A hospital, short on a general anesthetic, is rationing the drug. Doctors administer an insufficient dose, and a surgical patient awakens during the operation.
Out of morphine, some hospitals switch to hydromorphone, a similar but stronger narcotic — but without adjusting the dose. Two patients die.
Cancer patients, some nearly finished with their chemotherapy, are told that they can’t complete their treatment because the drug ran out. Some are switched to inferior regimens; some get nothing.
An intubated woman, given an inadequate dose of an IV sedative, tries to pull the breathing tube out herself and bites off a piece of her tongue.
These are not scenes from a walk-in clinic in Sudan or an army hospital during the Vietnam War. They are going on right now in hospitals across the United States.
People are dying because of critical shortages of hundreds of essential, commonly used drugs — the kind we take for granted.
And it’s getting worse. The United States saw shortages of 56 drugs in 2006, ballooning to about 200 last year. The Food and Drug Administration now lists 246 shortages — a five-fold jump in just five years.
Stranger still, the problem isn’t with new, complex drugs that are hard to make; it’s with routine products: saline solution, antibiotics, sedatives, epinephrine and morphine — supplies found in every emergency room.
There is no single cause; it’s a combination of economic, technological, regulatory and geographic factors.
Virtually all the scarce medications are generics — drugs whose patents have expired. Many have low profit margins, giving companies little incentive to make them. Plus, nearly all are sterile injectables, whose production requires stringent and specialized purification techniques. Some drugs are made by just one company, which can discontinue them at will. Although drug makers must notify the FDA in advance when they anticipate a critical shortage, they can’t be forced to make anything.
Complicating matters, most manufacturing is done abroad; political instability and natural disasters can disrupt access to vital raw materials, temporarily slowing or halting production.
Regulatory requirements also play a substantial role. The FDA is charged with ensuring that our drugs are prepared using good manufacturing processes — but it’s understaffed, which can mean delays anytime a company wants to add or expand capacity.
And more than 80 percent of generic-drug manufacturing is done overseas — but the FDA inspects only 10 percent of foreign production facilities. The lack of oversight makes errors inevitable.
Most notable was an incident in 2008, in which a bad batch of the blood thinner heparin killed 80 people and sickened hundreds more. Baxter Healthcare recalled the drug ASAP, causing a worldwide shortage. It was later determined that the heparin, made in China, had been adulterated with a similar, cheaper substance.
Fixing this mess won’t be easy, but at least there is a start. Generic makers and the FDA just reached a deal: The companies will pay a $300 million-a-year fee for the FDA to inspect plants worldwide every two years, significantly reducing approval delays.
But it’s foolish to stop there. Economic incentives for production of scarce drugs might ease the shortage. Perhaps an approach similar to the 1983 Orphan Drug Act, which provided patent protection and financial incentives for companies to develop drugs for limited markets, would be useful.
Finally, wouldn’t it be nice to lure some manufacturing back to this country for a change? How about some tax incentives for companies to do their work here?
Regardless of the approach, we must retake control of our own medications. It is simply a disgrace that we can’t provide routine, essential drugs in the United States.
Josh Bloom is director of chemical and pharmaceutical sciences at the American Council of Science and Health.