Embracing the Changing Needs for Pharmacovigilance in Africa

Abstract

Growing burden of communicable and non-communicable diseases in sub-Saharan Africa has necessitated the need for increased medicine use among the African population. Owing to the limited manufacturing capacity of medicines in the sub-continent, it became imperative for governments and Central Medical Stores to source medicines from countries such as India, Bangladesh and China. Such procurements were due to the affordability of generic products manufactured by manufacturers in these countries compared to innovator s, which might come at exorbitant prices and costs that might be prohibitive for most developing countries such as the ones in sub-Saharan Africa. Ascertaining the quality and efficacy of these products are always reliant on the judgment of national regulatory authorities (NRA), which might be ill equipped in most instances; human capacity both in knowledge and number are some of the banes of such NRAs. Aforesaid, pharmacovigilance does not take the front seat in most discussions rather the burden of diseases, thus the emphasis on medicines availability. Different researchers have highlighted the link between medicines/drugs availability and the need for pharmacovigilance among healthcare workers, policy makers and patients. Such approach will tend to limit the procurement of medicines that are substandard, falsified or fake, with the aim of protecting public health.

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. Integration of pharmacovigilance activities into mainstream healthcare system

2. Unreliable pharmacovigilance systems

3. Capacity and capability of pharmacovigilance personnel

4. Undefined relationship between regulatory authority and marketing authorisation holders

5. Reporting tools or modalities that are outdated

6. Awareness among healthcare workers and patients

7. Unavailability of drug utilization data

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].

(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.

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 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.

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).

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.

2.6 Inclusion of patient information leaflet (PIL) in every product

Mandatory inclusion of the details of MAH pharmacovigilance person within their organisation (preferably based within every country where their product is marketed) in the PIL accompanying medicines dispensed to patients will assist patients in knowing where to direct their enquiries or reports apart from their National Pharmacovigilance Centres; this can promote ease of reporting by the public/patients. In other for this initiative to be effective, pharmacovigilance centres along with the policymakers at the MoH will have to develop policies or regulations that will strengthen this position.

Since knowledge is vital in pharmacovigilance, inclusion of PIL in medicines packs that are self-administered by patients will help patients gain knowledge of the medicines they are taking and what ADRs to expect.

2.7 Standard operating procedures (SOP) in private practice settings

Pharmacovigilance Centres in conjunction with private healthcare practitioners can develop SOPs that will be kept at facilities. Such SOP will assist healthcare workers in ADR management and reporting, and all employees within the practice should be trained on such. The private practices envisaged should include suppliers of pharmaceuticals (i.e. wholesale distribution outlets, compounding pharmacies) and manufacturers.

2.8 Advocacy and educational interventions

Pharmacovigilance has an impact on the overall health of a population and the cost of healthcare services. In particular, strengthening the health system through incorporation of pharmacovigilance into the curricula of different healthcare cadres training schedules will add value to the academic learning and invariably assist in reducing the cost that might have been incurred due to ADRs. Thus, emphasis should be placed on inculcating good reporting culture by the students, not neglecting continued professional training of healthcare workers within the public and private healthcare settings.

Different stakeholders that contribute or are involved in healthcare provision and consumption (patients) need to be reached and made aware of the place of pharmacovigilance and the need for ADR reporting in patient management. Enlightening healthcare workers, policymakers and patients is an essential aspect of the promotion of pharmacovigilance; they need to be acquainted with ways of identifying whatever reaction occurs after the use of any clinical intervention such as medicines or unusual laboratory results and realize that such event requires reporting to the TIPC or any reporting centre within their region, will be paramount to optimizing the pharmacovigilance system.

3. Conclusions

We have explored possible ways of improving pharmacovigilance among healthcare workers, patients and other stakeholders within the public and private healthcare setting in SSA. Social inclusiveness and engagement are pivotal in understanding the current state of pharmacovigilance in the region.

Conflict of interest

The author declares no conflict of interest.