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[post_content] => From mid-2027, the availability of dozens and dozens of complementary medicines containing vitamin B6 will change.
Yesterday (25 November 2025), the Therapeutic Goods Administration (TGA) released the final decision on the scheduling of vitamin B6 containing medicines in response to safety concerns following consideration of the advice of the Advisory Committee on Medicines Scheduling in November 2024 and public consultation.
What's changing?
The TGA Delegate’s final decision will see scheduling changes for products containing vitamin B6, dependent on the product’s vitamin B6 dose. This means oral preparations containing:
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[post_content] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
Pharmacists may have had questions this week about antibiotic use in children following news articles highlighting the link between some antibiotics and vaccine efficacy. AP looks behind the headline to help pharmacists know how to respond
What’s driving this impairment?
Infants exposed to antibiotics in the neonatal period or first year of life had significantly lower antibody responses to vaccines including meningococcal ACWY and measles, mumps, rubella, found a study led by Australian experts.
The impact on antibody response is most likely due to disruptions in the development of gut bacteria.
‘We’ve known for some time that gut bacteria play an important role in shaping the immune system, but this study provides strong evidence that early life antibiotics can disrupt that process in a way that weakens vaccine responses,’ said Professor David Lynn, Professor of Systems Immunology at Flinders Health and Medical Research Institute, who co-led the study.
Infants who were treated with antibiotics had lower amounts of helpful gut bacteria at the time of vaccination, with Bifidobacteria particularly impacted. Children with this reduction in gut bacteria later showed weaker immune responses, indicated by reduced antibody levels at 6 and 14 months of age.
‘This suggests that these gut bacteria play a key role in helping the immune system respond optimally to vaccines,’ he said.
Interestingly, the study also found that babies whose mothers received antibiotics during labour did not have reduced vaccine responses.
‘This is an important distinction because it suggests that not all antibiotic exposure carries the same risks when it comes to the impact on the infant’s immune responses,’ Prof Lynn said. ‘[These findings] raise important questions about how we use antibiotics in newborns and what we can do to reduce any unintended consequences.’
What should pharmacists do?
Pharmacists should advise patients that routine vaccinations should not be postponed. At this stage, there have also not been changes to guidelines around antibiotic use. And antibiotics should also not be withheld when required, with infant infections often presenting as severe and requiring urgent treatment.
‘There’s usually a very good reason for giving the neonates those antibiotics, given that infections and sepsis in that critical early life period can be very serious,’ Prof Lynn told the Guardian.
Furthermore, infants treated with antibiotics still produce a sufficient immune response when vaccinated.
‘Around that 7-month time point, most of the infants are above what’s called the seroprotective threshold, so they will be expected to be protected against infection,’ Prof Lynn said.
‘What does seem to happen is that, over time, those responses wane a bit quicker in the infants that directly have antibiotics.’
The gut microbiome can also likely be repaired through the use of prebiotics and probiotics after antibiotic exposure, boosting impaired vaccine responses, found in an earlier preclinical study in mice led by Prof Lynn.
But antibiotics should continue to be used wisely.
‘In view of the importance of vaccination in maintaining health in society, this is yet another reason why antibiotics should be administered judiciously,’ said Associate Professor Peter Speck, from the College of Science and Engineering at Flinders University. ‘Antibiotic stewardship is clearly of great value, especially in the neonatal setting.’
What are the next steps?
While the findings are compelling, the authors acknowledge there are several limitations to the research . The study cohort was relatively small, and numbers in each antibiotic-exposed subgroup were even smaller.
Infants born by caesarean section or to mothers with a body mass index above 30 were excluded, so the results may not reflect the broader population seen in everyday practice. Immune responses were assessed with only limited functional assays and no detailed T cell analysis. Larger, more diverse studies will be needed to confirm and build on these early findings.
To that end, a human trial funded by the Women’s and Children’s Hospital Foundation is set to investigate if the infant immune response to vaccines can be improved by giving probiotics to babies treated with antibiotics in the first week of life.
‘This will provide evidence as to whether this simple probiotic intervention can support optimal immune responses to vaccination in early life, and we’ll also be able to identify the molecular mechanisms governing the differences in vaccine efficacy,’ Prof Lynn said.
‘Our findings could also be relevant to long-term child health, given prior associations between antibiotic exposure and an increased propensity to develop conditions such as allergies, asthma and obesity.’
Visit PSA’s Vaccination (Immunisation) Education Hub to access vaccination education and resources.
[post_title] => Early antibiotic use may blunt infant vaccine protection
[post_excerpt] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
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[post_content] => The new Medication Management at Transitions of Care Stewardship Framework highlights the pharmacist’s pivotal role in reducing medicine errors and supporting safe discharge.
Each year, an estimated 250,000 hospital admissions in Australia are caused by medicine-related errors, costing the health system around $1.4 billion annually. More than half of these errors occur during transitions of care.
Recognising the need for immediate action, the Australian Commission on Safety and Quality in Health Care has released the Medication Management at Transitions of Care Stewardship Framework – Australia’s first coordinated hospital-based model designed to reduce medicine errors, improve communication and support safer discharge and follow-up.
For pharmacists in hospitals, general practice, community and aged care, the Framework articulates an opportunity to take a leading role in safeguarding medicines management during the riskiest moments of care.
