Fresh Therapeutics Is Participating in NSW Health’s UTI Medication Pharmacy Trial

Fresh Therapeutics is participating in NSW Health’s UTI Medication Pharmacy Trial. As part of this clinical trial, eligible women from across New South Wales can visit our pharmacy for the treatment of uncomplicated urinary tract infections (UTIs), including receiving advice on how to best manage their UTI.

This clinical trial is being led by the University of Newcastle to gather data on the safety and ease of having pharmacists assess symptoms of a UTI and dispense a medication if appropriate. The data gathered may be used in future research, reports, publications and presentations.

You will not need a prescription for UTI medication from your GP or doctor; our pharmacists will evaluate your condition and dispense the medication if appropriate. Additionally, you will not need to pay for a consultation with our pharmacists. The only fee will be for the medication itself.

To be eligible to participate in this clinical trial and receive UTI medication from our pharmacists, you will need to meet the below criteria.

• Be aged 18–65 years old.
• Be female.
• Have symptoms, such as burning or stinging (hurts) when urinating and/or a frequent or urgent need to urinate.

For further information about this clinical trial, we have provided some answers to frequently asked questions below. Additionally, you can speak with one of our pharmacists or visit the NSW Health website.

FAQ

What is a clinical trial?

A clinical trial is a research study used by experts to examine a new approach to the prevention, screening, diagnosis or treatment of a medical condition. The aim is to help to continue to deliver safe care with improved understanding.

In this trial, participating pharmacies can supply medications to treat UTIs without women needing to acquire a prescription from their doctor first. The trial is examining how safe and easy it is to get these medicines from a pharmacist.

What is a urinary tract infection?

Commonly referred to as a UTI, this condition is an infection in any part of your urinary system. The urinary system includes your kidneys, bladder, ureters (the tubes that join your kidneys to your bladder) and urethra (the tube that carries urine outside your body).

The infection typically occurs in your bladder (known as cystitis), but it can also present in your urethra (urethritis), kidneys (pyelonephritis) or in multiple locations in your urinary system.

Key symptoms of an uncomplicated UTI are:

• Burning, stinging or hurting when you urinate.
• Having a frequent or urgent need to urinate.

What is the difference between an uncomplicated and a complicated UTI?

In this trial, our pharmacists can only provide medication to women they assess as having an uncomplicated UTI.

Your UTI will be classified as uncomplicated if:

• You are otherwise healthy.
• You are not pregnant.
• Your urinary tract is not abnormal and/or has no obstructions.
• There is an infection in the lower section of your urinary tract (bladder and urethra), as suggested by the symptoms listed above.

If you meet any of the below criteria, your UTI is more likely to be classified as complicated.

• You are male.
• You have had a UTI more than once, such as 2 or more in the last 6 months or 3 or more in the last 12 months.
• You are pregnant or have recently given birth.
• You are immunocompromised.
• You have diabetes.
• You have renal (kidney) disease and/or impaired renal function.
• You have an abnormal urinary tract, have had surgery or stents on your urinary tract and/or a history of urinary tract obstructions.
• You have a catheter or had one in the last 48 hours.
• You have an intrauterine device (IUD).
• You have symptoms suggesting a more serious infection or one that has moved into the upper urinary tract, like:
  • Fever or chills
  • Rapid breathing or difficulty breathing
  • Raid heart rate
  • Chest pain
  • Headaches, nausea or vomiting
  • Confusion

If one of our pharmacists assesses that you have a complicated UTI, they will refer you to your GP or an Emergency Department as appropriate. This helps ensure you receive the medical care you require.

What will happen if I have symptoms of an uncomplicated UTI?

Firstly, our pharmacist will ask if you would like to participate in the NSW Health UTI Clinical Trial. If you agree, they will ask you to scan the pharmacy QR code and provide consent for your information to be used by the researchers. If you consent to participating in the trial, the pharmacist will take you into the consulting room to ask more questions about your symptoms.

If you are assessed as having an uncomplicated UTI, our pharmacist will give you a urine collection jar and explain that you will need to collect a midstream urine sample before commencing any treatment. This sample will need to be labelled and stored in the fridge to be taken to your GP if symptoms do not improve within 48 hours.

Then the pharmacist will advise the best treatment for your symptoms which may include an antibiotic. The antibiotic should not be taken until the midstream urine sample has been collected. The pharmacist will then explain what to expect from the treatment including any side effects and give you a “Urinary Tract Infection Fact Card.”

How much will it cost to get UTI medication from my participating pharmacist?

In this clinical trial, you will not need to pay for a consultation with our pharmacist. The only fee will be for the medication; this will be the same as if you have a prescription from your GP. You can learn the exact pricing by speaking with one of our pharmacists.

Are pharmacists qualified to prescribe this medication to me?

As part of this clinical trial, our pharmacists have received additional training from the University of Newcastle and the Pharmaceutical Society of Australia to help them assess the appropriate treatment for your symptoms. This training is based on international best practice.

This training includes guidance and protocols to follow in regards to who is eligible to receive the UTI medication, and who should be referred to to their GP or an Emergency Department. This ensures you receive appropriate care, whether you have a complicated or uncomplicated UTI.

If I participate in this trial, what personal information will need to be provided and how will it be used and kept safe?

To receive advice and medication from our pharmacists, you will need to provide:

• Your name
• Your date of birth
• Your contact details
• Your GP’s name (if you have one)

You will also be asked for your consent to participate in the trial. This includes consenting to receiving a follow-up call or survey from the trial researchers 7 days after speaking with one of our pharmacists. All information you provide will be kept confidential and secure by our pharmacists. The research team will then collect it from us.

Your personal information and data will be securely stored by the University of Newcastle for at least 15 years after the project has been completed. It will be stored according to the University of Newcastle’s Research Data and Materials Management Guideline (or any successor Guideline), as well as any other applicable University of Newcastle policy provisions.

Additionally, if the data gathered from the trial is used in future publications, reports and presentations, it will be presented in such a way that no participants can be identified.

Do You Have a UTI?

If you are experiencing UTI symptoms and meet the eligibility criteria described above, please visit our pharmacy. Our pharmacists can assess if you have a complicated or uncomplicated UTI, and provide medication or referrals accordingly.