America’s current drug shortage problem is affecting thousands, possibly tens of thousands, of patients, physicians, and hospitals throughout the nation. Those with severe, life-threatening illnesses are being affected the most. A number of cancer drugs are among the 240 types of medications that are currently in short supply; and patients fear for their lives because missing multiple treatments can sharply reduce the chances of alleviating the disease.

According to the article FDA: New Suppliers to Ease Two Cancer Drug Shortages by Linda A. Johnson, “The shortages are caused primarily by problems with sterility and other serious issues that have led to shutdowns of production lines and occasionally entire factories.”[1]

Drug shortages have increased dramatically in the U.S. over the past six years, particularly for generic injected drugs, and at least 15 deaths since 2010 have been blamed on the shortages – which is a record high in the past five years for deaths linked to shortages.[1]

The FDA recently announced its approval of importing an unapproved drug, Lipodox (a replacement for Doxil – a medication for treating ovarian cancer) from India. According to the FDA, “Temporary importation of unapproved foreign drugs is considered ‘only in rare cases’ when there is a shortage of a treatment ‘that is critical to patients’ and can’t be resolved in a timely fashion with already approved drugs.”[2]

But is the FDA doing enough to help alleviate this problem? For many, that answer is, “no.”

For some, this problem has forced them to take legal action. In Pennsylvania, two attorneys and 25 Fabry’s Disease patients filed a lawsuit in the U.S. District Court in Washington, D.C., in a vigorous attempt to push the government to help with a shortage of Fabrazyme – the only drug approved in the U.S. for the debilitating genetic condition.[3] Though not a cancer disease, Fabry’s patients are one of the many serious non-cancer illnesses that have also been affected by the shortages. Genzyme, the maker of Fabrazyme, was previously accused of sending this medication to Europe – where a competitor offers the drug – while rationing to Americans.

In 2011, there were 267 drug shortages reported; today there is just under 240. Is this a drop? Yes. But most of these shortages remain unresolved. According to Awi Federgruen of The Wall Street Journal, this is partly due to government’s oversight of manufacturing safety and quality and their stringent price controls for generic drugs. (For more information, click here to read our blog entry entitled, “Drug Shortages: What is Causing Them and How Can They Be Fixed?”)

So what can you do to help? First of all, start utilizing compounding pharmacies. Many experts agree that compounding pharmacies can help alleviate the problem because they can compound commercially unavailable products. Second, make sure that you purchase from compounding pharmacies that work at only the highest-quality standards (click here for William’s guide to choosing the right compounding pharmacy). Hartley Medical continually asks, “Do you know what your sterile compounding pharmacy is doing?” It is time to make sure that your answer to this is, “yes!” And lastly, stay informed. Check your supplies and let your compounding pharmacy know if you have any stock that will be in short supply soon. This way, we can try our best to get the proper medications in advance to fulfill your needs.

Here at Hartley Medical, we have an unwavering dedication to providing only the highest-quality sterile pharmaceuticals; therefore, we compound these medications only to the highest quality standards. We think first and foremost about patient safety.

If Hartley Medical can assist you in any way during these shortages, please contact us. We are here to serve you. Click here to see a list of drugs that are currently in short supply.

For more information about the current drug shortage issue, visit Hartley Medical’s Knowledge Center by clicking here.


[1] http://www.google.com/hostednews/ap/article/ALeqM5jhuoQgrq6mJYoPZWcKCk-G6TkoOg?docId=28d74538aea44d91b5ce15cc8cc1aac2

[2] http://www.bloomberg.com/news/2012-02-21/cancer-drug-shortages-targeted-by-stopgap-fda-approval-of-similar-products.html

[3] http://www.post-gazette.com/pg/12052/1211668-176.stm?cmpid=latest.xml