AP spoke with Dr Phoebe Holdenson Kimura, GP and medical advisor to the Commission, to understand what this means in practice.
National guidance, local implementation
The Framework sets out four interlocking elements to improve safety at transitions of care, the first being the establishment of a governing committee responsible for leadership, oversight and local needs analysis.
‘Many hospitals already do significant work in transitions of care and medication safety, so we anticipate that this governing committee would sit within an existing medication safety or patient safety and quality committee,’ Dr Holdenson Kimura said.
[caption id="attachment_30957" align="aligncenter" width="600"]
Dr Phoebe Holdenson Kimura[/caption]
This committee develops the implementation plan, governs risk mitigation activity and evaluates impact. Beneath it sits the second element – a multidisciplinary stewardship team, where pharmacists play a central role.
‘Pharmacists are often the champions of medication safety. We’ve seen their transformative impact through antimicrobial and opioid stewardship models,’ she said.
This team focuses its energy on patients at the highest risk of medicines misadventure, coordinating proactive reviews from admission through to discharge.
The third element outlines specific activities required throughout the patient journey, including early discharge planning and prompt communication with GPs and community pharmacists about medicines changes, while the fourth emphasises ongoing monitoring, evaluation and reporting to ensure hospital systems evolve and improve over time based on real-world performance.
‘This framework aims to raise the bar nationally so that all hospitals take a proactive, systematic approach,’ she said.
Recognising high risk patients
The framework includes a comprehensive list of criteria that can be used to prioritise patients at risk of hospitalisation due to medicines misadventure. This includes patients who are:
High-quality medicines reconciliation should ideally occur in the emergency department or soon after admission to the ward.
‘Partnered pharmacist medication charting is also key to preventing errors from the outset,’ Dr Holdenson Kimura added.
Throughout the hospital stay, the Framework emphasises strengthened medicines review and shared decision-making – involving patients in conversations about risks, deprescribing and therapeutic goals.
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[post_content] => At the end of this year, the Australian Pharmacy Council (APC) will retire its Accreditation Standards for Continuing Professional Development Activities.
To ensure CPD activities can continue to be accredited, PSA is developing a brand new set of standards for Continuing Professional Development for pharmacists.
AP sat down with PSA’s CPD Manager, Chloe Tobin, to find out what this means for you.
Why is the CPD accreditation system changing?
The APC’s Accreditation Standards for Continuing Professional Development Activities will no longer be active from 31 December 2025. To ensure pharmacists can continue to access CPD which has been assessed for quality and reliability in education, PSA is in the process of developing a set of standards for CPD activities.
The aim of this change is to ensure pharmacists can continue accessing accredited CPD activities without having to assess for themselves whether an activity meets the Pharmacy Board of Australia’s requirements or is relevant to their practice.
What can pharmacists expect from PSA accredited CPD activities?
When a pharmacist selects PSA-accredited CPD activities, they can be confident the education they access is of high quality, upholds pharmacy practice standards, guidelines and ethics, and is free from commercial bias.
With the impending changes to CPD, will I need to do anything differently?
No. Following the retirement of the APC’s CPD standards, PSA’s standards will provide a seamless transition for pharmacists to new criteria for assessing CPD activities.
Can I still complete CPD activities accredited against the APC CPD Accreditation standards?
Yes. CPD activities which have been accredited against the current APC CPD Accreditation standards will remain accredited until their expiry date, or up until 31 December 2026 – whichever is earlier.
Will CPD activities still be worth the same number of credits?
At this stage, the Pharmacy Board of Australia’s CPD standard remains unchanged, so pharmacists will continue to accrue credits using the same ‘Group 1, Group 2, Group 3’ categories as they have when completing activities accredited against the current APC standards.
Can I still use the PSA CPD Planning Tool?
The PSA CPD Planning Tool will continue to be available to members to help identify professional development needs and create an annual CPD plan.
There will be no changes to the tool, and PSA-led activities will continue to be recorded automatically.
How far along is PSA in finalising the CPD standards?
Public consultation has closed for the PSA Standards for CPD for pharmacists.
The end of this consultation process marked the next step in finalising the new CPD standards, which PSA will use to assess the quality and applicability of education for pharmacists before accreditation.
We are currently incorporating feedback into the draft document ahead of seeking endorsement by the PSA Board next month.
What’s the feedback on PSA’s draft standards document so far?
During the consultation process, respondents have revealed that they value the concise and clear structure of the document, as well as the inclusion of guidance information. Stakeholders also expressed strong support for the standards’ focus on independence and practical applicability to pharmacy practice.
Where can I access more information?
Further details on PSA’s accredited CPD scheme will be available in January 2026, after publication of the new CPD standards in December.
Enquiries about the new standards and accreditation process can be directed to psaeducation@psa.org.au
[post_title] => PSA to accredit CPD against new standards from January
[post_excerpt] => At the end of the year, the APC will retire its Accreditation Standards for Continuing Professional Development Activities.
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[title_attribute] => PSA to accredit CPD against new standards from January
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[post_content] => 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.
[post_title] => Navigating legal red flags in the changing pharmacy landscape
[post_excerpt] => As pharmacy practice evolves, professional, ethical and legal expectations become more complex. Here's how pharmacists can avoid red flags.
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[title_attribute] => Navigating legal red flags in the changing pharmacy landscape
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[post_content] => From mid-2027, the availability of dozens and dozens of complementary medicines containing vitamin B6 will change.
