Baxter

关注并星标CPHI制药在线 警惕低价药的保障功能缺失 近日，美国一些医院因为生理盐水大输液断供，而陷入一个非常尴尬的状态，以至于对于一些病人提供佳得乐及其他口服电解质溶液，来代替大输液。        图源：STATNEWS 之所以这样，是因为台风袭击了北卡罗纳州的Baxter公司，据悉该公司承担了全国一半以上的静脉大输液产能，因台风关闭后。本身捉襟见肘的大输液，又可能因另个台风袭击第二大静脉大输液生产商而雪上加霜。 大输液，有氯化钠注射液、复方氯化钠注射液、葡萄糖注射液、葡萄糖氯化钠注射液等等种类。就我国而言目前文号很多，其中复方氯化钠注射液168个文号；缩合葡萄糖氯化钠注射液及葡萄糖氯化钠注射液有767个文号；还有很多已经提前预混了药品的相关注射液。    图源：药监局 就大输液而言，目前国家集采价格压的很多企业不太愿意生产。尽管配方表里组分非常单一，像氯化钠注射液主要成分就是氯化钠，治疗脱水，冲洗伤口、眼部，以及产科的水囊引产；复方氯化钠注射液相对复杂，里面包含氯化钠、氯化钾、氯化钙，预期用途是治疗各种原因的脱水，以及低氯性代谢性碱中毒等等。 当然常规用途中可能最多的是来溶解稀释其他药物组分，给患者静脉用药。但氯化钠注射液与葡萄糖注射液以及其他用来稀释溶解药物的注射液，往往不能相互替代。像培氟沙星、佛罗沙星、乳酸红霉素、硫酸普拉睾 酮钠、胺碘 酮、甘露醇、去甲肾上腺素、两性霉素B、奥沙利铂、洛铂、多稀磷脂酰胆碱，就不能用氯化钠注射液，一旦接触，有的会形成结晶，有的会形成沉淀，有的还会被降解。同样的氨苄西林、阿莫西林、乳糖酸红霉素、苯妥 英钠、伊曲 康唑、肝素钠、氨力农、曲妥珠单抗、多柔比星、呋塞米、布美他尼则不适用于葡萄糖注射液，接触后有的会出现沉淀，有的析出结晶，还有的会导致蛋白凝固。要根据药物的特性来选取具体大输液品种，没有一个是万 能溶媒，所以所有品种理论上都要有备货量。 集中起来，由一两个企业给全国备货，确实有其优势，资源利用度高，避免了大家都盲目竞争价格。但其缺陷也是显而易见，像这种大企业因为天气、地质灾害、火灾事故等等停产，企业可能本身就有财产保险，不会有太多损失，但对于整体医疗产业链的影响则是非常巨大的。患者无法按时手术治疗，其他治疗药物也无法达到最 佳使用条件。 大输液看着工艺并不复杂，成本也低，容易被视为底端品种，所以价格上不去。但同样的，相对于其他药品的运输成本与价格比，大输液就很吃亏，毕竟大输液往往500毫升，甚至冲洗膀胱肿瘤的生理盐水一袋子就3000毫升装量，对内包材质量要求高。玻璃瓶包装逐步被非PVC软包和直立式软袋取代。        图源：中国银河证券 但大输液又不是简单的氯化钠或者其他组分加水灭菌就可以灌装，因为是注射剂，所以各类风险，像可见异物、内毒素、无菌、不溶性微粒、渗透压等等都要做，属于高风险产品。比口服药的要求，严格很多。国内知名的大输液企业，有科伦制药、石四药、辰欣药业、山东齐都、华仁药业、华润双鹤、济民制药、哈三联等等。从产能看，大型企业还没有达到满产状态。        图源：中国银河证券 但此时已经有不少小企业被淘汰掉，中国的制药企业分布面较大，理论上不会出现美国这种几次台风就断供的状态。当然大输液企业也在布局其他药品，避免产品单一带来的风险性。在这个过程中，已经形成了较为稳定的竞争格局，多数企业不可避免的要面对一轮轮的淘汰压力。需要注意的是，在实现大企业分而持之的同时，要保证其他企业一定的竞争优势，不能一味的降低价格，避免走上美国这种路线。在美国大输液紧张的情况下，出口可能会是一个契机，但运输成本以及海关的检验时间，也会影响到最终的实际出口量。 总体来说，对于价格低，应用广的医药产品，保证有一部分能有较为自由的定价权，是分散风险的一种方式。这种思维在集采面前，可能会有压力，但美国这次的大输液危机则是一个很质朴的经验教训。 END 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

