Situation analysis of medicines traceability and product recall system in Uganda

Abstract

Background: A pharmaceutical industry devoid of substandard and falsified (SF) drugs is crucial to any health system as safe and efficacious medicines are essential to attaining desired outcomes from both prophylactic and curative interventions. Measures to track and trace medicines along the supply chain are essential to control of SF medicines in a country. Objective: The purpose of the study was to analyze the situation of the medicines traceability and product recall system in Uganda, particularly current operational status, components, design, compliance to global standards, and effectiveness. Method: The study adopted a concurrent explanatory mixed methods design targeting Local Technical Representative (LTR) staff and staff at National Drug Authority (NDA). The LTRs were randomly sampled, and staff therein purposively sampled. Key informants at NDA were also purposively sampled. Structured questionnaires and key informant interview guides were used to collect data. Quantitative data was entered into SPSS version 25 and analyzed descriptively. Qualitative data was manually thematically analysed. Results: Uganda’s traceability system is made of a simple design without a complex technological framework, involving communication between NDA and LTRs (open loop). The level of compliance of Uganda’s medicines traceability and product recall system with global best practices was found to be 48%. The traceability system involves the use of computer medicines cataloguing software of ones’ choice among LTRs, and the use of non-computer based activities to track and trace data, by NDA. The legal environment was described by all the respondents as unsupportive of the medicines traceability system. The political environment was rated as being favorable for the medicines traceability system. Most respondents noted that the medicines traceability system of Uganda was only partially effective in achieving effective product recall. Conclusion: Uganda’s traceability system is an open loop design with NDA and LTRs as the main players. Compliance of the traceability system with standard global practices is low. Unconducive legal and technological environments hinder effective performance of the traceability system. The medicines traceability system was rated as only partially effective in attaining its goal of facilitating effective product recall in Uganda.