Yesterday (25 November 2025), the Therapeutic Goods Administration (TGA) released the final decision on the scheduling of vitamin B6 containing medicines in response to safety concerns following consideration of the advice of the Advisory Committee on Medicines Scheduling in November 2024 and public consultation.
What's changing?
The TGA Delegate’s final decision will see scheduling changes for products containing vitamin B6, dependent on the product’s vitamin B6 dose. This means oral preparations containing:
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[post_content] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
Pharmacists may have had questions this week about antibiotic use in children following news articles highlighting the link between some antibiotics and vaccine efficacy. AP looks behind the headline to help pharmacists know how to respond
What’s driving this impairment?
Infants exposed to antibiotics in the neonatal period or first year of life had significantly lower antibody responses to vaccines including meningococcal ACWY and measles, mumps, rubella, found a study led by Australian experts.
The impact on antibody response is most likely due to disruptions in the development of gut bacteria.
‘We’ve known for some time that gut bacteria play an important role in shaping the immune system, but this study provides strong evidence that early life antibiotics can disrupt that process in a way that weakens vaccine responses,’ said Professor David Lynn, Professor of Systems Immunology at Flinders Health and Medical Research Institute, who co-led the study.
Infants who were treated with antibiotics had lower amounts of helpful gut bacteria at the time of vaccination, with Bifidobacteria particularly impacted. Children with this reduction in gut bacteria later showed weaker immune responses, indicated by reduced antibody levels at 6 and 14 months of age.
‘This suggests that these gut bacteria play a key role in helping the immune system respond optimally to vaccines,’ he said.
Interestingly, the study also found that babies whose mothers received antibiotics during labour did not have reduced vaccine responses.
‘This is an important distinction because it suggests that not all antibiotic exposure carries the same risks when it comes to the impact on the infant’s immune responses,’ Prof Lynn said. ‘[These findings] raise important questions about how we use antibiotics in newborns and what we can do to reduce any unintended consequences.’
What should pharmacists do?
Pharmacists should advise patients that routine vaccinations should not be postponed. At this stage, there have also not been changes to guidelines around antibiotic use. And antibiotics should also not be withheld when required, with infant infections often presenting as severe and requiring urgent treatment.
‘There’s usually a very good reason for giving the neonates those antibiotics, given that infections and sepsis in that critical early life period can be very serious,’ Prof Lynn told the Guardian.
Furthermore, infants treated with antibiotics still produce a sufficient immune response when vaccinated.
‘Around that 7-month time point, most of the infants are above what’s called the seroprotective threshold, so they will be expected to be protected against infection,’ Prof Lynn said.
‘What does seem to happen is that, over time, those responses wane a bit quicker in the infants that directly have antibiotics.’
The gut microbiome can also likely be repaired through the use of prebiotics and probiotics after antibiotic exposure, boosting impaired vaccine responses, found in an earlier preclinical study in mice led by Prof Lynn.
But antibiotics should continue to be used wisely.
‘In view of the importance of vaccination in maintaining health in society, this is yet another reason why antibiotics should be administered judiciously,’ said Associate Professor Peter Speck, from the College of Science and Engineering at Flinders University. ‘Antibiotic stewardship is clearly of great value, especially in the neonatal setting.’
What are the next steps?
While the findings are compelling, the authors acknowledge there are several limitations to the research . The study cohort was relatively small, and numbers in each antibiotic-exposed subgroup were even smaller.
Infants born by caesarean section or to mothers with a body mass index above 30 were excluded, so the results may not reflect the broader population seen in everyday practice. Immune responses were assessed with only limited functional assays and no detailed T cell analysis. Larger, more diverse studies will be needed to confirm and build on these early findings.
To that end, a human trial funded by the Women’s and Children’s Hospital Foundation is set to investigate if the infant immune response to vaccines can be improved by giving probiotics to babies treated with antibiotics in the first week of life.
‘This will provide evidence as to whether this simple probiotic intervention can support optimal immune responses to vaccination in early life, and we’ll also be able to identify the molecular mechanisms governing the differences in vaccine efficacy,’ Prof Lynn said.
‘Our findings could also be relevant to long-term child health, given prior associations between antibiotic exposure and an increased propensity to develop conditions such as allergies, asthma and obesity.’
Visit PSA’s Vaccination (Immunisation) Education Hub to access vaccination education and resources.
[post_title] => Early antibiotic use may blunt infant vaccine protection
[post_excerpt] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
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[title_attribute] => Early antibiotic use may blunt infant vaccine protection
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[post_content] => The new Medication Management at Transitions of Care Stewardship Framework highlights the pharmacist’s pivotal role in reducing medicine errors and supporting safe discharge.
Each year, an estimated 250,000 hospital admissions in Australia are caused by medicine-related errors, costing the health system around $1.4 billion annually. More than half of these errors occur during transitions of care.
Recognising the need for immediate action, the Australian Commission on Safety and Quality in Health Care has released the Medication Management at Transitions of Care Stewardship Framework – Australia’s first coordinated hospital-based model designed to reduce medicine errors, improve communication and support safer discharge and follow-up.
For pharmacists in hospitals, general practice, community and aged care, the Framework articulates an opportunity to take a leading role in safeguarding medicines management during the riskiest moments of care.
