Pharmacology (medical), Pharmacology, Toxicology and Pharmaceutics
8
Scopus Publications
140
Scholar Citations
6
Scholar h-index
4
Scholar i10-index
Scopus Publications
Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products Alemayehu Duga, Nebiyu Dereje, Mosoka Papa Fallah, Tedi Angasa, Abebe Genetu Bayih, Edinam Agbenu, Ngashi Ngongo, Raji Tajudeen, Jean Kaseya Vaccines, 2025 The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe—have attained ML3 status, marking a significant milestone in the continent’s regulatory landscape. Achieving ML3 confers critical benefits, including reducing substandard and falsified medicines, which enhances public health safety and fosters trust in healthcare systems. This progress encourages local manufacturing, diminishing reliance on imported medicines and promoting economic development. Furthermore, ML3 NRAs are better equipped to address public health emergencies, enabling swift approvals for vaccines and therapeutics while upholding safety standards. Nonetheless, challenges persist, including fragmented regulatory systems, the prevalence of counterfeit medicines, and limited resources. Overcoming these hurdles necessitates enhanced organizational capacity, investments in training, and the promotion of collaboration among NRAs. There is an urgent call for greater political commitment and resource allocation to strengthen regulatory systems across Africa. Achieving and maintaining ML3 status is essential for enhancing medicine regulation, supporting local manufacturing, and improving public health outcomes across the continent. While progress has been made, sustained efforts are crucial to tackling existing challenges and harnessing the full potential of advanced regulatory frameworks.
Development, assessment and educational impact of a blended e-learning training program on pharmacovigilance implemented in four African countries Francesco Schievano, Kissa W. Mwamwitwa, Seth Kisenge, Elice Mmari, 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 Frontiers in Medicine, 2024 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.
Safety Profile of Medicines Used for the Treatment of Drug-Resistant Tuberculosis: A Descriptive Study Based on the WHO Database (VigiBase®) Alemayehu Lelisa Duga, Francesco Salvo, Alexander Kay, Albert Figueras Antibiotics, 2023 Background: The introduction of new drugs that increase the usage of repurposed medicines for managing drug-resistant tuberculosis (DR-TB) comes with challenges of understanding, properly managing, and predicting adverse drug reactions (ADRs). In addition to the health consequences of ADRs for the individual, ADRs can reduce treatment adherence, thus contributing to resistance. This study aimed to describe the magnitude and characteristics of DR-TB-related ADRs through an analysis of ADRs reported to the WHO database (VigiBase) in the period from January 2018 to December 2020. Methods: A descriptive analysis was performed on selected reports from VigiBase on the basis of medicine-potential ADR pairs. The ADRs were stratified by sex, age group, reporting country, seriousness, outcome of the reaction, and dechallenge and rechallenge. Results: In total, 25 medicines reported to be suspected individual medicines or as a fixed-dose combination in the study period were included the study. Pyrazinamide (n = 836; 11.2%) was the most commonly reported medicine associated with ADRs, followed by ethionamide (n = 783; 10.5%) and cycloserine (n = 696; 9.3%). From the report included in this analysis, 2334 (31.2%) required complete withdrawal of the suspected medicine(s), followed by reduction of the dose (77; 1.0%) and an increased dose (4; 0.1%). Almost half of the reports were serious ADRs mainly caused by bedaquiline, delamanid, clofazimine, linezolid, and cycloserine that are the backbone of the DR-TB treatment currently in use. Conclusions: A third of the reports required medication withdrawal, which impacts treatment adherence and ultimately leads to drug resistance. Additionally, more than 40% of the reports indicated that ADRs appeared two months after the commencement of treatment, thus it’s important to remain alert for the potential ADRs for the entire duration of the treatment.
