Medicines and Healthcare products Regulatory Agency
HSSIB recommends that the Medicines and Healthcare products Regulatory Agency ensures that:
- routes for manufacturers and healthcare organisations to engage with them are clear and accessible
- it reviews and provides further guidance and clarification on when electronic prescribing and medicines administration (ePMA) software should be considered a medical device.
This will support how ePMA software can be appropriately classified and regulated to improve patient safety.
Department of Health and Social Care |
NHS England
HSSIB recommends that NHS England/Department of Health and Social Care establishes a national framework for core electronic prescribing and medicines administration (ePMA) safety. This will provide a clear set of minimum patient safety requirements, helping to reduce unwarranted variation in the safety of ePMA functionality.
Department of Health and Social Care |
NHS England
HSSIB recommends that NHS England/Department of Health and Social Care develops an external assurance framework for information standards notices relating to electronic prescribing and medicines administration (ePMA). This is to reduce unwarranted variation and improve patient safety through expert-led assurance processes.
Department of Health and Social Care |
NHS England
HSSIB recommends that NHS England/Department of Health and Social Care provides additional support to acute hospital trusts, in relation to:
- supporting healthcare providers to access digital clinical safety knowledge, capacity and capability
- integrating digital clinical safety and patient safety, including the associated terminology
- supporting robust assurance of whether electronic prescribing and medicines administration (ePMA) manufacturers comply with relevant standards in order to be considered for inclusion on an NHS procurement framework.
This will support effective decision making and oversight by acute hospital trusts and reduce unwarranted variation in the understanding of, and approach to, adopting ePMA.
Care Quality Commission
HSSIB recommends that the Care Quality Commission reviews the sector-level assessment frameworks it is developing to include assurance of ongoing compliance with the digital clinical safety standard (DCB0160) for electronic prescribing and medicines administration (ePMA) software. This will help to ensure oversight of ePMA functionality to improve patient safety.