A cancer patient has died and three others have been hospitalised after they were administered unlicensed versions of chemotherapy by Sciensus, a private company paid millions by the NHS to provide essential medication, the Guardian can reveal.
Three health regulators have launched inquiries into the incident, according to people familiar with the matter. It was caused by an issue at the firm’s medicines manufacturing unit.
In a statement, Sciensus confirmed an “isolated incident” had “affected four patients” and that it was “deeply saddened” that one of them had died.
Sciensus offered its “sincere condolences” to the family and friends of the patient who died, and is conducting a thorough investigation, it added.
The revelation follows a series of articles in the Guardian exposing how NHS patients have repeatedly been put at risk of harm by the botched provision of medicines by Sciensus.
The four patients received unlicensed versions of cabazitaxel, a licensed chemotherapy used to treat prostate cancer. Cabazitaxel blocks the growth of cancer and is typically administered via a drip into a patient’s bloodstream.
The versions administered to the patients differed from the licensed product and therefore were considered unlicensed medicines. Sciensus is authorised to manufacture these by the Medicines and Healthcare products Regulatory Agency (MHRA), which has launched an investigation into the incident.
Unlicensed medicines can be used to treat patients in certain circumstances. The incident affected only unlicensed versions of the chemotherapy that were manufactured by Sciensus to meet the individual needs of specific patients, according to people familiar with the matter. There are no concerns with licensed cabazitaxel products.
Sciensus is required to comply with official standards to ensure the quality of the products it produces and the protection of public health. Breaches of these standards can result in the MHRA suspending or removing a company’s licence.
“Patient safety is our highest priority,” said Dr Alison Cave, the MHRA’s chief safety officer. “We are urgently investigating this issue and we will take any necessary regulatory measures to ensure patients are protected.
“We ask healthcare providers to report any suspected side-effects or medication errors to the Yellow Card scheme website and their local risk management system.”
Cave added that she was saddened by the death of the patient and offered her deepest sympathies to their family. The MHRA said it could not provide any further details of the patients while its investigation was being carried out.
A spokesperson for the Care Quality Commission (CQC) said: “We are aware of these extremely serious incidents and are working closely with the General Pharmaceutical Council and Medicines and Healthcare products Regulatory Agency who have oversight of the regulation of medicines delivery and safety.
“Our thoughts are with those affected and their families and loved ones. We will not hesitate to take any action necessary within our remit to make sure people using services are safe.”
The CQC regulates some parts of the services provided by Sciensus, but other aspects are regulated by other agencies, including the MHRA and the General Pharmaceutical Council (GPhC).
Duncan Rudkin, the chief executive of the GPhC, said: “We wish to extend our sympathies to the patients and families who have been affected. We take all matters relating to patient safety extremely seriously.
“We are working closely with the other regulators involved in investigating this incident and have statutory powers to take action within our remit, in cases where there is serious risk to patients.
“Concerns over patient safety relating to pharmacists, pharmacy technicians or pharmacies should always be reported to us so they can be fully investigated.”
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. On its website, it promises patients “safe provision and application of high-end medicines in the home”.
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: “Sciensus can confirm that an isolated incident at our medicine manufacturing unit in April has affected four patients.
“We are deeply saddened that one of the patients has since died and wish to offer our sincere condolences to the patient’s family and friends.
“As soon as the incident was discovered, we immediately contacted the regulators, the patients and their doctors. We are currently conducting a thorough investigation into the incident and are working with the regulators.”
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