An evaluation of postmarketing reports of hyperglycaemia associated with dolutegravir for treatment of HIV in Eswatini Alemayehu L. Duga, Sibongile Magongo, Siphesihle Nhlabatsi, Denis O. Ladwar, Linda Härmark, Leàn Rolfes AIDS Research and Therapy, 2022 Background Dolutegravir (DTG) is an Integrase Strand Transfer Inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV infection. It is available in a number of pharmaceutical preparations including the fixed-dose combination (TLD) containing tenofovir (300 mg) + lamivudine (300 mg) + dolutegravir (50 mg). In 2018, Eswatini adopted TLD as the preferred first-line HIV treatment regimen for adults and adolescents as per WHO recommendations. From March 2019 to March 2020, the National Pharmacovigilance Center (NPC) in Eswatini received 8 reports of hyperglycaemia associated with the use of DTG. This study was conducted to investigate if Eswatini NPC database included cases suggestive of causality between dolutegravir and hyperglycaemia. Method A qualitative synthesis of information from the Eswatini national pharmacovigilance database from March 2019 to March 2020 was conducted to investigate a casual association between hyperglycaemia and dolutegravir. Results All reports with dolutegravir containing regimen and suspected Adverse Event of hyperglycaemia in the period of March 2019 to March 2020 were included in the study. Seven of the reports were serious (resulted in hospitalization and one case concerned optic neuritis, leading to blindness). Two patients had a medical history of diabetes while the rest of the patients had never experienced hyperglycaemia before starting dolutegravir. For all the reports, the time to onset of hyperglycaemia ranges from 2–5 months after the initiation of DTG. None of the patients discontinued the use of DTG. All the patients were treated with oral hypoglycaemic medication. In severe cases, patients were treated with intravenous normal saline and ringer lactate as well as rapid-acting insulins. All patients are currently stable on oral hypoglycaemic drugs. Conclusion Cases that support causality between dolutegravir containing regimen and hyperglycaemia were found. These cases were mainly serious. Based on these findings it is recommended that healthcare professionals (HCPs) actively screen all patients for risk factors of hyperglycaemia before DTG initiation. In addition, it is important that HCPs are aware of the possible association between DTG and hyperglycaemia.
Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis Everdina W. Tiemersma, Ibrahim Ali, Asnakech Alemu, Yohanna Kambai Avong, Alemayehu Duga, Cassandra Elagbaje, Ambrose Isah, Alexander Kay, Blandina Theophil Mmbaga, Elice Mmari, Kissa Mwamwitwa, Siphesihle Nhlabatsi, Kassech Sintayehu, Aida Arefayne, Mekonnen Teferi, Frank Cobelens, Linda Härmark BMC Health Services Research, 2021 Background New medicines have become available for the treatment of drug-resistant tuberculosis (DR-TB) and are introduced in sub-Saharan Africa (SSA) by the national TB programs (NTPs) through special access schemes. Pharmacovigilance is typically the task of national medicines regulatory agencies (NMRAs), but the active drug safety monitoring and management (aDSM) recommended for the new TB medicines and regimens was introduced through the NTPs. We assessed the strengths and challenges of pharmacovigilance systems in Eswatini, Ethiopia, Nigeria and Tanzania, focusing on their capacity to monitor safety of medicines registered and not registered by the NMRAs for the treatment of DR-TB. Methods Assessment visits were conducted to all four countries by a multidisciplinary team. We used a pharmacovigilance indicator tool derived from existing tools, interviewed key stakeholders, and visited health facilities where DR-TB patients were treated with new medicines. Assessment results were verified with the local NMRAs and NTPs. Results Most countries have enabling laws, regulations and guidelines for the conduct of pharmacovigilance by the NMRAs. The relative success of NTP-NMRA collaboration is much influenced by interpersonal relationships between staff. Division of roles and responsibilities is not always clear and leads to duplication and unfulfilled tasks (e.g. causality assessment). The introduction of aDSM has increased awareness among DR-TB healthcare providers. Conclusion aDSM has created awareness about the importance of pharmacovigilance among NTPs. In the future, a push for conducting pharmacovigilance through public health programs seems useful, but this needs to coincide with increased collaboration with between public health programs and NMRAs with clear formulation of roles and responsibilities.
