That drug shortages endanger patients by hindering access to needed pharmaceuticals is obvious. But there is another danger, less clear, yet no less troubling: when drug shortages force clinicians to substitute different medications, entries in computerized prescriber order entry systems have to be adjusted, changes in concentration may be required, and new drug monographs must be made available. Such changes are fraught with danger for processes and systems designed to ensure patient safety; if they are not made carefully, incorrect doses, unforeseen drug interactions or side effects are liable to occur.
This threat has grown particularly salient in recent years as drug shortages have spiked. From 2006 to 2011, the number of drugs added annually to the Food and Drug Administration's shortage list nearly quadrupled to 267, with oncology medicines accounting for the largest share. And though this number declined in 2012, drug shortages persist as a grave problem for U.S. health care, as a recent New York Times article notes. And the problem may well be exacerbated by the close of a major compounding pharmacy following revelations of meningitis contamination this fall. The Drug Shortage Crisis in the United States: Causes, Impact, and Management Strategies by C. Lee Ventola offers an overview of the factors contributing to the crisis and what can be done.
No longer should we consider our systems safe. Whatever safeguards have been implemented must be examined as they may no longer be effective. Another concern is the effectiveness of the substitute medications. A recent study in the New England Journal of Medicine underscores the problem, finding that substituting cyclophosphamide for the standard treatment with mechlorethamine resulted in significantly lower effectiveness “2-year event-free survival, 75% with cyclophosphamide [SE, 12.5%] vs. 88% with mechlorethamine.” As the author notes, “Our results suggest that even promising substitute regimens should be examined carefully before adoption; what might appear to be a suitable alternative regimen may result in an inferior outcome — an intolerable situation for young people with curable diseases.”
In the long run, I am confident that the FDA and local boards of pharmacy and public health departments will deal with the drug shortage problems now confronting us. But in the meantime, hospital and clinical leaders must be aware of the potential impact on patient safety. Resources must be allocated to ensure that shortages are addressed, not only in purchasing alternate medications, but also in ensuring that the many safeguards that have been put in place are reviewed and updated as needed. This must be a deliberate plan. Patients should be informed of choices available to them, and they should be reassured that no matter the setting, the clinical staff will do all within their power to provide safe care.
This is a daunting task, and we need to talk seriously about how to get it right. In August of 2011, I participated in a WIHI broadcast with Mike Cohen from the Institute for Safe Medication Practices and Lynn Eschenbacher from Wakemed to discuss ways to mitigate the impact of drug shortages on patient safety. But we need to think more comprehensively. In the spirit of “all teach, all learn,” I ask that you share your own plans for dealing with the drug shortage, so that others can benefit from your experience. What have you done? What’s worked? How would you counsel others to combat the pernicious effects of drug shortages?