{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T15:52:21Z","timestamp":1791388341702,"version":"4.3.3"},"reference-count":43,"publisher":"American Medical Association (AMA)","issue":"10","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Netw Open"],"abstract":"\n Importance<\/jats:title>\n In an effort to improve access, the Australian Therapeutic Goods Administration lifted prescribing and dispensing restrictions on mifepristone in August 2023. Mifepristone is approved for medication abortion up to 63 days\u2019 gestation and is marketed in Australia in a combipack with misoprostol (hereinafter, mifepristone-misoprostol). The previous restrictions were similar to current restrictions on mifepristone imposed by the US Food and Drug Administration.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess whether the number and geographic distribution of pharmacies ordering mifepristone-misoprostol in Australia increased after prescribing and dispensing restrictions were lifted in August 2023.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This cohort study used an interrupted time-series (ITS) analysis of monthly pharmacy orders, based on sales data from the sole Australian distributor of mifepristone for the 24-month periods before (August 1, 2021, to July 31, 2023) and after (August 1, 2023, to July 31, 2025) the regulatory change.<\/jats:p>\n <\/jats:sec>\n \n Exposure<\/jats:title>\n August 2023 removal of mifepristone prescribing and dispensing restrictions.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary outcome was the monthly count of unique pharmacies ordering mifepristone-misoprostol. The monthly proportion of postcodes with at least 1 ordering pharmacy was also assessed.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Overall, 2228 pharmacies ordered mifepristone-misoprostol before the policy change and 4107 after. In August 2021, 419 (95% CI, 393-444) pharmacies ordered mifepristone-misoprostol. The number of ordering pharmacies increased by 10 (95% CI, 9-12) per month before the 2023 regulatory change. When restrictions lifted, there was an immediate increase of 86 (95% CI, 16-157) pharmacies, and the increasing trend accelerated by 15 (95% CI, 10-20) additional pharmacies per month. As of July 2025, there were 446 (95% CI, 306-581) more ordering pharmacies (48.6% increase; 95% CI, 29.2%-72.4%) than expected. In August 2021, 11.5% (95% CI, 11.1%-11.8%) of postcodes contained at least 1 ordering pharmacy, increasing by 0.2% (95% CI, 0.2%-0.2%) per month. After the August 2023 regulatory change, there was an immediate and sustained increase. By July 2025, 4.4% (95% CI, 2.4%-6.4%) more postcodes than expected had at least 1 ordering pharmacy, representing a 19.9% (95% CI, 9.9%-31.4%) increase, with the change most pronounced in major cities.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this cohort study of pharmacy orders for mifepristone-misoprostol in Australia, the removal of prescribing and dispensing restrictions on mifepristone in August 2023 was associated with improved access through pharmacies. These findings support removing similar distribution restrictions on mifepristone in other countries, including the US.<\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamanetworkopen.2026.37766","type":"journal-article","created":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T15:00:32Z","timestamp":1791385232000},"page":"e2637766","source":"Crossref","is-referenced-by-count":0,"title":["Regulatory Policy Changes and Mifepristone Access Through Pharmacies in Australia"],"prefix":"10.1001","volume":"9","author":[{"given":"Kristina","family":"Edvardsson","sequence":"first","affiliation":[{"name":"Judith Lumley Centre, School of Nursing and Midwifery, La Trobe University, Bundoora, Victoria, Australia"},{"name":"SPHERE Centre of Research Excellence in Women\u2019s Sexual and Reproductive Health in Primary Care, Department of General Practice, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Schummers","sequence":"additional","affiliation":[{"name":"SPHERE Centre of Research Excellence in Women\u2019s Sexual and Reproductive Health in Primary Care, Department of General Practice, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia"},{"name":"Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica E.","family":"Moulton","sequence":"additional","affiliation":[{"name":"Judith Lumley Centre, School of Nursing and Midwifery, La Trobe University, Bundoora, Victoria, Australia"},{"name":"SPHERE Centre of Research Excellence in Women\u2019s Sexual and Reproductive Health in Primary Care, Department of General Practice, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xia","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Research