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Item Optimising adverse drug reactions reporting and strengthening of pharmacovigilance systems in Namibia(University of Namibia, 2021) Adenuga, Babafunso AderemiSpontaneous adverse drug reaction (ADR) reporting is a vital part of pharmacovigilance activities within a health system. Under-reporting of adverse drug reactions is a widespread phenomenon among healthcare workers. Little is known about the culture of reporting among healthcare workers in public healthcare settings in Namibia, in particular, in relation to adverse drug reactions. This required the determination of the basal effectiveness of pharmacovigilance systems and the capacity of the healthcare workers within the health system to carry out pharmacovigilance activities and the development of ways of mitigating whatever gaps exist within the system. This research depicted the current state of pharmacovigilance within the health system, healthcare workers‘ reporting abilities and capabilities, patient-level dynamics and possible pharmacovigilance system optimisation. Chapter 1, the general introduction, provided a background to the need for and the state of pharmacovigilance in Namibia and other low- and middle-income countries. It highlighted the challenges faced by healthcare workers in reporting ADRs and the possible ways of mitigating the challenges. Chapter 2, the literature review, discussed different aspects of therapeutics, links between therapy and development of adverse events, culture of pharmacovigilance in different regions of the world and identified ways of mitigation under-reporting among different cadres of healthcare workers. Chapter 3 sought to know the treatment outcomes of patients after the introduction of atazanavir boosted with ritonavir (ATV/r) as a preferred second-line protease inhibitor on the health of patients compared with lopinavir boosted with ritonavir (LPV/r) based second-line regimens with respect to the reported ADRs. Most ADR cases received on these two regimens were linked to ATV/r; however, no conclusion can be made considering the possibility of under-reporting of possible and suspected cases. Following the results obtained at patient-level, Chapter 4 evaluated and explored the reasons for the underreporting of ADRs by healthcare workers and the factors associated with such reasons in Namibia through a cross-sectional quantitative survey. Nursing cadre was the only predicting factor for under-reporting of ADRs among the healthcare workers, adjusted odds ratio (aOR) = 0.17(95% CI: 0.07, 0.401, p<0.01). Particular attention may be focussed on the nursing cadre because they are the first healthcare professionals seen by patients in the public healthcare sector. In a bid to develop an optimisation plan for strengthening the pharmacovigilance and ADRs reporting, a contextual study of the knowledge of 8 key informants about the pharmacovigilance system in Namibia and proposed ways of optimising the existing system was carried out in Chapter 5. Chapter 6 presents an electronic tool (Epicollect5® as a platform) that was developed in a bid to mitigate the under-reporting of ADRs. The tool was introduced and piloted during several training sessions among healthcare workers in Namibia, both in the public and private healthcare sectors. Chapter 7 presented the recommendations and conclusions drawn from the different studies in this research. In conclusion, in order to optimise the pharmacovigilance and ADR reporting system in Namibia, there is a need for political will on the part of decision-makers, mandating healthcare workers to report any suspected ADR by using designated means such as paper-based or electronic reporting platforms (considering the challenges related to paper-based reporting systems). Provision of feedback in the form of ADR case report analysis by the Therapeutic Information and Pharmacovigilance Centre to the reporting healthcare worker or facility will facilitate good rapport between the two parties. Incorporating pharmacovigilance into the curriculum of medical, pharmacy and nursing students can bridge the gap between knowledge and practice. Conducting in-service and continuing professional training might assist in providing the necessary education for older healthcare workers. The need for advocacy for pharmacovigilance among healthcare workers and patients cannot be overstated; involving facility-level and regional-level Therapeutic Committees in pharmacovigilance through advocacy, promotion and analysis of reported cases will go a long way in stimulating ownership of the activity.