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: