Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors
Abstract
OBJECTIVES: To assess the quality of amoxicillin products in Indonesia's private market by surveying the range of products available across different areas, followed by product sampling and laboratory testing. DESIGN: A cross-sectional survey employing mystery shoppers to purposively sample the widest possible range of amoxicillin products available to patients across different areas in Indonesia. SETTING: Licensed and unlicensed medicine outlets in remote, rural and urban areas and online. PARTICIPANTS: Amoxicillin products that are sold to patients as oral solid and dry liquid formulations. MAIN OUTCOME MEASURES: Quality of amoxicillin products, assessed using compendial testing of active pharmaceutical ingredient content and dissolution. Samples that failed any quality test were classified as substandard or out-of-specification (OOS). The raw prevalence of substandard amoxicillin was adjusted based on the national market volume of each product variant. RESULTS: We surveyed 476 outlets, mostly pharmacies (68.5%), websites (19.7%) and drug stores (10.9%). Among the 120 collected samples, there were 59 distinct products, collectively representing 95% of the estimated market volume for oral solid products and 65% for dry syrups. 12 out of 110 oral solid samples tested OOS (10.9%), as did 3 out of 10 dry syrups (30%). The samples that failed originated from various areas and types of outlets. We found no relation between the price and quality of amoxicillin. CONCLUSIONS: The…
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Evidence Hub reads this as a cross-sectional, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause.
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