药房热点话题：USP章节修订：下一步是什么？

欢迎收听ASHP官方播客，本节目将为您解读药物使用、公共卫生及药学专业相关议题。

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

感谢收听本期药学热点话题，我们将与专家深入探讨当前药学领域最受关注的问题。

Thanks for joining us for this episode of pharmacy hot topics, where we sit down with our experts and discuss what is currently top of mind in the world of pharmacy.

我是迈克·加尼奥。

My name is Mike Gagneo.

我现任ASHP药学实践与质量高级总监，负责处理药物短缺、复配药物及高危药品安全等药学实践相关事务。

I'm senior director of pharmacy practice and quality here at ASHP, and I'm responsible for pharmacy practice related issues, including drug shortages, compounding, and hazardous drug safety.

本期特邀嘉宾是来自卡地纳健康的帕蒂·基恩利女士，她担任认证与用药安全总监，同时是美国药典委员会复配药物专家组成员。

Joining me for today's episode is the incomparable Patty Keanely, director of accreditation and medication safety at Cardinal Health and USP Compounding Expert Committee member.

帕蒂还荣获了哈维·A·K·惠特尼演讲奖

Patty was also recognized with the Harvey A.

K·惠特尼演讲奖

K.

该奖项是在我们最近于凤凰城召开的夏季会议上颁发的。

Whitney Lecture Award during our recent summer meetings in Phoenix.

今天我们将讨论最新发布的美国药典章节内容，以及听众在未来几个月可以期待的变化。

We're going to be talking about the newly published USP chapters and what our listeners can expect in the coming months.

欢迎帕蒂，感谢你今天参与我们的节目。

Welcome, Patty, and thanks for joining us today.

谢谢，迈克。

Thanks, Mike.

好的。

Okay.

我们终于有了更新的章节。

So we finally have updated chapters.

帕蒂，这些章节已经修订了好几年。

Patty, these chapters have been in the process of being revised for years.

最近它们作为最终版本发布了。

Most recently, they were published as final versions.

它们曾被上诉，发回专家委员会，工作几乎又重新开始了。

They were appealed, remanded to the expert committee, and work kinda started over again.

但我们终于又有了新章节。

But we finally have new chapters again.

它们正朝着正式发布的方向推进。

They are on track to become official.

从高层次来看，你能告诉我们这些修订的主要内容吗？

And at a high level, what can you tell us about the revisions?

嗯，我想大家已经等待这些修订好几年了。

Well, I think everybody's been waiting for these for a number of years.

对吧？

Right?

从7月份非无菌配制的角度来看，我认为影响医疗系统最大的问题是其中定义的空间要求——虽然大多数机构已经具备，但需要确保符合标准中的具体规定。

So from a July perspective for nonsterile compounding, I think the biggest issues that probably affect us in health systems are the defined space that is there, and pretty much everybody has that, but just need to make sure that it meets what those criteria are in there.

唯一与个人防护装备相关的要求是必须戴手套，这一点我们大多数人已经执行多年了。

And then the only PPE specific that are there is the requirement for gloves, which most of us have been doing for years.

但797章确实与2008年以来的旧章节存在一些差异，这确实是很长一段时间了。

But seven ninety seven does have some differences that are there from the chapter that we've had since 2008, so that's a long time.

我希望听众们也能查阅USP委员会的会议记录，过去几年这些会议都是公开的，当时所有讨论都围绕这方面展开。

And I hope that people who are listening have also been accessing the USP committee meetings, which were public for the last couple of years when all of the discussion was around there.

你们可能已经了解这些内容，它们确实已被纳入最佳实践文件多年。

So you may know all of this, and it's certainly been in the best practices piece for a number of years.

我喜欢把事情分门别类，习惯将事务划分到小类别中。

I put things know, I like to put things in small buckets.

针对七月份的这些变更，我划分了四个类别：设施、培训、环境监测和超期使用日期。

I have four buckets for these changes for July, facilities, training, environmental monitoring, and beyond use dates.

从设施角度简单概括来说——这应该不会让人意外，因为我们已讨论多年——实际上你们只有两个选择。

So just real high level from a facilities perspective, and this shouldn't be a surprise to anyone because we've been talking about this for years, but you really have two options.

要么选择洁净室套间（至少包含两个独立房间：前室和至少一个缓冲间），要么选择隔离式配药区域。

You have a clean room suite, which is at least two separate rooms, an anteroom and at least one buffer room, or you can have a segregated compounding area.