AP spoke with Dr Phoebe Holdenson Kimura, GP and medical advisor to the Commission, to understand what this means in practice.
National guidance, local implementation
The Framework sets out four interlocking elements to improve safety at transitions of care, the first being the establishment of a governing committee responsible for leadership, oversight and local needs analysis.
‘Many hospitals already do significant work in transitions of care and medication safety, so we anticipate that this governing committee would sit within an existing medication safety or patient safety and quality committee,’ Dr Holdenson Kimura said.
[caption id="attachment_30957" align="aligncenter" width="600"] Dr Phoebe Holdenson Kimura[/caption]
This committee develops the implementation plan, governs risk mitigation activity and evaluates impact. Beneath it sits the second element – a multidisciplinary stewardship team, where pharmacists play a central role.
‘Pharmacists are often the champions of medication safety. We’ve seen their transformative impact through antimicrobial and opioid stewardship models,’ she said.
This team focuses its energy on patients at the highest risk of medicines misadventure, coordinating proactive reviews from admission through to discharge.
The third element outlines specific activities required throughout the patient journey, including early discharge planning and prompt communication with GPs and community pharmacists about medicines changes, while the fourth emphasises ongoing monitoring, evaluation and reporting to ensure hospital systems evolve and improve over time based on real-world performance.
‘This framework aims to raise the bar nationally so that all hospitals take a proactive, systematic approach,’ she said.
Recognising high risk patients
The framework includes a comprehensive list of criteria that can be used to prioritise patients at risk of hospitalisation due to medicines misadventure. This includes patients who are:
High-quality medicines reconciliation should ideally occur in the emergency department or soon after admission to the ward.
‘Partnered pharmacist medication charting is also key to preventing errors from the outset,’ Dr Holdenson Kimura added.
Throughout the hospital stay, the Framework emphasises strengthened medicines review and shared decision-making – involving patients in conversations about risks, deprescribing and therapeutic goals.
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[post_content] => At the end of this year, the Australian Pharmacy Council (APC) will retire its Accreditation Standards for Continuing Professional Development Activities.
To ensure CPD activities can continue to be accredited, PSA is developing a brand new set of standards for Continuing Professional Development for pharmacists.
AP sat down with PSA’s CPD Manager, Chloe Tobin, to find out what this means for you.
Why is the CPD accreditation system changing?
The APC’s Accreditation Standards for Continuing Professional Development Activities will no longer be active from 31 December 2025. To ensure pharmacists can continue to access CPD which has been assessed for quality and reliability in education, PSA is in the process of developing a set of standards for CPD activities.
The aim of this change is to ensure pharmacists can continue accessing accredited CPD activities without having to assess for themselves whether an activity meets the Pharmacy Board of Australia’s requirements or is relevant to their practice.
What can pharmacists expect from PSA accredited CPD activities?
When a pharmacist selects PSA-accredited CPD activities, they can be confident the education they access is of high quality, upholds pharmacy practice standards, guidelines and ethics, and is free from commercial bias.
With the impending changes to CPD, will I need to do anything differently?
No. Following the retirement of the APC’s CPD standards, PSA’s standards will provide a seamless transition for pharmacists to new criteria for assessing CPD activities.
Can I still complete CPD activities accredited against the APC CPD Accreditation standards?
Yes. CPD activities which have been accredited against the current APC CPD Accreditation standards will remain accredited until their expiry date, or up until 31 December 2026 – whichever is earlier.
Will CPD activities still be worth the same number of credits?
At this stage, the Pharmacy Board of Australia’s CPD standard remains unchanged, so pharmacists will continue to accrue credits using the same ‘Group 1, Group 2, Group 3’ categories as they have when completing activities accredited against the current APC standards.
Can I still use the PSA CPD Planning Tool?
The PSA CPD Planning Tool will continue to be available to members to help identify professional development needs and create an annual CPD plan.
There will be no changes to the tool, and PSA-led activities will continue to be recorded automatically.
How far along is PSA in finalising the CPD standards?
Public consultation has closed for the PSA Standards for CPD for pharmacists.
The end of this consultation process marked the next step in finalising the new CPD standards, which PSA will use to assess the quality and applicability of education for pharmacists before accreditation.
We are currently incorporating feedback into the draft document ahead of seeking endorsement by the PSA Board next month.
What’s the feedback on PSA’s draft standards document so far?
During the consultation process, respondents have revealed that they value the concise and clear structure of the document, as well as the inclusion of guidance information. Stakeholders also expressed strong support for the standards’ focus on independence and practical applicability to pharmacy practice.
Where can I access more information?
Further details on PSA’s accredited CPD scheme will be available in January 2026, after publication of the new CPD standards in December.
Enquiries about the new standards and accreditation process can be directed to psaeducation@psa.org.au
[post_title] => PSA to accredit CPD against new standards from January
[post_excerpt] => At the end of the year, the APC will retire its Accreditation Standards for Continuing Professional Development Activities.
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[title_attribute] => PSA to accredit CPD against new standards from January
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[post_content] => 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.
[post_title] => Navigating legal red flags in the changing pharmacy landscape
[post_excerpt] => As pharmacy practice evolves, professional, ethical and legal expectations become more complex. Here's how pharmacists can avoid red flags.
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[post_content] => From mid-2027, the availability of dozens and dozens of complementary medicines containing vitamin B6 will change.
