Project: East Africa Pharmacovigilance Initiative

Acronym	EAPI (Reference Number: EDCTP-Ethics2015-876)
Duration	01/03/2017 - 29/02/2020
Project Topic	The East African Pharmacovigilance Initiative is a partnership between the Pharmacy and Poisons Board and the University of Nairobi. The project also works with other organisations and stakeholders. The Pharmacy and Poisons Board (PPB) is the National Drug Regulatory authority in Kenya mandated to ensure that clinical trials involving the use of new investigational drugs and older drugs for new conditions or diseases or investigational devices in human subjects are in compliance with national regulations including procedures to protect the safety of all participants. The University of Nairobi is the first to train pharmacists in Kenya. University of Nairobi and the Pharmacy and Poisons Board are both jointly a Regional Center of Regulatory Excellence (RCORE) for Pharmacovigilance under the New Partnerships for African Development (NEPAD). PPB is responsible for registration of medicines and post-marketing surveillance and detection of adverse reactions to medicines. Substandard medicines including poor quality and counterfeit drugs are prevalent in Africa and can no longer be ignored. The proposed midterm solutions to the problem is short term trainings in pharmacovigilance. The long-term solutions include postgraduate training to build regulatory and ethical review capacity in the Master of Pharmacy programme. Surveys on the capacity gaps of drug regulatory agencies recommended improving pharmacovigilance, monitoring of clinical trials and management of the reporting systems. Drug regulatory agencies in many sub-Saharan African countries have limited budgets and cannot train highly qualified staff even though they may be needed. Part-time drug evaluators drawn from academia have been used to fill capacity gaps.  They require experiential training to effectively fulfil their social obligations. The project has supported faculty from the School of Pharmacy to prepare e-learning material to support the Master’s in Pharmacovigilance and Pharmacoepidemiology programme at the University of Nairobi. Content is now complete and it will facilitate blended learning as a model to offer access by pharmacists in Kenya and beyond. Furthermore, the partnership is undertaking to improve collection, analysis and relays of pharmacovigilance reports to the European Medicines Agency and the World Health Organization contributing to the international network for pharmacovigilance. The project has developed a drug coding system, which is expected to be piloted over the next year. The system will enrol pharmacists and prescribers in a network which allows track and tracing of pharmaceuticals in Kenya as an integral non- voluntary process. The system will allow continuous reporting by health professionals and patients as well. Communication at the start of the project has been done within the Pharmaceutical Society of Kenya and other target presentations is anticipated in meetings with regulatory authorities in East and Southern Africa, country health pharmacists, pharmaceutical industry, ERCs, NGOs in the health sector and representatives from the donor communities in partnership with the Pharmacy and Poisons Board. Presentations about the project and the mission to strengthen pharmacovigilance will create awareness and invite support by the wider network of players in the health sector.
Network	EDCTP2
Call	Ethics and Regulatory capacities 2015

Project partner

Number	Name	Role	Country
1	University of Nairobi	Coordinator	Kenya
3	Pharmacy and Poisons Board	Partner	Kenya