飓风海伦引发最新药品短缺，医院争相抢购静脉输液

【中美创新时报2024 年 10 月 4 日编译讯】（记者温友平编译）飓风海伦严重损坏了北卡罗来纳州一家生产该国大部分供应的工厂，暴露了制造和分销关键药物的不稳定系统，医院领导竞相储备静脉输液。《波士顿环球报》记者凯·拉扎尔(Kay Lazar)对此作了下述报道。

风暴带来的洪水损坏了蓝岭山脉马里昂镇的一家工厂，该工厂生产了该国 60% 的静脉输液供应，迫使其母公司 Baxter International Inc. 关闭该工厂。

目前，当地医院表示，他们还没有减少手术，但正在采取小措施来管理目前的供应，比如在可能的情况下给一些病人提供其他液体。然而，目前还不清楚北卡罗来纳州的工厂何时会重新开工，或者其他供应商是否会填补这一空白，因此医院是否能够将库存延长到足够长的时间还不得而知。

医生们表示，虽然医院之前也曾应对过药品短缺问题，但这次中断尤其具有挑战性。

“这次短缺真正棘手的地方，让我担心的是，这些产品无处不在，”马萨诸塞州中部最大的医疗系统的学术医院伍斯特市麻省大学纪念医学中心首席质量官 Kimi Kobayashi 博士说。“我们到处都使用静脉输液。在我们的重症监护室、外科病房、儿科和每个病人护理楼层都有静脉输液。”

静脉输液是一种救命的无菌溶液，在医院中广泛用于通过管线将患者补水。许多医院的患者都需要静脉输液，包括脱水或不能进食或饮水的患者。静脉注射袋中装有盐水或治疗感染、肾衰竭和许多其他疾病的药物。

小林说，百特告诉他的医院，工厂关闭可能会持续数周。在周二致全国医院的一封信中，百特表示，它只能提供正常水平 40% 的几种静脉注射产品，这促使许多医疗系统的医院管理人员立即采取措施节约静脉注射，同时竞相寻找其他分销商。

静脉注射液供应中断之前曾多次出现短缺，包括用于治疗注意力缺陷多动障碍 (ADHD) 患者的阿德拉 (Adderall)、儿童泰诺 (Tylenol) 和救命的癌症治疗药物。这并不是百特静脉注射液生产第一次中断：2017 年，另一场四级飓风玛丽亚 (Maria) 摧毁了波多黎各的百特工厂，导致该溶液短缺长达数月。

专家表示，当只有少数几家主要供应商时，美国制造业很容易受到干扰，因为其他公司认为不值得与低成本生产商竞争。

“成本最低的生产商往往会获得最大的市场份额，那么其他公司与他们竞争就不那么经济了，”哈佛商学院罗伯特和简·西齐克·贝克基金会教授威利·施说。“如果百特国际因为在相对较少的工厂高效生产静脉注射剂而获得市场份额，那么这种情况就会发生。”

施说，解决困扰国家供应链的许多问题需要时间，而且生产系统管理非常严格，几乎没有储备或备用。

“从历史上看，人们不愿意为[供应链中的]弹性付费，目前也不清楚他们今天是否会为此付费，”他说。“很多人已经忘记了疫情的教训”，当时医院措手不及，几乎没有足够的个人防护装备供工人使用。

施表示，可以增加一些药品或其他保质期较短的产品的生产工厂，但这些工厂需要更靠近客户，或者拥有经济快捷的运输系统。

与此同时，医院领导表示，他们正在采取积极的静脉注射节约措施，并正在研究如何在不影响日常运营的情况下进一步减少静脉注射的使用。目前还没有医院报告减少手术，例如择期手术。

麻省总医院布莱根分院首席准备和连续性官保罗·比丁格博士表示，当患者可以安全饮用时，医院会给患者提供佳得乐或水，而不是静脉注射液体。他还表示，当患者被转移到另一个病房时，工作人员现在不会例行准备备用静脉注射袋，这通常会迫使他们丢弃已打开但未使用的袋子。