Yesterday (25 November 2025), the Therapeutic Goods Administration (TGA) released the final decision on the scheduling of vitamin B6 containing medicines in response to safety concerns following consideration of the advice of the Advisory Committee on Medicines Scheduling in November 2024 and public consultation.
What's changing?
The TGA Delegate’s final decision will see scheduling changes for products containing vitamin B6, dependent on the product’s vitamin B6 dose. This means oral preparations containing:
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[post_content] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
Pharmacists may have had questions this week about antibiotic use in children following news articles highlighting the link between some antibiotics and vaccine efficacy. AP looks behind the headline to help pharmacists know how to respond
What’s driving this impairment?
Infants exposed to antibiotics in the neonatal period or first year of life had significantly lower antibody responses to vaccines including meningococcal ACWY and measles, mumps, rubella, found a study led by Australian experts.
The impact on antibody response is most likely due to disruptions in the development of gut bacteria.
‘We’ve known for some time that gut bacteria play an important role in shaping the immune system, but this study provides strong evidence that early life antibiotics can disrupt that process in a way that weakens vaccine responses,’ said Professor David Lynn, Professor of Systems Immunology at Flinders Health and Medical Research Institute, who co-led the study.
Infants who were treated with antibiotics had lower amounts of helpful gut bacteria at the time of vaccination, with Bifidobacteria particularly impacted. Children with this reduction in gut bacteria later showed weaker immune responses, indicated by reduced antibody levels at 6 and 14 months of age.
‘This suggests that these gut bacteria play a key role in helping the immune system respond optimally to vaccines,’ he said.
Interestingly, the study also found that babies whose mothers received antibiotics during labour did not have reduced vaccine responses.
‘This is an important distinction because it suggests that not all antibiotic exposure carries the same risks when it comes to the impact on the infant’s immune responses,’ Prof Lynn said. ‘[These findings] raise important questions about how we use antibiotics in newborns and what we can do to reduce any unintended consequences.’
What should pharmacists do?
Pharmacists should advise patients that routine vaccinations should not be postponed. At this stage, there have also not been changes to guidelines around antibiotic use. And antibiotics should also not be withheld when required, with infant infections often presenting as severe and requiring urgent treatment.
‘There’s usually a very good reason for giving the neonates those antibiotics, given that infections and sepsis in that critical early life period can be very serious,’ Prof Lynn told the Guardian.
Furthermore, infants treated with antibiotics still produce a sufficient immune response when vaccinated.
‘Around that 7-month time point, most of the infants are above what’s called the seroprotective threshold, so they will be expected to be protected against infection,’ Prof Lynn said.
‘What does seem to happen is that, over time, those responses wane a bit quicker in the infants that directly have antibiotics.’
The gut microbiome can also likely be repaired through the use of prebiotics and probiotics after antibiotic exposure, boosting impaired vaccine responses, found in an earlier preclinical study in mice led by Prof Lynn.
But antibiotics should continue to be used wisely.
‘In view of the importance of vaccination in maintaining health in society, this is yet another reason why antibiotics should be administered judiciously,’ said Associate Professor Peter Speck, from the College of Science and Engineering at Flinders University. ‘Antibiotic stewardship is clearly of great value, especially in the neonatal setting.’
What are the next steps?
While the findings are compelling, the authors acknowledge there are several limitations to the research . The study cohort was relatively small, and numbers in each antibiotic-exposed subgroup were even smaller.
Infants born by caesarean section or to mothers with a body mass index above 30 were excluded, so the results may not reflect the broader population seen in everyday practice. Immune responses were assessed with only limited functional assays and no detailed T cell analysis. Larger, more diverse studies will be needed to confirm and build on these early findings.
To that end, a human trial funded by the Women’s and Children’s Hospital Foundation is set to investigate if the infant immune response to vaccines can be improved by giving probiotics to babies treated with antibiotics in the first week of life.
‘This will provide evidence as to whether this simple probiotic intervention can support optimal immune responses to vaccination in early life, and we’ll also be able to identify the molecular mechanisms governing the differences in vaccine efficacy,’ Prof Lynn said.
‘Our findings could also be relevant to long-term child health, given prior associations between antibiotic exposure and an increased propensity to develop conditions such as allergies, asthma and obesity.’
Visit PSA’s Vaccination (Immunisation) Education Hub to access vaccination education and resources.
[post_title] => Early antibiotic use may blunt infant vaccine protection
[post_excerpt] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
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[post_content] => The new Medication Management at Transitions of Care Stewardship Framework highlights the pharmacist’s pivotal role in reducing medicine errors and supporting safe discharge.
Each year, an estimated 250,000 hospital admissions in Australia are caused by medicine-related errors, costing the health system around $1.4 billion annually. More than half of these errors occur during transitions of care.
Recognising the need for immediate action, the Australian Commission on Safety and Quality in Health Care has released the Medication Management at Transitions of Care Stewardship Framework – Australia’s first coordinated hospital-based model designed to reduce medicine errors, improve communication and support safer discharge and follow-up.
For pharmacists in hospitals, general practice, community and aged care, the Framework articulates an opportunity to take a leading role in safeguarding medicines management during the riskiest moments of care.
AP spoke with Dr Phoebe Holdenson Kimura, GP and medical advisor to the Commission, to understand what this means in practice.
