Information on Commonwealth, state and territory statutory declarations
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[post_content] => Australia’s understanding and adoption of Quality Use of Medicines (QUM) principles across general practice and primary care has led to overall improvements in medicine use, such as curtailing high-dose use of proton pump inhibitors.
But the challenge has since changed, with Australians living longer – resulting in an older, sicker population who uses more medicines, said Professor Libby Roughead – Director of the QUM and Pharmacy Research Centre at the University of South Australia.
‘Now the game is to say, how do we go forward when we’ve got a frail older population, and lots of specialty medicine? she asked.
This is the question a panel of experts sought to answer at the National Medicines Symposium 2024 yesterday (19 November).
Be wary of using ‘wonder drugs’ in older patients
When clinical trials are conducted on new medicines, they’re not tested in the over 65 age group, said Steve Waller, Senior Advisor, Medication without Harm, Australian Commission on Safety and Quality in Health Care.
[caption id="attachment_28267" align="alignnone" width="800"]
National Medicines Symposium 2024 speakers (L to R): Steve Waller, Professor Jennifer Martin, Professor Libby Roughead, Tegan Taylor[/caption]
‘That creates complications, because we often don’t know what the impact in that older age group is … and pharmaceutical companies don’t have that information when they’re making an application for a new drug to be listed with the TGA [Therapeutic Goods Administration] and PBS [Pharmaceutical Benefits Scheme],’ he said.
Healthcare professionals must have awareness of the limitations of the data, thinks Professor Jennifer Martin, clinical pharmacologist and president of the Royal Australian College of Physicians.
‘Often, I say to people “why are you using a statin in [an older] population? We know the life expectancy when you go to a nursing home is less than 2 years, and you have to be on this drug at this dose for 5 years just to see a small reduction in a composite end point”,’ she said.
Healthcare professionals should rely on Australia’s ‘good sources of objective information’ such as Therapeutic Guidelines and the Australian Medicines Handbook, said Prof Roughead.
But more work needs to be done on increasing uptake of non-pharmacological interventions that are suitable for many conditions, including art therapy, music therapy, exercise and diet.
‘We know compassion practices are really helpful in some of the hard-to-treat conditions [such as] pain and depression, so we need to get better at involving the whole therapeutic armamentarium,’ she said. ‘The first definition of QUM is judicious selection of management options.’
Involve older patients in deprescribing decisions
Doctors, pharmacists, family members and carers typically talk among themselves about an older patient's medicine regimen. But it’s the patient they need to focus on, thinks Prof Martin.
‘When you talk to an older person, they will typically say “I don’t know why they started those pills” or “I don’t think I was supposed to be on them long-term, but no one stopped them, so I just kept taking them”,’ she said.
‘So, come back to the patient and ask, “Why are you taking these medications? What are your goals of care? Do you want pain relief? What are you looking for?”’
As patients reach their final chapter, many are just after quality of life – which doesn’t necessarily entail losing cognitive function through heavy use of opioids.
‘Opioids may play some role in pain, but they certainly take away a lot of the quality of life for older people,’ said Prof Martin. ‘It’s not until you spend time talking to the person that you find out they actually want to be very sharp; they think they can cope with their pain by other measures, and we can probably reduce some of their opioids.’
Warranted distrust in medicines and healthcare needs to be built back up
While we live in an age where misinformation is rife, some of it stems from the health system and pharma model, said Prof Martin.
‘For example, we know with gabapentin, which some people use for pain, most of the information that got onto the market was fraudulent,’ she said. ‘[There] was then a big investigation, with lawsuits still ongoing.’
The same goes for opioids, ineffective for many of the conditions they are prescribed for – particularly chronic pain.
‘The public are looking at their health providers saying, “We now know this is misinformation, but you prescribed this”, so we’ve lost a bit of engagement with our community,’ said Prof Martin.
With many patients with chronic pain on high doses of opioids that are not treating their conditions and impairing their quality of life, Prof Martin thinks the healthcare sector has ‘something to answer for’.
‘That misinformation is coming from industry and from the fact that we’re too busy to actually go back to their source material,’ she said.
The good news is that opioid deaths have decreased over the last 5 years in Australia, thanks to tighter prescribing regulations and better resources such as the Opioid Analgesic Stewardship in Acute Pain Clinical Care Standard, said Mr Waller.
Work on state formularies has also reduced the number of opioids that people can prescribe, said Prof Martin.
‘It has helped to get that conversation going of “Why do you need to have access to 10 different opioids in an in-patient setting?” and “Why do you need all these different concentrations?”’ she said.
However, more changes in practice are required to ensure that trend continues in the right direction, said Mr Waller.
‘We need to stop using opioids for chronic pain,’ he said. ‘There’s limited to no evidence to suggest that they work, and we need to be very judicious about our use of modified-release opioid analgesics.’
Yet as that work is done, it’s crucial to remember that these patients are suffering and compassion should be brought to the encounter – rather than simply saying ‘you can’t have that’, said Prof Roughead.
‘It’s not just ceasing a medicine. It’s ceasing a medicine and starting other things that you might need to help you be well, whether it be an exercise program or psychological services,’ she said.
Pharmacists can bridge communication and healthcare gaps in RACFs
With the Aged Care On-site Pharmacist (ACOP) program kicking off on 1 July 2024, pharmacists can improve the approach to healthcare by simply getting to know people – a skill well-honed by pharmacists in other settings, said Prof Roughead.
This includes understanding patient preferences and non-pharmacological activities that might support them.
‘If we can build a system where we can create relationships, particularly in a virtual world … we’re all going to be safer and we’re all going to feel better,’ she said.
‘That’s got to be the strength of an embedded pharmacist in aged care, that day-to-day knowledge of what the patient’s likes and dislikes are and how they’ve been managed over a continuum, as opposed to a visit that might happen once a year,’ added Mr Waller.
As the custodian of the pharmacy profession’s Professional Practice Standards and an education and training provider, PSA has continued to invest and embark into practice support training and education for pharmacists to become ACOP credentialed, said PSA National President Associated Professor Fei Sim.
The training covers all elements of this role – from professionalism, to understanding the governance of an RACF, collaborative practice, providing person-centred medication management and working within a multidisciplinary team to improve the safe and quality use of medicines.
‘Pharmacists undertaking the training program would then acquire the necessary credentials, qualifications and skill set to be able to undertake the role as an aged care on-site pharmacist,’ she said.
‘We’re also providing ongoing resources and clinical updates for credentialed pharmacists so they can be kept up to date with their knowledge and skills to undertake the role.’
With any new areas of practice, there is a great need for mentoring and networking for like-minded pharmacists who work in the same area to forge bonds, said A/Prof Sim. ‘That’s why PSA created the Consultant Pharmacists CSI group [and] an annual Consultant Pharmacist Conference, focusing on supporting and meeting the learning needs of credentialed pharmacists.’
[post_title] => Giving a voice back to elderly patients
[post_excerpt] => Yesterday’s National Medicine Symposium delivered a stark critique of how our health system is failing older patients – and how to fix it.
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[post_content] => Mpox cases are surging in Australia. An expert reveals how pharmacists can address the rising spread.
When mpox was first reported in Australia in May 2022, case numbers remained relatively low for the better part of 2 years.
However, in 2024 there has been a significant spike in case numbers in several Australian states and territories, with New South Wales, Victoria and Western Australia all seeing rising locally acquired notifications.
In September, it was reported that mpox cases grew a staggering 570% since July 2024 –with over 724 cases recorded this year. Yet vaccination rates remain low.
Meanwhile, cases of clade Ib – which has a much higher fatality rate than clade IIb strain spreading in Australia – have been detected in numerous countries around the world, most recently the United States. The worldwide spread of the new clade led the World Health Organisation to declare the mpox outbreak a public health emergency of international concern.
At this stage, pharmacists can only administer the mpox vaccine in Victoria and the Northern Territory.
