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Confusion over UTI pharmacy prescribing ethics approval

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Last Thursday, NSW Health confirmed the commencement of its pharmacy prescribing trial, stating that eligible women who present with a UTI will be able to receive antibiotics from 100 pharmacies across the state without the need for a prescription.
 
Initially restricted to 10% of the 1000 community pharmacies expected to participate, the first phase of the Newcastle University-led trial has been described as a small ‘feasibility study’ to test the service in ‘real world conditions’.
 
‘We want to ensure this is done … safely – and we are determined to get it right,’ NSW Health Minister Ryan Park said.
 
‘That is why we are pleased to announce the details of this first phase of this state-wide trial.
 
‘This will not only improve access to medications – but it will also alleviate the pressure on GPs and primary care services.’
 
Details released by NSW Health include:

• patient eligibility criteria
• that the Government will cover the $20 patient consultation rebate, even if no medicines are dispensed
• broad information related to consulting room minimum requirements
• that the cost of medications will be the same as a private prescription.

In the same media release, pharmacist and lead researcher Dr Sarah Dineen-Griffin said the trial has been granted ethics approval and includes several safeguards to ensure that women needing care for UTIs are afforded ‘safe, appropriate and timely access to treatment’.
 
‘This trial is about strengthening the health system as a whole, including collaboration and ensuring GPs are informed when their patient sees a pharmacist,’ she said.
 
However, despite assurances from NSW Health that it would be registered with the Australian New Zealand Clinical Trial Registry (ANZCTR), at the time of publication (15 May) a search of the website’s database yielded no mention of the new pilot.
 
When approached for clarification, NSW Health declined to comment and directed newsGP to Newcastle University.
 
Dr Dineen-Griffin, via a Newcastle University spokesperson, subsequently explained that the trial has not been registered as the main trial is yet to begin, with the feasibility study only designed to test the viability of systems being used by the 100 initial pharmacies, such as:
 

• clinical management protocol, including referral processes to general practice
• data collection points and systems
• patient enrolment and consent
• payment processes of consultation fee to pharmacy
• out-of-pocket patient expenses for any medicines supplied
• patient follow up.

‘Refinements will be made to ensure patient safety and collaboration for the main trial,’ she said.
 
‘Ethics is considering the main evaluation trial protocol and as soon as it is approved, it will be registered on the ANZCTR.’
 
It is not clear how the ethics approval cited in the NSW Health release differs from that still being sought regarding the trial design, but Newcastle University has been approached for further clarification.
 
According to Nine Newspapers, the trial was originally expected to begin in but April delays involving the ethics approval process resulted in the UTI section of the trial being pushed back from its initial start.
 
It is also not clear why only 1000 pharmacies are now expected to participate, a number less than half the 2100 referenced by Newcastle University when it announced it had received a $3 million NSW Government grant to run the trial.
 
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