Barriers to adverse drug reaction reporting in Malaysia: a narrative review based on theoretical domains framework

Abstract

Abstract Objectives This review aims to determine the common barriers to adverse drug reaction (ADR) reporting in Malaysia based on theoretical domains framework (TDF). Methods Three online databases, PubMed (Medline), Scopus and Web of Science, were searched from 2000 to 2020 to identify related quantitative and qualitative studies. Key findings Eleven articles were reviewed – nine quantitative and two qualitative studies. Three domains from TDF were identified as the most common: (1) knowledge, (2) skills and (3) environmental context and resources. Lack of awareness of an ADR reporting system, lack of clinical and ADR knowledge and lack of time were identified as the main barriers. Additionally, assumption of healthcare professionals (HCPs) of ADR to be too insignificant or too well known and unavailability of the ADR form were also reported as barriers for reporting an ADR. Conclusions The findings from this narrative review could be useful for the policymakers in planning strategies at the national level to improve the reporting rate of ADR in Malaysia. It is necessary to promote and publicize pharmacovigilance activities and to enhance communication and engagement between the Malaysian ADR Advisory Committee and the HCPs and consumers. There is also a need to increase training and continuous education related to ADR and pharmacovigilance system and making ADR reporting compulsory for all HCPs.