However, pharmacists in all jurisdictions have an essential role in raising awareness of vaccine eligibility and dosing schedule, when to get vaccinated and where to get tested – all of which can help to bring down rising case numbers.
Watch the video below to hear sexual health expert Dr Tom Morley explain how pharmacists can go about this in a culturally safe way.
https://www.youtube.com/watch?v=ZPzbadkq8sM
[post_title] => Curbing the spread as mpox cases skyrocket
[post_excerpt] => Mpox cases are surging both in Australia and around the world. An expert reveals how pharmacists can address the rising spread.
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[post_date] => 2024-11-18 09:28:17
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[post_content] => Constipation can be an embarrassing topic to discuss with your patients. But irregular bowel movements can not only be uncomfortable, but can lead to other health conditions and severely impact a patient’s quality of life.
[caption id="attachment_28205" align="alignright" width="150"]
This CPD activity is sponsored by Reckitt. All content is the true, accurate and independent opinion of the speakers and the views expressed are entirely their own.[/caption]
Constipation is a common problem in the community,1 that can significantly impact quality of life if not properly managed.2 It’s also a common reason for primary care visits and referrals to gastroenterologists.3 Unfortunately, many patients are choosing laxatives without the help and advice of a health professional1 so may be choosing products that don’t work effectively5 or choosing to use laxatives when addressing dietary, lifestyle or medicine regimens may be the most appropriate course of action. In this CPD accredited podcast, listen to Priceline Health Services Manager Brett Macfarlane and Senior Clinical Pharmacist – Gastroenterology at the Royal Melbourne Hospital Stephanie Dimovski discuss the problem of constipation and how pharmacists can assist patients in managing this condition. They will address the importance of identifying whether insufficient fibre and fluid intake may be contributing and whether making dietary and exercise recommendations is enough to restore normal bowel habits.
After reading this article, pharmacists should be able to:
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[post_content] => The Therapeutic Goods Administration (TGA) has worked with Phenergan manufacturer Sanofi to develop a new contraindication for the medicine in children under 6.
The decision to restrict use of the medicine in this age cohort – commonly used to treat allergies, travel sickness and nausea – is based on a thorough evaluation of new scientific evidence that the risks outweigh the benefits, a spokesperson for Sanofi told Australian Pharmacist.
‘Following recent evaluations made by Sanofi Consumer Healthcare Pty Ltd, including a benefit-risk assessment, the research has shown a causal association between promethazine and safety concerns,’ said this spokesperson.
The sponsor-initiated update was prompted by advice from the TGA Advisory Committee on Medicines (ACM) – first-generation oral sedating antihistamines – do not use in children, said a spokesperson from the TGA.
‘Further review by the sponsor of cumulative safety data in children 2 to 5 years of age demonstrated sufficient evidence of a causal association between promethazine and psychiatric and central nervous system adverse events in this age group,’ the TGA spokesperson told AP.
The contraindication comes after Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, moved to contraindicate the use of the medicine in children under 6 due to the potential for fatal respiratory depression, psychiatric and central nervous system (CNS) events.
AP understands that the contraindication will affect other products. A spokesperson for AFT said a variation has been submitted to update the product information and label on Allersoothe Elixir with a change to the age indication from children 2 years and older to children 6 years and older. This submission is pending approval.
Will the packaging change?
Not immediately.
New labels for promethazine-containing products will be rolled out in 2025 due to production and logistics lead times, said the Sanofi spokesperson.
‘No immediate action is required regarding current stock. There is no need to set aside existing medications, as this communication does not constitute a recall,’ said the spokesperson. ‘Similarly, the revised labels do not create any changes in the ordering process.
The product information for Phenergan has been updated and is available here.
What should pharmacists do if they get a Phenergan script for an 18 month old infant?
The use of promethazine in children under 6 years of age is now both contraindicated and off label, said Peter Guthrey MPS, PSA Senior Pharmacist – strategic policy.
‘This means that if you choose to dispense, both the prescriber and dispenser carry the full indemnity risk, and you need to get the patient to provide informed consent,’ he said.
Should a parent present with a script for promethazine for use in a child under 6 years of age, pharmacists should contact the prescriber to discuss the risks and benefits, noting that it's contraindicated.
Is there any situation where it would be appropriate to dispense Phenergan to a young child?
It would need to be a pretty compelling case, where the benefit to a child outweighed the risk of respiratory depression, psychiatric or CNS events, said Mr Guthrey.
‘Given it’s a documented contraindication, it'd be pretty hard to demonstrate the medicine is ‘‘safe and therapeutically appropriate’’,’ he said.
‘It is going to be difficult to find a situation where supply is clinically justified and pharmacists have met their obligations to patient safety.’
What about prescribing Phenergan as a Schedule 3 medicine?
If a parent requests promethazine as a Schedule 3 medicine for someone under the age of 6 years, generally alternate products or advice for treatment should be provided following a discussion.
‘While a pharmacist prescribing promethazine as a Pharmacist Only Medicine is lawful for children aged 2-5 years, it is still contraindicated,’ said Mr Guthrey. ‘There would be very few, if any, situations where prescribing the medicine where contraindicated would be warranted.’
What about phenylephrine?
There are some combination phenylephrine products indicated for children under 6 years of age for nasal congestion. However, there is plenty of evidence showing that oral phenylephrine products are ineffective as a nasal decongestant.
In fact, the United States Food and Drug Administration (FDA) recently announced it will move to ban oral phenylephrine products because they simply don't work.
‘Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,’ said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
While a spokesperson for the TGA told Australian Pharmacist back in July that there are ‘no plans’ to review the effectiveness of oral phenylephrine, it will continue to monitor the outcomes of the FDA review.
What advice should pharmacists provide?
For children with allergies, non-sedating antihistamines are first line.
The best thing parents can do when a child under 6 years of age has cough or cold symptoms is to wait it out, with a review by a medical practitioner when appropriate.
‘It's about reassurance to parents that the cough in itself isn't harmful, and that kids don’t always need medicines for a cold – they need time and supportive therapy,’ said Mr Guthrey.
It’s important that pharmacists give parents confidence that they're doing the right thing by not treating the cough, and providing symptomatic relief for fever and chills – ensuring they are appropriately counselled on when review by a medical practitioner may be appropriate.
For more information, refer to the Australian Pharmaceutical Formulary and Handbook treatment guidelines on:
[post_title] => Do not supply Phenergan to children under 6, manufacturer warns
[post_excerpt] => The TGA has worked with Phenergan manufacturer Sanofi to develop a new contraindication for the medicine in children under 6.
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[post_content] => With cases of Respiratory syncytial virus (RSV) spiking this year, the federal government announced yesterday (10 November) that free vaccination would be offered to eligible pregnant people and babies.
Before the 2025 winter season, the RSV vaccine will be available under the National Immunisation Program (NIP) for all people in the third trimester of pregnancy via the Australian Infant RSV Immunisation Program.
Which RSV vaccines will pharmacists administer?
The RSV immunisation program will offer two Therapeutic Goods Administration approved protections against severe RSV.
Pharmacists can administer the maternal vaccine, Abrysvo, to pregnant women between 28-36 weeks of gestation.
Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%, a spokesperson from the Department of Health and Aged Care told Australian Pharmacist.
‘This is [through] passive protection by transplacental transfer of RSV-specific antibodies from the mother to the foetus during pregnancy.’
How popular will it be?
Federal Minister for Health and Aged Care Mark Butler said the RSV vaccine rollout has been modelled on the whooping cough vaccine in pregnant women, which is administered at around the same time and has an uptake rate of around 80%.
‘Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%.'
The Department of Health and Aged Care
‘So we have good confidence that there will be a significant uptake of this maternal vaccine by pregnant Australian women,’ he added.
What is covered for pharmacists under the NIP?
According to the Department of Health and Aged Care, both the cost of the maternal RSV vaccine (Abrysvo) and the vaccine administration fee will be covered under the NIP and The National Immunisation Program Vaccinations in Pharmacy (NIPVIP) Program.
