The severity of adverse drug reactions and their influencing factors based on the ADR monitoring center of Henan Province

Abstract Adverse drug reactions (ADRs) may be a serious public health problem and have received widespread attention in recent years. This study has analyzed the factors leading to the occurrence of serious ADRs (SADRs), determined the factors affecting the prognosis of patients with severe adverse reactions at different levels of medical institutions, and finally made corresponding recommendations for the monitoring, prevention, and treatment of SADRs. We used descriptive analysis and chi-square test to analyze the year, age, gender, proportion of SADRs, and the results of the ADRs in the report. Use the logistic regression to analyze the factors affecting the prognosis of SADRs in different levels of medical institutions. A total of 387 642 people’s 394 037 ADRs were collected from the Henan Provincial Adverse Drug Reaction Monitoring Center from 2016 to 2020. Among them 35 742 cases of serious ADRs (9.1%), 96.1% were eventually relieved or cured, but 39 cases of SADRs caused death. The main causes of death included hemorrhages, organ failure, and allergies. Age, number of medication and illnesses, level of medical institution, history of adverse reactions, and type and method of medication were all factors that affected the severity of ADR. The prognosis of SADRs is worse than normal ADRs. The ADRs in autumn and winter and new adverse reactions are unique risk factors found in this study. The elderly and patients with multiple diseases or taking multiple drugs should pay attention to their adverse reactions. They should be closely observed within a week after taking the medicine. The supervision of patients with a history of allergies and new adverse reactions should be strengthened by primary medical institutions, and in nonprimary medical institutions should paid attention with past medical histories, and use imported drugs and biological agents with caution to ensure the safety and health of patients.