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Drug Shortage Dilemma: The Problem

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WASHINGTON (Ivanhoe Newswire) - In the 80s, the war on drugs focused on ridding the U.S. of  illegal narcotics like crack, cocaine, and heroin. In 2012, we're in the midst of a different kind of drug war, fighting to get the ones many people need. Now, experts on the front lines of the ongoing struggle with prescription drug shortages.

Metal shards, glass shards and fungus growing in IV bags.

"I think the public has a right to be dismayed and outraged," RADM Sandra Kweder, M.D., deputy director of CDRR's FDA' s office of new drugs, told Ivanhoe.

Doctor Kweder heads the FDA's office of new drugs. She says quality control in manufacturing plants is causing nationwide recalls and massive drug shortages. A lack of raw materials, closures and consolidations among drug-makers and low profit margins on certain drugs have also added to the problem. According to the American Society of Healthcare System-Pharmacists we've seen shortages just about quadruple from 74 in 2005 to 267 in 201.

"We are in the midst of what we see as a crisis," Dr. Kweder said.

Pharmacists and the FDA have websites to help healthcare professionals monitor the situation. Almost every day, more drugs show up in short supply. The problem's hit every drug class, but the majority are generic sterile injectables. Medications used in everything from giving sick babies the nutrition they  need to surgical anesthesia to cancer treatments. A government report finds while the injectables make up only a small percentage of the overall prescription drug market in 2011 they accounted for 74 percent of drug shortages.

"We really saw it spike in the last 12-18 months," Gene Rhea, Pharmd, manager: procurement, distribution and repackaging of the department of pharmacy at Duke University Hospital, explained.

Rhea said some of his colleagues compare it to working in a third world country.

"On a daily basis, we probably only get in about 60 to 70 percent of the products that we order," Dr. Rhea said. "I probably spend more than 50 percent of my time managing drug shortages."

A recent survey found shortages cost U.S. hospitals 216 million dollars a year as they're forced to buy more expensive alternatives

"It's kind of the new norm," Dr. Rhea said.

Doctor Rhea said for many patients, including ovarian cancer patients on Doxil, it's led to rationing.

"Patients were put on waiting lists and it was a very difficult situation," Dr. Rhea said.

Production by a Johnson and Johnson contractor ceased late last year. The shortage continues to this day. A spokeswoman said the company regrets the circumstances and officials "remain focused on returning a reliable source of medicine as rapidly as possible." But getting Doxil and other crucial drugs back on track will take time.

"It didn't get this way overnight, and we're not going to fix it overnight," Dr. Kweder said.

"It's not going away. It's really kind of reached a steady state," Dr. Rhea said.

A state many can't believe we've reached in America.

"Who would have ever thought we'd be in this position?" Dr. Kweder said.

Reports attribute the drug shortage to only 15 deaths in the U.S including one man who died because the only antibiotic he responded to wasn't available. But Kweder said it's hard to figure out how many have been impacted by the shortages. She guesses the number to be in the hundreds of thousands if not millions.

RESEARCH SUMMARY

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: www.cnn.com, The Huff Post)

INTERVIEW

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?

Dr. Rhea: It's a very complex process, especially for generic sterile injectable products. There's a whole litany of issues that they can face, but one thing that we see more than anything else is that a lot of these companies actually don't manufacture the products themselves. They use third party contractors and some of them are not even in the United States so they don't have as much control as they could over the manufacturing process. If there's a problem along the line, they can't react to it very quickly and a lot of times it takes months to find secondary suppliers and secondary raw material ingredients that it takes to manufacture these products.

Where do you draw the line where you know you're putting the patient at risk versus not given them any treatment all?

Dr. Rhea: Yes, that's certainly something I think the FDA regulators deal with on an everyday basis. I think the new User Fee Act really puts the ball in their hands to make those determinations and make sure that there's a balance between public safety, which absolutely is a number one priority, and making sure that products are available when we need them.

What is your take on the User Fee Act? Do you think it's going to be enough, or what's kind of the buzz in the pharmacy communities?

