INTRODUCTION
The burden of adverse drug reactions (ADRs) in low- and middle-income
countries (LMICs) may differ from that in high-income settings for a
variety of reasons, including differences in disease burden, differences
in drug utilisation patterns, a potential lack of effective drug quality
control, and the high risk for prescribing and dispensing errors that
occur in overburdened healthcare systems. Previous systematic reviews
summarising the global burden of ADRs1-6 included only
a few surveys from LMICs, which limits the generalisability of their
results to LMIC settings.
In sub-Saharan Africa (SSA), an epidemiological transition is taking
place, with high prevalence of both non-communicable disease and
infectious disease, particularly HIV. The World Health Organization
first introduced guidelines for scaling up antiretroviral therapy (ART)
in resource-limited settings in 20027. Large national
ART programmes in SSA could potentially contribute significantly to the
burden of ADRs in this region.
Serious ADRs are those that result in death, are life-threatening,
result in hospital admission or prolong an existing hospital admission,
result in persistent or significant disability or incapacity, or result
in a congenital anomaly or cancer8,9. This systematic
review aims to summarise and describe data on the burden of serious ADRs
in SSA in the era of ART. We specifically focus on ADRs that cause
hospital admission, prolong an existing hospital admission, or cause
in-hospital death, as these three categories of serious ADRs are the
ones most frequently measured by surveys, are reasonably easy to verify,
are not subjectively judged, and do not require longitudinal data.
The specific objectives of this systematic review are: