Hospitals running low on medicine key to preemies' lung development

Wednesday, May 23, 2001

Misti Crane Dispatch Medical Reporter

Fragile premature babies soon could be without a drug that is vital to their development.

The pharmaceutical company Schering-Plough says its drug Celestone Soluspan is on indefinite back order.

Ohio State University Medical Center has about a month's worth on hand; Riverside Methodist Hospitals, Grant Medical Center and Doctors Hospital West are reporting "a critically short supply.'' Mount Carmel East, West and St. Ann's also are short.

"It's one of the most important drugs, and to be out of it is just unthinkable,'' said Dr. David Colombo, an OSU obstetrician who handles high-risk pregnancies.

Complicating matters is a limited national supply of dexamethasone sodium phosphate, the alternative to Celestone.

Both drugs are given to women when they go into early labor and are designed to help develop the tiny lungs of premature babies and to reduce the risk of bleeding in the baby's brain.

Colombo said OSU Medical Center uses the injectable medications about once a day.

Yesterday, one of the recent recipients -- 3-pound, 2-ounce Dean Joseph Janowiecki of Columbus -- was resting in the hospital's neonatal intensive-care unit. His mother, Janelle Janowiecki, said she was relieved that Dean was able to benefit from Celestone.

Born May 12, Dean was taken off a ventilator by Monday.

"He's doing really well -- he got off his IV yesterday and off the oxygen today,'' Janowiecki said. "He could be home in between two and five weeks.''

Dexamethasone is in short supply as manufacturers switch from beef protein sources to plant sources because of concerns about animal-based products. Several manufacturers make the drug, and some are out of stock pending Food and Drug Administration approval of the switch.

The shortage of Celestone has prompted some local doctors, including Colombo, to urge members of Ohio's congressional delegation to pressure Schering-Plough and the FDA, which has cited the company's plants in New Jersey and Puerto Rico for production problems.

Because Schering-Plough has had to interrupt some production lines for upgrades and to address other problems found by the FDA, it has stopped dispensing Celestone, spokesman Bob Consalvo said. He would not provide details.

"The product is on back order, and we cannot accurately predict when these back orders will be alleviated,'' Consalvo said. "We're aware of the importance of the product, and we're working with the FDA on this matter.''

The FDA's communications office did not respond to messages left yesterday regarding the shortage.

"It's not a large product,'' Consalvo said. "Its use is relatively small. . . . It's not like a drug that's used in great volume.''

Colombo said it doesn't matter how many babies use it a day, considering what's at stake.

"It's a crisis in obstetrics -- we see it coming, we just can't do anything about it.''

Dr. Tracy Cook, an obstetrician at Riverside, said the hospital has plenty of dexamethasone to make up for the Celestone shortage, but that doesn't erase her worries.

"We definitely have concerns,'' she said, adding that she has placed a call to Sen. Mike DeWine, R-Ohio.

The shortages are symptomatic of larger pharmaceutical-industry concerns, said Joseph Deffenbaugh, professional-practice associate with the American Society of Health- System Pharmacists in Bethesda, Md.

"These shortages are driven by so many different factors that it makes it hard to determine what's going on with any particular drug product or manufacturer,'' he said.

"We've been communicating for almost two years with the FDA and the Federal Trade Commission and with a number of manufacturers about the discontinuation of hospital products and the lack of information coming from manufacturers when one of their products is going to be in short supply or discontinued.''

Hospital drugs such as Celestone seem to fall victim to production issues much more often than more-lucrative, well-known drugs, he said.

Claritin, Schering-Plough's biggest pharmaceutical moneymaker, continues to be produced.

The group advises hospital pharmacists to come up with contingency plans in anticipation of drug shortages. But hoarding drugs is discouraged and can cause false shortages.

"It's a very difficult balancing act,'' Deffenbaugh said.

http://www.dispatch.com/news/news01/may01/706176.html

-- Martin Thompson (mthom1927@aol.com), May 25, 2001

Answers

Well maybe this drug isn't used "often", but let me tell you dexamethasone is used by the gallon. I am sitting here with a 50cc bottle on my kitchen counter right now. I raise donkeys and anytime there is a difficult birth, mamma and foal both get a hefty shot. I am sure that the thorobred industry uses buckets of it too. Taz

-- Taz (Tassie123@aol.com), May 25, 2001.