{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T16:06:20Z","timestamp":1787069180034,"version":"build-2736575974"},"reference-count":25,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,9,29]],"date-time":"2023-09-29T00:00:00Z","timestamp":1695945600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004423","name":"World Health Organization","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004423","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Intl J Gynecology &amp; Obste"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low\u2010 and middle\u2010income countries (LMIC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty\u2010four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol\u2010only and seven mifepristone\u2010only products. Overall, 54.7% of samples were non\u2010compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol\u2010only product was found.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/ijgo.15148","type":"journal-article","created":{"date-parts":[[2023,9,30]],"date-time":"2023-09-30T01:35:10Z","timestamp":1696037710000},"page":"405-415","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Quality testing of mifepristone and misoprostol in 11 countries"],"prefix":"10.1002","volume":"165","author":[{"given":"Jason","family":"Bower","sequence":"first","affiliation":[{"name":"Independent Consultant  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lester","family":"Chinery","sequence":"additional","affiliation":[{"name":"Concept Foundation  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Fleurent","sequence":"additional","affiliation":[{"name":"Concept Foundation  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A. Metin","family":"G\u00fclmezoglu","sequence":"additional","affiliation":[{"name":"Concept Foundation  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wallada","family":"Im\u2010Amornphong","sequence":"additional","affiliation":[{"name":"Concept Foundation  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Kilfedder","sequence":"additional","affiliation":[{"name":"International Planned Parenthood Federation  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Procter","sequence":"additional","affiliation":[{"name":"Concept Foundation  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Tomazzini","sequence":"additional","affiliation":[{"name":"Concept Foundation  Geneva Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,9,29]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"World Health Organization.Abortion [WHO website]. Accessed May 31 2023.https:\/\/www.who.int\/health\u2010topics\/abortion"},{"key":"e_1_2_13_3_1","volume-title":"Abortion care guideline","author":"World Health Organization","year":"2022"},{"key":"e_1_2_13_4_1","volume-title":"WHO Model List of Essential Medicines, 21st List, 2019","author":"World Health Organization","year":"2019"},{"key":"e_1_2_13_5_1","volume-title":"WHO Consolidated Guideline on Self\u2010Care Interventions for Health: Sexual and Reproductive Health and Rights","author":"World Health Organization","year":"2019"},{"key":"e_1_2_13_6_1","volume-title":"WHO Recommendations on Self\u2010Care Interventions: Self\u2010Management of Medical Abortion, 2022 Update","author":"World Health Organization","year":"2022"},{"key":"e_1_2_13_7_1","unstructured":"World Health Organization.WHO \u2010 Prequalification of Medical Products (IVDs Medicines Vaccines and Immunization Devices Vector Control) [WHO Prequalification Program Website]. Accessed May 31 2023.https:\/\/extranet.who.int\/pqweb"},{"key":"e_1_2_13_8_1","volume-title":"WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fifty\u2010First Report","author":"World Health Organization","year":"2017"},{"key":"e_1_2_13_9_1","volume-title":"WHO Quality Assurance Policy for the Procurement of Essential Medicines and Other Health Products","author":"World Health Organization","year":"2021"},{"key":"e_1_2_13_10_1","volume-title":"Quality Assurance Policy: Procurement of Medicines, Medical Devices and Other Health Products","author":"United Nations Office for Project Services (UNOPS)","year":"2021"},{"key":"e_1_2_13_11_1","volume-title":"A Study on the Public Health and Socioeconomic Impact of Substandard and Falsified Medical Products","author":"World Health Organization","year":"2017"},{"key":"e_1_2_13_12_1","first-page":"227","volume-title":"WHO Expert Committee on Specifications for Pharmaceutical Preparations: Fiftieth Report","year":"2016"},{"issue":"1","key":"e_1_2_13_13_1","first-page":"35","article-title":"Quality of medicines: quality of misoprostol products","volume":"30","author":"Hall PE","year":"2016","journal-title":"WHO Drug Info"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-018-1671-y"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12884-020-2810-9"},{"key":"e_1_2_13_16_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0245054"},{"key":"e_1_2_13_17_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0112401"},{"key":"e_1_2_13_18_1","unstructured":"International Planned Parenthood Federation.Medical Abortion Commodities Database [IPPF Website].2020. Accessed December 6 2021.https:\/\/www.medab.org\/"},{"key":"e_1_2_13_19_1","unstructured":"World Health Organization.PQT\/MED\u2010Specific Annotations for the ICH M9 Guideline for Biopharmaceutics Classification System (BCS)\u2010Based Biowaiver Applications. WHO PQT: Medicines2021."},{"key":"e_1_2_13_20_1","volume-title":"The International Pharmacopoeia","author":"World Health Organization","year":"2019"},{"key":"e_1_2_13_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.xphs.2018.01.025"},{"key":"e_1_2_13_22_1","volume-title":"Authorized USP Pending Standards for Mifepristone","author":"The United States Pharmacopeial Convention","year":"2008"},{"key":"e_1_2_13_23_1","volume-title":"International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human use (ICH). ICH Harmonised Tripartite Guideline: Impurities in New Drug Products Q3B(R2)","year":"2006"},{"key":"e_1_2_13_24_1","volume-title":"World Health Statistics 2017: Monitoring Health for the SDGs, Sustainable Development Goals. Annex C: WHO Regional Groupings","author":"World Health Organization","year":"2017"},{"key":"e_1_2_13_25_1","unstructured":"World Health Organization.Medical product alert N\u00b03\/2021: falsified CYTOTEC [WHO website]. WHO global surveillance and monitoring system for substandard and falsified medical products.2021. Accessed May 31 2023.https:\/\/www.who.int\/news\/item\/10\u201008\u20102021\u2010medical\u2010product\u2010alert\u2010n\u20103\u20102021"},{"key":"e_1_2_13_26_1","unstructured":"World Health Organization.WHO\u2010Listed Authority (WLA) [WHO website]. Accessed May 31 2023.https:\/\/www.who.int\/initiatives\/who\u2010listed\u2010authority\u2010reg\u2010authorities"}],"container-title":["International Journal of Gynecology &amp; Obstetrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/ijgo.15148","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,17]],"date-time":"2024-07-17T00:27:16Z","timestamp":1721176036000},"score":1,"resource":{"primary":{"URL":"https:\/\/obgyn.onlinelibrary.wiley.com\/doi\/10.1002\/ijgo.15148"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,9,29]]},"references-count":25,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1002\/ijgo.15148"],"URL":"https:\/\/doi.org\/10.1002\/ijgo.15148","archive":["Portico"],"relation":{"has-preprint":[{"id-type":"doi","id":"10.1101\/2023.07.10.23292436","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.3.rs-1909585\/v2","asserted-by":"object"},{"id-type":"doi","id":"10.21203\/rs.3.rs-1909585\/v1","asserted-by":"object"}]},"ISSN":["0020-7292","1879-3479"],"issn-type":[{"value":"0020-7292","type":"print"},{"value":"1879-3479","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,9,29]]},"assertion":[{"value":"2023-06-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-07","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-29","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}