Lifting the standards of drug safety in East Africa is the aim of a new project led by the Karolinska Institutet in Sweden.
While access to drugs and vaccines has increased in many African countries over recent years, the systems for monitoring treatment effects and reporting side-effects require further development, according to the institute. To remedy the problem the Karolinska Institutet is leading an international collaboration project on pharmacovigilance – dedicated to improving drugs safety – in four countries in East Africa.
Scientific coordinator for the project, Eleni Aklillu said: “The main aim of this project is to strengthen the national infrastructures for drugs safety monitoring in our partner countries in Africa. This involves developing regulatory capacity for routine surveillance and reporting, and training of staff working in healthcare and medical services and regulatory authorities.”
Drugs safety monitoring’
The project – known as PROFORMA – involves researchers from the Swedish institute working in partnership with researchers and experts from universities and regulatory authorities in Ethiopia, Kenya, Tanzania and Rwanda. Some regional and international stakeholders in the field of drugs safety are also taking part.
The PROFORMA is estimated to last five years and involve training at Master’s and postgraduate level and the exchange of knowledge between researchers and health care experts.
“The increasing number of clinical trials and different types of mass drug administration and vaccination programmes in African countries underlines the need to strengthen pharmacovigilance infrastructure,” said Aklillu, who is senior researcher at the Department of Laboratory Medicine at Karolinska Institutet and scientific coordinator for the project.
“One important tool is to improve collaboration between the Medical Universities and regulatory authorities in the countries concerned, and we’ve already made good progress in this area during the few months we’ve been working on the project,” added Aklillu.
Project funding is 6 million euros
The total project funding is 6 million euros, most of which is provided by the EU Framework Programme for Research and Innovation-Horizon2020, via the European and Developing Countries Clinical Trials Partnership (EDCTP). Other significant funding is being supplied by the Swedish International Development Cooperation Agency (SIDA), Karolinska Institutet, the Pharmacy and Poisons Board of Kenya, Muhimbili University of Health and Allied Sciences of Tanzania and the Tanzania Food and Drugs Authority.
More information about the project – which carries the full title: Pharmacovigilance infrastructure and post-marketing surveillance system capacity building for regional medicine regulatory harmonization in East Africa – is available here.
Meanwhile, the Karolinska Institutet in Stockholm is one of the world’s foremost medical universities. The institute is the country’s single largest centre of medical academic research and offers the country’s widest range of medical courses and programmes.
Since 1901, the Nobel Assembly at Karolinska Institutet has selected the Nobel laureates in the disciplines of Medicine and Physiology.