The Quality of marketed drugs in Ethiopia: A systematic Review

Abstract

Abstract Background Medicinal products, unlike any other consumer item, require special attention because excessive or suboptimal use can have unintended consequences. Ultimately, safety from unwanted toxicity and effectiveness at recommended dosage levels are desired, which are dependent on product quality. Objective Systematic Review of evidence available on the quality of drugs in Ethiopia. Methods A PRISMA checklist and medicine quality assessment reporting guidelines were used for systematic review. A web search was performed using key words such as "drug quality," "quality control," "in vitro drug quality evaluation," "physico-chemical quality," and "Ethiopia. The Web of Science, PubMed, Science Direct, and Google Scholar data sources were used to extract the information. Data inclusion and exclusion criteria were prepared and validated using the guide for systematic review. After data evaluation and harmonization with stated objectives, it is summarized using tables and graphs. Results A total of 33 assessment studies on 667 sampled products were sorted from web searches and included. The review has revealed that 21.73% of the products studied had quality parameters of dissolution, disintegration, and/or chemical assay that deviated from recommended values. Antibacterial drugs were the most frequently studied category (28.57%), followed by NSAIDs (14.29%), and anthelmintic (14.29%). Among the drug products studied, 17.24% were not registered for marketing. Conclusion The current systematic review has shown the gaps in post marketing quality assessment studies. Unlike existing efforts for product quality assurance, findings from marketed product studies warrant the need to minimize prevalence of substandard medicinal products.