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Mifepristone by prescription: a dream in the United States but reality in Australia

机译:米非司酮处方药:美国的梦想,但澳大利亚的现实

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The requirement that mifepristone be dispensed only by physicians in offices, clinics or hospitals-and not by prescription in pharmacies-has likely limited uptake by providers in the United States. However, in several other countries, provision by prescription in pharmacies is allowed, including in Australia. Mifepristone was first registered in Australia in 2012, and in 2015, a composite package including 200 mg mifepristone and four tablets of misoprostol 200 mcg was registered. Both were approved as Schedule 4 medications, which require prescribing by a physician and may be dispensed at pharmacies. As part of the registration for both products, a risk management plan was instituted that has several components. First, physicians must be certified to prescribe mifepristone. General practitioners wishing to become certified must complete online training that includes prescribing requirements and managing the medical abortion process; obstetrician-gynecologists are exempt from the online learning module. Pharmacists must also be certified in order to dispense the medication, although this does not require additional training. When a pharmacist receives a prescription for mifepristone, she or he must confirm through a secure website that the prescriber is certified. In every region of the country, there are more certified prescribers and dispensers of mifepristone than the number of facilities providing abortion care. The experience in Australia demonstrates the feasibility of mifepristone by prescription and should be a model for expanding access to early medical abortion in the United States. (C) 2015 Elsevier Inc. All rights reserved.
机译:米非司酮仅由办公室,诊所或医院的医师分发而不是由药房的处方分发的要求可能会限制美国供应商的使用。但是,在其他几个国家/地区,包括澳大利亚,也允许药房通过处方提供药品。米非司酮于2012年首次在澳大利亚注册,2015年注册了包含200毫克米非司酮和四片米索前列醇200 mcg的复合包装。两种药物均被批准为附表4药物,需要医生开具处方,并且可以在药房配药。作为这两种产品注册的一部分,制定了风险管理计划,该计划包含多个组成部分。首先,医生必须获得开米非司酮处方的认证。希望获得认证的全科医生必须完成在线培训,其中包括规定要求和管理药物流产过程;妇产科医生免于在线学习模块。药剂师还必须经过认证才能分配药物,尽管这不需要额外的培训。当药剂师收到米非司酮的处方时,她或他必须通过安全的网站确认处方者已通过认证。在该国的每个地区,米非司酮的合格处方者和配药者多于提供堕胎护理的设施数量。在澳大利亚的经验表明,米非司酮可通过处方行之有效,应成为在美国扩大获得早期药物流产的典范。 (C)2015 Elsevier Inc.保留所有权利。

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