Drug barcode guru and gadfly talks FDA rules and IV robotics

药品条形码专家和牛虻谈论FDA规则和IV机器人技术

2021-10-14 02:00:13 Healthcare IT News

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Mark Neuenschwander is founding director of the THRIV Coalition. He is a longtime patient safety advocate and academic responsible for hospital bar coding and other initiatives. He and THRIV now are focused on IV robotics. Neuenschwander is also partially responsible for the FDA Bar Coding Rule and says pharmacy automation in hospitals is the next phase of his work. Technicians preparing IVs, pharmacists checking techs' work and nurses hanging bags cannot verify contents simply by looking at the fluids. Nor do they have tests for confirming that the doses were accurately prepared. Only automation can ensure one removes the element of human error in providing patients the right drugs at the right dose, Neuenschwander says. Neuenschwander sat down with Healthcare IT News to discuss the FDA rule, IV robotics and reducing errors during the IV process. Q. You are in part responsible for the FDA Bar Coding Rule. Please explain what healthcare provider organization IT leaders need to know about it. A. Well, I was one of a chorus of voices. For sure, mine was among the more unrelenting. Some have suggested that I was to the [bar coding] cause what Ralph Nader was to seatbelts laws – a gadfly that refused to go away. But I was not alone. At a 1995 pharmacy conference, I observed a tabletop model of a multi-axis, bar-code-literate robot designed to automatically pick custom bar-coded medications for patient cassettes in hospital pharmacies. They were designed to retrieve meds more efficiently and accurately than humans. In what seemed to me at the time a throwaway line, the developers noted, "One day, because of the robot's bar-coded packaging, hospitals may someday be able to scan patient wristbands and medications for a match at the point of care." His words arrested my imagination and changed the trajectory of my life. Enough that for more than two decades the license plates on my car have read BARCODE. Interestingly, the barcode was invented in 1948 – the year I was born. Growing checkout lines induced by post-war prosperity nudged the grocery industry to find technologies to speed customers through their lines. Their research also revealed high error rates from cashiers manually keying in numbers and decimals. Industry leaders were led to believe that newly imagined electronic code readers might help in fulfilling their vision. Except barcode readers were nowhere near small enough to integrate with checkout stands. Not until 1974 was the first retail product scanned. Even then it took another 10 years before barcode scanning was ubiquitous in grocery stores. The main barrier? Product packaging arrived on loading docks without barcodes, requiring stores to manually apply barcoded stickers to each item. This was labor-intensive and error-prone. Eventually, to the delight of grocers, manufacturers began voluntarily applying barcodes at the source – once they discerned grocers were giving priority to purchasing coded over non-coded items. By 1985, virtually everything landing in grocery stores arrived with barcodes. Within another five years, barcodes had moved into all retail, showing up on toothpaste at drug stores, screwdrivers at hardware stores, dresses at department stores and even items in hospital gift shops. Point-of-sale scanning was ubiquitous. Barcodes were on everything – except on immediate drug packages being