Drug shortage dilemma: The patients
BACKGROUND: In the past few years there have been drug shortages of over 200 different drugs in the United States, some which are ‘life saving’ as well as those for treatment and pain management. The shortage has caused a serious problem in patient care and many patients are unable to get ahold of their necessary medications. 80% of the drugs in short supply are generic injectable medications and they are used for many health issues including cancer, infections, and cardiovascular disease. In 2011 alone around 550,000 cancer patients have already been affected by these drug shortages. (Source: www.npr.org)
HOW PATIENTS ARE AFFECTED: The effect these drug shortages have had on patients is varied and far-reaching, as many different drugs have been in short supply. Some of the main adverse effects patients have been experiencing due to drug shortages include:
· Delays or Cancellation of Treatments - when established therapies for managing certain issues are not available, the treatments may be postponed until they become available once again.
· Substandard Care – if a patient can no longer get access to the best possible drug to treat or manage their condition, then many times they must settle for the next best thing which may not be as good.
· Compromised Patient Safety – the risk of error or adverse side effects increases when a patient needs to switch from the drug they had been using to an alternative because dosages, side-effects, and effectiveness may differ between the drugs. (Source: www.aacnjournals.org)
WHAT PATIENTS CAN DO: The most important thing patients can do to help themselves concerning the drug shortages is to be aware of the possibility that a drug they use for their health may become unavailable at some point. People should talk with their doctors who may be able to tell them whether or not their medications and treatments are at risk of going into shortage and come up with a plan if they do. ( Source: Bona Benjamin, American Society of Health Pharmacists)
For more Information on drug shortages go to the ASHP website http://www.ashp.org/shortages or the FDA website at www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm
Bona Benjamin, M.D., Director of Medication Use/Quality Improvement at the American Society of Health System Pharmacists, talks about recent drug shortages and the possible implications of these shortages.
Over the last few years there has been an increase in drug shortages. In 2011 over 267, correct? What’s going on?
Dr. Benjamin: That’s right. Well, there have been a lot of different reasons for an increase in drug shortages just in the past 2 years, but where we really started to see drug shortages escalate was between 2007 and 2011 where there were 267 new shortages. There was a quadruple increase in the number of shortages, there were supply issues, there were raw material issues, there were manufacturing issues and quality issues. In the last 2 years when we have had the worst shortages, the main reasons for them were quality problems at the manufacturing level and lack of capacity to fill in the gap created by quality problems that prevented the release of drugs.
Can you go into detail about quality problems? What is one of those things that you are seeing?
Dr. Benjamin: Some of that stuff is on our website. We report the quality problems that we are able to learn about, things like glass particles and metal shards in injectable products, and other issues related to the quality of an injectable drug. These are mainly injectable drugs that are problematic with shortages. The quality control is so very demanding and specific for a drug that you are putting in someone’s vein, that quite often there are problems in the manufacturing. There is a very rigid quality control process to detect those. They are going to happen, but hopefully if your manufacturing processes are good, you will not have too many. For some reason recently, there have been a lot more problems and it has caused recalls, it has caused shutdown of lines in the plants, and it has caused plant shutdowns. All of these actions compromise the ability of a pharmaceutical manufacturer to produce drug products.
What are the drugs that are affected the most?
Dr. Benjamin: Well, we have been tracking that over the past 6 years and the lead drug classes change every now and then, but the top 8 are always the top 8 and that is the central nervous system drugs. Those are the drugs for pain, for fever, for anesthesia, for arthritis, for reversing narcotic overdoses, for seizures, so this is a very important class of drugs used by many people. That is the top one now, but we have also seen a time when chemotherapy drugs, drugs used for treating cancer, were in the top class. The anti-infections, the drugs used to treat everything from HIV to just a common skin infection, these have also been in shortage. The electrolyte caloric and water balance, what we call the drugs that are usually given to people in the hospital when they are dehydrated, when their electrolytes are out of balance, or when they cannot eat by mouth, all of these have been in shortage. That has particularly affected pediatric patients.
It seems like a of those drugs are in shortage. What has not been in shortage?
Dr. Benjamin: Almost every class of drug has been affected.
