Development and validation of the national High-Risk Medicine Classification using the Delphi method.

Background: High-risk medicines (HRMs) are medicines that have a higher risk of causing severe consequences for the patient when used in error.

Objective: This study aimed to develop a Finnish High-risk Medicine Classification (FIN-RiskMeds) to support healthcare professionals in HRM risk management.

Methods: The development of FIN-RiskMeds was coordinated by the Finnish Medicines Agency (Fimea) using the Delphi consensus method. The preliminary list of HRMs was based on an inventory of existing HRM lists, literature, and the expertise of the working group (WG). A three-round Delphi survey with 60 panelists and a public hearing were used to achieve consensus on the content of the classification. The consensus threshold was set at 70 %.

Results: The expert panel agreed on 42 medicines or medicine classes (later 'items') to be included in the FIN-RiskMeds. A 70 % consensus was reached on 30 out of 60 items in Round 1 and on 13 out of 31 items in Round 2a. The strongest consensus was reached for warfarin, methotrexate, and opioids. The serious consequences and key risks of medicines and the medication process were described for all items after Rounds 2b and 3. Based on the WG's decision after a public hearing, the final classification consists of 38 items.

Conclusion: This study produced expert consensus-based classifications of HRMs and a comprehensive list of their key risks. HRMs and their risks should be identified across health and social care to prevent potential medication errors. It is necessary to develop medication processes to minimize the risks associated with HRMs.