Public Health Care Crisis: Drug ShortagesFeb 18, 2014
While hospitals and physicians do their best to workaround drug shortages, the fact remains they continue to be a major problem and continue to impact patient care on a daily basis. Dr. Tom Miller and Erin Fox, PharmD and Director of Drug Information Service for University of Utah Hospitals and Clinics, talk about the shortages, why they’re happening, and what can be done about them.
Tom Miller: Drug shortages affecting patient care. That doesn't seem to be changing. I'm Tom Miller and this is The Scope. We're going to talk about that next.
Man: Medical news and research from University of Utah physicians and specialists you can use for a happier and healthier life. You're listening to The Scope.
Tom Miller: Today I have Erin Fox here. Erin is the Director of Drug Information Services here at University of Utah. She's also a PhD pharmacist and, Erin, tell me what's going on. This is the United States. We're not supposed to have drug shortages for prescription medications, but I hear this has been getting worse in the last several years. What is going on with that?
Erin Fox: You're right. Unfortunately, we do have drug shortages here in the U.S. Mostly they're generic products and they're injectable products. So most of the time the shortages or impacting hospitals rather than your retail pharmacy.
Tom Miller: So this is really a problem for hospitals and particularly patients who are admitted and might need these medications. Is that right?
Erin Fox: That's right.
Tom Miller: How severe is this problem? Is this a major problem around the country, or is it local to the west or this state?
Erin Fox: That's a good question. This is a national problem. It is really what I would consider to be a public healthcare crisis. When we are short of the medicine that we need to treat our patients and we have to think of alternatives, most of the time we can think of a good alternative. You know that we can, but it takes a tremendous amount of work and effort to do that.
Tom Miller: Probably cost as well.
Erin Fox: Absolutely.
Tom Miller: Can you give me an example of one of those medications and how the absence of that medicine or the inability to get it might impact patient care?
Erin Fox: One of the most recent shortages that we've been watching nationally is the shortage of saline injection. Unfortunately, there basically on three companies that makes saline solutions. One company makes such a small amount that for all intents and purposes it's only two companies. Both of those companies make only just enough for hospitals to buy. They don't have any extra in their supply chain.
We had a shortage because one company needed to close for some routine maintenance. They decided to close even though they didn't have that additional cushion and we ended up with a national shortage.
Tom Miller: What's going on to try to remedy the situation? How can the government help us with this problem?
Erin Fox: We've seen some great action over the past few years. Before 2012 if a company had a shortage they didn't even have to tell the FDA that they were going to have a shortage. They didn't have to tell anybody. It would just a surprise and an emergency.
Now Congress passed a new law. It's called FDASIA law F-D-A-S-I-A law. One of the parts of that law was that the companies have to notify the FDA that they're going to have a shortage. What good is that? Does that help? It actually does because if the FDA has an idea ahead of time then the FDA can help to prevent that shortage from happening.
Tom Miller: How would it prevent the shortage from happening?
Erin Fox: If they knew early enough, they could ask another company to ramp up supply, they can approve a company that might be kind of in the wings waiting to get that product approved, and in some cases we can use imported product. They can allow that to come into the U.S. as long as it's safe.
Tom Miller: So I guess we don't allow too many medications to come into the United States from foreign manufacturers. Is that true?
Erin Fox: That's true.
Tom Miller: So they would have to make an exception for that if we had a shortage?
Erin Fox: That's exactly right.
Tom Miller: Would they apply the same rigorous standards for quality and safety of those medications?
Erin Fox: They do. So sometimes that is the limiting step. They have to make sure that they find an imported product that does meet all of our standards here in the U.S.
Tom Miller: I've heard some of the shortage is based on the fact that the companies just simply can't afford to manufacture the generic medication and then distribute it. Is that true?