National guidance, local implementation
The Framework sets out four interlocking elements to improve safety at transitions of care, the first being the establishment of a governing committee responsible for leadership, oversight and local needs analysis.
‘Many hospitals already do significant work in transitions of care and medication safety, so we anticipate that this governing committee would sit within an existing medication safety or patient safety and quality committee,’ Dr Holdenson Kimura said.
[caption id="attachment_30957" align="aligncenter" width="600"] Dr Phoebe Holdenson Kimura[/caption]
This committee develops the implementation plan, governs risk mitigation activity and evaluates impact. Beneath it sits the second element – a multidisciplinary stewardship team, where pharmacists play a central role.
‘Pharmacists are often the champions of medication safety. We’ve seen their transformative impact through antimicrobial and opioid stewardship models,’ she said.
This team focuses its energy on patients at the highest risk of medicines misadventure, coordinating proactive reviews from admission through to discharge.
The third element outlines specific activities required throughout the patient journey, including early discharge planning and prompt communication with GPs and community pharmacists about medicines changes, while the fourth emphasises ongoing monitoring, evaluation and reporting to ensure hospital systems evolve and improve over time based on real-world performance.
‘This framework aims to raise the bar nationally so that all hospitals take a proactive, systematic approach,’ she said.
Recognising high risk patients
The framework includes a comprehensive list of criteria that can be used to prioritise patients at risk of hospitalisation due to medicines misadventure. This includes patients who are:
High-quality medicines reconciliation should ideally occur in the emergency department or soon after admission to the ward.
‘Partnered pharmacist medication charting is also key to preventing errors from the outset,’ Dr Holdenson Kimura added.
Throughout the hospital stay, the Framework emphasises strengthened medicines review and shared decision-making – involving patients in conversations about risks, deprescribing and therapeutic goals.
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[post_content] => At the end of this year, the Australian Pharmacy Council (APC) will retire its Accreditation Standards for Continuing Professional Development Activities.
To ensure CPD activities can continue to be accredited, PSA is developing a brand new set of standards for Continuing Professional Development for pharmacists.
AP sat down with PSA’s CPD Manager, Chloe Tobin, to find out what this means for you.
Why is the CPD accreditation system changing?
The APC’s Accreditation Standards for Continuing Professional Development Activities will no longer be active from 31 December 2025. To ensure pharmacists can continue to access CPD which has been assessed for quality and reliability in education, PSA is in the process of developing a set of standards for CPD activities.
The aim of this change is to ensure pharmacists can continue accessing accredited CPD activities without having to assess for themselves whether an activity meets the Pharmacy Board of Australia’s requirements or is relevant to their practice.
What can pharmacists expect from PSA accredited CPD activities?
When a pharmacist selects PSA-accredited CPD activities, they can be confident the education they access is of high quality, upholds pharmacy practice standards, guidelines and ethics, and is free from commercial bias.
With the impending changes to CPD, will I need to do anything differently?
No. Following the retirement of the APC’s CPD standards, PSA’s standards will provide a seamless transition for pharmacists to new criteria for assessing CPD activities.
Can I still complete CPD activities accredited against the APC CPD Accreditation standards?
Yes. CPD activities which have been accredited against the current APC CPD Accreditation standards will remain accredited until their expiry date, or up until 31 December 2026 – whichever is earlier.
Will CPD activities still be worth the same number of credits?
At this stage, the Pharmacy Board of Australia’s CPD standard remains unchanged, so pharmacists will continue to accrue credits using the same ‘Group 1, Group 2, Group 3’ categories as they have when completing activities accredited against the current APC standards.
Can I still use the PSA CPD Planning Tool?
The PSA CPD Planning Tool will continue to be available to members to help identify professional development needs and create an annual CPD plan.
There will be no changes to the tool, and PSA-led activities will continue to be recorded automatically.
How far along is PSA in finalising the CPD standards?
Public consultation has closed for the PSA Standards for CPD for pharmacists.
The end of this consultation process marked the next step in finalising the new CPD standards, which PSA will use to assess the quality and applicability of education for pharmacists before accreditation.
We are currently incorporating feedback into the draft document ahead of seeking endorsement by the PSA Board next month.
What’s the feedback on PSA’s draft standards document so far?
During the consultation process, respondents have revealed that they value the concise and clear structure of the document, as well as the inclusion of guidance information. Stakeholders also expressed strong support for the standards’ focus on independence and practical applicability to pharmacy practice.
Where can I access more information?
Further details on PSA’s accredited CPD scheme will be available in January 2026, after publication of the new CPD standards in December.
Enquiries about the new standards and accreditation process can be directed to psaeducation@psa.org.au
[post_title] => PSA to accredit CPD against new standards from January
[post_excerpt] => At the end of the year, the APC will retire its Accreditation Standards for Continuing Professional Development Activities.
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[title_attribute] => PSA to accredit CPD against new standards from January
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[post_content] => 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.
[post_title] => Navigating legal red flags in the changing pharmacy landscape
[post_excerpt] => As pharmacy practice evolves, professional, ethical and legal expectations become more complex. Here's how pharmacists can avoid red flags.
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[post_content] => From mid-2027, the availability of dozens and dozens of complementary medicines containing vitamin B6 will change.
