Pharmacist UTI prescribing and the scandalous silence of the regulators

The ability of pharmacists to both prescribe and dispense S4 antibiotics for UTIs is now mainstream Australian healthcare. 

Two weeks ago, the Queensland Government announced that its controversial prescribing trial, which has involved 817 pharmacies treating women and more than 240 reports of adverse events, will continue indefinitely.  

Doctors remain alarmed. But the destruction of the prescriber–dispenser divide, the limited diagnostic training pharmacists undergo and the threat of fuelling antimicrobial resistance in the community have been met with silence by the regulators tasked with protecting the public.

Dr Evan Ackermann, a Gold Coast GP and former chair of the RACGP’s quality and safety expert committee, wants to know why bodies like the TGA, AHPRA and the Pharmacy Board of Australia have said so little.  

Is it a scandal?

In the Queensland pharmacy UTI trial, the Pharmacy Guild of Australia has proven that, if you have the complicity of a state health minister, you can bypass national standards and provide S4 antibiotics as OTC drugs.

Indeed, you can circumvent any drug therapy monitoring, fortify a pharmacy business model and get regulators involved in patient safety to play dumb and say nothing. How easy it seems.

They should take a look at the long-awaited evaluation of the trial; it was finally released this month.

It runs to 118 pages and has lots of charts and graphs and numbers, but despite all this, much of it is vacuous and self-serving, offering no proper evidence of patient benefit.

The trial was never about assessing a legitimate clinical service, a fact illustrated by the tick-box protocol of the trial itself.

The financial-conflict effect was patently obvious. Women were asked to pay $19.95 for the consult with the pharmacist and then charged between $10 to $15 on average for any antibiotic prescribed.

Read more: Here’s the pharmacy UTI trial evidence we’ve been waiting for

Pharmacists noted it was hard to charge for a service if an antibiotic was not given, and this probably explains why 96% of the women who presented received antibiotics.

Compare that figure for the moment with the 2019 GP registrar study in a higher complexity cohort, where only 86% were given immediate antibiotics. 

Worse still, the outcomes data show that 10% of the antibiotics were provided by just five (1%) pharmacies that took part.

Maybe these pharmacies were super-sized behemoths, maybe not — the evaluation report doesn’t seem that interested in finding out.

But these pharmacies dispensed antibiotic scripts at 5-10 times the trial average; that’s pill-mill-like activity.

The service seems to have promoted inappropriate antibiotic sales in ways that many of us predicted when this trial was first announced.

But as has been discussed at length, the evaluation’s methodology was so poor that it didn’t employ a mechanism to track whether this was happening. Perhaps it felt it was better not to know.

Hence its disturbing silence on the impact, or otherwise, of breaking down the prescriber–dispenser divide and replacing it with financial incentives to prescribe antibiotics. Despite its length, the topic is not mentioned, never mind discussed.

And hence its disturbing silence on whether pharmacists were also engaged in ‘coke and fries’ onselling, flogging unnecessary supplements and pharmacy product to women on the back of the consults they were running.

In the UK, where there is similar pharmacist UTI prescribing, Boots pharmacy chain introduced a Cystitis Test and Treat Service in 37 stores and stocked cystitis tests to nearly 300 stores across the UK.

It has seen rapid commercialisation in diagnostic kits, e-technology tools for automated antibiotic prescriptions, complementary therapies and associated products.

But antibiotic prescribing for UTIs seems to be a business model that some pharmacies desperately want to be engaged in.

Related news:

• Pharmacy guild accuses AMA of making up claims that women were harmed by pharmacist UTI trial
• Pharmacy guild says doctors made up UTI adverse events: A GP responds

With the Queensland Government extending the trial indefinitely, we now have a situation where pharmacies can provide three different antibiotics OTC without any regulatory oversight.

No government department is monitoring this going forward; there is no independent body continuing to provide oversight.

If care goes bad or the profiteering comes at the expense of patient safety, it will only get picked up if the patient complains or doctors dealing with the aftermath start lodging AHPRA notifications.

A pharmacist in Queensland, subject to the online training, can now provide an antibiotic for anything, anytime; no-one is watching.

This is a codeine-like situation, and drug misuse will be the ultimate endpoint.

Has any pharmacy body — I’m talking about the Pharmacy Board of Australia and the Pharmaceutical Society of Australia — discussed the financial conflict of interest? No.

Has any pharmacy regulator expressed a concern about the very high antibiotics prescribing in some pharmacies? No.

Have any pharmacists spoken about the fact that UTI symptoms failing to resolve in 13% of ‘uncomplicated’ cases is clinically significant and worrisome? No.

Has any pharmacist mentioned the ethics or professional etiquette of dumping treatment failures on GPs? No.

And what is the stance of the pharmacy board and the Pharmaceutical Society of Australia, which set standards for the profession, on destroying the prescriber–dispenser split? They don’t care? Have no view?

Some pharmacists seemed to be ecstatic about providing a pseudo-clinical service that undercuts their core values in quality use of medicines.

Yet the leaders of the profession don’t see the dangers of basic standards being tied to the commercial dictates of the guild — it’s a professional death spiral.

Management of UTIs in an antimicrobial-stewardship era supports getting the diagnosis right, not prescribing antibiotics when there is no UTI, waiting for confirmation in equivocal cases and getting the right antibiotic the first time by knowing the local microbial aetiologies and resistance patterns.

So where are the regulators? Where are those people who gave GPs the nudge letters, who put GPs before the Professional Services Review because of antibiotic prescribing sins? Where are the audits to combat the national ’emergency’ of antimicrobial stewardship? Where?

Read more:

• Paying overstressed pharmacists to do GPs’ work is not the answer
• Did the pharmacist UTI prescribing trial ever secure ethics approval?

It is strange to me that the Queensland Chief Health Officer, Dr John Gerrard, who happens to be an infectious diseases specialist, has been silent on the issue.

Health policy is being dictated by absurd demands of pharmacy ownership, not population priorities.

The push for diabetes screening and pain management programs by pharmacists have been rejected by the Medical Services Advisory Committee, but the UTI trial escaped independent scrutiny by way of a special deal with the State Government.

It appears the guild has proven that political donations seem more effective than evidence for a service.

The trial has set back the quality use of medicines and antimicrobial stewardship, and the usual regulators and health managers are quiet.

It seems the pharmacy guild is the new health regulator of medicines in Queensland, and what a shameful outcome this is.