Pharmacy prescribing trial protocol made public

The NSW pharmacy prescribing trial for uncomplicated UTIs has been retrospectively registered with the Australian and New Zealand Clinical Trials Registry and the study protocol published online.
 
The trial, which has been ongoing since May, is referred to by its acronym ‘PATH-UTI’ (PATHway to access: UTI management) and has one primary outcome; the proportion of patients who report that they are symptom-free seven days after treatment.
 
There are an additional 30 secondary outcome measures including rates of prescribing, antibiotic choice, hospital admissions, emergency department presentations, GP follow-up and adverse events.
 
The trial design is described as an open-label, mixed method cohort study and at the time of writing 273 patients had already been included in the study. All patients must be female, aged 18–65, and have symptoms suggestive of an uncomplicated UTI to be enrolled.
 
The trial aims to accrue 12,000 participants over a 10-month period.
 
Chief investigator and project lead Dr Sarah Dineen-Griffin from The University of Newcastle told newsGP that a collaborative effort with local GPs resulted in strong clinical guidance for the NSW pharmacists that are expected to take part in the trial.
 
‘In my view, the greatest strength is how the clinical management protocol was developed for this trial on the basis of an international review and co-designed locally by general practitioners and pharmacists,’ she said.
 
‘The primary objectives were patient safety and collaboration.’
 
It is expected that most patients will attend pharmacies on a ‘walk-in’ basis, with the pharmacist providing information on the trial and consultation process via a QR code that directs patients to an online platform that they can access using a mobile device.
 
The pharmacists will then undertake a structured consultation lasting approximately 10 minutes utilising a computer program to follow the clinical guidance document known as the PATH-UTI clinical management protocol. 
 
The PATH-UTI protocol details how diagnosis and management of UTI will be performed by pharmacists. This includes a detailed history, such as information on past medical history, previous infections, pregnancy details, the type of contraception used, sexual partners in the preceding 60 days and whether there has been contact with sex workers.
 
Pharmacists will use the PATH-UTI protocol to decide if the patient should be treated with antibiotics, over-the-counter measures, or referred to either their GP or the emergency department.
 
‘Good decision making can be guided, and that in itself isn’t a bad thing,’ Dr Michael Bonning, a member of the RACGP Expert Committee – Funding and Health System Reform, told newsGP.
 
‘But we have to also recognise that there are limitations for any guidance document, especially because there are many other lower urinary or lower abdominal conditions that may have symptoms that mimic a UTI.’
 
A major limitation of the trial is that no confirmed diagnosis of UTI via urinalysis or microscopy and culture is included in the study protocol, with pharmacists instead relying on patient-reported symptoms.
 
‘To appropriately diagnose a UTI, a urine sample should be assessed in office with a dipstick it and decisions made on that basis, in addition to symptoms, to potentially prescribe antibiotics,’ Dr Bonning said.
 
‘Resolution of symptoms at seven days is not particularly meaningful when the initial cause has not been sufficiently identified.’
 
Current therapeutic guidelines report that most women under the age of 65 with uncomplicated acute cystitis will be symptom-free within seven days without antibiotic treatment.
 
Patients will be offered a urine specimen jar at the time of the consultation and will be advised to collect a sample before commencing treatment and to bring this to their GP if their symptoms worsen or do not improve within 48 hours.
 
Dr Bonning also voiced concerns about the potential impacts of the funding structure for the pharmacy-based consultation. For the purposes of the trial, the NSW Government will pay the pharmacy $20 per consultation regardless of whether the patient required treatment advice or not.
 
‘What isn’t being assessed in this is the market distorting factor of the trial cost being absorbed by a third party,’ he said.
 
‘So patient decision making, when it comes to access to this form of care is being subsidised and therefore potentially sending a price signal to patients.’
 
Communication with a patient’s regular GP to advise on the outcome of the consultation is an ongoing concern.
 
‘The most significant limitation is that we don’t have a formal secure system of communication between community pharmacy and general practice,’ Dr Dineen-Griffin said.
 
‘To avoid the fragmentation of primary healthcare, it is critical to develop a national or state-based system where information, with consent of the patient, can be provided from community pharmacy to the patient’s regular GP.’
 
Patients will be sent a follow up survey seven days after their consultation through text message, email or by phone. This survey will assess adherence to the recommended treatment and referral advice.
 
A smaller sample of patients will also be offered a semi-structured interview to further evaluate their experience with the trial.
 
‘I’m open minded about the trial objectives and outcomes and recognise that a suitable understanding of adoption and unintended or unexpected outcomes of the trial need to be looked for and assessed,’ Dr Bonning said.
 
‘Only once the trial has reported should anyone make decisions about the future of any form of expanded pharmacy care.’
 
Dr Dineen-Griffin explained that the trial data can be used to inform any necessary changes to pharmacy prescribing for uncomplicated UTIs.
 
‘The evidence generated will be used to inform health policy and further improve, if required, the clinical management protocol,’ she said.
 
The study enrolment period is expected to end in May next year, with data collection finalised the following month.
 
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