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Analysis

GPs dissect pharmacy prescribing folly


Karen Price


26/01/2023 4:22:50 PM

Drs Stephanie Dawson-Smith and Karen Price review the murky history of pharmacy prescribing in Australia and warn of the significant dangers ahead.

Pharmacist prescribing to a patient
Independent pharmacy prescribing has long been a controversial issue within Australian healthcare.

In late 2022, political promises of major changes to pharmacist scope of prescribing were announced in New South Wales, Victoria and North Queensland.
 
The promised changes to pharmacist prescribing defy recommendations made by the Therapeutic Goods Administration (TGA), and have been described by the Department of Health and Aged Care as, ‘not consistent with Commonwealth medicines policy’.
 
The North Queensland pilot implementing these changes is reportedly the brainchild of the Pharmacy Guild of Australia, the lobby group for pharmacist owners and the sixth highest political donor in Australia.
 
The issue is not that the prescription of Schedule 4 (S4) medications should be restricted to medical doctors; nurse practitioners and certain other health professionals who have undertaken the necessary training and assessment are already able to do so.
 
Rather, there are four key problems with the proposed prescribing changes:

  • The abject failure of governance of the landmark Australian pharmacy prescribing pilot in Queensland – particularly the degree of influence wielded by what has been described as Australia’s most influential lobby group: the Pharmacy Guild of Australia
  • The training being provided to pharmacists to learn to safely diagnose and manage the relevant conditions has been entirely inadequate
  • This arrangement allows pharmacists to do something that other healthcare workers are prohibited from doing in Australia due to the risk of conflict of interest – which is to profit through both prescribing and dispensing S4 medications
  • The changes are presented as a solution to the GP accessibility crisis in Australia when there is evidence they will actually exacerbate the issue
Failure of governance in the Queensland UTI pharmacy pilot
The decision to move forward with pharmacists prescribing S4 medications follows extensive lobbying by the Guild.
 
The announced pharmacy pilots build on the purported success of the UTIPP-Q, a pilot conducted in Queensland from June 2020 to December 2021 that allowed pharmacists to prescribe antibiotics for urinary tract infection symptoms in women aged 18–65 years at very low risk of complicated infection.
 
Proponents of the pilots have said that the Queensland trial delivered safe outcomes, while detractors have flagged major concerns with patient safety and the development of increased rates of antibiotic resistance in the community.
 
The pilot that took place was not a clinical trial and was not designed to adequately evaluate relevant safety outcomes, such as mortality and morbidity related to misdiagnosis.
 
In fact, the only sufficient evaluation of adverse events included in the research design was for medication side effects. This is extraordinary given the side effects for these antibiotics were already well-established.
 
Meanwhile, the protocol used by pharmacists in the pilot, the intervention itself, was untested.
 
The Outcomes Report for the UTIPP-Q contained two protocols: 
 
  • The original protocol, which was developed by a consortium composed of seven universities and the Pharmaceutical Society of Australia, with assistance from the UTIPP-Q Steering and Advisory Group
  • The implemented protocol used in the pilot software, which deviated significantly from the Universities’ finalised protocol
This software was provided by GuildCare – a subsidiary company of the Guild.
 
These alterations of the protocol were not discussed or acknowledged by the Queensland University of Technology (QUT) UTIPP-Q Outcomes Report authors.
 
In the absence of another explanation, it does appear that a software company owned by the Pharmacy Guild of Australia lobby group has unilaterally altered the UTIPP-Q protocol, overriding decisions made by the Steering and Advisory Group – a group that included representation from Queensland Health, the governmental body that had commissioned the pilot in the first place.
 
The changes to the original protocol increased the risk to patient safety in that patients became eligible for treatment when they had presentations which the pharmacist treatment algorithm was not equipped for. This included:
 
  • patients who had a UTI just two weeks earlier who ought to have had a urine test (urine testing was not performed by pharmacists) to exclude resistant bacteria and confirm the diagnosis – the original protocol had stipulated that patients could only be treated by pharmacists if it had been six months since their last UTI
  • patients with a male urinary tract who identified as female gender
  • patients with vomiting, which is suggestive of a kidney infection.
These changes increase the risk that patients will be undertreated or misdiagnosed and increase the risk of complications, including hospitalisation.
 
