- Trust had to find external supplier after criticism from MHRA
- Managed or outsourced service expected to take over
- Aseptics production likely to increase
An acute trust is to abandon manufacturing its own radiopharmaceuticals after a regulator said it needed more quality improvement work and better facilities.
The Royal Surrey Foundation Trust has been sourcing radiopharmaceuticals — used in cancer treatment — from an external supplier after a Medicines and Healthcare products Regulatory Agency inspection found “critical deficiencies” in its manufacturing unit and suspended its production licence in April.
In its October board papers, the trust said it has now decided to go out to tender for a managed or outsourced service for radiopharmacy services.
Radiopharmaceuticals are commonly used for diagnosis and treatment of cancer and are radioactive. The Royal Surrey manufactured radiopharmaceuticals for its own cancer centre, as well as outreach services held at other trusts, such as Ashford and St Peter’s Hospitals FT and Frimley Health FT, under a licence from the MHRA.
The MHRA first raised concerns about the unit in October 2018, including staff shortages and their impact on quality systems and documentation. This led to a partial suspension of the trust’s licence to manufacture some products, and delays to patients starting cancer trials.
At the most recent inspection, the MHRA said the unit would not be fully compliant until March 2020 and made additional recommendations about the physical infrastructure of the unit.
The trust’s aseptics unit — where production of other, non-cancer medicines had also been partially suspended — has been reinspected and the MHRA has asked for a plan for increasing production of these medicines.
In a statement, the trust said: “Having reviewed the scale of the estate and quality improvement work that that would be required to return to a compliant status, the trust has taken the decision to go out to tender for a managed or outsourced service while it considers longer term options.
“This process is not yet complete, so we are not in a position to add any further comments at this point.”
The trust is also considering outsourcing aftercare for 293 patients to a local private hospital this winter. Board papers showed the patients could be treated at the Royal Surrey but then moved to the nearby Nuffield Health hospital for post-op care. This would free up four beds for use between November and March.
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