A psychiatrist who treated patients with the anaesthetic and recreational party drug ketamine for depression was not carrying out research or experimental treatment, but better records of the treatment should have been kept, the Health and Disability Commissioner has found.
In a report released overnight, Commissioner Anthony Hill said that while the clinician, named only as Dr A, had complied overall with practice guidelines when prescribing ketamine to the patients, a more explicit discussion of the fact it was "off-label" prescribing, the anticipated end of the treatment, and careful recording of that discussion should have occurred.
The treatment occurred in Ward X of an unnamed public hospital in 2010.
Mr Hill found that the Southern DHB should have had in place a requirement that management be informed about the proposed prescribing of medication in a manner not previously known in New Zealand.
"In my view, it was suboptimal for Southern DHB to adopt a 'hands off' system of oversight," Mr Hill said.
Ketamine is commonly used as a horse tranquiliser, and on the party drug scene is known as "Special K". It has shown promise as a potential new antidepressant, following clinical trials overseas.
Dr A, who is employed at a university and who holds a clinical position with the Southern DHB, treated a number of patients suffering from treatment-resistant depression (TRD) with ketamine injections.
Ketamine is approved for use in New Zealand only as an anaesthetic. The unapproved use of an approved medicine is termed "off-label".
Six patients were prescribed ketamine between April 19, 2010 and September 13, 2010. While there were discussions with each patient about the use of ketamine and the patients gave verbal consent, they did not give written consent, Mr Hill said.
On September 20, 2010 an information/consent sheet on the use of ketamine in treating depression was created. The five patients who were subsequently treated with ketamine for TRD signed it but the sheet was modified in April 2011 to include a sentence to the effect that the use of ketamine in such a way was off-label.
None of the patients complained about the consent process or the provision of ketamine but the Health and Disability Commission began an investigation following a complaint from a third party.
Mr Hill accepted that the patients were provided with the information they needed and that the decisions they made were informed.
However, there was insufficient formality in relation to what was clearly an uncommon approach to treatment of TRD and aspects of the record-keeping processes should have been better.
"I am satisfied that the evidence does not, on the balance of probabilities, support a finding that research was being undertaken. I am also satisfied that the evidence does not, on the balance of probabilities, support a finding that the treatment, although uncommon, was experimental," Mr Hill said.
As ketamine had not been used previously to treat TRD in any New Zealand DHB, it should have been viewed as unusual. The DHB should have had in place a requirement that management be informed about the proposed prescribing of medications in such circumstances, Mr Hill said.
At the time, the DHB did not did not have a policy in place regarding off-label prescribing. It had since developed one but Mr Hill did not consider it sufficient.
"Additionally, I consider that the DHB should ensure that it has policies that make clear requirements and reporting expectations where the distinction between research and treatment is at risk of becoming (or being seen to be becoming) blurred," he said.
Mr Hill made a number of recommendations, including that Southern and other DHBs:
* review their current policy on off-label prescribing
* ensure they have in place policies and protocols that assist staff to determine whether or not proposed prescribing falls in the "grey area" of uncertainty between common off-label use and experimental treatment
* ensure they have in place policies and protocols that set out what is required of staff members in relation to their clinical and research activities
* audit compliance with the policies to ensure their effectiveness and that clinicians have similar understandings of their application