Drug prescriptions spark DHB probe

05:03, Jul 30 2013

The Southern District Health Board has accepted changes are needed after an investigation into its use of animal tranquilliser Ketamine, also enjoyed by some humans as a recreational high.

The DHB's chief medical officer, David Tulloch, said today the board welcomed stringent recommendations of a Health and Disability Commission (HDC) investigation report released overnight.

"It is a thorough report and makes sensible recommendations which we have already begun a process to implement.

"It is a complex area and it will help improve the processes of Southern DHB and other DHBs nationally."

Policies and processes of the Southern DHB and DHBs across the country surrounding off-label prescribing of drugs is to come under the microscope as a result of the investigation.

The 75-page report by Health and Disability Commissioner Anthony Hill outlined findings into a complaint against the Southern DHB's treatment of patients with treatment-resistant depression (TRD) using the drug Ketamine.


The commissioner's report chastised a board psychiatrist, referred to as Dr A, who was responsible for unorthodox or off-label use of the drug.

It is licensed in New Zealand only as an anaesthetic for the treatment of humans. It is widely used as a tranquilliser for animals.

The board displayed insufficient oversight in the prescribing of off-label drugs, the report said.

Background in the report said ketamine could, among other symptoms, cause hallucinations in humans.

It was known for inducing a state referred to as dissociative anaesthesia, and is used as a recreational drug.

One of many practitioners consulted for the report, a registered nurse working on the ward where the drug was administered, described it as horse tranquilliser and knew it was "sometimes used as a drug of abuse".

Hill has recommended DHBs tighten up policies, protocols and procedures concerning treatments involving off-label drugs, and has called for the reviewed policies be lodged with the National Health Board by September.

The report also recommends audits of the policies to ensure their effectiveness, and that the outcomes be reported to the HDC by June next year.

The commissioner recommended Dr A ensure consultations with peers about off-label drug use are recorded, including dissenting opinions and literature considered.

Dr A should also form a process to ensure all elements of the Royal Australian and New Zealand College of Psychiatrists guidelines are considered and recorded, and arrange for this process to be reviewed by a college-approved clinician by August 20.

The investigation was sparked by a complaint made by the board's former Dunedin-based mental health adviser, Graham Roper, and later referred to the HDC via the National Health Board.

Roper, questioned whether the off-label prescribing of ketamine to the board's TRD patients at one of the board's Dunedin mental health facilities, was part of a research project and possibly experimental.

The worker raised questions regarding whether appropriate consent was obtained from patients, and whether they were properly informed about the drug.

The commissioner said he was satisfied the evidence provided showed no research was being undertaken in administering ketamine and he was also satisfied its use was not experimental.

However, the actions of Dr A when prescribing the drug, while complying with college of practice guidelines, lacked formality in what was clearly an uncommon approach to the treatment of TRD, the commissioner found.

"A more explicit discussion of the fact this was off-label prescribing, and the anticipated end point of treatment, and careful recording of that discussion, should have occurred with all patients."

In 2010 when the off-label prescribing of ketamine began, the Southern DHB, in contrast to other DHBs, had no policy requiring the psychiatrist to report his intention to prescribe an off-label drug.

It had since formed a policy was that was not "sufficiently specific" to make the board's expectations clear, for example where peer review was required, the commissioner said.