The fentanyl shortage: yet another example of our vulnerable drug supply system

When most people go into the hospital it does not occur to them that, here in America, an acute scarcity of a standard medication will affect their health. But they would be wrong. Sudden, random, and dangerous shortages of key, life-saving medicines are happening increasingly frequently. For example, there is this recent shortage of chemotherapeutic drugs to treat cancer. We have also had recent shortages of such commonly used PICU drugs as phenobarbital and propofol. The latest shortage is with fentanyl, a synthetic narcotic pain-killer. I really need fentanyl in my practice to relieve pain and sedate children. There are other narcotics we can use, but none have the special attributes of fentanyl that make it, in experienced hands of course, a safe and key PICU medication.

Why do we have these drug shortages? Where do they come from? All of these drugs share the attribute of being generic medications. This means the patent has expired on them and any pharmaceutical company can choose to make and sell them. They can, but they won’t make much money doing so, because generic drugs are much, much cheaper than are ones still under patent. Injectable drugs, the drugs I and my ICU colleagues use every day, are especially expensive to make because they must be sterile. The result is that, for the majority of injectable generic drugs, there may only be a single company with a single factory even making it. If there is a problem at the factory, everything stops. And these are not esoteric drugs; they are ones hospital physicians rely on every day. People die when we don’t have them. The upshot is that our care of critically ill patients depends upon whether or not the roof of a factory somewhere leaks or not.

I don’t know what the answer to this problem is, but it is a serious danger. There are so-called “orphan drug” incentives to encourage drug companies to make rarely needed drugs that are essential for people with rare disorders. Since there is only a tiny market for such drugs, companies otherwise wouldn’t make them. To safeguard our nation’s injectable drug supply, I think we should figure out some sort of similar system for injectable generic drugs. The problem is getting worse, not better.

Update: President Obama, through the FDA, has taken steps to help the situation, offering incentives for companies to make injectable generic medications. You can read details here.

Another update: This editorial in the New England Journal of Medicine makes it clear: shortages of all manner of generic injectable drugs are popping up. These these shortages will cause people to die, if they haven’t already. For those lovers of the free market as the best way to practice medicine in America, this example shows how mistaken that viewpoint is.