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.