Doesn’t that mean that they do not know that they are going to pay more for something than they usually would?
Dr. Benjamin: We have heard that. We have heard that because the drug of choice is not available, or the drug in the insurance company’s first tier of payment is not available, that patients have to shoulder additional out-of-pocket expenses for the drugs that are available. But at least their drugs are available. I believe Premier, which is a group purchasing organization, did a survey on how much additionally hospitals have to spend for drugs, and I think they projected $200 million annually in additional costs to hospitals to buy more expensive therapeutic alternatives.
How do we fix it? Have there ever been any deaths associated with the drug shortage that you know about?
Dr. Benjamin: I do not know that there have been any studies. We have heard anecdotal reports that there have been deaths. We certainly know that there has been harm. The Institute for Safe Medication Practices did a survey in which hospitals reported harm or an impact on patient safety resulting from drug shortages. 1 in 4 of those hospitals reported an error as a result of drug shortages and 1 in 5 reported adverse outcomes on their patients because of drug shortages.
That is a huge number.
Dr. Benjamin: It is an impact on patients. The impact on patients, the impact on the finances of a hospital, and the additional labor costs; this is what affects hospitals as an organization. So it has had an impact on hospitals in that way as well.
Is there anything that the FDA is doing to crack down on the third parties trying to hoard drugs?
Dr. Benjamin: I am not sure that we have a good way to gauge how much hoarding is going on. We know it is going on, but we cannot tell who and to what extent. A certain amount of stock piling by an organization is understandable; especially if you have patients already on these therapies and you want to continue their therapy. But, we have urged our members not to overstock a lot of these products because it takes them out of the supply chain and makes them unavailable to others who might also need them.
Can you talk about the gray market?
Dr. Benjamin: Well, these are nontraditional third party distributors who have sources for obtaining products in short supply. I am not sure what they are, but somehow they manage to have product to offer that is on our shortage list and there is a premium charge for buying these products. We really discourage our members and anyone else from resorting to the gray market as a source of drugs in shortage because we have no way of knowing where the drugs came from, how they have been handled, how they have been stored, and there have been reports of counterfeiters introducing products into the market that are in shortage. I think the most recent one was counterfeit Adderall.
What is the worst that could happen?
Dr. Benjamin: The best thing that could happen to you is that it does not work. The worst thing is it is adulterated or deteriorated in some way and might actually cause you harm.
How can we control something like that from happening?
Dr. Benjamin: Well, you had asked about FDA. The FDA has no authority over distribution; they do not have any authority over people who sell drugs, only over manufacturers. What we tell our members are just do not buy from them. If they do not have a market for what they are selling, then they will not stay in business. We do not believe that the gray market is causing shortages. I have heard that as a hypothesis, but we believe that it is a symptom of drug shortages.
What do we do now to warn the hospitals and pharmacists that there are drug shortages?
Dr. Benjamin: We have maintained a drug shortages web resource center since 2001, over 10 years, and we depend on our members to alert us whenever there is a shortage so that we can post it there and provide information about alternative agents and perhaps other sources to obtain the drug. We post that information as soon as we get it, but it is never soon enough because by the time a member reports a shortage to us, the shortage has already evolved. We know that that information is important; it gets the most hits of any page on our website. However, we think that the new shortage legislation which will require manufacturers to report this information to FDA will be way more timely and way more helpful to practitioners and the whole healthcare community.
What part in the decision did your organization play? You said you got 90% of what you guys were looking for, right? What were those 90% and what was that 10% that you guys did not get?
Dr. Benjamin: Our most important plank in that platform was early notification by manufacturers to the FDA of any production problem that might cause a drug to not be available. We did not ask manufacturers to determine if it would cause a shortage, we just wanted them to report anything. The FDA in their oversight role could tell from where they sit nationally whether or not the drug would cause a shortage. They know how many people make the drug and they know where, at any time, in regulatory procedures all those companies are. The earlier the FDA knows, the more they can do to either prevent or to mitigate a shortage.
What do you think is the next step and what do you think that patients should know about the shortages and about the new law?
Dr. Benjamin: The next step in our view is that we need to study the fundamental causes of drug shortages in a lot more depth so that we can understand fully what causes them to happen. Why drug shortages occur, what are the main causes, what are all the other little contributory factors, so that we can recommend effective solutions. If we do not really know everything we need to know we will just continue to slap Band-Aids on the problem and will not get at the root cause. The reason we recommended early notification by the FDA was because we knew it worked. The FDA told us that if we know in time, there are things we can do; we knew that that was going to be a valid, or at least temporary, solution. Now is the time to really take a deep dive into all the data and all the information people have about drug shortages and work with manufacturers, with suppliers overseas of raw material and active pharmaceutical ingredients, with the supply chain, with physicians, with everybody that has a stake in this so that we can come up with lasting solutions.
Let’s talk about Doxil. There is only one company in the United States that makes it. Why is that?
Dr. Benjamin: I believe it is because Doxil uses a unique drug delivery system, and I think it is proprietary to one company, so one company makes it. They distribute it overseas as well, and there may be more than one; it is possible to have more than one manufacturing site, but in this case, there was one company, one manufacturing site.
Is there anything that patients can do to protect themselves?
Dr. Benjamin: Well, I have encouraged patients who have called me to monitor our website and look for any notifications of shortages of their own products and to discuss with their physician how they would handle it if there was a shortage of their product. This is particularly true of products, as you mentioned, that have one company, one manufacturing site, or maybe only two, or that are injectable products; those are the ones that are most frequently affected. Try to have a proactive plan. ASHP has assisted a lot of individuals and groups with trying to find alternative methods of obtaining products in the past. Our ability to do that is limited. We work with the FDA, but I think a proactive plan of what can we do, at minimum discussing it with your physician and finding out you do not have worry about it, would ease your mind. It is better to know if what you are taking is at risk of a shortage and to get ready for it.
It quadrupled you said?