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	<title>Mifepristone Archives - Pharmacy Update Online</title>
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	<title>Mifepristone Archives - Pharmacy Update Online</title>
	<link>https://pharmacyupdateonline.com/tag/mifepristone/</link>
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		<title>Local access to abortion services expanded with mifepristone in community pharmacies</title>
		<link>https://pharmacyupdateonline.com/2025/04/local-access-to-abortion-services-expanded-with-mifepristone-in-community-pharmacies/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Wed, 09 Apr 2025 08:00:42 +0000</pubDate>
				<category><![CDATA[Medicines & Therapeutics]]></category>
		<category><![CDATA[Obstetrics & Gynaecology]]></category>
		<category><![CDATA[Pharmacy Services]]></category>
		<category><![CDATA[Practices & Services]]></category>
		<category><![CDATA[Service Developments]]></category>
		<category><![CDATA[abortion]]></category>
		<category><![CDATA[Community pharmacy]]></category>
		<category><![CDATA[drug safety]]></category>
		<category><![CDATA[female health]]></category>
		<category><![CDATA[Mifepristone]]></category>
		<category><![CDATA[rural areas]]></category>
		<guid isPermaLink="false">https://pharmacyupdate.online/?p=16582</guid>

					<description><![CDATA[<p>Before 2017, abortions were generally performed as procedures in fewer than 100 hospitals and clinics mostly in urban centres, leading to delayed care, particularly for people living in rural [&#8230;]</p>
<p>The post <a href="https://pharmacyupdateonline.com/2025/04/local-access-to-abortion-services-expanded-with-mifepristone-in-community-pharmacies/">Local access to abortion services expanded with mifepristone in community pharmacies</a> appeared first on <a href="https://pharmacyupdateonline.com">Pharmacy Update Online</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Before 2017, abortions were generally performed as procedures in fewer than 100 hospitals and clinics mostly in urban centres, leading to delayed care, particularly for people living in rural areas. Medication abortions, mainly via off-label use of methotrexate, were infrequent.</p>
<p>Researchers looked at population data from ICES to examine abortion service availability changes in Ontario from January 2017 to December 2022. Between 2017 and 2022, there were more than 226 000 abortions provided to 175 091 people. The proportion of regions with a pharmacy that dispensed mifepristone increased from 20% in 2017 to 82% in 2022. Only 37% of abortion service users lived in a region with either a mifepristone-dispensing pharmacy or procedural provider in 2017, but this increased to 91% by 2022.</p>
<p>Access to abortion services increased in both urban and rural areas.</p>
<p>“Despite these rapid gains in access to procedural or medication abortion services, in 2022, 6% of regions had no pharmacy at all, nearly 20% of regions with a pharmacy still lacked a pharmacy that dispensed mifepristone, and roughly 9% of abortion service users lived in a region without a local procedural provider or a pharmacy that dispensed mifepristone,” writes Dr. Laura Schummers, Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, with coauthors.</p>
<p>The authors note that the expansion of mifepristone to community pharmacies shifted the delivery of abortions from procedural abortions to more accessible mifepristone abortions, a trend they expect to continue.</p>
<p>“Abortion service needs are time-sensitive, as risks of abortion complications increase exponentially with increasing gestational age. It is likely that the proportion of abortions provided by medication in Ontario will continue to increase beyond our study period, mirroring trends elsewhere.”</p>
<p><em>“Changes in local access to mifepristone dispensed by community pharmacies for medication abortion in Ontario: a population-based repeated cross-sectional cohort study”</em> is published April 7, 2025.</p>
