Development and validation of explicit criteria to identify potentially inappropriate prescribing for adults with type 2 diabetes mellitus

Background: Early detection and timely resolution of potentially inappropriate prescribing (PIP) prevents adverse outcomes and improves patient care. An explicit tool specifically designed to detect PIP among people with Type 2 Diabetes Mellitus (T2DM) has not been published. Objectives: This study aims to develop and validate the Inappropriate Medication Prescribing Assessment Criteria for Type 2 Diabetes Mellitus (IMPACT2DM); an explicit tool that can be used to identify PIP for adults with T2DM. Methods: Current national and international guidelines for the management of T2DM and drug information software programs were used to generate potential items. The content of the IMPACT2DM was validated by 2 consecutive rounds of Delphi method. Physicians and clinical pharmacists experienced in providing care for people with diabetes and authors of selected diabetes guidelines were invited to participate in the Delphi panel. Consensus was assumed if 90% (first round) and 85% (second round) of expert panelists showed agreement to include or exclude an item. Results: A total of 95 potential items were generated from selected diabetes guidelines and drug information software programs. After the first Delphi round 27 items had >= 90% agreement and were included in the tool; 19 items were considered not PIP and were excluded from the tool. The second round contained 49 items; of these 43 were included and 6 were excluded from the tool. The final IMPACT2DM contains 70 items categorized by type of PIP and arranged in terms of medical conditions and medication classes. IMPACT2DM can be applied using information on medical charts and requires minimal or no clinical knowledge to assess quality of diabetes care and improve medication selection. Conclusions: IMPACT2DM has been developed from current quality evidence and undergone content validation. It is the first explicit tool specifically designed to identify PIP for adults with T2DM.