Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors

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...

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Main Authors: Amalia Hasnida, Maarten Olivier Kok, Ayu Rahmawati, Yusi Anggriani, Mawadatti Rahmi, Frank C M van Leth
Format: Article
Language:English
Published: BMJ Publishing Group 2025-07-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/7/e093785.full
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author Amalia Hasnida
Maarten Olivier Kok
Ayu Rahmawati
Yusi Anggriani
Mawadatti Rahmi
Frank C M van Leth
author_facet Amalia Hasnida
Maarten Olivier Kok
Ayu Rahmawati
Yusi Anggriani
Mawadatti Rahmi
Frank C M van Leth
author_sort Amalia Hasnida
collection DOAJ
description 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 oral solid amoxicillin products that tested OOS represent an estimated 12.7% of the national market volume. We found no relation between the price and quality of amoxicillin. Combining product-variety sampling with data on market volume presents a promising approach to gain insight into the prevalence of poor-quality medical products using a relatively small sample size.
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spelling doaj-art-c19beffba538449eb94c4002c866f4952025-08-20T03:56:00ZengBMJ Publishing GroupBMJ Open2044-60552025-07-0115710.1136/bmjopen-2024-093785Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factorsAmalia Hasnida0Maarten Olivier Kok1Ayu Rahmawati2Yusi Anggriani3Mawadatti Rahmi4Frank C M van Leth5Health Care Governance, Erasmus University Rotterdam, Rotterdam, The NetherlandsHealth Care Governance, Erasmus University Rotterdam, Rotterdam, The NetherlandsCenter for Pharmaceutical Policy, Management, and Services Studies, Faculty of Pharmacy, Universitas Pancasila, Jakarta, IndonesiaCenter for Pharmaceutical Policy, Management, and Services Studies, Faculty of Pharmacy, Universitas Pancasila, Jakarta, IndonesiaCenter for Pharmaceutical Policy, Management, and Services Studies, Faculty of Pharmacy, Universitas Pancasila, Jakarta, IndonesiaHealth Sciences, Vrije Universiteit Amsterdam, Amsterdam, The NetherlandsObjectives 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 oral solid amoxicillin products that tested OOS represent an estimated 12.7% of the national market volume. We found no relation between the price and quality of amoxicillin. Combining product-variety sampling with data on market volume presents a promising approach to gain insight into the prevalence of poor-quality medical products using a relatively small sample size.https://bmjopen.bmj.com/content/15/7/e093785.full
spellingShingle Amalia Hasnida
Maarten Olivier Kok
Ayu Rahmawati
Yusi Anggriani
Mawadatti Rahmi
Frank C M van Leth
Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors
BMJ Open
title Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors
title_full Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors
title_fullStr Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors
title_full_unstemmed Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors
title_short Assessing the quality of amoxicillin in the private market in Indonesia: a cross-sectional survey exploring product variety, market volume and price factors
title_sort assessing the quality of amoxicillin in the private market in indonesia a cross sectional survey exploring product variety market volume and price factors
url https://bmjopen.bmj.com/content/15/7/e093785.full
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