delivered to hospitals. It wasn't until 2000 that two drug companies experimented with applying barcodes to a handful of their products. In late 1999, unwilling to wait, the Veterans Administration Hospital in Topeka, Kansas, developed its own barcode medication-administration system. However, this involved pharmacies overwrapping each item with custom barcode packaging. Sound familiar? Like the grocery industry, the pharmacy labeling was inefficient and, more important, prone to error. It became painfully obvious to me that, unlike food manufacturers, drug manufacturers saw little if any economic incentive to barcode their products – though one would think the safety proposition would have been convincing enough. I was convinced that getting drug companies to apply barcodes at the source would require a mandate from the FDA. That's when I went all in and refused to relent, until, in 2004, the FDA issued a regulation requiring that drug manufacturers include barcodes, embedded with National Drug Code numbers, on all immediate packages. This proved to be the tipping point. Finally, hospitals could use scanning technology to improve accuracy at the point of care, which had been tested and proven at points of sale. Today's best practices find caregivers scanning barcodes on patient wristbands and drugs for a match. Making it easier to get medication administrations right, more difficult to get them wrong. Given the proven safety benefits, there is not a hospital in the country that would go back to pre-bedside-scanning days. Q. You and the THRIV Coalition currently are focused on IV robotics. Please describe how IV robotics work and why healthcare CIOs and pharmacy executives should be concerned with this technology. A. The most important medication safety technology to be developed since my entering this rodeo over 25 years ago is applying bar coding to medication preparation, which THRIV calls IV-workflow management systems. Like BCMA, which ensures the right medications are matched with the right patients, IV-WMS uses similar technology to ensure the right volumes of the right ingredients match physician orders during drug compounding. Having completed my mission around universal adoption of BCMA, I signed onto one more rodeo and founded the THRIV Coalition for IV Accuracy. THRIV has moved upstream from the bedside to the clean room. We champion the universal adoption and faithful utilization of semi-automated and fully robotic IV-WMS. Backing up for a moment, one of the benefits hospitals experienced from the FDA Bar Code Rule involved enabling hospitals to accurately load their automated dispensing cabinets. In 2007, Denis Quaid's infant twins nearly died from receiving adult doses of heparin by mistake. Though the nurse retrieved the medications from the ADC storage bin assigned for pediatric Heplock, that bin had accidentally been loaded with adult Heparin – 1,000 times the dose ordered. Today's BCMA would intercept these errors prior to administration. Nevertheless, everything should be done to prevent dispensing mishaps upstream. Current best practices for ADC loading involve scanning barcodes on each medication, which automatically triggers dispensing machines to open the correct drawers and exact pockets for placing each medication where it belongs. Believe it or not, a year after the Quaid episode, 19 other infants in one Texas hospital also received adult-, instead of pediatric-strength Heparin. All were endangered. Two died. This time, however, BCMA could neither have detected nor