Advancing Drug Standards and Pharmacogenomics: USP’s Mission and Future in Personalized Medicine at STRIPE 2024

Pharmacy Times® interviewed Blaine Groat, PharmD, a senior scientist, personalized medicine at US Pharmacopeia (USP), on his presentation at the Standardizing Laboratory Practices in Pharmacogenomics (STRIPE) Annual Meeting and Consensus Workshop at USP headquarters in Rockville, Maryland. Groat’s presentation described the evolution of drug standards in the US since 1820, when 11 physicians developed a standard recipe book for apothecaries, establishing consistent medication quality. Today, USP continues this mission with enhanced compounding standards, including tests for quality, sterility, and appearance to ensure stability.

Groat highlighted USP’s interest in pharmacogenomics as identified in a 2018-2019 survey of health care practitioners. Recognizing the growing importance of personalized medicine, USP has undertaken research to explore standards in pharmacogenomics, including nomenclature, labeling, and health care IT. This could involve creating a personalized medicine expert committee and possibly exploring standards for laboratory diagnostics to support consistent quality across stakeholders.

Groat also noted overlaps between drug compounding and pharmacogenomics in oncology, where customized compounds and infusions are tailored for patients with cancer. He emphasized that pharmacogenomics can reduce adverse events and enhance therapeutic efficacy, though he acknowledged that opinions vary on implementation challenges.

Finally, Groat encouraged interested individuals with expertise in pharmacogenomics, digital therapeutics, or related fields to apply for USP’s upcoming personalized medicine expert committee, which will start in 2025. This committee will explore standards in these areas, offering stakeholders an opportunity to contribute to advancing personalized medicine. Applications for chair positions are open until December 2024, and for committee members until March 2025.

Pharmacy Times: Could you share an overview of your STRIPE presentation?

Blaine Groat, PharmD: So, as I mentioned, in 1820, 11 physicians got together in the United States Capitol building and came together to develop a set of standards for how to create medicines that they knew would have a certain level of quality. At that point in time, it was a set of what we call now monographs but was similar to a recipe book—this is how you make this medicine. And that ensured that apothecaries and physicians across the very young US at the time were using the same recipe, giving the same medicines to patients. We've developed a lot since then. I will say, I'm very fortunate to have been able to work with the compounding expert committee during my time at USP. I work with our monograph development subcommittee, which takes compounding monographs and publishes them, similar to what they were doing over 200 years ago. We use a little bit more data nowadays; obviously, labs have developed a lot more with technology and our expectation for quality has changed a lot since then, too. Nowadays, when it comes to a compounded preparation monograph, we have the ingredients, we have instructions for how to make it, but in addition to that, we'll include things like an assay. So, if you wanted to, you know, go to a lab and confirm that you have this quantity of medicine in your compounded preparation, you could do it using this assay. We also have specific tests so that you can test things like antimicrobial effectiveness, sterility, the appearance—which sounds sort of silly to us, but one of the things I teach pharmacy students is don't discount the importance of the appearance of a compounded preparation, because it can tell you a lot about the stability of that product. As things change color, you can estimate how much of the active pharmaceutical ingredient has degraded.

Pharmacy Times: What are US Pharmacopeia’s interests and long-term goals regarding pharmacogenomics and standards-setting?

Groat: So, before I started at USP, I think it was 2018 or 2019, USP conducted a survey of health care practitioners to ask them where they thought there was a need for USP standards. One of the key topics they identified was personalized medicine, and as part of that pharmacogenomics. I was hired in 2021 to begin conducting comprehensive research to see what the landscape of pharmacogenomics looks like. Where are these opportunities for USP to develop standards? Novel standards, yes, but also, is there any low-hanging fruit, things that we're already doing that we could adopt for pharmacogenomics, things like nomenclature and labeling, things like health care information technology, these are all things we're already doing in HQS, why not establish a personalized medicines expert committee, bring in pharmacogenomics experts, and create a pharmacogenomics standard that has to do with those very topics. We're also aware that USP is going to have to decide on whether we pursue newer types of standards, things like laboratory diagnostic tests. To my knowledge, I don't know if we're in that field just yet. I know we do a lot of laboratory standards, but that's something, there’s a great need in pharmacogenomics for USP to be involved, because there's a lot of key stakeholder leaders providing great quality evidence. But sometimes they need a way to amplify that message, to reach more stakeholders, to bring regulators and industry and health care practitioners and patient advocates together in one room to say, this is the minimum level of quality that we should expect, this is the standard.

Pharmacy Times: Is there any overlap between drug compounding in pharmacy and pharmacogenomics?

Groat: Well, certainly, it was mentioned today, oncology has a lot of pharmacogenomics, somatic and germline. There's a lot of compounding that goes on for oncology—preparing infusions, putting together other products for cancer patients. So, it's important to not rule out compounding when it comes to that.

Pharmacy Times: Are there key takeaways from the presentations at STRIPE that would be valuable for pharmacists?

Groat: Yeah. So, when it comes to pharmacogenomics, people's opinions differ. Some people are all in, like “this is how we address a lot of adverse events in our patients, how we optimize therapeutics to make sure we're getting the most efficacy possible.” Then you have some that are doubters, like “there's not enough clinical evidence. This is too expensive. How would we adopt something like this in our program?” If we learned anything today and yesterday, it's that there are already several organizations putting in a lot of really, really good groundwork at developing the evidence, setting standards, reaching out to various stakeholders on pharmacogenomics, showing us—the audience—that it is possible and it is cost effective, and it is fairly simple to implement in different types of health care systems.

Pharmacy Times: Is there anything else you would like to add?

Groat: One of the encouragements I have for the audience is to consider applying to the personalized medicine expert committee that will be starting in USP’s next 5-ear cycle. 2025, we’ll be starting in the fall of that year. Applications are open for chairs until December, for members, all the way to March. Some of the key topics that we'll be talking about standards for in the personalized medicine expert committee include pharmacogenomics, like we've been discussing at the STRIPE conference, but also digital therapeutics, that's another major topic that we've been talking about, software that can be used to treat, diagnose, monitor diseases. We think about them just being apps, but a lot of these have a lot of clinical evidence to back them. So, anyone who has expertise in these areas, I'm talking to various stakeholders from industry, patient advocacy, regulators, health care practitioners who want to be involved in USP’s volunteer expert process, I recommend that you apply. I believe the website is callforcandidates.usp.org.