East African Pharmacovigilance Initiative (EAPI)
EAPI is a partnership between the Pharmacy and Poisons Board and the University of Nairobi funded by European & Developing Countries Clinical Trials Partnership (EDCTP) grant number; EDCTP CSA Ethics 876 EAPI (CSA Ethics and Regulatory Capacities). The project also works with other organizations 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 are short term training in pharmacovigilance. The long-term solutions include postgraduate training to build regulatory and ethical review capacity in the Master of Pharmacy program. 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 countries have limited budgets and cannot hire highly qualified staff even though they may be available. Part-time drug evaluators drawn from academia have been used to fill capacity gaps. They require experiential training to effectively fulfill 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 program at the University of Nairobi. When complete, it will facilitate use of blended learning as a model to offer access by pharmacists in Kenya and beyond. Further, 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 web reporting portal and the accompanying videos are undergoing changes to make the site more attractive for reporting by health professionals and patients.
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, county 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.
Dr. Kefa Bosire
EAPI Project Principal