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Pharmacovigilance, risk mangement, poor quality medicines, adverse drug reactions, counterfeit medicines


The purpose of this study was to explore ways of improving the pharmacovigilance quality system employed by the Pharmacy and Poisons Board of Kenya. The Pharmacy and Poisons Board of Kenya employs a hybrid system of pharmacovigilance that utilizes an online system of reporting pharmacovigilance incidences and a physical system, where a yellow book is physically filled by the healthcare worker and sent to the Pharmacy and Poisons Board for onward processing. This system, even though it has been relatively effective compared to other systems employed in Africa, has one major flaw. It is a slow and delayed system that captures the data much later after the fact and the agency will always be behind the curve in controlling the adverse incidents and events. This means that the incidences might continue to arise or go out of control. This project attempts to develop a system that would be more proactive in the collection of pharmacovigilance data and more predictive of pharmacovigilance incidences. The pharmacovigilance system should have the capacity to detect and analyze subtle changes in reporting frequencies and in patterns of clinical symptoms and signs that are reported as suspected adverse drug reactions. The method involved carrying out a thorough literature review of the latest trends in pharmacovigilance employed by different regulatory agencies across the world, especially the more stringent regulatory authorities. A review of the system employed by the Pharmacy and Poisons Board of Kenya was also done. Pharmacovigilance data, both primary and secondary, were collected and reviewed. Media reports on adverse drug reactions and poor-quality medicines over the period were also collected and reviewed. An appropriate predictive pharmacovigilance tool was also researched and identified. It was found that the Pharmacy and Poisons Board had a robust system of collecting historical pharmacovigilance data both from the healthcare workers and the general public. However, a more responsive data collection and evaluation system is proposed that will help the agency achieve its pharmacovigilance objectives. On analysis of the data it was found that just above half of all the product complaints, about 55%, involved poor quality medicines; 15% poor performance, 13% presentation, 8% adverse drug reactions, 7% market authorization, 2% expired drugs and 1% adulteration complaints. A regulatory pharmacovigilance prioritization tool was identified, employing a risk impact analysis was proposed for regulatory action.