Drug prescriptions spark DHB probe
WILMA MCCORKINDALE IN DUNEDIN
Southern District Health Board policies and processes are to come under the microscope after a Health and Disabilities Commission investigation into the off-label use of drugs.
A 75-page report by Health and Disabilities Commissioner Anthony Hill, released overnight, 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 unorthodox or off-label use of the drug, which is licensed in New Zealand only as an anaesthetic.
The board displayed insufficient oversight in the prescribing of off-label drugs, the report said.
The complaint, originally made by the board's former Dunedin-based mental health advisor Graham Roper and later referred to the Health and Disabilities Commission via the National Health Board, 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.
Roper 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 the board's psychiatrist when prescribing the drug, while complying with Royal Australian and New Zealand College of Psychiatrists 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.
He 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 2013.
The report also recommends audits of the policies to ensure their effectiveness, and the outcomes reported to the Health and Disabilities Commission by next June.
The commissioner recommended Dr A ensure consultations with peers about off-label drug use were recorded, including dissenting opinions and literature considered.
Dr A should also form a process to ensure all elements of Royal College guidelines were considered and recorded, and arrange for this process to be reviewed by a Royal College-approved clinician by August 20, 2013.
- © Fairfax NZ News
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