<p><strong>Media contact: </strong>Media relations, ICES, <a href="https://can01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpublic-can.mkt.dynamics.com%2Fapi%2Forgs%2Fc59caf51-e992-4e40-b94f-9188b947e9d8%2Fr%2F2BLkh0X-AkewU_BTCjIAAAMAAAA%3Ftarget%3D%257B%2522TargetUrl%2522%253A%2522mailto%25253Amedia%252540ices.on.ca%2522%252C%2522RedirectOptions%2522%253A%257B%25225%2522%253Anull%252C%25221%2522%253Anull%257D%257D%26digest%3DGfKaBbaqW9nLUtfVY8%252Bq%252F%252BuuCVp%252FBGy0P%252FbTe9%252FJON4%253D%26secretVersion%3D79707ce120dd403a8634c032af94bd4c&amp;data=05%7C02%7Cemii.morgan%40cmaj.ca%7Cdb4bf9c9114c41f5369708dd710c7f05%7C1fd963d3d81c4b05812fd9efe7544399%7C0%7C0%7C638791020708150040%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=s2jqTIKbLDHO18EWexUAyPNTJrBcVCqY9U9R16p%2FqNQ%3D&amp;reserved=0">media@ices.on.ca</a></p>
<p><strong>General media contact:</strong> Kim Barnhardt, <em>CMAJ</em>, <a href="https://can01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fpublic-can.mkt.dynamics.com%2Fapi%2Forgs%2Fc59caf51-e992-4e40-b94f-9188b947e9d8%2Fr%2F2BLkh0X-AkewU_BTCjIAAAQAAAA%3Ftarget%3D%257B%2522TargetUrl%2522%253A%2522mailto%25253Akim.barnhardt%252540cmaj.ca%2522%252C%2522RedirectOptions%2522%253A%257B%25225%2522%253Anull%252C%25221%2522%253Anull%257D%257D%26digest%3D1xkZQV9csDL85m%252FhRkesByBOis2Z%252BHLcI2xUPQtPfhE%253D%26secretVersion%3D79707ce120dd403a8634c032af94bd4c&amp;data=05%7C02%7Cemii.morgan%40cmaj.ca%7Cdb4bf9c9114c41f5369708dd710c7f05%7C1fd963d3d81c4b05812fd9efe7544399%7C0%7C0%7C638791020708161761%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&amp;sdata=R5ijEH7d13IYco406G7jBD5845T0GDa7CQljr2VpY7M%3D&amp;reserved=0">kim.barnhardt@cmaj.ca</a></p>
<p><em>Please credit CMAJ, not the Canadian Medical Association (CMA). CMAJ is an independent medical journal; views expressed do not necessarily reflect those of its owner, CMA Impact Inc., a CMA company, or CMA.</em></p>
<p>The post <a href="https://pharmacyupdateonline.com/2025/04/local-access-to-abortion-services-expanded-with-mifepristone-in-community-pharmacies/">Local access to abortion services expanded with mifepristone in community pharmacies</a> appeared first on <a href="https://pharmacyupdateonline.com">Pharmacy Update Online</a>.</p>
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		<title>Updated drug information handout outdoes FDA’s version</title>
		<link>https://pharmacyupdateonline.com/2025/02/updated-drug-information-handout-outdoes-fdas-version/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Wed, 12 Feb 2025 08:00:35 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Practices & Services]]></category>
		<category><![CDATA[drug handout]]></category>
		<category><![CDATA[drug information]]></category>
		<category><![CDATA[drug research]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[Mifepristone]]></category>
		<category><![CDATA[patient safety]]></category>
		<guid isPermaLink="false">https://www.pharmacyupdate.online/?p=15914</guid>

					<description><![CDATA[<p>A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an updated version developed by researchers at the University of [&#8230;]</p>
<p>The post <a href="https://pharmacyupdateonline.com/2025/02/updated-drug-information-handout-outdoes-fdas-version/">Updated drug information handout outdoes FDA’s version</a> appeared first on <a href="https://pharmacyupdateonline.com">Pharmacy Update Online</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an updated version developed by researchers at the University of Pittsburgh that quantifies a drug’s risk and benefits showed that the latter was more informative and helped patients feel better equipped to make decisions.</p>
<p>Published today in <em>JAMA Network Open</em>, the study, which used the drug mifepristone as an example, highlights the importance of communicating risks and benefits of prescription medications – and the size of those risks and benefits.</p>
<p>“The FDA’s proposed patient medication information handout gets a lot of things right: it’s succinct and it’s simple,” said lead author Tamar Krishnamurti, Ph.D., associate professor in the <a href="https://dom.pitt.edu/dgim/">Division of General Internal Medicine</a> at the Pitt School of Medicine and <a href="https://mageewomens.org/">Magee-Womens Research Institute</a>. “But it’s missing nuances about risks and assumes that a patient already knows a drug’s benefits. Our study shows that this complexity can be explained in an easy-to-understand way, which can support people in making more informed decisions about their health.”</p>
