FT fined after cancer clinical trial death

The 80-year-old terminally ill patient was prescribed a low dose of cytarabine for 10 days during the trial at Royal Bournemouth and Christchurch Hospitals Foundation Trust — however, she was given five times the amount required over the course of four days.

She was admitted on 4 January 2018 and died two days later.

The trust was fined at Bournemouth Crown Court on 10 December after pleading guilty in August to supplying a medicinal product which was not of the nature or quality demanded.

A Medicines and Healthcare Products Regulatory Agency investigation found there was confusion between the high and low doses of the drug, leading to the patient being given a higher dose on two occasions.

The patient’s treatment was recorded, including the incorrect dosage. However, when this was questioned by the staff member administering the medication, they were told it was correct. The mistake was picked up four days later when the same error occurred.

Senior specialist prosecutor in the specialist fraud division of the Crown Prosecution Service Andy Young said: “This was an innovative treatment but in this case a serious error was made by the hospital when it was dispensing the medicine.”

“The [trust] had plenty of chances to fix the problems within the unit, but failed to do so.”

The trust has apologised for the error and confirmed changes have been implemented following a full internal review, to make sure the same mistake does not happen again.

A spokesman said: ”During the course of a medical trial in 2017, the Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust gave a patient suffering with terminal illness medication of a higher dose than had been prescribed and whilst this was within prescriptive guidelines, it was not intended that the patient should have received this dose.

 “The trust is very sorry for the distress this has caused.

“The trust immediately notified the relevant authorities when the error was noted and has worked closely with the MHRA throughout its investigation.

“A full internal review has been undertaken and changes have been made to prevent a similar incident occurring in the future.”

This article was updated at 14:00 on 11 December to clarify the patient was terminally ill at the time of the trial. The quotes from the CPS and RBCH were updated to reflect this.