**2. Making a case for improved pharmacovigilance**

Pharmacovigilance (PV), the practice of the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, has been promoted over the last two decades in Low- and Medium-Income Countries (LMIC). Nonetheless, the systems and coordinated efforts to support the reporting of Adverse Drug Reactions (ADRs) remain suboptimal in these settings [12]. The Therapeutic Information and Pharmacovigilance Centre (TIPC), a unit of the Ministry of Health and Social Services, Namibia, is a case in point. The quantitative and qualitative impact of such centres in SSA, on informing policy change on drug choice, safety and effectiveness of medicines Namibia remains underutilized.

Healthcare workers in both public and private healthcare facilities in Namibia are believed to under-report ADRs; this might be partly due to a poor acceptance and implementation of pharmacovigilance systems at health facility level [13, 14]. In most LMICs such as Ethiopia, among the factors that promote underreporting of ADRs, are lack of awareness of ADRs Monitoring Centres (AMC) and pharmacovigilance program in the settings, complacency, lack of training to identify ADRs etc. [15, 16]. In addition, about half of the health workers do not know how to report ADRs and/or are not aware of the existence of a formal ADR reporting schemes.

#### **2.1 Improving adverse drug reactions reporting in resource limited settings**

Healthcare workers are vital to effective reporting adverse events within healthcare systems; however, the place of patients should not be under-emphasized. In a country like Namibia where most or all of the reports received by the TIPC come from healthcare workers, such system does not have the political strength to empower patients to report whatever they experience after they have left healthcare facilities and started taking medicines prescribed. It is evident that the reports submitted to TIPC will be limited, thus, it is necessary for the system to create awareness by promoting pharmacovigilance among the populace.

Another vital area that should be looked at it, is the mode of reporting. In the **Figure 1** above, it reveals the average number of reports submitted to TIPC over a period of 10 years. It should be highlighted that the reports were made using the Yellow Form – paper-based reporting modality, this has its limitations, especially in

#### **Figure 1.**

*Number of reports submitted to TIPC per year, between 2009 and 2019 (adapted from [5]—Developing an electronic mobile reporting modality for pharmacovigilance in Namibia).*

an era of advanced electronic communication, Adenuga et al. [5], commented on the need to develop a mobile electronic platform for reporting of ADRs which will be accessible to both healthcare workers and the entire populace. An engaging session that will not only focus on the healthcare professionals can assist in mitigating the low number of ADR reports in a LMIC such as Namibia.

Stakeholders such as policy makers and healthcare workers at different levels of the health system has to be aware of the possible impact of adverse events such as ADRs, medication errors, etc. on individual patient and the health system as a whole, thus the need to develop policies, guidelines and advocacy programs geared towards better patient management, which might include proper record keeping at every level of the healthcare delivery system. Economic consequences of a huge burden of ADRs can undermine the provision of quality healthcare services. This calls for both social inclusion and intersectoral engagements of entities such as Non-Governmental Organisations (NGOs) and Community-Based Organisations (CBOs), which might have closer relationships with people at the grassroots (patients being the focus of such activities), thus, might be able to pass across the "gospel effective medicine stewardship".

Primary Health Care (PHC) facilities such as clinics and health centres, are the first contact of patients with the health system, these should be utilized in maximizing the reach of pharmacovigilance campaigns. Educating healthcare workers at PHC level on the need for effective pharmacovigilance will go a long way in mitigating the impact of adverse events on patients, health system and the country as a whole. It should be highlighted the adverse events have both debilitating and mortifying effects on individuals and can negatively impact the growth of a country if conscious efforts are not taken to put their development in check.

Engaging healthcare workers in the private settings on the need to know and realize the necessity of reporting suspected adverse events will reveal the inclusiveness of the endeavour; with pharmacovigilance being a collaborative activity, it is essential that every stakeholder should be involved. The need to engage every stakeholder including patients cannot be over-emphasized.

For this to be achieved, political will and effective stakeholder engagements will be vital. Adenuga et al. [17], highlighted how this can be achieved.

Some strategies that can be used to social inclusiveness and effective stakeholder engagements are explained below.

#### **2.2 Introducing pharmacovigilance into the curriculum of healthcare workers**

A shift in the training paradigm of healthcare workers through the introduction pharmacovigilance into both pre-registration and registered educational systems might improve pharmacovigilance and subsequently reports being generated by these healthcare workers.

Incentives such Continuing Professional Development (CPD) points, can serve as an encouragement for some healthcare workers. This was highlighted by respondents in study carried out by Adenuga et al. [14].

#### **2.3 Social engagements and needs assessment**

Tailoring interventions to the peculiarity of communities requires social engagement and needs assessment. In settings with low pharmacovigilance knowledge and practice among healthcare as seen in many sub-Saharan African countries [18], it is necessary to develop interventions that are locally feasible and acceptable so as to achieve the goals of pharmacovigilance. Creation of awareness among patients/general population (primary stakeholder), healthcare workers at different levels of the health system (students and workers), policymakers (government, non-governmental organisations (NGOs), community-based organisations (CBOs) and private sector (health- and non-health related)) is important. Such awareness programs have to be suited to the group in question, so as to be able to produce the desired results.

Pharmacovigilance Centres can carry out public awareness campaigns for example road-shows or through dedicated activities t cultural events, to highlight the need for pharmacovigilance. Such an initiative will help improve public awareness regarding pharmacovigilance, ADRs and their reporting.

#### **2.4 Policy development and implementation**

Development of policies and guidelines by the health policymakers at different levels of the healthcare delivery system, in conjunction with other stakeholders, that will enhance pharmacovigilance. Policies developed should assure healthcare workers there will be no litigation or reprimand for reporting whatever event they picked up or encounter in the course of managing their patients. In other to achieve effectiveness of policies, implementation pathway has to be incorporated into the policies and proper management frameworks should be itemized prior to rollout of the policies.

Effective engagement with stakeholders involved in the development of these policies, implementation and eventual rollout will not be cumbersome if everyone was carried along from the onset and they realize each one of them has a role to play.

#### **2.5 Inclusive pharmacovigilance systems**

Social inclusiveness has been highlighted as one on of the ways of engaging the community in pharmacovigilance activities, such inclusiveness should be centred around patients. Enhanced functionality of Therapeutic Committees at the facility and regional levels in pharmacovigilance activities might assist in the promotion of better patient management and contribute to a reduction in the costs due to ADR. However, patients or their advocates or representatives can be included in Therapeutic Committee meetings, thus, allowing them to see and appreciate what goes into patient management.

Patient reporting platforms, either in an electronic format or paper-based systems, can assist in getting first-hand reports, thus, boosting the number of ADR reports received by Pharmacovigilance Centres. Patient reporting has been identified as one of the avenues that might contribute to more ADR pool within a country in some settings. In this vein, allowing the general population to provide the regulatory authority with reports will be seen as improved awareness and such an initiative will, in the long run reduce ADR burden thus, affording the Ministry of Health better patient management.

Considering widespread use of electronic devices, introduction of a mobile electronic platforms for reporting ADRs, working in conjunction with mobile telephone networks at no cost to reporters might assist in boosting the number of reports received or submitted to pharmacovigilance centres. Paper-based reporting modality cannot be phased in the nearest future, taking into consideration those areas within the country or individuals with no access to electronic devices.
