Firms fined after drug dose blunder linked to death of hospital patient

The mistake was revealed in a court case in which two firms were fined a total of more than £500,000 for blunders that contributed to the death of one patient.

In the case in Shrewsbury, drug firm Calea manufactured a batch of pre-prepared Tobramycin syringes – used to treat infections – that were administered to a patient with cystic fibrosis at the Royal Shrewsbury Hospital in August 2011.

On this occasion the syringes, which were prepared and delivered direct for the patient by Calea, were each found to contain three times the prescribed daily dose.

The over-medication came to light after the patient reported an adverse reaction, described as a fizzing sensation, although there were no lasting effects.

The court heard another blunder contributed to the death of patient Neil Judge, from Barnsley in South Yorkshire, who suffered multi-organ failure while he was being treated at the Northern General Hospital, in Sheffield, in November 2010.

An investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) found Mr Judge, 58, had been treated with a batch of intravenous insulin syringes that actually contained no insulin at all, just saline.

His multi-organ failure was triggered by diabetic ketoacidosis because his body was deprived of insulin for more than 13 hours, the MHRA said.

A judge at Sheffield Crown Court heard how the faulty syringes were supplied to Sheffield Teaching Hospitals NHS Foundation Trust by Fresenius Kabi Ltd as a licensed wholesaler for Calea UK Ltd, which manufactured the product.

The agency said Fresenius Kabi, of Eastgate Way, Manor Park, Runcorn, was fined a total of £500,000 and ordered to pay a further £5,900 in costs after pleading guilty to breaching Sections 64(1) and 67(2) of the Medicines Act 1968.

Calea UK, of the same address, was fined £50,000 with £5,900 costs after also pleading guilty to similar breaches.