**1. Introduction**

Pharmacovigilance is a necessity in any healthcare setting [1]. Adverse drugs reactions (ADR) reporting, a major part of pharmacovigilance, is either not reported or under-reported in different settings all over the world [2]. Number of ADR reports received by a national pharmacovigilance centre reflects how effective the pharmacovigilance systems are, within the country [3]; it is the role of regulatory agencies which are either part of Ministries of Health or parastatals within such ministries to ensure the quality, safety and efficacy of medicines that are approved by National Regulatory Authorities (NRA), thus, protecting the health of the population. Development of effective systems to mitigate gaps due to low level of pharmacovigilance in the healthcare system so as to enhance ADR reporting by both healthcare workers and patients is important [4].

It should be emphasized that policy development and enforcement of implementation of such policies are important and integral role of Ministry of Health through their departments such as the Namibia Medicines Regulatory Council (NMRC), South Africa Health Products Regulatory Agency, Medicines Control Authority of Zimbabwe, etc.

Using Namibia as an example, the number of ADR reports received by the Therapeutic Information and Pharmacovigilance Centre (TIPC) is relatively low in comparison to the population [5]. This is not in line with the stated number of reports that should be submitted to WHO Upsala Monitoring Centre (WHO-UMC), i.e. 200 reports per 1,000,000 population; with an assumption that a country with a population similar to Namibia should be reporting at least 400 ADRs per year. Below is a figure showing the number of ADR reports submitted to NMRC between 2009 and 2019.

According to Kiguba et al. [6], health systems in low- and middle-income countries (LMICs) are fragile, this is reflected in the capacity of pharmacovigilance structures available within the health systems. As highlighted earlier, the number of ADR reports submitted to pharmacovigilance centres is an indication of the strength of that system. Some of the factors associated with observed challenges facing pharmacovigilance centres and invariably, the structures, which include,


### **1.1 Linking the unlinked**

According to Adenuga et al. [5], it is imperative to develop effective links between stakeholders within the healthcare system and outside it so as to achieve the goal of effective pharmacovigilance. Below is a conceptual framework developed by the authors. The central theme is focused on patients. Effective pharmacovigilance of medicines is part of the Sustainable Development Goals (SDGs) [7].

#### *Embracing the Changing Needs for Pharmacovigilance in Africa DOI: http://dx.doi.org/10.5772/intechopen.106356*

(Adapted from Adenuga et al. [5]. Conceptual framework for effective stakeholder engagement for pharmacovigilance in a resource limited setting)

Funding of health programs has been a bane of developing the healthcare system in some developing countries [8, 9], with most funding coming from donor organisations such as United States Agency for International Development (USAID), FHI 360, Bill and Melinda Gates Foundation and other similar organizations [10, 11]. An example is the establishment of the Pharmacovigilance Centre in Namibia through funding from USAID.

Marketing Authorisation Holders (MAH) of registered medicines can be engaged in patient management with regard to pharmacovigilance, especially, with respect to the applicants who register generic products, might assist in better pharmacovigilance of such medicines or products.
