倡导影响力：复合更新——2023年须知

欢迎收听ASHP官方播客，我们将为您解读与药物使用、公共卫生及药学专业相关的议题。

Welcome to the ASHP official podcast, your guide to issues related to medication use, public health, and the profession of pharmacy.

感谢您收听ASHP《倡导影响力》播客，每期节目都会探讨影响药学实践的政策议题。

Thank you for joining us for the ASHP Advocating for Impact podcast, where every episode covers a policy issue impacting the practice of pharmacy.

我们将尽力解读政策与政治因素，帮助您理解这些问题如何影响您的实践和专业。

We'll do our best to translate the policy and the politics to help you understand how these issues affect your practice and your profession.

我是Jillian Schulte Wall，SHB健康与监管政策高级总监，今天将由我主持本期节目。

My name is Jillian Schulte Wall, I'm SHB's senior director for health and regulatory policy, and I will be hosting today's episode.

今天与我同台的是同事Mike Gagneo，他是我们机构的复配药与USP专家，也是本期节目中唯一的药剂师。

Today I'm joined by my colleague Mike Gagneo, our resident compounding and USP expert and the only pharmacist on this podcast today.

我们将讨论我们最喜爱的话题之一——复配药，这个话题在我们俩加入ASHP那年真正兴起，具体来说是FDA对复配药的一见钟情。

We're going to cover one of our favorite topics which really got going the year we both joined ASHP and that's compounding, namely FDA compounding at first sight.

在正式展开讨论前，我先简要回顾下2023年复配药的发展现状。

So before we kind of launch into the discussion, I'm just going to give a quick kind of refresher on where we are with compounding in 2023.

想必大家都记得，这一切始于NACC（新英格兰复配药中心）灾难事件，随后出台了《药品质量与安全法案》，该法案为复配药设立了新范式，赋予FDA更多监管权限。

As everyone probably remembers, this was all kicked off by NACC, the New England Compounding Center disaster, and there was a law, the Drug Quality and Security Act, which kind of set out a new paradigm for compounding, gave FDA more oversight over compounding.

随着时间的推移，FDA逐步完善了基于该法律的监管体系。

And over time FDA has built out the regulation stemming from this law.

我记得首批指导文件是在2016年发布的。

So we got an initial set of guidances in I believe it was 2016.

距今已经很久了。

It's been a long time now.

最初医疗机构对拥有专属指导文件存在抵触，但FDA认为医院复配药体系确实需要独立框架，这与社区药房、独立药房甚至部分门诊药房的操作方式截然不同。

And initially there was some pushback about health systems having their own guidance, but FDA felt that the compounding structure hospitals really did deserve their own framework, that it was different than the way compounding is done in community pharmacies or independent pharmacies or even in some outpatient pharmacies.

但关键在于，根据你在生态系统中的位置不同，会有几套不同的指导原则。

But the key here is that there are a couple of different sets of guidances depending on where you sit in the ecosystem.

如果你是503B机构，适用的指导原则就不同。

If you're a 503B there's a different set of guidances.

如果你是社区药房，适用的指导原则也不同。

If you are a community pharmacy there is a different set of guidances.

作为社区药房你是503A类药房，但如果你同时属于医院卫生系统下的503A类药房，则有专门的指导原则。

You're a 503A pharmacy as a community pharmacy but if you are also a 503A but your hospital health system, you have your own guidance.

在我们深入探讨指导原则内容之前——包括最初版本、现行版本以及未来修订方向——有必要提醒大家：就FDA而言，其对药物调配的定义与USP（美国药典）的定义是不同的。

And before we even launch into what the guidance says, what it said initially and then what it says now, we want it to say down the road, it's important to kind of remind folks when we're talking about compounding for FDA purposes FDA's definition of compounding is different than USP's definition of compounding.

所以从一开始考虑药物调配时，就必须关注产品的制备方式。

So just right out of the gate when you're thinking about compounding you really have to consider how the product is being prepared.

如果只是按照包装说明操作多个产品进行制备，这不属于FDA定义的药物调配。

If you're just manipulating several products preparing according to package instructions, that is not FDA compounding.

FDA定义的药物调配要求为特定患者对产品进行变更。

FDA compounding requires a change to a product for an identified patient.

关于变更内容有具体参数要求，必须是具有临床意义的变更。

There are some parameters around what the change, it has to be a clinically significant change.

否则就会产生是否只是仿制产品的疑问。

Otherwise you get into a question of whether you're just creating a copy.

因此产品必须经过实质性变更，才能被认定为FDA标准下的调配药物。

So you really do have to have a real change to the product to qualify as an FDA compounded medication.

要知道，FDA完全不涉及标准制备流程的监管。

That's, you know, FDA doesn't want to have anything to do with just standard preparation.

这些仍将全部归属于USP（美国药典）范畴。

That is still all going to fall under USP.

FDA资源有限，因此他们希望集中精力处理高风险事项。

FDA has limited resources so they really want to focus on things that they consider higher risk.

