The expansion to 1000 sites was expected, but the trial’s protocol is yet to be registered.
After just a month of trialling pharmacist-led prescribing at 100 sites across NSW, the program is set to be expanded to 1000 pharmacies across the country’s most populous state.
The promised clinical trial registry, though, is still missing.
The scale-up has been on the cards since the trial was initiated, and early reports suggest an overwhelmingly positive public reception.
Under the current protocol, pharmacists participating in the trial are able to provide first-line antibiotics for women aged 18 to 65 who present with symptoms of an uncomplicated UTI, without performing a dipstick test or involving a doctor.
At some point later this year, participating pharmacists will also be permitted to dispense the oral contraceptive pill to women aged 18 to 35 who have been prescribed the pill for contraceptive purposes some time in the previous two years.
A major point of difference to the Queensland-based pharmacist prescribing trials is that the NSW edition, which is being led by the University of Newcastle, will be registered as a clinical trial with the Australian New Zealand Clinical Trials Registry.
The upshot of this is that there is more transparency around the trial protocol and outcomes, which has given groups like the RACGP and AMA more confidence in the initiative.
To date, however, TMR has been unable to find the trial on the registry.
Media reports from last month suggested that University of Newcastle’s ethics approval process had slowed down the process.
Regardless, a smaller feasibility study involving 100 pharmacies began in May.
Speaking in NSW parliament today, state Health Minister Ryan Park announced that 500 women had been treated through the trial scheme already.
“I’m extremely proud of this trial – a trial that will be researched, undertaken by a number of universities and evaluated,” he said.
“We’re working with the RACGP to get their support to make sure that links between pharmacy and doctors remains very strong and is at the core of the way in which healthcare needs to be delivered.”
Mr Park said the NSW government was committed to expanding the trial to the planned 1000 sites.
“We make no apology. In a time where we have a critical shortage of healthcare workers, and in particular GPs, we make no apology for looking at the way in which we can utilise the professional scope of our healthcare professionals,” he said.
RACGP NSW chair Professor Charlotte Hespe told The Medical Republic that the college was working toward ensuring the trial was fit for purpose.
“The outcomes we’re wanting to learn from running this as a proper trial is about seeing whom the trial benefits and are there any women that we’re missing?” she said.
“Is the protocol itself a safe one? What are the numbers of women who need to go and seek attention secondary to this?
“What are the numbers of inappropriate antibiotic use?”
While Professor Hespe hasn’t seen any of the data herself, she said her understanding was that pharmacies had seen more women in the first month than expected.
One detail that hasn’t been ironed out yet is GP communication.
In theory, pharmacists should be notifying a patient’s general practitioner if they’re treated as part of the trial.
“As always, it’s around funding and systems, because the pharmacists don’t have access to the same secure messaging that GPs do,” Professor Hespe said.
“And so the communications for them currently is quite clunky.
“From my perspective, anything that is clunky or difficult will be a barrier to it actually happening.”
TMR asked the NSW Ministry of Health and the University of Newcastle to confirm whether the trial had been put on the registry.
NSW Health said the university was the appropriate body to ask, but the university said the lead researcher was out of the country and that it would not be able to comment either way.