BACKGROUND:  Drug shortages have been an ongoing problem that has spiraled in the last few years with number of drug shortages increasing almost 300% since 2005. 80% of the drugs currently in short supply are generic injectable medications and many patients have been unable to receive their usual drugs. This has been especially hard for those people with cancer because some of the drugs affected were chemotherapy treatments such as Doxil and others used to treat cancer. Both patients and health care providers are in a difficult situation of having to find alternatives for drugs that just are not available at the moment.

MAIN PROBLEMS:  The main problems to be affecting the drug shortage seem to be on the manufacturing side which can be difficult because of regulations on how drugs are made, especially for injectable medications. Some manufacturing plants have even been shut down because of multiple problems in the manufacturing process discovered by the FDA. In the case of Ben Venue Laboratories, inspectors found various problems from metal shards in some of the drugs produced on site to a 10-gallon can filled with urine in the storage room. Due to these issues the lab was shut down in November 2011, and Ben Venue was one of the largest drug manufacturing companies in the United States. However, that is an extreme case and many times the difficulties in the manufacturing process are due to how stringent the requirements for making these drugs are.

WHO’S TO BLAME?:  Some have put the blame on the Food and Drug Administration (FDA) for the drug shortages because some believe FDA regulations on manufacturing companies in the United States have made it harder and a longer process for the companies to produce the drugs. When discussing the drug shortage, the House Oversight Committee also said that the FDA is partly to blame for the current situation as their regulatory activities have shut down 30% of total manufacturing power at four of the U.S.’s largest producers of generic injectables. However, others claim the FDA is part of the solution, not the problem and that the responsibility for the drug shortages cannot be placed on any one person or organization.

Drug shortages occur, manufacturers report (according to the Food and Drug Administration's website), because of unanticipated increase in demand or due to shortages of raw materials. Also, some companies have experienced quality control and other manufacturing problems that take time to correct. Others have made business decisions to stop making older, less profitable drugs.An article in the New England Journal of Medicine laid much of the blame for cancer drug shortages on the way oncologists in private practice operate. (Source:, The Huff Post)

ASPE ISSUE BRIEF-Economic Analysis of the Causes of Drug Shortages:

Gene Rhea, PharmDManager of Procurement for Packaging and Distribution at Dukes Hospital, talks about the drug shortages and what that means for patients as well as medical professionals.

Tell me when you started noticing things were getting bad with drug shortages.

Dr. Rhea: I started noticing shortages get worse probably between two and three years ago. We really saw a spike within the last twelve to eighteen months and statistics have backed that up from both the FDA and the American Society of Health System Pharmacists that do a really good job of tracking this. They’ve got a lot of information showing that the spike really hit within the last two or three years.

What is it that we had ample of before but that it’s starting to not be there?

Dr. Rhea: We just saw a lot of products. Mostly they’re generic sterile injectable products, products that have been on the market for a number of years. For whatever reason, either through consolidations or dropping out of the market of various manufacturers, they weren’t able to come by the products nearly as easily as we were able to in the past. They just weren’t available for sometimes long periods of time like multiple months.

Can you go in to what some of those drugs would be that you would use generic sterile injectables for?

Dr. Rhea:  Sure. Generic injectable is essentially a product that’s been on the market for a number of years, it’s lost its patentprotection, and it’s traditionally able to be made by multiple different companies. Generic injectable products are things that are very difficult to make. They are very intricate and very time consuming, and typically if one thing goes wrong in the manufacturing process, it’s very difficult to overcome and there’s no quick and easy fix to make sure the product is available.

So we’re talking cancer drugs and things of that kind?

Dr. Rhea:  Absolutely, these are drugs used in cancer, anesthesia, pain medicine, things very simple like nutritional additives like potassium and magnesium, and things that we need to maintain our diet and our blood levels of these critical nutrients.

How has that impacted you and your ability to care for patients?

Dr. Rhea:  For me, I probably spend more than fifty percent of my time managing drug shortages: making sure that we have the products that we need and trying to figure out what is more difficult to get a hold of. On a daily basis we probably only get in about sixty or seventy percent of the products that we order, so we have to somehow fill that gap and that’s most of the way I spend my time.

Is that the way you spent your time before or is it something you’ve experienced in the last two to three years?

Dr. Rhea: It’s really something we’ve focused more time on in the last two or three years. It’s always been a problem but it certainly has spiked significantly compared to where we were five or ten years ago.

What does that mean for the patients if you’re only getting fifty to seventy percent of what you’re ordering? Then do they have no way for treatment? Do you have to find a new drug for them?

Dr. Rhea: Generally we try to do our best across the country to make sure this doesn’t impact patients. There have been a couple different instances where patients just could not receive the agent that was the most preferable product for them. We’ve had to go to the next best product and that’s definitely not a situation that we like, but unfortunately we’ve see that happen on a number of occasions.

How frustrating is it for you to deal with this? I believe it really peaked last year?

Dr. Rhea: I think for healthcare practitioners across the country it’s been incredibly frustrating. It’s a situation that we at first were appalled by, and now I believe we’re just kind of getting used to it; it’s kind of the new norm.  We saw the situation peak and certainly the FDA has stepped in and done a lot to help with the situation, but it’s not going away. It’s really kind of reached a steady state and it’s something that we’ve learned to deal with in our everyday life.

What kind of role does the FDA play in this new norm and hope maybe it’s not the new norm?

Dr. Rhea: I think they’ve done a great job of helping to stem a lot of drug shortages. They posted that last year in 2011 they were able to eliminate or prevent two hundred shortages from coming to the market. So far through the first half of 2012 they’ve been able to prevent 100 drugs shortages from coming the market. So they’ve got a team of people that are really helping to mitigate some of these issues and a lot of the issues that we see are due to issues with the manufacturing process, which is a very complex and rule driven area. Their job is to make sure that the public safety of the nation is protected, but at the same time not put up barriers so these manufacturers can bring their products to market again.

What are some of those quality issues that we’re seeing on some of the problems on the manufacturing side of things that will halt drugs from being produced?