| アブストラクト | INTRODUCTION: Efforts to improve medication access in low-and middle-income countries, particularly in Sub-Saharan Africa, have made progress, especially in the fight against infectious diseases such as tuberculosis. However, challenges exist in establishing effective pharmacovigilance systems. The PhArmacoVIgilance Africa (PAVIA) project was committed to enhancing pharmacovigilance in Tanzania, Eswatini, Nigeria, and Ethiopia, with an emphasis on anti-tuberculosis drugs, utilizing various methods, including training. This study evaluates the PAVIA training program's effectiveness and its adaptation during the COVID-19 pandemic. METHODS: A blended e-learning program, incorporating two courses and a platform for educational materials, was developed. This program, designed to train healthcare professionals in pharmacovigilance, was incorporated into a Training of Trainers model. To evaluate the program effectiveness, we used multiple measures such as assessing knowledge gain through pre-and post-test scores, assessing learners' satisfaction and attitudes via questionnaires, and analyzing Individual Case Safety Reports (ICSRs) in VigiBase to determine the impact on spontaneous reporting systems in the PAVIA countries. RESULTS: 121 learners enrolled in the pilot trainings, including 36 from Tanzania, 34 from Eswatini, 25 from Nigeria, and 26 from Ethiopia. Notably, post-test scores were significantly higher than pre-test scores in all four countries. Following the pilot trainings, multiple step-down training sessions were held in Tanzania, Eswatini, and Nigeria, with a total of 827 learners registering and 421 successfully completing the program. Learners' scores on the post-tests were significantly higher than on the pre-tests for both courses in all three countries. Learners' feedback on the training was overwhelmingly positive. Additionally, a qualitative analysis of ICSRs revealed a substantial increase in reports after the training in Tanzania, Eswatini, and Nigeria. DISCUSSION: An innovative e-learning program trained healthcare professionals in pharmacovigilance and anti-tuberculosis drug safety over 3 years in four PAVIA countries. The program effectively improved participants' knowledge, received positive feedback, and likely had an impact on reporting rates in Tanzania, Eswatini, and Nigeria, although a direct causal link could not be definitively established due to data limitations and other factors, such as the heightened reporting rates associated with COVID-19 vaccines, that could have contributed to the notable increase in ICSRs. |
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| ジャーナル名 | Frontiers in medicine |
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| 投稿日 | 2024/5/2 |
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| 投稿者 | Schievano, Francesco; Mwamwitwa, Kissa W; Kisenge, Seth; Mmari, Elice; Duga, Alemayehu; Nhlabatsi, Siphesihle; Elagbaje, Cassandra; Abiola, Abiodun Sadikat; Meshesha, Solomon Getnet; Pagani, Silvia; Lora, Riccardo; Sabaini, Alberto; Cobelens, Frank; Harmark, Linda; Eko, Eric Battey; Conforti, Anita; Venegoni, Mauro; Magro, Lara; Moretti, Ugo |
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| 組織名 | Section of Pharmacology, Department of Diagnostics and Public Health, University;of Verona, Verona, Italy.;Section of Clinical Trials Control and Pharmacovigilance, Tanzania Medicines and;Medical Devices Authority (TMDA), Dar es Salaam, Tanzania.;KNCV Tuberculosis Foundation, Dar es Salaam, Tanzania.;Doctoral School Societies, Politics, Public Health, Pharmacoepidemiology and;Pharmacovigilance, University of Bordeaux, Bordeaux, France.;National Pharmacovigilance Center, Eswatini Ministry of Health, Mbabane,;Eswatini.;Baylor College of Medicine Children's Foundation-Eswatini, Mbabane, Eswatini.;KNCV Tuberculosis Foundation, Abuja, Nigeria.;National Agency for Food and Drug Administration and Control (NAFDAC), Abuja,;Nigeria.;Armauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia.;Unit of Medicine, Hospital of Vimercate, Vimercate, Italy.;MedBrains, Department of Computer Science, University of Verona, Verona, Italy.;Department of Global Health and Amsterdam Institute for Global Health and;Development, Amsterdam University Medical Centers, University of Amsterdam,;Amsterdam, Netherlands.;Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, Netherlands. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38695021/ |
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