Heparin Banner

Drug stayed on hospital shelves despite recall

10/02/2008

By SHAYA TAYEFE MOHAJER Associated Press Writer

LOS ANGELES—Nearly 100 pharmacists and the hospitals they work for face fines for failing to remove a blood thinner from their shelves after a federal recall last winter, a state agency said Thursday.

The recalled drug heparin was found 94 times in inspections of all 533 hospitals in California, and at least 16 hospitals administered the drug to patients, according to the state Board of Pharmacy. Fines range from $2,500 to $5,000.

"This was really an alert that the recall system doesn't work," Virginia Herold, head of the state's pharmacy board, told The Associated Press.

Regulators have not released the full list of hospitals involved. However, documents obtained by the Daily Journal show newborns were allegedly given heparin at the University of California San Francisco Medical Center and Children's Hospital of Central California in Madera. Both hospitals are appealing the charges.

Heparin, which is often used in premature children to prevent blood clots, has come under scrutiny because of accidental life-threatening overdoses given to babies, including actor Dennis Quaid's newborn twins at a Los Angeles hospital last November. Fourteen other babies received accidental heparin overdoses in July at a hospital in Corpus Christi, Texas.

The Federal Drug Administration issued a drug recall in February because "a higher than usual number" of patients reported adverse effects to heparin, which include chest pain, dizziness and headache.

The state's Department of Public Health has also launched an investigation to determine whether recalled heparin, Digitex and Procrit caused harm to any patients.

No link has been found, though a state health official said the state will try to ensure recalled drugs are taken out of hospitals

"Our actions are to act as both a partner and an enforcer to look at what kinds of system breakdowns are taking place, to make sure we don't have a reoccurrence of this in the future," Kathleen Billingsley, deputy director of the state's Center for Healthcare Quality, told the AP.

In March, the state Board of Pharmacy voted 12-0 to give drug makers, wholesalers and pharmacies until Jan. 1, 2011, to start electronically tracking drugs from factory to patient. The electronic tracking system has been delayed a number of times since 2004, when a recall of 175,000 bottles of fake Lipitor, the cholesterol drug, led state regulators to require tracking.

Herold said although it's unclear whether the tracking system would have prevented this incident, it will give pharmacists a better idea of what is on their shelves.

Last week the Oakbrook Terrace, Ill.-based Joint Commission, an independent, not-for-profit organization health quality group, issued a safety alert asking hospitals nationwide to adopt stricter measures to prevent errors involving blood thinners, including heparin.

Copyright 2008 The Associated Press.

Next: Regulator says hospitals need strict heparin rules

For information on the recall, click here:

FDA Information

To contact us, call 800-992-9447.
g@gordonjohnson.com

Gordon Johnson is the Owner of the Johnson Law Office.

Disclaimer

Heparin

To contact us
call 800-992-9447

For Our Latest Information on Heparin go to our Blog:

Link to heparin blog

Heparin Glossary

 

Heparin Molecule

 

 

 

Link to Blog

TOPICS:

©Gordon S. Johnson, Jr. 2008