As pharmacy practice evolves, professional, ethical and legal expectations become more complex.
From blurred relationship boundaries to compounding compliance and medicinal cannabis oversight, regulators reflect on five situations where pharmacists must exercise sound judgement, integrity and professional autonomy.
Flag 1. A carer blurs professional boundaries
Relationships with carers can shift over time, especially when familiarity leads to interactions that feel more personal. For example, a carer who regularly collects medicines may begin asking a pharmacist personal questions or even hint at romantic interest.
Should this happen, pharmacists must recognise the emerging risk and reinforce clear professional boundaries to prevent blurred lines from escalating, said Dennis Leung, clinical advisor (pharmacy) at the Australian Health Practitioner and Regulatory Agency (Ahpra) at the recent PSA webinar Navigating Legal Boundaries in Evolving Pharmacy Practice.
‘Supplying a medicine is a form of therapeutic relationship, because clinical and professional responsibilities apply to ensure duty of care to the patient’ he said. ‘There is always a potential power imbalance between you as the health practitioner and the patient or carer.’
If the relationship becomes overfamiliar, misunderstandings may open the door to professional conduct complaints.
‘When relationships move into a personal nature – whether sexual, psychological, financial or social – these are what we call boundary issues,’ Mr Leung said. ‘This is why it’s prudent for a workplace to develop a policy that gives guidance to employees.’
If continuing to act as both pharmacist and personal acquaintance feels conflicted, stepping back or transferring care may be necessary to protect the patient’s interests.
‘You have to be mindful of how objective you can remain if you enter into a relationship with the carer,’ he said. ‘You may decide early on that the best thing is to change who provides care to the patient.’
Timely communication helps to maintain mutual respect and reduces risk.
‘People often forget to reflect, and before they realise it, the situation has progressed beyond where they’re comfortable,’ Mr Leung said. ‘Professional boundaries allow all parties to engage safely and effectively.’
Flag 2. An unsafe or non-compliant compounding request
Compounding often puts pharmacists at the crossroads between clinical judgement, legal requirements and business expectations. Consider if a cosmetic clinic requests a compounded topical anaesthetic with high-strength active ingredients that appear to breach Schedule 3 limits. Even if the pharmacy has dispensed the formulation previously, the pharmacist must assess current standards and patient risk, Kylie Neville, professional officer with PDL, told webinar participants.
‘Compounding is definitely an area where PDL receives frequent questions about risk,’ she said. ‘Unfortunately, it’s also an area where pharmacists may be unsure of their legal and professional obligations.’
This type of request carries potential regulatory breaches and professional liability if harm occurs.
‘There is a regulatory risk if you supply a compounded item that exceeds Schedule 3 limits,’ Ms Neville said. ‘And of course, there is the risk to the patient – if they experience toxicity or an adverse effect … they may not have access to medical care at that time.’
Competence must extend beyond technical compounding skills to include risk awareness, indication, appropriateness and safe use. If those elements can’t be safely assessed, the product shouldn’t be compounded.
‘You also need to consider whether this activity is truly within your scope,’ she said. ‘Individual pharmacists are responsible for the safety and wellbeing of the patient and … any consequences of providing the compounded product.’
Using a two-stage risk assessment can help to catch issues early.
‘A risk assessment can actually happen twice: once before you supply, and once again at the end,’ Ms Neville said. ‘You confirm formulation, stability, expiry, and double-check your calculations to ensure the product you think you’re supplying is actually what you’re supplying.’
Flag 3. Cultural safety blindspots
Cultural safety is increasingly recognised as central to pharmacy practice. Let’s say a patient attends a GLP1-RA injection education session expecting it to be run by a pharmacist they are familiar with, or someone of the same gender or cultural background. If another pharmacist steps in without clarification, the patient may feel uncomfortable.
‘Cultural safety is probably a concept that wasn’t always considered in the past … and it’s now a very important aspect of practice,’ Mr Leung said. ‘Despite your good intentions, the patient might have been expecting a different staff member.’
If the patient feels uncomfortable due to a perceived power imbalance, differences in cultural norms or unmet privacy expectations – learning and treatment adherence can be disrupted.
‘The patient may feel less receptive to the education you’re trying to provide,’ he said. ‘They may even refuse to proceed with the consult entirely.’
Culturally safe care involves awareness of personal assumptions and actively creating an inclusive environment.
‘Cultural safety involves acknowledging the social, economic, cultural, historical, generational and behavioural factors that influence health,’ Mr Leung said. ‘It requires adopting practices that respect diversity and avoiding biases or discrimination, including racism.’
Clarifying expectations ahead of time allows patients to express preferences and increases the likelihood of a respectful, effective consultation.
‘Ideally, you ask the patient for their preferences and expectations,’ he said. ‘Initial consent isn’t blanket consent for changes to who provides the care.’
Flag 4. Medicinal cannabis scripts where products, dosing and evidence
Medicinal cannabis has created numerous challenges for pharmacists, including the availability of a wide range of products, inconsistency in strengths and formulations, and varying legal requirements.
For example, patients may present with multiple prescriptions, unclear dosing sequences or expectations of early supply.
‘Many pharmacists have experienced quite a sharp increase in the number of medicinal cannabis prescriptions,’ Ms Neville said. ‘There are so many non-approved products … it’s incredibly challenging for pharmacists to keep track.’
Many of these products are Controlled Drugs (Schedule 8 medicines). So the same level of clinical judgement must be applied to medicinal cannabis as any other Controlled Drug.
Real-time prescription monitoring is essential for ensuring patients are not receiving unsafe or overlapping supply from multiple providers.
‘There is a total monthly THC quantity that must be monitored carefully,’ Ms Neville said. ‘This is where real-time prescription monitoring becomes vital.’
If you’re not sure how and why patients are using it, it’s ‘absolutely appropriate to ask’.
‘[And] if you have a good relationship with the prescriber, talk to them – ask for guidance,’ she added.
Flag 5. Unusual doses of high-risk medicines
Professional autonomy becomes critical when prescriptions seem unsafe – especially when high-risk medicines such as methotrexate are involved. For example, a script instructing ‘10 mg daily for 5 days’ should raise immediate concern. Even if the patient insists it’s correct and the prescriber is unreachable, the pharmacist can’t proceed without clarity.
‘The Pharmacy Board has highlighted issues around this, particularly regarding methotrexate,’ Mr Leung said. ‘In 2019, they commissioned research covering notifications from mid-2010 to mid-2019. There were 28 notifications – seven deaths and nine hospitalisations. All seven deaths were considered preventable.’
Unclear labels or directions are unacceptable for a medicine with a well-documented history of fatal dosing errors.
‘Labels must include clear directions for use – “take as directed” is not acceptable,’ he said. ‘Methotrexate has a narrow therapeutic index, and ambiguous directions are dangerous.’
Sometimes the safest course is simply to pause supply and direct the patient back to the prescriber.
‘Pharmacists must exercise independent judgement to ensure a medicine is appropriate and safe,’ Mr Leung said. If you cannot clarify the dose … you must decline to dispense.’
Coronial findings across multiple cases reinforce that pharmacists are expected to uphold safety – even when it requires uncomfortable or assertive decision-making.
‘Professional autonomy means centering your decisions around patient safety,’ he added.
Learn more about developing your pharmacy career while remaining compliant by attending the upcoming Voices of Pharmacy – Passion, Purpose, and Possibility webinar.
