RESUMO
OBJECTIVE: Trigger tool method (TTM) is an active surveillance method for adverse drug reaction (ADR) monitoring. The study aimed to evaluate TTM for ADR monitoring in indoor patients of the surgery department. MATERIALS AND METHODS: This prospective, observational study was conducted at the Department of Surgery of a Tertiary Care Teaching Hospital in Gujarat. Patients of either gender and more than 18 years of age admitted to two selected surgery units were enrolled with prior informed consent. Preliminary trigger tool list (PTTL) comprising 13 drug triggers (DTs), 13 patient triggers (PTs), 9 laboratory triggers (LTs), and 12 surgical module triggers (STs) were used. Patients were followed up till discharge to monitor the occurrence of triggers and adverse events. RESULTS: A total of 400 patients were included (male: female ratio of 2.3:1; mean age: 43.07 ± 16.4 years; and mean length of hospital stay: 5.75 ± 3.12 days). Of 400 patients, triggers were present in 359 patients (89.75%) and no trigger was observed in 41 patients (10.25%). Of the 47 triggers in PTTL, 24 triggers were observed 1155 times, of these 14 triggers lead to the detection of 49 ADRs in 43 patients. The rate of adverse drug events was 12.25/100 patients. DT was the most common trigger identified (81.64%). Positive predictive values (PPV) for PTs, STs, DTs, LTs were 26.88%, 23.07%, 10.3%, and 5.55%, respectively. The comprehensive PPV of PTTL was 11.97%. Modified trigger tool list consists of 14 triggers. CONCLUSION: TTM is an effective method of ADR monitoring in the surgery department. An awareness of TT helps better detection of ADRs.