Abrysvo NIP vaccine stock will also be available to community pharmacists, said the spokesperson.
What about protection for neonates?
Access has also widened for more babies to receive a protection against RSV soon after birth, particularly those whose mother did not opt to have the vaccine during pregnancy.
Beyfortus (nirsevimab), an antibody therapy for the prevention of RSV-related lower respiratory tract disease, will be available in hospitals, immunisation clinics and general practices for infants before or during their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease throughout their second RSV season can also access the vaccine.
‘Beyfortus is a monoclonal antibody treatment which is administered to babies by injection,’ said Minister Butler. ‘[It can be received] immediately after birth … if their mother has not been vaccinated against RSV.’
Why did the government decide to take action against RSV?
Australia recorded the highest ever number of RSV cases this year, with 165,910 reported notifications.
Most cases were recorded in the 0–4 age cohort, among whom RSV can be fatal, and is the leading cause of hospitalisation for Australian children under five years of age.
The Australian Immunisation Foundation estimates that around 12,000 Australian babies aged 12 months or younger are admitted to hospital with RSV annually. Around 25% of these children will require intensive care.
The inclusion of an RSV vaccine in the NIP is an important step to protect newborn children and infants from severe RSV infection, said the spokesperson.
‘The highest rate of RSV-related hospitalisations is in infants during their first few months of life,’ said the spokesperson.
‘Infants with medical risk factors, such as being born very [premature], under 32 weeks gestational age, have an increased risk of severe disease.
‘Up to 80% of infants who are hospitalised due to RSV are otherwise healthy children with no predisposing conditions.’
What’s the expected impact?
The Immunisation Foundation of Australia has estimated that the nationwide availability of new RSV immunisations will help to keep 10,000 infants out of hospital with related bronchiolitis or pneumonia each year.
‘The immunisations being funded in Australia protect babies against severe RSV and have been shown to slash hospitalisation rates by up to 90 per cent,’ said Catherine Hughes AM, Founder and Director of the Immunisation Foundation of Australia.
Western Australia was the first state to implement an infant RSV immunisation program with Beyfortus. More than 23,000 infants received RSV protection this year, resulting in up to 84% fewer hospitalisations in immunised newborns compared to those who were not RSV protected. In Queensland, where a statewide infant RSV immunisation program commenced in April 2024, similar results were observed.
‘The exceptional results in Western Australia and Queensland contrast sharply with other parts of Australia where hospitals were overwhelmed by babies struggling to breathe due to severe RSV,’ she said.
Will older patients be able to receive the RSV vaccine under the NIP?
No. Well at least, not yet.
Vaccines can only be listed on the NIP after a positive recommendation from the Pharmaceutical Benefits Advisory Committee’s (PBAC) as required by the National Health Act 1953, said the spokesperson.
‘Several vaccine sponsors have made submissions in relation to RSV vaccines for older populations to the PBAC to consider for NIP listing,’ said the spokesperson.
‘The outcomes of these meetings will inform future government considerations regarding the potential listing of RSV vaccines on the NIP for older Australians.’
While a positive PBAC recommendation is an essential requirement in the NIP-listing process, other steps need to be completed before a vaccine can be given final approval for NIP listing, said the spokesperson.
‘These include negotiations with the relevant pharmaceutical company, finalisation of conditions for listing, quality and availability checks and final consideration by the government,’ said the spokesperson. ‘These considerations and decisions of government cannot be preempted.’
[post_title] => Government-funded RSV vaccines to protect infants from severe disease
[post_excerpt] => With cases of RSV spiking in 2024, the federal government announced free vaccination would be offered to eligible pregnant people and babies.
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[post_content] => Australia’s understanding and adoption of Quality Use of Medicines (QUM) principles across general practice and primary care has led to overall improvements in medicine use, such as curtailing high-dose use of proton pump inhibitors.
But the challenge has since changed, with Australians living longer – resulting in an older, sicker population who uses more medicines, said Professor Libby Roughead – Director of the QUM and Pharmacy Research Centre at the University of South Australia.
‘Now the game is to say, how do we go forward when we’ve got a frail older population, and lots of specialty medicine? she asked.
This is the question a panel of experts sought to answer at the National Medicines Symposium 2024 yesterday (19 November).
Be wary of using ‘wonder drugs’ in older patients
When clinical trials are conducted on new medicines, they’re not tested in the over 65 age group, said Steve Waller, Senior Advisor, Medication without Harm, Australian Commission on Safety and Quality in Health Care.
[caption id="attachment_28267" align="alignnone" width="800"] National Medicines Symposium 2024 speakers (L to R): Steve Waller, Professor Jennifer Martin, Professor Libby Roughead, Tegan Taylor[/caption]
‘That creates complications, because we often don’t know what the impact in that older age group is … and pharmaceutical companies don’t have that information when they’re making an application for a new drug to be listed with the TGA [Therapeutic Goods Administration] and PBS [Pharmaceutical Benefits Scheme],’ he said.
Healthcare professionals must have awareness of the limitations of the data, thinks Professor Jennifer Martin, clinical pharmacologist and president of the Royal Australian College of Physicians.
‘Often, I say to people “why are you using a statin in [an older] population? We know the life expectancy when you go to a nursing home is less than 2 years, and you have to be on this drug at this dose for 5 years just to see a small reduction in a composite end point”,’ she said.
Healthcare professionals should rely on Australia’s ‘good sources of objective information’ such as Therapeutic Guidelines and the Australian Medicines Handbook, said Prof Roughead.
But more work needs to be done on increasing uptake of non-pharmacological interventions that are suitable for many conditions, including art therapy, music therapy, exercise and diet.
‘We know compassion practices are really helpful in some of the hard-to-treat conditions [such as] pain and depression, so we need to get better at involving the whole therapeutic armamentarium,’ she said. ‘The first definition of QUM is judicious selection of management options.’
Involve older patients in deprescribing decisions
Doctors, pharmacists, family members and carers typically talk among themselves about an older patient's medicine regimen. But it’s the patient they need to focus on, thinks Prof Martin.
‘When you talk to an older person, they will typically say “I don’t know why they started those pills” or “I don’t think I was supposed to be on them long-term, but no one stopped them, so I just kept taking them”,’ she said.
‘So, come back to the patient and ask, “Why are you taking these medications? What are your goals of care? Do you want pain relief? What are you looking for?”’
As patients reach their final chapter, many are just after quality of life – which doesn’t necessarily entail losing cognitive function through heavy use of opioids.
‘Opioids may play some role in pain, but they certainly take away a lot of the quality of life for older people,’ said Prof Martin. ‘It’s not until you spend time talking to the person that you find out they actually want to be very sharp; they think they can cope with their pain by other measures, and we can probably reduce some of their opioids.’
Warranted distrust in medicines and healthcare needs to be built back up
While we live in an age where misinformation is rife, some of it stems from the health system and pharma model, said Prof Martin.
‘For example, we know with gabapentin, which some people use for pain, most of the information that got onto the market was fraudulent,’ she said. ‘[There] was then a big investigation, with lawsuits still ongoing.’
The same goes for opioids, ineffective for many of the conditions they are prescribed for – particularly chronic pain.
‘The public are looking at their health providers saying, “We now know this is misinformation, but you prescribed this”, so we’ve lost a bit of engagement with our community,’ said Prof Martin.
With many patients with chronic pain on high doses of opioids that are not treating their conditions and impairing their quality of life, Prof Martin thinks the healthcare sector has ‘something to answer for’.
‘That misinformation is coming from industry and from the fact that we’re too busy to actually go back to their source material,’ she said.
The good news is that opioid deaths have decreased over the last 5 years in Australia, thanks to tighter prescribing regulations and better resources such as the Opioid Analgesic Stewardship in Acute Pain Clinical Care Standard, said Mr Waller.
