A psychiatrist, who held dual appointments at a university and at a DHB, prescribed ketamine for 11 of his patients who suffered from treatment resistant depression. Ketamine is only approved in New Zealand for use as an anaesthetic agent, and it was alleged that the psychiatrist's "off-label" use was part of his research agenda, and patients had not given their consent to participate in research. The Health and Disability Commissioner initiated an investigation after the case was referred to him by the National Health Board.
As part of his investigation, the Commissioner talked with the patients involved and reviewed the consent processes. The Commissioner concluded that patients were provided with sufficient information to make informed decisions about the ketamine. Further, while noting that there are often fine lines between innovative treatment and research, the Commissioner accepted that the psychiatrist's use of ketamine was for the "primary purpose of treatment", was not clinical research, and was not an "experimental procedure" for the purposes of Right 7(6). However, the psychiatrist was criticised for "insufficient formality in relation to what was clearly an uncommon approach". In particular, the Commissioner stated that the psychiatrist should have formally documented the collegial discussions he had about the proposed treatment, and warned the psychiatrist of the "need to exercise caution in situations where his clinical and research activities may overlap... in a situation such as this, there is a risk that the treatment will be viewed as having being incorporated into, and having formed part of, the research output...". The Commissioner also criticised the DHB for not having an off-label prescribing policy or any requirement to inform management where a practitioner was proposing to use a medication in a new manner: "it was suboptimal for [the DHB] to adopt a "hands off" system of oversight". 11HDC01072