intercepted the errors. While the human- and machine-readable labeling on the IVs matched the order, during preparation the wrong ingredients were compounded. There was no way for nurses to detect the error by looking at the clear fluids. When this happens, it is impossible for nurses to get things right. IV-WMS in cleanrooms help ensure the IV orders are compounded with the right amounts of the right ingredients. Not incidentally, THRIV exists not only to protect patients from being harmed, but also to protect nurses from unwittingly doing harm. There is not a nurse who wants to hurt a patient. Each started their profession with an oath: "I shall not knowingly administer any harmful drug." Several years ago, a nurse at a children's hospital here in Seattle unintentionally overdosed a tiny patient with sodium chloride. The child died. Three months later the nurse took her own life. We did not need to lose either of these precious lives. IV-WMS has proven to intercept hundreds of thousands of preparation errors, many of which could have done similar harm. Q. Reducing errors through IV accuracy automation is one of your major talking points. You've said only automation can ensure you remove the element of human error in providing patients the right drugs at the right dose. Please elaborate. A. Several years ago, a 62-year-old grandmother, experiencing anxiety following brain surgery, was admitted to the ER of a fine Oregon hospital. Her condition was not considered critical and her attending physician ordered Fosphenytoin, a low-risk sedative.  Pharmacy received and approved the order, which was prepared by a technician, checked by a pharmacist and sent to the ER. The patient's wristband and the IV bar codes were scanned. A match was confirmed, the bag was hung, and the drip was started. 30 minutes later the patient was braindead. Forensics revealed that instead of retrieving Fosphenytoin, the compounding technician unwittingly pulled Rocuronium, a paralytic agent used in surgeries. IV-WMS could have intercepted this tragedy upstream. Some IVs make their way from the manufacturer to the bedside without manipulation, ready to administer. Think Coronas or hard lemonade that wind their way from the bottling plant to the bar where they are opened in front of the customer. You know what you are getting. THRIV argues that such IVs should be purchased and used when available and affordable. Then there are the IVs that require compounding multiple ingredients in the pharmacy. Sometimes called "cocktails," these require that technicians carefully follow precise recipes.  Now, if a bartender gets a mojito wrong, no harm, no foul. You probably will get a free drink. Not following an IV recipe down to the T, however, can result in harm or death. With the dip of a straw, a bartender performs a taste test and knows if an ingredient is missing or if they included too little or too much of any one thing. Nurses have no test for discerning what's in the IV they are about to hang. They simply must trust that what the label and barcode display is what's in the syringe or bag. So, the pharmacy better get it right. Yet, a 1999 five-hospital study on manual IV compounding showed a 9% error rate, with most of the errors involving incorrect ingredients and/or volumes. While one may think that study may have reached its beyond-use date, it should be noted that most hospitals are using the same manual systems today that they were four decades ago. Imagine if Amazon had an error rate of 9%. They'd be out of business. One of their