Introduction:
Today's guest is Dr Helen Ndagije, Director of Product Safety at the National Drug Authority in Uganda.
In this podcast, Helen shares her insights and experiences at the forefront of regulatory science in Uganda. She sheds light on the challenges of marshaling support to mature her agency's regulatory capabilities and collaborate with regulatory networks in sub-Saharan Africa.
Helen is a highly experienced and thoughtful scientist and regulator. I hope that you enjoy this interview.
Interview Questions and Timestamps:
Helen, welcome to the podcast!
Q: How did you come to work for the Uganda NDA, and what is your interest in pharmacovigilance? (1:00)
The African Union has established The African Medicines Agency to support the growth of the local pharmaceutical industry, coordinate joint reviews and assessments of product dossiers and clinical trial applications for vaccines, biosimilars, and other complex products, and develop common standards and regulations to harmonize legislation.
Q: What was the origin of the AMA? (3:00)
Q: What have been your experiences working with the AMA, particularly with respect to the joint reviews and assessments? (6:50)
Uganda is a partner state in the East African Community (EAC), a regional intergovernmental organization encompassing one of the fastest-growing regional economic blocs in the world. The EAC is widening and deepening cooperation among the Partner States in political, economic, and social spheres.
Q: Can you tell us about the role of the WHO-supported African Vaccine Regulator’s Forum (AVAREF) in shaping regulatory review processes? (7:50) What are the strengths and challenges of working within these networks? (9:40) Tell us about the gentamicin quality issue. (12:00)
The WHO has played an essential role in strengthening regulatory science in sub-Saharan Africa, including advocating for implementing regulatory reliance as a regulatory best practice and publishing the Global Benchmarking Tool for evaluating national regulatory systems.
Q: What have been your experiences implementing regulator reliance? (15:00)
Q: Tell us about the Global Benchmarking Tool and how it has affected your agency. (16:40)
Q: Uganda NDA is level one on the WHO global benchmarking tool. What is the significance of the maturity level? What are the biggest obstacles to increasing the maturity level? (18:30)
Helen, you have faced many challenges in introducing new medicines to clinical practice in Uganda, not the least of which is the need for more data from clinical trials conducted on local populations.
Q: What have been the consequences of inadequate drug efficacy and safety data? How will this situation change over the next several years? (24:00)
Q: Given unexpected safety issues post-approval, how do you think about risk management and pharmacovigilance? (29:00)
Q: How do you see the trajectory of regulatory capacity development changing over time? (30:20)
Q: Do you have any last thoughts? (33:00)
Supplemental Readings:
ISoP Africa gets a fresh start with its first chapter meeting in Uganda
Drug Development and Clinical Research in Africa Part 1: Reversing the Impact of Omitting More than One Billion People from Global Research
Expanding regulatory science: Regulatory complementarity and reliance
Glimpsing the Future of Regulatory Science
Acknowledgements:
We gratefully acknowledge Joe Brancato's generosity in allowing us to use his original composition of Extraordinary People as music for the podcast.
Brief Biographic Sketch:
Helen Byomire Ndagije, a pharmacist and clinical epidemiologist, is the Director of Product Safety at the National Drug Authority in Uganda.
Helen was instrumental in establishing a decentralized pharmacovigilance system in Uganda. She is the President of the African Society of Pharmacovigilance and a partner in the East African Community Pharmacovigilance Expert working group.
Helen has been the vice chairperson of the WHO-supported African Vaccine Regulator’s Forum (AVAREF), a network that strengthens the regulatory system for clinical trials of medicines and vaccines.
Helen is a leader in growing her agency's regulatory capacity in all aspects of clinical trials, good manufacturing practice, post-market surveillance, and pharmacovigilance. Her agency has implemented regulations and guidelines for regulatory review and simplified regulatory processes for drug development to foster clinical trials in Uganda.
Full Profile and Publications - Helen Byomire Ndagije, PhD
Profile
Pharmacist with a doctorate in Public health and over a decade of Pharmacovigilance achievements in regulation, research and policy in Uganda and Africa. I have a keen commitment to the improvement of Pharmacovigilance Systems across Africa.
Educational Background:
I hold a PhD degree from the Université Catholique de Louvain, Belgium and my thesis was “Monitoring Safety of Medicines in Uganda: Strategies for better Pharmacovigilance Systems in Settings with Limited Resources”. I also hold a Master’s degree in Business Administration from Herriot-Watt University, UK. I graduated with an undergraduate honors degree in Pharmacy and a Master of Science degree in Clinical Epidemiology and Biostatistics from Makerere University.
