Hospitals and pharmacists are increasingly worried about drug shortages. And well they should be: 178 drugs are running short today, more than three times the number in 2005. Manufacturing problems, industry consolidation, and bottom-line worries are fueling scarcity, and the solutions aren't clear. When only a few companies make a particular drug, one idled production line makes a big difference.
The scarce drugs are often low-margin generics that contribute little to their makers' income statements. So, there's less incentive to fix problems if and when they arise. Consider Teva Pharmaceutical Industries' decision to stop making the anesthetic propofol. Problems at its Irvine, California, plant prompted a recall, and FDA found "significant" manufacturing problems there. The company decided to give up on the drug because, as a spokeswoman said at the time, Teva realized little to no profit from it.
Hospira, recently decided to stop making another anesthesia drug, sodium thiopental. That choice captured a lot of attention because the drug is part of the cocktail used to execute death-row prisoners. But it was a cut-and-dried business decision: Manufacturing problems in North Carolina had already stopped production; moving manufacturing to Italy became a political problem; and the drug only accounted for a tiny fraction of Hospira's sales.
Trouble is, hospitals say they're now having to substitute less-effective drugs for the scarce meds they can't get. Often, drugs that run short don't have direct substitutes, FDA officials told the Wall Street Journal. And many of them are cancer drugs or anesthetics, so oncology patients have to accept alternative chemo regiments or delay treatment, and some surgeries are canceled at the last minute.
The FDA has limited power to change things. Some complain that stringent manufacturing approvals contribute to the shortages, but do we really prefer the alternative, especially when we've seen so many drug recalls over the past year? What the FDA can do is look for alternative suppliers, provided it knows that a drug will run low--and provided that there are alternatives. One lawmaker wants to require companies to alert FDA when supplies tighten up. It wouldn't fix all the problems, but at least we'd know exactly where all the problems are.
- get the USA Today story
- see the coverage in the WSJ
- check out Pharmalot's take