Why pharmacist protocol prescribing is deeply flawed — a GP’s view
Protocol prescribing is the basis for all the recent proposals for pharmacist prescribing.
Whether it be antibiotics for UTIs, scripts for the oral contraceptive pill, or more complex prescribing roles in the North Queensland trial, the protocols look superficially simple and seemingly logical, but are in reality deeply flawed.
Community-pharmacy-based protocol prescribing is virtually useless and potentially dangerous without a raft of clinical skills at its foundation.
These are skills pharmacists do not have.
Allow me some leeway to explain.
A GP colleague of mine who is doing her first term in rural general practice was consulted by a 57-year-old male patient with new onset of right facial pain, jaw discomfort and unilateral headache.
He had a history of right dental disease, with examination revealing pain near the right temporomandibular joint (TMJ). He was otherwise normal.
She prescribed high-dose steroids on a presumptive diagnosis of giant cell arteritis (GCA).
Urgent pathology revealed a low ESR, but she maintained steroid therapy.
It was only several days later when specialist review and diagnostic imaging confirmed the GCA diagnosis.
Her clinical diagnosis and therapy proved to be correct.
So why did the GP prescribe steroids and not pursue more common protocols, such as analgesics for dental pain, TMJ dysfunction; antibiotics for a presumed dental abscess; or even a strategy to exclude an oropharyngeal cancer?
She used the skills of clinical reasoning: with a core knowledge on aetiology of diseases, she collected information through structured history taking, unconscious cues, examination and pattern recognition, and used clinical judgment that comes from training/experience, and the application of multiple clinical tools, such as Murtagh’s “diagnostic principles”, to form a diagnosis (see box below).
Although uncertainty and ambiguity existed, this process guided her to the proper clinical diagnosis and selecting the right therapeutic protocol.
| The ‘Murtagh’ diagnostic model The strategy of the model is to ask five self-posed questions about this particular presenting problem: What is the probable diagnosis? What serious disorder/s must not be missed? What conditions can be missed in this situation? Could the patient have one of the ‘masquerades’ commonly encountered? Is the patient trying to tell me something? (Look for ‘yellow’ flags.) |
These thought processes, or something similar, will be familiar to all medical practitioners. It’s so ingrained from medical training that it’s assumed by many medicos that all clinicians act and think this way.
But that’s a false assumption. Others don’t think like medical practitioners — pharmacists in particular.
Nor do they have the same diagnostic process or skills.
These are not specious claims, but the result of extensive pharmacy research.1,2,3,4,5,6,7,8
Pharmacy is a highly rules-based and protocol-driven profession.
In the highly regulated, complex and litigious worlds of medicines, protocols give pharmacists a safety shield in which to operate.
They are educated that way; they practise that way; they have been socialised into a belief that following rules results in the best outcomes.
Protocols are good for the standardisation of daily work in drug procurement and dispensing roles.
When the pharmacy profession embarked on more clinical roles in advising patients for self-care, pharmacy educators began to teach symptom recognition, but the approach was largely through protocol-driven questioning and mnemonics, which has limited evidence as being effective in establishing diagnoses.9,10
Pharmacists find it difficult to consistently interpret signs and symptoms to arrive at a clinical judgment through appropriate questioning and counselling.11
Their diagnostic decision-making involves poor clinical reasoning because of over-reliance on protocol-driven questioning or mnemonics.12
Patients have experienced seemingly endless and sometimes public questioning to meet a protocol,13 or questions focused on specific products sales.14
Even when given complete clinical information on a cardiovascular risk, testing of interpretation and reasoning skills revealed Australian pharmacists had knowledge gaps and biases, leading to inappropriate recommendations of referral.15
In justifying further prescribing activity, pharmacy used protocols for prescription of S3 and previous S4 medications such as ophthalmic antibiotics and emergency contraception; but this is where pharmacy-protocol practice demonstrably failed.
The conclusion of Australian pharmacy research16 into the appropriateness of pharmacy sales of emergency contraception and antibiotic drops in Australia was:
“Although the market for dispensing over-the-counter medication in Australia is regulated, relatively high rates of overtreatment [31%] and some cases of undertreatment were observed in this study. Given the unintended adverse effects, including overuse of antibiotics and corticosteroids, these observations suggest the advisability of regulatory intervention ensuring compliance [study noncompliance rate 42%] with professional protocols.”
(Emphasis added, and data in square brackets added from study.)
The impact of protocol-guided pharmacy care was poor clinical medicine and evidence of patient harm. Pharmacist clinical performance was even worse if appropriate referral was also considered.
Regulatory failure is a recurrent finding with pharmacist prescribing.17,18
Pharmacists claim they have the training to appropriately monitor S4 sales, but this study reveals that activity occurs sub-optimally and clinical oversight is poor. Any doubts, think codeine.
Normally, a study revealing regulatory non-compliance and high rates of overmedication would set off alarms in health authorities. But no further interventions came.
By default, a pharmacy-prescribing protocol gives legitimacy to unfettered sales of regulated drugs without appropriate clinical oversight.
Urinary tract antibiotics and oral contraceptives will most likely follow the same path.
Despite the obvious deficiencies, pharmacists retain their faith in clinical protocols. To boost protocol credibility, pharmacists use the Australian publication of Therapeutic Guidelines as a basis for their protocols.19
This is seen in the North Queensland pharmacy prescribing trial, and the Queensland urinary tract infection prescribing trial.20
Therapeutic Guidelines is a well-regarded publishing body, respected for its synthesis of evidence to guide clinical prescribing. It provides pharmacists with insights on disease basics, and the clinical and therapeutic knowledge that they normally lack.
