Challenges and lessons learned from four years of planning and implementing pharmacovigilance enhancement in sub-Saharan Africa

Abstract

Pharmacovigilance (PV) systems in many countries in sub-Saharan Africa (SSA) are not fully functional. The spontaneous adverse events (AE) reporting rate in SSA is lower than in any other region of the world, and healthcare professionals (HCPs) in SSA countries have limited awareness of AE surveillance and reporting procedures. The GSK PV enhancement pilot initiative, in collaboration with PATH and national PV stakeholders, aimed to strengthen passive safety surveillance through a training and mentoring program of HCPs in healthcare facilities in three SSA countries: Malawi, Côte d’Ivoire, and Democratic Republic of Congo (DRC). Project implementation was country-driven, led by the Ministry of Health via the national PV center or department, and was adapted to each country’s needs. The implementation phase for each country was scheduled to last 18 months. At project start, low AE reporting rates reflected that awareness of PV practices was very low among HCPs in all three countries, even if a national PV center already existed. Malawi did not have a functional PV system nor a national PV center prior to the start of the initiative. After 18 months of PV training and mentoring of HCPs, passive safety surveillance was enhanced significantly as shown by the increased number of AE reports: from 22 during 2000–2016 to 228 in 18 months to 511 in 30 months in Malawi, and ~ 80% of AE reports from trained healthcare facilities in Côte d’Ivoire. In DRC, project implementation ended after 7 months because of the SARS-CoV-2 pandemic. Main challenges encountered were delayed AE report transmission (1–2 months, due mainly to remoteness of healthcare facilities and complex procedures for transmitting reports to the national PV center), delayed or no causality assessment due to lack of expertise and/or funding, negative perceptions among HCPs toward AE reporting, and difficulties in engaging public health programs with the centralized AE reporting processes. This pilot project has enabled the countries to train more HCPs, increased reporting of AEs and identified KPIs that could be flexibly replicated in each country. Country ownership and empowerment is essential to sustain these improvements and build a stronger AE reporting culture.

Stakeholders’ Perspective on the Integration of Pharmacovigilance Activities into the Eritrean Healthcare System: A Qualitative Study

“…Similarly, the absence of effective communication as a limiting factor for integration has been reported in other Sub-Saharan African countries. 6 , 28 Effective operation of a pharmacovigilance center necessitates the exchange of information with stakeholders 4 and coordination of such exchange through the identification of mechanisms to communicate the information to link medicines safety with healthcare practices and health policies. 29 In this respect, a regular platform involving annual conferences, regular biannual or quarterly meetings, and consistent publication of the medicines bulletin should be established by the EPC to correct the existing inconsistent and ad hoc communications.…”

“…Therefore, to address the training issues, the EPC should regularize the formal training and supportive supervision, and incorporate pharmacovigilance courses into the curriculum of medical and health science colleges. 12 , 28 , 33 …”

“…In support of this, a study conducted by Stegmann et al highlighted that having clinicians and pharmacists as pharmacovigilance focal points could be advantageous as they could have a motivating influence on the healthcare system. 28 Currently, the EPC relies on zonal pharmaceutical services to carry out pharmacovigilance activities in terms of collecting and sending ADR reports, organization of training activities, communication of findings, and other liaisons. Such reliance, however, cannot be sustained as there is high staff turnover and poor follow-up of their performance.…”

“…Thus, the EPC in conjunction with the Ministry of Health has to make concerted efforts to promote pharmacovigilance activities and advocate the incorporation of pharmacovigilance training into the curricula of health science students. 28 , 33 In addition, there is a need for a policy framework, incorporating communication and decentralization strategies to ensure sustainable integration of the pharmacovigilance system at the PHPs and health facilities. 35 …”

Strategies and interventions to strengthen pharmacovigilance systems in low- and middle-income countries: a scoping review

“…India contributes 3% ADRs to the global safety database, with a completeness score of 0.93 out of 1. Likewise, in Malawi, a step-wise approach targeting different PV components, with the collaboration of different technical agencies, enabled the creation of a national PV system, with guidelines, organisational structure, PV infrastructure and mechanisms for ADR reporting and other PV processes such as active surveillance (44,56,65).…”