Establishing a Trigger Tool Based on Global Trigger Tools to Identify Adverse Drug Events in Obstetric Inpatients in China

Background: To examine the performance of an obstetric trigger tool, compared with the spontaneous reporting system (SRS) and global trigger tools (GTTs), in detecting adverse drug events (ADEs) experienced by obstetric units, and to assess the utility and value of the obstetric trigger tool in identifying ADEs of obstetric inpatients. Methods Our obstetric triggers were established on the basis of a literature review, retrospective obstetric ADE investigations, trigger extraction and revision, and expert investigations. We conducted a retrospective study to identity ADEs in 300 obstetric inpatient records at the Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital from June 1 to September 30, 2018. Results Through two rounds of expert investigation, we established 39 preliminary triggers that comprised four modules (12 laboratory tests, nine medications, 14 symptoms, and four outcomes). Three hundred medical records were reviewed by using the obstetric triggers with 49 cases of ADE detected, and the incidence of ADE was 16.33%. Among the 39 obstetric triggers, 22 triggers were positive (56.41%) and 11 of them detected ADE. The positive predictive value (PPV) was 36.36%, and the number of ADEs/100 patients was 16.33 (95% CI, 4.19–17.81). The ADE detection rate, positive trigger rate, and PPV value for the obstetric triggers were significantly augmented, confirming that the obstetric triggers were more specific and sensitive than SRS and GTT. Conclusion The obstetric triggers were proven to be sensitive and specific in the active monitoring of ADE for obstetric inpatients, and this could constitute a reference for ADE detection of obstetric inpatients at medical institutions.