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.