Finding into death of Ian Fraser

Contributing factors

• Poor usability design of electronic medical records system (mode confusion displaying inpatient and discharge medications on same screen)
• Inadequate visual differentiation between inpatient and outpatient medication icons on computer monitor
• Electronic medical record lack of alert system for duplicate drug class prescriptions
• Confusing EMR terminology (ordered vs prescribed, discontinued vs suspended vs withheld)
• Inadequate EMR training on medication order status modification
• Prescribing error occurring out-of-hours when EMR support reduced
• Lack of standardisation and regulation of EMR software design across health services

Coroner's recommendations

1. Recommend the Therapeutic Goods Association (TGA) reassign the risk-level of EMRs (specifically the electronic prescribing component) to require assessment of and compliance with usability standards, developed in conjunction with key stakeholders including the Australian Commission of Safety and Quality in Health, state health departments, and relevant overseas agencies
2. Recommend the TGA develop pathways for users to report adverse events involving software as a medical device (including EMRs), similar to existing pathways for medical devices, medicines and vaccines
3. Recommend the TGA assess EMR vendor improvements in response to incidents for usability and share findings with other health services
4. Recommend the TGA develop promotional material for adverse event reporting pathways similar to those existing for medical devices, medicines and vaccines
5. Recommend Safer Care Victoria promote the TGA's adverse event reporting pathway to both health-service safety departments and clinicians