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Introduction: Smartphone applications (apps) for pharmacovigilance present an opportunity for integration as cost-effective healthcare service intervention into basic healthcare services in low-resource settings. This study aimed to (i) evaluate the implementation of the Med Safety app in Burkina Faso, and (ii) compare the characteristics of the reports sent by the Med Safety app with those sent on paper form. Methods: The study had two components: (i) a cross-sectional online survey assessing the Med Safety app, and (ii) a retrospective analysis comparing the characteristics of the Med Safety reports with those of the paper form, received by the National Pharmacovigilance Centre of Burkina Faso (CNVPS), from January 1, 2021 to December 31, 2022. We evaluated the success of the implementation of the Med Safety intervention using measures of acceptability, usefulness and feasibility. This assessment involved a set of 14 items rated on a 4-point Likert scale. Acceptability, feasibility, and usefulness were determined based on achieving a total score higher than the mean. Subsequently, we computed the proportion of participants whose overall score for all items exceeded the mean. Continuous and categorical variables were compared using the Wilcoxon rank-sum test and the Chi2 test, respectively. The significance level of the statistical test was set at 5%. Results: The survey participation rate was 51.9% (160/308). Half of the respondents were in the 35-44 age group (50.6%), and participants were predominantly male (71.9%). The Med Safety app was acceptable, feasible, and useful to 58.1% of respondents. The most useful features of the app were "reporting" (53.1%), "news" (13.6%) and "watch list" (12.4%). During the period, a total of 1,472 reports were received, including 357 (24.3%) through Med Safety and 1,115 (75.7%) through the paper form. The reports of adverse events following immunization received at the CNVPS numbered 974 (66.2%), these were related to COVID-19 vaccines, with 256 (26.3%) through the Med Safety and 718 (73.7%) through the paper form. The median time to submit the reports to the CNVPS was 159 (IQR 59–187) days for the Med Safety and 166 (IQR 107–281) days for the paper form (p < 0.001). Conclusion: In Burkina Faso, the Med Safety was found to be acceptable, useful, and feasible by users surveyed. In addition, and compared to the paper form, the app reduces the time to submit a report, and with increase in use, the reporting timeframe could be further improved. [ABSTRACT FROM AUTHOR]

Background: Burkina Faso, like other Sub-Saharan African countries, has recently experienced a large-scale deployment of new medicines for the prevention and treatment of notable diseases of public health interest, including malaria, HIV/AIDS and meningitis. This new context rendered the implementation of pharmacovigilance necessary in order to monitor and establish the safety and effectiveness of these medicines. In 2008, the Ministry of Health of Burkina Faso, West Africa, launched a formal pharmacovigilance system to respond to this need. Objective: The aim of this study was to evaluate the early-stage pharmacovigilance system of Burkina Faso through a comprehensive and system-based approach with the prospect of identifying areas for improvements. Methods: We conducted a descriptive cross-sectional study in Burkina Faso. Sixteen key informants from the National Drug Authority (NDA), public health programmes (PHPs) and hospitals were interviewed. Study participants were selected based on a convenience sampling in the NDA, three teaching hospitals, two regional hospitals and six PHPs. Data were collected using the Indicator-based Pharmacovigilance Assessment Tool (IPAT), a metric instrument recently designed and validated by 'Management Sciences for Health', a US non-profit organization. The evaluation also involved the collection and review of relevant pharmacovigilance-related documentation in the institutions assessed. A scoring system was used for the quantification of assessment results. Results: The NDA of Burkina Faso, the institution statutorily in charge of pharmacovigilance, achieved a performance score of 70 %. The basic structures for pharmacovigilance activities were in place; however, the lack of specific laws dedicated to pharmacovigilance, the lack of national guidelines and standard operating procedures on pharmacovigilance, and the insufficient coordination of pharmacovigilance stakeholders in the country were identified as the main weaknesses. Safety data collected thus far have not led to the identification of local drug-related risks; yet, relevant external safety alerts are monitored and acted upon. In 2010, 31 marketing authorizations were modified to include new safety information; seven others were suspended and the corresponding medicines were withdrawn from the national market. In PHPs, pharmacovigilance activities were not formalized, and in hospitals, pharmacovigilance structures were still under development. Conclusion: Relevant interventions aimed at strengthening the legal framework and structures for pharmacovigilance activities, and improving the coordination of stakeholders countrywide, should be undertaken as soon as possible. Such an investment is necessary before the national pharmacovigilance system is able to collect its own data, generate signals, evaluate and manage local medicine-related risks and then become a genuine tool for public health. [ABSTRACT FROM AUTHOR]