The trial protocol is reportedly more rigorous than the Queensland version, but NSW Health won’t release it to the public yet.
At some point this month, roughly 1000 community pharmacies in Australia’s most populous state will begin to prescribe and dispense antibiotics for uncomplicated cystitis in adult women.
From July, pharmacists will also be allowed to write ongoing scripts for the hormonal contraceptive pill for women who have received a GP or nurse practitioner script in the previous two years.
The wheels for the trial were set in motion last year by then premier Dominic Perrottet, but the program has bipartisan support and will be going ahead under the Minns government.
It was initially set to begin at the start of April but was reportedly pushed back due to delays with the University of Newcastle’s ethics approval process.
NSW Health would not give an exact date for when it will start, only that it “expects the trial to commence shortly”.
“The University of Newcastle is conducting a robust co-design process and, given this is a clinical trial, is enhancing patient safety by ensuring ethics approval is granted prior to each phase of the trial commencing,” NSW Health told The Medical Republic.
“This will give the women of NSW safe and appropriate access to treatment.”
The University of Newcastle told TMR that it had received ethics approval and was working to enrol and train interested pharmacists, but would not share the trial protocol.
According to AMA NSW chair Dr Michael Bonning, the protocol for NSW has gone through a stricter ethics process compared to the “closed and narrow trial” run by the Queensland University of Technology.
The RACGP reports that, unlike Queensland’s, the NSW trial will be registered on the Australian New Zealand Clinical Trials Registry.
“From the briefings and the discussions we’ve had at all levels through NSW Health, there’s been a willingness to consider how this becomes … part of integrated primary care,” Dr Bonning told TMR.
“Which is a significant difference from what happened in North Queensland.”
The AMA nationally and its NSW branch remain opposed to what Dr Bonning calls “open slather” pharmacist-led prescribing in siloed community pharmacy, but open to a model where pharmacists are embedded in a general practice.
“There is a willingness to accept the process of a clinical trial, so long as that clinical trial remains free from any political influence and is reviewed and peer-reviewed on its merits,” he said.
“And those merits … need to understand the full impact on the health system, not just the convenience measurement of … access.”
QUT and Queensland Health were notoriously close-lipped about the Queensland UTI trial, which was made into a permanent program last year.
The fact that QUT both ran the study and wrote the favourable evaluation report that secured the pilot program’s permanency was criticised by doctor’s groups.
As reported by Australian Doctor today, the final evaluation – published last month – identified 192 patients who were treated, but should not have been treated under the trial protocol.
These were patients that had presented to a pharmacist with cystitis symptoms two or more times within six months.
Under QUT’s guidelines, women with recurrent or relapsing UTIs should have been excluded from the trial and referred to their treating GP.
While it is hoped that the NSW trial will be different, NSW Health also refused TMR’s request to see the trial protocol or reveal which exact groups will be involved.
In the meantime, virtually all other states and territories have confirmed that they will proceed with some version of a pharmacist-led UTI trial.
South Australia commissioned a Parliamentary Select Committee on Access to Urinary Tract Infection Treatment to investigate the need for a trial, but it isn’t due to report until the end of August.
RACGP SA chair Dr Sian Goodson appeared in front of the committee recently, to reiterate the potential for poor outcomes.
“The reason we have always separated prescribing and dispensing is to avoid any potential conflict of interest,” Dr Goodson said.
“We certainly don’t want any model where pharmacists diagnose and prescribe for a condition, such a UTI, and then sell the very drugs required to treat that health issue.
“Let’s stick with what we know works best – GPs diagnosing and prescribing and pharmacists dispensing.”