这类操作通常涉及大量非患者专属制剂——比如在制备过程中添加说明书外成分、改变标准制备流程，或是将新药物混合使用。

So that would be practices where you're preparing a lot of non patient specific preparations, but you're doing it in a way that either you know you're adding a different dealing with it, what's in the package insert, or you're making some change to the way it's supposed to be prepared, or you're adding new medications together.

需注意有许多情况都符合标准，但完全按照说明书操作的情况则普遍不在此列。

Know there are a lot of different things that would qualify, but what doesn't qualify across the board is just preparation according to package instructions.

这是基本原则，也是考量FDA指南时的首要判断依据。

That's sort of the guiding principle, the first thing you're going look at when you're thinking about FDA guidances.

因此当评估自身操作时，若医院涉及非患者专属处方（几乎所有医院都会），就必须遵循FDA要求。

So then once you're looking at what you're doing, if you are doing non patient specific prescriptions in almost every hospital is, you're going to look at what the FDA requires.

最初指南出台时，这彻底改变了医院和医疗系统制剂生产的监管方式。

And so initially when the guidances arose, this was a wholesale change in how hospital and health system compounding was going to be overseen.

其核心思想是对医院和医疗系统实施特定限制。

And the idea was for hospitals and health systems you were going to be limited in a specific way.

FDA在指南初版中明确表示：'对于大量非患者专属制剂操作，必须设置相应规范'。

So FDA initially, and this was the initial version of the guidance, said, Look, we want to make sure that if you're going to be doing a lot of non patient specific compounding, there are some guardrails around it.

机构律师团队最终出台的指南中，划定了1英里半径限制。

And you had the lawyers at the agencies sit down and drop the guidance, and what they came up with was a one mile radius.

仅可为本院患者配药（不含出院处方），且配制药品只能在1英里范围内的关联药房流通。

So you had to compound for your own patients only, you couldn't compound discharge prescriptions, and then you can only compound and send compound within one mile pharmacy where you were compounding and it had to be to your own facilities.

有些医院园区超1英里范围——比如路边的门诊诊所，就无法配送符合FDA定义的配制药品。

So in some cases hospital campuses are longer than a mile, you know, so if you have an outpatient clinic down the road you're not going to be able to send anything that's prepared over there that meets FDA's compounding definition again.

你必须选择注册为503B机构，或者从外包商那里采购所有物品。

You're going to have to either register as a 503B or buy everything from outsourcers.

这就是我们最初的情况，但这并非最佳选择。

So that's where we stood initially, and that was not the best option.

于是我们回到机构并表示：我们希望建立一个可行的框架，能兼顾医院和医疗系统的护理服务模式。

So we went back to the agency and said, Look, we really want to have a workable framework that takes into account hospital and health system care delivery models.

我们建议他们采用USP超期使用日期标准。

And we suggested that they adopt USP beyond use dating.

他们再次回应说会对指导文件进行小幅修订。

And again, they came back and said, we're going to revise this guidance a little bit.

现在他们取消了那种三重测试要求，改为规定药品离开药房后必须在24小时内使用或废弃。

So instead of having kind of this three prong test, they now have this requirement about when a product leaves a pharmacy, and it's a twenty four hour use or discard after the product leaves a pharmacy.

关于这项规定的具体含义存在很多疑问。

So there are a lot of questions about what that means.

'离开药房'具体指什么情况？

What does it mean to leave a pharmacy?

为什么是24小时？

Why twenty four hours?

这些都是很好的问题。

They're good questions.

我们已向机构提出了这些疑问。

These are questions we pose to the agency.

当产品离开药房到达会员手中后，机构是否认定存在风险并进行监管，还取决于其他多项因素——这些我们稍后会详细讨论。

And once you've gotten to the member you have a product that's off the pharmacy, then whether or not the agency is going to consider what you're doing risky and get involved and oversight it depends on a number of other factors you know that are kind of outlined further down we'll talk about those in a minute.

但这就是我们目前的处境。

But this is where we are.

我们现在已经摆脱了地理限制，进入了这个24小时要求阶段，接下来是基于风险的评估。

We're now away from geographic limitation and into this twenty four hour requirement and then a risk based assessment.

我要再次强调，我们还没有达到理想状态，迈克稍后可以补充他的看法，但比起最初，现在的情况已经好很多了。

And I will say again we're not at an ideal place and Mike can add what his thoughts here in a second but this is a much better place than where we started.

所以虽然不完美，但比起那个灾难性的一英里半径要求，现在的情况已经大不相同了。

So it's not perfect, but it's definitely a far cry from the kind of disastrous one mile radius requirement.

那么迈克，你对我们目前的状况有什么看法？

So Mike, what are your thoughts on where we sit?

是的，我有点同意。

Yeah, I kind of agree.

有改善，但还不够理想。

Better, but still not there yet.

老实说，这两项规定都很武断。

Both of these are arbitrary, let's be honest.

