COMMENTARY

Drug Shortages: A Situation Going to the Dogs

Bruce D. Cheson, MD

Disclosures

March 15, 2012

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Hello again. Welcome to Medscape Hematology. I'm Bruce Cheson from Georgetown University Hospital, the Lombardi Comprehensive Cancer Center. This is one of the months of the year when I am on the inpatient service, which is every February, for a variety of reasons. The obvious one is that it is the shortest month. Second, not much is going on in the way of travel. For more than a decade, I have always done this in February and I always have a new revelation. This year's experience has really brought home the drug supply problem.

Drug shortage is a major issue, and more than 100 drugs are in short supply or are unavailable. Fortunately, we have been able to get around the deficit because we have them in stock or we have ways of getting them, but in most of the outside world, this creates some very difficult situations. You ask yourself why we can't get methotrexate for people with leukemia and why we can't get Doxil® for people with Kaposi sarcoma. There are a lot of reasons and many of you are familiar with them. Some companies just don't make them anymore. They are not profitable. A lot of these drugs are old drugs. They are effective drugs and have become part of our standard armamentarium, but they are old. You can't make a buck on them. Some of the companies have disappeared or have had issues with manufacturing. Occasionally, you find out that a company blew up, a plant blew up, or something blew up and they can't make a drug for 6 months, a year, or longer. That has always been a problem; we saw that happen with DTIC-Dome®.

There are issues with US Food and Drug Administration (FDA) compliance, manufacturing issues, production issues, shipping issues, and issues with quality control. Quality control is becoming tighter. There are regulatory issues and free marketing limitations. Drug reimbursements are average sales price plus 6%, so the amount of money you can make from a drug cannot be increased. Companies are saying, "I don't want to do this anymore with that particular drug."

We can consider offering incentives to manufacturers. You can try to increase reimbursement and work on that. Some not-for-profit organizations have formed in an attempt to put pressure on Congress and on companies, and to also make it easier to import those drugs that we no longer make in this country. Maybe we can decrease some of these regulatory problems and encumbrances that we face.

Being a hematologic oncologist, we see diseases like acute leukemia. They tell us that we can't have the drugs for 7 plus 3 chemotherapy for acute leukemia. That is a big issue. In our clinical trials, what are we going to do if we can't get Velban® for ABVD? What are we going to do if we can't get vincristine for another regimen? It really challenges our ability to conduct clinical research. If you suddenly have to switch to an inferior drug in a regimen, what does that do to the data in that study?

Personally, it really struck home. The other day, I found out that there is no longer a supply of interceptor flavor tabs. It has gone that far. The heartworm medicine that Annie, my golden retriever, needs to take on a monthly basis is no longer available. What happened? Why is this relevant to our discussion? I couldn't find the tabs on one Website so I went to another Website, but I couldn't find them there either. I went back to the first one and called their number to ask what is going on. Why can't I get interceptor flavor tabs for the golden retriever? The answer was that these are made in the same plant as drugs from a major pharmaceutical company -- one of the biggest ones in the world -- and some FDA inspections are being anticipated. The company has to shift all their attention and resources to the human side of things, ignoring poor Annie and her colleagues who need their interceptor flavor tabs. What do you think of that?

The drug shortage problem is not only a human problem but a canine problem as well. It should not be ignored in either of these realms. Obama said he was going to put pressure on the appropriate people to hopefully move this forward and solve the problem. Hopefully that will happen, because if things get much worse, patient care and patient survival will be jeopardized. This is Bruce Cheson, signing off for Medscape Hematology. I hope the next time I talk to you, we will have a resource for these unavailable drugs and the problem will be solved. Take care and good day.

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