Our protocol is consistent with “therapeutic guidelines”, they say, but this is a logical flaw.
Therapeutic protocols must be the end point of clinical reasoning and diagnosis, not a means for determining patient allocation into a pharmacist prescribing protocol.
For example, for the protocol for gastro-oesophageal reflux (see below), the North Queensland pharmacy trial suggests that assessment and diagnosis are simply based on patient history: “A presumptive diagnosis of GORD can be made based on presence of typical symptoms of heartburn and regurgitation.”
Commencement of therapy and supply of medications is “in accordance with Therapeutic Guidelines”.
Source: https://www.health.qld.gov.au/__data/assets/pdf_file/0029/1166429/Pilot_Services.pdf
Read the pharmacy gastro-oesophageal reflux protocol and then analyse it using just one clinical tool; for example, Murtagh’s diagnostic reasoning.
Every doctor knows that, even for patients under 50 years, gastro-oesophageal reflux is a diagnosis of exclusion; that is, you must reasonably exclude an atypical cardiac pain and every other significant pathology that raises intrabdominal pressure or has epigastric pain as a symptom.
That includes a complete history, including medications (strangely absent in a pharmacy protocol), alcohol and tobacco, hepatic and gastric disorders, and even chronic anxiety.
The danger of this protocol is obvious to all medical practitioners. There is an inherent risk for patients of missed diagnosis, delayed diagnosis and inappropriate care.
To our pharmacy colleagues, prescribing under the auspices of a “protocol” does not translate into safety — far from it.
The Therapeutic Guidelines disclaimer is clear:
“We provide no warranty that the information accessible from Therapeutic Guidelines Limited publications (information) is accurate, up-to-date or complete, and in no circumstance does the information constitute professional advice.
“We disclaim all responsibility.”
Therapeutic Guidelines cannot ensure people choose the right guideline, nor can they provide guidance for every clinical context.
Pharmacy researchers also know the weakness of protocol-driven care and are imploring pharmacy training in clinical reasoning.21,22
Clinical reasoning is not taught in pharmacy schools and has been described by pharmacist researchers as difficult to describe and harder to learn.23
Medicos call it medical training.
The Australian Pharmacy Council recently issued invitations to multiple groups for the development of accreditation standards for pharmacist prescribing.
The RACGP’s decision to turn down an invitation to join the council’s Stakeholder Reference Group was wise.
Fundamentally, the proposal would require the adoption of medical training standards, or the enshrinement of protocol care, which is known to be poor medicine.
Who would want to endorse either of these?
The Australian Pharmacy Council call is a clear admission that these prescribing proposals require pharmacists to practise outside their current domain, in areas they are untrained for and unskilled.
The RACGP knows full well that most of primary care is undifferentiated, often incomplete or ambiguous, and that a wide scope of clinical skills are required for proper evaluations of even simple presentations.
No supervision, no practical experience, just education. No, it takes more than a couple of months’ education to gain the skills associated with primary care presentations. Who would think giant cell arteritis with jaw pain?
Competency is crucial, and who wants to be associated with pharmacy protocols when something goes wrong?
And that brings us to liability: Who is liable if these protocols are accepted? The pharmacist, the pharmacy, the protocol developer, or a doctor?
I’m certain it won’t be the Pharmacy Guild of Australia.
Examining the proposal to continue prescription of the oral contraceptive pill, the question is a case point.
When asked for a repeat prescription of any medication, I go through a mental process on the patient’s health to check the safety and effectiveness of the prescription, check the appropriateness of continued prescribing, medication cessation and other alternatives.
Other medicos may have similar systems, but it is not a reflex tick-box exercise.
Clinical contexts change, and what pharmacists are doing is assuming the prescribing risk assessment, health surveillance of monitoring and efficacy of the medication; a brave task given the TGA has determined this should be a doctor’s responsibility.
An adverse event may be rare, but it will happen.
It is my assumption that a medical practitioner cannot accept responsibility for adverse events if medication oversight is usurped to lesser-qualified personnel, without consent of the original prescriber.
It is imperative that our medical representatives, and medicolegal advisers, clarify responsibilities under these proposals.
While no-one doubts the pharmacist’s role in drug dispensing, research has clearly documented repeated poor performance of community pharmacists in further health provision; to accurately seek and evaluate symptoms, and to construct and manage accurate diagnoses.
That is, there is little evidence that pharmacists have the skills for the new roles they want or are being asked to acquire.
Health bodies have drastically overestimated, or have been misled on, the clinical capabilities of pharmacists for these roles.
Protocols do not cover these deficiencies. Implementation of pharmacy-protocol prescribing lowers quality and safety standards of patients, and often translates into poor patient care.
It is the Dunning-Kruger approach to health provision.
Pharmacy groups currently have the ear of politicians and the financial backing to influence political will to enhance pharmacists’ scope of practice.
That does not change the fact that patients should be the prime beneficiaries of the health system.
Giving a drug and giving a drug appropriately are two very different actions.
These research warnings need to be heeded.
Dr Ackermann is a GP on the Gold Coast and was previously chair of the RACGP Expert Committee – Quality Care.
Read more:
- Revealed: The training pharmacists will undergo to prescribe independently of doctors
- RACGP boycotts role in pharmacist prescribing standards group
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