Enhancing drug-safety monitoring

Increasing access to new medications in sub-Saharan Africa is highlighting the need for effective national drug-monitoring systems.

Protecting participants in clinical trials, and the general public once new medicines are introduced, requires effective systems to monitor for potential adverse reactions (pharmacovigilance). Comprehensive systems need to be in place to identify reactions when they occur, to investigate them to determine whether they are truly related to a new intervention, and to take action if public health is threatened.

Many countries in sub-Saharan Africa have weak infrastructure for pharmacovigilance. Building pharmacovigilance capacity is part of several EDCTP-funded projects building national regulatory capacity in clinical research. For example, the Africlinique project, funded in 2019, is building pharmacovigilance capacity in countries in Central Africa, starting with Cameroon and the Republic of the Congo, in collaboration with EU institutions and regional bodies such as the African Vaccine Regulatory Forum (AVAREF) and the EDCTP-funded Central African Network on Tuberculosis, HIV/AIDS and Malaria (CANTAM).

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The PROFORMA project has brought together Ethiopia, Tanzania, Kenya and Rwanda. It has also undertaken baseline national assessments and begun to develop country-specific pharmacovigilance improvement plans. It has also assessed current pharmacovigilance teaching in East Africa in order to inform curriculum development. The project is initially focusing on mass drug administration campaigns and vaccine introductions.

Two major international projects are also focused on pharmacovigilance. The PAVIA project is building pharmacovigilance capacity in Eswatini, Ethiopia, Nigeria and Tanzania. It has established links between key national stakeholders and undertaken baseline studies of national pharmacovigilance capabilities, to inform the development of national capacity-building plans. It is also engaging with the African Union Development Agency (AUDA-NEPAD), to coordinate activities, particularly regarding the African Union Model Law for Medical Products Regulation. The project is initially focusing on TB treatment, with the potential to expand into other disease areas.

In addition, the EAPI project is addressing the shortage of capacity within national regulatory agencies to conduct pharmacovigilance activities. EAPI is a partnership between the Pharmacy and Poisons Board – the national regulatory agency in Kenya – and the University of Nairobi. The partners are jointly developing e-learning materials to enable academic staff to contribute to practical national pharmacovigilance activities. The virtual training tools could also be used to develop capacity across other countries in East Africa.

In addition, the newly awarded SPaRCS project is supporting coordinated development of pharmacovigilance capacity in four southern African states – Eswatini, Namibia, South Africa and Zimbabwe – helping to build a sub-regional community of practice to promote coordinated capacity development.

Project Q&A

PROFORMA

The PROFORMA project is developing the drug safety monitoring capacities of four East African countries. We asked Prof. Eleni Aklillu, PROFORMA project coordinator, about the expected impact of the project and achievements in 2019.

What are the pharmacovigilance challenges in sub-Saharan Africa? How will the project address them?

In recent years, access to new drugs and new vaccines in Africa has increased, yet national systems for monitoring the safety of medicines require further development. Shortage of pharmacovigilance-trained personnel and lack of coordination between national medicine regulatory authorities (NMRAs), public health programmes, health care professionals and researchers to monitor public safety and detect adverse events are major gaps that need urgent pharmacovigilance capacity development in sub-Saharan Africa.

PROFORMA, a 5-year multinational collaborative project, aims to strengthen national pharmacovigilance regulatory capacity and post-marketing surveillance systems for drugs and vaccines deployed in Ethiopia, Kenya, Rwanda and Tanzania. To achieve these objectives, PROFORMA has established a trilateral partnership (called the PROFORMA Model) between local academia (for training-of-trainers), NMRAs (establishing policy and regulations) and public health programmes (changing policy into practice).

Through these unique stakeholder collaborations and a network established within and across the four participating African countries, PROFORMA is engaged in short- and long-term pharmacovigilance training and research to produce a critical and sustainable mass of pharmacovigilance-trained personnel in East Africa.

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Professor Eleni Aklillu
(Sweden)

What progress was made in 2019?

We first conducted a comprehensive baseline assessment of the existing pharmacovigilance systems and practices in Ethiopia, Tanzania, Rwanda and Kenya to identify the missing pharmacovigilance structural elements, strengths, deficiencies and gaps. Based on the identified gaps, a comprehensive national pharmacovigilance roadmap and interventional measures aligned with the local needs and priorities were developed and introduced in each country.

A total of 10 students (seven PhDs and three MScs) were registered and are currently pursuing their postgraduate studies to serve as part of the future pharmacovigilance expert regional task force. A one-week undergraduate pharmacovigilance curriculum was developed and adopted by local medical universities.

In 2019, more than 45,000 individuals who received mass drug administration (MDA) as preventive chemotherapy for the control of neglected tropical diseases have been actively followed for safety monitoring as detailed below:

  • Mass praziquantel and albendazole administration for the control of schistosomiasis and soil-transmitted helminths in 6,000 school children living near Lake Hawassa in Southern Ethiopia
  • A similar use of praziquantel and albendazole for the treatment and control of schistosomiasis and soil-transmitted helminths in 10,000 school children living near Lake Kivu in Rwanda
  • Mass administration of ivermectin and albendazole for the control of lymphatic filariasis and onchocerciasis in 10,000 individuals from Tanga region, Tanzania
  • Mass administration of diethylcarbamazine and albendazole with or without ivermectin for the control of lymphatic filariasis in 20,000 individuals from Mombasa, Kenya
  • Active safety surveillance of human papillomavirus (HPV) vaccine in more than 3,000 vaccinated girls in Addis Ababa, Ethiopia

In addition, more than 2,000 individuals across the different stakeholder groups, including healthcare professionals and community healthcare workers, were trained on active cohort safety monitoring and data collection.

