The Process of Developing a Pharmacovigilance Policy: Experiences from Nigeria and Eswatini

Background/Introduction: The increasing awareness of the importance of medicines safety amongst the population on the African continent necessitated the development of a national policy on pharmacovigilance (PV) that ensures multistakeholder participation of various actors concerned with the use of medicines. Moreover, a consensual document taking into cognisance stakeholders inclusive of the conventional Ministry of Health (MOH), National Medicines Regulatory Authority (NMRA) and Market Authorization Holders (MAH) as well as patients/consumers is likely to embrace issues of medicine safety in-depth without undermining other extant statutory laws and regulations. Such a document is likely to strengthen PV with increased reporting of adverse drug reactions which has been low due to several prevailing factors in resource limited settings. The use of a Standalone PV document will obviate the present situation where PV policies are embedded as terse statements in other health and pharmaceutical policy documents. Objective/Aim: To present a practical outline for use in the development of a PV Policy document. Methods: The initial step was an advocacy engagement at government levels on the need for a policy document as a tool to further strengthen PV. The arrow head was the National Drug Safety Advisory Committee (Nigeria) and the PV Unit (Eswatini). Following approval, the responsible organs of Government on Policy development as well as the MOH and the NMRAs carried out further preparatory work. Multisectoral stakeholders were then identified and invited for a number of intense discussions on various aspects of the PV system. A framework was developed so as to capture the processes and note the provisions for the various elements of the Policy. A zero draft was developed by a core team and further circulated for notification, clarifications, inputs etc. from stakeholders and a general call for comments. Subsequent drafts had the input of other organs in the system to avoid conflicts with extant laws and regulations. Following a final stakeholder engagement, the draft was forwarded to the requisite organs and the MOH for endorsement and thereafter approval was granted by the Executive/Management Results: The process was used in the development of PV policy documents for Nigeria [2, 3] and Eswatini [4] in 2010 and 2020, respectively. Conclusion: The consensual development of the policy documents with intense multisectoral stakeholder engagement provides a tool l