Risk Management Assessments of Adverse Drug Reactions: A Systematic Review of the Literature

Abstract

Abstract Background Improving the quality of life of patients is a key concern in public health. In the context of improving therapeutic compliance, quality of life of patients undergoing anti-tuberculosis treatment, and prevention of antibiotic resistance, we conducted this systematic review to support risk minimization actions. Methods A literature review of risk management strategies targeting adverse drug reactions to anti-tuberculosis drugs was conducted, including published observational studies. Two independent reviewers identified studies through Medline, Scopus, and Web of Science. The methodological quality of the included studies was assessed using criteria defined by the Newcastle Ottawa Scale. Results Seven studies were included in this review, which identified four risk management strategies (psychological intervention, reduction of drug dose with or without prescription of adjunctive medications, change of medication, permanent or temporary discontinuation of medication). The strategies adopted were dependent on the nature and severity of the adverse events. All drugs responsible for serious adverse events were changed or discontinued. Three studies had a moderate risk of methodological bias. Conclusions Strategies to minimize the risk of adverse drug reactions and improve adherence to therapy have a strong potential to improve adherence to therapy, improve patient quality of life, and reduce antibiotic resistance. However, high-level evidence on the effectiveness of strategies to minimize the risk of adverse events is limited. Key messages Strategies to manage the risk of adverse drug reactions have a strong potential benefit for TB patients on treatment; and improve adherence to treatment. High-level evidence on the effectiveness of strategies to minimize the risk of adverse events is limited.