The changes also removed advice for patients to see their GP if their symptoms hadn’t responded to treatment after 48 hours, effectively removing the safety net for patients.
 
The alterations meant that prior overseas research on pharmacist prescribing for UTIs did not align with the protocol used in the Queensland pilot. Therefore, the protocol had never undergone Human Research Ethics Approval.
 
The authors of the UTIPP-Q Outcomes Report claimed in their key findings that safety was demonstrated. However, safety was not proven.
 
In fact, an issues paper sent to the relevant bodies involved in the UTIPP-Q in August 2022, contended that all of the ‘key findings’ in the UTIPP-Q Outcomes Report were either demonstrably false or unproven.
 
No explanation has been given by QUT for why the original protocol was changed at the software development stage.

Pharmacy-prescribing-pilots-article.jpgDr Stephanie Dawson-Smith is a GP in Queensland, where the first UTI pharmacy prescribing pilot was launched. 
 
In private correspondence following this issues paper, the QUT Office of Research Ethics and Integrity stated these concerns were outside its jurisdiction because the university’s code for responsible conduct of research did not apply to the UTIPP-Q, as the pilot was implemented as a ‘clinical service’, rather than research.
 
QUT advised the concerns should be sent to the State Health Ombudsman, who in turn advised the concerns should be sent to the QUT Council. The QUT Chancellor has advised that QUT Council cannot clarify these procedural matters and that they should instead be addressed by Queensland Health.
 
Despite Queensland Health being made aware of these concerns in August, the taxpayer-funded government department has not addressed them either.
 
Inadequate training
The UTIPP-Q Outcomes Report concluded that, ‘pharmacists have the appropriate skills, competencies and training to manage the empiric treatment of uncomplicated UTIs in the community pharmacy’.
 
However, the training that allows a pharmacist to transition from being ineligible to prescribe antibiotics for UTIs to eligible consists entirely of a 1.5-hour online module with an open-book, multi-attempt, multiple-choice quiz.
 
This is not an adequate mode for teaching or assessing clinical competency in appropriate history taking, diagnosis and management for uncomplicated UTIs.
 
Clinical competency should be assessed by evaluating healthcare providers in a clinical encounter and this did not occur. In a recent Australian study, pharmacists received training on ear health assessment and management that did not include prescribing S4 medications.
 
Pharmacists received 55 hours of face-to-face and online training. After participating in the ear health trial, pharmacists identified that they needed even more face-to-face training and more training in identifying various diseases.
 
This highlights just how inadequate the 1.5 hours of online UTIPP-Q training is. This is particularly true when you consider mimics of UTI include cancers, serious sexually transmitted infections and ectopic pregnancy. Doctors have reported treating patients with these complications and more in relation to the UTIPP-Q pilot in Queensland.
 
Conflict of Interest
Doctors do not sell prescription-only medications. Separating prescribing and dispensing is a legal safeguard that has been long established.
 
One benefit of this separation is it prevents the conflict of interest that arises when a health provider stands to gain financially from medication they prescribe.
 
A contemporary example of the positive impact of separating dispensing and prescribing in the Australian health system was the banning of prescription of low-dose codeine products by pharmacists in 2018. This ban resulted in a 50% reduction in codeine overdoses and sales, without a concomitant increase in overdoses with stronger opioids or high-strength codeine.
 
The UTIPP-Q Outcomes Report found that more than 60% of pharmacists either agreed or strongly agreed with the statement that ‘it was difficult to charge the patient for the UTI service when I did not supply an antibiotic’. This demonstrates a conflict of interest where the pharmacist feels more comfortable charging for the service if they prescribe, and prescribing also allows them to maximise profits by dispensing and selling the medication prescribed.
 