Work on state formularies has also reduced the number of opioids that people can prescribe, said Prof Martin.
‘It has helped to get that conversation going of “Why do you need to have access to 10 different opioids in an in-patient setting?” and “Why do you need all these different concentrations?”’ she said.
However, more changes in practice are required to ensure that trend continues in the right direction, said Mr Waller.
‘We need to stop using opioids for chronic pain,’ he said. ‘There’s limited to no evidence to suggest that they work, and we need to be very judicious about our use of modified-release opioid analgesics.’
Yet as that work is done, it’s crucial to remember that these patients are suffering and compassion should be brought to the encounter – rather than simply saying ‘you can’t have that’, said Prof Roughead.
‘It’s not just ceasing a medicine. It’s ceasing a medicine and starting other things that you might need to help you be well, whether it be an exercise program or psychological services,’ she said.
Pharmacists can bridge communication and healthcare gaps in RACFs
With the Aged Care On-site Pharmacist (ACOP) program kicking off on 1 July 2024, pharmacists can improve the approach to healthcare by simply getting to know people – a skill well-honed by pharmacists in other settings, said Prof Roughead.
This includes understanding patient preferences and non-pharmacological activities that might support them.
‘If we can build a system where we can create relationships, particularly in a virtual world … we’re all going to be safer and we’re all going to feel better,’ she said.
‘That’s got to be the strength of an embedded pharmacist in aged care, that day-to-day knowledge of what the patient’s likes and dislikes are and how they’ve been managed over a continuum, as opposed to a visit that might happen once a year,’ added Mr Waller.
As the custodian of the pharmacy profession’s Professional Practice Standards and an education and training provider, PSA has continued to invest and embark into practice support training and education for pharmacists to become ACOP credentialed, said PSA National President Associated Professor Fei Sim.
The training covers all elements of this role – from professionalism, to understanding the governance of an RACF, collaborative practice, providing person-centred medication management and working within a multidisciplinary team to improve the safe and quality use of medicines.
‘Pharmacists undertaking the training program would then acquire the necessary credentials, qualifications and skill set to be able to undertake the role as an aged care on-site pharmacist,’ she said.
‘We’re also providing ongoing resources and clinical updates for credentialed pharmacists so they can be kept up to date with their knowledge and skills to undertake the role.’
With any new areas of practice, there is a great need for mentoring and networking for like-minded pharmacists who work in the same area to forge bonds, said A/Prof Sim. ‘That’s why PSA created the Consultant Pharmacists CSI group [and] an annual Consultant Pharmacist Conference, focusing on supporting and meeting the learning needs of credentialed pharmacists.’
[post_title] => Giving a voice back to elderly patients
[post_excerpt] => Yesterday’s National Medicine Symposium delivered a stark critique of how our health system is failing older patients – and how to fix it.
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[post_content] => Mpox cases are surging in Australia. An expert reveals how pharmacists can address the rising spread.
When mpox was first reported in Australia in May 2022, case numbers remained relatively low for the better part of 2 years.
However, in 2024 there has been a significant spike in case numbers in several Australian states and territories, with New South Wales, Victoria and Western Australia all seeing rising locally acquired notifications.
In September, it was reported that mpox cases grew a staggering 570% since July 2024 –with over 724 cases recorded this year. Yet vaccination rates remain low.
Meanwhile, cases of clade Ib – which has a much higher fatality rate than clade IIb strain spreading in Australia – have been detected in numerous countries around the world, most recently the United States. The worldwide spread of the new clade led the World Health Organisation to declare the mpox outbreak a public health emergency of international concern.
At this stage, pharmacists can only administer the mpox vaccine in Victoria and the Northern Territory.
However, pharmacists in all jurisdictions have an essential role in raising awareness of vaccine eligibility and dosing schedule, when to get vaccinated and where to get tested – all of which can help to bring down rising case numbers.
Watch the video below to hear sexual health expert Dr Tom Morley explain how pharmacists can go about this in a culturally safe way.
https://www.youtube.com/watch?v=ZPzbadkq8sM
[post_title] => Curbing the spread as mpox cases skyrocket
[post_excerpt] => Mpox cases are surging both in Australia and around the world. An expert reveals how pharmacists can address the rising spread.
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[post_content] => Constipation can be an embarrassing topic to discuss with your patients. But irregular bowel movements can not only be uncomfortable, but can lead to other health conditions and severely impact a patient’s quality of life.
[caption id="attachment_28205" align="alignright" width="150"] This CPD activity is sponsored by Reckitt. All content is the true, accurate and independent opinion of the speakers and the views expressed are entirely their own.[/caption]
Constipation is a common problem in the community,1 that can significantly impact quality of life if not properly managed.2 It’s also a common reason for primary care visits and referrals to gastroenterologists.3 Unfortunately, many patients are choosing laxatives without the help and advice of a health professional1 so may be choosing products that don’t work effectively5 or choosing to use laxatives when addressing dietary, lifestyle or medicine regimens may be the most appropriate course of action. In this CPD accredited podcast, listen to Priceline Health Services Manager Brett Macfarlane and Senior Clinical Pharmacist – Gastroenterology at the Royal Melbourne Hospital Stephanie Dimovski discuss the problem of constipation and how pharmacists can assist patients in managing this condition. They will address the importance of identifying whether insufficient fibre and fluid intake may be contributing and whether making dietary and exercise recommendations is enough to restore normal bowel habits.
After reading this article, pharmacists should be able to:
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[post_content] => The Therapeutic Goods Administration (TGA) has worked with Phenergan manufacturer Sanofi to develop a new contraindication for the medicine in children under 6.
The decision to restrict use of the medicine in this age cohort – commonly used to treat allergies, travel sickness and nausea – is based on a thorough evaluation of new scientific evidence that the risks outweigh the benefits, a spokesperson for Sanofi told Australian Pharmacist.
‘Following recent evaluations made by Sanofi Consumer Healthcare Pty Ltd, including a benefit-risk assessment, the research has shown a causal association between promethazine and safety concerns,’ said this spokesperson.
The sponsor-initiated update was prompted by advice from the TGA Advisory Committee on Medicines (ACM) – first-generation oral sedating antihistamines – do not use in children, said a spokesperson from the TGA.
‘Further review by the sponsor of cumulative safety data in children 2 to 5 years of age demonstrated sufficient evidence of a causal association between promethazine and psychiatric and central nervous system adverse events in this age group,’ the TGA spokesperson told AP.
The contraindication comes after Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, moved to contraindicate the use of the medicine in children under 6 due to the potential for fatal respiratory depression, psychiatric and central nervous system (CNS) events.
AP understands that the contraindication will affect other products. A spokesperson for AFT said a variation has been submitted to update the product information and label on Allersoothe Elixir with a change to the age indication from children 2 years and older to children 6 years and older. This submission is pending approval.
Will the packaging change?
Not immediately.
New labels for promethazine-containing products will be rolled out in 2025 due to production and logistics lead times, said the Sanofi spokesperson.
‘No immediate action is required regarding current stock. There is no need to set aside existing medications, as this communication does not constitute a recall,’ said the spokesperson. ‘Similarly, the revised labels do not create any changes in the ordering process.
The product information for Phenergan has been updated and is available here.
What should pharmacists do if they get a Phenergan script for an 18 month old infant?
The use of promethazine in children under 6 years of age is now both contraindicated and off label, said Peter Guthrey MPS, PSA Senior Pharmacist – strategic policy.
‘This means that if you choose to dispense, both the prescriber and dispenser carry the full indemnity risk, and you need to get the patient to provide informed consent,’ he said.
Should a parent present with a script for promethazine for use in a child under 6 years of age, pharmacists should contact the prescriber to discuss the risks and benefits, noting that it's contraindicated.
Is there any situation where it would be appropriate to dispense Phenergan to a young child?
It would need to be a pretty compelling case, where the benefit to a child outweighed the risk of respiratory depression, psychiatric or CNS events, said Mr Guthrey.