但你知道，FDA的初衷是为了防止大规模批发式调配。

But you know, the intent from FDA is to prevent wholesale compounding on a very large scale.

你想，如果整批产品被污染，就可能影响数十甚至上百名患者。

You know, you contaminate an entire batch of something and now you've got tens, dozens of patients potentially affected by it.

所以他们正在努力降低这种风险。

So they're trying to mitigate that risk.

所以一英里规则显然会限制你的分发量。

So the one mile rule would have prohibited obviously how much you could dispense.

二十四小时要求也是同样的道理。

Same thing with the twenty four hour requirement.

其理念在于限制生产量。

The idea is that you are limiting how much is produced.

这确实会给任何医院药房带来工作流程问题，因为每天都要去偏远诊所补货根本不现实。

So this causes workflow problems really for any hospital pharmacy because it's just not realistic to have to go restock a remote clinic or something daily.

这根本不可行。

It just is not feasible.

这存在多重问题，因为你更倾向于哪种方式？

There are multiple problems with this because what are you more comfortable with?

你是更倾向于让技术员每天制作10份并确保每周每天都准确无误？

Are you more comfortable with a technician making 10 a day and getting that correct every single day of the week?

还是更倾向于让技术员一次性准备100份，可能因为这是单次操作而有更好的质量控制，或许还有药剂师可以监督，而不必每天都做？

Or are you more comfortable with a technician preparing 100 all at once, potentially with better quality control because it's a single exercise and potentially there's a pharmacist who's able to observe versus having to do it every single day.

双方观点都有道理，但你这是在强迫机构每天都要这样做。

You can make an argument either way there, but you're now forcing the hand of the site to try to do this daily.

虽然可能接触到的患者数量不会那么多，但这项本可以一次性完成的任务却要在一周内重复多次。

So while the number of patients exposed may not be as high, you have a task that could be done as a single exercise done multiple times throughout the week.

要知道，另一个问题是虽然我理解药房撤销后的二十四小时规定，但FDA实际上并未采取任何措施来降低这里的风险。

You know, the other issue is that while I understand the twenty four hour from the removal of the pharmacy, FDA really hasn't done anything to mitigate the risk here.

要知道，必须每天准备一次的说法其实并不正确。

Know, the idea that you would have to prepare it once every day is actually not true, you know.

所以如果你按照USPB的使用日期操作，仍然可以制作那100份。

So if you work within USPB on use dates, you could still make that 100.

你可以把它们存放在药房里。

You can store them in your pharmacy.

你只需要每天去那个区域补货。

You just have to go and restock that area daily.

因此同样的100名患者可能会受到两种方式的影响。

So the same 100 patients could be affected either way.

所以这确实很随意，不可行，我们认为有更好的解决方案。

So it really it's arbitrary, it's not workable, and we think there's a better solution.

这件事的积极之处在于你提到的基于风险的评估。

The good thing about this is that risk based assessment that you mentioned.

虽然一英里的规定看起来严格而迅速，但这一条至少允许——不确定‘执法自由裁量权’是否准确——但如果他们要评估监管行动，他们会考虑一系列条件。

So whereas the one mile seemed to be kind of hard and fast, this one at least allows don't know if enforcement discretion is the right word, but if they are going to evaluate for regulatory action, they're looking at a set of conditions.

首要条件是糟糕的配药操作、缺乏无菌保障，这基本上指的是不卫生的环境。

The first of which is poor compounding practice, lack of sterility assurance, which basically references insanitary conditions.

嗯，反正你应该继续遵守，所以没什么大不了的。

Well, you should keep following that anyway, so not a big deal.

第二条是针对紧急使用的配药。

Second one is compounding for emergency use.

这有点棘手，因为我质疑FDA会如何定义‘紧急’。

This gets kind of tricky because I question how FDA would interpret emergency.

我想问FDA：你们更倾向于让处方医师、医疗提供者、执业护士等人在病床边临时配制药物，还是选择在符合USP标准的洁净室中，在ISO五级层流罩下制备，并采用药房洁净室所有质量控制流程的产品？你们会选择哪一种？

I would pose to the FDA if you would prefer to have a prescriber, provider, nurse practitioner, whomever drawing stuff up at the bedside or have something that was prepared in a ISO five hood inside a cleaning room that's compliant with USP that was done you know using all the quality controls in our pharmacy clean rooms, which would you rather have?

是的，这可能是一项计划中的手术——因为FDA举了这个例子——但这并不意味着提前一晚为患者单独准备产品是现实的。

So yeah, it may be a planned procedure because that's one of the examples FDA uses, but that doesn't mean it's realistic to have individually prepared product for that patient, you know, from the night before.

面对这两种选择，我会选择药房产品而非床边临时配药。

I think having those two options, I would choose the pharmacy product versus having someone have to compound at the bedside.

我认为这个领域需要FDA提供更明确的指导，并加强相关倡导工作。

This is kind of an area for some more clarity with FDA and some more advocacy, I think.

