Trust postpones trials after regulator partially suspends licence

The Medicines and Healthcare Products Regulatory Agency partially suspended Royal Surrey County Hospital Foundation Trust’s licence to manufacture some medicines and told it to stop any new aseptic work – where medicines are produced or repackaged in a sterile environment for specialist use – following an inspection last October.

The inspection identified areas for improvement including staffing levels, and their impact on quality systems, and documentation of some cancer medicines. 

Because of the suspension, the trust has had to refer some patients to neighbouring centres to access trials and shift its focus to other trials which do not require it to manufacture products.

Royal Surrey’s pharmacy aseptic unit manufactures medicines for the trust’s St Luke’s Cancer Centre – which has outreach services at Ashford and St Peter’s Hospitals and Frimley Park Hospital – some non-cancer medicines for other specialties such as ophthalmology, gastroenterology and paediatrics, and other medicines for Ashford and St Peter’s Hospitals FT.

Royal Surrey said it could not quantify the income lost by not being able to start trials, but the financial impact was likely largely mitigated by channelling patients towards unaffected, existing studies. 

The trust has said it is addressing these issues and the suspension had already been lifted on some aseptic products. It is also obtaining some medicines from third party suppliers.

Bob Peet, the trust’s chief operating officer, said it had redoubled recruitment efforts, brought in additional specialist interim staff, invested in upgrades to the physical environment and undertaken a review into systems and processes.

Mr Peet said: “The trust takes these concerns extremely seriously and recognises the importance of these support services to our patients, clinical teams and research partners.

“We would like to reassure patients, the public and our partners that we believe there is little or no impact on our excellent cancer care and that we are doing all we can and taking the necessary actions to put these things right.”

Royal Surrey County Hospital FT has also been served with two improvement notices by the Health and Safety Executive. These require it to introduce a surveillance system to detect skin problems for nurses and healthcare assistants, and to have adequate arrangements to mitigate health risks, particularly from occupational dermatitis and blood-borne viruses.

The trust said there is no evidence of harm having occurred with blood-borne viruses and it has shared details of a plan to ensure appropriate measures are in place with the HSE.