Friday, November 30, 2007

$27,000 fine follows probe in clinic deaths ERIC FRAZIER

Story can be found at: http://www.charlotte.com/112/story/383144.html

$27,000 fine follows probe in clinic deaths ERIC FRAZIER

N.C. regulators probing the deaths of at least 13 patients in a Charlotte
company's methadone clinics have fined the firm $27,000 for violations of
safety-and-treatment rules.

A state report detailing the allegations specifically mentions the deaths of
two people who received methadone at a Statesville clinic run by McLeod
Addictive Disease Center, a nonprofit based in Charlotte.

The report says McLeod didn't follow precautions that might have prevented
the deaths, and then failed to report the fatalities to a state agency as
required.

The fines were among the heaviest of more than 200 imposed this year by the
N.C. Division of Health Service, which oversees facilities ranging from
methadone clinics to group homes for mentally ill children. Methadone
clinics administer the drug to those recovering from addictions to heroin,
and increasingly, to powerful painkillers.

McLeod President Eugene Hall on Wednesday called the accusations untrue, and
accused investigators of being ill-informed about how his clinics work. He
said none of McLeod's seven other clinics were fined even though they
operate under the same rules and management as the Statesville office.

He said he will appeal. "This is just terribly frustrating and angering to
me."

The fines stem from the state agency's investigation of at least 16 McLeod
patient deaths in just over a year. Officials list two probable
causes: methadone toxicity, and a lethal combination of methadone and other
drugs.

State officials declined to comment Wednesday, saying they are wrapping up
their inquiry and wouldn't speak about their findings until complete.

They have said they began the investigation because of recent federal
advisories about the dangers of methadone.

They also have said they are checking for deaths in the 27 other methadone
programs around the state, but it's unclear whether any of those face the
intensive reviews given McLeod.

Regulators probed the Statesville clinic in October. Their report zeroes in
on the October 2006 death of a 28-year-old man. He died of acute methadone
and oxycodone toxicity, plus an abnormal build-up of fluid in the lungs
caused by heart failure.

Oxycodone, sometimes marketed under the better-known name of OxyContin, is a
powerful painkiller; methadone is sometimes used to wean people off
oxycodone addictions.

An autopsy report also showed that the man had ingested benzodiazepines --
sedatives doctors warn methadone patients against taking. The mixture can
send patients into a sleep so deep that they stop breathing and die.

Still, patients combine the drugs for the euphoric high they can't get from
methadone.

According to the state report, the 28-year-old tested positive at least
three times for the sedatives after he began treatment.

`I wanna go up'

The state report also accuses McLeod of improperly increasing the man's
methadone dosage more quickly than a doctor recommended. The report quotes
the man's sister as telling the state: "They give you such high doses, it
just puts them to sleep."The dead man's father, who was also being treated
at the clinic, told the state if a patient wanted a higher dosage, "all you
had to do was stand at the window and say, `I wanna go up.' They never asked
you nothing."

The clinic's medical director told investigators the man's death prompted
policy changes at McLeod in April. The clinic began using a more immediate
test for benzodiazepines. It allowed doctors to keep prospective patients
out of the program until they gave up the sedatives.

Other changes included new limits on dosage increases and upgraded
patient-education sheets warning about the dangers of mixing drugs.

But the state report said the changes weren't enacted in time to save a
53-year-old woman who died in April, nine days after starting treatment. The
state report says her counselor's notes did not contain required
documentation about the risks of methadone.

She had a history of depression, and was taking Prozac and fentanyl, a
painkiller.

State rules required McLeod to report the deaths to the Division of Health
Service Regulation within 72 hours.

Investigation criticized

Hall said regulators at the N.C. Division of Mental Health told him to send
the reports to them. An official with that agency even praised the
thoroughness of McLeod's reporting, he added.

When officials at mental health failed to send the reports on to their
sister agency, they stacked up on one official's desk, he said. Some were
even misplaced, he said, requiring McLeod to re-send copies.

He accused regulators of using criteria not normally applied to methadone
clinics.

"If these standards were to apply," he said, "there's no (methadone) program
in North Carolina that can operate."

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