以及常规性大批量非患者专用的复配药品。

And then routine large amounts of non patient specific compounded products.

再次强调Jillianne的观点，如果你批量准备头孢唑林或万古霉素，从FDA角度看这不属于复配。

And again, to Jillianne's point, if you're preparing a bunch of cefazolins or vancomycin, this is not compounding from FDA's perspective.

如果你过量配制利多卡因与碳酸氢钠混合液，FDA很可能会将其视为高风险行为。

So if you're doing an inordinate amount of lidocaine with sodium bicarbonate for lidocaine, and potentially FDA is going to look at that as, you know, that's high risk.

说不定你正在某处卡车后厢偷偷销售这些药品呢。

It could be maybe you're selling them off the back of a truck somewhere.

好吧，这例子有点极端，但道理没错。

Okay, extreme example, but still.

你的操作是否在合理范围内？

Are you doing things within reason?

很可能是的，因为生产过剩只会造成浪费。

And more than likely you are because anything you produce that you don't use, you're wasting.

所以你大概只会配制刚好够用的量。

So you're probably making just enough for what you need.

其实这些基于风险的评估并不那么糟糕，但我认为这份指南仍有改进空间。

So really those risk based assessments aren't that terrible, but again I think there's room for improvement on this guidance.

我们通过多种渠道——Jillian和我都与FDA进行过沟通，包括正式记录的公开意见征询，以及过去几年线上线下各种会议交流。

And we have through multiple avenues, Jillian and I both had this conversation with FDA, both you know official recorded public comments and through different in person or virtual I guess over the last couple years meetings.

这大致就是我的想法。

That's kind of my thoughts.

是的，这真的很有趣。

Yeah it's really interesting.

我在整理这些时其实没考虑到这一点。

I actually hadn't thought about this when I was putting this together.

这某种程度上是与FDA进行的典型对话。

This is sort of the conversation that goes on with FDA.

所以会议室一边坐着律师，另一边是临床医生，而FDA的特点在于他们有很多工作人员。

So you have a lawyer on one side of the room and you have a clinician on another and the thing about FDA is you know they have a lot of staff.

人数虽不多，他们是药剂师但不一定属于监管政策组，即使属于监管政策组，也可能缺乏医疗系统经验。

There aren't a ton, they're pharmacists they aren't necessarily in the regulatory policy group, and even if they are in the regulatory policy group, they may not have health system experience.

因此ASHP的价值在这里真正体现，因为Mike刚才的解释对临床医生来说完全合理。

And so there really is a situation here where this is the value that ASHP brings to the table, because what Mike just explained is going to make sense to a clinician.

对律师而言这就像《花生漫画》里的老师说话，所以需要从法律角度进行转译。

It's going to sound like the teacher in Charlie Brown to a lawyer, so you're trying to translate it into something that makes sense from a legal standpoint.

要知道FDA的目的不是刁难医院和医疗系统，甚至不是针对配药机构，只是想为法律适用划定明确界限。

So you know FDA's goal here is not to torture hospitals and health systems or even other compounders, it's just to kind of set some bright line rules about how to apply the law.

问题在于实际操作很复杂，用单一明确界限的法律来套用就非常困难，所以才产生了基于风险的框架。

The problem is the practice is complicated, so applying a law that has like a one single bright line rule, it makes it really difficult, which is why you end up with a risk based framework.

这真是个绝佳的横截面，能看出我们现行监管政策的形成原因。

And it's just such an interesting kind of cross section of why we end up with the regulatory policy we do.

这并不是在诋毁FDA。

And this is not to malign FDA.

我的意思是，就利益相关方参与而言，他们可以说是最容易合作的机构之一，而且他们确实会倾听意见。

I mean, will say they're one of the easiest agencies to work with in terms of stakeholder engagement and they do listen.

我们确实看到了从第一版指南到第二版的许多变化。

We did see a lot of changes from the first iteration of the guidance to the second.

另外我想指出但之前没有详细说明的是，这是一份临时草案指南，实际意味着它不具备强制执行力。

And the other thing I would note here that I didn't kind of touch on earlier is that this is an interim draft guidance What that means practically speaking is it is not enforceable.

还需要提醒收听本期播客的非律师听众——可能人数不少——注意。

And it's worth also noting here for the non attorneys listening to this podcast, which may be quite a few people.

指南是机构对某个主题的最佳思考成果。

Guidance is the agency's best thinking on a topic.

它本身并不像法令或法规那样具有法律约束力。

It is actually by itself not binding law the way that statute or regulation is.

问题在于当各州将其纳入自己的监管框架时——通常是通过引用方式。

Where it becomes an issue is when states adopt it into their own regulatory framework, and it's by reference.

本质上他们就是说'我们将强制执行FDA所有指南'等等这类话。

So essentially they say, you know, we're gonna enforce all FDA guidances blah blah blah blah.