但需要提醒大家：原先将抗缓冲区域合并在一个房间的配置，现在不再被视为合规的配药套间。

But just so people are aware, folks who have had a combined antibuffer area in one room, that is no longer considered a compounding suite.

你们或许能满足隔离式配药区域的要求，但区别在于这种情况下需要使用更短的有效期时限。

You are likely to be able to meet the segregated compounding area requirements for that, but the difference there is your ability to need to use the lower, the shorter beyond use times for those.

另外需要牢记的是：虽然我们多年来都在使用'隔离器'这个术语，但实际上在配药中使用的是配药专用隔离器，而非制药用隔离器。

The other thing we need to keep in mind is we've all been kicking around the term isolator for years, but really what we use in compounding is a compounding isolator, not a pharmaceutical isolator.

因此若要继续使用完整的有效期标准，这些配药隔离器必须安装在洁净室套间内。

So in order to use the full BUDs going forward, those compounding isolators need to be in a clean room suite.

重申一次，否则你们可能只能满足隔离式配药区域的要求。

And again, otherwise, you can probably meet the requirements for a segregated compounding area.

以上就是两个最重要的要点。

So those are the two big things there.

从环境监测的角度来看，人们需要知道实际进行的监测类型是相同的，包括空气和表面监测，但表面采样必须每月进行一次。

From an environmental monitoring perspective, people need to know that it's really the same type of monitoring, air and surface, that's occurring, but surface sampling has to be done monthly.

因此你们的认证机构不太可能——大多数机构都是每半年才进行一次环境监测。

So it's unlikely that your certifier, which is what most places have been using to do the every six months environmental monitoring.

他们不太可能做到每月监测一次。

It's unlikely that they'd be able to do that on a monthly basis.

所以考虑下你们要如何实施这个方案。

So think of how you're gonna play this out.

你们需要一个培养箱，或者至少需要培养箱空间。

You need an incubator, or at least you need incubator space.

也许你们的微生物部门可以处理，但他们可能也没有资源来做这件事。

Perhaps your micro department can handle that, but they may not be resourced to do that either.

所以考虑下这个需求。

So think of that need.

你们需要准备合适的培养基，并且需要配备微生物学家以防检测结果超出规格或高于行动限值。

You're going to need the appropriate media to use, and you're going to need a microbiologist in case those results are out of spec or above the action level.

从培训角度来看，要清楚初始培训和再认证培训之间存在明显区别，现在再认证培训必须每半年进行一次，而非每年一次。

From a training perspective, know that there's a very distinction between the initial training and the requalification training, and requalification now has to be every six months, not every twelve months.

除了我们多年来一直在做的培养基灌装和手套指尖测试外，还需要在该流程中进行一次表面采样，这能全面反映被检查人员在配制操作中的能力水平。

And in addition to the media fill and gloved fingertip tests that we've been doing for years, there's also a need to do a single surface sample in that process, which gives you a whole picture of the competency of whoever you're checking for compounding.

培养基灌装证明该人员能进行无菌配制，手套指尖测试表明他们能保持自身无菌状态，而表面采样则证明他们能保持工作区域清洁。

The media fill showing that that person can aseptically compound, the gloved fingertip showing that they can keep their own asepsis going, and that surface sample to demonstrate that they can keep that area clean.

所有这些最终都指向我在考虑超期使用状态时的最后一个重要环节。

So that all kind of plays up to the last big bucket in my consideration of the beyond use states.

我们多年来处理的风险等级——低、中、高风险——将不复存在，这改变了复合制剂的分类标准。

The risk levels that we've been dealing with for years, that low, medium, and high risk, go away, and that changes the categories of compounding.

第一类可以理解为在隔离复合区域进行的操作。

So category one, you can think of it as what you do in a segregated compounding area.

实际上，这类制剂的保质期还会有所延长。

And the beyond use dates actually increase on that.

现在冷藏条件下允许保存长达24天。

We're now allowed up to 24 refrigerated.

第二类可能是多数人会采用的方式，必须将保质期视为最长保质期而非默认值，因为可能存在需要缩短期限的情况。

Category two, which is what most people will probably be doing and you have to think of the beyond use dates as maximum beyond use dates, not defaults, because there might be reasons that you need less than this.