Professional Experience:
I joined the National Drug Authority as the Head of the Drug Information Department in 2006. I am the Director Product Safety at NDA and the head of the National Pharmacovigilance Centre in Uganda.
Contribution and service to ISoP
President of the African Chapter of ISoP since November 2019.
A member of the Patient Engagement SIG where I contributed to Patient Engagement SIG article proposing a paradigm shift in patient advocacy.
Reviewed documents of the Risk Management SIG.
Reviewed abstracts for the ISoP Bali 2023 and ISoP Verona 2022 annual scientific conference.
Pharmacovigilance Contributions
1. Panel discussions on pharmacovigilance in Uganda world patient safety days since 2019 to-date.
2. Presented about pharmacovigilance in Africa at the European November 2021 and 2022.
3. Published an expert opinion on Drug Safety in Africa, September 2023
4. Editor of quarterly pharmacovigilance bulletin of the National Pharmacovigilance Centre.
5. Developed accredited Pharmacovigilance CPD Course with Uganda Allied Health Professionals’ Council, July 2023
6. Reviewed the certificate, diploma and degree for adequacy of pharmacovigilance training curriculum in the health professional training institutions in Uganda and identified training gaps and opportunities for improvement, April 2023
7. Hosted the Africa chapter virtual meeting in 2020 following a needs assessment among the members.
8. Delivered a webinar on Good Pharmacovigilance Practice in 2021 during the COVID-19 pandemic restrictions.
9. Mentored and supervised 4 masters and PhD theses in pharmacovigilance.
10. Chaired the Regulatory team of Ugandan national COVID-19 response coordinating committee that advised the Ministry of health about the safety of vaccines.
11. Key note speaker at a webinar “PV and CTs oversight in the COVID-19 ERA” organized by the SPaRCS project- Strengthening Pharmacovigilance and Regulatory capacities in 4 Southern African countries (Namibia, Eswatini, South Africa and Zimbabwe), May 2021.
12. Reviewer of the UMC pharmacovigilance Regulatory e-learning course in 2021.
13. Participated in the COVID-19 Vaccines Safety Preparedness Working group of the WHO Global Advisory Committee on Vaccine Safety (GACVS) where the working group defined the elements of the pandemic and prepared guidance for COVID-19 vaccine safety preparedness at global, regional and national levels. This work also included pharmacovigilance preparedness, mapped capacities in countries.
14. Developed a community dialogue toolkit to enhance direct patient reporting model following a successful pilot in rural Uganda, Dec 2020.
15. Participated in two regulatory system assessments using the WHO Global Benchmarking of the National Regulatory System of Nigeria ‐ 17 to 21 June 2019 (pharmacovigilance) and Zanzibar Food and Drug Agency 14‐18 May 2018 (pharmacovigilance and clinical trials).
16. Local host for the 40th annual meeting of National Pharmacovigilance Centres’ participating in the WHO Programme for International Drug Monitoring in Kampala, November 2017.
17. Developed accredited Pharmacovigilance CPD Course with Uganda Nurses and Midwives Council.
18. Participated in setting the minimum requirements for pharmacovigilance for countries applying for global fund grants in 2010.
Publications
1. Ndagije HB, Walusimbi D, Atuhaire J and Ampaire S. Drug safety in Africa: a review of systems and resources for pharmacovigilance, Expert Opinion on Drug Safety, Sept (2023). https://doi.org/ 10.1080/14740338.2023.2251375
2. Kiguba, R., Zakumumpa, H., Ndagije, H.B. et al. Facilitators and Barriers to Uptake of the Med Safety Mobile App for Adverse Drug Reaction Reporting by Health Workers in Uganda: A Qualitative Study. Drug Saf 46, 565–574 (2023).
3. Younus MM, Alkhakany M, Bahri P, Caro A, Rostom H, Ndagije HB, and Elhawary MA. The ISoP PatEG-SIG for Promoting Patient Engagement in Pharmacovigilance: A Change of Paradigm is Needed. Drug Saf 46, 619–623 (2023). https://doi.org/10.1007/s40264-023-01313-4.
4. Zakumumpa H*, Kiguba R, Ndagije HB, Ategeka G, Ssanyu JN and Kitutu FE. Patient experiences of sexual dysfunction after transition to dolutegravir-based HIV treatment in mid-Western Uganda: a qualitative study. BMC Infectious Diseases. 2022 Aug; 22:692.