executives here in Seattle told me their fulfillment error rate was south of 0.1%. I think it's reasonable to assume that compounding error rates should be chasing zero. Similar to Amazon's fulfillment technology, IV-WMS is helping hospitals get there. To this end, THRIV has created a Technology Checklist that outlines five criteria we believe IV-WMS should meet or exceed, including: Combining these elements in robotic formats provides additional efficiencies and safety, as well as safeguards for compounding technicians subject to needle sticks and exposure to hazardous drugs. But there will always be the need for making plenty of IVs using human eyes and hands. In either category of technology, the above five criteria can and must be met by IV-WMS. THRIV suggests it is as unconscionable for hospitals to not use these proven safety technologies as it would be for parents to not secure their children and themselves in automobile seat restraints. I don't recall meeting a pharmacist who doesn't affirm that compounding should employ IV-WMS. However, repeatedly I am told their line-item requests for IV-WMS keep being red-lined during their hospital's budget process. This, even though implementing a semi-automated system to ensure accuracy is a small fraction of the cost of complying with USP's technology standards for ensuring sterility in their cleanrooms. THRIV argues that like two wings of an airplane, neither sterility nor accuracy is less important than the other. I find it instructive that after manufacturers were required to install seat belts in automobiles, it took decades for many in our nation to use them. It wasn't until laws were enacted that buckling up for safety exceeded 70%. Even then, driver adherence varied and still varies state-by-state in direct proportion to the level of click-it-or-ticket fines incurred by violators. We must get beyond merely viewing IV-WMS as something hospitals should do to being declared as something they shall do. THRIV will continue pleading for voluntary utilization. However, we fear too many hospitals will not, unless and until the USP requires them to use IV-WMS technology to achieve accuracy, as they require filters and air systems to achieve sterility. In the meantime, THRIV hopes your hospital will employ reliable IV-WMS to ensure your patients receive just what the doctor ordered – the drug, the whole drug, and nothing but the drug, so help us God. We also invite you to spend a few minutes at THRIVcoalition.org and add your good name to our compelling list of champions for IV accuracy. Meanwhile, this cowboy won't be hanging up his spurs until bar coding in the cleanroom is as ubiquitous as bar coding at the bedside. Twitter: @SiwickiHealthIT Email the writer: bsiwicki@himss.org Healthcare IT News is a HIMSS Media publication.
Mark Neuenschwander是THRIV联盟的创始董事。他是一个长期的病人安全倡导者和学者,负责医院条形码和其他倡议。他和THRIV现在专注于IV机器人技术。 Neuenschwander还部分负责美国食品和药物管理局的条形码规则,并表示医院的药房自动化是他工作的下一阶段。 准备IVs的技术人员、检查技术人员工作的药剂师和挂袋的护士不能简单地通过查看液体来验证内容。他们也没有测试来确认剂量是准确制备的。Neuenschwander说,只有自动化才能确保在以正确的剂量为患者提供正确的药物时消除人为错误的因素。 Neuenschwander与Healthcare IT News坐下来讨论美国食品和药物管理局的规则、静脉注射机器人技术和减少静脉注射过程中的错误。 Q.你对FDA条形码规则负有部分责任。请解释医疗保健提供商组织的IT领导者需要了解哪些信息。 a.嗯,我是一群人中的一员。当然,我的是更无情的人之一。有些人认为我对[条形码]的影响就像拉尔夫·纳德对安全带法的影响一样--一只拒绝离开的牛虻。但我并不孤单。 在1995年的一次药学会议上,我观察到一个桌面模型,它是一个多轴条形码识别机器人,旨在自动为医院药房的病人盒式磁带挑选定制的条形码药物。它们被设计成比人类更有效、更准确地取回药物。 在当时我看来是一次性的一句话中,开发人员指出,“有一天,由于机器人的条形码包装,医院可能有一天能够在护理点扫描病人的腕带和药物是否匹配。” 他的话抓住了我的想象力,改变了我的生活轨迹。够了,二十多年来,我车上的车牌都是条形码。 有趣的是,条形码是在1948年发明的--也就是我出生的那一年。战后繁荣导致的结账线不断增长,促使杂货店行业寻找技术来加快顾客通过他们的线。