Hospital Where I am to Deliver- 17 Babies Given OD of Heparin!
Posted 09 July 2008 - 12:00 PM
One of the babies has died, but they are unsure if it was related to the heparin OD.
Newborn dies; not known if drug had role : Corpus Christi Local | Caller-Times |
Infant seriously ill before blood thinner error
By Jaime Powell (Contact)
Originally published 03:54 a.m., July 9, 2008
Updated 03:54 a.m., July 9, 2008
One newborn is dead after a Christus Spohn Hospital South pharmacy error that led to as many as 17 babies getting as much as 100 times the recommended dosage of the blood thinner heparin.
It's still unclear what role, if any, the heparin played in the infant's death, because the child already was seriously ill and being cared for in the neonatal intensive care unit before dying Tuesday morning, said Dr. Richard Davis, chief medical officer for Christus Spohn Health System.
Heparin routinely is used in the hospital's neonatal intensive care unit to flush intravenous lines and prevent blood clots from forming. The dosing error was discovered by nurses Sunday night, during routine blood work, hospital spokeswoman Sherri Carr-Deer said.
"With babies, that is usually a heel stick and the nurses noticed that the blood was not clotting," Carr-Deer said.
They discontinued the drug's use immediately and gave newborns who needed it medications to counter its effects.
One infant remains in critical condition in the unit, and was in that condition for several days before the heparin dosages, Davis said. Three infants have been discharged and 12 are stable and remain in intensive care. Officials said an autopsy on the deceased infant will be conducted but did not say when that would occur.
A preliminary investigation indicates that the error happened during a process Thursday in which pharmacy personnel mixed the heparin with other solutions, including saline.
There was a double-verification process in place in which the pharmacy technician prepared the medication and the pharmacist signed off on it.
The heparin first was administered in the neonatal intensive care unit Friday. It's unclear how many of the children were dosed, because there were syringes from a different drug batch in medical cabinets in the unit, Davis said.
"Our pharmacies have very specific processes to follow in the preparation of medications," said Bruce Holstien, president and CEO of Christus Spohn Health System. "Obviously in this case something went terribly wrong."
The hospital's immediate actions included a review of policies and procedures with pharmacy staff and the implementation of a third layer in the drug verification process, meant as a stopgap measure to prevent similar incidents, Holstien said.
Two members of the hospital's pharmacy staff have taken voluntary leave, pending an investigation that could take as long as two weeks, Holstien said, adding state and federal agencies including the Texas Department of Health Services and the U.S. Food and Drug Administration have been notified.
Emily Palmer, a spokeswoman with the Texas Department of Health Services, said the agency is aware of the situation, but said she could not disclose whether there is a complaint or investigation because of confidentiality rules.
"We license hospitals and within that licensing there are a number of things we can do," she said. "We can make visits, we can make recommendations, we can make requirements and there can be penalties. This is speaking in general about hospital licensing."
The incidents also have been reported to the Joint Commission on Accreditation of Healthcare Organizations, an independent, nonprofit agency that accredits and certifies more than 15,000 hospitals in the U.S. including those in the Spohn system, Holstien said.
During the past 18 months, there have been roughly 250 medical errors nationwide involving heparin and children a year or younger, according to U.S. Pharmacopeia, the public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements and other health-care products manufactured and sold in the United States.
In September 2006, three infants died in an Indianapolis neonatal intensive care unit after receiving a 1,000-fold overdose of heparin. And in November 2007, the infant twins of actor Dennis Quaid and his wife, Kimberly, were the victims of a nearly identical mistake, an overdose of heparin at Los Angeles' Cedars-Sinai Medical Center, where the pharmacy dispensed the wrong dose to the nursing station, according to reports from the Associated Press.
In December 2007, Baxter Healthcare Corp., the drug's maker, introduced a new drug safety initiative that includes labeling with a 20 percent larger font size, a different color combination, and a red cautionary tear-off label.
On vials of the drugs meant for adults, the label now warns that it should not be given to infants.
Davis said labeling likely had nothing to do with the Spohn incident because the pharmacy mixed the drug batch itself.
Posted 09 July 2008 - 12:12 PM
hopefully now all hospitals will review P&P so it doesn't happen again. really, like 3 major newsworthy incidents in less then 5 years?
Posted 09 July 2008 - 12:16 PM
Very scary though! Those poor babies!
Posted 09 July 2008 - 12:17 PM
Posted 09 July 2008 - 12:24 PM
Posted 09 July 2008 - 12:39 PM
I can't believe one baby has died....breaks my heart!
We will see what happens in the next 4 month.
Posted 09 July 2008 - 01:24 PM
Still, this is unacceptable and should not have happened!!!! My heart goes out to all those babies and their families, including the baby that past away. How sad!
Posted 09 July 2008 - 01:25 PM
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