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Newsletter

September 2006

Volume 1, No 12

Newer Antidepressants
Raise the Risk of Suicide

Newer antidepressants, already suspected of raising the risk of suicide, may also cause a few people to become violent, researchers reported on Monday.

They found that people who took GlaxoSmithKline's antidepressant Paxil were twice as likely to have what was called a "hostility event" as those given a placebo.

Paxil, known generically as paroxetine, is in a class of drugs called selective serotonin reuptake inhibitors or SSRIs.

They came under scrutiny when some doctors reported that teenagers taking the drugs might be more likely to commit suicide.

In 2004, the U.S. Food and Drug Administration concluded there was a higher risk of suicidal behavior among children and teenagers and ordered strong label warnings on several SSRI drugs. It has urged close monitoring of adults.

David Healy and David Menkes from Cardiff University in Britain and Andrew Herxheimer from the Cochrane Center used several sources of information to see what the risk of violent behavior was among people taking SSRIs.

They included data on paroxetine presented to Britain's Committee on Safety of Medicines Expert Working Group by GlaxoSmithKline, legal cases and e-mails from 1,374 patients in response to a British television program on the subject.

They found that 60 out of 9,219 people who took Paxil or 0.65 percent, had "a hostility event," compared to 20 of 6,455 given a placebo, or 0.31 percent.

Writing in the online journal Public Library of Science-Medicine, the researchers said, however, that such violence was likely to be rare.

"The new issues highlighted by these cases need urgent examination jointly by jurists and psychiatrists in all countries where antidepressants are widely used," they wrote.

"When violence is a suspected outcome, every case has to be considered carefully, on the principle that individuals are responsible for their conduct, unless there is clear evidence of compromised function that cannot be otherwise explained."

Source: September 12, 2006 Reuters Limited.

Concerns Over "Factive" or-"Gemifloxacin", An Antibiotic Used to Treat Sinus Infections

WASHINGTON - An antibiotic proposed as a treatment for acute sinus infections should be studied further because of serious skin reactions associated with its use, federal health officials said in documents released Monday.

When compared with other antibiotics used to treat minor infections, the incident of serious rashes has Food and Drug Administration officials concerned about the safety of the drug, Factive or gemifloxacin. The regulatory agency released the documents ahead of a Tuesday meeting of outside experts asked to consider the drug.

The FDA approved the drug in 2003 to treat pneumonia and acute bronchitis. Its manufacturer, Oscient Pharmaceuticals Corp., is seeking expanded approval to treat acute bacterial sinusitis as well. In 2002, the FDA had declined to approve that use.

Real-world use of Factive has shown what clinical trials previously revealed: the risk of rashes associated with the antibiotic appears to be greater when compared with that seen in other, similar antibiotics, according to the FDA documents.

In the documents, Oscient said its drug “represents an important additional therapeutic option for treatment” of acute bacterial sinusitis. Factive offers clear benefits and has a safety profile equivalent to other antibiotics. Oscient said.

At Tuesday’s meeting, the FDA will ask members of its anti-infective drugs advisory committee whether the benefits of Factive outweigh its risks as a treatment for acute sinusitis. The FDA isn’t required to follow the advice of its outside panels of experts, but usually does.

If the panel fails to endorse the drug, the FDA will ask whether further study could support the expanded use of the drug.

FDA briefing documents show that some within the agency already think more study is needed, given the risk of skin reactions associated with the drug: “The magnitude of the benefit gained from the use of gemifloxacin for the indication under discussion (acute bacterial sinusitis) needs to be clearly defined to weigh the magnitude of this drug-related risk,” FDA medical officer Dr. Andrew Mosholder wrote in a Sept. 5 memo released Monday.

Source: September 11,2006. The Associated Press

Dietary Supplements Containing Ephedrine Are Illegal in the U.S.

