Shortages of important generic drugs have become a pressing concern in health care, with hundreds of drugs in short supply across the country.
Doctors and hospitals are particularly worried about shortages of two key chemotherapy drugs: cisplatin and carboplatin. Both drugs treat a variety of cancers. Cisplatin was declared in short supply to the U.S. Food and Drug Administration in February, while carboplatin was reported in late April.
The Michigan Health and Hospital Association (MHA) said the shortage of these drugs has become critical across the U.S., and in every region of Michigan. MHA Executive Vice President Laura Appel said that’s forcing hospitals to extend their supply however they can, and scramble to find alternative drugs or compound them in-house.
“They are doing everything they know how to do to extend the supply that they have, and to make sure that they can take care of all of the patients that need these drugs,” Appel said. “But it is very disturbing and disruptive to know that we've got these patients who need lifesaving medications, and know that we're short of them.”
The shortages reveal deep and complex problems within the generic drug supply chain. Parts of it remain obscure, even to the people tasked with overseeing it, akin to what Appel describes as a “black box.”
Compounding the problem is the fact that about 80% of active pharmaceutical ingredients — the key ingredients that make drugs work — come from overseas, mainly India and China. “And it makes it hard to know when the shortages are going to start, what the manufacturing cycle might look like, whether or not they're going to be shipped, etc.,” Appel said.
A March report from the U.S. Senate Committee on Homeland Security and Governmental Affairs, chaired by Michigan Senator Gary Peters, explored the ongoing problems in depth. It found that drug shortages “are caused by a number of factors, including economic drivers, insufficient supply chain visibility, and a continued U.S. overreliance on both foreign and geographically concentrated sources for medications and their raw materials. These shortages have cascading effects on patient care, causing delays in treatment, increasing the risk of medication errors, and requiring the use of less effective alternative treatments.”
The report also found that drug shortages “predominately affect older generic drug products,” which account for about 90% of all drugs in the U.S., but only 18% of costs. It calls for government action to address the issue, but adds that “Neither the federal government nor industry has end-to-end visibility of the pharmaceutical supply chain. … This lack of transparency limits the federal government’s ability to proactively identify and address drug shortages.”
As for cisplatin and carboplatin, the MHA says that “manufacturing delays at several pharmaceutical companies” are largely to blame for the current shortage. That includes Intas Pharmaceuticals in India, which “temporarily suspended manufacturing of the drugs after the F.D.A. found serious quality-control violations,” according to a New York Times report.
The MHA’s Appel said cisplatin likely won’t be widely available again until at least late June, while carboplatin “might be more available by the end of this month. But even that is a bit uncertain.”
