Abstract
Introduction
Spontaneous reporting of adverse events (AEs) is a mainstay of pharmacovigilance, and an ongoing challenge is how to ensure that more high-quality reports are collected for comprehensive information provision. The Med Safety App, a smartphone-based application, was launched in Nigeria in November 2020 to provide an electronic platform for users to seamlessly report AEs. There has been a paucity of evidence on the use of this application or other mobile applications for reporting adverse drug reactions/AEs following immunization in the Nigerian environment.
Objective
The aim of this study was to evaluate the trends in adverse event reporting before and after the introduction of the Med Safety App in Nigeria.
Methods
This was a retrospective, observational study using data from the VigiFlow database to compare adverse event reporting in Nigeria before and after the deployment of the Med Safety App. The baseline period was 1st April 2019 to 30th October 2020 and the comparison period was 1st November 2020 to 31st May 2022. We used Vigilance Hub, the back-end system for the Med Safety App, to extract data on App downloads and de-identified user statistics. Data were summarized using descriptive statistics, frequencies and proportions. Quality was assessed by assigning a completeness score to each individual case safety report. The Kruskal–Wallis test was used to test for differences in medians between groups.
Results
Following deployment of the App, the Nigerian National Pharmacovigilance Centre recorded an increase in the total number of adverse event reports received in VigiFlow, from 2051 in the baseline period to 18,995 following deployment of the App, with 81.7% of those reported via the Med Safety App. There was a reduction in the proportion of paper-based reporting from 98.4 to 15.7% post-deployment, and direct reporting by consumers increased from 2.7 to 17.6%. Of the 15,526 reports submitted via the App, 15,111 (97.3%) had a completeness score above 70% and 6993 (45%) had a completeness score of 100%. The median completeness score of adverse event reports on the Med Safety App was 6 out of 7. On bivariate analysis using the Kruskal–Wallis test, there was an association between means of reporting and completeness score, and this association was significant, with a p value of 0.0001, which may reflect the validation rules that are applied within the App.
Conclusion
Deployment of the Med Safety App increased both the number and quality of adverse event reports; however, more awareness and capacity building are needed to strengthen and sustain reporting on the tool by all categories of healthcare professionals and consumers/patients.
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Uchenna Geraldine Elemuwa, Fraden Bitrus, Ibrahim Adekunle Oreagba, Adeline Ijeoma Osakwe, Abiola Sadikat Abiodun, Kenneth Onu, Asmau Abubakar, Angela E. Faniyi, Victoria Etuk, Daniel Yuah, Rametu Momodu, and Christiana Mojisola Adeyeye declare no conflicts of interest relating to this article.
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Ethical approval was not required for this study. Permission to carry out the study was duly obtained from the Director General of the NAFDAC
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The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.
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UGE conceived the study. UGE and FB developed the proposal for the study. IAO and CMA reviewed the proposal. DY extracted data from VigiFlow for analysis. UGE and VE analyzed the extracted data. UGE drafted the manuscript. FB, IAO, AIO, ASA, KO, AA, AEF, RM and CMA reviewed and approved the manuscript.
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Elemuwa, U.G., Bitrus, F., Oreagba, I.A. et al. Trends in Adverse Event Reporting Before and After the Introduction of the Med Safety App in Nigeria. Pharm Med 38, 251–259 (2024). https://doi.org/10.1007/s40290-024-00524-z
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DOI: https://doi.org/10.1007/s40290-024-00524-z