‘Sham’ trial slammed after Queensland moves on pharmacy prescribing

Doug Hendrie

10/03/2020 5:33:40 PM

Antibiotics for urinary tract infections will be available over the counter without a prescription in Queensland by the end of the year.

Concerns are rising as Queensland moves to make UTI antibiotics available over the counter.

The Queensland Government made the announcement on Sunday – without having any results from its trial of pharmacist prescribing for urinary tract infections (UTIs), which is yet to launch.
At a press conference coinciding with International Women’s Day, Premier Annastacia Palaszczuk said it would be a ‘win in my books’ if the antibiotics could be readily available without a prescription.
In response, a GP who first trained as a pharmacist said the proposal risks misdiagnosis or delayed diagnoses of dangerous conditions, given pharmacists cannot conduct examinations or send away for tests.
The news that GPs would be effectively bypassed as part of Queensland’s ongoing push to devolve services traditionally delivered by GPs to non-medically-trained pharmacists has led to a new outcry around the influence of the pharmacy lobby in that state.
Queensland is seen as the most pharmacy-friendly Australian state, having given pharmacists the right to offer flu vaccinations to children as young as 10, as well as travel vaccinations, ahead of other states.  
Dr Bruce Willett, Chair of RACGP Queensland, told newsGP the news suggests the pharmacy lobby is getting what it wants.
‘Whatever the Pharmacy Guild wants, it gets – in Queensland,’ he said.
‘The Guild gets a foot in the door and wedges it open.’
The comments come after it was revealed that Pharmacy Guild researchers will be involved in the UTI pharmacy prescribing trial, expected to launch mid-year.
RACGP President Dr Harry Nespolon and Dr Willett have warned repeatedly that making antibiotics available over the counter risks worsening the threat of antimicrobial resistance, which the World Health Organization considers one of the major threats to public health.
Dr Willett dubbed the seemingly superseded trial a ‘sham’.
‘The outcome is a foregone conclusion. The trial has been set up to not be a trial of anything,’ he said.
‘Antimicrobial resistance is such a huge issue. This really is an irresponsible effort to buy a few votes in a short-term move. It’s selling out the future of our access to antibiotics.
‘It’s not as if pharmacists have no treatments for UTIs; there are urinary alkalinisers which should be used in the first instance. Pharmacists should be encouraging non-antibiotic options first.’
Dr Willett – who provided evidence at Queensland’s inquiry into pharmacy ownership that gave rise to the trial – believes the State Government’s goal has been clear since the beginning.
‘The attitude has been so strongly, “this has to happen”,’ he said. ‘It was a done deal 18 months ago, and everything has just been window dressing between then and now.’
Dr Willett said that moving to offer antibiotics over the counter at pharmacies will increase costs for women, as well as the risk of misdiagnosis, in addition to the risk of antimicrobial resistance.

Dr Bruce Willett has dubbed the seemingly superseded pharmacy trial a ‘sham’.

