One in three Australian pharmacists is not adhering to therapeutic guidelines when distributing over-the-counter drugs, an undercover probe has found.

In an investigation by the Queensland University of Technology (QUT), fake shoppers were sent into pharmacies pretending to need the ‘morning after pill’ or advice on eye infections. A third of the professionals erred.

The results have sparked calls for heightened regulatory oversight of the sector, “to ensure compliance with professional protocols”.

The investigation, by researchers from QUT’s Business School and Faculty of Health School of Clinical Sciences (Pharmacy), found that pharmacists were:

• Over-selling medications
• Over-treating or under-treating customers
• Providing medications off-label (use outside its stated consumer medicine information) and unapproved by government regulators
• Failing to properly diagnose certain conditions
• And failing to provide a physician’s referral as required by circumstance – that is, they didn’t advise customers to take their problem to a doctor

Secret shoppers with a delicate problem

The investigation was conducted as a sophisticated secret shopper exercise, involving two standard patient scenarios.

In one scenario, nine undergraduate business students (aged 19 to 29) requested an emergency hormonal contraceptive pill, Levonorgestrel – which is considered effective if taken within 72 hours of sexual activity.

The contraception is often referred to as the ‘morning after pill’. Photo: Getty

At the time of this part of the three-year study, Levonorgestrel was the only morning-after pill available as an over-the-counter medicine. In one version of the scenario, the secret shoppers visited 45 pharmacists and advised the pharmacist they’d had intercourse within 24 hours – and were appropriately provided the medicine.

However, in another version of the scenario, the secret shoppers visited 44 pharmacies and advised that they’d had intercourse outside the 72 hours, using the scripted words: “Probably three days ago last night.”

A third of pharmacists failed to advise a GP visit

In almost half the cases, the drug was inappropriately supplied – including instances where the customer was advised the drug probably wouldn’t work.

In this scenario, a physician’s referral would have been appropriate – but a third of the pharmacists didn’t supply one.

As the researchers write: “Provision of this drug after 72 hours is strictly off label… and unapproved by government regulators because of reduced efficacy and because post-coital contraception with higher efficacy rates after 72 hours are available, albeit only as administered or prescribed by a physician.”

It’s worth noting that until 2004, Levonorgestrel was a prescription-only medicine; it was downgraded to a pharmacist-only medicine to reduce barriers to supply.

Significant misdiagnosis and over-treatment

In the second scenario, the secret shoppers requested help for either viral or bacterial conjunctivitis, but on behalf of a friend or family member. The two forms of conjunctivitis respond to different treatments.

So the challenge for the pharmacist was to ask the correct questions to make a correct diagnosis.

While 82.7 per cent of pharmacists were compliant with the therapeutic guidelines in diagnosing and treating bacterial conjunctivitis, only 28.8 per cent were successful with viral conjunctivitis.

This led to significant over-treatment, sometimes with multiple medicines, suggesting a high prevalence of ambiguous or wrongful diagnosis.

Professor Greg Kyle, from QUT’s School of Clinical Sciences, was involved in designing the case studies. The publication of the investigation comes at a tricky time. “A lot of politics going on in the pharmacy space at this minute,” he said.

Since 2016, the Pharmaceutical Society of Australia has argued pharmacists should play a larger part in reducing the burden of increasing health costs across the sector.

The Pharmacy Board of Australia has just issued a discussion paper on pharmacists prescribing medicines.

Doctors protecting their patch

Doctors groups have jumped on the QUT study “to say pharmacists can’t be trusted … and the pharmacists are trying not to inflame the situation”.

Indeed. So far, instead of acknowledging any need for pharmacists to lift their game, Dr Shane Jackson, CEO of the Pharmaceutical Society of Australia – the national peak body for the sector – told the Australian Journal of Pharmacy the study “suggests consumers receive focused and cautious care from pharmacists in response to the simulated case studies”.

He concluded “consumers would benefit from a remuneration structure which supported longer patient-pharmacist interactions, particularly in more complex cases”.

In other words, if pharmacists were better paid, they would be in a position to provide “more targeted treatments tailored to each consumer’s specific health needs”.

Professor Kyle said there could be an argument for pharmacists to charge a consulting fee – as doctors do for their time.

He also said that instances of over-treatment and over-selling may have their complexities as opposed to being matters of greed or incompetence.

“Consumers should be given the appropriate advice for over-the-counter medications,” he said.

“It seems that is not always the case. Financial considerations may play a role but oversupply could also be due to pharmacists trying to deliberately reduce risk of adverse outcomes – for example, when the patient’s GP is not available late at night or on a weekend.”

But in the end, “we can only observe that the supply decisions are not in line with the recommendations of the therapeutic guidelines”.