Pharmacy hours interviewed Vimala Raghavendran, MBA, Manager of the United States Pharmacopeia (USP) Pharmaceutical Supply Chain Center, on the USP Drug Supply Map and details regarding the Vulnerability Information Series USP drug supply.
Alana Hippensteele: Hi, I’m Alana Hippensteele with Pharmacy hours. With me is Vimala Raghavendran, MBA, who directs the Pharmaceutical Supply Chain Center at the US Pharmacopeia, or USP. Vimala is here to discuss the USP Drug Supply Map and her recent findings on vulnerabilities in the global pharmaceutical supply chain.
This is 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 current and topical issues in the field.
So what is the USP Drug Supply Card and why was it created?
Vimala Raghavendran: So, Alana thank you again for this opportunity. The USP Drug Supply Map: Think of it as an information platform, but it’s also a capability that USP is developing, and our goal is to identify, characterize and quantify risks in the upstream supply chain of pharmaceutical products.
Thus, we have information about where the drugs are made, as well as where the ingredients come from. We also have information that helps us predict the likelihood of a shortage of specific drugs and the causes of this risk.
The reason we built this is, if you think back to 2 years ago, almost exactly 2 years ago, when [the World Health Organization] declared COVID-19 a pandemic, there were many questions about where our medicines are made. We realised [USP was] ideally placed to answer this question.
Our standards are used in 22,000 locations around the world, so we have a dynamic view of the pharmaceutical supply chain, and have been working for several years to build this data set for internal purposes. So we were in a good position to pivot and look at that from a supply chain perspective, and so that’s what we did.
Alana Hippensteele: Right, absolutely. What makes the USP Drug Supply Card the first of its kind?
Vimala Raghavendran: So we have a view of the upstream supply chain of pharmaceuticals, it’s unique. We cover 92% of generic drugs. The reason we are able to do this in a different way than anyone else is our standards data.
The standards, as I mentioned, are used in 22,000 locations around the world, giving us a dynamic view of the pharmaceutical supply chain. We also have on-the-ground intelligence from our offices in India, China, Europe and the United States. This allows us to contextualize the data based on the information we get from manufacturers and regulators in those countries.
Finally, we have significant expertise in analytical chemistry, and this is important, because to identify the risk at [active pharmaceutical ingredient (API)] level, you need to know how APIs are made and our analytical chemists know and understand that.
Alana Hippensteele: Absoutely. So how is the data used in the USP drug supply map, collated and analyzed for the purpose of this map?
Vimala Raghavendran: Yeah, so as I mentioned, at the center of the drug supply map is USP data on standards utilization. But on top of that, we have enriched and aggregated additional information, and this comes from over 40 different datasets from 5 different countries. We have information on where the manufacturers are for the final dose as well as the active ingredient, and we also have risk information. So, for example, price and quality.
Alana Hippensteele: Okay, so what is the USP Drug Supply Vulnerability Insight Series and what have its findings shown so far?
Vimala Raghavendran: So yeah, I’m excited to share that we’re going to start sharing the drug supply map information. Thus, until now, the understanding of this upstream supply chain is poorly characterized. We know, for example, that low-cost generic injectables are in short supply, but what we have done is we have identified various risk factors and quantified them.
So we’re starting to get a clearer picture of upstream supply chain vulnerabilities. So we’ll start by posting information about where the APIs are made. Again, there is general information that we are very dependent on China, for example. So our data shows that. While it is true that China contributes significantly to API manufacturing, India is by far the country we depend on the most for API manufacturing.
Alana Hippensteele: Fascinating. Yeah. So you talked a bit about the series in relation to understanding APIs. Specifically, how does the USP Drug Supply Vulnerability Information Series help assess the global distribution of APIs against the risks associated with specific drug classes?
Vimala Raghavendran: So yes, we will be looking at the global distribution of API manufacturing at the class level, and we will be looking at widely used classes like antimicrobials or statins. We will also look at more specialist courses like pediatric oncology. What we’ve done is we’ve mapped out where API manufacturing is for the US, and so we’ll share the breakdown of that distribution by class.
Alana Hippensteele: Law? How can information from the drug supply map also help in decision-making?
Vimala Raghavendran: Yes, excellent question. So I know your audience is pharmacists. So, let’s say you’re a pharmacist responsible for managing your organization’s inventory, or dealing with the repercussions of drug shortages, this information may be useful to you.
So for example you learn that – this happened with losartan impurities – you identify that a particular drug has an impurity issue that comes from the API level, you need to know what other brands or NDCs use this API maker. So that’s one of the ways the drug supply map can be useful.
The other thing we’re really excited to share with pharmacists is a shortage forecasting model. So what we’ve done is we’ve identified the long-term structural risks associated with specific drug supply chains.
So it won’t tell you which medicine is in short supply and might need stockpiling. Instead, what the tool does is it not only identifies which drugs are most vulnerable to shorting, but it also tells you what is causing that vulnerability and it quantifies it. .
So, for example, maybe the drug is only made in one country or a few countries, maybe the problem is that the facilities that make the drug have never had a lot of quality issues, it the price may be too low.
So identifying what is causing the vulnerability of a specific medicine will then allow you to build resilience in that supply chain by taking action. So, for example, find another supplier or create a predictable market or maybe even increase the price, and the solution will depend on the drug. So that’s what our information will help you with, it will tell you what the diagnosis is so you can find a cure.
Alana Hippensteele: Law. Do you think the information from the drug supply map would be useful to consider and apply in legislation?
Vimala Raghavendran: Yeah, absolutely. So the U.S. government has invested and continues to invest significantly in pandemic preparedness, and part of that is strengthening pharmaceutical supply chains.
It’s important to have data to help inform that decision-making, and then to back it up and say, “Do we get a return on the investments we have made? And we think the drug supply map can help do that by identifying which drugs are most at risk by identifying the solutions that exist, because each drug has a different source of vulnerability. So what are you doing?
So, for example, for a drug where the vulnerability is mainly due to price, the solution may not be to outsource the production of a drug, it may be a different solution. It is therefore important to know what is causing a weak supply chain, and we believe that the drug supply map can be a useful tool for the US government because it helps to strengthen the American supply chain.
Alana Hippensteele: How can interested pharmacists learn more or get involved?
Vimala Raghavendran: If you are a pharmacist and you think the drug supply card could be a useful tool for you, please contact us. We are at a stage where we are seeking feedback on any specific unmet needs you may have and how the drug supply map could help you.