Why pharmacist S4 prescribing is a grand clinical delusion

Some 3000 doctors have now signed the AusDoc petition calling for the pharmacy prescribing experiment in North Queensland to be disbanded.

Next week the list of names and the petition itself will be sent to the Queensland health minister along with all the other state, territory and federal health ministers who see pharmacist prescribing as a potential cure to their numerous headaches.

AusDoc is encouraging you and your colleagues to add your names before that happens (you can sign here). Why should you do it?

Here is my answer.

The assumption that a policy radically expanding pharmacy scope of practice will miraculously fix the fallout following a collapse in bulk-billing or say provide an alternative to GPs amid a workforce crisis is a grandiose delusion.

There is hype but no evidence that the pharmacist trial being rolled out to 600,000 people across North Queensland can deliver.

The trial, as I will show, is simply bizarre in aspects of its clinical approach.

Generally, expanding community pharmacy roles has been described as policymaking in the absence of policy-relevant evidence.[i]

Evidence syntheses and cost-effective reviews[ii] of pharmacy prescribing for instance are few and far between, and available results usually reveal poor or inconclusive outcomes.[iii][iv][v]

Unlike the methodology used by the MBS review[vi] to identify and strip away low value medical care, evidence underpinning appropriateness, effectiveness, safety, and cost-effectiveness of many pharmacy services is missing.

And this is not absence of evidence. There is evidence of absence. For example, pursuant to the Sixth Community Pharmacy Agreement the evidence base for all Australian pharmacist clinical interventions was undertaken in the cost–benefit review of pharmacy programs.

The review outcomes were all poor, but the funding for these pharmacy programs did not stop, in fact it increased.

This also applies to the involvement in prescribing and dispensing S2 (pharmacy only) and S3 (pharmacist only) drugs for many years.

It has given Australian pharmacists the ability to prescribe many drugs that are found in other countries’ minor ailment and pharmacist prescribing schemes. In this regard, Australia was well ahead of the pack.

Both S2 and S3 drug categories are a lucrative monopoly for pharmacy in Australia, as drug sales are only allowed in pharmacy areas, and drug markups are high.[vii]

But S2 and S3 drug scheduling is also an area where there is no proof of consumer benefit.[viii][ix]

The main consequence seems to be higher drug costs for patients.

Increased pharmacy prescribing has also expanded through the pharmacies’ involvement in the administration of influenza vaccines to adult patients.

Clearly the diagnostic complications here are limited. It is about patient selection. It does seem an easy and obvious task to transfer to pharmacists.

But while influenza vaccination has good evidence in specific age groups and morbidities, the problem is that pharmacy-based influenza vaccination[x] is based on low-risk healthy adults.

This population is less likely to get influenza and at very low risk of suffering serious consequences or hospital visits — hence vaccination has less impact.[xi]

Canadian pharmacists acknowledge the lack of robust trials on outcomes of pharmacy influenza vaccination;[xii] a systematic review found healthy adult vaccination was only cost-effective in some cases.[xiii]

A UK review published in the Journal of Public Health in 2018 questioned the value of pharmacy coverage.[xiv]

Yet despite this debate every year, millions are spent by low-risk groups for their yearly influenza vaccination from pharmacies.

It may not have any public health benefit at all.

Now these roles have been expanded again with pharmacists prescribing antibiotics for patients with “UTI-like symptoms”.

The misnomer is deliberate; there was never confirmatory evidence gathered in any of the main studies that the women given antibiotics actually had a UTI, uncomplicated or otherwise.

Concerns raised in Queensland by its recent trial (not a clinical trial it is important to add) regarding the appropriateness of antibiotic prescribing were met with the ‘pharmacist follows antimicrobial stewardship guidelines’ argument; but this is a deceptive response as the real question was whether the antibiotic should have been prescribed at all.

This is particularly important in the context of Australian pharmacy research[xv] which suggests that once outside scrutiny, overselling and regulatory non-compliance of antibiotics and contraception sales occurs.

The harsh reality here is one we learned with codeine; over time pharmacies treat medications as commodities for sale rather than therapies for judicious use.

And now, the North Queensland Community Pharmacy Scope of Practice Pilot is before us — something beyond mere mission creep.

The primary motivation was an election commitment to the Pharmacy Guild of Australia.

In a marketing blitz, the guild fired a scattergun of trigger words.

“Easing some of the burdens on busy GPs”, “overcrowded [EDs]”, “decrease unnecessary [ED] presentations and ambulance ramping”.[xvi][xvii]

Yet look hard: there is no community pharmacist activity[xviii][xix][xx] that has been proven to reduce GP, ED or hospital use.

And certainly no document has been published which provides the evidence base for appropriateness, effectiveness and safety for the North Queensland pharmacy pilot.

Queensland Health is still to publish a scoping review to confirm actual scope of practice proposals.

It is a foundational problem for the pilot.

The argument that it is “low risk”[xxi] is clearly debunked once you examine the protocols.

Where are the safety parameters around pharmacist therapeutic substitution,[xxii] given that pharmacists will be empowered to unilaterally change a patient’s medication?[xxiii]

Where is the study on the safety and effectiveness of pharmacy asthma prescribing?[xxiv]

What is the rationale for pharmacists to treat patients over the age 18 for cardiovascular risk, when young adults who have significant cardiovascular risk factors at this age require specific attention.

The pilot appears to lower medication safety for the patients being treated. How these issues were missed reflects poorly on clinical oversight of the pilot.

And what about the evidence of patient benefit in the pilot?

It is noticeable that the activities licensed by the pilot steer patients away from the protection of PBS drug safety — none of the S4s that will be prescribed by pharmacists will be funded under the PBS because their prescribing has not been endorsed or even assessed by the PBAC.

The financing arrangements for this extensive list of pharmacy services is all in terms of private fees — even the Queensland Government believes it is not worth funding.

The benefit seems purely for the pharmacy business model not patients.

It is worth mentioning that pharmacists in Canada — a jurisdiction where pharmacy prescribing is pushed hard — reject pharmacist care for asthma, COPD and cardiovascular services based on lack of effectiveness and cost-effectiveness.[xxv]

The trial also includes a weight management protocol. It looks flimsy and again there is a paucity of evidence for pharmacist involvement in weight management.[xxvi]

And what about pharmacists treating psoriasis? Where is the evidence for simply treating the skin of a systemic illness?

Some protocols are simply bizarre; like acute wound management that requires local anaesthetic and sutures yet excludes people with a full thickness wound.

And why allow pharmacists to manage cardiovascular risk reduction from 18 years, when practically you cannot even calculate the risk until age 45?

Again, it all points to poor clinical oversight in this pilot.

The Queensland Government clinical oversight process has failed. The health system is not a retail playground for pharmacy business. Consumers have the right to be protected against products, processes and services that are hazardous to health.[xxvii]

The support of pharmacist prescribing of products and services with dubious or no benefit to public health would normally be regarded as improper.

To do this by a ‘pilot’ of pharmacy care where consumer protections are removed is scandalous.

Dr Evan Ackermann is a Gold Coast GP and former chair of the RACGP’s quality and safety expert committee. 

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