A Study to Evaluate the Trigger Tool Method (TTM) in Detection, Monitoring, and Reporting of Adverse Drug Reactions (ADRS)
Authors/Creators
- 1. Associate Professor, Department of Pharmacology, Shree Narayan Medical Institute and Hospital, Saharsa, Bihar, India
- 2. Assistant Professor, Department of Pharmacology, Gouri Devi Institute of Medical Sciences and Hospital, Durgapur, West Bengal, India
Description
Aim: The aim of the present study was to evaluate the trigger tool method (TTM) in detection, monitoring, and reporting of adverse drug reactions (ADRs). Methods: This was prospective, interventional, single center study conducted at Shree Narayan Medical Institute and Hospital, Saharsa on a permanent basis, posted in Department of Medicine. A total 650 patients were admitted during the study period in the respective medicine unit. Results: Of the 650 patient cases, triggers were observed in 80 patients (12.30%). Among 95 patient’s cases with triggers, 60 (75%) patients did not suffer from an ADR, while 20 (25%) suffered one or more ADRs. A list of 17 triggers was given to 30 nurses for identification of ADEs. List of 17 triggers consists of 9 DT, 1 LT and 7 PT. Of these 17 triggers, 14 triggers were identified by nurses in the study population and 3 triggers were not observed. These 14 triggers were noticed 130 times, with an average 12.53 triggers observed per patient. These included DT (100 times), LT (0 times) and PT (30 times). Triggers were identified for a minimum once and maximum 3 times in 95 patients. Of the various triggers observed, 7 drug triggers and 4 patient triggers were related to ADRs. Hence 11 triggers (64.70%) were positive (related to ADRs), out of total 17 triggers under evaluation. A total 24 ADRs were observed in 25 inpatients during study period. One or more triggers were observed in these patients. The commonly detected ADRs were gastritis, thrombophlebitis, diarrhea and vomiting. Chills, cough, headache, joint pain, metallic taste, pruritus and weight gain were also observed. Conclusion: The reporting system is operational at the study site and ADRs are being reported using a standard form. Patients recovering from the reactions following the withdrawal of the suspected drug, and the majority of ADRs were mild. TTM can be used as an add‑on tool to existing methods like spontaneous method for the health‑care professionals for better detection of ADRs in the pharmacovigilance program. However, further research is required to explore the feasibility and acceptability of TTM.
Abstract (English)
Aim: The aim of the present study was to evaluate the trigger tool method (TTM) in detection, monitoring, and reporting of adverse drug reactions (ADRs). Methods: This was prospective, interventional, single center study conducted at Shree Narayan Medical Institute and Hospital, Saharsa on a permanent basis, posted in Department of Medicine. A total 650 patients were admitted during the study period in the respective medicine unit. Results: Of the 650 patient cases, triggers were observed in 80 patients (12.30%). Among 95 patient’s cases with triggers, 60 (75%) patients did not suffer from an ADR, while 20 (25%) suffered one or more ADRs. A list of 17 triggers was given to 30 nurses for identification of ADEs. List of 17 triggers consists of 9 DT, 1 LT and 7 PT. Of these 17 triggers, 14 triggers were identified by nurses in the study population and 3 triggers were not observed. These 14 triggers were noticed 130 times, with an average 12.53 triggers observed per patient. These included DT (100 times), LT (0 times) and PT (30 times). Triggers were identified for a minimum once and maximum 3 times in 95 patients. Of the various triggers observed, 7 drug triggers and 4 patient triggers were related to ADRs. Hence 11 triggers (64.70%) were positive (related to ADRs), out of total 17 triggers under evaluation. A total 24 ADRs were observed in 25 inpatients during study period. One or more triggers were observed in these patients. The commonly detected ADRs were gastritis, thrombophlebitis, diarrhea and vomiting. Chills, cough, headache, joint pain, metallic taste, pruritus and weight gain were also observed. Conclusion: The reporting system is operational at the study site and ADRs are being reported using a standard form. Patients recovering from the reactions following the withdrawal of the suspected drug, and the majority of ADRs were mild. TTM can be used as an add‑on tool to existing methods like spontaneous method for the health‑care professionals for better detection of ADRs in the pharmacovigilance program. However, further research is required to explore the feasibility and acceptability of TTM.
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IJTPR,Vol13,Issue12,Article58.pdf
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Additional details
Dates
- Accepted
-
2023-07-20
Software
References
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