USP Expert: Pharmacists Are Key, Play a Critical Role in USP’s Standards Setting Process


This World Standards Week, Carrie Harney, JD, vice president, US Government and Regulatory Affairs at US Pharmacopeia (USP), explains how pharmacists contribute to USP’s standards setting process.

For World Standards Week, Pharmacy Times interviewed Carrie Harney, JD, vice president, US Government and Regulatory Affairs at US Pharmacopeia (USP) on USP’s history with standards and where pharmacists have fit in throughout USP’s 200 years of developing these standards.

Alana Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy Times. Joining me is Carrie Harney, JD, vice president, US Government and Regulatory Affairs at US Pharmacopeia, or USP, who is here to discuss how pharmacists contribute to the standards setting process.

So Carrie, can you tell me a bit about yourself and your role at USP?

Carrie Harney: Thank you for having me here today, Alana. So as you said, my name is Carrie Harney, and I lead our US government and regulatory affairs team at USP. So that means that I have the privilege of working with a talented group of colleagues on really a wide range of issues. So pretty much any issue that USP touches our team will touch in some form or other from a regulatory policy or government affairs way.

So when I think about kind of at a high level of what we do, we develop the public policy and advocacy initiatives for USP to help advance the quality of medicines, dietary supplements, food, and health care. We also work closely on FDA regulatory issues and lead USP’s interaction with federal and state regulators. So for example, the state Boards of Pharmacy.

Alana Hippensteele: That's really interesting. Can you provide some insight into USP’s history with standards—and I know that history is rather a long one as well.

Carrie Harney: It dates back actually over 200 years. So back in 1820, a group of 16 physicians came together, and they were very concerned about poor quality medicines in America. So they came together to form the US Pharmacopoeia, or USP. As a part of that, USP published the first set of national standards for medicinal preparations to ensure that they were prepared consistently.

Over time, USP and the practice of pharmacy have really grown up together. We saw the preparation of medicines leave the exclusivity of the doctor's office and move to the corner drugstore, and we saw the practice of pharmacy develop as a specialty all of its own. Then kind of along the way, USP was there with our standards, and our standards evolved as medicines evolved.

So from the time of preparing maybe botanical preparations and a mortar and pestle to what we see today in large manufacturing plants and standards now that are a collection of tests and assays that manufacturers run to confirm the quality of their product. So our history is long with standards.

But I think one thing that I find inspiring is that our mission has remained constant over all of this time, even with all of these changes. That mission is to set these quality standards, these public standards that can help ensure that patients and practitioners can trust the quality of their medicines.

Alana Hippensteele: Right, absolutely. So we know standards are critical to manufacturing. But what role exactly do they play toward the end of the supply chain when pharmacists are involved?

Carrie Harney: Yeah, that's a great question. And maybe to answer it, I will start kind of taking a step back and looking at the supply chain as a whole.

When we think about the lifecycle of a medicine, that covers everything from discovery and development of the medicine through manufacturing it through transporting it and distributing it all the way to delivery to the patient. And kind of across each of those segments of the supply chain, we have standards—a variety of different types of standards—that can be used to ensure the quality of the product.

We really believe that having these standards that apply from beginning to end build strength in our supply chain, and that strength helps ensure that patients have access to quality medicines when they're needed. I think as your audience of practicing pharmacists knows that availability is really key to patients and to pharmacists—everyone wants to make sure that quality medicines are available.

So I think that's just kind of the 30,000 foot view is helping to ensure that availability, but maybe to zoom in a little bit on that downstream part of the supply chain where a lot of the practice of pharmacy does live I wanted to provide a couple of examples of USP standards that apply in this space.

The first is around a standard for prescription container labeling. And this is the label that is on every vial of medicines that patients pick up from the pharmacist. This chapter helps to set kind of uniform expectations for what the language of the label should be, the format of it, even the font size of it, and having this uniform approach, we believe really can help ensure that all patients can understand those instructions for their medicine. It takes into account different levels of health literacy, language differences, all sorts of things to provide this kind of uniform approach.

In addition to that prescription container labeling, we have standards that apply to the packaging of products, standards that apply to the nomenclature or naming of medicines. So those are ones that pharmacists would likely obviously come to have intersection with in their day-to-day practice.

We also have standards that apply to the transportation and storage of products. And I think this is a particularly exciting area, because as medicines are moving all over the world, there are many forms of transportation, and our expert committees have been hard at work at really trying to provide standards and best practices to ensure that the quality of medicine can be kind of maintained across modes of transportation. And so they've actually established some recent chapters around risk mitigation strategies when we have temperature excursions in transportation, for example. So all of these chapters are relevant to pharmacist as they're getting the medicines in their facilities.

Then finally, I'll just note that we have a number of standards that apply to the handling and storage of medicines in a home health care setting. So, I think these can really be a valuable resource to pharmacist when a patient may come in and have questions about, ‘How do I store my product in my house?’, ‘Where do I store it?’, ‘How do I handle it?’ So we've really, I think, at USP paid equal attention to all parts of the supply chain and recognize the importance of that downstream part and the work that pharmacists do with patients when dispensing medicines.

