Monday, February 17, 2014

What’s behind the nation’s prescription drug shortage?


HARI SREENIVASAN: Earlier this week, the Government Accountability Office issued a report detailing serious and growing drug shortages in the United States.
Sabrina Tavernise covered the story for the New York Times and joins us now from Washington.
So first of all, how big of a problem is it? How widespread are these shortages?
SABRINA TAVERNISE:  So it’s actually a fairly serious problem. The number of shortages since 2010 or rather 2007 – have tripled. This is anything from cancer drugs to drugs like nitroglycerine that are used in heart surgeries. It’s a very, very wide range of drugs and has presented problems for hospitals around the country.
HARI SREENIVASAN: So how did we get here? Is there any cause for the shortages?
SABRINA TAVERNISE: So, it might seem kind of strange but often there is a sort of a mystery when drugs go into shortage as to why. You would think there’d be a straight plain, simple answer but in many cases there are not. The producers themselves are a bit secretive. They say it’s a trade secret to tell the world exactly what’s happening to cause the shortage so they don’t need to detail the reason. Oftentimes however, it’s that there are very few producers of sterile injectable drugs — those are the drugs that are most often in shortage in the United States — say two, three, four producers only. And many of the production lines that they have are quite old. So kind of like and old car needs a lot of repairs – more focus and attention. The same thing goes with these plants. And when something goes wrong the FDA steps in and says “well, we can’t produce on this line if there’s contamination in the drug.” So what happens is the line is shut down and sometimes even an entire factory and a drug goes into shortage because the few number of other producers aren’t in a position to ramp up production quickly enough to keep up.
HARI SREENIVASAN: Are there economic factors that contribute to this?
SABRINA TAVERNISE: Yes, very interestingly there were economic factors. So sterile injectable drugs and generic drugs are generally very, very low-margin drugs – so a very, very small profit margin. So sometimes what happens is a line goes down, something breaks down and a company, a producer looks at the margins and the economics and says ‘well, you know it’s not really worth the margins we’re getting on this drug in continuing the line – in putting the money in to fix it. So they let the drug go into shortage. And even if people need it – say its nitroglycerine which is critical in heart surgery – they just don’t produce it. And, at the end of the day the FDA can encourage producers to keep going but doesn’t’ really have the power to force them to do that.
HARI SREENIVASAN: So what are the recommendations by the GAO of what the FDA should be doing?
SABRINA TAVERNISE: What the GAO said essentially is that the FDA needed to be more nimble in how it’s predicting these shortages. It has now an enormous database of numbers that tell it what’s in shortage and how long it’s been in shortage. So there’s a fair amount of data, but the GAO said the FDA wasn’t using that data to look at overall patterns in the country – to look at kind of how these things tended to shake out and then try to predict when these shortages occur. So, that’s what the GAO told the FDA they need to get better at.
HARI SREENIVASAN: Sabrina Tavernise from the New York Times thanks so much.

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