Analysis of adverse drug reaction reporting at Hue University of Medicine and Pharmacy Hospital

Background: In Pharmacovigilance, spontaneous reporting of adverse drug reactions is the most common method used in many countries around the world to detect and monitor adverse drug reactions. Among sources of ADR reports, reports performed at health facilities play an important role in detecting adverse drug reactions of newly introduced drugs, serious adverse reactions, and adverse drug reactions which can be detected early. Objectives: (1) To investigate the implementation of adverse drug reaction reporting activities at Hue University of Medicine and Pharmacy Hospital for the period 2017-2019, (2) To analyze activities of reporting adverse reactions of drugs at Hue University of Medicine and Pharmacy Hospital for the period of 2017-2019. Materials and methods: We performed a descriptive cross-sectional study on pharmacists who reported ADR and a total of 138 ADR reports archived at pharmacy department of the hospital. Results and Conclusions: The groups of evaluation criteria for the management organization, resources and communication activities related to the adverse drug reaction reporting were scored over 75% of the maximum. In 2017, the reporting rate compared to the whole country reached 0.62% and decreased to 0.37% in 2019. The proportion of good quality reports increased from 34.62% in 2017 to 91.49% in 2019. Almost ADR reports came from nurses (85.51%). The other beta - lactam antibacterial group was the most reported group of suspect drugs (52.17%). The most reported pairs of drugs - adverse reactions were Ceftriaxon - rash (13.04%), Ceftriaxon - pruritus (7.97%) and Ceftriaxon - vomiting (7.97%). Key words: Pharmacovigilance, adverse drug reactions, medical facility