Yesterday (25 November 2025), the Therapeutic Goods Administration (TGA) released the final decision on the scheduling of vitamin B6 containing medicines in response to safety concerns following consideration of the advice of the Advisory Committee on Medicines Scheduling in November 2024 and public consultation.
What's changing?
The TGA Delegate’s final decision will see scheduling changes for products containing vitamin B6, dependent on the product’s vitamin B6 dose. This means oral preparations containing:
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[post_content] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
Pharmacists may have had questions this week about antibiotic use in children following news articles highlighting the link between some antibiotics and vaccine efficacy. AP looks behind the headline to help pharmacists know how to respond
What’s driving this impairment?
Infants exposed to antibiotics in the neonatal period or first year of life had significantly lower antibody responses to vaccines including meningococcal ACWY and measles, mumps, rubella, found a study led by Australian experts.
The impact on antibody response is most likely due to disruptions in the development of gut bacteria.
‘We’ve known for some time that gut bacteria play an important role in shaping the immune system, but this study provides strong evidence that early life antibiotics can disrupt that process in a way that weakens vaccine responses,’ said Professor David Lynn, Professor of Systems Immunology at Flinders Health and Medical Research Institute, who co-led the study.
Infants who were treated with antibiotics had lower amounts of helpful gut bacteria at the time of vaccination, with Bifidobacteria particularly impacted. Children with this reduction in gut bacteria later showed weaker immune responses, indicated by reduced antibody levels at 6 and 14 months of age.
‘This suggests that these gut bacteria play a key role in helping the immune system respond optimally to vaccines,’ he said.
Interestingly, the study also found that babies whose mothers received antibiotics during labour did not have reduced vaccine responses.
‘This is an important distinction because it suggests that not all antibiotic exposure carries the same risks when it comes to the impact on the infant’s immune responses,’ Prof Lynn said. ‘[These findings] raise important questions about how we use antibiotics in newborns and what we can do to reduce any unintended consequences.’
What should pharmacists do?
Pharmacists should advise patients that routine vaccinations should not be postponed. At this stage, there have also not been changes to guidelines around antibiotic use. And antibiotics should also not be withheld when required, with infant infections often presenting as severe and requiring urgent treatment.
‘There’s usually a very good reason for giving the neonates those antibiotics, given that infections and sepsis in that critical early life period can be very serious,’ Prof Lynn told the Guardian.
Furthermore, infants treated with antibiotics still produce a sufficient immune response when vaccinated.
‘Around that 7-month time point, most of the infants are above what’s called the seroprotective threshold, so they will be expected to be protected against infection,’ Prof Lynn said.
‘What does seem to happen is that, over time, those responses wane a bit quicker in the infants that directly have antibiotics.’
The gut microbiome can also likely be repaired through the use of prebiotics and probiotics after antibiotic exposure, boosting impaired vaccine responses, found in an earlier preclinical study in mice led by Prof Lynn.
But antibiotics should continue to be used wisely.
‘In view of the importance of vaccination in maintaining health in society, this is yet another reason why antibiotics should be administered judiciously,’ said Associate Professor Peter Speck, from the College of Science and Engineering at Flinders University. ‘Antibiotic stewardship is clearly of great value, especially in the neonatal setting.’
What are the next steps?
While the findings are compelling, the authors acknowledge there are several limitations to the research . The study cohort was relatively small, and numbers in each antibiotic-exposed subgroup were even smaller.
Infants born by caesarean section or to mothers with a body mass index above 30 were excluded, so the results may not reflect the broader population seen in everyday practice. Immune responses were assessed with only limited functional assays and no detailed T cell analysis. Larger, more diverse studies will be needed to confirm and build on these early findings.
To that end, a human trial funded by the Women’s and Children’s Hospital Foundation is set to investigate if the infant immune response to vaccines can be improved by giving probiotics to babies treated with antibiotics in the first week of life.
‘This will provide evidence as to whether this simple probiotic intervention can support optimal immune responses to vaccination in early life, and we’ll also be able to identify the molecular mechanisms governing the differences in vaccine efficacy,’ Prof Lynn said.
‘Our findings could also be relevant to long-term child health, given prior associations between antibiotic exposure and an increased propensity to develop conditions such as allergies, asthma and obesity.’
Visit PSA’s Vaccination (Immunisation) Education Hub to access vaccination education and resources.
[post_title] => Early antibiotic use may blunt infant vaccine protection
[post_excerpt] => Early-life exposure to antibiotics can weaken the immune response to several routine vaccinations in infants, research has found.
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[post_content] => The new Medication Management at Transitions of Care Stewardship Framework highlights the pharmacist’s pivotal role in reducing medicine errors and supporting safe discharge.
Each year, an estimated 250,000 hospital admissions in Australia are caused by medicine-related errors, costing the health system around $1.4 billion annually. More than half of these errors occur during transitions of care.
Recognising the need for immediate action, the Australian Commission on Safety and Quality in Health Care has released the Medication Management at Transitions of Care Stewardship Framework – Australia’s first coordinated hospital-based model designed to reduce medicine errors, improve communication and support safer discharge and follow-up.
For pharmacists in hospitals, general practice, community and aged care, the Framework articulates an opportunity to take a leading role in safeguarding medicines management during the riskiest moments of care.
AP spoke with Dr Phoebe Holdenson Kimura, GP and medical advisor to the Commission, to understand what this means in practice.