and Infrastructure, La Trobe University, Bundoora, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lucy","family":"Cheng","sequence":"additional","affiliation":[{"name":"Collaboration for Outcomes Research and Evaluation, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, British Columbia, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Danielle","family":"Mazza","sequence":"additional","affiliation":[{"name":"SPHERE Centre of Research Excellence in Women\u2019s Sexual and Reproductive Health in Primary Care, Department of General Practice, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia"},{"name":"Department of General Practice, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Goldstone","sequence":"additional","affiliation":[{"name":"MSI Australia, Melbourne, Victoria, Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Grossman","sequence":"additional","affiliation":[{"name":"Advancing New Standards in Reproductive Health, Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California San Francisco, Oakland"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"10","published-online":{"date-parts":[[2026,10,7]]},"reference":[{"issue":"3","key":"zoi261019r1","doi-asserted-by":"publisher","first-page":"366","DOI":"10.1111\/ajo.12608","article-title":"Efficacy and safety of mifepristone-buccal misoprostol for early medical abortion in an Australian clinical setting.","volume":"57","author":"Goldstone","year":"2017","journal-title":"Aust N Z J Obstet Gynaecol"},{"issue":"4","key":"zoi261019r3","doi-asserted-by":"publisher","first-page":"e31","DOI":"10.1097\/AOG.0000000000004082","article-title":"Medication abortion up to 70 days of gestation: ACOG practice bulletin, number 225.","volume":"136","author":"American College of Obstetricians and Gynecologists\u2019 Committee on Practice Bulletins\u2014Gynecology, Society of Family Planning","year":"2020","journal-title":"Obstet Gynecol"},{"issue":"5","key":"zoi261019r4","article-title":"Medical methods for first trimester abortion.","volume":"5","author":"Zhang","year":"2022","journal-title":"Cochrane Database Syst Rev"},{"issue":"2","key":"zoi261019r5","doi-asserted-by":"publisher","first-page":"95","DOI":"10.1136\/bmjsrh-2018-200149","article-title":"Trends in the method and gestational age of abortion in high-income countries.","volume":"45","author":"Popinchalk","year":"2019","journal-title":"BMJ Sex Reprod Health"},{"issue":"1","key":"zoi261019r6","doi-asserted-by":"publisher","first-page":"3","DOI":"10.1111\/psrh.12294","article-title":"The role of medication abortion provision in US states without total abortion bans, 2023.","volume":"57","author":"DoCampo","year":"2025","journal-title":"Perspect Sex Reprod Health"},{"issue":"2","key":"zoi261019r7","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyaf028","article-title":"Time trends and characteristics associated with abortion method used by young Australian women.","volume":"54","author":"Edvardsson","year":"2025","journal-title":"Int J Epidemiol"},{"issue":"4","key":"zoi261019r8","doi-asserted-by":"publisher","DOI":"10.1136\/bmjsrh-2020-200724","article-title":"Abortion regulation in Europe in the era of COVID-19: a spectrum of policy responses.","volume":"47","author":"Moreau","year":"2021","journal-title":"BMJ Sex Reprod Health"},{"issue":"8","key":"zoi261019r9","doi-asserted-by":"publisher","first-page":"790","DOI":"10.1056\/NEJMsb1612526","article-title":"Sixteen years of overregulation: time to unburden mifeprex.","volume":"376","author":"Raymond","year":"2017","journal-title":"N Engl J Med"},{"issue":"46","key":"zoi261019r10","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1016\/j.rhm.2015.10.002","article-title":"Medical abortion in Australia: a short history.","volume":"23","author":"Baird","year":"2015","journal-title":"Reprod Health Matters"},{"issue":"7","key":"zoi261019r12","doi-asserted-by":"publisher","first-page":"619","DOI":"10.1001\/jama.2025.23091","article-title":"The US Food and Drug Administration\u2019s regulation of mifepristone.","volume":"335","author":"Dilek","year":"2026","journal-title":"JAMA"},{"issue":"4","key":"zoi261019r13","doi-asserted-by":"publisher","first-page":"1191","DOI":"10.1038\/s41591-024-02834-w","article-title":"Effectiveness and safety of telehealth medication abortion in the USA.","volume":"30","author":"Upadhyay","year":"2024","journal-title":"Nat Med"},{"issue":"18","key":"zoi261019r14","doi-asserted-by":"publisher","first-page":"1630","DOI":"10.1001\/jama.2026.3419","article-title":"Changes in mifepristone use at pharmacies after removal of the FDA in-person dispensing