Not the solution to GP accessibility crisis
The Guild has presented a community need for rapid treatment of UTIs to reduce complications such as hospitalisation by stating that in 2018 there were more than 20,000 potentially preventable hospitalisations in Queensland due to urinary tract infections and kidney infections.
 
However, people at highest risk for hospitalisation are not eligible for pharmacist prescribing because the pharmacy pilots are only designed for those patients who do not have risk factors for complications. In Australia, adults aged over 65 are five times more likely to be hospitalised for UTIs and kidney infections than younger adults, yet age over 65 is one of the exclusion criteria for pharmacist prescribing.
 
When assessing the likely relevance of the pilots in reducing hospitalisations it would be useful to consider the question, ‘what percentage of hospitalisations are accounted for by urinary tract infections in non-pregnant, non-diabetic, immunocompetent, constitutionally-well women aged between 18–65 years with no risk of STI infection, no features of kidney infection, no renal impairment, an anatomically normal and uncatheterised urinary tract, no history of renal stones, no spinal cord injury, no hospitalisation in the last four weeks and no history of UTI in the last fortnight or history of three or more UTIs in the last year?’
 
After all, these are the patients eligible for pharmacist UTI prescribing.
 
Patients eligible for pharmacist prescribing are at the lowest risk for complications and the least in need of urgent treatment. It is curious that so much emphasis has been put on increasing access for the group that is least vulnerable to complications of urinary tract infection.

Pharmacy-prescribing-pilots-article2.jpgFormer RACGP President Adjunct Professor Karen Price has long-opposed independent pharmacy prescribing.
 
Not enough doctors are specialising in general practice – the proportion of medical graduates moving into general practice used to be 50% but is now 13.8%.
 
Pharmacy prescribing pilots are likely to exacerbate the problem – more than half of the of over 1300 Queensland doctors surveyed about the North Queensland Pharmacy Pilot said it would deter them from working in the region.
 
There is also a workforce shortage of pharmacists, and in North Queensland pharmacists are less well distributed in rural and remote areas than GPs. Pharmacy prescribing may also exacerbate workforce shortages in pharmacy.
 
A 2022 poll in the Australian Journal of Pharmacy found ‘increasing professional services workload e.g. vaccination’ was the third highest ranked reason for pharmacists to be considering leaving the profession.
 
Moreover, the systemic underfunding of general practice is regularly cited as a core reason why medical students are pursuing other specialties. 
 
Instead of every other ‘clear, simple and wrong’ solution being implemented, an immediate boost in funding to patients accessing general practice care would send a strong signal to the nation’s medical students and currently exiting GPs.
 
Supporting coordination of care to allied health is key, not a fragmented uncoordinated approach. In the UK, research has suggested the fragmentation and multiple players in primary care is reducing patient satisfaction with these services.
 
And in the US, physician continuity of care was associated with significant cost savings in ongoing care.
 
The outcomes of strong, physician-led primary care systems are incontrovertible.
 
There are many reasons patients are increasingly finding it difficult to see their GP. Anecdotally, what patients are seeking is a bulk-billed GP service, which we know is in decline.
 
There is also a challenge in sustainability of practice, especially in rural and remote locations. Many of these issues relate to systematic defunding of general practice by successive governments over the past decade. Medicare now covers less than half of the cost of a standard consultation.
 
Complex healthcare and mental healthcare have particularly been impacted by defunding.
 
October’s General Practice Crisis Summit released a white paper which contained short-, medium- and long-term solutions for many of the current issues. At no time during the Summit did a group of academics, consumers, GPs, Primary Health Networks, or nurses suggest that a fragmented pharmacist arm of prescribing in a conflicted manner was a solution.
 
Providing a lesser standard of care with health staff who are untrained in either physical examination, the implementation of appropriate testing or the great skill of formulating a differential diagnoses list seems courageous on the part of government. 
 
We know from the AMA Queensland Survey Report that sexually transmitted diseases were missed, teratogenic medication was prescribed to pregnant women and a pelvic mass remained undiagnosed at least.
 
