After reading this article I would prefer the FDA to resolve all labeling issues even if it takes time rather than be deceased and have my estate suing for a recovery.Confus'ing Package Blamed for Deaths 0 A Syracuse man is one of nine people nationwide to die from a hospital overdose. By JOHN O'BRIEN The PmfStmdard The maker of an emergency heart medication was warned five years ago that its packaging held the potential for a lethal mix-up by doctors and nurses. The standard medical practice is to use a glass ampule for a "loading dose," ready to be injected directly into a patient's vein, according to the Institute for Safe Medication Practices. The loading dose normally contams a diluted, and therefore weaker, dose of a medication. The undiluted dose ot a cirug is usually packaged in a vial, intended to be n-dxed with a saline solution in an intravenous bag, then injected into a patient with a syringe, the institute said. But the manufacturer of Brevibloc, du Pont Merck Pharmaceuticals, did the opposite. The company packaged the undiluted and more powerful dosage in ampules, and the diluted, weaker version in vials. Robert Dunning of Syracuse paid the price, along with eight other patients nationwide who died of accidental overdoses of Brevibloc since 1992 , according to institute president Michael Cohen, Dunning's widow and FDA records. A fadw of six Dunning was a 54-year-old fa- ther of six in February 1995 when he went to University Hos- pital for emergency surgery on a bleeding ulcer. Four days after surgery, he was in need of Bre- vibloc at the hospital. Brevibloc is used to slow down a rapidly beat- ing heart in patients who have just had surgery. Dunning got the ampule, not the vial, and was dead within min- according to his death certif- His widow, Margaret Dunning, is siu-ng du Pont and Ohmeda Pharmaceutical, which now mar- kets Brevibloc, for $ 11 million 'm U.S. District Court. She sued state-run University Hospital last vear. and the state settled for t850,000. Margaret Dunning said she was shocked to learn through her lawyers that her husband was not the first patient to fall victim to an accidental overdose of Brevib- loc. Since 1988, at least 28 pa- tients have received accidental overdoses of the drug in hospitals across the country, according to Robert Dwming would be alive today if Ohmeda or du Pont had repackaged @ vibloc, according to his widow's lawsuit. He worked at Accurate Die Casting for 13 years, was a courier for Fuji Film and a Rea market vendor at the Regional Market. "I don't think anyone else should die or be injured by these problems," Margaret Dunning said. "If our case prevents one more mistake, that won't bring Bob back, but it would be a good result'for other families, and it would save them from the pain and loss my own @y has suffered." in the offlng In 1992, the Institute for Safe Medication Practices told du Pont that the packaging reversal was a disaster in the offing. Even though the company put a warning on the ampule saying it had to be diluted before use, health professionals in an emergency might not read the label and would assume the ampule contained the diluted form, said Cohen, the institute's president. Cohen said he pleaded with du Pont and the Food and Drug Administration to reverse the packaging. "Doctors say, 'Give me an amp,' and what they really mean is a loading dose, and usually loading doses come in the ampule form," Cohen said. "Hearing that, I could definitely see where an inexpertenced nurse or doctor might grab an ampule if it's in proximity, and draw that up and give it in an injection.,, The patient would get a dosage stop his or her powerful enough to heart cold , he said. The company didn't heed the warning. Many of the overdoses occurred the way that Cohen's institute had warned they might: Health professionals assumed the ampule contmned the weaker dosage of the drug, even though the package included a warning label saying the concentrated dosage needed to be (Muted. The latest reported fatal overdose was in August 1996, One year after the manufacturer put a brighter caution label on the ampule and sent out a warning letter to hospital pharmacists across the country. Cohen said he wasn't aware Of how widespread the mix-ups were until a reporter told him last week of the reports filed with the FDA. "When you start seeing 15 and they just keep 20, you know that relying on practitioners to not allow this to-happen," Cohen said. "That's not enough of a barrier to prevent a patient death. "As long as it stays on the market in its present form, which is confusing to Practitioners, it is a given that there will be another death in the near future." He didn't hwe to dle Margaret Dunning claims in her lawsuit that du Pont and Ohmeda ignored the overdosing errors over t7he years and failed to correct the confusion over the packaging. "I