National guidance, local implementation
The Framework sets out four interlocking elements to improve safety at transitions of care, the first being the establishment of a governing committee responsible for leadership, oversight and local needs analysis.
‘Many hospitals already do significant work in transitions of care and medication safety, so we anticipate that this governing committee would sit within an existing medication safety or patient safety and quality committee,’ Dr Holdenson Kimura said.
[caption id="attachment_30957" align="aligncenter" width="600"] Dr Phoebe Holdenson Kimura[/caption]
This committee develops the implementation plan, governs risk mitigation activity and evaluates impact. Beneath it sits the second element – a multidisciplinary stewardship team, where pharmacists play a central role.
‘Pharmacists are often the champions of medication safety. We’ve seen their transformative impact through antimicrobial and opioid stewardship models,’ she said.
This team focuses its energy on patients at the highest risk of medicines misadventure, coordinating proactive reviews from admission through to discharge.
The third element outlines specific activities required throughout the patient journey, including early discharge planning and prompt communication with GPs and community pharmacists about medicines changes, while the fourth emphasises ongoing monitoring, evaluation and reporting to ensure hospital systems evolve and improve over time based on real-world performance.
‘This framework aims to raise the bar nationally so that all hospitals take a proactive, systematic approach,’ she said.
Recognising high risk patients
The framework includes a comprehensive list of criteria that can be used to prioritise patients at risk of hospitalisation due to medicines misadventure. This includes patients who are:
High-quality medicines reconciliation should ideally occur in the emergency department or soon after admission to the ward.
‘Partnered pharmacist medication charting is also key to preventing errors from the outset,’ Dr Holdenson Kimura added.
Throughout the hospital stay, the Framework emphasises strengthened medicines review and shared decision-making – involving patients in conversations about risks, deprescribing and therapeutic goals.
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[post_content] => At the end of this year, the Australian Pharmacy Council (APC) will retire its Accreditation Standards for Continuing Professional Development Activities.
To ensure CPD activities can continue to be accredited, PSA is developing a brand new set of standards for Continuing Professional Development for pharmacists.
AP sat down with PSA’s CPD Manager, Chloe Tobin, to find out what this means for you.
Why is the CPD accreditation system changing?
The APC’s Accreditation Standards for Continuing Professional Development Activities will no longer be active from 31 December 2025. To ensure pharmacists can continue to access CPD which has been assessed for quality and reliability in education, PSA is in the process of developing a set of standards for CPD activities.
The aim of this change is to ensure pharmacists can continue accessing accredited CPD activities without having to assess for themselves whether an activity meets the Pharmacy Board of Australia’s requirements or is relevant to their practice.
What can pharmacists expect from PSA accredited CPD activities?
When a pharmacist selects PSA-accredited CPD activities, they can be confident the education they access is of high quality, upholds pharmacy practice standards, guidelines and ethics, and is free from commercial bias.
With the impending changes to CPD, will I need to do anything differently?
No. Following the retirement of the APC’s CPD standards, PSA’s standards will provide a seamless transition for pharmacists to new criteria for assessing CPD activities.
Can I still complete CPD activities accredited against the APC CPD Accreditation standards?
Yes. CPD activities which have been accredited against the current APC CPD Accreditation standards will remain accredited until their expiry date, or up until 31 December 2026 – whichever is earlier.
Will CPD activities still be worth the same number of credits?
At this stage, the Pharmacy Board of Australia’s CPD standard remains unchanged, so pharmacists will continue to accrue credits using the same ‘Group 1, Group 2, Group 3’ categories as they have when completing activities accredited against the current APC standards.
Can I still use the PSA CPD Planning Tool?
The PSA CPD Planning Tool will continue to be available to members to help identify professional development needs and create an annual CPD plan.
There will be no changes to the tool, and PSA-led activities will continue to be recorded automatically.
How far along is PSA in finalising the CPD standards?
Public consultation has closed for the PSA Standards for CPD for pharmacists.
The end of this consultation process marked the next step in finalising the new CPD standards, which PSA will use to assess the quality and applicability of education for pharmacists before accreditation.
We are currently incorporating feedback into the draft document ahead of seeking endorsement by the PSA Board next month.
What’s the feedback on PSA’s draft standards document so far?
During the consultation process, respondents have revealed that they value the concise and clear structure of the document, as well as the inclusion of guidance information. Stakeholders also expressed strong support for the standards’ focus on independence and practical applicability to pharmacy practice.
Where can I access more information?
Further details on PSA’s accredited CPD scheme will be available in January 2026, after publication of the new CPD standards in December.
Enquiries about the new standards and accreditation process can be directed to psaeducation@psa.org.au
[post_title] => PSA to accredit CPD against new standards from January
[post_excerpt] => At the end of the year, the APC will retire its Accreditation Standards for Continuing Professional Development Activities.
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[title_attribute] => PSA to accredit CPD against new standards from January
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[post_content] => 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.
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[post_excerpt] => As pharmacy practice evolves, professional, ethical and legal expectations become more complex. Here's how pharmacists can avoid red flags.
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CPD credits
Accreditation Code :
Group 1 : CPD credits
Group 2 : CPD credits
This activity has been accredited for hours of Group 1 CPD (or CPD credits) suitable for inclusion in an individual pharmacist's CPD plan, which can be converted to hours of Group 2 CPD (or CPD credits) upon successful completion of relevant assessment activities.
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
