Drug Topics - January 28, 2008 - (Page H1) www.drugtopics.com JANUARY 28, 2008 DRUG TOPICS HSE 1 HEALTH-SYSTEM EDITION Drug error that harmed Quaid twins shows need for better safety measures Michael Barbella S hortly after their birth, the newborn twins of actor Dennis Quaid were hospitalized at CedarsSinai Medical Center in Los Angeles with staph infections. While they were being treated for the infections, the twins were among three patients who were given 1,000 times the normal concentration of heparin. Such a high dose can cause severe bleeding and death if left untreated. Michael L. Langberg, chief medical officer for Cedars-Sinai, said the Nov. 18 overdose was the “result of a preventable error.” Quaid’s twins and one other patient had their IV catheters flushed with heparin from vials containing a concentration of 10,000 units per milliliter instead of similar vials that had a concentration of 10 units per milliliter. All three patients given the wrong dose were children and were receiving intravenous medications. The error was identified by hospital staff, who quickly tested the blood-clotting function of the three affected, along with four other patients as a precaution, Langberg explained. Two patients were given protamine sulfate, a drug that reverses the effects of heparin and helps restore normal blood clotting function. “How many wake-up calls do we need?” asked Henri R. Manasse Jr., Ph.D., Sc.D, executive VP and CEO of ASHP. “What keeps us up at night is that we know how to prevent these serious errors. Yet here we are again, facing the exact same error that killed three infants in Indiana.” The Indiana infants died in September 2006 after they were given an accidental overdose of heparin through their IVs at Methodist Hospital in Indianapolis. A hospital investigation concluded the overdose was caused by a pharmacy technician mistakenly storing adult doses of the blood thinner in Methodist’s neonatal unit drug cabinet. Those deaths prompted the drug’s manufacturer, Baxter Healthcare Corp. of Deerfield, Ill., and the Food & Drug Administration to issue a statement warning of the “potential for life-threatening medication errors involving heparin products.” Baxter also revamped its packaging and labeling of heparin; the drug’s new label features bigger font size, a unique color combination and a large red cautionary tear-off label. Baxter’s warning and new labeling, however, was not enough to fend off a lawsuit filed by Quaid. The lawsuit accuses Baxter of failing to put clear distinguishing labels on its 10-unit and 10,000-unit vials of heparin, and fail- Hospital makes changes in wake of Rx error O ver the last two months, Cedars-Sinai Medical Center has taken these steps to prevent medication errors such as the one that affected actor Dennis Quaid’s newborn twins: • Sequestering high-concentration heparin (10,000 units per milliliter) in all pharmacies. • Using only saline to flush peripheral IV catheters on all pediatric patient-care units. This was already standard practice in the hospital’s adult patient-care units. • Prior to the error, the hospital required that all high-alert medications leaving the main pharmacy be checked by two members of the pharmacy staff. Hospital policy also required that high-alert drugs be checked again by staff in the satellite pharmacy. Now, high-alert drugs must go through a second check by satellite pharmacy staff before being stocked on floors. • Reinforcing the importance of nurses verifying medication and dosage before giving patients high-alert drugs. • Starting on Nov. 20, 2007, the hospital re-trained about 1,800 nurses and 200 members of the pharmacy staff on high-alert medication policies and procedures. Nurses were required to pass a written test on the material before they could continue caring for patients. ing to recall the product after the Indiana infants died. The Quaids are asking at least $50,000 in damages. Baxter spokeswoman Erin Gardiner declined to comment on the lawsuit, saying the company had not yet received a copy of it. But she noted that the medical mixup is “not a product issue” but rather the “improper use of a product.” Susan E. Loggans, a Chicago attorney who filed the lawsuit on the Quaids’ behalf, said the twins have recovered from the overdose. “The Quaids are very religious and they believe their children’s recovery is a real miracle. THE AUTHOR is a writer based in New Jersey. http://www.drugtopics.com
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