虽然原先低风险允许14天、中风险允许9天，但随着风险等级的取消，我们统一设定保质期为10天。

But where low has been allowed fourteen days and medium has been allowed nine days, because those risk levels go away, we have to come up with one time so that time for a beyond use date is ten days.

总的来说，这些都是修订章节中需要大家注意的关键问题。

So overall, I think those are the big issues that people need to be aware of with the revised chapter.

是的。

Yeah.

有些不错的更新和信息。

Some good updates and some good information.

我想我们在新冠疫情期间已经提前见识过部分保质期设定和复合制剂的相关考量了。

And I think, you know, we got a kind of a sneak preview of some of the beyond use dates and the considerations for compounding during COVID nineteen.

当然，在前几章我们也看到过类似的保质期规定。

And, of course, we saw these in the previous chapters, some of the similar beyond use dates.

就像你说的，这些内容大多应该不算意外，不过我们还是来谈谈正式生效日期吧。

So like you said, a lot of this shouldn't really be that much of a surprise, but let's talk about the official date.

你能告诉我们这些章节的正式生效日期及其对听众的意义吗？

Can you tell us about the official date for the chapters and what it means for our listeners?

你认为监管机构、州药房委员会以及像联合委员会这样的认证机构能在正式生效首日准备就绪吗？

Do you think regulators, state boards of pharmacy, and accreditors like the Joint Commission are gonna be ready to go on day one of the official date?

每当USP章节新增或修订时，从发布日期到正式生效至少会有六个月的过渡期。

Well, whenever a USP chapter is either new or revised, that publication date, there's always at least a six month time period between the publication date and when it becomes official.

而这次我们看到这个期限被延长了。

Now, in this case, we're seeing an extension of that.

现在延长到了整整一年，这样人们能有更充分的时间确保合规。

We're seeing it go up to a year out, so people have a little bit more time to be able to be sure they're compliant with things.

至于州药房委员会等其他方面，许多州委员会已将部分或全部要求纳入州法规。

Other issues like state boards of pharmacy, many state boards have already incorporated some or all of these requirements in the state regulations.

认证机构也采取了类似措施，因为他们可以沿用现有标准——其中很多内容与7月和7月的信息重叠。

And accreditation organizations have done that as well because they can use their existing standards, many of which overlap with the information in July and July.

所以他们其实已经着手开展部分工作了。

So they have already started to do some of that.

我提到过之前的最终章节795、797和825都遭到了申诉。

So I mentioned that the previous final chapters were appealed, both seven nine five, seven nine seven, eight twenty five were all appealed.

能谈谈专家委员会为应对申诉做了哪些工作吗？

Can you talk a little bit about the work the expert committee did in response to the appeals?

我知道当时还征询了相关利益方的意见。

I know there was some stakeholder engagement.

这些章节与申诉版本相比有哪些不同？

And how do the chapters look different than the appealed versions?

他们被申诉的主要依据是超出使用时间和过期日期。

Primary reason they were appealed was based on beyond use times and beyond use dates.

这很大程度上并非医疗系统问题，而是社区配药人员需要更长的有效期来为患者配药。

And it was largely not so much health system issues, but the community compounders who need longer dates in order to fill prescriptions for patients.

因此委员会对此进行了审查，并由多位成员多次讨论了每一个问题。

So the committee looked at this and went through every one of those issues multiple times by multiple people.

正如你所说，我们进行了大量利益相关方参与工作，其中大部分是公开进行的。

There were a lot, as you mentioned, a lot of stakeholder engagement, and much of this was public.

我希望听众们有机会收听到其中部分内容。

And I hope that folks listening had an opportunity to listen into some of those.

但我可以向您保证，委员会和USP全体工作人员都深入研究了这些问题，提出申诉的当事人也参与了这些讨论。

But I can assure you that the committee and all of the USP staff really went over these extensively, and the folks who did the appeals, the appellants, were involved in those discussions as well.

是的。

Yeah.

这是个很好的流程，我和几位ASHP成员不仅参与了申诉流程和利益相关方互动，还注意到在审议最新修订意见时，收听评论的ASHP成员数量明显增加。

It was a great process, and I know I, along with several ASHP members, were engaged in participating in not just the appeals process and the stakeholder engagement, but we really saw an uptick in the number of ASHP members who were listening in as the comments were reviewed on the the most recent proposed revisions.