Dr Krystyna de Lange, Chair of the RACGP’s GPs in Training Faculty, told newsGP the announcement is concerning.
Dr de Lange trained and worked as a pharmacist before becoming a GP. That experience demonstrated to her that pharmacist training regarding counselling patients on medication usage is very different to diagnosis.
‘Taking that next step into diagnosis is completely different. This announcement moves into an inappropriate scope of practice,’ she said.
‘For instance, pharmacists have no way of excluding pregnancy other than taking a woman’s word for it. But trimethoprim, one of these antibiotics in the trial, is contraindicated in pregnancy. It can cause congenital abnormalities if a woman takes it in her first trimester.’
Dr de Lange said the fact pharmacists will be unable to examine patients or undertake any investigations of other possible conditions raises the risk of misdiagnosis.
‘If you can’t send off a dipstick of a urine sample, there is a big risk of getting incorrect diagnoses,’ she said. ‘It’s not uncommon patients think it’s a UTI, but it’s herpes or chlamydia, or even a complication like pyelonephritis, where the infection ascends into the kidney.’ 
In her work, Dr de Lange said, she often sees patients with UTIs resistant to common antibiotics.
‘That information isn’t going to be available to pharmacists, so they’re not going to be able to tailor treatment based on what microscopy shows,’ she said.
Dr de Lange believes delayed diagnosis of potentially fatal issues such as bladder cancer is another major issue.
‘Pharmacists will argue they can follow a clinical protocol. But it’s more than just an algorithm – it’s clinical acumen and working through the differential diagnoses,’ she said.
The RACGP recently pulled out out of a steering group for the trial over its concerns regarding the lack of monitoring for potentially serious outcomes.
On Sunday, Premier Palaszczuk also announced her government will allow pharmacists to offer an interim supply of up to four months of the contraceptive pill without the need to see a GP. To do this, the Queensland Government will effectively bypass the Therapeutic Goods Administration process for down-scheduling by making changes to state medicines regulation.
‘It’s unfortunate that a government is seeking to undermine the due process of the Therapeutic Goods Administration,’ Dr Willett said. ‘They’re bypassing the proper approval procedure.’
Dr de Lange said state governments avoiding the existing rigorous process for scheduling sets a ‘dangerous precedent’
‘This creates an alternative route around current national guidelines and standards for scheduling,’ she said.
Queensland will also lobby the Federal Government to officially down-schedule the pill to make it Schedule 3 pharmacy-only medication.
State Health Minister Steven Miles said he is ‘not interested in the turf war between doctors and pharmacists’ in response to a question over the impact on GPs at the press conference.
‘I am interested in making decisions in the best interest of Queenslanders and Queensland women. The evidence points to the fact [the pill] is very safe,’ he said.
Premier Palaszczuk said the pill move will help to free up GP waiting rooms.
‘The changes we’re making by the end of the year will make women’s lives easier,’ she said. 
‘These changes are about improving reproductive healthcare for women in Queensland and, in particular, regional Queensland, where sometimes it’s easier to access a pharmacy than a doctor.’
The news has raised concerns after Queensland University of Technology researchers last year found many pharmacists were not following therapeutic guidelines for dispensing morning-after pills and conjunctivitis treatment.
After the pharmacy inquiry committee handed down its 2018 report, paving the way for the prescribing trial, the Pharmacy Guild’s then-Executive Director Pam Price wrote in a Guild publication that she expected the ‘usual predictable naysaying from certain doctor groups, whose knee-jerk concern for their business model masquerades as concern for patient safety’.
‘What we say to them is: recognise the potential patient benefit and convenience this represents within a safe framework, and work with pharmacists to ensure it is implemented in a collaborative and expeditious way. Put patients first, and give patients more control of their own health,’ she wrote.
‘We are sure most GPs will adopt this positive approach, regardless of what their peak body may say.’
Pharmacy Guild Queensland President Trent Twomey – who is regarded as an effective lobbyist – has previously dismissed criticism in a letter to Queensland MPs.
In the email, cited in the Australian Journal of Pharmacy, Mr Twomey said the concerns of the RACGP and Australian Medical Association (AMA) around antimicrobial resistance were ‘unfounded opinions’.
‘As medicines experts, the role and input of pharmacists in antimicrobial stewardship programs is very well established [and] the Australian Commission on Safety and Quality in Healthcare [has] highlighted the pharmacist’s key role in antimicrobial stewardship in hospitals, aged care facilities and the community,’ he wrote.
Mr Twomey framed criticism of pharmacist prescribing as a campaign ‘against advances in primary healthcare’. 
Both the RACGP and AMA have come out forcefully against the pharmacy prescribing trial. Both organisations have written to every Queensland MP over their concerns.
A spokeswoman for Minister Miles said in an email that the pill and the UTI announcements were separate, and that the UTI announcement was that the Queensland University of Technology had been engaged to run the trial.
The press release, however, states that Queensland will move to ‘make the pill and UTI medications available over the counter’.
The three antibiotics to be trialled will be trimethoprim, nitrofurantoin and cephalexin.
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Dr D Bower   11/03/2020 7:53:53 AM

Disappointing and potentially dangerous.

Dr David James Maconochie   25/08/2020 3:28:41 PM

This is nothing more than an unsubtle vote catcher for womens' votes. Either that or someone in the government is taking a bung from the Pharmacy Guild.

We can counter this. Pharmacists are registered with AHPRA, and no doubt like us they also dread receiving a notification. If is made known that any pharmacist playing "doctor" outside his skill set will receive an AHPRA notification, then it is likely that there will be few willing to take the risk.

Anonymous   27/01/2023 9:25:30 AM

The time for negotiation is over!
The college needs to make a formal complaint to the QLD Office of the Health Ombudsmen that pharmacists are operating outside their scope of practice, expertise and training for monetary gain and as such, are creating a dangerous situation for the public. Please just do this. Being nice does not work!