Why sign the petition against the pharmacist prescribing trial? This is how they’ll manage CV risk in T2DM

The opposition to the North Queensland trial is simple.

It is about the clinical safety of community pharmacists diagnosing, prescribing, managing and dispensing well beyond their usual scope of practice… nothing more.

Here, Dr Evan Ackermann — former chair the RACGP’s quality and safety committee — unpicks the protocol for pharmacists to manage patients’ cardiovascular risk factors.

“This creates the foundations of harm … How is it that the Pharmacy Board of Australia stays silent?” he writes.

You can read the petition by clicking here. You can sign the petition at the end of this article.

And you can share this bitly link – https://bit.ly/430GisF – for your medical colleagues to sign.

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Dr Ackermann writes:

I want to examine the services being rolled out in North Queensland that are designed to reduce cardiovascular risk for adult patients with type 2 diabetes (T2DM), dyslipidaemia and hypertension.

My first thoughts are that anyone with T2DM, hypertension or marked dyslipidaemia in the young adult (18-plus) population is an area of specific investigation.^1,2

The last person a patient needs is a pharmacist doing this.

Yet, here it is in a pharmacy treatment protocol published by Queensland Health.

It reflects the lack of clinical insight, lack of experience and lack of clinical governance that have gone into developing these protocols.

Having poor exclusion criteria just creates the foundations of harm.

The protocol is modelled on the RxEACH (Alberta Vascular Risk Reduction Community Pharmacy Project).

The study was a randomised trial conducted in 56 community pharmacies in Alberta, Canada.

Participants were recruited by their pharmacist, seen monthly and the outcome was the surrogate marker of cardiovascular risk calculation change at three months.

There were no clinical outcomes. The trial lasted only three months.

The intervention group had greater improvements in LDL cholesterol (-0.2mmol/L), systolic blood pressure (-9.37mmHg), glycosylated haemoglobin (-0.92%) and smoking cessation (20.2%).

This was achieved by adding extra lipid agents, antihypertensive drugs and oral hypoglycaemics. There were methodology issues.

The ‘recruit, test, add drugs, retest’ intervention tends to work in the short term (three months).

Longer term, this approach tends to run into compliance issues and side effects — not to mention issues of disease complications, multimorbidity and polypharmacy.

Another trial touted by pharmacists to support prescribing for hypertension was the (RxACTION ) trial over six months, which saw pharmacist reduce systolic blood pressure.³

Again, short-term care and the calculated economic benefits it produced were viewed as “brave”, as a key source of uncertainty was the assumption that long-term CVD reduction based on observed six-month outcomes in blood pressure reduction would not have a long-term effect in actual clinical practice.⁴

Same story for lipidaemia and diabetes: short-term improvement in surrogate markers but loss of long-term care¹¹.

The Canadian pharmacists state that “due to paucity of appropriate evidence (randomised controlled trials of effectiveness and costs), modelling the scale-up of pharmacist intervention for the control of HbA1c in diabetics may not be substantiated”.⁵

Further, there is not enough evidence of scale-up interventions for the purpose of reducing cases of congenital heart disease, heart failure , dyslipidaemia or diabetes at this time.⁵

Yet, here we are in North Queensland proposing the exact pharmacist activity that has poor evidence support on impact on health and healthcare utilisation.

Chronic disease is dependent on long-term care; it is why continuity of care works.^6,7,8 The literature is extensive and consistent.

Even when there is newly diagnosed hypertension, diabetes and dyslipidaemia, there is evidence of lower costs and lower hospital admissions with doctor continuity of care.⁹

Now, high-quality studies are providing evidence of population effectiveness of Australian Medicare-funded chronic disease management policies in general practice; this strengthens national policy to continue chronic disease management in primary care for cardiovascular care.¹⁰

Strategies that impose a decline in provider continuity or steer patients away from known evidence-based systems of care are a sure way to worsen patient care, increase costs and increase hospital utilisation in chronic disease.

This is what the North Queensland pilot proposes.

This is the primary concern of GPs for the pharmacy trial, but there are more.

Practically, it is not clear how pharmacists plan to recruit in the North Queensland pilot. Treating cardiovascular risk is not low risk as the Pharmacy Guild of Australia proclaims¹².

As yet, it is unclear if the consent process will inform patients there is little evidence pharmacy intervention helps but extensive support for continued doctor care.

The consent process looks to be a tick-box on a phone app¹³ — but happy to be told otherwise.

The whole pharmacy cardiovascular risk reduction protocol mimics aspects of the chronic disease plans in general practice, but that cannot happen in the retail environment of community pharmacy.

If pharmacists get involved, they will find the initial assessment and plan development a little out of their scope.

They will find regular follow-up appointments and review assessments difficult, and that co-ordinating of care with other health professionals and organising referrals and letters will be problematic.

There are others who do it better, faster and cheaper.

Along with the costs of pathology, things start to add up to a significant financial impact on the patient.

PoCT by the pharmacy will not help, and I presume they will be using the national medical record or sending patients to their GP to request blood tests.

Proper co-ordinated care by pharmacists will not last, but that is not the target.

The targets are pharmacist involvement in chronic disease management with MBS payments, as well as the business of prescribing and supplying multiple cardiovascular and diabetes drugs.

It seems that pharmacists want to prescribe/supply a huge range of different drugs under this proposal, plus all the insulins.

If you go through an earlier draft version of the protocol, it actually lists 52 of them — all drugs that the TGA normally restricts to prescription only.

This is a random sample, but they included the following:

• Atorvastatin
• Rosuvastatin
• Pravastatin
• Captopril
• Losartan
• Telmisartan
• Nifedipine modified release
• Chlortalidone
• Metformin
• Glipizide
• Insulins
• Acarbose
• Glimepiride

When it comes to the published protocol — the one published by Queensland Health last year — the S4 drug list is missing, so it is hard to see the precise ambition of the protocol.

But the premise remains that pharmacists are ‘medication specialists’ and can/will initiate and optimise therapy for cardiovascular risk reduction.

That is a false premise.

Community pharmacists have little expertise or experience in therapeutics and certainly nowhere near the knowledge and experience that GPs have in managing and prescribing for these conditions.

It would be unsafe and ethically questionable to transfer responsibility for clinical decisions and prescribing to lesser-qualified people; it would be wrong for pharmacists to assume it.

Simply reducing cardiovascular risk does not justify the right to initiate, alter or prescribe/supply this range of medication for pharmacists either, and there is little evidence they can do this long term.

There is a total lack of safety netting in this pilot; there is nothing to record harmful or clinical effects.

Again, the lack of clinical governance and oversight in this pilot is appalling.

Chronic disease management in general practice is a proven model for cardiovascular disease and mostly provided free of charge.

Getting patients to pay for an unproven service, as well as for the pathology and medication costs and remove PBS safety nets are professionally dubious.

How is it that the pharmacy board stays silent given the lack of evidence on efficacy and risk to patients?

It looks like the guild has corrupted the standards and norms that ensure patient safety and has taken the pharmacy board along with it in this venture.

Editor’s note: You can click here to read and sign the petition calling for the North Queensland pharmacy prescribing trial to be stopped — or you can sign the petition below.

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