Dr. Rhea: I think everyone across the pharmacy community and the medical community really applauded the act. We really think that it's a step in right direction. It gives FDA authority to take some actions that will help to mitigate shortages and hopefully prevent them from ever occurring. I think we are kind of in a wait-and-see mode. I really am very hopeful that it will start eliminating some of the issues that we've seen and we can get back to really taking care patients as our full-time priority, but I think it's yet to be seen.

One thing that stuck out to me mostly when we talked last time was you talked to some your colleagues about working in Third World countries. Did you ever get that feeling as well? What kind of take did you put on?

Dr. Rhea: I think what we've seen is a general resetting of our expectations. In medical school and pharmacy school we're taught to use the best evidence-based regiment for patients when they come in and that's true, but today really we use the best evidence based regiment among products that are available. In today's world in the United States, we figure that we should have the best medicine and have these products constantly available on our shelves when the reality today is that's not always the case. So we have to take into account what we have available and be able to use that.

What was the worst-case scenario you had to deal with yourself when it came to shortages? Were you ever at a point where you couldn't give the patients the care that you thought was the best for them or had to find an alternative?

Dr. Rhea: Probably the worst-case scenario that we've seen is a product called Doxil; it's a cancer drug and there's really no alternative to it that you can substitute and have the exact same effect and the exact same side-affect profile. That was a drug that was not available for multiple months and patients were on a waiting list and it was a very difficult situation. Now the FDA has actually allowed us to import that from overseas which has really helped, but there were a number of months where the product was not available and it was a heart breaking situation in a lot of cases.

Were there any other extremes that you had to take to get the drugs that you needed? Did you ever find yourself in the situation where you had to buy from a third party that was jacking up the prices by three hundred to a thousand percent?

Dr. Rhea: By practice we do not use gray market distributors at Duke Hospital. It's a practice we've stayed away from whole heartedly. I truly do not believe that those are good decisions to make. When you start going to those gray market distributors you don't know where the product came from. We can't insure that it's been kept at the right storage conditions, that it's sterile, and that it's really even the product that you intend to give. What we really tend to go to are more imported products. The FDA has certified certain products that are available overseas that were not available in the United States and allowed us to import them to be used on patients here in the US, and that's really helped. Certainly it comes at an expense over our commercially available products that were here if the manufacturers were able to bring them to market, but it's really helped on a number of different occasions.

Is there a stockpile overseas or is there another manufacturer overseas where you can get that from?

Dr. Rhea: It just depends. In certain circumstances there are other manufacturers overseas that use FDA inspected and maintained facilities and we can use those once the FDA goes through the process and allows us to import them. Here in the United States we really only have about five to seven big generic houses that make ninety percent of our generic injectable products. So what we see is if maybe only two of or three of those companies make one highly used product, if the company that is driving the market's product is unavailable all of a sudden then all of that product dries up. It could be for days but more than likely it's weeks or months that we have to fight for that product.

Did you find yourselves stockpiling stuff as much as you could or making different doses out of higher doses?

Dr. Rhea: I don't like the word stockpiling at all. We stock as much as we can to help our patients. It's a thing where we really coordinate with a lot of the hospitals in the region as well. We're all in this battle together and if I have more of an agent than another hospital down the street and they've got a need, we work very well together to share product and make sure that we can all treat our patients accordingly.

Like you said, it's kind of like the new norm and you've had to adapt to the situation. Did you find it was a difficult process or did you have a lot of cooperation with other hospitals to work your way around the situation?

Dr. Rhea: We work very well with our other hospitals. We have a clear line of communication, I know the pharmacist in charge of procurement in each of those facilities, and whenever we run in to issues we get on the phone and we talk. We use our resources and we really work within the supply chain of a lot of different options. We work with different wholesalers, we work direct to manufacturing purchasing that we didn't used to have to do that we have to do today, so a lot of avenues. We make that sure we coordinate with all of our healthcare partners in the area to make sure that everyone is able to treat their patients.

So you had to think out of the box in some situations.

Dr. Rhea: Yes, absolutely. A lot of these situations are really moving targets; you can have certain information one minute and then an hour, two hours later the situation completely changes. So it's really nice to have people who are dedicated to making sure that they stay on top of these things and make sure that we have products on a daily basis.

There's no simple solution to this, do you think there ever will be?

