Britain’s health regulator has partly suspended the manufacturing licence of Sciensus, a private company paid millions by the NHS to provide vital medicines, after the death of a cancer patient who was given the wrong dose of chemotherapy.
The Medicines and Healthcare products Regulatory Agency (MHRA) said it had taken “immediate” action under regulation 28 of the Human Medicines Regulations 2012 law “where it appears to the MHRA that in the interests of safety the licence should be suspended”.
The MHRA found “significant deficiencies” in standards at Sciensus during an investigation triggered by the death of one patient and the hospitalisation of three others. The incident was first reported by the Guardian earlier this month.
All four patients were administered “incorrect” doses of an unlicensed version of cabazitaxel, a licensed chemotherapy used to treat prostate cancer, according to people familiar with the matter.
Sciensus was authorised by the MHRA to manufacture an unlicensed version of the medicine. This can sometimes be necessary to treat specific patients with specialised requirements. However, an IT blunder led to four patients being given the “incorrect strength” of the unlicensed versions.
The suspension follows a series of articles in the Guardian exposing how NHS patients have repeatedly been put at risk of serious harm by the botched provision of medicines by Sciensus.
Dr Laura Squire, the MHRA’s chief healthcare access and quality officer, said: “After conducting an inspection of Sciensus manufacturing facilities, we have partially suspended their manufacturing licence due to significant deficiencies in relation to good manufacturing practice (GMP) standards.
“This immediate partial suspension is a result of identified concerns with one aspect of the setup of their IT system and will remain in place until corrective actions are implemented.”
Squire said there was no evidence to suggest any of Sciensus’s other medicines were unsafe or of unacceptable quality. “We are in regular contact with the company and continue to investigate this issue,” she added. “We will take any further regulatory measures as needed to ensure patients are protected.”
Sciensus is the UK’s biggest private provider of homecare medicines services to NHS and private patients. It is contracted by the NHS and other organisations to deliver and administer vital medicines and medical items to about 200,000 patients with complex conditions, including cancer, heart disease, diabetes, dementia and HIV.
In April, a Guardian investigation revealed serious and significant concerns of patients, clinicians and health groups about Sciensus. Subsequent articles have exposed how sick children and adults have suffered avoidable harm as a result of failings by the company.
In May, the Guardian disclosed that the chief executive of Sciensus was warned three years ago that the company was putting patients at risk. Darryn Gibson was told in 2020 that patients were being left dangerously exposed to internal bleeding with little or no treatment at home as a result of missing, incomplete or inaccurate deliveries.
In June, the House of Lords public services committee began a formal inquiry into private health companies providing homecare medicines services. The inquiry is continuing.
A Sciensus spokesperson said: “As soon as the incident was discovered, we identified the issue and immediately advised the MHRA. The MHRA has conducted an inspection and partially suspended our new product setup. This does not affect existing products, which will continue as normal.”