Two major hurricanes in the eastern U.S. in recent weeks have had medtech companies, including Baxter, B. Braun Medical and Fresenius Medical Care, scrambling to prevent an IV bags shortage. According to media reports, hospitals across the country are facing disruption in the supply of some sterile intravenous fluids used in everything from intravenous dialysis care to some surgeries. The problems started late last month after Hurricane Helene flooded Baxter’s largest manufacturing facility — its North Cove plant in Marion, North Carolina. The 1.4-million-square-foot facility employs 2,500 people and is the largest manufacturer of intravenous and peritoneal dialysis products in the United States, according to the company. Since the disaster, Baxter has scaled production across its global locations, working with the FDA on temporarily importing products to boost available inventory. Thanks to the efforts, Baxter announced on Oct. 9 that it was increasing U.S. allocation levels of its highest demand IV fluids for direct customers to 60% from 40%, and for distributors to 60% from 10%. Baxter says its goal is to restore customers to 100% allocation levels as soon as possible. The plan is to return North Cove production in phases and return to 90% to 100% allocation of certain IV solution product codes by the end of 2024. “We will spare no resource — human or financial — to restart operations and help ensure patients and providers have the products they need,” said CEO Joe Almeida. Meanwhile, other medtech companies have sought to respond to the shortage. But B. Braun Medical faced its own challenge this week as Hurricane Milton approached Florida, with the New York Times describing a scene of B. Braun workers loading trucks at the company’s Daytona Beach plant and driving the medical bags north to what the company hoped would be safer locations. The Daytona Beach IV solutions manufacturing site and distribution center had been a key part of B. Braun’s efforts to address the supply shortages caused by Baxter’s North Cove outage. After Milton had passed through Florida, B. Braun Medical reported that the hurricane had not seriously impacted Daytona Beach facility. In partnership with the Administration for Strategic Preparedness and Response, the company is boosting production of critical IV fluids at its plant in Irvine, California — with plans to resume work in Daytona Beach today. Fresenius Medical Care, a major provider of products and services for individuals with renal diseases, is also responding as it ramps up production of peritoneal dialysis products (PD) and IV fluids to boost supply. In the short term, this includes maximizing the use of existing production capacity at international sites, according to a news release that the company posted yesterday. In an Oct. 9 letter to health providers, U.S. Health and Human Services Department Secretay Xavier Becerra said the federal government is actively working with both public and private health providers to address the IV supplies shortage: ” FDA will continue working with Baxter to identify both potential products already in their system and alternative manufacturing sites, including for potential temporary imports. As alternatives are identified, FDA is expediting assessments of those options. FDA will also expedite consideration of any shelf-life extension requests manufacturers submit for short-dated product. FDA will continue to work with Baxter as they bring their plant back online and with other suppliers to increase supply.” This isn’t the first time that hurricanes have had a significant impact on medical device companies. In September 2017, Hurricane Maria took Medtronic’s four manufacturing plants in Puerto Rico offline for nearly two weeks; the cost for Medtronic was $60 million. With climate change causing ever more extreme weather events, medical device manufacturing companies and corporations, in general, are increasingly seeking to innovate their supply chains to make them more resilient to the challenges.

Baxter is limiting how much saline, dextrose and PD solution products its customers can order as it works on restoring its North Cove site in Marion, North Carolina, which Hurricane Helene flooded. Deerfield, Illinois–based Baxter yesterday said, “We are working with the greatest urgency, but we do not yet have a timeline for when operations will be back up and running.” According to media reports, hospitals across the country are facing disruption in the supply of some sterile intravenous fluids used in everything from intravenous dialysis care to some surgeries. Mike Ganio, senior director at the American Society of Health-System Pharmacists, told Axios that on top of taking stock of inventories, hospitals should be taking mitigation efforts such as having patients hydrate orally when possible and delivering medications via syringes rather than IV drips. Opened in 1972, Baxter’s North Cove facility is the largest manufacturer of intravenous and peritoneal dialysis products in the United States, according to the company. The 1.4-million-square-foot facility employs 2,500 people. With cell phone access still a problem in the area, Baxter was still trying to reach some of its North Cove employees as of yesterday to confirm their well-being, though it had reached the vast majority of them. Baxter said it has remediation firms already on site, with roughly 500 workers in action. The number of workers seeking to restore North Cove will double over the next week. Here’s more from Baxter about efforts to restore operations at the North Cove facility: “As shared in our press release, bridges to our site were damaged in the storm. One access point requires re-establishing the county-maintained bridge. This will allow us to both transport remediation equipment to the site and get some finished goods that were stored in trailers and not impacted by the storm to our customers and patients. Our team has worked diligently to establish a temporary bridge to support limited transfers, and with tremendous support from state and local officials, ASPR and FEMA, we expect a permanent bridge will be installed by the Army Corps of Engineers and North Carolina Department of Transportation in the coming weeks.” On top of limiting orders, Baxter is also working with the FDA to use more of the company’s global manufacturing network to help mitigate potential supply problems. This isn’t the first time that a hurricane had a significant impact on medical device companies. In September 2017, Hurricane Maria took Medtronic’s four manufacturing plants in Puerto Rico offline for nearly two weeks; the cost for Medtronic was $60 million. With climate change causing ever more extreme weather events, medical device manufacturing companies and corporations, in general, are increasingly seeking to innovate their supply chains to make them more resilient to the challenges.