I wrote my last blog on the drug shortage crisis almost 10 months ago and it is clear from the daily calls we get at JCB Laboratories that the drug shortage crisis is far from resolved. The names of the drugs in short supply may have changed but the reasons for and the effects of the shortages are all too familiar.
Recently, I have seen a new way to quantify the drug shortages. Because of the length of time some of the drug shortages are lasting, the number of drugs in short supply are described as “active” drug shortages rather than “new” drug shortages. If you look at the new drug shortages thus far in 2013, the number is down dramatically (40 for the first quarter of 2013).
However, active drug shortages paint another picture entirely. At the end of the fourth quarter of 2012, the number of active drug shortages hit an all-time high of 299. In the first quarter of this year, there were still 295 active drug shortages.
Those drugs that are in short supply continue to be drugs that are used in emergent situations, antibiotics, chemotherapeutics and CNS medications. Over the last three years, the common drug classes in short supply are shown below:
Additionally, I am sure none of you will be surprised to hear that injectables continue to represent a large portion of the drug shortages:
There is no single reason for all of these drug shortages but, like in 2012, quality issues at the manufacturing level and manufacturing issues account for 80% of the shortages. The last report I read separated out these two causes but many of the manufacturing issues are also related to quality. Erin Fox, manager of the University of Utah Drug Information Service describes the current drug shortage situation as a “public health crisis as patients and clinicians are impacted daily.”
We are seeing some relief with the passage of the Food and Drug Administration Safety and Innovation Act of 2012. Included in this legislation is an early notification system requiring drug manufacturers to notify the FDA of any production issues at their facilities and to give the FDA 6 months notice for a planned discontinuation of a medication. Additionally, in February of this year, the FDA formed an internal Drug Shortage Task Force and called for stakeholders to provide suggestions for a strategic plan to enhance efforts to address and prevent drug shortages.
These actions will certainly help but, until manufacturing facilities are improved, drug shortages that affect patient care will continue for the next few years. It is prudent for your facility to have plans in place to mitigate the effects of these shortages. A reliable pillar in this plan is finding a properly vetted, high quality compounding pharmacy that can be a partner in providing solutions to many short supply medication issues.