What has it been like for pharmacists and for hospitals that have to deal with the shortage? Are they using alternatives that are as effective as the drugs that are on shortage?
Dr. Benjamin: Well, I will talk about pharmacists first because where we get the most feedback is from our members, and pharmacists are very frustrated and concerned about this whole situation. They spend a lot of extra time trying to obtain products for their patients and keep the communication lines open with physicians, nurses, and other care providers who need to use these drugs. I think that the last survey we did showed that a pharmacist is spending, on average, 9 extra hours a week; that is almost 2 extra hours a day just on trying to get drug products, working on shortages. Pharmacy technicians, in addition to that, are spending an additional 8 hours a week. So, we have got a lot of personnel time devoted to something that is essentially a procurement function and not patient care.
I did read that it is costing over $260 million.
Dr. Benjamin: An additional $260 million in labor, just to deal with shortage. That is the projected annual estimate. Yes.
Just because they are spending more time?
Dr. Benjamin: Yes. They are spending more time, they have added FTEs, and they have added personnel, all just to deal with shortage personnel. I talked with someone yesterday whose main job is simply to make sure that the drugs are on the shelves when the patients need them.
If they do not have it, do you have to find a substitute?
Dr. Benjamin: If they do not have it, the pharmacists are also working with the medical staff to try to figure out what do with what we have. It’s funny because our pharmacists do say instead of talking with physicians about what is the best drug for this patient, now we are asking what do we have and how can we use it to take care of the patient. It is what you have left, not what the best thing is.
How is it impacting patient care?
Dr. Benjamin: The patients we have spoken to are very alarmed, especially the cancer patients because it is very stressful to deal with a diagnosis of cancer, but imagine adding on top of that the fact that the drug you need to treat your disease is not available. There are really not that many therapeutic alternatives among the cancer drugs. They are very targeted at particular types of malignancies or hematology type disorders so it is not like antibiotics, where if I do not have one there is another that is similar. For pediatric patients, especially neonates, newborns who cannot eat, if the nutritional supplements that are needed to feed them through IV are not available, they will fail to thrive. Vitamins that the same neonates need to help them build their bones, calcium; these have not been available either. It has been very concerning to the pediatric community; both physicians and pharmacists alike are concerned about these patients. These are just two examples. A lot of different patients have been affected, but oddly enough, there are still patients who do not know that there are drug shortages other than just reading an article in the paper because I think their pharmacists and physicians have done a pretty good job of taking care of them with what they have.
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?
Dr. Benjamin: From 70 to 267 in 5 years.
Where do you think we are going to be in the next couple of years?
Dr. Benjamin: Well, there is good news. There are only 97 new shortages right now, and last year at this time there was many more. I cannot give you the number, but I can find it if you needed it. We are encouraged by this downward trend of new shortages in the first six months since the President signed the bill into law. We hope it keeps up and we would like to see it be doing a little bit better than that. We would like to see shortages go down to the past levels; we usually maintained around 40 or 50 and that was kind of a low, steady level. As I said, quality problems happen and people take care of them, but we will be monitoring to see what happens when all of the legislation that has to do with shortages is implemented. We hope it will help. When shortages occur pharmacists and physicians get together and they try to develop prioritization protocols that make sure that the most needy patients get the scarce supply. So, this essentially is rationing.
How do you make this decision?
Dr. Benjamin: It is done usually with the hospital ethics committee, the medical staff, and pharmacy. It is a very difficult decision. It is similar to what you do with solid organ transplant. Who gets the kidney? Who gets the heart? Who gets the lungs? I mean, it is a very difficult decision. It has been quite stressful for all the care providers involved and certainly mostly for the patients.
Do the patients know that they are on a certain list when they hear about a shortage?
Dr. Benjamin: What we have heard that practitioners are doing is whenever a patient’s drug is in shortage and there is an alternative therapy or the patient will have to get a lesser dose or the patient will have to skip maybe a cycle of his drug, the physician and pharmacist, either or both, can discuss this with the patient and tell them what the potential effect on their care might be, how it might affect the outcome of their disease, and what we are going to do now moving forward. We have heard that patients have really been drawn into and engaged in their own care and in these decisions.
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