LAUSR

In this issue of Drug Safety, Ndagije et al. [1] reports on an active follow-up study to establish the burden of adverse drug reactions (ADRs) due to artemisinin-based antimalarial treatment in selected urban and rural health facilities in Uganda. The study recorded a high (22.5%) burden of common adverse events among the study population of 782 participants, with females having an 80% risk of having an ADR compared to males and urban dwellers and patients with co-morbidities also having high risks for developing ADRs. The study did not report any new ADR to the anti-malarial medications studied. The authors highlighted important issues relating to the deployment of appropriate pharmacovigilance (PV) methods to complement national healthcare policies in countries with limited resources. Artemisinin-based combination therapies are potent medicines which are nonetheless used as ‘‘over-the-counter’’ products in the management of uncomplicated malaria. This is because of the dearth of health facilities and healthcare professionals in several countries. This widespread use therefore calls for pragmatic approaches for safety surveillance in order to establish the burden of ADRs and assure public health. It, however, comes associated with issues of data quality as well as the detection of rare but important ADRs, which is a key aim of PV. Should the limited resources be utilised to undertake well-designed, rigorous, phase IV studies, which would require extensive human, financial and technical resources, or should PV experts focus on bringing PV to the community and the community to PV, thereby building trust as the authors alluded to? The challenges of routine spontaneous reporting PV systems in Africa and other low-resource settings are well documented [2, 3]. Even though the African Union and the World Health Organization (WHO) African Regional Office have outlined strategies for stronger PV and medicinal product regulation [4], it is doubtful whether these will, at least in the short to medium term, lead to any improvement in the spontaneous reporting PV systems in Africa. African countries will therefore have to devise practical approaches for PV, especially in association with treatment policy changes as reported by Ndagije et al. [1] in this issue of Drug Safety and when products which have not been used anywhere else are going to be introduced first in Africa, as in the case of the malaria vaccine [5].