他们未必会考虑指南的起草方式或在实践中可能产生的影响。

It doesn't necessarily look at how the guidance is drafted or what that might mean in practice.

因此当你处于草案指南阶段时，这些内容完全不具备强制执行力。

And so when you enter a draft guidance stage, they are absolutely not enforceable.

如果你遇到州药房委员会试图在你的医院或医疗系统强制执行24小时规定的情况，那名州药房委员会检查员的行为已经超出了其职责范围。

So if you're in a situation where you have a state board of pharmacy trying to enforce the twenty four hour rule at your hospital or health system, that state board of pharmacy inspector is not doing what they are supposed to be doing.

我可以直截了当地这么说。

I can say that flatly.

指南首页有一项免责声明，指出该文件不具备强制力且不用于实施。

There is a disclaimer on the first page of the guidance that it is not enforceable and not for implementation.

尽管如此，这一点有时似乎会被忽略。

Regardless, this seems to get lost sometimes.

因此这是我们真正希望推动大家关注的领域之一。

So this is one of the areas we really do want to push folks.

如果你看到这种情况，请告知我们。

If you are seeing this, let us know.

我们会就此与FDA沟通。

We will talk to FDA about it.

FDA在湿磨半径的初始指南草案中就遇到过这个问题，他们不希望任何人强制执行的原因是知道标准会变动。

FDA had this problem with the initial draft guidance with wet mil radius, and the reason they didn't want anybody enforcing it is because they knew it would shift.

所以现在的问题是，理论上这份指南在下次修订时会如何调整？

So now the question is, how is this guidance theoretically going to shift in its next iteration?

首先需要明确的是，我们完全不知道下一版指南文件何时发布。

And the first thing to know here is we have no idea when the next guidance document will drop.

即使机构愿意，他们也无法向我们透露这类信息——说实话，如果我是机构，我也不会透露文件发布时间。

The agencies can't share that kind of information with us even if they wanted to, which, you know, if I were an agency, I wouldn't share when my next document was going to be dropped.

但我们真正要推动的是Mike谈到的理念：避免浪费，解决那些制造工作流程问题却未提升患者安全性的情况。

But the thing that we're really pushing here is what Mike talked about, which is this idea of avoiding wastage, of working as situations that create workflow issues without increasing patient safety.

从实践和监管框架来看，最合理的做法之一就是利用现有资源。

So one of the things that makes a lot of sense from both a practice and a regulatory framework is to kind of use what's already in existence.

也就是该领域已经在执行的标准。

So standards that are already being practiced in the field.

大家对它们都很熟悉。

Folks are familiar with them.

它们并不令人意外。

They are not a surprise.

你知道，大家基本上都清楚规则，这就是USP（美国药典标准）。

You know, everybody kind of knows the rules, and that's USP.

正因如此，我们默认要说的是，你们真的需要考虑在这里的使用期限之外应用USP标准。

Which is why we defaulted to say, look, you really need to think about using USP beyond use dates here.

因为当你增加诸如24小时要求这样的条款时，这实际上与联邦层面现有的其他层层监管更新并不一致，只会变得难以实施。

Because when you add something like a twenty four hour requirement, that doesn't actually align with all this other existing layering of regulation update in the federal level, it just becomes unworkable.

它最终会因自身负担过重而崩溃。

It just collapses under its own weight at some point.

而FDA的问题在于，他们用于复合药物监管的资源再次受限。

And the thing with FDA is that again they have limited resources for compounding enforcement.

在几乎所有情况下，他们都希望重点关注最高风险、最令人担忧的行为。

They want to focus on the highest risk, most concerning behaviors in almost every case.

问题不会出在医院和医疗系统的复合药物操作上。

It's not going to be hospital and health system compounding trouble.

问题将出在那些跨州运输、大量进行非患者特定处方工作的大规模复合药物操作上，这才是他们真正要关注的重点。

It's going to be large scale compounding operations that ship across state lines, that do a lot of non patient specific prescription work, and that's really where they're going focus.

为医院分析制定一个可行框架的目标，就是要表明我们不会创建一个可能从理论上削弱审批机制的系统。

The goal in kind of creating some workable framework for the hospital analysis is just to say like we're not creating a system where they could theoretically undercut the approval mechanism.

这就是另一关键点。

That's the other thing here.

竞争性药物本质上是指未经批准就投入使用的新药，因此FDA有既得利益要确保这种情况不会发生。

Competitive medications are essentially new medications that are being provided without approval, and so FDA has a vested interest in making sure that that's not happening.

所以Mike，你现在处于这样的境地——作为USP专家，你整天面对的都是USP相关问题，对于转向USP框架体系以及新修订章节这件事，你怎么看？

And so Mike, guess you know you're in the situation now where you're a USP expert, you get nothing but USP questions all the time, but what do you think about shifting to a USP based framework and also the new revised chapters?

是否存在某些因素会让情况复杂化或改变你的评估？

Is there anything that kind of complicates that or changes your assessment?