‘Given it’s a documented contraindication, it'd be pretty hard to demonstrate the medicine is ‘‘safe and therapeutically appropriate’’,’ he said.
‘It is going to be difficult to find a situation where supply is clinically justified and pharmacists have met their obligations to patient safety.’
What about prescribing Phenergan as a Schedule 3 medicine?
If a parent requests promethazine as a Schedule 3 medicine for someone under the age of 6 years, generally alternate products or advice for treatment should be provided following a discussion.
‘While a pharmacist prescribing promethazine as a Pharmacist Only Medicine is lawful for children aged 2-5 years, it is still contraindicated,’ said Mr Guthrey. ‘There would be very few, if any, situations where prescribing the medicine where contraindicated would be warranted.’
What about phenylephrine?
There are some combination phenylephrine products indicated for children under 6 years of age for nasal congestion. However, there is plenty of evidence showing that oral phenylephrine products are ineffective as a nasal decongestant.
In fact, the United States Food and Drug Administration (FDA) recently announced it will move to ban oral phenylephrine products because they simply don't work.
‘Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,’ said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
While a spokesperson for the TGA told Australian Pharmacist back in July that there are ‘no plans’ to review the effectiveness of oral phenylephrine, it will continue to monitor the outcomes of the FDA review.
What advice should pharmacists provide?
For children with allergies, non-sedating antihistamines are first line.
The best thing parents can do when a child under 6 years of age has cough or cold symptoms is to wait it out, with a review by a medical practitioner when appropriate.
‘It's about reassurance to parents that the cough in itself isn't harmful, and that kids don’t always need medicines for a cold – they need time and supportive therapy,’ said Mr Guthrey.
It’s important that pharmacists give parents confidence that they're doing the right thing by not treating the cough, and providing symptomatic relief for fever and chills – ensuring they are appropriately counselled on when review by a medical practitioner may be appropriate.
For more information, refer to the Australian Pharmaceutical Formulary and Handbook treatment guidelines on:
[post_title] => Do not supply Phenergan to children under 6, manufacturer warns
[post_excerpt] => The TGA has worked with Phenergan manufacturer Sanofi to develop a new contraindication for the medicine in children under 6.
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[post_content] => With cases of Respiratory syncytial virus (RSV) spiking this year, the federal government announced yesterday (10 November) that free vaccination would be offered to eligible pregnant people and babies.
Before the 2025 winter season, the RSV vaccine will be available under the National Immunisation Program (NIP) for all people in the third trimester of pregnancy via the Australian Infant RSV Immunisation Program.
Which RSV vaccines will pharmacists administer?
The RSV immunisation program will offer two Therapeutic Goods Administration approved protections against severe RSV.
Pharmacists can administer the maternal vaccine, Abrysvo, to pregnant women between 28-36 weeks of gestation.
Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%, a spokesperson from the Department of Health and Aged Care told Australian Pharmacist.
‘This is [through] passive protection by transplacental transfer of RSV-specific antibodies from the mother to the foetus during pregnancy.’
How popular will it be?
Federal Minister for Health and Aged Care Mark Butler said the RSV vaccine rollout has been modelled on the whooping cough vaccine in pregnant women, which is administered at around the same time and has an uptake rate of around 80%.
‘Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%.'
The Department of Health and Aged Care
‘So we have good confidence that there will be a significant uptake of this maternal vaccine by pregnant Australian women,’ he added.
What is covered for pharmacists under the NIP?
According to the Department of Health and Aged Care, both the cost of the maternal RSV vaccine (Abrysvo) and the vaccine administration fee will be covered under the NIP and The National Immunisation Program Vaccinations in Pharmacy (NIPVIP) Program.
Abrysvo NIP vaccine stock will also be available to community pharmacists, said the spokesperson.
What about protection for neonates?
Access has also widened for more babies to receive a protection against RSV soon after birth, particularly those whose mother did not opt to have the vaccine during pregnancy.
Beyfortus (nirsevimab), an antibody therapy for the prevention of RSV-related lower respiratory tract disease, will be available in hospitals, immunisation clinics and general practices for infants before or during their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease throughout their second RSV season can also access the vaccine.
‘Beyfortus is a monoclonal antibody treatment which is administered to babies by injection,’ said Minister Butler. ‘[It can be received] immediately after birth … if their mother has not been vaccinated against RSV.’
Why did the government decide to take action against RSV?
Australia recorded the highest ever number of RSV cases this year, with 165,910 reported notifications.
Most cases were recorded in the 0–4 age cohort, among whom RSV can be fatal, and is the leading cause of hospitalisation for Australian children under five years of age.
The Australian Immunisation Foundation estimates that around 12,000 Australian babies aged 12 months or younger are admitted to hospital with RSV annually. Around 25% of these children will require intensive care.
The inclusion of an RSV vaccine in the NIP is an important step to protect newborn children and infants from severe RSV infection, said the spokesperson.
‘The highest rate of RSV-related hospitalisations is in infants during their first few months of life,’ said the spokesperson.
‘Infants with medical risk factors, such as being born very [premature], under 32 weeks gestational age, have an increased risk of severe disease.
‘Up to 80% of infants who are hospitalised due to RSV are otherwise healthy children with no predisposing conditions.’
What’s the expected impact?
The Immunisation Foundation of Australia has estimated that the nationwide availability of new RSV immunisations will help to keep 10,000 infants out of hospital with related bronchiolitis or pneumonia each year.
‘The immunisations being funded in Australia protect babies against severe RSV and have been shown to slash hospitalisation rates by up to 90 per cent,’ said Catherine Hughes AM, Founder and Director of the Immunisation Foundation of Australia.
Western Australia was the first state to implement an infant RSV immunisation program with Beyfortus. More than 23,000 infants received RSV protection this year, resulting in up to 84% fewer hospitalisations in immunised newborns compared to those who were not RSV protected. In Queensland, where a statewide infant RSV immunisation program commenced in April 2024, similar results were observed.
‘The exceptional results in Western Australia and Queensland contrast sharply with other parts of Australia where hospitals were overwhelmed by babies struggling to breathe due to severe RSV,’ she said.
Will older patients be able to receive the RSV vaccine under the NIP?
No. Well at least, not yet.
Vaccines can only be listed on the NIP after a positive recommendation from the Pharmaceutical Benefits Advisory Committee’s (PBAC) as required by the National Health Act 1953, said the spokesperson.
‘Several vaccine sponsors have made submissions in relation to RSV vaccines for older populations to the PBAC to consider for NIP listing,’ said the spokesperson.
‘The outcomes of these meetings will inform future government considerations regarding the potential listing of RSV vaccines on the NIP for older Australians.’
While a positive PBAC recommendation is an essential requirement in the NIP-listing process, other steps need to be completed before a vaccine can be given final approval for NIP listing, said the spokesperson.
‘These include negotiations with the relevant pharmaceutical company, finalisation of conditions for listing, quality and availability checks and final consideration by the government,’ said the spokesperson. ‘These considerations and decisions of government cannot be preempted.’
[post_title] => Government-funded RSV vaccines to protect infants from severe disease
[post_excerpt] => With cases of RSV spiking in 2024, the federal government announced free vaccination would be offered to eligible pregnant people and babies.
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[post_content] => Australia’s understanding and adoption of Quality Use of Medicines (QUM) principles across general practice and primary care has led to overall improvements in medicine use, such as curtailing high-dose use of proton pump inhibitors.
But the challenge has since changed, with Australians living longer – resulting in an older, sicker population who uses more medicines, said Professor Libby Roughead – Director of the QUM and Pharmacy Research Centre at the University of South Australia.
‘Now the game is to say, how do we go forward when we’ve got a frail older population, and lots of specialty medicine? she asked.
This is the question a panel of experts sought to answer at the National Medicines Symposium 2024 yesterday (19 November).
