{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,14]],"date-time":"2026-03-14T05:44:41Z","timestamp":1773467081793,"version":"3.50.1"},"reference-count":71,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T00:00:00Z","timestamp":1747267200000},"content-version":"unspecified","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Department of Foreign Affairs and Trade, Australia, under the Stronger Health Systems for Health Security Scheme"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,4,17]]},"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>In Indonesia, antibiotics are often purchased without a prescription at community pharmacies, contrary to current regulations. This practice may increase the risk of out-of-specification (OOS) medicines being dispensed, potentially contributing to treatment failure and antibiotic resistance. To address this concern, we assessed the quality of antibiotics purchased without a prescription at private drug retail outlets (PDROs) in Indonesia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design and setting<\/jats:title>\n                    <jats:p>We conducted a cross-sectional study in Tabalong and Bekasi, Indonesia, using standardised patients (SPs) who purchased antibiotics without a prescription for three clinical scenarios: upper respiratory tract infection (URTI), tuberculosis (TB) and child diarrhoea. The pharmacies and drug stores were randomly selected from each subdistrict based on the probability proportional method. We measured the active pharmaceutical ingredient (API) content of the antibiotic samples using high-performance liquid chromatography (HPLC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Samples and analysis<\/jats:title>\n                    <jats:p>The quality of 183 antibiotics including amoxicillin tablets (148\/183, 80.9%, 95% CI 74.7% to 86.1%), amoxicillin dry syrup (12\/183, 6.6%, 95% CI 3.6% to 10.8%), ampicillin tablets (5\/183, 2.7%, 95% CI 1.1% to 5.9%) and ciprofloxacin tablets (18\/183, 9.8%, 95% CI 6.2% to 14.8%) obtained from 117\/166 (70.5%, 95% CI 62.8 to 77.2) PDROs were tested. Descriptive statistics were used to describe the characteristics of the purchased antibiotics, and the API content of each antibiotic was compared against the United States Pharmacopeia 43-National Formulary 38 (USP 43-NF 38) standards in absolute values and percentages.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Almost all samples produced in Indonesia (182\/183, 99.5%, 95% CI 97.5% to 99.9%) were unbranded (123\/183, 67.2%, 95% CI 60.2% to 73.7%) or branded generic (60\/183, 32.8%, 95% CI 26.3% to 39.8%) and packaged in strips (165\/183, 90.2%, 95% CI 85.2% to 93.8%). Around 12\/183 (6.6%, 95% CI 3.6% to 10.8%) antibiotics were found to be OOS; these were mostly amoxicillin 125\u2009mg dry syrup (6\/12, 50%, 95% CI 24.3% to 75.7%) and ciprofloxacin 500\u2009mg tablet (5\/18, 27.8%, 95% CI 11.5% to 50.6%). Around 33% (4\/12, 95% CI 12.5% to 61.2%) of amoxicillin 125\u2009mg dry syrup samples had an API content above the label claim, the highest being 187%, whereas 16.7% (2\/12, 95% CI 3.6% to 43.6%) were below the label claim, the lowest being 64%. About 27.8% (5\/18, 95% CI 11.5% to 50.6%) of ciprofloxacin samples tested had an API content above the label claim; the highest was 120%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>While the proportion of OOS antibiotics identified was relatively small, at a population level, it represents a significant proportion of sub-optimally treated infections.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-087801","type":"journal-article","created":{"date-parts":[[2025,5,15]],"date-time":"2025-05-15T02:05:18Z","timestamp":1747274718000},"page":"e087801","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":4,"title":["Post-market quality assessment of antibiotics: findings from a cross-sectional study using standardised patients in Tabalong and Bekasi districts, Indonesia"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3494-9842","authenticated-orcid":false,"given":"Yusuf Ari","family":"Mashuri","sequence":"first","affiliation":[{"name":"Faculty of Medicine, Universitas Sebelas Maret, Surakarta, Indonesia"},{"name":"Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Miratul","family":"Hasanah","sequence":"additional","affiliation":[{"name":"Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"},{"name":"Faculty of Medicine, Universitas Jember, Jember, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ihsanti Dwi","family":"Rahayu","sequence":"additional","affiliation":[{"name":"Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"},{"name":"Department of Pharmacy, Faculty of Medicine, Universitas Lampung, Bandar Lampung, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marco","family":"Liverani","sequence":"additional","affiliation":[{"name":"Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK"},{"name":"School of Tropical Medicine and Global Health, Nagasaki University, Nagasaki, Japan"},{"name":"Faculty of Public Health, Mahidol University, Bangkok, Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3171-5271","authenticated-orcid":false,"given":"Ari","family":"Probandari","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, Universitas Sebelas Maret, Surakarta, Indonesia"},{"name":"Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8175-8125","authenticated-orcid":false,"given":"Neha","family":"Batura","sequence":"additional","affiliation":[{"name":"Institute for Global Health, University College London, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gill","family":"Schierhout","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Astri","family":"Ferdiana","sequence":"additional","affiliation":[{"name":"Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"},{"name":"Faculty of Medicine and Health Sciences, University of Mataram, Mataram, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Luh Putu Lila","family":"Wulandari","sequence":"additional","affiliation":[{"name":"The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Berlian Kusuma","family":"Dewi","sequence":"additional","affiliation":[{"name":"Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"},{"name":"Politeknik Negeri Indramayu, Indramayu, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephen","family":"Jan","sequence":"additional","affiliation":[{"name":"The George Institute for Global Health, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0997-0850","authenticated-orcid":false,"given":"Shunmay","family":"Yeung","sequence":"additional","affiliation":[{"name":"Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK"},{"name":"Department of Clinical Research, London School of Hygiene & Tropical Medicine, London, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginia","family":"Wiseman","sequence":"additional","affiliation":[{"name":"Department of Global Health and Development, London School of Hygiene & Tropical Medicine, London, UK"},{"name":"The Kirby Institute, University of New South Wales, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6045-6937","authenticated-orcid":false,"given":"Richard","family":"Day","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology & Toxicology, St Vincent\u2019s Clinical School - University of New South Wales, Sydney, New South Wales, Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0477-4575","authenticated-orcid":false,"given":"Tri","family":"Wibawa","sequence":"additional","affiliation":[{"name":"Center for Tropical Medicine, Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Mada, Yogyakarta, Indonesia"},{"name":"Department of Microbiology, Facuty of Medicine, Public Health and Nursing Universitas Gadjah Mada, Yogyakarta, Indonesia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,5,14]]},"reference":[{"key":"2025121411273861000_15.5.e087801.1","unstructured":"O\u2019Neill J . 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