5. Kiguba R, Ndagije HB et al. Implementation of a peer support intervention to promote the detection, reporting and management of adverse drug reactions in people living with HIV in Uganda: a protocol for a quasi-experimental study. bmjopen-2021-056039.R3. Accepted for print in 2022 May.
6. Zakumumpa H, Kitutu FE, Ndagije HB, Diana NK, Ssanyu JN, Kiguba R. Provider perspectives on the acceptability and tolerability of dolutegravir-based anti-retroviral therapy after national roll-out in Uganda: a qualitative study. BMC Infectious Diseases. 2021 Dec 7;21(1):1222.
7. Kutyabami P, Munanura EI, Kalidi R, Balikuna S, Ndagire M, Kaggwa B, et al. Evaluation of the Clinical Use of Ceftriaxone among In-Patients in Selected Health Facilities in Uganda. Antibiotics. 2021 Jun 25;10(7):779.
8. Kiguba R, Ndagije HB, Nambasa V, Manirakiza L, Kirabira E, Serwanga A, et al. Pharmacovigilance of suspected or confirmed therapeutic ineffectiveness of artemisinin-based combination therapy: extent, associated factors, challenges and solutions to reporting. Malaria Journal. 2020 Dec 3;19(1):389.
9. Ogar C, Mathenge W, Khaemba C, Ndagije H. The challenging times and opportunities for pharmacovigilance in Africa during the COVID-19 pandemic. Drugs & Therapy Perspectives. 2020 Aug 26;36(8):351–4.
10. Ndagije HB, Kiguba R, Manirakiza L, Kirabira E, Sserwanga A, Nabirye L, et al. Healthcare professionals’ perspective can guide post-marketing surveillance of artemisinin-based combination therapy in Uganda. Malaria Journal. 2020 Dec 10;19(1):63.
11. Manirakiza L, Nambasa V, Nanyonga S, Serwanga A, Alphonsus M, Denis N, et al. Drug Use Evaluation (DUE) of Ceftriaxone in Mubende Regional Referral Hospital, Uganda: A Cross-Sectional Survey. Journal of Pharmacy and Pharmacology Research. 2019;03(03).
12. Ndagije HB, Manirakiza L, Kajungu D, Galiwango E, Kusemererwa D, Olsson S, et al. The effect of community dialogues and sensitization on patient reporting of adverse events in rural Uganda: Uncontrolled before-after study. PLOS ONE. 2019 May 9;14(5):e0203721.
13. Kiguba R, Ndagije HB, Nambasa V, Bird SM. Adverse Drug Reaction Onsets in Uganda’s VigiBase®: Delayed International Visibility, Data Quality and Illustrative Signal Detection Analyses. Pharmaceutical Medicine. 2018 Dec 17;32(6):413–27.
14. Ndagije HB, Nambasa V, Manirakiza L, Kusemererwa D, Kajungu D, Olsson S, et al. The Burden of Adverse Drug Reactions Due to Artemisinin-Based Antimalarial Treatment in Selected Ugandan Health Facilities: An Active Follow-Up Study. Drug Safety. 2018 Aug 7;41(8):753–65.
15. Ndagije H, Nambasa V, Namagala E, Nassali H, Kajungu D, Sematiko G, et al. Targeted Spontaneous Reporting of Suspected Renal Toxicity in Patients Undergoing Highly Active Anti-Retroviral Therapy in Two Public Health Facilities in Uganda. Drug Safety. 2015 Apr 7;38(4):395–408.
16. Kiguba R, Waako P, Ndagije HB, Karamagi C. Medication Error Disclosure and Attitudes to Reporting by Healthcare Professionals in a Sub-Saharan African Setting: A Survey in Uganda. Drugs - Real World Outcomes. 2015 Sep 25;2(3):273–87.
17. Kiguba R, Karamagi C, Waako P, Ndagije HB, Bird SM. Rare, Serious, and Comprehensively Described Suspected Adverse Drug Reactions Reported by Surveyed Healthcare Professionals in Uganda. PLOS ONE. 2015 Apr 23;10(4):e0123974.
18. Kiguba R, Karamagi C, Waako P, Ndagije HB, Bird SM. Recognition and reporting of suspected adverse drug reactions by surveyed healthcare professionals in Uganda: key determinants. BMJ Open. 2014 Nov 24;4(11):e005869.
Share this post