Dr. Rhea: I hope so and the one thing to understand about this situation is we've had congressional hearings, there's been summits, there's been conferences and the one thing that's come out of all of those discussions is that there's no one cause and there's no one answer. So I think as long as we keep this in the forefront of our minds, if people throughout the healthcare community and the regulatory community continue to identify problems, to identify solutions, and to work together, hopefully in the future this situation will minimize to a point where we don't have to worry and talk about drug shortages in the way that we do today.

You said it's stabilized now but do you ever see it getting worse again?

Dr. Rhea: I hope it doesn't get worse. I think it's a partnership between manufacturers, government regulators like the FDA and DEA, and consumers to make sure that we work together, set expectations, and that all of us meet those expectations.

I realize there were some drugs that weren't on the list and some people weren't happy about that. Do you think those will be added at some point? Or do you think it's kind of a living breathing thing that will adapt as need be?

Dr. Rhea: I think so. The FDA maintains a list of drugs that are in shortage and I know there are a number of products that aren't on their list that they're currently working on. Perhaps they're just working on them so hard that they haven't been able to update their website and things. So I really think that the User Act is going to help. I think it's an evolving thing and that as manufacturers get used to the requirements that are on them now, hopefully they'll start making smart decisions that will help us treat our patients in the future.

What are those requirements? Is it six month notice?

Dr. Rhea: From my understanding there is now a six month notice period where the FDA requires manufacturers if they're going to permanently discontinue marketing a product, if there is any type of planned interruption, or even unplanned interruption. As soon as they know there's a chance there could be a supply disruption they're legally required to contact the FDA and let them know, mainly so the FDA can work with them and other manufacturers to make sure they can mitigate these other problems from coming to the market in the first place.

The notification, is that something that the FDA is going to share with pharmacists and physicians?

Dr. Rhea: I believe so, yes. I think they're probably going to work a lot behind the scenes because this is a large complex process that involves companies around the globe and making sure they can bring materials to the manufacturers. Sometimes it's something as simple as not having a foil overwrap to go over a bag and because the suppliers are overseas and/or they don't have a secondary backup supplier for the manufacturer, then the product can't come to the market. So I think these things the FDA can really help with and they're really going to now have the authority to do that. I think that's a really good thing and hopefully it prevents some of the problems that we've been seeing.

It's not just generic injectables because I talked to a doctor and he said he had patients that needed oxycodone and he can't find it anywhere. So it's not just for people who go to the hospital, it's for people who have back problems down the street who need pain medications and can't get it.

Dr. Rhea: Yes, absolutely. The vast majority of the problem has been sterile injections, but we've seen it across all different dosage forms and types. The problem has extended to brain drugs, engineered drugs. One thing that we've seen, you mentioned oxycodone, is problems where at certain points in the year manufacturers are held up by DEA limits on the amount of controlled substances they can produce. There are reasons for that, but when there are shortages in the market one of the things the User Fee Act does is it allows the FDA to work closely with the DEA on making sure that if there's a quota issue that's keeping product from the market, they can raise those limits and allow patients the needed treatment that they deserve.

Are patients helpless in this situation or is there anything they can do?

Dr. Rhea: Like in every situation asking questions is a good thing. Whenever you see your healthcare practitioner ask them about your medications and ask them if they've heard of any supply interruptions. If they're in a situation where they're having difficulty obtaining a drug their physicians can hopefully work with local pharmacists or groups or organizations that might be able to help them. So I think keeping abreast of the situation and asking lots of questions when you go in to all of your healthcare practitioners can really help to keep them informed.

I was reading on line if a patient does find a drug overseas or another country that is legitimate their doctor can actually get a prescription for them but only up to ninety days. Is that correct?

Dr. Rhea: I don't know the details on that, but I think if patients are in situations where they're not able to find a product that they need they really need to contact their physician and make sure that they have a long conversation about the different options that they have because most of the time there are different options available. Sometime physicians just don't know that they're in that position in the first place.

FOR MORE INFORMATION, PLEASE CONTACT:

Sarah Avery
Duke Medicine Marketing and Communications
(919) 660-1306
sarah.avery@duke.edu

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