We know 65% of people dropped out of the trial and there is no known follow-up on this cohort and what happened to their health needs. There are many failings that make implementing this policy seem premature and very poorly advised.
 
Democracy under threat
Last month, Queensland Greens Senator Larissa Waters reintroduced the Banning Dirty Donations Bill 2022, to ‘stop dirty industries with a track record of seeking to influence decision-makers through donations’.
 
Liberal Senator James McGrath stated this bill would prevent community pharmacists from, ‘getting involved in the political process’ and would send the message that community pharmacists are, ‘not worthy of participating in Australia’s democracy’.
 
This implies that it is only through political donations that democratic participation is available and therefore, as the RACGP does not make political donations, according to Senator McGrath at least, GPs are not considered worthy of participating in Australia’s democracy. This is certainly illuminating.
 
In short, with the questionable ethical tactics of hijacking policy with donations, the numerous research level challenges of the Queensland trial and the lack of response from the authorities, together with the states’ circumventing of national medicines policy informed by TGA decisions, it would seem that the Australian people need to be better informed on the origins and evidence for new health policy.
 
With the stewardship of taxpayers’ funding and health system reform as a contract with the Australian electorate, the current Pharmacy Guild influence and the problematic Queensland UTI pharmacy pilot need to be questioned vigorously and transparently to avoid unintended health consequences to individuals and to populations.
 
To keep framing this as a turf war is a political misdirect.
 
To consider it a convenience issue also misses the paired convenience issue of receiving two month’s supply of PBS medications at a time, which was vigorously blocked by the Pharmacy Guild. We do not consider it heroic or smart politics to subvert standards of care with political donations and, however it might be framed, paid for policy would not be in the best interests of the Australian people.
 
Healthcare reform, especially in general practice and the community more broadly, needs clever and urgent reform that is free from political, commercial or lobbying bias.
 
In Denmark, as represented in a keynote presentation at GP22 by Professor Jens Sondergard, it is clear that an equitably accessible primary care team led by GP care coordination, has such great benefit to the community that hospitals were closed.

It is very much time to implement the clever country metaphor we are so fond of and finally live up to its meaning within healthcare systems evidence and implementation. There should be zero tolerance for anything less. 
 
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Pharmacy Guild of Australia pharmacy prescribing


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Dr Mehrdad Majedi   27/01/2023 9:57:34 AM

I see at least two patients per week who had been mismanaged by the pharmacy prior to their visit with me. Concerningly, I see an increasing number of patients with unilateral red eye i.e. keratitis/anterior uveitis/foreign body, who are managed on OTC Chlorsig and other eyedrops to the extent some have experienced severe visual loss when they presented to me.

It is obvious to me that an average pharmacist is not capable of recognising the red flags and managing the conditions appropriately, and my impression from their management is that the whole concern is to sell the products for a benefit.

I think it is about time for us GPs to speak up about the cases and start reporting them to the authorities.


Dr W   27/01/2023 11:04:55 AM

Well summed up Stephanie and Karen. I might have supported a well run trial and evaluation (although noting the absolute conflict of interest in prescribing and selling) but the one done was an embarrassment to evidence based medicine.


Dr J   27/01/2023 2:04:54 PM

I understand the importance of treating UTIs with respect. We all no doubt have stories of patients who look well but are very unwell and end up in hospital after a good physical examination.

What I never hear when discussing pharmacist prescribing, is the amount of prescribing out of indication and indeed scheduling that pharmacists do - eg chlorsig for woundcare, metoclopramide/paracetamol combination for gastro.

With this being done, what effect will giving pharmacists antibiotics have? Will they too be diverted to treatments outside of their indications / scheduling?

If there is a shortage of pharmacists, perhaps the government can look to deregulate pharmacy ownership so that it frees up their business management time to colesworth so that they be involved moreso in healthcare, or perhaps GPs can hand out simple prescriptions and medicines for chronic disease under the PBS.