Shortage of ovarian cancer treatment (Doxil-doxorubicin hydrochloride liposome injection) & FDA action-is it enough?
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  • Shortage of ovarian cancer treatment (Doxil-doxorubicin hydrochloride liposome injection) & FDA action-is it enough?

Having a life-threatening diagnosis such as cancer is bad enough, but learning that a drug shortage of crucial chemotherapy may interrupt treatment is horrible. Today the FDA took a crucial response to a critical shortage of a widely used cancer medicine called doxorubicin. To be complete, the full name is doxorubicin hydrochloride liposome injection and the brand is Doxil. This newer form of the older chemo doxorubicin is less toxic than the earlier forms. Unfortunately, it is not available. The press release can be seen atwww.fda.gov.

What the FDA has done is to temporarily allow importation of a replacement medicine Lipodox (doxorubicin hydrochloride liposome injection). If they have estimated the needs correctly, this action should resolve the shortage of this particular drug. US and other hospitals are still faced with a daunting shortage problem that hospital pharmacists and physicians try to deal with every day. Many drugs are in short supply, are no longer being made or have manufacturing issues that put them on an "out" list for the near future. This list of drug shortages can be seen athttp://www.fda/gov/Drugs/DrugSafety/DrugShortages/default.htm. It is a long list.

There has been a response by the Obama administration in the form of an Executive Order of Oct 31, 2011 and it appears to be helping. The FDA press release mentions 195 shortages prevented in 2011 and 114 drug shortages prevented since the Executive Order was made. Still, the long list of drug shortages continues and the real answer is very early notificiation by manufacturers of potential shortages and of course, increased  and/or redundant manufacturing capacity.

The administration and the FDA face a huge challenge in that we all want to have safe and effective medicines (good manufacturing practice and strong drug pedigree) and no one wants a shortage. One way to help address this immense problem is to create a national "Essential Drug List" (something the World Health Organization has tried to do in its Use of Essential Drugs Publication). The FDA and US/world experts could partner on identifying key medicines (or combinations) required to treat prevalent diseases and conditions and build redundancy in manufacturing capacity and manufacturers, perhaps driven by tax incentives.

Medicines matter and no one wants to hear that the pharmacy has run out of drug to treat their cancer. Since 1978, the Essential Guide to Prescription Drugs has striven to bring exceptionally complete and accurate information to consumers--yet all the information in the world doesn't do the patient any good if the medicine simply isn't available.   

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