Headline: Drug Shortages Become Worry at Hospitals Around the Country [excerpts]

Source: New York Times, 3 Jan 2001

Link: http://www.nytimes.com/2001/01/03/business/03SHOR.html?pagewanted=all

Doctors, pharmacists and federal regulators are increasingly concerned about what they say is a growing number of drug shortages, particularly at hospitals. Where a few years ago a hospital might experience a shortage of one or two critical drugs a year, the number in the last year has been closer to two dozen at some hospitals, doctors and pharmacists say.

"This past year's shortages have been the worst I've seen in 26 years of hospital practice," said Dr. Burnis D. Breland, director of pharmacy at Columbus Regional Medical Center in Columbus, Ga. "We have not had any life-threatening cases, but it certainly could have happened." . . .

"Something strange is going on," Dr. Acker said. . .

There is no single reason for the shortages. Some stem from the drug industry's rapid consolidation, which has led to fewer companies making each drug or supplying the raw materials. In some cases, like this year's shortage of flu vaccine, federal regulators found problems at factories making the drugs and shut down production until procedures were improved. And some big drug companies have stopped making the older drugs and have instead reserved factory capacity for newer drugs, which bring higher profits.

James A. Jorgenson, director of pharmacy at the University of Utah's hospitals and clinics, said, "You can't just order drugs any more and just assume they will be there." . . .

Many shortages are of older drugs that have lost their patent protection and are now sold as lower-priced generics. The substitutes are often newer brand-name drugs that may be several times as expensive. The shortages have been made worse by the tendency of drug makers, distributors and hospitals to keep lower levels of drugs on hand as they have adopted an inventory- management technique that originated in industries like automaking. Under the technique, often referred to as just-in-time inventory, drug supplies are kept to a minimum to save on storage costs and to tie up less money in drugs sitting on shelves. . .

At some hospitals, the shortages have become so frequent they require constant monitoring by pharmacists, who notice them first, and by doctors, who must adjust treatments. At the Detroit Medical Center, drug shortages are a standing topic at staff meetings. The shortages are raising difficult ethical questions for hospitals. How, for instance, do you ration a lifesaving drug? "How can we say," Dr. Tyler asked, that "one person needs a drug more than another?" . . .

The tetanus-diphtheria vaccine is now being distributed under a rationing system created by Aventis, one of its two manufacturers. Aventis says it fell behind in making the vaccine after routine maintenance at its factories took longer than expected. The vaccine's other maker, American Home, has temporarily stopped making it after F.D.A. inspectors found poor manufacturing practices at two factories. . .

Other shortages have occurred soon after a drug has lost its patent protection. . .

The F.D.A. has tried to minimize some shortages by helping to find other companies willing to make a drug or supply the raw materials, and then expediting the regulatory approval process for those new manufacturers and suppliers. The agency has also worked with companies to help them fix manufacturing problems quickly. But F.D.A. officials admit that such actions can only ease the shortages, not eliminate them. "We can't control who is making drugs," said Dr. Mark J. Goldberger, an F.D.A. official who monitors drug shortages. "That is determined by the marketplace."

With shortages on the rise recently, hospital pharmacists say they fear the problem could get worse. "Shortages are now a fact of life," Dr. Tyler said. "We have to find ways to deal with them."

-- Andre Weltman (aweltman@state.pa.us), January 03, 2001

Answers

I've written Aventis to get more information
on the shortages but they failed to respond.

-- spider (spider0@usa.net), January 03, 2001.

This is a great find! I've been wondering why multiple drug manufacturers have had problems with the flu vaccine. Regarding the Td vaccine, I like the phrase "routine maintenance at it's factories took longer than expected"... Could this "routine maintenance" involve Y2K repairs?

-- slza (slzattas@erols.com), January 03, 2001.