A private health company paid millions by the NHS has failed to fix safety defects that led to the death of a cancer patient, the Guardian can reveal.
Three patients were hospitalised and a fourth died when they were given the wrong doses of a powerful chemotherapy drug after a catastrophic IT failure at the medicine manufacturing unit of Sciensus in April this year.
The incident, first revealed by the Guardian in July, prompted an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA). Its inspectors found “significant deficiencies” at the Sciensus manufacturing facilities and ordered the partial suspension of its manufacturing licence.
However, six months after the IT blunder, Sciensus has not fixed the problems identified by the regulator, according to people familiar with the matter. As a result, the suspension of its licence – originally due to be lifted last month – has been extended until July next year.
Sciensus is the UK’s biggest provider of medicines services to NHS and private patients at home. It is contracted by the NHS and other organisations to deliver and administer medicines to more than 200,000 people with conditions such as heart disease, diabetes, dementia, HIV and cancer.
“The partial suspension period has been extended for nine months and the MHRA’s inspection action group continues to oversee the company’s work to resolve the identified deficiencies,” a spokesperson for the MHRA told the Guardian.
“The initial licence partial-suspension period could only be for a maximum of three months and, as the deficiencies have not yet been fully resolved, the group recommended that the licence should remain partially suspended.”
The suspension was issued in accordance with regulation 28 of the 2012 Human Medicines Regulations. This gives the MHRA the power to act where it appears that, in the interests of safety, a company’s licence should be suspended.
In a statement, Sciensus said it was working to resolve the problems. “We want to assure all our patients that their medicines are safe,” a spokesperson added.
The revelation follows a series of articles in the Guardian exposing how patients were repeatedly put at risk of serious harm due to the botched provision of medicines by Sciensus.
Sciensus gave the four patients unlicensed versions of cabazitaxel, a licensed chemotherapy medicine used to treat prostate cancer, according to people familiar with the matter. Cabazitaxel is typically administered by drip into a patient’s bloodstream.
Sciensus is allowed to give certain patients unlicensed medicines, when there are no licensed medicines that are available or capable of meeting their clinical needs.
However, the unlicensed version of cabazitaxel was set up with the incorrect strength in the company’s IT systems, according to people familiar with the matter. The blunder resulted in the four patients receiving the wrong dose.
“Our investigation, and that of the company, confirmed the issues were related to a specific element of their IT system,” a spokesperson for the MHRA said. “The company needs to implement the necessary corrective actions to address the identified deficiencies before the suspension can be lifted.”
A Sciensus spokesperson said: “The issue was contained to the setup of a small amount of new medicine, and there have been no new products set up on our system since the partial suspension was put in place. We will not be setting up new products until the MHRA completes their reinspection to their satisfaction.
“We continue to work closely with MHRA to resolve the issue to the agreed timescales and are confident that the suspension will be removed at the next reinspection.”
The MHRA has refused a request from the Guardian for a copy of the report detailing its investigation into Sciensus.
“The MHRA refrains from disclosing information related to its inspections and investigations while it oversees a return to compliance,” a spokesperson for the MHRA said. “This non-disclosure is based on an exemption in the 2000 Freedom of Information Act.”
In April, a Guardian investigation revealed serious and significant concerns among patients, clinicians and health groups about Sciensus. Subsequent articles have exposed how sick children and adults suffered avoidable harm as a result of failings by the company.
In May, the Guardian disclosed that the chief executive of Sciensus, Darryn Gibson, was warned three years ago that the company was putting patients at risk. He was told in 2020 that patients were being left dangerously exposed to internal bleeding as a result of missing, incomplete or inaccurate deliveries.
In June, the House of Lords public services committee launched an inquiry into Sciensus and other private companies paid millions by the NHS to provide homecare medicines services. Its final report is due later this month.
