Pharmacovigilance in low‐ and middle‐income countries: A review with particular focus on Africa

Abstract

Low‐ and middle‐income countries (LMIC) face unique challenges with regard to the establishment of robust pharmacovigilance systems capable of generating data to inform healthcare policy and practice. These include the limited integration and reliability of pharmacovigilance systems across LMIC despite recent efforts to harmonize pharmacovigilance rules and regulations in several regional economic communities. There are particular challenges relating to the need to translate reporting tools into numerous local languages and the low numbers of healthcare providers relative to number of patients, with very short consultation times. Additional factors frequent in LMIC include high uptake of herbal and traditional medication, mostly by self‐medication; disruptive political conflicts jeopardizing fragile systems; and little or no access to drug utilization data, which makes it difficult to reliably estimate the true risks of medicines use. Pharmacovigilance activities are hindered by the scarcity of well‐trained personnel with little or no budgetary support from national governments; high turnover of pharmacovigilance staff whose training involves a substantial amount of resources; and little awareness of pharmacovigilance among healthcare workers, decision makers and consumers. Furthermore, little collaboration between public health programmes and national medicines regulatory authorities coupled with limited investment in pharmacovigilance activities, especially during mass drug administration for neglected tropical diseases and mass vaccinations, produces major challenges in establishing a culture where pharmacovigilance is systematically embedded. Very low spontaneous reporting rates with poor quality reports hinders robust signal detection analyses. This review summarises the specific challenges and areas of progress in pharmacovigilance in LMIC with special focus on the situation in Africa.

A Qualitative Study of Stakeholders’ Views on Pharmacovigilance System, Policy, and Coordination in Pakistan

“…To see if it has an impact, it must get a foothold in the system and start to build roots. Similar findings were observed in the study by Kiguba et al, (2022 ) on pharmacovigilance in low- and middle-income countries. This is when compared with the high-income countries, the majority of low- and middle-income countries’ regulatory pharmacovigilance systems are nascent or nonexistent.…”

“…Pakistan’s pharmacovigilance system is facing the challenges of budgetary constraints, and there is some support from international organizations ( Junaidi, 2021 ). Similar findings were recorded in a study that most LMIC face financial issues, and they rely on the donor’s support ( Kiguba et al, 2022 ).…”

Safety and Tolerability of Ivermectin and Albendazole Mass Drug Administration in Lymphatic Filariasis Endemic Communities of Tanzania: A Cohort Event Monitoring Study

“…However, as distribution is usually random, whether the same individuals are always exposed on each round remains to be cross-examined. National medicines regulatory authorities in Africa, including the Tanzania Medicines and Medical Devices Authority (TMDA) strive to obtain safety data after marketing authorization of many drugs [ 10 , 11 ]. A recent comparative assessment of the pharmacovigilance systems in the NTD Programs in four East African countries indicated that no adverse events following MDA were reported to the National Medicines Regulatory Authorities despite millions of people being exposed to MDA in the year 2017/2018 [ 12 ].…”

“…Large-scale safety surveillance studies are pivotal in detecting rare severe adverse events [ 16 ]. Although millions of people in Africa are receiving periodic MDA, safety data from large-scale active CEM studies are scarce partly due to the lack of fully functional pharmacovigilance systems in the region [ 10 , 11 , 12 ]. The WHO’s global individual case safety reports database (VigiBase) recently reported serious suspected ADRs and safety signals associated with ivermectin use and the under-reporting of ADRs in SSA [ 17 ].…”

The development of a pharmacovigilance system in Bahrain

“…In Pakistan, for example, the absence of a reporting system was found to be the main barrier of the reporting process ( Hussain et al, 2020 ). In low-middle income countries (LMIC), the main challenge was the lack of time because of the shortage of doctors in comparison to the number of patients ( Kiguba et al, 2021 ). Another factor that affects the reporting process in many countries is the limited financial resources which plays an essential role in underreported medicine-related problems ( Kaeding et al, 2017 ).…”