Drug safety lapses at Cedars-Sinai

State investigation confirms internal findings

The California Department of Public Health says Los Angeles' Cedars-Sinai Medical Center's handling of high-risk drugs placed its pediatric patients in harms way. State officials spoke out after their investigation of an overdose involving the newborn twins of actor Dennis Quaid. The 20-page state report said the hospital gave the twins and another infant 1,000 times the intended dosage of heparin.

"This violation involved multiple failures by the facility to adhere to established policies and procedures for safe medication use," the report said. "These violations caused, or were likely to cause, serious injury or death to the patients who received the wrong medication." Further, state inspectors said, the unsafe medication practices "created a risk of harm for all hospital patients."

Cedars-Sinai chief medical officer Michael Langberg said the state report confirmed the hospital's internal findings identifying at least three separate safety lapses leading to the overdoses. "While this is a rare event, we are pleased that the [state agency] shares our view that it is an important opportunity for the entire institution to explore any and all ways we can further improve medication safety," Langberg said.

Errors cited by the state included nurses and pharmacy technicians not checking product labels before dispensing heparin and not keeping adequate records of when it was used and the hospital not taking steps to implement its own policies on high-risk medications.

Meanwhile, Quaid and his wife complained about a lack of candor in hospital officials dealing with them, saying they learned from the state report that their babies each were given two vials of heparin containing 10,000 U/mL rather than the common dosage of 10 U/mL. They said they had been told by hospital officials that each twin had received only one vial.

"We find it outrageous and totally unacceptable that we are learning for the first time … exactly what transpired," said Quaid and his wife Kimberly in a statement to the Los Angeles Times. "We were told by upper Cedars-Sinai administration that our children had received only one 10,000 unit dose of heparin when in fact they had received two 10,000 unit doses over an eight-hour period that we now know of. The hospital's lack of candor has left us with an uneasy feeling that we may never know the whole story."

The twins, who had been born to a surrogate mother 10 days before the incident, were at the hospital for treatment of an infection.

The state report found that mishandling the drug put pediatric patients in "immediate jeopardy," meaning it caused or was likely to cause "serious injury or death to patients who received the wrong medication." The lapse began when two pharmacy technicians mistakenly delivered 100 vials of the high-concentration heparin to the pediatric unit.

The Quaids sued Baxter Healthcare, which distributes heparin, accusing the firm of negligence in packaging different doses of the product in similar vials with blue backgrounds. Baxter has sent a letter to healthcare workers urging that they read labels on heparin packages to avoid confusion.