The report comes at a time of significant national focus on digital transformation, including the drive towards a single patient record as part of the 10 Year Health Plan for England. While this presents opportunities to improve patient care, we have warned that the current framework does not adequately support safe adoption of digital technologies.
Challenges for NHS hospital trusts
Electronic prescribing and medicines administration (ePMA) software is widely used to prescribe and record medication given to patients during hospital stays. While ePMAs can reduce certain types of medication error, our investigation found there are no core national patient safety standards guiding their design or procurement. This has led to wide variation in how they function, creating challenges for NHS staff when prescribing and administering medication to patients.
There are legally mandated NHS standards for digital clinical safety and interoperability that apply to software, including ePMAs. However, the report identifies unwarranted variation in how NHS hospitals comply with these standards, alongside a lack of national oversight or assurance to ensure consistent implementation.
The investigation also highlights confusion about the roles and responsibilities of national bodies, including the Care Quality Commission (CQC) and the Medicines and Healthcare products Regulatory Agency (MHRA), in overseeing patient safety in this area. This lack of clarity contributes to gaps in accountability and assurance.
We found that patient safety learning about ePMAs is not consistently identified or shared across the healthcare system. Instead, learning often relies on informal networks, meaning important safety insights may not reach all organisations or inform system design and procurement decisions.
The responsibility for managing these safety risks largely falls to individual NHS hospital trusts. However, many trusts do not have the necessary resources, skills or support to robustly assess and manage the safety risks associated with ePMAs.
Investigator's view
Clare Crowley, Senior Safety Investigator at HSSIB, said: “ePMA is a core component of modern healthcare, but its safety depends on how it is designed, implemented and overseen. Our patient safety investigation highlights the need for greater clarity, consistency and national coordination so that ePMA software reliably supports safe care for patients.
“In the absence of this, NHS hospital trusts are being asked to carry the responsibility of assuring themselves that the ePMA software they choose to use is safe. This is a complex and resource intensive task. Not all trusts have the capacity, capability or support they need to do it robustly.
“As the NHS continues its rapid shift towards digital care and a single patient record, it is essential that patient safety is built in from the outset, rather than relying on individual organisations to identify and manage the risks.”
Safety recommendations
We have made a series of safety recommendations to national bodies, including calls to:
- develop a national framework for core ePMA safety
- improve regulatory clarity on when ePMAs should be classified as a medical device
- introduce national assurance mechanisms for digital clinical safety and interoperability standards relating to ePMA
- provide additional support to NHS acute hospital trusts to improve access to digital clinical safety capability and capacity
- support the integration of digital safety and patient safety across the healthcare system.
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