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 reliance of pharmacovigilance
systems across LMIC despite recent efforts to harmonize
pharmacovigilance rules and regulations in several regional economic
communities; the need to translate reporting tools into numerous local
languages; low numbers of healthcare providers relative to number of
patients, with very short consultation times; scarcity of well-trained
pharmacovigilance personnel with little or no budgetary support for
these activities from national governments; high turnover of
pharmacovigilance staff whose training involves a substantial amount of
resources; little awareness of pharmacovigilance among healthcare
workers, decision makers and consumers; very low spontaneous reporting
rates with poor quality reports which hinders robust signal detection
analyses; little collaboration between public health programmes and
national medicines regulatory authorities; limited investment in
pharmacovigilance activities especially during mass drug administration
for neglected tropical diseases; 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
safety risks of medicine use. This review summarises the specific
challenges and areas of progress in pharmacovigilance in LMIC with
special focus on the situation in Africa.