<p>Currently, patient medication guides are provided under <a href="https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-208/subpart-A/section-208.1#p-208.1(c)">certain circumstances</a> such as for drugs with serious risks or where product information could prevent serious adverse effects. But because these handouts do not have a standardized format, they can be lengthy — often four or five pages long — and unclear.</p>
<p>To help patients use medications more safely and effectively, the FDA <a href="https://www.fda.gov/about-fda/economic-impact-analyses-fda-regulations/medication-guides-patient-medication-information-proposed-rule-preliminary-regulatory-impact">recently proposed</a> a new patient medication information (PMI) <a href="https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-medication-information-pmi#Example%20of%20Patient%20Medication%20Information%20for%20a%20fictitious%20drug,%20Rheutopia">one-page handout</a> for all prescription drugs used in an outpatient setting that clearly lays out directions for use, safety information, warnings and common side effects.</p>
<p>But there are no requirements to list the benefits of the medication, to quantify how effective it is or how often common side effects occur, or to explain how the medication works.</p>
<p>“The FDA may be assuming that when patients pick up their drugs, the benefits of the medication will have already been clearly communicated to them by their provider, but if someone is relying on a PMI to help them make a decision, this information should be included,” said Krishnamurti. “It’s also important to tell people about the size of risks and benefits of a medication, so that they know how likely something is to occur, not just that it’s possible.”</p>
<p>According to Krishnamurti, PMIs should also include a mechanistic explanation of how the drug works so that patients can understand what is happening in their body.</p>
<p>Focusing on mifepristone — which is used in combination with another drug called misoprostol to end pregnancies that are less than 10 weeks along — Krishnamurti and her team developed a so-called Decision Critical PMI that is similar to the FDA’s PMI but explains how the drug works, how often it is effective and how often side effects occur. For example, instead of stating that fever and headache are common side effects, it specifies that 48% of patients experience fever and 43% experience headache.</p>
<p>To test the effectiveness of different communications about mifepristone, the researchers recruited 330 female participants via an online survey. After being randomly assigned to view the <a href="https://www.fda.gov/media/164654/download">drug vendor’s five-page medication guide</a>, the FDA’s PMI or the Decision Critical PMI, participants were tested on their knowledge about the drug and answered questions about the usefulness of the information.</p>
<p>Participants rated both the FDA and Decision Critical PMIs as having higher readability compared with the vendor’s handout. The Decision Critical PMI scored better than the other two communications in terms of comprehension, supporting decision making and drug use directions.</p>
<p>“Our findings support other evidence that being transparent about uncertainty and giving people the numbers to evaluate the strength of evidence about a medication themselves is best practice for risk communication,” said Krishnamurti. “Our hope is that these findings inform changes to the FDA’s final requirements for the proposed PMI, which could be an incredibly useful communication for patients, particularly for drugs that may be subject to popular misinformation.”</p>
<p>According to Krishnamurti, the FDA’s proposal does not currently require pharmaceutical companies to test the messaging in their PMIs.</p>
<p>“The proposed regulation will tell vendors what topics they need to cover in the PMI, but there is no requirement for testing for how well people read or understand the materials,” she explained. “User testing should be a requirement for public-facing information on all drugs.”</p>
<p>Other authors on the study were Gianna White, M.S., Barry Dewitt, Ph.D., and Baruch Fischhoff, Ph.D., all of Carnegie Mellon University; and Elizabeth Mosley, Ph.D., M.P.H., of Pitt.</p>
<p>The post <a href="https://pharmacyupdateonline.com/2025/02/updated-drug-information-handout-outdoes-fdas-version/">Updated drug information handout outdoes FDA’s version</a> appeared first on <a href="https://pharmacyupdateonline.com">Pharmacy Update Online</a>.</p>