Be wary of using ‘wonder drugs’ in older patients
When clinical trials are conducted on new medicines, they’re not tested in the over 65 age group, said Steve Waller, Senior Advisor, Medication without Harm, Australian Commission on Safety and Quality in Health Care.
[caption id="attachment_28267" align="alignnone" width="800"] National Medicines Symposium 2024 speakers (L to R): Steve Waller, Professor Jennifer Martin, Professor Libby Roughead, Tegan Taylor[/caption]
‘That creates complications, because we often don’t know what the impact in that older age group is … and pharmaceutical companies don’t have that information when they’re making an application for a new drug to be listed with the TGA [Therapeutic Goods Administration] and PBS [Pharmaceutical Benefits Scheme],’ he said.
Healthcare professionals must have awareness of the limitations of the data, thinks Professor Jennifer Martin, clinical pharmacologist and president of the Royal Australian College of Physicians.
‘Often, I say to people “why are you using a statin in [an older] population? We know the life expectancy when you go to a nursing home is less than 2 years, and you have to be on this drug at this dose for 5 years just to see a small reduction in a composite end point”,’ she said.
Healthcare professionals should rely on Australia’s ‘good sources of objective information’ such as Therapeutic Guidelines and the Australian Medicines Handbook, said Prof Roughead.
But more work needs to be done on increasing uptake of non-pharmacological interventions that are suitable for many conditions, including art therapy, music therapy, exercise and diet.
‘We know compassion practices are really helpful in some of the hard-to-treat conditions [such as] pain and depression, so we need to get better at involving the whole therapeutic armamentarium,’ she said. ‘The first definition of QUM is judicious selection of management options.’
Involve older patients in deprescribing decisions
Doctors, pharmacists, family members and carers typically talk among themselves about an older patient's medicine regimen. But it’s the patient they need to focus on, thinks Prof Martin.
‘When you talk to an older person, they will typically say “I don’t know why they started those pills” or “I don’t think I was supposed to be on them long-term, but no one stopped them, so I just kept taking them”,’ she said.
‘So, come back to the patient and ask, “Why are you taking these medications? What are your goals of care? Do you want pain relief? What are you looking for?”’
As patients reach their final chapter, many are just after quality of life – which doesn’t necessarily entail losing cognitive function through heavy use of opioids.
‘Opioids may play some role in pain, but they certainly take away a lot of the quality of life for older people,’ said Prof Martin. ‘It’s not until you spend time talking to the person that you find out they actually want to be very sharp; they think they can cope with their pain by other measures, and we can probably reduce some of their opioids.’
Warranted distrust in medicines and healthcare needs to be built back up
While we live in an age where misinformation is rife, some of it stems from the health system and pharma model, said Prof Martin.
‘For example, we know with gabapentin, which some people use for pain, most of the information that got onto the market was fraudulent,’ she said. ‘[There] was then a big investigation, with lawsuits still ongoing.’
The same goes for opioids, ineffective for many of the conditions they are prescribed for – particularly chronic pain.
‘The public are looking at their health providers saying, “We now know this is misinformation, but you prescribed this”, so we’ve lost a bit of engagement with our community,’ said Prof Martin.
With many patients with chronic pain on high doses of opioids that are not treating their conditions and impairing their quality of life, Prof Martin thinks the healthcare sector has ‘something to answer for’.
‘That misinformation is coming from industry and from the fact that we’re too busy to actually go back to their source material,’ she said.
The good news is that opioid deaths have decreased over the last 5 years in Australia, thanks to tighter prescribing regulations and better resources such as the Opioid Analgesic Stewardship in Acute Pain Clinical Care Standard, said Mr Waller.
Work on state formularies has also reduced the number of opioids that people can prescribe, said Prof Martin.
‘It has helped to get that conversation going of “Why do you need to have access to 10 different opioids in an in-patient setting?” and “Why do you need all these different concentrations?”’ she said.
However, more changes in practice are required to ensure that trend continues in the right direction, said Mr Waller.
‘We need to stop using opioids for chronic pain,’ he said. ‘There’s limited to no evidence to suggest that they work, and we need to be very judicious about our use of modified-release opioid analgesics.’
Yet as that work is done, it’s crucial to remember that these patients are suffering and compassion should be brought to the encounter – rather than simply saying ‘you can’t have that’, said Prof Roughead.
‘It’s not just ceasing a medicine. It’s ceasing a medicine and starting other things that you might need to help you be well, whether it be an exercise program or psychological services,’ she said.
Pharmacists can bridge communication and healthcare gaps in RACFs
With the Aged Care On-site Pharmacist (ACOP) program kicking off on 1 July 2024, pharmacists can improve the approach to healthcare by simply getting to know people – a skill well-honed by pharmacists in other settings, said Prof Roughead.
This includes understanding patient preferences and non-pharmacological activities that might support them.
‘If we can build a system where we can create relationships, particularly in a virtual world … we’re all going to be safer and we’re all going to feel better,’ she said.
‘That’s got to be the strength of an embedded pharmacist in aged care, that day-to-day knowledge of what the patient’s likes and dislikes are and how they’ve been managed over a continuum, as opposed to a visit that might happen once a year,’ added Mr Waller.
As the custodian of the pharmacy profession’s Professional Practice Standards and an education and training provider, PSA has continued to invest and embark into practice support training and education for pharmacists to become ACOP credentialed, said PSA National President Associated Professor Fei Sim.
The training covers all elements of this role – from professionalism, to understanding the governance of an RACF, collaborative practice, providing person-centred medication management and working within a multidisciplinary team to improve the safe and quality use of medicines.
‘Pharmacists undertaking the training program would then acquire the necessary credentials, qualifications and skill set to be able to undertake the role as an aged care on-site pharmacist,’ she said.
‘We’re also providing ongoing resources and clinical updates for credentialed pharmacists so they can be kept up to date with their knowledge and skills to undertake the role.’
With any new areas of practice, there is a great need for mentoring and networking for like-minded pharmacists who work in the same area to forge bonds, said A/Prof Sim. ‘That’s why PSA created the Consultant Pharmacists CSI group [and] an annual Consultant Pharmacist Conference, focusing on supporting and meeting the learning needs of credentialed pharmacists.’
[post_title] => Giving a voice back to elderly patients
[post_excerpt] => Yesterday’s National Medicine Symposium delivered a stark critique of how our health system is failing older patients – and how to fix it.
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[post_content] => Mpox cases are surging in Australia. An expert reveals how pharmacists can address the rising spread.
When mpox was first reported in Australia in May 2022, case numbers remained relatively low for the better part of 2 years.
However, in 2024 there has been a significant spike in case numbers in several Australian states and territories, with New South Wales, Victoria and Western Australia all seeing rising locally acquired notifications.
In September, it was reported that mpox cases grew a staggering 570% since July 2024 –with over 724 cases recorded this year. Yet vaccination rates remain low.
Meanwhile, cases of clade Ib – which has a much higher fatality rate than clade IIb strain spreading in Australia – have been detected in numerous countries around the world, most recently the United States. The worldwide spread of the new clade led the World Health Organisation to declare the mpox outbreak a public health emergency of international concern.
At this stage, pharmacists can only administer the mpox vaccine in Victoria and the Northern Territory.
However, pharmacists in all jurisdictions have an essential role in raising awareness of vaccine eligibility and dosing schedule, when to get vaccinated and where to get tested – all of which can help to bring down rising case numbers.
Watch the video below to hear sexual health expert Dr Tom Morley explain how pharmacists can go about this in a culturally safe way.
https://www.youtube.com/watch?v=ZPzbadkq8sM
[post_title] => Curbing the spread as mpox cases skyrocket
[post_excerpt] => Mpox cases are surging both in Australia and around the world. An expert reveals how pharmacists can address the rising spread.