requirement.","volume":"335","author":"Scannell","year":"2026","journal-title":"JAMA"},{"issue":"13","key":"zoi261019r16","doi-asserted-by":"publisher","first-page":"E345","DOI":"10.1503\/cmaj.241505","article-title":"Changes in local access to mifepristone dispensed by community pharmacies for medication abortion in Ontario: a population-based repeated cross-sectional study.","volume":"197","author":"Schummers","year":"2025","journal-title":"CMAJ"},{"issue":"6","key":"zoi261019r17","doi-asserted-by":"publisher","first-page":"324","DOI":"10.31128\/AJGP-02-20-5223","article-title":"Medical abortion.","volume":"49","author":"Mazza","year":"2020","journal-title":"Aust J Gen Pract"},{"issue":"3","key":"zoi261019r23","doi-asserted-by":"publisher","first-page":"416","DOI":"10.1080\/14490854.2024.2374993","article-title":"When history won\u2019t go away: abortion decriminalisation, residual criminalisation and continued exceptionalism.","volume":"21","author":"Baird","year":"2024","journal-title":"History Australia"},{"issue":"3","key":"zoi261019r26","doi-asserted-by":"publisher","first-page":"335","DOI":"10.1111\/ajo.12800","article-title":"A direct-to-patient telemedicine abortion service in Australia: retrospective analysis of the first 18 months.","volume":"58","author":"Hyland","year":"2018","journal-title":"Aust N Z J Obstet Gynaecol"},{"issue":"11","key":"zoi261019r27","doi-asserted-by":"publisher","first-page":"496","DOI":"10.5694\/mja2.51979","article-title":"Reimagining medical abortion in Australia: what do we need to do to meet women\u2019s needs and ensure ongoing access?","volume":"218","author":"Mazza","year":"2023","journal-title":"Med J Aust"},{"issue":"1","key":"zoi261019r32","first-page":"348","article-title":"Interrupted time series regression for the evaluation of public health interventions: a tutorial.","volume":"46","author":"Bernal","year":"2017","journal-title":"Int J Epidemiol"},{"issue":"4","key":"zoi261019r33","doi-asserted-by":"publisher","first-page":"299","DOI":"10.1046\/j.1365-2710.2002.00430.x","article-title":"Segmented regression analysis of interrupted time series studies in medication use research.","volume":"27","author":"Wagner","year":"2002","journal-title":"J Clin Pharm Ther"},{"issue":"2","key":"zoi261019r34","doi-asserted-by":"publisher","first-page":"143","DOI":"10.1016\/j.jclinepi.2008.08.007","article-title":"Methods for estimating confidence intervals in interrupted time series analyses of health interventions.","volume":"62","author":"Zhang","year":"2009","journal-title":"J Clin Epidemiol"},{"issue":"3","key":"zoi261019r35","doi-asserted-by":"publisher","first-page":"e246","DOI":"10.1016\/S2468-2667(25)00010-6","article-title":"Abortion care in Alberta, Canada, from 2012 to 2023: a population-based, cross-sectional analysis of use and geographical access.","volume":"10","author":"Brennand","year":"2025","journal-title":"Lancet Public Health"},{"key":"zoi261019r36","doi-asserted-by":"publisher","DOI":"10.2196\/45671","article-title":"The role of telehealth in promoting equitable abortion access in the United States: spatial analysis.","volume":"9","author":"Koenig","year":"2023","journal-title":"JMIR Public Health Surveill"},{"issue":"8","key":"zoi261019r38","doi-asserted-by":"publisher","first-page":"366","DOI":"10.5694\/mja2.51275","article-title":"Early medical abortion services provided in Australian primary care.","volume":"215","author":"Subasinghe","year":"2021","journal-title":"Med J Aust"},{"issue":"11","key":"zoi261019r39","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2022-066650","article-title":"Improving experience of medical abortion at home in a changing therapeutic, technological and regulatory landscape: a realist review.","volume":"12","author":"Baraitser","year":"2022","journal-title":"BMJ Open"},{"issue":"1","key":"zoi261019r41","doi-asserted-by":"publisher","first-page":"57","DOI":"10.1056\/NEJMsa2109779","article-title":"Abortion safety and use with normally prescribed mifepristone in Canada.","volume":"386","author":"Schummers","year":"2022","journal-title":"N Engl J Med"},{"key":"zoi261019r18","volume-title":"Australian Product Information: MS-2 Step (Mifepristone and Misoprostol) Tablets","author":"Therapeutic Goods Administration","year":"2024"},{"key":"zoi261019r19","volume-title":"Australian Public Assessment Report for MS-2 Step (Composite Pack)","author":"Therapeutic Goods Administration","year":"2024"},{"key":"zoi261019r21","volume-title":"Ending the Postcode Lottery: Addressing Barriers to Sexual, Maternity and Reproductive Healthcare in Australia","author":"Community Affairs References Committee","year":"2023"},{"key":"zoi261019r28","volume-title":"Policy. Termination of Pregnancy. Version 2.0. Approval Date: 2 June 2022. PDS Reference No: DO495","author":"SA Health","year":"2022"},{"key":"zoi261019r37","volume-title":"Maintaining Essential Health Services: Operational Guidance for the COVID-19 Context. Interim Guidance 1 June 2020","author":"World Health Organization","year":"2020"},{"key":"zoi261019r42","volume-title":"Abortion Care Guideline","author":"World Health Organization","year":"2022"},{"key":"zoi261019r2","unstructured":"Sedgh? G, Taqi? I. Mifepristone for abortion in a global context: safe, effective and approved in nearly 100 countries. Guttmacher Institute. 