确实，我认为通过更多利益相关方参与——无论是收听评论还是正式参与机会——各章节内容都得到了加强。

So, really, I think the chapters are strengthened through more stakeholder engagement, be it through listening in on comments or through official stakeholder engagement opportunities.

帕蒂，你怎么看？

So what do you think, Patty?

你认为这些还可能再次被申诉吗？

Do you think these could be appealed again?

嗯，显然存在这种可能性。

Well, there's obviously that opportunity to do that.

我们有一个短暂的时间窗口可以提出上诉，届时我们会知道结果。

So we have a short period of time that the appeals process can come in, and we'll know at the end of that.

嗯。

Mhmm.

是的。

Yeah.

所以你指的是六十天的窗口期。

So you're referring to a sixty day window.

我确实查看了2020至2025年大会的最新章程，它们和之前一样都涉及上诉程序。

I did look at the updated bylaws and for the twenty twenty to twenty twenty five convention, and they do address appeals as did the previous.

但看起来流程更完善了，上诉方当然有权陈述理由，而USP这边对于需要采取的行动也规定得更具体。

But it looks like the process is a little more complete where whoever appeals will, of course, have their ability to make their case, but it looks like on the USP side, it's a little more concrete as to the actions that need to be taken.

而且，你知道的，如果有上诉，可能会也可能不会推迟正式日期，但请继续关注ASHP。

And, you know, it may or may not delay the the official date if there are appeals, but stay tuned to, ASHP.

一旦有进一步消息，我们会立即通知大家。

We'll keep you updated as soon as we hear anything more.

我认为这两章还有一个重要更新，我想花一分钟谈谈USP第800章。

There's one more major update, I think, that comes with these two chapters, and I'd like to talk for a minute about USP chapter 800.

它已经悬而未决好几年了。

It's been in limbo for a few years now.

现在终于正式生效了。

It's finally official.

虽然之前已经正式发布，但在这些章节的正式日期之前，它不被视为强制适用。

It's been official, but it's not it it's considered not compenually applicable until the official dates for these chapters.

既然这些章节即将正式生效，这对第800章意味着什么？

So now that these chapters are scheduled to become official, what does that mean for chapter 800?

第800章和第825章涉及放射性药物，将具有强制执行力、联邦强制力，或按药典适用——这是USP在七月修订时使用的术语。

Both chapter eight hundred and eight twenty five, which deals with radiopharmaceuticals, will become enforceable, federally enforceable, or compendially applicable is the USP term that's used when either July or July is revised.

原因是这样的，回顾时间线，第800章自2016年2月起就已经是正式章节了。

And the reason for that is, think back on the timeline of this, 800 has actually been an official chapter since February 2016.

但由于它未被其他章节提及，所以才出现了这种悬而未决的状态。

But because it wasn't mentioned in another chapter, that's why this sort of limbo position came up.

但我们必须记住，八月条款是为保护我们而设的。

But we have to remember, August is there for our protection.

许多地方，包括几个州委员会，已经开始实施该条款。

And many places, and several state boards as well, have already begun to implement that.

我希望这些保护措施——让我们免受危险药物污染的能力——从药房角度也至关重要，对任何配制或使用化疗药物的人都是如此。

And I hope those protection issues, the ability to keep us free from the contamination of hazardous drugs, is certainly important from a pharmacy perspective as well, and anybody who compounds or administers chemo.

所以我希望人们一直在遵守并推进这项工作。

So I hope that people have been complying with that and moving along there.

但当七月修订版正式生效时，它将具有药典适用性。

But it will become compendially applicable when July or July become official.

我觉得'药典适用性'这个概念对我们大多数人来说都有点困惑。

I think the whole compendially applicable thing was kind of confusing for most of us.

我们一直学到的是编号低于一千的章节被视为正式且可强制执行，后来似乎总通知或其他文件被修订过，以插入你提到的这种关联性。

We always learned that a chapter below a thousand was considered official and enforceable, And then it looked like the general notices or something was revised somewhere to to insert that linkage that you mentioned.

所以它必须以某种方式链接到另一个章节才能使其正式生效。

So it has to be linked to another chapter in a way that that makes it official.

在这些修订之前，你知道的，800号标准并未关联。

And until these revisions, you know, 800 wasn't linked.

好的，感谢你的见解，帕蒂。

Well, thanks for the insight on that, Patty.