不，我认为医院药房已经在疲于应对人员配置问题、药品短缺问题，还要争取符合340B条款等等。

No I think the hospital pharmacies are already struggling with workforce issues, drug shortages, trying to fight for like 340B compliance, etc.

要处理的事情已经够多了。

There's enough going on.

精简法规和标准确实很有必要。

Streamlining regulations and standards, it really just it makes sense.

要知道，药事管理委员会随时可能派检查员过来。

Know, look, you've got an inspector coming in from the Board of Pharmacy.

但愿永远不会发生——但FDA检查员也可能突然到访。

Please, I hope it never happens, but you could have an FDA inspector come in.

联合委员会、DMV或你们合作的任何机构都可能派人来检查。

You could have a joint commission come in or DMV or whomever you use.

只要这些标准都统一，工作量就能减轻些。

As long as those things all align, it's a little less work.

麻烦也会少一些。

It's a little less hassle.

如果每家机构的要求都有细微差异，就像你说的那样，简直让人难以忍受或无法维持。

If each one of them has slightly different expectations, it's just unbearable or untenable, as you noted.

我认为采用795和797标准不会有问题。

I don't think there's an issue with using seven ninety five and seven ninety seven standards.

要知道，这些标准是由专家委员会制定的。

You know, those are developed by an expert committee.

FDA对此也有一定发言权。

FDA has some input on that too.

他们确实有政府联络员可以提供意见。

They do have government liaisons to offer input.

要知道，即将出台的一些改动可能会影响某些小型医院，或是那些使用CAI隔离箱（姑且这么称呼）而非洁净室的医院。

You know, there's some changes coming to these that could affect some smaller hospitals or hospitals that are using CAI or CAI, for lack of a better word, glove boxes that aren't in a clean room.

新章节生效后，这些产品的使用期限会变得更短。

They're going to have shorter beyond use dates once the new chapters take effect.

如果他们生产的产品用于院外或诊所等场所，那么无论如何使用期限都将被限制在24小时内。

And if they are making products for off-site or, you know, clinic use, etc, then they're going to be limited anyway to twenty four hours.

这还是指冷藏保存的情况，而实际不太可能做到。

And that's if it's stored in a fridge, which is unlikely to happen.

所以我认为，转向USP规定的使用期限可能是最可行的解决方案，能让医院药房和医疗系统正常运作。

So, you know, shifting to USP beyond use dates, I think, is probably the most obvious solution to make this workable for pharmacies in hospitals and health systems.

我们能等到这一天吗？

Will we see that?

我不知道。

I don't know.

我们已经在第一版指南发布后和原指南第二次修订时反复提出过这个请求。

We've repeatedly asked for that both after the first guidance and the second revision to the original guidance.

我们拭目以待吧。

We'll see what happens.

但USP会带来很多变化。

But there's a lot of changes coming from USP.

我认为大家需要意识到这些变化。

I think folks need to be aware of those.

对于非无菌复配设施的要求更加规范了。

There's a little more structure around the facilities for non sterile compounding.

我觉得很多人都忽略了这点——当你把苯海拉明、利多卡因、制霉菌素等混合成所谓的'神奇漱口液'时，根据795条款这实际上属于非无菌复配。

I think a lot of folks just kind of overlook, you know, you're mixing diphenhydramine with lidocaine with nystatin with, you know, whatever your magic mouthwash combination is, that's technically non sterile compounding under seven ninety five.

你们的设施是否按照修订要求准备就绪？

Are your facilities in order according to the revisions?

七月份的情况也一样。

Same thing with July.

有一些新的变化。

There's some new changes.

现在有了不同分类，对应不同的使用期限和人员培训要求。

There's different categories now with different beyond use dates that correspond with those different training personnel requirements.

800条款正式生效了。

800 becomes official.

这个话题足够我们做一整期播客了。

We could do an entire podcast on this.

我们之前和Patty做过一期，但更多是初步反应。确实，再做期深度解析会更好，可以带大家了解些重点注意事项。

So we did one earlier with Patty, but it was more of an initial reaction, but yeah, a more in-depth one probably wouldn't hurt just to go through some of the high level things that people need to be aware of.

确实，即将迎来许多变革，但我认为这些都与FDA的目标并不冲突。

But yeah, it's a lot of change coming, but nothing there I think is incompatible with what FDA is trying to do.

没错。

Right.

我是说，我认为围绕这份指南仍存在许多普遍性的未解问题，所以FDA在指南中提出将药房排除在外的做法，实际上明确指向了医院层面，这意味着会涉及到Pixis机器。

I mean I think there are still a lot of open questions in general around the guidance, so this idea of leaving the pharmacy FDA in its guidance makes it pretty clear that it means hitting the hospital floor, so that includes going into Pixis machine.

因此尽管Pixis机器属于药房部门管辖，但在FDA看来，这更像是将药房本体排除在外的权宜之计。

So even though Pixis machine is, you know, under the auspices of the pharmacy department, to FDA it's more of the cynical act of leaving the pharmacy proper.

