or quality specified in the prescription dated 27 May 2014.
The country’s Crown Prosecution Service (CPS) also deemed there to be enough evidence to charge the firm with not taking reasonable steps to ensure patients were not infected by contaminants.
Commenting on the CPS’ decision ITH Pharma said in statement, “We have every sympathy for all the families affected, regardless of the cause.
“However, we are disappointed by the decision to charge the company and will vigorously defend this case. It would not be appropriate to comment further at this stage.
“Since 2008, ITH has manufactured more than 1.4-million components of total parenteral nutrition and is the sole commercial supplier of reactive feeding solutions to the NHS. This product has helped thousands of extremely vulnerable infants survive premature and complex births.
ITH said that it imposed rigorous environmental monitoring on its manufacturing process adding that the company has always had a strong relationship with the Medicines and Healthcare Products Regulatory Agency (MHRA) and that the firm continued to receive exemplary ratings for quality and safety.
MHRA and police investigation
Results of the investigation conducted by the Metropolitan Police and the MHRA found 23 babies at nine hospitals in London acquired a bacterial infection after receiving total parenteral nutrition supplied by ITH Pharma.
Whilst three of these babies died, it was it was the death of a twin born eight weeks premature from septicaemia that was linked to ITH Pharma’s parenteral nutrition. All the other babies, who were given the feed survived.
NutraIngredients first reported on details of the four-year investigation back in 2014, where health authorities began probing the death of a baby linked to the suspected contamination of a food drip.
Here, Public Health England (PHE) and the Medicines and Healthcare Regulatory Agency (MHRA) 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 added.
ITH Pharma, who are charged with offences under Section 3 and 33 Health and Safety at Work Act and Section 64 and 67 of the Medicines Act, are due to appear at Westminster magistrates court on 17 December.
