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Q&A: Are Drug Shortages Multiplying?

If you’re a patient in the emergency room, or fighting a long battle with cancer, there’s a chance your doctors may not have access to the best drugs to treat you because of rising prescription drug shortages.

In his latest article, “Shortages of Key Drugs Endanger Patients,” Washington Post reporter Rob Stein detailed the frightening trend in Monday’s paper:

Doctors, hospitals and federal regulators are struggling to cope with an unprecedented surge in drug shortages in the United States that is endangering cancer patients, heart attack victims, accident survivors and a host of other ill people.

A record 211 medications became scarce in 2010 – triple the number in 2006 – and at least 89 new shortages have been recorded through the end of March, putting the nation on track for far more scarcities.

The paucities are forcing some medical centers to ration drugs – including one urgently needed by leukemia patients – postpone surgeries and other care, and scramble for substitutes, often resorting to alternatives that may be less effective, have more side effects and boost the risk for overdoses and other sometimes-fatal errors.

The NewsHour caught up with him this week to talk about what he found during his reporting. Answers have been edited for space and clarity.

NEWSHOUR: Why are we seeing these shortages?

Rob Stein, Reporter, Washington Post: It’s really a combination of factors that are all sort of coming together to cause these shortages. The main sort of driver is the consolidation in the pharmaceutical industry, and that’s resulted in a lot of companies dropping out of producing some of the older, less profitable drugs, so that we’re left with only one or two companies making a lot of these really important drugs. And so, when you have that situation, if just one or two companies experiences some sort of problem — they have an equipment breakdown, they have a problem getting some raw materials, it can very quickly produce a shortage.

NEWSHOUR: Have there been any notable trends?

Stein: Yes, it’s been getting much worse over the last few years. In fact, in 2010, the number of shortages was triple the number of shortages in 2006 in the United States. And so far this year, it’s going to be even worse. We’re on track to have perhaps double the number of shortages this year than we had last year.

NEWSHOUR: Are there specific classes of drugs, or specific manufacturers’ drugs that are affected? Is there an easy way to classify the 211 medications?

Stein: It’s really across the board. It’s affecting pretty much every class of drugs that are out there. There are some drugs that are being affected that are of more concern than other drugs because they’re so critical. That includes at least one cancer chemotherapy drug that’s been causing a lot of concern, it’s a drug called cytarabine that’s use to treat lymphoma and leukemia, and that’s been in very short supply. And that’s of concern, because it’s the kind of drug that’s needed once somebody’s diagnosed with leukemia, they need to be treated as soon as possible. And if they can’t get the drug, it can cause some real problems as you might imagine. But it’s not just in chemotherapy drugs. It’s affecting drugs that are used in emergency rooms, like norepinephrine, it’s affecting drugs that are used as sedatives, like morphine and propofol. It’s really just across the board.

NEWSHOUR: What are the alternatives? What are hospitals and doctors doing when they encounter one of these shortages?

Stein: They’re basically trying to patch together solutions whenever they can. And in most cases, they can. They can find alternative drugs they can use, or alternative sources for the drugs. But the problem is that creates a new set of problems, which is that doctors and nurses have to use drugs that may be either less effective, or have more side effects, or just not as familiar with, so they’re more prone to causing mistakes and errors that can be life threatening. In fact, there have been at least some reports of death that have occurred because of overdosing.

NEWSHOUR: Some shortages you write about are the form of the drug — for example, pre-filled syringes. Is that an easy fix?

Stein: Yeah, it would seem like it should be, but it’s actually not. That’s one class of drugs that is affected the most that is causing some of the biggest problems.
If you’re in the emergency room and an emergency patient comes in, and you’re a nurse or a doctor, and you’re used to just turning and grabbing a syringe and injecting a patient with a drug that you know you’re going to get exactly the right dose, and that’s not available. So instead you have to stop, you have to find the right syringe, you have to find the right drug, you have to make sure you fill it with the right amount. You can see how that can easily lead to mistakes and errors that could be life-threatening.

NEWSHOUR: Where are patients most likely to encounter these shortages?

Stein: It’s mostly in the hospital. These shortages have been reported across the country, in big city hospitals and more rural areas. It can be in the emergency room, it can be in the operating room, it could be in the intensive care unit — it could pop up anywhere.

NEWSHOUR: Who’s tracking this? How did we get ourselves in this situation?

Stein: The situation has slowly been getting worse and worse over the last few years with the changes in the pharmaceutical industry. The FDA is the regulatory body that’s mainly charged with trying to deal with it. And they have been working really hard to try to deal with it. In many cases, they have been able to alleviate some of these shortages or prevent some of these shortages by doing things like finding overseas companies to import the drug from, or helping companies that have been having problems get back on line more quickly. But there’s only so much they can do to try to keep up with this.

NEWSHOUR: What’s the timeframe for a solution?

Stein: There are things that people are trying to do to address this situation. There is some legislation that has been introduced in Congress that would help somewhat. It would do things like require companies to notify the FDA whenever something happens that could cause a shortage as soon as possible. It’s a very simple sounding thing, but it could have a big impact.

NEWSHOUR: In your article, Allen Vaida, the executive director of the Institute for Safe Medicine Practices, described this to you as a “national crisis.” After all your reporting on this issue, how serious do you think this shortage is?

Stein: There’s no question that it’s very serious. I talked to a lot folks in various positions of authority — from leading medical groups to government regulators to pharmaceutical representatives — and everybody agrees it is a big problem, a serious problem. And it is a problem that’s already directly affecting patients and is likely to affect more patients as time goes on.

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