我知道你对危险药品安全充满热情。

I know you're passionate about hazardous drug safety.

因此，当我们最终推进800号标准的实施与执行时，会很有趣。

So it would be interesting to see as as we finally move toward implementation and enforcement of 800.

但我我认同你的希望，考虑到我们在讨论工人安全，希望许多场所已认真对待这些章节，我们从全国调查数据和其他来源了解到，很多场所已经实施了800号标准。

But I I share your your hope that given the you know, we're talking about worker safety, hopefully, we've a lot of sites have been taking these chapters seriously, and and we know that from national survey data and from other sources that a lot of sites have already implemented 800.

好的，我将把最后发言权交给你，帕蒂。

Well, I'm gonna turn it over to you for any final thoughts, Patty.

关于修订内容，你还有什么想与听众分享的吗？

Anything else about the revisions you'd like to share with our listeners?

嗯，你知道，我只是认为这是一份活文件，我们等待这次更新已很久，特别是随着七月技术变革，以及我们所知和工作实践的变化等。

Well, you know, I just think that, you know, this is a living document, and we've we've waited a long time for the update for these, particularly with July as all of the technologies changed and what we know and how we or our work practices, things like that.

所以这是份动态文件，你知道，内容还会再次修订。

So it's a living document, and, you know, things will be revised again.

当然，我们需要些时间来完成这项工作，但如果有人有特别需要解决的问题，无论是在某个章节或其他主题，USP都开放接收这些意见。

Certainly, we need some some time to to get this done, but if anybody has particular things that they need, they think need to be addressed, either in a chapter or even some other topic, USP has an open opportunity for you to provide those comments to them.

这些意见会被高度重视，因为新章节和新委员会的组建甚至专家小组的成立都会参考。

And they're taken very seriously as the new chapters and the new committees are developed and even expert panels that are there.

因此，参与USP活动的机会很多。

So there's lots of opportunities to participate in USP activities.

你知道，你提到技术这个话题很有意思。

You know, it's interesting you mentioned technology.

我认为在复合章节和标准制定方面，这个领域还有进一步发展的空间。

It's one of the areas that I think there is room for further growth in the in the compounding chapters and establishing standards.

很好的想法。

So good thoughts.

我们对此表示赞赏。

We appreciate that.

好的，我们今天的时间就到这里。

Well, that's all the time we have today.

非常感谢帕蒂·金利加入我们，讨论USP更新的795和797复合章节。

I'd really like to thank Patty Keenly for joining us to discuss the updated USP compounding chapters seven nine five and seven nine seven.

不要错过即将召开的临床年中会议上关于USP更新章节的更多内容。

Don't miss more content on the updated USP chapters at the upcoming midyear clinical meeting.

届时USP专家委员会成员凯文·汉森和联合委员会药物管理章节主任罗伯特·坎贝尔将与我一起讨论这些更新及其对医疗系统的意义。

I'll be joined by USP expert committee member Kevin Hansen and director of medication management chapters at the Joint Commission Robert Campbell to discuss these updates and what they mean for health systems.

正如你听到的，这包括现在开始强制执行的800章节。

That'll include chapter 800, as you heard, that now becomes enforceable.

这对你们下次联合委员会调查意味着什么？

What does that mean for your next Joint Commission survey?

欢迎参加我们12月4日周日下午3:30到4:45的会议来了解详情。

Well, come in to our session Sunday, December 4 from 03:30 to 04:45 to find out.

如果你还没看过，我建议你去看看ASHP的在线资源。

And if you haven't before, I encourage you to check out ASHP's online resources.

您可以找到会员专享服务，如导师工具包、资源中心等。

You can find member exclusive offerings such as a preceptor toolkit, resource center, and more.

再次感谢您收听本期《药学热点话题》。

Thanks again for joining us for this episode of Hot Topics in Pharmacy.

如果您喜欢今天的对话，请务必订阅ASHP官方播客，获取更多精彩内容。

And if you've enjoyed today's conversation, be sure to subscribe to the ASHP Official podcast for more great content.

感谢您收听ASHP官方频道——药剂师推动医疗进步的声音。

Thank you for listening to ASHP Official, the voice of pharmacists advancing health care.

请访问ashp.org/podcast，探索更多精彩节目、获取节目笔记并下载文字稿。

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

如果您喜欢本期节目并想收听更多内容，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，ASHP官方频道再见。

Join us next time on ASHP official.