An electronic adverse drug reaction reporting system for Uganda

Abstract

Background: Adverse drug reactions (ADRs) are a major health problem, which impose profound morbidity, mortality and financial burden on patients and health systems. Adverse drug reactions monitoring in Uganda is paper-based, and faces challenges including delayed report delivery, and errors in transcription. Although electronic reporting systems are associated with timely report delivery and good report completeness, their implementation is still limited in Uganda and the East African Region. Using the user requirements including capturing data in the respective fields of the national ADR form, capacity to acknowledge receipt of submitted ADRs, ensuring privacy and data confidentiality, and capacity to generate summary trend reports, this study aimed to develop and validate an electronic ADR reporting system for Uganda. Methods: The study adopted the design science methodology to develop and evaluate the usefulness and usability of the electronic ADR system. Within the design science methodology, we used qualitative methods (in-depth interviews, review of documents and process observation) to collect system user requirements. The system prototype was developed, by configuring an instance of DHIS2 to meet system requirements. System validation was based on user satisfaction questionnaires among health workers who used the system. Findings: Users found the system useful and acceptable for the purpose of reporting ADRS. We established that the system met all its functional requirements. Particularly the system was capable of capturing all minimum event data, reporter feedback, analysis and trending of reported data to guide decisions on drug safety as reported by the respondents from the Cancer Institute in Uganda. Conclusion: The electronic ADR reporting system prototype was useful for the purpose of reporting and timely delivery of ADR reports. Therefore deduced that electronic systems provide a viable solution to the problem of delayed ADR reporting in Uganda. However, it faced limitations of compatibility of the MedDRA standard terminology with the DHIS2 set up used, and Internet interruptions. Any future attempts at automating ADR reporting should purpose to address these challenges.