我的意思是，FDA在构想中把医院药房想象成这些大型精美的生产设施。

I mean, think FDA in their minds, they envision this like giant beautiful manufacturing facility in these hospitals when they're thinking about pharmacies.

要知道，直到我在ASHB的第二年才真正见过医院药房。

It's you know I hadn't seen a hospital pharmacy until I was in my second year at ASHB.

我从未见过，所以想象中的样子与现实完全不同。

I'd never seen one and so in my mind what it actually looked like was very different than what it looks like in real life.

我确实去过大型医疗系统，他们的设施可能比资源匮乏的小型乡村医院要豪华得多。

And I did go to a large health system, so you know their facilities are probably quite fancy compared to some of the other options at smaller rural hospitals, you know, that don't have this resources.

不过关于将药房排除在外的问题，另一个难题是如何处理机器人和技术解决方案，根据现行指南这很难回答。

So the the other question around leaving the pharmacy though is what to do about things like robots and tech solutions, and that is a hard question to answer based on the current guidance.

这方面没有简单的答案，我认为FDA仍在斟酌考量。

There's not an easy response there, and I think FDA is still kind of mulling some of that over.

他们也在努力了解问题具体所在，比如是否存在引发安全隐患的特定事项。但总体而言，我们ASHP始终倡导能提升患者安全、增加工作流程灵活性、全面提升安全性的方案。

I think they're also trying to educate themselves on exactly where the issues are, know, if there are particular things that raise red flags around safety, but for the most part we as ASHP have really advocated for things that improve patient safety and increase workflow flexibility and allow for just a better all around kind of safety profile.

因此我们要确保FDA采取的措施不会不必要地限制技术发展。

So we want to make sure that whatever FDA adopts doesn't unnecessarily cut off tech.

我们也知道这在州一级是个问题。

We also know this is a problem at the state level.

我们听闻检查员的各种说法，以及他们如何解读指南并试图应用——这再次表明他们本不该这么做。

We've heard of different things inspectors have said or how they've interpreted the guidance and tried to apply it, which they again should not be doing.

但这确实具有指导意义。

But it is instructive.

这确实让我们在向FDA表态时感到些许安心，可以说'我们认为各州会这样解读，因为他们目前正试图如此应用'。

It does provide us some level of comfort in saying to FDA like this is what we think states are going to interpret this to mean because that's how they are currently trying to interpret it to apply.

这类问题我们仍在与机构反复沟通。

So that's the kind of stuff we're still kind of back and forth with the agency on.

另外我认为核心问题是如何最优解决这个24小时要求。

And then I think just in general there's a question of how best to resolve this twenty four hour requirement.

机构可能会表示'我们将坚持现行规定'。

It's possible the agency will say look we're just going to stick with this.

不过我认为更有可能的是他们会找到某种折中方案。

I think it's more likely though that they'll find some sort of middle ground.

关键要点在于：他们确实希望承认医院和医疗系统配药工作的独特性，这与社区药房503条款及3B类机构运作形成对比。

Know kind of the key takeaway here is they do want to recognize the kind of unique pieces of the hospital and health system compounding work versus what you see in 503s that are community pharmacies and also certainly what 3Bs are doing.

另需注意的是FDA全面监管Revives Revives。

The other thing to note here is that FDA fully oversees Revives Revives.

Revives Revives向FDA注册的部分原因是他们清楚将完全受FDA约束。

So Revives Revives registers with the FDA in part because they know that they are going to be totally beholden to the FDA.

他们不必过多担忧各州会采取什么行动。

They don't have to worry so much about what states are going do.

但值得注意的是，FDA始终、始终、始终拥有随时进入药房的权力。

But it's worth also noting the FDA has always, always, always had the authority to come into your pharmacy at any time.

这一点从未改变。

This has not changed.

本指南中的任何内容都未改变这一事实。

Nothing in this guidance changed that.

所以要知道，只要接到不卫生条件的报告，他们就可以直接进入你的药房，没有任何限制，这里也没有任何扩大权限的内容。

So you know anytime there's a report of insanitary conditions they can march right into your pharmacy, there's nothing that stops that and nothing that kind of expands that scope here.

但我认为我们的长期目标是建立一个框架，该框架基于现有法规，或至少重新利用人们熟悉的现有法规和标准，同时让监管机构对其监督能力感到放心。

But I think our longer term goal is to create a framework that builds on existing regulations, or at least repurposes existing regulations and standards that folks are comfortable with, in a way that also makes the agency comfortable with its ability to kind of oversee.

我确实认为他们更倾向于将大部分监管权留给州政府。

I do think their preference is to leave most of the regulation to the state.

正如我所说，他们希望将有限的资源集中用于其庞大业务中最具意义的环节，即那些发生在医院和医疗保健系统之外的大规模资金运作。

Like I said, they really want to focus their limited resources for this particular piece of their huge portfolio on where it's going to be most meaningful, and that's at some of the larger scale funding operations that happen outside of hospitals and health care.

