'Grey area' possible in use of ketamine

Mental health patients in Dunedin were not treated experimentally when they were given ketamine, but it was ''borderline'', the Health and Disability Commissioner has found.

Approved in New Zealand as an anaesthetic, ketamine was prescribed to 11 patients with treatment-resistant depression in 2010 and 2011.

Referred to as Dr A in the report, the psychiatrist has been previously identified as Prof Paul Glue, who is jointly appointed at the Southern District Health Board and the University of Otago.

Health and Disability Commissioner Anthony Hill said both the health board and Dr A needed to tighten practices around off-label drug-prescribing.

The ''off-label'' term means a drug is being used for an indication not approved by Medsafe.

He recommended DHBs ensure they have policies dealing with off-label prescribing.

The off-label prescribing was unusual, but Mr Hill found it did not constitute research or experimental treatment.

''There can be a grey area with no clear line between an accepted (although uncommon and off-label) treatment and an experimental treatment.

''On balance, however, I consider that it was open to Dr A and his colleagues to conclude that the prescribing of ketamine for [treatment resistant depression] was not experimental.

''However, in my view, it was a borderline situation.''

In the finding released yesterday, Mr Hill said Dr A ought to have had clearer discussions with patients, kept better records of discussions, and clearly advised them of the anticipated end-point of the treatment.

Given his known research interest in ketamine, and the fact the treatment had not been used before in New Zealand, Dr A ought to have taken a more formal approach.

At the time, there was no requirement for him to advise the health board he was prescribing off-label.

''In my view, it was sub-optimal for Southern DHB to adopt a hands-off system of oversight.''

Since then, the board had adopted a policy for off-label drug use, but Mr Hill considered it insufficiently clear, and recommended a review.

The first six patients were prescribed ketamine in 2010, between April and September.

The patients gave verbal consent and received an information sheet. In September 2010, a consent sheet was drawn up, and the five patients who subsequently had the drug off-label signed it.

Mr Hill's first look at the issue was in response to a complaint laid by Mike McAlevey, of the Otago Mental Health Support Trust.

In 2011, concerns raised by the National Health Board prompted him to launch a full investigation.

''Dr A's research interests in this area undoubtedly informed his use of ketamine in Ward X. There is nothing unusual or inappropriate in that.

''However, these interests were generally known, and thus it was not beyond the realms of possibility that his treatment of patients in Ward X with ketamine would raise questions as to whether or not research was being undertaken.''

At the time, Dr A was developing a trial to use ketamine to treat depression in cancer patients on another ward.

Dr A told the commissioner the adverse comment about him was unduly harsh, because it related principally to lapses in record-keeping and documentation. He had co-operated fully with the investigation, which had been stressful and distracting, he told Mr Hill.

Southern DHB chief medical officer David Tulloch welcomed the report's ''sensible'' recommendations.

''It is a complex area and it will help improve the processes of Southern DHB and other DHBs nationally,'' Dr Tulloch said in a statement when contacted for comment.

Mr McAlevey said he accepted the finding, which had answered many questions. He added the health board ought to have been more receptive to the group's initial concerns, raised almost three years ago.

Some of the issues aired in the report could have been discussed then, which would have alleviated concerns.

eileen.goodwin@odt.co.nz

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