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[title_attribute] => Curbing the spread as mpox cases skyrocket
[title] => Curbing the spread as mpox cases skyrocket
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[post_date] => 2024-11-18 09:28:17
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[post_content] => Constipation can be an embarrassing topic to discuss with your patients. But irregular bowel movements can not only be uncomfortable, but can lead to other health conditions and severely impact a patient’s quality of life.
[caption id="attachment_28205" align="alignright" width="150"] This CPD activity is sponsored by Reckitt. All content is the true, accurate and independent opinion of the speakers and the views expressed are entirely their own.[/caption]
Constipation is a common problem in the community,1 that can significantly impact quality of life if not properly managed.2 It’s also a common reason for primary care visits and referrals to gastroenterologists.3 Unfortunately, many patients are choosing laxatives without the help and advice of a health professional1 so may be choosing products that don’t work effectively5 or choosing to use laxatives when addressing dietary, lifestyle or medicine regimens may be the most appropriate course of action. In this CPD accredited podcast, listen to Priceline Health Services Manager Brett Macfarlane and Senior Clinical Pharmacist – Gastroenterology at the Royal Melbourne Hospital Stephanie Dimovski discuss the problem of constipation and how pharmacists can assist patients in managing this condition. They will address the importance of identifying whether insufficient fibre and fluid intake may be contributing and whether making dietary and exercise recommendations is enough to restore normal bowel habits.
After reading this article, pharmacists should be able to:
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[post_content] => The Therapeutic Goods Administration (TGA) has worked with Phenergan manufacturer Sanofi to develop a new contraindication for the medicine in children under 6.
The decision to restrict use of the medicine in this age cohort – commonly used to treat allergies, travel sickness and nausea – is based on a thorough evaluation of new scientific evidence that the risks outweigh the benefits, a spokesperson for Sanofi told Australian Pharmacist.
‘Following recent evaluations made by Sanofi Consumer Healthcare Pty Ltd, including a benefit-risk assessment, the research has shown a causal association between promethazine and safety concerns,’ said this spokesperson.
The sponsor-initiated update was prompted by advice from the TGA Advisory Committee on Medicines (ACM) – first-generation oral sedating antihistamines – do not use in children, said a spokesperson from the TGA.
‘Further review by the sponsor of cumulative safety data in children 2 to 5 years of age demonstrated sufficient evidence of a causal association between promethazine and psychiatric and central nervous system adverse events in this age group,’ the TGA spokesperson told AP.
The contraindication comes after Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, moved to contraindicate the use of the medicine in children under 6 due to the potential for fatal respiratory depression, psychiatric and central nervous system (CNS) events.
AP understands that the contraindication will affect other products. A spokesperson for AFT said a variation has been submitted to update the product information and label on Allersoothe Elixir with a change to the age indication from children 2 years and older to children 6 years and older. This submission is pending approval.
Will the packaging change?
Not immediately.
New labels for promethazine-containing products will be rolled out in 2025 due to production and logistics lead times, said the Sanofi spokesperson.
‘No immediate action is required regarding current stock. There is no need to set aside existing medications, as this communication does not constitute a recall,’ said the spokesperson. ‘Similarly, the revised labels do not create any changes in the ordering process.
The product information for Phenergan has been updated and is available here.
What should pharmacists do if they get a Phenergan script for an 18 month old infant?
The use of promethazine in children under 6 years of age is now both contraindicated and off label, said Peter Guthrey MPS, PSA Senior Pharmacist – strategic policy.
‘This means that if you choose to dispense, both the prescriber and dispenser carry the full indemnity risk, and you need to get the patient to provide informed consent,’ he said.
Should a parent present with a script for promethazine for use in a child under 6 years of age, pharmacists should contact the prescriber to discuss the risks and benefits, noting that it's contraindicated.
Is there any situation where it would be appropriate to dispense Phenergan to a young child?
It would need to be a pretty compelling case, where the benefit to a child outweighed the risk of respiratory depression, psychiatric or CNS events, said Mr Guthrey.
‘Given it’s a documented contraindication, it'd be pretty hard to demonstrate the medicine is ‘‘safe and therapeutically appropriate’’,’ he said.
‘It is going to be difficult to find a situation where supply is clinically justified and pharmacists have met their obligations to patient safety.’
What about prescribing Phenergan as a Schedule 3 medicine?
If a parent requests promethazine as a Schedule 3 medicine for someone under the age of 6 years, generally alternate products or advice for treatment should be provided following a discussion.
‘While a pharmacist prescribing promethazine as a Pharmacist Only Medicine is lawful for children aged 2-5 years, it is still contraindicated,’ said Mr Guthrey. ‘There would be very few, if any, situations where prescribing the medicine where contraindicated would be warranted.’
What about phenylephrine?
There are some combination phenylephrine products indicated for children under 6 years of age for nasal congestion. However, there is plenty of evidence showing that oral phenylephrine products are ineffective as a nasal decongestant.
In fact, the United States Food and Drug Administration (FDA) recently announced it will move to ban oral phenylephrine products because they simply don't work.
‘Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,’ said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
While a spokesperson for the TGA told Australian Pharmacist back in July that there are ‘no plans’ to review the effectiveness of oral phenylephrine, it will continue to monitor the outcomes of the FDA review.
What advice should pharmacists provide?
For children with allergies, non-sedating antihistamines are first line.
The best thing parents can do when a child under 6 years of age has cough or cold symptoms is to wait it out, with a review by a medical practitioner when appropriate.
‘It's about reassurance to parents that the cough in itself isn't harmful, and that kids don’t always need medicines for a cold – they need time and supportive therapy,’ said Mr Guthrey.
It’s important that pharmacists give parents confidence that they're doing the right thing by not treating the cough, and providing symptomatic relief for fever and chills – ensuring they are appropriately counselled on when review by a medical practitioner may be appropriate.
For more information, refer to the Australian Pharmaceutical Formulary and Handbook treatment guidelines on:
[post_title] => Do not supply Phenergan to children under 6, manufacturer warns
[post_excerpt] => The TGA has worked with Phenergan manufacturer Sanofi to develop a new contraindication for the medicine in children under 6.
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[post_content] => With cases of Respiratory syncytial virus (RSV) spiking this year, the federal government announced yesterday (10 November) that free vaccination would be offered to eligible pregnant people and babies.
Before the 2025 winter season, the RSV vaccine will be available under the National Immunisation Program (NIP) for all people in the third trimester of pregnancy via the Australian Infant RSV Immunisation Program.
Which RSV vaccines will pharmacists administer?
The RSV immunisation program will offer two Therapeutic Goods Administration approved protections against severe RSV.
Pharmacists can administer the maternal vaccine, Abrysvo, to pregnant women between 28-36 weeks of gestation.
Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%, a spokesperson from the Department of Health and Aged Care told Australian Pharmacist.
‘This is [through] passive protection by transplacental transfer of RSV-specific antibodies from the mother to the foetus during pregnancy.’
How popular will it be?
Federal Minister for Health and Aged Care Mark Butler said the RSV vaccine rollout has been modelled on the whooping cough vaccine in pregnant women, which is administered at around the same time and has an uptake rate of around 80%.
‘Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%.'
The Department of Health and Aged Care
‘So we have good confidence that there will be a significant uptake of this maternal vaccine by pregnant Australian women,’ he added.
What is covered for pharmacists under the NIP?
According to the Department of Health and Aged Care, both the cost of the maternal RSV vaccine (Abrysvo) and the vaccine administration fee will be covered under the NIP and The National Immunisation Program Vaccinations in Pharmacy (NIPVIP) Program.
Abrysvo NIP vaccine stock will also be available to community pharmacists, said the spokesperson.
What about protection for neonates?
Access has also widened for more babies to receive a protection against RSV soon after birth, particularly those whose mother did not opt to have the vaccine during pregnancy.
Beyfortus (nirsevimab), an antibody therapy for the prevention of RSV-related lower respiratory tract disease, will be available in hospitals, immunisation clinics and general practices for infants before or during their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease throughout their second RSV season can also access the vaccine.