Alana Hippensteele: That point that you raised around the uniformity of labeling, but it sounds like I'm actually like my field like editorial, or to kind of the layout of texts and how we engage with it. And uniformity is absolutely an area that we talked about in terms of format. And so that that's really, really interesting to think about that in this in this area. What are some recent examples of how pharmacists and USP work together to address a quality problems or develop a standard?

Carrie Harney: Yeah, so there are many, but I know we don't have all day. So I will be I will pick a few that I think are really good examples. And maybe I'll start with some from the COVID-19 pandemic, and then I'll also highlight some more recent work that we've done with pharmacists. But during the COVID-19 pandemic, I think it was probably daily communication between USP staff expert committees and pharmacists, and there are a couple areas where this was particularly noticeable. And the first is in the area of hand sanitizer, even though I think it may be a little bit of a distant memory in people's minds, for a period of time there was a shortage of hand sanitizers, and established drug manufacturers couldn't keep up with the demand. So FDA did allow for a variety of entities to produce hand sanitizers, everyone from compounding pharmacists to distilleries, and I think as USP and our expert committees, many of which include members of the pharmacy community, were kind of watching these developments, we realized that there was a need for some guidance and some support to make sure that quality product was being produced. So working closely together, they developed a series of resources and tools to help support these new producers of hand sanitizer.

Then kind of along the lines of hand sanitizer, there was another period of time where there were a number of safety alerts issued by FDA around some hand sanitizers that had been contaminated with methanol, which is a toxic compound that can cause injury and even death in some circumstances. USP worked with FDA, with the manufacturing industry, and with other stakeholders, like pharmacists, to revise our alcohol standard. That revision helped ensure the quality of the supply chain of alcohol to prevent methanol from getting into the supply chain.

So one last COVID-19 example—and I know you've talked, Alana, to some of my colleagues at USP about this—is the vaccine handling toolkit. I think, not to get into to too many details, but I think that is a wonderful example of the power of collaboration to develop a resource that really pulls a lot of operational efficiencies together, a lot of guidance, a lot of knowledge that can be used as a resource for pharmacists and their staffs to help ensure that vaccines can be administered safely and effectively.

Then just more recently, we've been working over the last several years with a broad range of stakeholders, including pharmacists, from all practices on the revision of our compounding chapters. Those revisions are actually going to be published on November 1. So on November 1, we'll publish our revised chapters on non-sterile and sterile compounding and those involved a lot of input from the pharmacy community.

Alana Hippensteele: Great, that's really interesting. As USP recognizes World Standards Week, what does the future of standards look like?

Carrie Harney: Yeah, so maybe to refer back to our first question about the past, I think that can help inform the future. So when we think about the evolution that's occurred, with standards as medicines evolve, I fully expect that will continue moving forward. Medicine standards must evolve, as medicines evolve, so that we ensure the quality of all these new medicines.

Over the past couple of years, we've seen new technologies come to market like mRNA vaccines, like cell and gene therapies, and other personalized medicines, and USP and our expert committees have been evaluating where there may be challenges, from a quality perspective in these new technologies and these new innovative therapies and working to develop standardized approaches to address those quality challenges.

I think just as most standards no longer reflect a mortar and pestle, these new standards may not look like the standards of today either. They may be more broadly applicable standards to address a form of technology versus a specific product, for example.

Then I'll also note, just as there have been many new innovations in medicine, there also have been many innovations in how medicines are made in manufacturing technologies. I think at USP, we've recognized that these new technologies certainly have a lot of promise and potential benefit. But there are some real barriers to kind of widespread adoption of those technologies. So what we've been doing over the past several years is to really understand those barriers and think about where standards can help maybe lower some of those barriers to adoption [of those] standards, and I'll say other resources as well, because it may be guidance or other documents that could be helpful to facilitate the adoption of these new technologies.

Alana Hippensteele: Absolutely. Where do pharmacists fit in shaping the future of standards?

Carrie Harney: Yeah, not to be like a broken record, but I think they fit where they've always fit, which is right in the middle of all of it. As we think about the critical role that pharmacists play in the supply chain as that kind of direct interaction with patients with other health care providers and with medicines, the insights and expertise of pharmacists are extremely valuable to help inform both our current standards as well as maybe the path of where we want to go with standards because they're hearing from patients about maybe what challenges they're having, or they're experiencing challenges themselves and could identify those as a potential area that USP could work on. So I think having pharmacist is part of our standard setting process, maintaining strong relationships is critically important as our standard setting work continues into the future.

Then I'll also just note, as I was talking about some of the new manufacturing technologies, there may be a future where manufacturing moves from having a central location to maybe more point of care manufacturing or 3D printing type of experience. We believe that pharmacists may be more involved in that part of the medicine lifecycle than they have been in the past. So having pharmacists at the table as USP and our expert committees are considering what standards or other resources may be useful, I think will be extremely valuable because they may point out challenges or other things that just wouldn't necessarily be apparent to the more traditional stakeholders as part of that standard setting process. So, I think pharmacists are key to a lot of what we do and will continue to play a critical role moving forward.

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