Erin Fox: Generic medicines are cheap and it's difficult because the companies don't really talk a lot about the costs, but if you look at the shareholder statements, it does seem like these companies are turning a profit. One of the issues with these companies is they haven't updated their factories in sometimes 50 or 60 years and so the machinery is really falling apart and that's how we end up with products with glass shavings, metal shavings, bacterial contamination. All of those things you wouldn't want injected into your vein.
Tom Miller: So let's say the FDA comes through and they do an analysis of the medication and they find that there are impurities. They might shut down the factory. Is that right?
Erin Fox: The FDA actually can't shut down the factory but when they do that inspection they tell the company what they need to fix it and then the company makes the decision. Sometimes the FDA works really hard to get the factory to fix things while they're staying open. Other times the conditions are so egregious that they have to close.
Tom Miller: They have to stop manufacturing until they get that fixed.
Erin Fox: That's right.
Tom Miller: Well, then it sounds to me like the company might just say it's now worth it for us to retool or bring the factory equipment up-to-date.
Erin Fox: That's exactly what happened with one of the major suppliers of genetic medicines last year. It was Ben Venue Laboratories. They were one of the top four producers of generic products. They decided to close their factory. They had actually already spent $300 million to fix the problems at their factory and they said it was going to be too expensive to finish, and so they've shut down.
Tom Miller: You've mentioned that the FDA is allowing in certain cases when we have temporary shortages of medicines, that we could import those medications from other countries. Are we talking about maybe opening up the markets to foreign manufacturers for medications in the long haul?
Erin Fox: Potentially. In most of the cases of the imported products that are coming into the U.S., they're actually international companies that have a factory not only here in the U.S. but maybe one in Denmark or in the UK. These large companies have manufacturing all over the place.
Why would they have manufacturing in the U.S.? When you think about injectable drugs, they're sometimes larger, they're in glass vials, they're heavy to ship. So that's why a lot of the manufacturing has been in the U.S. We're not talking about outsourced factories that are in bad shape. We're talking about factories that are in bad shape here in our own country.
Tom Miller: What changes do you think will happen in the next five years aside from the law mentioned a minute ago to address the problem? How do you see things getting better ultimately?
Erin Fox: We've seen a trend of things getting better with the new law. That has resulted in a decrease in the number of new shortages that are happening, but we're not seeing the shortages that we have resolve because those factories aren't fixed yet. So we're kind of at a crossroads right now where the manufacturers need to really step up, make quality a priority, and if they are not willing to do that, if they're willing to just do the bare minimum to get by the FDA, then we are going to continue to have these cycles of shortages.
Tom Miller: This may be a difficult question, but are you aware of circumstances where patients were actually harmed by the absence of these medications?
Erin Fox: Absolutely. We know of at least 15 patients who have died in the U.S. because of drug shortages. We also have reports of patients with cancer that haven't died but their outcomes were less because they had to use an alternative chemotherapy that was not as effective.
Tom Miller: Any final word for our listeners in terms of a question they might ask if they come to the hospital, whether that hospital is facing shortages of necessary medications?
Erin Fox: I think patients and healthcare practitioners should know that there are armies of pharmacists all over the country working to make sure that patients are not impacted by these shortages. However, there are cases where a medicine just might not be available but those are pretty rare and we do everything we can to make sure that patients are not impacted.
Tom Miller: Does it bother you that only one or maybe two companies at most manufacture these medications? Shouldn't there be more manufacturing a generic medication?
Erin Fox: That is really one of the key reasons why we have shortages. Here in the U.S. we have a free market so if other manufacturers want to get into the game they certainly can, especially if these are genetic medicines, but for whatever reason they're not.
Tom Miller: Do you think the market for drug manufacturing, especially in generics is over regulated? Might that be one reason that they struggle to develop a new manufacturing basis?
Erin Fox: Well, on the one hand, it can be hard to comply with the FDA's rules, but the FDA rules for good manufacturing practices haven't changes for 40 years. So it's hard for me to swallow that the companies can't follow the rules when they're the same rules that have been around for 40 years.
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