麻省总医院也联系了其他静脉注射液供应商，但过去发现在危机期间很难更换制造商。

“历史上的情况是，其他制造商倾向于将产品分销限制在现有客户，以确保他们能够支持他们的客户，”比丁格说。

他说，百特的替代制造工厂位于西班牙和墨西哥，但不确定这些工厂的供应状况。

“我们确实在不断寻找可以实现供应链多元化的地方。有时这在经济上不可行。但我们确实会尽可能地尝试开发冗余，”比丁格说。 “我们尽可能地在经济可承受的范围内储备药品。”

因为静脉输液是通过静脉输给患者的，所以这些液体必须是无菌的，这样才不会造成问题。这意味着它们的保质期很短，以防止细菌或任何其他传染性物质的生长，这对储备也是一个挑战。这些产品体积庞大，需要大量的存储空间，而且由于它们的重量和体积，空运的量是有限的。

来自马萨诸塞大学的 Kobayashi 表示，尽管医院已经制定了应对近年来如此多短缺的计划，但每一种计划都是独一无二的：药物是可以口服还是静脉注射，或者是否有现成的替代产品。

“虽然我们已经习惯了，”他说，“但你不能只是复制粘贴计划。”

在新罕布什尔州，州立医院协会表示，短缺正在“严重影响”那里的医院。

“短缺迫使医院仔细检查其供应，寻找替代产品并修改治疗方案，这可能会中断护理，增加成本并给医护人员带来压力，”该协会执行副总裁/联邦关系 Kathy Bizarro-Thunberg 在一份声明中表示。

“新罕布什尔州的医院正在积极监控其库存，告知临床医生节约注意事项并相互合作分享最佳实践，”她说。

在罗德岛，经营多家医院和健康中心的 Lifespan 在一份声明中表示，它也在密切监控供应链，并有一个团队致力于确保更多的静脉注射。

“虽然我们继续提供高质量的护理，”Lifespan 发言人 Jessica A. Wharton 在一份声明中表示，“我们正在采取措施节约现有供应，并希望 FDA 能够介入，通过临时进口和增加替代制造商的产量来解决短缺问题。

记者 Rachel Umansky-Castro 对本文亦有贡献。

题图：静脉输液袋中装有盐水或治疗感染、肾衰竭和许多其他疾病的药物。华盛顿邮报/华盛顿邮报通过盖蒂图片社

附原英文报道:

Hospitals scramble for IV fluids as Hurricane Helene triggers latest drug shortage

By Kay Lazar Globe Staff,Updated October 3, 2024

IV bags contain salt water or medicines to treat infections, kidney failure, and a host of other conditions.The Washington Post/The Washington Post via Getty Images

Hospital leaders raced to shore up stocks of IV fluids after Hurricane Helene severely damaged a plant in North Carolina that produces much of the country’s supply, laying bare the precarious system for manufacturing and distributing critical medicines.

Flooding from the storm damaged the plant in the Blue Ridge Mountains town of Marion that produces 60 percent of the country’s IV supply, forcing its parent company, Baxter International Inc., to shut it.

For now, local hospitals say they have not had to curtail procedures, but are taking small steps to manage their current supply, such as giving some patients other fluids when possible. However, it’s unclear when the North Carolina plant would reopen, or other suppliers would fill the void, making it uncertain whether hospitals will be able to stretch their stockpiles long enough.

While hospitals have contended with previous drug shortages, this disruption is particularly challenging, doctors said.

“What’s really tricky about this shortage, and has got me worried, is how ubiquitous these products are,” said Dr. Kimi Kobayashi, chief quality officer of UMass Memorial Medical Center in Worcester, the academic hospital for the largest health care system in central Massachusetts. “We use IV fluids everywhere. It’s in our ICU, in our surgical units, in pediatrics, and in every patient care floor.”

Intravenous fluids are life-saving, sterile solutions widely used in hospitals to hydrate patients through a line into their veins. They’re given to many hospital patients, including those who are dehydrated or can’t eat or drink. The IV bags contain salt water or medicines to treat infections, kidney failure, and a host of other conditions.

Kobayashi said Baxter told his hospital the plant closure could extend for many weeks. In a letter Tuesday to hospitals nationwide, Baxter said it could provide several IV products only at 40 percent of normal levels, prompting hospital administrators at many health systems to immediately enact measures to conserve IVs, while they race to find other distributors.

