THE NHS trust which runs the Royal Bournemouth Hospital has been fined £45,000 after “basic errors” led to a cancer sufferer taking medication five times the strength it should have been.
As part of a clinical trial 80-year-old Barbara Curtis, who was being treated for acute myeloid leukaemia, should have been given a dose of 20 milligrams of chemotherapy drug cytarabine to take twice daily.
But a mistake by a junior medic meant she was actually given a dose of 100mlg.
Despite the dosage being checked by two staff members, the error was not spotted and Mrs Curtis took 900mlg of it across nine doses for the next four-and-a-half days before the error was flagged up.
Days later Mrs Curtis was admitted to hospital and she died around a fortnight after that due to bronchial pneumonia.
The Royal Bournemouth and Christchurch Hospitals Trust (RBCHT) has apologised publicly to Mrs Curtis’ family. It stressed it has since made improvements to its procedures.
On Monday RBCHT appeared at Bournemouth Crown Court for sentencing having admitted at an earlier hearing one count of supplying Mrs Curtis with a medical product which was not of the nature or the quality demanded.
It pleaded guilty on a basis in which it apologised and acknowledged her family was caused “distress and upset”.
Prosecutor Robin Leach said the problems concerned the hospital’s Aseptic Pharmacy Unit (APU) in December 2017 during a clinical medical trial instigated by Cardiff University.
A junior technician in the APU made a basic error of giving an incorrect dose of the drug to Mrs Curtis, as well as amending an associated worksheet, Mr Leach said.
Those errors were compounded by two other staff members failing to spot them or undertake checks correctly.
The syringes used to administer the dosage were prepared by an assistant technician, while the third “gatekeeper” in the process was an experienced locum pharmacist – who had been employed to plug potential staff shortages – but he failed to properly check the medication or worksheet.
When a second batch of the medication was prepared in the APU, Mr Leach said the clinician and the locum pharmacist both failed to spot the dosage was excessive for a second time.
Mr Leach explained Mrs Curtis first took the medication on 28th December 2017, and when the error was spotted it aroused huge anger from her family, including her husband Peter.
Days later on 4th January he rang the hospital to report his wife was ill, and she was admitted to the emergency department suffering with a chest infection and anaemia.
‘The trust is very sorry for the distress’
Mrs Curtis died on 17th January 2018 – the cause being given as bronchial pneumonia.
A subsequent report looking into whether the overdose contributed to her death said that possibility “could not be answered categorically”, the prosecutor stated.
The Medicines and Healthcare products Regulatory Agency (MHRA) launched an investigation and found issue with practices in the ACU, Mr Leach said. When investigators attended the premises the low-dosage medication was not in the correct drawer.
There had also been suggestions the department at the time was understaffed – although it was said that in no way contributed to Mrs Curtis’ death.
Mr Leach revealed in 2013 there was an incident in the unit where a syringe had been incorrectly prepared and an audit of the pharmacy in 2017 described it as working “over capacity”.
Prior to the clinical trial an internal report highlighted the APU as “at risk”, the prosecutor continued, but that had not been reported to the clinical trial sponsors.
Defending, trust barrister James Leonard said the mistakes made were “fundamental and rudimentary”.
But he highlighted how RBCHT had investigated the incident and responded by putting together a “detailed action plan” that addressed the mistakes made – which he handed to the judge.
Staff had been provided refresher training, while the APU department had gained an additional pharmaceutical employee and a technician, so was now “at full strength”, Mr Leonard said.
The trust did not want to blame staff, he said, but he pointed out it did have systems in place and could do little when human errors occurred, although it had to take responsibility for them.
“There is a system in place – it just wasn’t sufficiently adhered to or implemented,” Mr Leonard said. “The word ‘systematic’ is often bandied around without any definition; what it tends to mean is a problem with the system in place as inadequate or no system to address a particular risk – but I say neither of those applies in this case.”
The three staff members involved made statements and none expressed concerns about staff shortages, while RBCHT was now well-known for having an open-cultured approach that encouraged whistleblowers or staff with concerns to speak out, Mr Leonard said.
He referred to the mistake made by the pharmacist as “inexplicable”, adding that the individual was a member of the General Pharmaceutical Council who had experience working in a trust setting.
Sentencing, Judge Brian Forster said: “The correct preparation and dispensing of medication is essential for patients’ benefit. It’s important that those who bear the duty and who may often be working in a busy environment recognise the importance of what they do and those they care for.”
At the “most basic level”, Judge Forster said the case concerned taking “responsibility for repeated errors” made by staff. He fined RBCHT £45,000 and ordered it pay £5,000 court costs.
In a statement, the RBCHT said: “During the course of a medical trial in 2017, RBCH NHS Foundation Trust gave a patient medication of a higher dose than had been prescribed and while this was within prescriptive guidelines, it was not intended that the patient received this dose.
“The trust is very sorry for the distress this has caused the patient and their family.
“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.”