- Aseptic unit was closed after a water leak in January
- Royal Surrey faces £3m risk as it turns to external suppliers
- It says patient impact is “minimal” but some research studies are affected
A trust has been forced to close its sterile drugs production unit due to “increasing infrastructure weakness”, risking a £3m annual bill for purchasing the medicines.
The Royal Surrey Foundation Trust — which runs a large cancer service — has resorted to buying pre-prepared cancer drugs from alternative suppliers since its aseptic unit closed in January.
Hospitals use aseptic units to manufacture injectable chemotherapy drugs and other medicines in a sterile environment, often preparing them for specific patients who are booked in for treatment. The cancer-killing drugs often have short shelf lives, meaning on-site preparation is frequently used to reduce waste and expense.
In a statement, Royal Surrey FT said its unit had been experiencing “increasing infrastructure weakness” last year. A water leak in a neighbouring area led to it being closed in January.
The Medicines and Healthcare Products Regulatory Authority confirmed the unit’s manufacturing licence was suspended in March after an inspection identified “serious deficiencies”. The suspension will last until September, unless the trust can show it has made improvements.
A trust board paper last month said it has a £3m risk related to buying pre-prepared medicines from external suppliers and has seen a £130,000 increase in aseptic waste.
The trust said the issue should have a “minimal” impact on patients but was affecting some research studies.
It told HSJ it was considering several options to address the problem but would not elaborate on what they were. While many NHS trusts run aseptic units, some buy in ready-prepared drugs under arrangements with private companies, and some work in partnership with external firms — who can invest in facilities and technology — to provide on-site services.
The NHS spends around £4bn a year on injectable medicines. In 2020, Lord Carter of Coles proposed a hub and spoke system, with regional hubs, potentially run by companies, producing large-volume standardised products, while spokes — in sites like cancer centres — focusing on bespoke or very short-lived medicines.
Earlier this year, another aseptic unit in the South East was found to have three “critical deficiencies” after an inspection by the NHS Specialist Pharmacy Service. This raised issues including a leaking roof, unsuitable storage conditions and the risk of contamination at the unit at East Kent University Hospitals FT.
Source
Board papers and statements
Source Date
May and June 2024
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