There is a new problem plaguing hospitals nationwide. No, it’s not a new superbug, or an outbreak of a new disease. It is what is lacking that is the problem: drugs. The number of drugs in short supply has tripled since 2005, and currently over 200 drugs are listed as in short supply on the FDA website. These drugs range from commonly used drugs, to chemotherapy, anesthetics, and critical care medicines. Many are generics.
The shortages put patient lives in danger and raise health care costs. Drug shortages have allowed the “gray market” to flourish. These secondary suppliers are able to search the FDA’s shortage website to determine which drugs are in short supply, stockpile the medications, and try to sell them to hospitals at exorbitant markups- on average 650%. Notably, the heart medication Labetolol was listed at a 13,000% markup from one supplier. Not only is this unethical behavior that drives up health care costs, but it is unsafe. Hospitals cannot determine the source of the medication, whether it was stored correctly, or whether it really is what the label claims it to be.
As an intern in both the community and hospital setting, I’ve witnessed these shortages firsthand. An ongoing shortage that has recently been brought to the forefront of the media is ADHD medications, particularly generics. Because of the potential for abuse, the DEA strictly regulates the production of this medication, setting quotas on how much can be produced to prevent diversion and illicit use. Due to the current shortage the DEA has increased the quotas to help alleviate the problem. In the hospital setting, one example of shortages is chemotherapy. Heartbreaking stories of patients who rely on Doxil, a chemotherapy agent with less toxicity than other medications in its class have been published in the media. Manufacturing problems halted the production of Doxil, and because it is only produced at one plant, shortages quickly followed. At my workplace there is a strictly controlled supply of Doxil, split up by patient. Patients now must add availability of their medication to the list of worries concerning their survival.
So what is the problem? The pharmaceutical industry has consolidated recently, and as a result only a few manufacturers make certain drugs. When one plant fails, the effect quickly snowballs. The effects can be potentially catastrophic for both individual patients and public health.
At the end of October 2011, President Obama signed an Executive Order that supports requiring drug companies to report drug shortages. Currently, drug companies are only required to report discontinuation of drugs when they are the sole manufacturer of the drug. Reporting drug shortages is voluntary. The Executive Order also supports preventing illegal price gouging and stockpiling of medications.
Unfortunately, there is no quick fix. For now hospitals are left dealing with shortages by using more expensive substitutes including brand name drugs and drugs that are potentially more toxic. It also increases the risk of medical errors, as medical staff must be educated to use and administer unfamiliar drugs.
So, what can patients do to navigate this crisis? First, they need to have a discussion with their doctor about the supply of the medications they are prescribed, and inquire if a waiting list for a particular drug exists. It is extremely important that patients are frank and complete about their medical history and medication use so that the most appropriate alternative drug can be chosen when necessary. Also, patients should refrain from purchasing drugs from the internet or unconfirmed sources, as the safety, efficacy, and identity of the drugs cannot be ascertained.
Since President Obama’s Executive Order, the FDA has prevented over 100 shortages. Hopefully we can continue on this path to recovery, and in the meantime, work together as a healthcare team to ensure optimal outcomes for patients using available drugs. What drug shortages have been huge issues where you work? Are you concerned that there won’t be a fix? We’d love to hear from you!
Additional Reading & Videos
http://www.whitehouse.gov/the-press-office/2011/10/31/we-can-t-wait-obama-administration-takes-action-reduce-prescription-drug
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