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A London-based pharmaceutical company has been charged with offences relating to the nature and quality of medicinal product used for parenteral nutrition in babies.
A pharmaceutical company based in London, UK, ITH Pharma, has been charged with seven counts of ‘supplying a medicinal product not of the nature or quality specified in the prescription on May 27, 2014’, according to a statement from the Metropolitan Police on Oct. 31, 2018.
Additionally, the police have stated that the company has also been charged with ‘failing to take all reasonably practicable steps to ensure that patients were not infected by contaminants, in breach of the Health and Safety at Work Act’. The charges relate to offences that occurred between Aug. 1, 2009 and Jun. 1, 2014.
ITH Pharma, which specialises in the provision of aseptic compounding services for therapeutic areas, particularly parenteral nutrition, chemotherapy, and CIVAS, has responded to the charges, indicating its disappointment. It stated on its website, "As founders of ITH 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."
In a four-year long case, the Metropolitan Police have been investigating the deaths of three babies and 20 instances where babies required treatment as a result of contracting septicaemia following administration of a feeding drip in a neonatal setting.
Since it was founded in 2008, ITH Pharma has manufactured more than a million components for total parenteral nutrition and reported that it is the only commercial supplier of this sort of solution to the National Health Service. It specified on its website, "ITH imposes rigorous environmental monitoring on its manufacturing process. The company has always had a strong relationship with the [Medicines and Healthcare products Regulatory Agency] and continues to receive exemplary ratings for quality and safety."
Representatives from the company are due to appear at Westminster Magistrates’ Court on Dec. 17, 2018.