他们的研究还显示,收银员手动键入数字和小数的错误率很高。 行业领袖们被引导相信新设想的电子代码阅读器可能有助于实现他们的愿景。除了条形码阅读器远没有小到足以与结账台集成。 直到1974年才有了第一个被扫描的零售产品。即使在那时,又过了10年,条形码扫描才在杂货店无处不在。主屏障?到达装货码头的产品包装没有条形码,要求商店手动在每个商品上贴条形码标签。 这是劳动密集型和容易出错的。最终,令杂货商高兴的是,制造商开始自愿在源头应用条形码--一旦他们发现杂货商优先购买编码而不是非编码的商品。 到1985年,几乎所有进入杂货店的东西都带有条形码。又过了五年,条形码进入了所有的零售业,出现在药店的牙膏上,五金店的螺丝刀上,百货商店的连衣裙上,甚至医院礼品店的商品上。 销售点扫描无处不在。条形码在所有东西上--除了直接送到医院的药品包装上。直到2000年,两家制药公司才尝试将条形码应用于他们的少数产品。 1999年末,不愿等待,堪萨斯州托皮卡的退伍军人管理局医院开发了自己的条形码药物管理系统。然而,这涉及药店用自定义条形码包装覆盖每个商品。听起来耳熟?像杂货店行业一样,药房标签效率低下,更重要的是,容易出错。 对我来说,痛苦地显而易见的是,与食品制造商不同,药品制造商几乎看不到对其产品进行条形码的经济激励--尽管人们会认为安全主张已经足够令人信服。我确信,让制药公司在源头应用条形码需要FDA的授权。 就在那时,我全力以赴,拒绝让步,直到2004年,FDA发布了一项规定,要求药品制造商在所有即时包装上包括条形码,嵌入国家药品代码号码。这被证明是引爆点。最后,医院可以使用扫描技术来提高护理点的准确性,这已经在销售点进行了测试和证明。 今天的最佳做法是护理人员扫描患者腕带和药物上的条形码来匹配。使正确的药物管理更容易,错误的药物管理更难。鉴于已被证明的安全好处,该国没有一家医院会回到床边扫描前的日子。 Q.你和THRIV联盟目前专注于IV机器人技术。请描述静脉注射机器人是如何工作的,以及为什么医疗保健首席信息官和药房主管应该关注这项技术。 A.自从我25年前参加这个牛仔竞技会以来,最重要的药物安全技术是将条形码应用于药物制备,THRIV称之为IV-工作流管理系统。与BCMA一样,它确保正确的药物与正确的患者匹配,IV-WMS使用类似的技术来确保正确成分的正确体积与药物配制过程中的医生命令相匹配。 在完成了关于BCMA的普遍采用的任务后,我又签了一个牛仔竞技会,并建立了四精度THRIV联盟。THRIV已经从床边向上游移动到了洁净室。我们支持半自动和完全机器人的IV-WMS的普遍采用和忠实利用。 回顾一下,医院从FDA条形码规则中体验到的好处之一是使医院能够准确地装载他们的自动配药柜。 2007年,丹尼斯·奎德(Denis Quaid)的双胞胎婴儿因误服成人剂量的肝素而差点死亡。尽管护士从分配给儿科Heplock的ADC储存箱中取回了药物,但那个箱子意外地装满了成人肝素--是订购剂量的1000倍。 今天的BCMA将在管理前拦截这些错误。然而,应该尽一切努力防止上游的配药事故。当前ADC装载的最佳做法包括扫描每种药物上的条形码,这会自动触发分发机打开正确的抽屉和准确的口袋,将每种药物放在它所属的地方。 信不信由你,奎德事件发生一年后,德克萨斯州一家医院的其他19名婴儿也接受了成人肝素,而不是儿科肝素。都濒临灭绝。两个死了。然而,这一次,BCMA既不能检测到也不能截获错误。 虽然IVs上的人类和机器可读标签符合顺序,但在制备过程中,错误的成分被复合。护士没有办法通过查看透明的液体来检测错误。当这种情况发生时,护士是不可能把事情做好的。洁净室中的静脉注射WMS有助于确保静脉注射订单与正确数量的正确成分复合。 不是顺便说一句,THRIV的存在不仅是为了保护病人免受伤害,也是为了保护护士免受无意中的伤害。没有一个护士想伤害病人。每个人在开始他们的职业时都发誓:“我不会故意服用任何有害的药物。” 几年前,西雅图一家儿童医院的护士无意中给一名小病人过量服用氯化钠。孩子死了。三个月后,护士自杀了。我们不需要失去这些宝贵的生命。IV-WMS已经被证明拦截了数十万个准备错误,其中许多可能会造成类似的伤害。 Q.通过IV精确度自动化来减少错误是你的主要谈话要点之一。你说过只有自动化才能确保你在以正确的剂量为病人提供正确的药物时消除人为错误的因素。请详细说明。 a.几年前,一位62岁的祖母在脑部手术后感到焦虑,住进了俄勒冈州一家好医院的急诊室。她的情况不被认为是危急的,她的主治医生命令福苯妥英钠,一种低风险的镇静剂。 药房收到并批准了订单,订单由技术人员准备,药剂师检查,并发送到急诊室。病人的腕带和静脉条形码被扫描。确认了一个匹配,挂上袋子,开始点滴。30分钟后,病人清醒了。 法医显示,配料技师没有取回福苯妥英,而是无意中拔出了罗库溴铵,这是一种用于手术的麻痹剂。IV-WMS本可以在上游截获这场悲剧。 一些IVs在没有操作的情况下从制造商来到床边,准备好进行管理。想想电晕或硬柠檬水,它们从装瓶厂蜿蜒而至酒吧,在那里它们被打开在顾客面前。你知道你得到的是什么。 THRIV认为,这种IVs应该在可用和负担得起的情况下购买和使用。然后是需要在药房混合多种成分的IVs。有时被称为“鸡尾酒”,这些要求技术人员仔细遵循精确的食谱。 现在,如果一个酒保喝错了莫吉托酒,没有伤害,没有犯规。你可能会得到一杯免费的饮料。然而,不遵循静脉注射处方直到T时,可能会导致伤害或死亡。 酒保用吸管蘸一下,就可以进行味觉测试,并知道是否缺少了一种成分,或者它们是否包含了太少或太多的任何一种东西。护士没有测试来辨别他们即将悬挂的静脉注射中有什么。他们只需相信标签和条形码显示的是注射器或袋子里的东西。所以,药房最好把它弄好。 然而,1999年五家医院关于人工静脉配料的研究表明,错误率为9%,大多数错误涉及不正确的成分和/或体积。虽然人们可能认为这项研究可能已经到了不能使用的时候,但应该注意到,今天大多数医院都在使用与40年前相同的人工系统。 想象一下,如果亚马逊有9%的错误率。他们就会倒闭。他们在西雅图的一位高管告诉我,他们的执行错误率在0.1%以上。我认为假设复合错误率应该为零是合理的。与亚马逊的实现技术类似,IV-WMS正在帮助医院实现这一目标。 为此,THRIV创建了一个技术清单,列出了我们认为IV-WMS应该达到或超过的五个标准,包括: 以机器人的形式结合这些元素提供了额外的效率和安全性,以及对受针刺和接触危险药物的复合技术人员的保障。但是总是需要用人类的眼睛和手来制造大量的IVs。在任何一类技术中,IV-WMS都可以而且必须满足上述五项标准。 THRIV建议,医院不使用这些经过验证的安全技术,就像父母不将他们的孩子和自己固定在汽车座椅上一样不合理。 我不记得见过一个药剂师不肯定复方应该使用IV-WMS。 然而,我一再被告知,在他们医院的预算过程中,他们对静脉注射WMS的项目要求一直是红色的。这一点,即使实施一个半自动系统来确保准确性,也只是遵守美国药典技术标准确保洁净室无菌的一小部分成本。THRIV认为,就像飞机的两个翅膀一样,不可靠和准确都不比另一个重要。 我发现,在制造商被要求在汽车上安装安全带后,我们国家的许多人花了几十年时间才使用它们,这很有启发性。直到法律颁布后,为了安全而扣紧的比例才超过70%。即便如此,司机的遵守情况也各不相同,而且各州之间仍然存在差异,这与违规者被罚款的程度成正比。 我们必须超越仅仅将IV-WMS视为医院应该做的事情,而被宣布为他们应该做的事情。THRIV将继续请求自愿使用。然而,我们担心太多的医院不会这样做,除非美国药典要求他们使用IV-WMS技术来实现准确性,因为他们需要过滤器和空气系统来实现无菌。 与此同时,THRIV希望您的医院将使用可靠的IV-WMS,以确保您的患者收到医生命令的--药物,整个药物,除了药物之外什么也没有,所以上帝保佑我们。 我们也邀请您花几分钟在Thrivclionition.org上,并将您的好名字添加到我们引人注目的IV准确性冠军名单中。与此同时,这个牛仔不会挂上他的马刺,直到洁净室的条形码像床头的条形码一样无处不在。 推特:@SiwickiHealthit 给作者发电子邮件:bsiwicki@himss.org Healthcare IT News是一个HIMSS媒体出版物。

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