Mystery over proposed pharmacy prescribing ‘trials’

There is growing concern over the New South Wales Government’s election promise to further extend its pharmacy prescribing pilots, despite much of the program having not even begun.
 
Announced over the weekend by Premier Dominic Perrottet, the latest extension of the scheme will allow pharmacists to renew prescriptions for the contraceptive pill as part of a ‘fast-tracked’ plan laid out ahead of next month’s state election.
 
However, while the government press release contained information on the start date (1 July) and out-of-pocket costs (free, aside from the cost of medication), it contained minimal information on patient safeguards, other than stipulating that pharmacists will need to undertake ‘additional training’.
 
When approached, NSW Health declined to provide more information on the length and type of training pharmacists will need to do prior to renewing oral contraceptive prescriptions, other than to say it will be a ‘key requirement’ of the trial.
 
Instead, the spokesperson told newsGP that NSW Health ‘has worked, and will continue to work’ with the ‘clinical trial team’ to consider issues concerning safety and appropriateness of care.
 
‘The clinical trial is being run by a consortium led by the University of Newcastle, involving Charles Sturt University, the University of New England and the University of Technology, Sydney,’ the spokesperson said.
 
‘The University of Newcastle consortium was selected by an expression of interest process. They had prior experience piloting a Minor Ailment Service in Western Sydney, where pharmacists were integrated into HealthPathways to ensure appropriate referrals to GPs and emergency departments, but also definitive care when appropriate.
 
‘A key feature of the clinical trial will be its integration with general practice, and others.’
 
Despite both the media release and the NSW Health spokesperson repeatedly referring to the scheme as a clinical trial, a search of the Australian Clinical Trial Registry did not yield any results for either pharmacist UTI prescribing, nor oral contraceptive renewal. The spokesperson also did not respond to a query as to when, or if, this would occur.
 
The extension of the trial to include oral contraceptive renewal appears to directly contradict the will of the Therapeutic Goods Administration (TGA), which in 2021 ruled out over-the-counter sales of the medication, citing patient safety.
 
It also follows the recent publication of Australian Electoral Commission records showing that the Pharmacy Guild of Australia, which has lobbied strongly for extending pharmacists’ scope of practice, had given $107,950 to the NSW Liberal and National parties in 2021–22.
 
NSW GP and RACGP Expert Committee – Funding and Health Reform (REC–FHSR) member Dr Michael Bonning told newsGP the recent develops are concerning.
 
‘Any clinical trial needs to clearly describe what it will provide and what limits that trial will have,’ he said.
 
‘NSW Health and the trial investigators need to clearly explain the trial parameters to the public and to the clinicians it will impact – GPs – so that for any patients who subsequently visit a GP, it can be known about what health summary information has been generated and where that can be accessed.
 
‘It is fundamental that there are clear follow up protocols for patients who have suspected UTIs and if there is no plan to take urine samples from these patients then that should be a transparent limitation of this trial, as we’ll never know whether the patient had a urinary tract infection or something else, or whether these kinds of trials are contributing to antibiotic resistance.’
 
NSW Health did not provide any clarification when asked about patient safety or follow up, other than noting that participation would be restricted to certain groups as one of ‘a number of important safeguards’.
 
‘In relation to UTIs, the trial will involve women aged 18–65 years of age who have had a previously treated uncomplicated UTI and who do not have significant risk factors identified through the consultation process,’ the spokesperson said.
 
‘In relation to the OCP [oral contraceptive pill], the trial will involve women aged 18–35 years, who have been issued a prescription for the OCP in the past two years by a medical or nurse practitioner, who are on the OCP only for oral contraception and be limited to the lower risk OCPs.
 
‘If a patient is taking the OCP for other health conditions, eg hormonal migraine, they will be referred back to a GP.’
 
It is not yet clear what will constitute ‘significant risk factors’, nor how pharmacists will be trained to identify them.
 
However, the spokesperson did note that the oral contraceptive consultation will include sexual health, consideration of contraception choices, checking that the person is up to date with screening and ‘other relevant health concerns’.
 
‘There will be an emphasis on ensuring the usual treating clinician is informed that the consultation has occurred, with the patient’s permission,’ the spokesperson said.
 
Criticism has previously been levelled at the Queensland UTI pharmacy prescribing pilot after 64% of the more than 4300 patients who took part were not reached for comment following treatment.
 
Reports from GPs of ‘alarming’ complications in patients following autonomous pharmacist intervention also plagued the pilot, with an AMA Queensland survey highlighting 73 apparent cases where conditions such as chlamydia, herpes, gonorrhoea, and an ectopic pregnancy were allegedly mistakenly categorised as UTI.
 
Dr Bonning believes the lack of detail and sudden changes to the trials suggest a lack of clear direction on the part of the NSW Government.
 
‘This is an area where the government is undertaking healthcare experiments without a clear idea of what they are trying to achieve and changing the goal posts,’ he said.
 
‘Originally, the out-of-pocket cost was reported to be $25–30, but now it is reported this will be covered by the State Government.
 
‘Meanwhile, new things such as extended prescribing of contraceptives have been added in far sooner than was originally planned, even though the trial hasn’t been fully laid out in any way, especially regarding the outcome, measures or the impact on fragmentation of care.’
 
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