GPs and medical groups raise concerns about adverse patient outcomes, but what does the evidence say so far?

With Queensland now allowing pharmacists to prescribe medicines for uncomplicated urinary tract infections after a two-year pilot, and more trials beginning elsewhere, the debate about potential harms continues.

In New South Wales the pharmacy prescribing trial for uncomplicated UTIs has begun, with skin conditions and infections, and resupply of oral contraceptives, to follow.

Plans for a similar pharmacy prescribing trial in Victoria are also underway, and in North Queensland a trial to expand pharmacist prescribing to a broad range of conditions is set to begin later this year. And Victoria has plans to begin a trial similar to the one that has commenced in NSW.

However, a new Healthed survey reveals that many GPs have concerns about the impact of pharmacy prescribing on patients.

When Healthed asked GPs ‘Are you aware of any adverse health outcomes associated with pharmacy prescribing?’ in a free text box as part of a national survey, half of the more than 900 respondents identified possible or actual adverse outcomes. One quarter expressed general concerns about the schemes, and another quarter cited specific examples of adverse outcomes.

“Treating suspected UTIs with antibiotics without dipstick testing of urine, resulting in unnecessary antibiotics.”

Consequences of misdiagnosis

A number of respondents noted specific pitfalls of pharmacists prescribing for UTIs. In particular, several cited examples of pharmacists misdiagnosing and prescribing antibiotics for UTIs when symptoms had actually been caused by STIs, including chlamydia and mycoplasma, or ectopic pregnancy, among other underlying conditions. Others expressed concerns about antibiotics being prescribed without a urine sample, making it difficult for GPs to choose next line antibiotics when patients present with unresolved symptoms.

Several respondents also identified adverse patient outcomes related to inadequate pharmacy diagnosis and treatment of a range of other conditions, including eye conditions, thrush and skin conditions.

Key areas of concern:

• Pharmacists’ lack of training, knowledge and skill in diagnosis and treatment
• The risk of inaccurate or incomplete diagnosis and treatment – including inability to investigate and lack of clinical monitoring and follow up
• Risk of serious adverse consequences from misdiagnosis, including delays in investigations.
• Financial conflict of interest
• Lack of continuity of care
• Risk of increasing antibiotic resistance

Source: Survey data from 900 respondents to a free text question in Healthed’s 2 May survey

Many concerns have centred on the lack of proper diagnosis. In a measured op-ed in the MJA, Sydney GP Dr Alisha Dorrigan points to the complexity of some medical conditions proposed for the North QLD pharmacy prescribing trial, including infections such as otitis media and otitis externa, noting differentiating the two is impossible without being experienced in the use of an otoscope.

Despite all this, 50% of respondents did not note any concerns and were not aware of any adverse outcomes from pharmacy prescribing, and an earlier survey of 350 GPS last year found many respondents were open minded about a trial of pharmacist prescribing certain medications.

“Pharmacist missed several cases of chlamydia and mycoplasma leading to potential infertility”

The evidence so far

Pharmacist prescribing already occurs internationally, including in the UK, Canada and New Zealand, and a number of studies have shown promising results. A UK study of pharmacist-led assessment and treatment of uncomplicated UTIs found it was safe and benefited patients. Evaluations of two Canadian schemes—one that also looked at pharmacist prescribing for uncomplicated UTIs in New Brunswick, and a randomised control trial of pharmacist prescribing of antihypertensives (where the intervention group also received education and assessment of BP and CVD risk, laboratory monitoring and monthly follow ups for 6 months)—found the schemes led to better clinical outcomes.

“In the UK our pharmacist worked within the surgery and we had good feedback as well as records of prescriptions. How will the communication be made for what has been prescribed?”

Understandably, evidence from Australia is limited.

The report into QLD’s UTI pilot found the service was effective in treating UTIs overall; UTI symptoms resolved in the majority of patients following antibiotic treatment, and patient-reported adverse events during the 7-day follow-up matched the expected effects from the antibiotic treatment. Of the 2409 patients available for follow up (one third of the participants), 87 percent reported their symptoms had resolved following antibiotics, and three quarters of those whose symptoms hadn’t resolved visited a GP, with five visiting a hospital.

The report also found that overall, patients were happy with the service, would use it again and would recommend it to others.

However, the RACGP Vice President Dr Bruce Willett notes evidence of treatment protocol deviation, after nearly 200 women were given antibiotics despite not being eligible to participate due to recurrent infection or relapse, which should have seen them referred to a GP. Dr Willet believes this calls into question the capacity of pharmacists to manage more complex diseases such as heart disease and diabetes.

Despite predictable enthusiasm from the Pharmacy Guild, the RACGP and AMA have remained opposed to the trials. In its “You deserve more” campaign, the AMA warns that patients will be “part of an experiment” if they take part in the upcoming trials, and that pharmacist prescribing threatens patient safety, fragments care and undermines the Australia’s world class health system.

But the ball appears to be rolling.

More than 1000 pharmacies have signed up to the NSW trial, which will include antibiotics for UTIs, treatments for skin conditions and infections, and resupplying oral contraceptives.

The NSW clinical trial will examine the safety and effectiveness of pharmacy prescribing schemes. More than 1000 pharmacies have signed up to the NSW trial, which is being led by the University of Newcastle and NSW Health.

A spokesperson for the NSW clinical trial stressed that safeguards are in place for UTI prescribing, including limiting the trial to “women aged 18 to 65 years of age who are displaying symptoms consistent with uncomplicated UTI and who do not have significant risk factors identified through the consultation process.”

A start date for the Victorian pilot has not yet been announced, but will allow pharmacists to treat some mild skin conditions and uncomplicated UTIs in women, administer public health vaccinations and reissue oral contraceptive prescriptions.

“I have been standing in line waiting for a script and heard the terrible advice given to a young female asking about abdominal pain. I still regret not speaking to her afterwards, as she was given an OTC PPI when it could have been anything, including an ectopic pregancy from the history that was taken, in full earshot of everyone else in the place. I hope she saw a Dr…”
-Survey respondent