Scientific Publications by FDA Staff

Am J Health Syst Pharm 2016 Apr 15;73(8):576-85

Recommendations for selecting drug-drug interactions for clinical decision support.

Tilson H, Hines LE, McEvoy G, Weinstein DM, Hansten PD, Matuszewski K, le Comte M, Higby-Baker S, Hanlon JT, Pezzullo L, Vieson K, Helwig AL, Huang SM, Perre A, Bates DW, Poikonen J, Wittie MA, Grizzle AJ, Brown M, Malone DC

PURPOSE: Recommendations for including drug-drug interactions (DDIs) in clinical decision support (CDS) are presented. SUMMARY: A conference series was conducted to improve CDS for DDIs. A work group consisting of 20 experts in pharmacology, drug information, and CDS from academia, government agencies, health information vendors, and healthcare organizations was convened to address (1) the process to use for developing and maintaining a standard set of DDIs, (2) the information that should be included in a knowledge base of standard DDIs, (3) whether a list of contraindicated drug pairs can or should be established, and (4) how to more intelligently filter DDI alerts. We recommend a transparent, systematic, and evidence-driven process with graded recommendations by a consensus panel of experts and oversight by a national organization. We outline key DDI information needed to help guide clinician decision-making. We recommend judicious classification of DDIs as contraindicated and more research to identify methods to safely reduce repetitive and less-relevant alerts. CONCLUSION: An expert panel with a centralized organizer or convener should be established to develop and maintain a standard set of DDIs for CDS in the United States. The process should be evidence driven, transparent, and systematic, with feedback from multiple stakeholders for continuous improvement. The scope of the expert panel's work should be carefully managed to ensure that the process is sustainable. Support for research to improve DDI alerting in the future is also needed. Adoption of these steps may lead to consistent and clinically relevant content for interruptive DDIs, thus reducing alert fatigue and improving patient safety.