Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries
IntroductionEfforts 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 Ph...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2024-04-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2024.1347317/full |
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| author | Francesco Schievano Kissa W. Mwamwitwa Seth Kisenge Elice Mmari Alemayehu Duga Alemayehu Duga Alemayehu Duga Siphesihle Nhlabatsi Cassandra Elagbaje Abiodun Sadikat Abiola Solomon Getnet Meshesha Silvia Pagani Riccardo Lora Alberto Sabaini Frank Cobelens Linda Härmark Eric Battey Eko Anita Conforti Mauro Venegoni Lara Magro Ugo Moretti |
| author_facet | Francesco Schievano Kissa W. Mwamwitwa Seth Kisenge Elice Mmari Alemayehu Duga Alemayehu Duga Alemayehu Duga Siphesihle Nhlabatsi Cassandra Elagbaje Abiodun Sadikat Abiola Solomon Getnet Meshesha Silvia Pagani Riccardo Lora Alberto Sabaini Frank Cobelens Linda Härmark Eric Battey Eko Anita Conforti Mauro Venegoni Lara Magro Ugo Moretti |
| author_sort | Francesco Schievano |
| collection | DOAJ |
| description | IntroductionEfforts 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.MethodsA 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.Results121 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.DiscussionAn 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. |
| first_indexed | 2024-04-24T08:13:42Z |
| format | Article |
| id | doaj.art-2f90c022a6d946dca96ecd23aef3259b |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-24T08:13:42Z |
| publishDate | 2024-04-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-2f90c022a6d946dca96ecd23aef3259b2024-04-17T04:39:15ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2024-04-011110.3389/fmed.2024.13473171347317Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countriesFrancesco Schievano0Kissa W. Mwamwitwa1Seth Kisenge2Elice Mmari3Alemayehu Duga4Alemayehu Duga5Alemayehu Duga6Siphesihle Nhlabatsi7Cassandra Elagbaje8Abiodun Sadikat Abiola9Solomon Getnet Meshesha10Silvia Pagani11Riccardo Lora12Alberto Sabaini13Frank Cobelens14Linda Härmark15Eric Battey Eko16Anita Conforti17Mauro Venegoni18Lara Magro19Ugo Moretti20Section of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, ItalySection of Clinical Trials Control and Pharmacovigilance, Tanzania Medicines and Medical Devices Authority (TMDA), Dar es Salaam, TanzaniaSection of Clinical Trials Control and Pharmacovigilance, Tanzania Medicines and Medical Devices Authority (TMDA), Dar es Salaam, TanzaniaKNCV Tuberculosis Foundation, Dar es Salaam, TanzaniaDoctoral School Societies, Politics, Public Health, Pharmacoepidemiology and Pharmacovigilance, University of Bordeaux, Bordeaux, FranceNational Pharmacovigilance Center, Eswatini Ministry of Health, Mbabane, EswatiniBaylor College of Medicine Children’s Foundation-Eswatini, Mbabane, EswatiniNational Pharmacovigilance Center, Eswatini Ministry of Health, Mbabane, EswatiniKNCV Tuberculosis Foundation, Abuja, NigeriaNational Agency for Food and Drug Administration and Control (NAFDAC), Abuja, NigeriaArmauer Hansen Research Institute (AHRI), Addis Ababa, Ethiopia0Unit of Medicine, Hospital of Vimercate, Vimercate, Italy1MedBrains, Department of Computer Science, University of Verona, Verona, Italy1MedBrains, Department of Computer Science, University of Verona, Verona, Italy2Department of Global Health and Amsterdam Institute for Global Health and Development, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, Netherlands3Netherlands Pharmacovigilance Centre Lareb, ‘s-Hertogenbosch, NetherlandsSection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, ItalySection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, ItalySection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, ItalySection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, ItalySection of Pharmacology, Department of Diagnostics and Public Health, University of Verona, Verona, ItalyIntroductionEfforts 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.MethodsA 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.Results121 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.DiscussionAn 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.https://www.frontiersin.org/articles/10.3389/fmed.2024.1347317/fullpharmacovigilanceblended-learningtuberculosiscascade trainingAfrica |
| spellingShingle | Francesco Schievano Kissa W. Mwamwitwa Seth Kisenge Elice Mmari Alemayehu Duga Alemayehu Duga Alemayehu Duga Siphesihle Nhlabatsi Cassandra Elagbaje Abiodun Sadikat Abiola Solomon Getnet Meshesha Silvia Pagani Riccardo Lora Alberto Sabaini Frank Cobelens Linda Härmark Eric Battey Eko Anita Conforti Mauro Venegoni Lara Magro Ugo Moretti Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries Frontiers in Medicine pharmacovigilance blended-learning tuberculosis cascade training Africa |
| title | Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries |
| title_full | Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries |
| title_fullStr | Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries |
| title_full_unstemmed | Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries |
| title_short | Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries |
| title_sort | development assessment and educational impact of a blended e learning training program on pharmacovigilance implemented in four african countries |
| topic | pharmacovigilance blended-learning tuberculosis cascade training Africa |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2024.1347317/full |
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