A question of ethics: FIP President calls for annual review

With no mandated CPD requirement in ethics or legislation, some practitioners are entering complex practice environments without a current understanding of their professional obligations.

As pharmacists, we are disciplined about maintaining our clinical knowledge across evolving therapeutic areas, new medicines and updated guidelines. When disease states or treatments change, most of us retain a strong foundation because we engage with them in practice every day. 

However, the same rigour is not consistently applied to legislation and ethics. For some practitioners, understanding of the legislative and ethical framework has gradually eroded, and in many cases not revisited or contemporised for 10, 20 or even 40 years. While medicines are regularly discussed with patients and colleagues, equivalent engagement with legal obligations and ethical principles does not occur – despite the fact that sound ethical decision-making depends on a solid grasp of the legislative framework governing practice.

What regulators are seeing in practice

Before my appointment as President of the International Pharmaceutical Federation (FIP), I spent nine years with the Pharmacy Council of New South Wales. In that role, I had oversight of pharmacists across practice settings – including community, hospital, education and research – from newly registered practitioners to those with decades of experience.

During that time, I observed a wide range of practice standards, with recurring themes emerging in some of the more serious matters before the Council. In a number of cases, there appeared to be limited familiarity with relevant legislation and relatively little engagement with ethics in day-to-day practice.

When questioned about legislation, many practitioners noted that it had been covered at university. And when asked whether it had been reviewed at any point since graduation, the answer was invariably no.

In complaint investigations and interviews – including matters where urgent intervention was required to protect public safety under Section 150 of the Health Practitioner Regulation National Law – it became clear that there was little understanding of the legislation.

Decisions were not always made with proper regard to core ethical responsibilities, including protecting patient wellbeing and exercising sound professional judgement. In some instances, pharmacists were not aware of the PSA Professional Practice Standards or the PSA Code of Ethics for Pharmacists. From a regulatory perspective, that raises serious concerns and suggests a broader gap within the profession in understanding these two essential pillars of practice.

The matters before the Council were not limited to one-off dispensing errors. In a number of cases, patterns of behaviour raised concerns.

This included dispensing Schedule 8 medicines or Schedule 4 benzodiazepines in volumes or circumstances where appropriate indication and professional judgement should have prompted closer scrutiny. 

Habits can develop over time. If pharmacists base decisions on flawed inputs, those patterns will continue unchecked – often until a regulator intervenes.

Rethinking how we approach CPD

Under current requirements, pharmacists must complete 40 CPD credits each year, with 20 of those as assessable (Group 2) activities. There is no mandated requirement that any of those credits specifically address legislation or ethics.

But based on my experience, there is merit in introducing an annual, assessed CPD component focused on these areas.

This could take the form of structured case studies requiring pharmacists to apply relevant legislative provisions and ethical principles to practical scenarios, with a defined minimum number of Group 2 credits allocated each year.

The objective would be to ensure every pharmacist revisits the legislative and ethical foundations of practice regularly and tests their understanding in a practical context. If a practitioner can work through an ethical dilemma in a structured case study and apply the correct legislative framework, they are more likely to make sound decisions in real-world practice.

It is a practical and achievable step that could significantly strengthen how practitioners approach decision-making in the best interests of patients and in accordance with good pharmacy practice.

Expanded scope increases responsibility

As scope of practice expands, pharmacists are assuming more autonomous clinical roles, including prescribing. While this evolution is positive for the profession and patients, increased autonomy brings increased responsibility. Clinical authority must be matched by a strong understanding of the legislative and ethical framework that governs how that authority is used.

A baseline expectation across the profession would promote consistency and reinforce the importance of these competencies for all practitioners, regardless of scope or practice setting.

At the FIP World Congress, ethics is a key part of the program each year. We include ethics presentations at every congress in recognition of how important these considerations are in our daily practice.

Embedding competence in everyday practice

If an annual ethics and legislation requirement were introduced, I would hope it would become part of routine competency review, rather than something revisited only when a practitioner appears before a regulator. Embedding this into regular professional development would strengthen patient safety, ensuring that decisions are consistently aligned with the patient’s best interests.

Culturally, this would support a safer and stronger profession, with practitioners accepting responsibility for maintaining currency of practice – not only in medicines and dispensing processes, but also in understanding relevant state and Commonwealth legislation and the ethical basis of decision-making.

This is particularly important for early career pharmacists. Young practitioners learn by observing those around them. The most effective way to guide them is to ensure they see best practice consistently modelled. If that does not occur, ‘what I see, I do’ can become the norm, and ECPs may be reluctant to question senior pharmacists.

Pharmacy proprietors are responsible for what happens within their pharmacy, including the capability of employed pharmacists. So it’s reasonable for employers to ensure their staff not only meet registration requirements, but also understand the legislative frameworks. 

By adhering to regulation, legislation and ethical decision-making processes, we reduce the likelihood of complaints – many of which arise from serious harm to patients, an outcome we all seek to avoid. 

Maintaining competence in ethics and legislation is not an additional burden. It is part of maintaining the standard of practice that our patients and the community expect.

PSA has opened public consultation on its draft Code of Ethics for Pharmacists until 17 April. Click here to have your say.