所以我不确定，Mike，你对下一阶段还有什么宏观层面的期待吗？

So I don't know Mike, anything else big picture you're really looking to see from the next iteration?

不，我认为明确药房定义将是关键。

No, think defining pharmacy is going to be key.

要知道，他们可能会坚持24小时营业的标准。

Know, they could choose to stick to the twenty four hour.

正如我们所说，他们不希望看到大型跨州医疗系统在一个站点大量调配药物然后四处配送。

As we stated, they don't want to see a large multi state health system compounding a ton of things in one site and then shipping them all over the place.

这确实不是他们的初衷，他们想要阻止这类行为。

That really is not that's kind of their intent to stop.

一方面，能够将这些药品装入自动配药机确实很棒，我认为大多数医院医疗系统的药房若能将这些药品存放在配药柜中，就能符合相关指导要求。

So, you know, on one hand, having the ability to load these in automated dispensing machines would be great, and I think most hospital health system pharmacies could then comply with the guidance if they could stock them in dispensing cabinets.

但这能否解决FDA的担忧呢？即一个地点、一批受污染产品可能扩散到多个州的不同医院医疗系统，导致再次出现类似NECC的情况？

But does that stop what FDA's concern is, which is one site, one batch of contaminated product making it all over a multiple hospital health system in different states, and then they have another NECC situation on their hands?

因此从FDA的角度来看，这有助于塑造我们的倡导方向。

So looking at it from the lens of FDA, that kind of helped shape our advocacy.

我认为你用了'教育'这个词，这确实是思考任何倡导工作的好方式。

And I think you used the word educate, and I think that's a good way to think about any advocacy, really.

要知道，我们前去是为了教育，但我想我们已经与FDA工作人员建立了良好的关系，我们能做到这一点。

You know, you're going in to educate, but I think we've built up a pretty good relationship with the FDA staff, and we can do that.

我们可以与他们讨论医院运作机制、医院药房工作流程以及门诊诊所的运行方式。

We can talk to them about what works in a hospital, how a hospital pharmacy works, how do these outpatient clinics work.

我们正试图通过在比临床现场更好的环境中做好准备，来做正确的事。

We're trying to do the right thing by preparing them in a better environment than what's happening in the bedside.

因此对于下一份指导文件，我们将关注24小时规则是否会调整为更符合787条款，或者对'离开药房'的定义能否获得更多灵活性。

So I think for the next guidance, we'll see whether that twenty four hour rule changes to be more in line with seven eighty seven, or do we get a little more flexibility on what quote unquote leaving the pharmacy means?

这些都是我正在密切关注的事项。

Those are things I'm keeping an eye on.

这正好为我提供了关于教育部分的完美过渡。

Well, provided me a perfect segue with the education piece.

一如既往，我们确实鼓励在复合制剂方面遇到问题的人们。

So as always, we really encourage folks who are having issues around compounding.

如我之前所说，如果州药房委员会前来试图执行任何规定，请立即告知我们。

If you, as I said earlier, if your state board is coming in and trying to enforce anything, do let us know right away.

除非我们自己先受教育，否则我们无法教育FDA，而且你知道我们从会员那里获取最优质的信息。

We can't educate FDA unless we are educated, and you know we get the best intel from our members.

值得注意的是，每天从事这项工作的人可能比FDA一般的复方政策律师更了解情况。

It's worth noting here that everybody who does this on a daily basis is probably better informed than the average compounding policy attorney over at FDA.

所以你知道，我们提供的信息越多，他们就越容易制定出可能长期可行的政策。

So you know the more information we can provide, the easier it is for them to kind of shape a policy that's possible long term.

这就是我们今天所有的时间了。

So that's all we have time for today.

我要感谢迈克加入我们讨论复方制剂的话题。

I want to thank Mike for joining us to discuss compounding.

请确保你的声音被听到。

Be sure that your voice is heard.

作为药剂师和选民，你在州和联邦层面拥有巨大的影响力。

As a pharmacist and a constituent, you have tremendous influence at the state and federal level.

访问ashp.org了解更多关于关键问题、基层努力以及参与ASHP倡导工作的方式。

Visit ashp.org to learn more about key issues, grassroots efforts, ways that you can get involved in ASHP's advocacy efforts.

感谢收听ASHP官方频道，这里是推动医疗进步的药剂师之声。

Thank you for listening to ASHP official, the voice of pharmacists advancing healthcare.

请务必访问ashp.org/podcast，探索更多精彩剧集，查看节目笔记，并下载剧集文字稿。

Be sure to visit ashp.org/podcast to discover more great episodes, access show notes, and download the episode transcript.

如果你喜欢这期节目并想听到更多内容，请务必订阅、评分或留下评论。

If you loved the episode and wanna hear more, be sure to subscribe, rate, or leave a review.

下次节目再见，ASHP官方频道。

Join us next time on ASHP official.