On Oct. 31, 2011, President Barack Obama issued an executive order to the Food and Drug Administration to do everything possible to detect and deter drug shortages in the United States, which have been a problem for years and have recently reached record levels.
Flash forward to mid-February, when we watched the FDA scramble to avoid shortages of two critical cancer drugs, demonstrating just how real the problem is as the country was in serious danger of running out of Doxil, used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma and Methotrexate, used to treat childhood leukemia.
As a short-term fix, the FDA allowed provisional shipments of Lipodox (similar to Doxil) from India, and pharmaceutical company Hospira rushed a one-month supply of Methotrexate here from a plant in Australia. The FDA is also fast-tracking an application from another pharmaceutical manufacturer to produce Methotrexate.
Although these crises were temporarily averted, none of us should rest easy.
When I speak with supply chain executives and pharmacy managers around the country, I hear two themes repeated often: the problem is not going away anytime soon and it’s costing big bucks.
Mary Selzo of Shands Healthcare in Gainsville, Fla., calls the drug shortage situation the “new normal.” She reports that the health system’s pharmacy staff spends hours every day finding alternative therapies and drugs in different forms or doses. The cost of buying drugs has increased by as much as 15 times in some cases, but the hospital pays the high prices. As Selzo puts it, “We don’t balk at the prices. We normally would split hairs, but now we have no choice.”
They have no choice because patients are in dire need of the medication, for severe pain management and often for lifesaving therapies. “We haven’t up to this point had to do anything dramatic or make a decision that comprises patient care,” said Selzo. “The worst case scenario is to not have enough doses.”
Doug Bowen, vice president of supply chain at Banner Health agrees that drug shortages are a major problem, calling the situation “a mess.”
Bowen says Banner Health allocates a considerable amount of staff time to “managing these shortages” as they “try to track down product.”
In response to the President’s executive order, on Feb. 21 the FDA issued draft guidance for the pharmaceutical industry on notifying the government of impending shortages of prescription drugs and biological products.
That same day, the Obama administration released a statement indicating that the executive order has been successful in preventing 114 shortages. According to the statement, “In part, this (prevention) resulted from the administration’s call for voluntarily notification to the FDA of potential shortages. Notification of a potential shortage is crucial: with enough advance warning, FDA can take action to help stop a potential drug shortage. And since President Obama signed his executive order, voluntary notifications have increased six-fold.”
Although the administration is pointing to its victories, the supply chain experts I speak with know there’s a lot of work still to do to ensure the safe and cost-effective delivery of medications throughout the healthcare system.
Let’s not allow this small but important win to distract us from the very real pharmaceutical supply challenges that persist. This problem should matter to all of us, not just supply chain executives, and we cannot lose sight of the crisis as long as patients are in danger of not receiving the drugs they need to win the battle for their lives.
Every single one of us should take it personally when any child in this country can’t get access to the lifesaving drugs needed to fight leukemia.