Fixing the Drug Shortage: It’s About Time
President, Levine Cancer Institute
Yet, I’ve also witnessed the unfortunate reality that timing is crucial. Previously, lives may have been lost due to the lack of available treatments, but today, there’s a different issue—access.
An Inventory Crisis
The shortage of some intravenous cancer treatment drugs should be seen as nothing less than a travesty which, if left unchecked, could lead to avoidable deaths.
While performing patient rounds several years ago, I recall being warned by an oncology pharmacist that we were running short on some of our cancer medications and to be prepared to have to make tough choices.
Years later, it has become increasingly clear that this continues to be a major problem, and it seems as though very little has been done to fix it. People are at risk of dying of cancer unnecessarily because of the unavailability of crucial, irreplaceable therapeutic agents.
Last fall, the American Society of Clinical Oncology, a national cancer physician’s group, convened for a meeting in Washington, DC. The group concluded there’s an urgent need to do the following to mitigate the drug shortage:
- Improve rapid communication between the pharmaceutical supply chain and providers, so providers have more advance notice and can better understand, prepare and manage through shortages.
- Remove barriers faced by drug manufacturers and the FDA to minimize the impact of drug shortages.
- Improve the clarity of the definition “medically necessary,” the term that prompts advance notifications of drug shortages to the FDA, to ensure the FDA is aware of pending shortages like those the oncology community is experiencing.
Some months ago, both houses of Congress introduced bills that began to cover some of these issues and required the pharmaceutical industry to notify the government of impending shortages. As is so often the case, these bills have slowly and steadily been working their way through the political process, in a period when patients continue to suffer from drug shortages.
At Carolinas HealthCare System, throughout our 33 hospitals, we see more than 11,000 new cases of cancer a year. This volume of care provides us with stronger negotiating power for drug acquisitions as well as the ability to move medications around the system to areas of greatest need. Our pharmacy team has been outstanding in monitoring this issue, watching supplies, negotiating to obtain drugs and warning the oncology staff of impending shortages. Our teams have convened a systemwide committee that helps prioritize and manage available supplies, but as the problem worsens, prioritization has become an increasing challenge.
How does one prioritize between a patient with curable Hodgkin’s disease who’s due to receive one combination of drugs and a patient with curable testicular cancer who’s due to receive another combination using similar, dwindling ingredients? The time to sit by, worrying about our patients, concerned about the challenging decisions we need to make to compensate for an industry that’s behaving irresponsibly, may be nearing an end.
I’m encouraged by President Obama’s issuance of an executive order for the FDA to take action to reduce the shortage. It’s the first step on a long road to fixing this problem, and we hope Congress will make meaningful contributions to the process.
Let’s continue the momentum to find a long-term solution to drug shortages. Professional organizations, patient advocacy groups, everyone: Keep this issue in public debate and urge legislators to continue their work!
Leading the Way in Cancer Care
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