RECENT SCHOLAR PUBLICATIONS
Visualizing Proxy Indicators for Pharmacovigilance Maturity in Africa J Doherty, A Figueras, S Gesuale, C Muli, A Duga DRUG SAFETY 48 (12) , 2025 2025
Strengthening Pharmacovigilance Systems in Africa: Lessons Learned from the Lives and Livelihood (SLL) Phase One Initiative A Duga, M Fallah, C Kilowe, J Murtala, K Kayumba, T Angasa, A Kuba DRUG SAFETY 48 (12) , 2025 2025
Self-Medication for Mitigating Adverse Events Following Immunization During COVID-19 Mass Vaccination Campaigns in the Democratic Republic of Congo K Kayumba, A Duga, MP Fallah, BW Bicaba, B Coulibaly, A Kima, ... DRUG SAFETY 48 (12) , 2025 2025
Generation of Safety Evidence in the Context of Public Health Emergency: Scoping Review of Mpox Vaccines Active Safety Surveillance Protocols A Stergachis, E Sevene, MGS Alam, WT Huang, RE Chandler, A Duga, ... DRUG SAFETY 48 (12) , 2025 2025
Strengthening National regulatory authorities in africa: A critical step towards enhancing local manufacturing of vaccines and health products A Duga, N Dereje, MP Fallah, T Angasa, AG Bayih, E Agbenu, N Ngongo, ... Vaccines 13 (6), 646 , 2025 2025 Citations: 8
Diethylene glycol: Unnoticed threat in the landscape of fixed-dose combination medications AL Duga, MP Fallah, A Figueras Journal of Public Health in Africa 16 (1), 1271 , 2025 2025
Resurgence of malaria and artemisinin resistance in Africa requires a concerted response N Dereje, MP Fallah, T Shaweno, A Duga, ML Mazaba, T Raji, ... nature medicine 31 (2), 362-363 , 2025 2025 Citations: 4
Malaria vaccine rollout begins in Africa: the need to strengthen regulatory and safety surveillance systems in Africa AL Duga, N Ngongo, MP Fallah, A Figueras, C Kilowe, J Murtala, ... BMJ Global Health 9 (10) , 2024 2024 Citations: 2
A community engagement framework to accelerate the uptake of malaria vaccines in Africa N Dereje, MP Fallah, N Ndembi, A Duga, T Shaweno, M Aragaw, ... nature medicine 30 (10), 2706-2707 , 2024 2024 Citations: 4
Patterns of adverse drug reactions in patients with drug resistant tuberculosis in Eswatini: a retrospective cohort study AL Duga Université de Bordeaux , 2024 2024
Effets indésirables des médicaments de la tuberculose pharmaco-résistante en Eswatini et comparaison des caractéristiques des EI avec la base de données mondiale de … AL Duga Bordeaux , 2024 2024
Adverse events following immunization during COVID-19 mass vaccination campaigns in the Democratic Republic of Congo: Findings from active safety surveillance K Kayumba, A Duga, M Papa Fallah, C Tshidibi, N Lubaki, B Coulibaly, ... medRxiv, 2024.08. 18.24312190 , 2024 2024
Development, Assessment And Educational Impact Of A Blended Elearning Training Program On Pharmacovigilance Implemented In Four African Countries F Schievano, KW Mwamwitwa, S Kisenge, E Mmari, A Duga, S Nhlabatsi, ... Frontiers in Medicine 11, 1347317 , 2024 2024 Citations: 4
Safety Profile of Medicines Used for the Treatment of Drug-Resistant Tuberculosis: A Descriptive Study Based on the WHO Database (VigiBase ® ) AL Duga, F Salvo, A Kay, A Figueras Antibiotics 12 (5), 811 , 2023 2023 Citations: 11
An evaluation of postmarketing reports of hyperglycaemia associated with dolutegravir for treatment of HIV in Eswatini AL Duga, S Magongo, S Nhlabatsi, DO Ladwar, L Härmark, L Rolfes AIDS Research and Therapy 19 (1), 54 , 2022 2022 Citations: 14
Oral Presentation: Development and Evaluation of a Blended Pharmacovigilance e-Learning Course in Africa L Magro, M Venegoni, F Schievano, S Pagani, R Lora, A Sabaini, ... Drug Safety 45 (10), 1127-1127 , 2022 2022
The Process of Developing a Pharmacovigilance Policy: Experiences from Nigeria and Eswatini A Isah, R Ozolua, A Opadeyi, S Ayinbuomwan, A Osakwe, I Ali, P Bassi, ... Drug Safety 44 (12), 1449-1450 , 2021 2021
Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis EW Tiemersma, I Ali, A Alemu, YK Avong, A Duga, C Elagbaje, A Isah, ... BMC Health Services Research 21 (1), 1062 , 2021 2021 Citations: 9
Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort S Koirala, S Borisov, E Danila, A Mariandyshev, B Shrestha, N Lukhele, ... Pulmonology 27 (5), 403-412 , 2021 2021 Citations: 60
Eswatini’s formidable task of fighting against COVID-19 M Diluxe, AL Duga, G Girinshuti, A Ahmadi, DE Lucero-Prisno III Razi International Medical Journal 1 (1) , 2021 2021 Citations: 1
