Expert: USP Medicine Supply Map Can Help Pharmacists Assess the Risk in Their Medicine Supply Chains

Pharmacy Times interviewed Vimala Raghavendran, MBA, head of the Pharmaceutical Supply Chain Center at US Pharmacopeia (USP), on USP’s Medicine Supply Map and details regarding USP’s Medicine Supply Vulnerability Insights Series.

Alana Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy Times. Joining me is Vimala Raghavendran, MBA, who heads the Pharmaceutical Supply Chain Center at US Pharmacopeia, or USP. Vimala is here to discuss USP’s Medicine Supply Map and its recent findings on global pharmaceutical supply chain vulnerabilities.

This is the also the tenth discussion in the video series collaboration between Pharmacy Times and USP, in which we highlight USP’s work to support the pharmacist and discuss USP’s perspective on timely and topical issues in the field.

So, what is the USP medicine supply map, and why was it created?

Vimala Raghavendran: So, Alana thanks again for this opportunity. The USP medicine supply map—think of it as an information platform, but it's also a capability that USP is building, and our goal is to identify, characterize, and quantify risk in the upstream supply chain for pharmaceuticals.

So, we have information on where medicines are made, as well as where ingredients come from. We also have information that helps us predict the likelihood of shortage for specific drugs as well as what is driving that risk.

The reason we built this is, if you think back 2 years ago, almost exactly 2 years ago, when [the World Health Organization] declared COVID-19 to be a pandemic, there were a lot of questions about where our medicines are made. We realized [USP was] uniquely situated to answer that question.

Our standards are used in 22,000 locations around the world, so we have a dynamic view on the pharmaceutical supply chain, and we've been working on building this data set for internal purposes for several years. So, we were well positioned to pivot and look at this from a supply chain perspective, and so that's what we did.

Alana Hippensteele: Right, absolutely. What makes the USP medicine supply map the first of its kind?

Vimala Raghavendran: So, we have a view into the upstream supply chain for pharmaceuticals, that's unique. We cover 92% of generic pharmaceuticals. The reason we're able to do this in a way that's different than anybody else is our data on standards.

Standards, as I mentioned, are used in 22,000 locations around the world, and that gives us a dynamic view into the pharmaceutical supply chain. We also have on the ground intelligence from our offices in India, China, Europe, and the US. That allows us to contextualize the data based on insights we're getting from manufacturers and regulators in those countries.

Then finally, we have significant analytical chemistry expertise, and this is important, because to identify the risk at the [active pharmaceutical ingredient (API)] level, you need to know how APIs are made and our analytical chemists know that and understand that.

Alana Hippensteele: Absolutely. So how is data used in the USP medicine supply map, gathered, and analyzed for the purposes of that map?

Vimala Raghavendran: Yeah, so like I mentioned, central to the medicine supply map is USP’s data on standards usage. But additional to that, we've enriched and aggregated additional insights, and these come from over 40 different data sets from 5 different countries. We have information about where manufacturers are located for the finish dose as well as the active ingredient, and we also have information related to risk. So, for example, price and quality.

Alana Hippensteele: Right, and what is USP’s Medicine Supply Vulnerability Insights Series and what have its findings shown so far?

Vimala Raghavendran: So yeah, I'm excited to share that we're going to be starting to share insights from the Medicine Supply Map. So, previously the understanding of this upstream supply chain is poorly characterized. We know, for example, that low cost generic injectables go into shortage, but what we've done is we've identified various drivers of risk and we've quantified those.

So, we're starting to form a firmer picture of what the vulnerabilities are in the upstream supply chain So, we're going to start with releasing insights on where APIs are made. Again, there's some general information that, we're very reliant on China, for example. So, our data shows that. While it is true that China does contribute significantly to API manufacturing, India, by far is the country that we're most reliant on for API manufacturing.

Alana Hippensteele: Fascinating. Yeah. So, you've talked a bit about the series in relation to understanding API's. Specifically, how does USP’s Medicine Supply Vulnerability Insights Series help assess the global distribution of APIs in relation to risks associated with specific drug classes?

Vimala Raghavendran: So yeah, we will look at the global distribution of API manufacturing at a class level, and we'll look at broadly used classes like antimicrobials or statins. We'll also look at classes that are more niche like pediatric oncology. What we've done is we've mapped where the API manufacturing for the US is, and so we'll share how that distribution breaks down by class.

Alana Hippensteele: Right? How might insights from the Medicine Supply Map also help with decision making?

Vimala Raghavendran: Yeah, great question. So, I know your audience is pharmacists. So, say you're a pharmacist that's responsible for managing inventory at your organization, or you must deal with the repercussions of drug shortages, this information can be useful to you.

So, for example, you learn that—this happened with the losartan impurities—you identify that a particular drug has an impurity issue that originates at the API level, you need to know what other brands or NDCs are using that API manufacturer. So that's one way that the medicine supply map can be helpful.

The other thing that we're really excited about sharing with pharmacists is a shortage prediction model. So, what we've done is we've identified the long-term structural risks associated with the supply chains of specific drug products.

So, this isn't going to tell you what drug is going into shortage and might need to be stocked up. Instead, what the tool does is it identifies not just the drugs that are most vulnerable to short it, but it also tells you what is driving that vulnerability and it quantifies it.

So, for example, maybe the drug is only made in one country or a couple of countries, maybe the problem is that the facilities that manufacture the drug never had a lot of quality issues, it could be that the price is too low.

So, identifying what is driving the vulnerability of a specific drug will then allow you to shore up the resilience of that supply chain by acting. So, for example, maybe finding an alternate supplier or creating a predictable market or maybe even raising price, and the solution will depend on the drug. So, that's what our information will help with, it will tell you what the diagnosis is so you can find a cure.

Alana Hippensteele: Right. Do you think insight gleaned from the medicine supply map would be valuable to consider and apply in legislation?

Vimala Raghavendran: Yeah, absolutely. So, the US government has invested and is continuing to invest significantly in pandemic preparedness, and part of that is shoring up the supply chains of pharmaceuticals.

It's important to have data to help inform that decision making and then at the back and say, ‘Have we got a return on the investments we've made?’ And we think the Medicine Supply Map can help do that by identifying what medicines are most at risk by identifying what solutions are there, because every medicine has a different source of vulnerability. So, what do you do?

So, for example, for a medicine where the vulnerability is mostly driven by price, the solution may not be to onshore the production of a medicine it may be a different solution. So, knowing what's driving weakness in a supply chain is important, and we think that the medicine supply map can be a useful tool to the US government as it helps shore up America’s supply chain.

Alana Hippensteele: How can pharmacists who are interested, learn more, or get involved?

Vimala Raghavendran: If you're a pharmacist and you think the medicine supply map might be a useful tool for you, please get in touch with us. We're at a stage where we're looking for feedback on the specific unmet needs that you may have and how the medicine supply map might be able to help.

So, the best way to get in touch of course is our website. But also, email us at medicinesupplymap@usp.org. That's all one word. So, it’s medicinesupplymap@usp.org.