Pharmalot: What is the chapter supposed to accomplish? Hunt: This guidance document will codify what are some of the best industry practices that can be transmitted to members throughout the supply chain (read more here). The issue most people think about is honing in on manufacturers, but as we know, depending on the size of manufacturer and their resources, the supply chain strategy can be vast and multi-faceted. We need to focus on other members. For instance, the counterfeit Avastin involved clinics. Do they have enough knowledge to know how to qualify a supplier?
Pharmalot: So how are you going to reach those other entities? Hunt: We have a list of suppliers we’ll send it to… The workshop will review the chapter to decide what else needs to be done to reach everyone. I think at the end of the day, we’ll get a wide breath of feedback from all members of the supply chain. This is the first proposal of the chapter we’re putting out. I’m almost 100 percent certain, though, that what you see today will change.
Pharmalot: How would you characterize the supply chain problem? It’s not just counterfeit, of course. Look at what happened with Ranbaxy (the FDA issued an import alert for two plants in India in 2008 and, more recently, a consent decree was signed over all sorts of manufacturing problems - see this). Hunt: People need to know more than just their supplier. The larger companies do a good job of auditing their supply chain members. Some of the smaller players may not do so as much. When you start talking about smaller players, how far are they going to go to qualify them? It comes down to resources.
But how do you transmit these common themes in the supply chain? A logistical provider may not even think they’re part of the supply chain, so how do you ensure they’re storing product properly? You could have a counterfeit product inserted into the chain or one that is also stored improperly, but in each case you have a substandard product.
So this is about risk management – do you know your supply chain? How do you identify risks and once you do, how do you mitigate them? Are you qualifying supply chain partners? Reviewing forms or actually visiting facilities?
We talk about quality – how do you measure quality within your organization? Do you have a system in place? Theft and diversion is also a big topic. What are they doing to reduce that? Do they have safety mechanisms in place? Are they using tracking systems? How can they recover stolen trucks? These are issues the large manufacturers are grappling with as well… These are questions that need to be asked.
Pharmalot: So is this like plugging the flood wall with your finger? Hunt: Look at the length of the supply chain. There are many steps. The longer it gets, the greater the opportunity for things to happen and there are people out there looking to take advantage of that. The US supply chain is the safest in the world. But it’s always going to be a problem when there’s money to be made by counterfeiters. But we’re at a point where we can grasp the enormity of the issue. I do think it is worse 10 to 15 years ago.
Pharmalot: But what you’re proposing are just suggestions. You can’t make them do anything. Hunt: At the end of the day, it’s up to the manufacturer to know its product is up to standard… At some point, they have to test materials when they come in the door… I do think companies are doing more due diligence than they have in the past…. But how far back should you go? How much risk-based assessment do you do? Is there a new supplier you should qualify? Do you want to go back further? ..No, it won’t be mandated… It’s up to the expert committee and panel to say what companies ought be thinking about.
Pharmalot: To what extent does all this bump up against cost considerations? Hunt: I’ll be honest with you, cost hasn’t come up… The big companies are already auditing and trying to use different technologies… We think, though, that having a document that outlines best practices adds value to the big manufacturers so they can determine the best direction in the future…
Pharmalot: What about other perspectives? Hunt: Well, we currently have quite a few participants from industry, large companies… After the workshop, hope to bring in people from other places –pharmacists, raw materials suppliers, wholesalers. But you know, cost is an issue for a lot of people, not just large drugmakers. Pharmacies, for instance, may have a financial burden for scanning product. There’s a cost associated with having the technology to do that. Or for a logistics provider for scanning truckloads, too. Smaller players may not have thought about how this will impact them in the long run….
Pharmalot: You mentioned Avastin and clinics. How do you grapple with that piece of the puzzle? Some of these practices apparently were either fooled or looked the other way. In any event, it seems like they’re a very weak link in the chain (read more here). Hunt: The clinic needs to know who they’re getting product from… It’s totally different than a hospital. They may be looking for a best price or just finding a shortage and buying what they can. That’s the hard question… If there was an association, we could reach out to them. But if there’s no association, I’m not sure exactly how that’s going to be done.
But if we can move to a global system and require people to scan product to come in for authenticity, you can actually fill those gaps.. Until then, there are opportunities for problems. You know, we went from 197 wholesales in 2000 to where, today, just three sell 95 percent of the medications. That’s a major reason why the US drug supply chain is much better than many other countries. But how do you get rid of gray market wholesales? There’s no way we can address those issues in the compendia standard…. But I do think information changes your mindset….