Addressing Variability in Drug Quality: Finding The Right “Quality” Framework(s)

Background: In many countries, a significant proportion of medicines traded and consumed are of poor or variable quality. Meanwhile, failures in appropriately framing and responding to the problem have led to a proliferation of public health and governance challenges. Objective: To examine the issues exacerbating the trade and consumption of medicines of poor or variable quality, as well as present locally relevant strategies. Methods: Analytic triangulation was applied to the synthesis of publicly available documents. Results: Where economic and regulatory environments are less structured, supply chain security strategies that fixate on ‘counterfeits’ often fail in limiting the prevalence of poor quality medicines. In addition to a multivariate drug quality classification chart, three quality frameworks are presented for examining appropriate policy strategies in mediating drug quality. Conclusion: These tools can assist stakeholders in determining more locally relevant and context-specific strategies, while interrogating the proposition for greater transparency vis-à-vis drug quality.MAS