2023. Accessed July 20, 2026. https:\/\/www.guttmacher.org\/2023\/07\/mifepristone-abortion-global-context-safe-effective-and-approved-nearly-100-countries"},{"key":"zoi261019r11","unstructured":"Understanding the practical implications of the FDA\u2019s December 2021 and January 2023 Mifepristone REMS Decisions. American College of Obstetricians and Gynecologists. December 4, 2023. Accessed July 20, 2026. https:\/\/www.acog.org\/news\/news-articles\/2022\/03\/understanding-the-practical-implications-of-the-fdas-december-2021-mifepristone-rems-decision"},{"key":"zoi261019r15","unstructured":"Regulatory decision summary for Mifegymiso. Health Canada. Accessed July 20, 2026. https:\/\/dhpp.hpfb-dgpsa.ca\/review-documents\/resource\/RDS00294"},{"key":"zoi261019r20","unstructured":"Amendments to restrictions for prescribing of MS-2 Step (Mifepristone and Misoprostol). Australian Government Department of Health and Aged Care. 2023. Accessed July 20, 2026. https:\/\/www.tga.gov.au\/news\/media-releases\/amendments-restrictions-prescribing-ms-2-step-mifepristone-and-misoprostol"},{"key":"zoi261019r22","unstructured":"National Statement on Ethical Conduct in Human Research. National Health and Medical Research Council, Australian Research Council, and Universities Australia. Accessed August 30, 2026. https:\/\/www.nhmrc.gov.au\/research-policy\/ethics\/national-statement-ethical-conduct-human-research"},{"key":"zoi261019r24","unstructured":"Abortion laws for each state. Children by Choice. 2025. Accessed July 20, 2026. https:\/\/www.childrenbychoice.org.au\/organisational-information\/legislation\/australian-abortion-law-and-practice\/"},{"key":"zoi261019r25","unstructured":"Concession and health care cards. Australian Government Services Australia. 2025. Accessed July 20, 2026. https:\/\/www.servicesaustralia.gov.au\/concession-and-health-care-cards?context=60091"},{"key":"zoi261019r29","unstructured":"Remoteness areas. Australian statistical geography standard (ASGS) edition 3. Australian Bureau of Statistics. 2023. Accessed July 20, 2026. https:\/\/www.abs.gov.au\/statistics\/standards\/australian-statistical-geography-standard-asgs-edition-3\/jul2021-jun2026\/remoteness-structure\/remoteness-areas"},{"key":"zoi261019r30","unstructured":"Socio-Economic Indexes for Areas (SEIFA), Australia Canberra. Australian Bureau of Statistics. 2021. Accessed July 20, 2026. https:\/\/www.abs.gov.au\/statistics\/people\/people-and-communities\/socio-economic-indexes-areas-seifa-australia\/latest-release"},{"key":"zoi261019r31","unstructured":"1270.0.55.001: Australian statistical geography standard (ASGS). Volume 1: main structure and greater capital city statistical areas, July 2016. statistical area level 3 (SA3). Australian Bureau of Statistics. 2016. Accessed July 20, 2026. https:\/\/www.abs.gov.au\/ausstats\/abs@.nsf\/Lookup\/by%20Subject\/1270.0.55.001~July%202016~Main%20Features~Statistical%20Area%20Level%203%20(SA3)~10015"},{"key":"zoi261019r40","unstructured":"Questions and answers on mifepristone for medical termination of pregnancy through ten weeks gestation. US Food and Drug Administration. Accessed July 20, 2026. https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation"},{"key":"zoi261019r43","unstructured":"South Australians will have access to a new method of abortion care. MSI Australia. June 24, 2022. Accessed July 20, 2026. https:\/\/www.msiaustralia.org.au\/south-australians-will-have-access-to-a-new-method-of-abortion-care\/"}],"container-title":["JAMA Network Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/articlepdf\/2854929\/edvardsson_2026_oi_261019_1790787570.06905.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T15:00:37Z","timestamp":1791385237000},"score":1,"resource":{"primary":{"URL":"https:\/\/jamanetwork.com\/journals\/jamanetworkopen\/fullarticle\/2854929"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10,7]]},"references-count":43,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10,1]]}},"URL":"https:\/\/doi.org\/10.1001\/jamanetworkopen.2026.37766","relation":{},"ISSN":["2574-3805"],"issn-type":[{"value":"2574-3805","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,10,7]]}}}