Dunedin Hospital is under
investigation over the use of drugs in medical research
without proper patient permission.
The National Health Board yesterday released terms of
reference to examine the use of ketamine in Dunedin Hospital's mental-health
service.
The review will determine whether patients prescribed
ketamine "could be considered to have been participating as
research subjects without having been so advised or having
given their consent".
Included in the investigations would be scrutiny of hospital
processes on "off-label" prescribing, a use not specifically
approved.
Ketamine is licensed by Medsafe as a fast-acting general
anaesthetic and is commonly used by vets. The class C
controlled drug is also used recreationally for its
hallucinogenic effects.
The Health and Disability Commissioner began an investigation
this month after earlier rejecting a complaint from a Dunedin
mental-health trust about Prof Paul Glue's prescribing of
ketamine.
Prof Glue is a hospital psychiatrist and head of
psychological medicine at the Dunedin School of Medicine.
In April, commissioner Anthony Hill, responding to Otago
Mental Health Support Trust advocate Mike McAlevey, said
patients were given information about the risks, side effects
and benefits of ketamine in treatment-resistant depression.
They were assessed as able to give consent, and none was
subject to compulsory mental-health treatment orders..
Although deciding to take no further action, Mr Hill told
Prof Glue and the Southern District Health Board it needed to
be made clear the drug was being used "off-label".
DHB (Otago) chief medical officer Richard Bunton said the DHB
was satisfied Prof Glue had followed correct protocol.
"We felt there had been no misuse of the drug at all."
Mr McAlevey said an abstract from a presentation Prof Glue
gave at a conference last October had the appearance of
"organised research". Fast acting antidepressants: Past,
present, and future prospects for ketamine summarises the
results of "local experience" of treating 10 adults with
"treatment-resistant major depression" using an intramuscular
injection of ketamine.
A spokeswoman for Otago University said a response issued to
the ODT on Prof Glue's behalf last November, which
said ketamine prescribing was not a "formal research study",
still stood.
In the response, Prof Glue wrote that patients provided
informed consent and although it was an off-label use of
ketamine, its use was supported by clinical trial data and it
was found to be safe and well tolerated.
- eileen.goodwin@odt.co.nz
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