New data reignites safety concerns as pharmacist prescribing push accelerates

Lynnette Hoffman

writer

Lynnette Hoffman

Managing Editor

Lynnette Hoffman

Medical indemnity insurer Avant has inserted itself into the pharmacy prescribing debate, citing deep concerns over patient harm – and its own statistics about prescribing risks – adding further weight to Healthed survey findings which highlight concerns related to pharmacist prescribing…

Last week the Pharmacy Guild released part of its ‘Rewriting the Script’ report, which argues that a nationally consistent approach to pharmacist prescribing — including allowing pharmacists to autonomously prescribe for cardiovascular risk reduction — would save the health system billions and “complement the GP workforce, shifting millions of routine consultations from general practice to pharmacy annually, freeing GPs to focus on patients with more complex and multimorbid needs.”

According to the report, pharmacist prescribing will create $1 billion in annual health system savings, free up over 10 million GP appointments each year and prevent 30,000 hospitalisations annually.

Problems already arising, GP surveys show

However, a series of national Healthed surveys of around 2000 GPs between 17 March and 26 May suggest GPs are already bearing witness to the problems caused by pharmacists’ expanding scope:

  • 45% of ~2000 surveyed GPs reported that in the past 12 months, they’d encountered at least one problematic brand substitution by a pharmacist
  • 65% of 940 GPs who answered yes to the above scenario had at least one instance where the brand substitution had potential to significantly impact their patient’s health or safety
  • 49% of ~1850 GPs had encountered at least one adverse outcome arising from pharmacist prescribing in the last 12 months
  • 30% of ~2000 GPs had encountered unsatisfactory experiences related to pharmacists prescribing of antibiotics for UTIs
  • 30% of 1860 GPs had one or more patients who had an unsatisfactory experience or outcome relating to pharmacist-led immunisation
  • Loss of opportunistic health checks and fragmented care were the two biggest negative impacts GPs saw with pharmacist-led immunisations (cited by 67% and 62% of surveyed GPs, respectively).

Prominent GPs say the survey data rings true

“This HealthEd data reveals the reality of what medical peaks bodies and insurers have been warning about – that independent pharmacy prescribing in retail environments can, and already is, causing harm,” said Dr Anita Muñoz, chair of the RACGP’s Victoria Council.

Likewise, Dr Ramya Raman, a specialist GP and practice owner in Perth, said the survey shows adverse outcomes are already occurring.

She disputed suggestions made by some pharmacy advocates that given only around 400 pharmacists in Australia are prescribing, the data may reflect instances where patients see their GP after non-prescription medicines have proved ineffective.

“We know our patients enough and we take a clinical history to know what the difference is when there’s pharmacy prescribing versus when a patient has received an over-the-counter medication. We ask about that,” Dr Raman said.

A spokesperson for the Pharmacy Guild previously stated that “Prescribing pharmacists operate within strict treatment protocols after they have completed significant additional training. There have been zero cases of malpractice or referrals to Aphra.”

“Pharmacists are already able to prescribe in the UK, Canada and New Zealand. International evidence, as well as the recent University of Newcastle study, shows pharmacist prescribing is safe and effective.”

Dr Raman questioned that evidence – noting the lack of randomisation and blinding in most pharmacy trials—and the fact that pilots have been rolled out without waiting for evaluations.

“Most pharmacy trials conducted to date have actually not met accepted clinical trial standards, which understandably then raises the question about their safety, validity and reliability of their findings,” she said.

She said pharmacy care should be embedded within general practice in a GP-led team – rather than “retail prescribing.”

“When health care is provided in a retail setting, there is the risk of putting business considerations ahead of the patient needs,” Dr Raman said.

The inadvertent conflict of interest in that process is “undeniable,” she added.

Dr Muñoz shares this concern.

“I welcome pharmacists as important members of multidisciplinary team care within the clinical governance framework of a general practice. I certainly hope the federal government will assist general practice to employ pharmacists in their teams,” Dr Muñoz said.

“But independent prescribing in a retail shop where the skills to assess, investigate and diagnose the condition are not there is not a model RACGP believes to be safe – and is one which entails the unacceptable conflict of interest of profiting from the act of prescribing.”

Medical indemnity insurer Avant joins the debate

Last week the medical indemnity provider Avant joined those raising concerns, saying proposals to significantly expand pharmacist prescribing have “crossed a critical safety threshold” with “a very real risk of patient harm” due to misdiagnosis or inappropriate prescribing.

An analysis of Avant’s medical indemnity claims found medication related issues were involved in one in six matters that resulted in regulatory action or patient compensation, making them one of the higher risk activities in healthcare.

Avant’s Chief Medical Officer Professor Steve Robson said that even among highly trained and experienced doctors, prescribing is a significant driver of medical negligence claims and regulatory notifications — and the risk will only increase by expanding prescribing to those with far less training and experience.

“Policymakers need to pause before assuming prescribing responsibilities can continue to expand into increasingly complex areas based primarily on projected efficiency gains or theoretical cost savings, rather than patient safety. Affordability should not come at the cost of quality, good patient care and ultimately lives,” Professor Robson said.

“The question isn’t who can prescribe. The question is what level of diagnostic capability, clinical training and ongoing oversight is required to prescribe safely,” he said.

“From our perspective as an insurer, the greater the complexity, uncertainty and potential consequences of error, the higher the threshold should be for expanding prescribing.”

Pharmacists’ professional indemnity provider weighs in

In response, Pharmaceutical Defence Limited (PDL), the largest professional indemnity insurance provider for pharmacists in Australia, said “Avant insures medical practitioners, not pharmacists, and is therefore not likely to be in an informed position to comment on pharmacist prescribing.”

PDL said it has been “intricately involved” with the scope of practice changes and believes “suitably trained and authorised pharmacists are needed nationally” to improve timely healthcare delivery and outcomes, and to help address workforce needs.

“PDL supports the expansion of the profession’s scope of practice, supported by appropriate education programs to address the demand for pharmacists qualified to provide diagnostic and prescribing services for the community in both current and emerging models of care across Australia,” it said.

Consistent framework needed across Australia

One thing Avant and the Pharmacy Guild agree on is the need for a nationally consistent approach – but to different ends, with the insurer arguing it’s a safety issue.

“We believe a nationally consistent prescribing framework is overdue, developed by doctors, pharmacists, regulators, patient representatives and governments, with input from Avant and other indemnity insurers to establish clear, evidence-based principles for prescribing,” Professor Robson said.

For its part, the Guild’s report calls for a “nationally aligned framework enabling endorsed pharmacists to prescribe autonomously within individual scopes of practice,” as well as “shared electronic health records, secure messaging and interoperable prescribing systems to ensure real-time communication with general practice and continuity of care.”

Lastly, they are urging the government for “Appropriate remuneration for pharmacist consultations, PBS eligibility for medicines prescribed within scope, and funding models that incentivise collaborative care are critical to equitable and scalable implementation.”

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