美国雌激素供应紧张加剧，女性寻求替代短缺贴片姆里纳利卡·罗伊 10月28日美国女性在寻找缓解更年期症状的激素替代疗法时面临困难，除了雌激素贴片短缺外，需求激增也导致部分注射用雌激素和阴道用雌激素产品供应不足。
US estrogen supply crunch widens as women seek alternatives to scarce patches By Mrinalika Roy Oct 28 - Women in the US struggling to find hormone replacement treatments to manage menopause symptoms are facing shortages beyond estrogen patches amid surging demand, with some injectable and vaginal estrogen products also in short supply.
美国食品药品监督管理局（FDA）自9月以来一直与制造商合作，以增加雌激素贴片的供应，此前该药品已短缺数月。但药房和药品短缺监测机构报告称，其他形式的该激素也出现问题。
The US Food and Drug Administration has been working with manufacturers since September to boost supplies of estrogen patches after months of shortages. But pharmacies and drug-shortage monitors are reporting problems with other forms of the hormone.
去年，FDA 取消了某些激素疗法上长期存在的黑框警告，该警告提示乳腺癌、卵巢癌、中风以及2002年一项大型研究发现的其他严重疾病风险可能升高。此后，激素替代疗法的需求有所增加。
Demand for hormone replacement therapy has increased following the FDA's removal last year of a long-standing boxed warning on some hormone therapy that had signalled possible heightened risk of breast and ovarian cancer, as well as strokes and other serious conditions found in a large 2002 study.
制药咨询公司 ProPharma 的产品生命周期管理总监凯文·希珀表示，新的短缺可能部分反映出女性从越来越难以找到的贴片转向其他激素疗法产品。
The new shortages may partly reflect women switching from patches that have become harder to find to alternative hormone therapy products, said Kevin Schipper, director of product lifecycle management at pharmaceutical consulting firm ProPharma.
美国卫生系统药剂师协会（ASHP）9月初将 Hikma、American Regent 和 Par Sterile Products 的多种雌二醇注射产品列入短缺名单。
The American Society of Health-System Pharmacists early in September listed multiple estradiol injection products from Hikma, American Regent and Par Sterile Products as being in shortage.
此外，ASHP 还将 Viatris 旗下 Mylan 部门、Padagis 和 Teva 生产的阴道用雌二醇乳膏列为缺货或配给状态。美国 FDA 未回应就上述最新短缺问题发表评论的请求。供应链问题CVS Health 表示，过去几个月，制造商一直难以提供足够数量的某些规格的雌二醇注射产品，该公司称这一情况在最近几周有所恶化。
Separately, ASHP lists vaginal estradiol creams made by Viatris' Mylan unit, Padagis, and Teva as being on backorder or allocation. The FDA did not respond to a request for comment on the latest shortages. SUPPLY-CHAIN ISSUES CVS Health said manufacturers have struggled over the past several months to provide sufficient supplies of certain strengths of estradiol injections, a situation it said has worsened in recent weeks.
远程医疗提供商 Midi Health 的首席医疗官凯瑟琳·乔丹博士描述了日益增多的供应链问题。
Dr. Kathleen Jordan, chief medical officer of telehealth provider Midi Health, described a growing number of supply-chain issues.
“贴片短缺的问题已经持续了一段时间。随着处方医生及其患者转而使用替代性凝胶和乳膏，这也产生了连锁反应，影响了这些处方药的供应，”她说。
"Persistent patch shortages have been going on for a while and as prescribers and their patients go to alternative gels and creams, there has been a domino effect impacting the supplies of these prescriptions as well," she said.
由亿万富翁企业家马克·库班创立的在线药店Cost Plus Drugs表示，该公司正尽可能多地从供应商处采购，以维持库存水平。库班表示，由于平台价格低廉，所售产品“几乎每一种”的需求都激增了5至10倍，而其供应商也正在扩大产能。
Cost Plus Drugs, the online pharmacy founded by billionaire entrepreneur Mark Cuban, said it was buying as much as possible from suppliers to maintain inventory levels. Cuban said demand for products sold through the platform had surged fivefold to tenfold "for almost every product" because of its low prices, while its suppliers were expanding capacity.
库班表示，Cost Plus Drugs得以维持雌激素替代药物的供应，仅出现间歇性中断。需求旺盛美国食品药品监督管理局（FDA）9月表示，美国市场上经FDA批准的雌二醇贴片供应量较上一年几乎翻了一番，但仍未跟上需求。
Cost Plus Drugs has been able to maintain estrogen replacement supplies with only intermittent interruptions, Cuban said in an HIGH DEMAND The FDA said in September that the US supply of FDA-approved estradiol patches had nearly doubled over the previous year but had not kept up with demand.
雌二醇贴片和乳膏的制造商之一晖致表示，其需求“大幅激增”，公司全年都在努力增加供应。该公司今年早些时候在其位于佛蒙特州圣奥尔本斯的工厂增加了一个生产班次，使工厂实现全天候生产，并表示目前产量已显著提高。
Viatris, one of several manufacturers of estradiol patches and creams, said it had seen a "significant surge in demand" and had been working throughout the year to increase supply. The company added a production shift at its St. Albans, Vermont, facility earlier this year, taking the plant to around-the-clock production, and said its output was now significantly higher.
“我们正在落实当前雌二醇阴道乳膏的供应计划，并致力于支持患者获得这一所需治疗，”晖致表示。
"We are meeting our current supply plans for estradiol vaginal cream and are committed to supporting patient access to this needed treatment," Viatris said.
该公司还表示，正在投资购置更多设备，并新增一条生产线以扩大长期产能。此外，公司还在寻求与第三方建立潜在合作关系，以进一步增加贴片供应。
The company added that it was investing in additional equipment and adding a new production line to expand long-term capacity. It is also pursuing potential partnerships with third parties to further increase the patch supply.
另一家雌二醇贴片制造商安姆尼尔表示，在FDA解除警告后，需求大幅增加，该公司正努力提高产量。
Amneal, another manufacturer of estradiol patches, said demand had increased significantly following the FDA's warning removal and that it was working to increase production.
梯瓦、帕达吉斯、希克马、美国瑞金特和帕尔健康未回应路透社的置评请求。
Teva, Padagis, Hikma, American Regent and Par Health did not respond to Reuters requests for comment.
普罗制药的希珀表示，短缺的态势似乎并未表明原材料普遍短缺，不过他提醒说，供应链问题仍可能导致供应中断。
ProPharma's Schipper said the pattern of shortages did not appear to point to a broad lack of raw materials, although he cautioned that supply-chain problems could still be contributing to disruptions.