The disruption to the IV fluid supply comes on the heels of many previous shortages, including Adderall for people with ADHD, children’s Tylenol, and lifesaving cancer treatments. This isn’t the first time Baxter’s IV fluid production was disrupted: In 2017 another Category 4 hurricane, Maria, knocked out a Baxter facility in Puerto Rico, creating a months-long shortage of the solutions.

Experts said US manufacturing can be vulnerable to disruptions when there are just a few main suppliers because other companies conclude it’s not worth competing against lower-cost producers.

“The lowest-cost producer will tend to get the most market share and then it’s less economic for others to compete with them,” said Willy Shih,Robert and Jane Cizik Baker Foundation professor at Harvard Business School. “If Baxter International achieves a market share because they have been efficient producing IVs at relatively few plants, that’s how this type of thing happens.”

Shih said it takes time to fix a lot of the problems plaguing the nation’s supply chain, and the production system is so tightly managed there is little allowance for reserves or backup.

“Historically, people haven’t been willing to pay for resiliency [in the supply chain] and it’s not clear they will pay for it today either,” he said. “A lot of people have already forgotten the lessons from the pandemic,” when hospitals were caught off guard with not nearly enough personal protective gear for workers.

Shih said it is possible to have more manufacturing plants for some medicines or other products that have a short shelf life, but those facilities need to be closer to their customers or have an economical and quick system of shipping.

In the meantime, hospital leaders say they are taking aggressive conservation measures for IVs and are studying ways to further reduce their use without affecting daily operations. No hospitals have yet reported curtailing operations, such as elective surgeries.

Mass. General Brigham is giving patients Gatorade or water instead of fluids intravenously when a patient can safely drink, said Dr. Paul Biddinger, MGB’s chief preparedness and continuity officer. He also said workers now will not routinely prepare a back-up IV bag when a patient is moved to another unit, which typically forces them to discard open but unused bags.

Mass General has also reached out to other IV fluid suppliers, but in the past has found it difficult to switch manufacturers amid a crisis.

“What happens historically is that the other manufacturers tend to limit their distribution of their products to their existing customers to make sure they can support their customers,” said Biddinger

He said alternative manufacturing facilities for Baxter are in Spain and in Mexico but was unsure of the status of supplies from those plants.

“We do look constantly at where we can diversify our supply chain. Sometimes that’s economically not feasible. But we do try and develop redundancy whenever we can,” Biddinger said. “We develop stockpiles as much as we can within the context of, again, what we can sustain economically.”

Because IV fluids are given to patients through their veins, the fluids have to be sterile so they don’t cause problems. That means they have a short expiration date to guard against growth of bacteria or any other infectious substances, also a challenge for stockpiling. The products also are bulky, requiring a lot of storage space, and because of their weight and bulk, there is a limit on the volume that can be transported by air.

Kobayashi, from UMass, said that even though hospitals have developed plans from dealing with so many shortages in recent years, each one is unique: whether the drug can be given orally or by IV, or there is an alternative product readily available.

“While we are used to it,” he said, “you can’t just copy-paste the plan.”

In New Hampshire, the state hospital association said the shortage is “significantly impacting” hospitals there.

“A shortage forces hospitals to scrutinize their supplies, seek alternative products, and modify treatment protocols, which can interrupt care, increase costs, and strain health care workers,” Kathy Bizarro-Thunberg, the association’s executive vice president/federal relations said in a statement.

“New Hampshire’s hospitals are actively monitoring their inventories, informing clinicians on conservation considerations and collaborating with each other to share best practices,” she said.

In Rhode Island, Lifespan, which runs several hospitals and health centers, said in a statement that it, too, is closely monitoring the supply chain and has a team working to secure more IVs.

“While we continue to deliver high-quality care,” Jessica A. Wharton, Lifespan spokesperson, said in a statement, “we are taking measures to conserve our existing supply, and are hopeful that the FDA will step in to address the shortages through temporary imports and increased production by alternate manufacturers.

Correspondent Rachel Umansky-Castro contributed to this story.