FDA informed consumers and healthcare professionals that all dietary
supplements containing ephedrine alkaloids are illegal to market in the
United States. Dietary supplements containing ephedrine alkaloids,
regardless of the dosage, are considered adulterated and pose an unreasonable
risk of illness or injury to users, especially those suffering from heart disease and
high blood pressure. FDA conducted an
exhaustive evaluation of relevant scientific data evidence on ephedrine alkaloids
before issuing this decision in a final rule in 2004. On August 17, 2006, a Court of
Appeals ruling upheld this final rule,
reversing an earlier decision by the District Court of Utah.

http://www.fda.gov/bbs/topics/NEWS
/2006/NEW01434.html

________________________________________________________________________
PAGE 2

OB Call Issue Spawns
EMTALA Suit

US District Court for the Middle District of Alabama has ruled that a pregnant woman
has a potential EMTALA claim against
an Alabama hospital based on the allegations of her complaint, and refused
hospital motions to dismiss the suit against
Medical Center Enterprise hospital (MCE).

Ginger Henderson alleges that she was 38 weeks pregnant when she was involved in an
auto accident and began to experience
contractions. The court opinion indicates that she contacted her personal physician
who advised her to go to the nearest
hospital emergency department.

The complaint alleges that Henderson presented to a clerk and advised that she was pregnant, had been involved in
an auto accident, and was experiencing contractions two minutes apart. She says
that she was directed to the waiting area
and at some point was summoned back to the desk and told that she would have to
wait while the hospital contacted the on-call
obstetrician and determined whether
he would see her because she was not a regular OB patient at the hospital. She left and sought treatment elsewhere.

The Court found that the hospital policy was that OB patients over 20 weeks estimated
gestation should be evaluated by the
emergency department physician prior to being sent to the OB area. There is no
indication of triage or physician medical
screening exam, according to the opinion.

“A jury could find that Mrs. Henderson was treated differently from other patients
presenting with the same information.

http://www.medlaw.com/cgi-bin/moxiebin/bm_tools.cgi?print
=312;s=2_6;site=1

Human Dosing Error Kills 2 Infants In Indiana

Premature Infants Given Adult Amounts of Blood Thinner, Hospital Says

INDIANAPOLIS - Two premature infants died after receiving adult doses of a blood thinner, a hospital said Sunday, blaming the incident on human error.

Four other infants in the Newborn Intensive Care Unit of Methodist Hospital also received adult doses of Heparin, and one might need surgery, said Sam Olde, chief executive of Methodist and Indiana University Hospitals. The other three were in serious condition.

Two babies born at 25 and 26 weeks’ gestation died Saturday night, Odle said. Both were born in the last week, officials said. A full-term pregnancy lasts 38 to 42 weeks.

“These are very, very small babies,” Odle said. “We are confident that no other infants except for the six were affected.”

Heparin is routinely used in premature infants to prevent blood clots that could clog intravenous drug tubes, said Dr. James Lemons, a neonatologist at Riley Hospital for Children.

An overdose could cause severe internal bleeding, he said.

Hospital officials had met with family members, Odle said, adding: “Our hearts go out to the families.”But apologies did not satisfy Whitney Alexander, mother of one of the infants who died.

“They may apologize but it didn’t help,” she told WTHR-TV in Indianapolis. “It didn’t help, because I feel like whoever the nurse was on call, they should know what they were doing and how much my baby should have.”

“This was human error — that’s all,” Odle said.
Pharmacy technicians place pre-packaged vials in a computerized drug cabinet, where they are retrieved by nurses who then administer the drugs, Odle said. The adult and infant doses are packaged similarly, and the hospital will contact the manufacturer to see if there is any way to make the packaging more distinct.

The hospital was investigating how the error occurred and reviewing its drug-handling procedures. Some corrective steps had already been taken, Odle said.

Babies born before the completion of week 37 are considered premature. Those born before 32 weeks face the greatest risk of death — about one-fifth don’t survive a year — and disabilities including cerebral palsy and retardation.

September 17, 2006

Source: Associated Press

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