What comes next?

Currently data analysis and manuscript writing is ongoing for all pharmacovigilance studies conducted through the PROFORMA project, and results will be published in peer-reviewed scientific journals. Findings from the pharmacovigilance studies are being disseminated to all local stakeholders, including regulatory staff, public health programmes and healthcare practitioners.

We are developing a pharmacovigilance e-learning module for health care professionals to be hosted by local medical universities in Kenya, Ethiopia, Tanzania and Rwanda. Likewise, curriculum development has begun for postgraduate training in pharmacovigilance and pharmaco-epidemiology.

Country-specific interventional measures designed based on the baseline assessment will continue being implemented, including short-term pharmacovigilance training workshops.

This project will have a lasting impact in strengthening pharmacovigilance and post-marketing surveillance systems. It will enhance systems for spontaneous reporting, collection and analysis of adverse events associated with the use of drugs, identification of signals or emerging problems, communication to minimise or prevent harm, and provide evidence for regulatory action to protect public safety.

Project: PROFORMA project: Pharmacovigilance Infrastructure and Post-Marketing Surveillance System Capacity Building for Regional Medicine Harmonisation in East Africa

Project lead: Professor Eleni Aklillu, Karolinska Institute, Sweden

Countries involved: Ethiopia, Kenya, Rwanda, Sweden, Tanzania

Target population(s): All

Year funded: 2018

EDCTP funding: €3 M

Total project funding: €6 M

Grant agreement: CSA2016S-1618

Project website: https://proforma.ki.se/

Professor Eleni Aklillu


PROFORMA is engaged in short- and long-term pharmacovigilance training and research to produce a critical and sustainable mass of pharmacovigilance-trained personnel in East Africa.

Night blood screening for Lymphatic Filariasis microfilaria in Tanga, Tanzania

Laboratory technicians screening for Schistosomiasis in Rwanda

Project Q&A

EAPI

The EAPI project is building pharmacovigilance capacity in Kenya by strengthening links between academia and national regulatory agencies. We asked Dr Kefa Bosire, EAPI project coordinator, a few questions on the impact of the project and achievements in 2019.

What are the challenges of pharmacovigilance in sub-Saharan Africa? How will the project address them?

Pharmacovigilance challenges in sub-Saharan Africa include insufficient qualified human resources, technology, and financial resources. The East Africa Pharmacovigilance Initiative attempted to demonstrate that limited investment can be used to enhance training numbers and quality while retaining personnel at their workplaces, by using blended learning as opposed to traditional face-to-face methods. The project successfully developed 11 modules for short courses in pharmacovigilance and 13 for a Master’s in Pharmacovigilance and Pharmacoepidemiology.

The project also developed two complementary mobile applications to provide an automated method of capturing pharmacovigilance and other information about the distribution and use of medicines. These are an enhancement on the previous method that relied on voluntary paper reports.

In relation to pharmacovigilance on snakebites, the project also facilitated the development of a national guideline on prevention and management of snakebites, with an accompanying short course with modular options suited for either the public or healthcare providers.

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Dr Kefa Bosire
(Kenya)

What progress was made in 2019?

In 2019, the project completed the conversion and online publication of the short courses on pharmacovigilance and management of snakebites. The project completed the alternate mechanism for collecting pharmacovigilance information from pharmacies using a feedback system that can run on mobile phones.

What comes next?

The East African Pharmacovigilance Initiative will live on as a multifaceted project that seeks to utilise technological innovations to improve patient safety by evaluating mobile or internet-based solutions suited for resource-limited settings in Africa.

The project put together a system for identifying skills gaps, training strategies and materials to suit the background of target audiences, ranging from the public to specialised pharmacovigilance personnel. The project has continuously adapted how it used the mobile or internet platforms that have proved visionary later in the era of COVID-19.

Prior to the EAPI project, all teaching on the Master of Pharmacy course was face to face. As a pilot, EAPI led a review of the curriculum and content writing for adoption of online support for the Master’s in Pharmacovigilance and Pharmacoepidemiology. It is the only master’s level course that had ready content out of 13 in the School of Pharmacy and over 50 in the rest of the University of Nairobi College of Health Sciences. It was the only programme in the College that was fully COVID-19-proof by design.

It has now become clear that the drug-tracking software and patient drug feedback systems developed by EAPI would have been a vital source of live data that could greatly improve public health management during the COVID-19 pandemic. The tools provide live data on drug use down to individuals and their locations. Use of AI would have helped compare patterns of infection transmission as a layer over drug use. If the applications were fully implemented, treatment outcomes based on the coincidence in medications used would help us see which concurrent medicines are helping the spread or slowing it down.

We at EAPI plan to seek funding to assess the impact of the EDCTP investments, including contributions in a crisis such as the COVID-19 pandemic.

Project: EAPI project: East African Pharmacovigilance Initiative

Project lead: Dr Kefa Bosire, University of Nairobi, Kenya

Countries involved: Kenya

Target population(s): All

Year funded: 2017

EDCTP funding: €300,000

Grant agreement: CSA2015ERC-876

Project website: http://eapi.uonbi.ac.ke/

Dr Kefa Bosire


The project successfully developed 11 modules for short courses in pharmacovigilance and 13 for a Master’s in Pharmacovigilance and Pharmacoepidemiology.

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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