MOST CITED SCHOLAR PUBLICATIONS
Outcome of treatment of MDR-TB or drug-resistant patients treated with bedaquiline and delamanid: Results from a large global cohort S Koirala, S Borisov, E Danila, A Mariandyshev, B Shrestha, N Lukhele, ... Pulmonology 27 (5), 403-412 , 2021 2021 Citations: 60
Assessments of patterns and determinants of contraceptive Use among females of reproductive age in Kelala Town, Northern Ethiopia GM Kassie Exp J 22 , 2014 2014 Citations: 15
An evaluation of postmarketing reports of hyperglycaemia associated with dolutegravir for treatment of HIV in Eswatini AL Duga, S Magongo, S Nhlabatsi, DO Ladwar, L Härmark, L Rolfes AIDS Research and Therapy 19 (1), 54 , 2022 2022 Citations: 14
Safety Profile of Medicines Used for the Treatment of Drug-Resistant Tuberculosis: A Descriptive Study Based on the WHO Database (VigiBase ® ) AL Duga, F Salvo, A Kay, A Figueras Antibiotics 12 (5), 811 , 2023 2023 Citations: 11
Baseline assessment of pharmacovigilance activities in four sub-Saharan African countries: a perspective on tuberculosis EW Tiemersma, I Ali, A Alemu, YK Avong, A Duga, C Elagbaje, A Isah, ... BMC Health Services Research 21 (1), 1062 , 2021 2021 Citations: 9
Strengthening National regulatory authorities in africa: A critical step towards enhancing local manufacturing of vaccines and health products A Duga, N Dereje, MP Fallah, T Angasa, AG Bayih, E Agbenu, N Ngongo, ... Vaccines 13 (6), 646 , 2025 2025 Citations: 8
Resurgence of malaria and artemisinin resistance in Africa requires a concerted response N Dereje, MP Fallah, T Shaweno, A Duga, ML Mazaba, T Raji, ... nature medicine 31 (2), 362-363 , 2025 2025 Citations: 4
A community engagement framework to accelerate the uptake of malaria vaccines in Africa N Dereje, MP Fallah, N Ndembi, A Duga, T Shaweno, M Aragaw, ... nature medicine 30 (10), 2706-2707 , 2024 2024 Citations: 4
Development, Assessment And Educational Impact Of A Blended Elearning Training Program On Pharmacovigilance Implemented In Four African Countries F Schievano, KW Mwamwitwa, S Kisenge, E Mmari, A Duga, S Nhlabatsi, ... Frontiers in Medicine 11, 1347317 , 2024 2024 Citations: 4
MATERNAL AND PERINATAL HEALTH IN ETHIOPIA DTT Alemayehu Lelisa Duga Journal of Biotechnology and Biosafety 3 (2), 191-196 , 2015 2015 Citations: 3
Comparative study of the effect of Antiretroviral Therapy(ART) on CD4 count in Jimma University Specialized Hospital AL Duga, GM Kassie, BA Horsa, E Jimma Journal of Pharmaceutical and Scientific Innovation , 2014 2014 Citations: 3
Malaria vaccine rollout begins in Africa: the need to strengthen regulatory and safety surveillance systems in Africa AL Duga, N Ngongo, MP Fallah, A Figueras, C Kilowe, J Murtala, ... BMJ Global Health 9 (10) , 2024 2024 Citations: 2
Eswatini’s formidable task of fighting against COVID-19 M Diluxe, AL Duga, G Girinshuti, A Ahmadi, DE Lucero-Prisno III Razi International Medical Journal 1 (1) , 2021 2021 Citations: 1
Susceptibility pattern of empirical therapy for upper respiratory infections at Pigg’s Peak Government Hospital SC Mhlanga, AL Duga, AT Makunde, S Zwane, S Menon European Journal of Biomedical 5 (1), 106-112 , 2018 2018 Citations: 1
ACUTE KIDNEY INJURY: PREVALENCE, DIAGNOSIS, CAUSES AND TREATMENT AL Duga Texila International Journal of Clinical Research 3 (2) , 2017 2017 Citations: 1
Visualizing Proxy Indicators for Pharmacovigilance Maturity in Africa J Doherty, A Figueras, S Gesuale, C Muli, A Duga DRUG SAFETY 48 (12) , 2025 2025
Strengthening Pharmacovigilance Systems in Africa: Lessons Learned from the Lives and Livelihood (SLL) Phase One Initiative A Duga, M Fallah, C Kilowe, J Murtala, K Kayumba, T Angasa, A Kuba DRUG SAFETY 48 (12) , 2025 2025
Self-Medication for Mitigating Adverse Events Following Immunization During COVID-19 Mass Vaccination Campaigns in the Democratic Republic of Congo K Kayumba, A Duga, MP Fallah, BW Bicaba, B Coulibaly, A Kima, ... DRUG SAFETY 48 (12) , 2025 2025
Generation of Safety Evidence in the Context of Public Health Emergency: Scoping Review of Mpox Vaccines Active Safety Surveillance Protocols A Stergachis, E Sevene, MGS Alam, WT Huang, RE Chandler, A Duga, ... DRUG SAFETY 48 (12) , 2025 2025
Diethylene glycol: Unnoticed threat in the landscape of fixed-dose combination medications AL Duga, MP Fallah, A Figueras Journal of Public Health in Africa 16 (1), 1271 , 2025 2025
