Electronic Prescribing and Medicines Administration Systems: report adverse incidents on a Yellow Card
We ask healthcare professionals to be vigilant to adverse incidents involving software, apps, and artificial intelligence (AI) as medical devices and to report incidents to us via the Yellow Card scheme.
Advice for healthcare professionals:
- be alert for potential errors occurring when using Electronic Prescribing and Medicines Administration Systems (ePMAS) which may lead to patient harm, especially errors involving the dosing of medicines or vaccines
- ePMAS and other software, apps and artificial intelligence intended to be used for a medical purpose are likely to be medical devices and any adverse incidents involving these devices should be reported to the MHRA’s Yellow Card scheme
- use the new digital Yellow Card report form to inform us about adverse incidents involving software as a medical device
Background
The term ‘medical device’ covers a broad range of products that are used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.
Electronic Prescribing and Medicines Administration Systems (ePMAS) are used widely across the UK healthcare system and may qualify as medical devices. Where necessary, they should be CE or UKCA marked to demonstrate conformity with the UK Medical Device Regulations (2002).
The MHRA has been undertaking work with manufacturers of these ePMAS devices following the publication of the Healthcare Safety Investigations Board (HSIB) report on weight-based medication errors in children. This review was conducted following a case in which a child received a 10-times overdose of an anticoagulant medicine due to errors in the prescription, dispensing and administration processes. The HSIB noted that, although ePMAS are considered an effective way to reduce medication errors they may cause new technology-related errors.
We ask for any potential errors with ePMAS to be reported to us, to help us work with manufacturers to reduce these risks.
Report incidents on a Yellow Card
ePMAS products and other software, apps and Artificial Intelligence intended to be used for a medical purpose are likely to be medical devices. The MHRA has developed a version of the digital Yellow Card report form for suspected adverse incidents involving software as a medical device. Please select ‘standalone software and medical device apps’ in the drop-down menu to access the software medical device form.
There are specific arrangements for healthcare professionals to follow in each of the devolved administrations.
Healthcare professionals should report incidents to:
- in England and Wales to the Yellow Card scheme or via the Yellow Card app
- in Scotland to NHS National Services Scotland online incident reporting system and their local incident recording system
- in Northern Ireland to the Northern Ireland Adverse Incident Centre and their local incident recording system
Healthcare professionals should continue to report suspected adverse drug reactions to the Yellow Card scheme. Patients and caregivers can also report suspected adverse drug reactions and medical device incidents directly to the Yellow Card scheme.
The public consultation on how the MHRA communicates medicines and medical devices safety information to healthcare professionals is now open. The consultation is a unique opportunity to influence future MHRA safety communications and safety reporting systems so please encourage all healthcare professionals to complete the survey. The deadline for responses has been extended to 11.45pm on Tuesday 31 January.
Article citation: Drug Safety Update volume 16, issue 6: January 2023: 3.