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		<title>Doctor and pharmacist revamp standard processes for ordering and documenting mifepristone use</title>
		<link>https://pharmacyupdateonline.com/2023/09/doctor-and-pharmacist-revamp-standard-processes-for-ordering-and-documenting-mifepristone-use/</link>
		
		<dc:creator><![CDATA[Charlie King]]></dc:creator>
		<pubDate>Mon, 25 Sep 2023 08:00:28 +0000</pubDate>
				<category><![CDATA[Legislative and Regulatory]]></category>
		<category><![CDATA[Medicines & Therapeutics]]></category>
		<category><![CDATA[Obstetrics & Gynaecology]]></category>
		<category><![CDATA[Practices & Services]]></category>
		<category><![CDATA[abortion]]></category>
		<category><![CDATA[drug safety]]></category>
		<category><![CDATA[Mifepristone]]></category>
		<category><![CDATA[misoprostol]]></category>
		<category><![CDATA[pregnancy]]></category>
		<guid isPermaLink="false">https://www.pharmacyupdate.online/?p=10794</guid>

					<description><![CDATA[<p>Clinical researchers at the University of Minnesota Medical School partnered with the university health system’s compliance department to create standard processes for ordering and documenting mifepristone administration, which [&#8230;]</p>
<p>The post <a href="https://pharmacyupdateonline.com/2023/09/doctor-and-pharmacist-revamp-standard-processes-for-ordering-and-documenting-mifepristone-use/">Doctor and pharmacist revamp standard processes for ordering and documenting mifepristone use</a> appeared first on <a href="https://pharmacyupdateonline.com">Pharmacy Update Online</a>.</p>
]]></description>
										<content:encoded><![CDATA[<p>Clinical researchers at the University of Minnesota Medical School partnered with the university health system’s compliance department to create standard processes for ordering and documenting mifepristone administration, which adhere to the Risk Evaluation and Mitigation Strategy (REMS) requirements. They established a single prescriber account to represent all system prescribers who met REMS requirements, allowing for centralized ordering and distribution by the pharmacy purchasing team. This process mirrors other standard operating procedures used by the health system to purchase other medications. Establishing processes for mifepristone for early pregnancy loss accelerated integration of its use for medical abortion. As the barriers to mifepristone use are similar, regardless of indication, the new process reduced barriers to providing abortion care at a time when access has become limited throughout the Midwest.</p>
<p><strong>What We Know: </strong>Mifepristone and misoprostol taken together remain the standard for medical management of early pregnancy loss (EPL) and first-trimester abortion. While misoprostol is readily available, distribution of mifepristone has been restricted, regardless of reason for its use. Despite its documented safety, mifepristone is regulated by a Risk Evaluation and Mitigation Strategy (REMS) program—a barrier for both labeled and off-label use.</p>
<p><strong>What This Study Adds: </strong>Study authors created standard processes for ordering and documenting mifepristone administration that were in compliance with the new regulations restricting use of this medication. This process reduced barriers to providing both management of early pregnancy loss and first-trimester abortion care.</p>
<p><em>Streamlining the Use of Mifepristone for Early Pregnancy Loss Across a Large Health Care System Sets the Stage for Rapid Expansion of Medication Abortion Access in a Post-Roe Environment</em></p>
<p>Nicole Chaisson, MD, MPH, University of Minnesota Medical Center Residency Program, Department of Family Medicine and Community Health, University of Minnesota Medical School, St. Paul, Minnesota, and Katherine Montag Schafer, PharmD, St. John’s Hospital Family Medicine Residency Program, Department of Family Medicine and Community Health, University of Minnesota Medical School, St. Paul, Minnesota</p>
<p>The post <a href="https://pharmacyupdateonline.com/2023/09/doctor-and-pharmacist-revamp-standard-processes-for-ordering-and-documenting-mifepristone-use/">Doctor and pharmacist revamp standard processes for ordering and documenting mifepristone use</a> appeared first on <a href="https://pharmacyupdateonline.com">Pharmacy Update Online</a>.</p>
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