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
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