couldn't believe that no one had fixed the problems before Bob died." Dunning said in a written Accident overdoses ' These are cases of accidental overdoses with Brevibloc since 1987. There have been nine deaths, six patients with brain damage and 28 cases of accidental overdoses: Year Age 1987 70 1988 49 1988 78 1988 24 1989 73 1989 73 1989 29 1990 31 1992 Unknown 1992 25 1992 45 1993 61 1993 Unknown 1993 Unknown '@93 53 1'993 Unknown 1994 Unknown 1994 20 1995 46 1995 65 1996 54 1995 54 1995 Unknown 1995 56 1995 86 1995 78 1996 78 iource: U.S. Food and Drug Administration response to questions given to her lawyer. She turned down interview requests. "My husband Bob didn't have to die. His death could have been prevented." Officials from Ohmeda, wtiicn bought Brevibloc from du Pont in January 1993, declined to comment. But in court papers filed in response to Dunning's lawsuit, the company's lawyers said that the roblem was out of Ohmeda's control because it had properly warned doctors and nurses, and that the FDA had approved the drug and the packaging. Gary Buehler, a pharmacist with the FDA arid chairman of the agency's medication errors committee, said the Brevibloc overdoses are a major concern at the FDA. "As is the cause of most medication errors, people just aren't reading things and they're pulling the wrong things," Buehler said. "I just looked at some reports, and I can tell you that people are still mixing them up." Ohmeda relabeled Brevibloc in 1995, after three patients died from overdoses within one month. The,company sent the warning letter to hospitals emphasizing the different strengths of the drug in the ampule and vial. The new package included a sticky label that went over the top of the ampule. "You can't break the top of the ampule without actually removing this little sticky thing, which says ever inject in essence, 'Don't you out putting this into someone with into an IV (intravenous),' " LI hler said. "Right now, I believe ]5ue our best safeguard against this thing is that little top hat over the ampule. a medical But in the heat of ctors and emergency, in which do nurses need to slow a patient's heart beat or stop it from beating too forcefully, they may not take the time to read Brevibloc's label, Cohen said. "People don't always read the labels when they' re in these tough I tuations where somebody's got SI an arrhythmia or hypertension, and you need to rapidly reverse it," he said. Doctors aren't supposed to ask for a dosage by ampule or vial, but Sox outcome Female recovered Female brain damage Female brain damage Female Recovered Mate Recovered Female Died Female Recovered Male Unknown Unknown Died Male Recovered Male Unknown Female Brain damage Unknown Brain damage Unknown Brain damage Male Recovered 1 Female Recovered 1 Male Recovered I Female Brain damage i . Male Recovered Male Died Female Died Male Died Female Recovered Male Died Male Died Female Died Male Died by specific amount, such as loo milligrams, Cohen said. His nonprofit institute, out of the Philadelphia area, advises companies on ways to make medication packages easier to use so mistakes are less likely. Buehler said Ms "pie in the sky" solution is to persuade Ohmeda to only market the concentrated form of Brevibloc diluted in a ready-touse 500 milbeter IV bag instead of undiluted in the 10 milliliter ampule, Buehler said. But that could be too expensive, and the FDA would Rely have legal difficult tea trying to order such a change, Buehler said. 'Sure dwthl 9 m A similar situation occurred in recent years with the anesthetic lidocaine, Buehler said. There was a 100 milligram syringe to be given in emergencies, and a 2,000 milligram syringe that was supposed to be diluted in an IV bag. But health professionals were injecting the more i)otent dose into patients and causing- their deaths, he said. The solution was to manufac. ture the more powerful dosage into TV bags before they were shipped, Buehler said. William Sawyer, a Syracu@area toxicologist, said the concentrated dosage of Brevibloc never should have been shipped. "There are some drugs that can be shipped in higher conce ntrations that you dilute upon receipt", Sawyer said. "There's some risk, but not nearly as high as this drug. This drug is sure death if this mistake is made." The safe medications institute wants 06eda to remove all the ampules from hospitals, or at least make sure the ampules are no longer in the operating room or emergency room. "In the heat of the moment, which is usually during a code blue (life-threatening) type situation, communication and reading and all of those things kind of go out the window and we grab for what we 're familiar with," said Stacy Wiegman, a pharmacist with the institute. "When they say 'Give me an amp,' they don't stop to read what it says." Dale Severance Syracuse, NY 13104 [log in to unmask]