‘Beyfortus is a monoclonal antibody treatment which is administered to babies by injection,’ said Minister Butler. ‘[It can be received] immediately after birth … if their mother has not been vaccinated against RSV.’
Why did the government decide to take action against RSV?
Australia recorded the highest ever number of RSV cases this year, with 165,910 reported notifications.
Most cases were recorded in the 0–4 age cohort, among whom RSV can be fatal, and is the leading cause of hospitalisation for Australian children under five years of age.
The Australian Immunisation Foundation estimates that around 12,000 Australian babies aged 12 months or younger are admitted to hospital with RSV annually. Around 25% of these children will require intensive care.
The inclusion of an RSV vaccine in the NIP is an important step to protect newborn children and infants from severe RSV infection, said the spokesperson.
‘The highest rate of RSV-related hospitalisations is in infants during their first few months of life,’ said the spokesperson.
‘Infants with medical risk factors, such as being born very [premature], under 32 weeks gestational age, have an increased risk of severe disease.
‘Up to 80% of infants who are hospitalised due to RSV are otherwise healthy children with no predisposing conditions.’
What’s the expected impact?
The Immunisation Foundation of Australia has estimated that the nationwide availability of new RSV immunisations will help to keep 10,000 infants out of hospital with related bronchiolitis or pneumonia each year.
‘The immunisations being funded in Australia protect babies against severe RSV and have been shown to slash hospitalisation rates by up to 90 per cent,’ said Catherine Hughes AM, Founder and Director of the Immunisation Foundation of Australia.
Western Australia was the first state to implement an infant RSV immunisation program with Beyfortus. More than 23,000 infants received RSV protection this year, resulting in up to 84% fewer hospitalisations in immunised newborns compared to those who were not RSV protected. In Queensland, where a statewide infant RSV immunisation program commenced in April 2024, similar results were observed.
‘The exceptional results in Western Australia and Queensland contrast sharply with other parts of Australia where hospitals were overwhelmed by babies struggling to breathe due to severe RSV,’ she said.
Will older patients be able to receive the RSV vaccine under the NIP?
No. Well at least, not yet.
Vaccines can only be listed on the NIP after a positive recommendation from the Pharmaceutical Benefits Advisory Committee’s (PBAC) as required by the National Health Act 1953, said the spokesperson.
‘Several vaccine sponsors have made submissions in relation to RSV vaccines for older populations to the PBAC to consider for NIP listing,’ said the spokesperson.
‘The outcomes of these meetings will inform future government considerations regarding the potential listing of RSV vaccines on the NIP for older Australians.’
While a positive PBAC recommendation is an essential requirement in the NIP-listing process, other steps need to be completed before a vaccine can be given final approval for NIP listing, said the spokesperson.
‘These include negotiations with the relevant pharmaceutical company, finalisation of conditions for listing, quality and availability checks and final consideration by the government,’ said the spokesperson. ‘These considerations and decisions of government cannot be preempted.’
[post_title] => Government-funded RSV vaccines to protect infants from severe disease
[post_excerpt] => With cases of RSV spiking in 2024, the federal government announced free vaccination would be offered to eligible pregnant people and babies.
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[post_content] => Australia’s understanding and adoption of Quality Use of Medicines (QUM) principles across general practice and primary care has led to overall improvements in medicine use, such as curtailing high-dose use of proton pump inhibitors.
But the challenge has since changed, with Australians living longer – resulting in an older, sicker population who uses more medicines, said Professor Libby Roughead – Director of the QUM and Pharmacy Research Centre at the University of South Australia.
‘Now the game is to say, how do we go forward when we’ve got a frail older population, and lots of specialty medicine? she asked.
This is the question a panel of experts sought to answer at the National Medicines Symposium 2024 yesterday (19 November).
Be wary of using ‘wonder drugs’ in older patients
When clinical trials are conducted on new medicines, they’re not tested in the over 65 age group, said Steve Waller, Senior Advisor, Medication without Harm, Australian Commission on Safety and Quality in Health Care.
[caption id="attachment_28267" align="alignnone" width="800"] National Medicines Symposium 2024 speakers (L to R): Steve Waller, Professor Jennifer Martin, Professor Libby Roughead, Tegan Taylor[/caption]
‘That creates complications, because we often don’t know what the impact in that older age group is … and pharmaceutical companies don’t have that information when they’re making an application for a new drug to be listed with the TGA [Therapeutic Goods Administration] and PBS [Pharmaceutical Benefits Scheme],’ he said.
Healthcare professionals must have awareness of the limitations of the data, thinks Professor Jennifer Martin, clinical pharmacologist and president of the Royal Australian College of Physicians.
‘Often, I say to people “why are you using a statin in [an older] population? We know the life expectancy when you go to a nursing home is less than 2 years, and you have to be on this drug at this dose for 5 years just to see a small reduction in a composite end point”,’ she said.
Healthcare professionals should rely on Australia’s ‘good sources of objective information’ such as Therapeutic Guidelines and the Australian Medicines Handbook, said Prof Roughead.
But more work needs to be done on increasing uptake of non-pharmacological interventions that are suitable for many conditions, including art therapy, music therapy, exercise and diet.
‘We know compassion practices are really helpful in some of the hard-to-treat conditions [such as] pain and depression, so we need to get better at involving the whole therapeutic armamentarium,’ she said. ‘The first definition of QUM is judicious selection of management options.’
Involve older patients in deprescribing decisions
Doctors, pharmacists, family members and carers typically talk among themselves about an older patient's medicine regimen. But it’s the patient they need to focus on, thinks Prof Martin.
‘When you talk to an older person, they will typically say “I don’t know why they started those pills” or “I don’t think I was supposed to be on them long-term, but no one stopped them, so I just kept taking them”,’ she said.
‘So, come back to the patient and ask, “Why are you taking these medications? What are your goals of care? Do you want pain relief? What are you looking for?”’
As patients reach their final chapter, many are just after quality of life – which doesn’t necessarily entail losing cognitive function through heavy use of opioids.
‘Opioids may play some role in pain, but they certainly take away a lot of the quality of life for older people,’ said Prof Martin. ‘It’s not until you spend time talking to the person that you find out they actually want to be very sharp; they think they can cope with their pain by other measures, and we can probably reduce some of their opioids.’
Warranted distrust in medicines and healthcare needs to be built back up
While we live in an age where misinformation is rife, some of it stems from the health system and pharma model, said Prof Martin.
‘For example, we know with gabapentin, which some people use for pain, most of the information that got onto the market was fraudulent,’ she said. ‘[There] was then a big investigation, with lawsuits still ongoing.’
The same goes for opioids, ineffective for many of the conditions they are prescribed for – particularly chronic pain.
‘The public are looking at their health providers saying, “We now know this is misinformation, but you prescribed this”, so we’ve lost a bit of engagement with our community,’ said Prof Martin.
With many patients with chronic pain on high doses of opioids that are not treating their conditions and impairing their quality of life, Prof Martin thinks the healthcare sector has ‘something to answer for’.
‘That misinformation is coming from industry and from the fact that we’re too busy to actually go back to their source material,’ she said.
The good news is that opioid deaths have decreased over the last 5 years in Australia, thanks to tighter prescribing regulations and better resources such as the Opioid Analgesic Stewardship in Acute Pain Clinical Care Standard, said Mr Waller.
Work on state formularies has also reduced the number of opioids that people can prescribe, said Prof Martin.
‘It has helped to get that conversation going of “Why do you need to have access to 10 different opioids in an in-patient setting?” and “Why do you need all these different concentrations?”’ she said.
However, more changes in practice are required to ensure that trend continues in the right direction, said Mr Waller.
‘We need to stop using opioids for chronic pain,’ he said. ‘There’s limited to no evidence to suggest that they work, and we need to be very judicious about our use of modified-release opioid analgesics.’
Yet as that work is done, it’s crucial to remember that these patients are suffering and compassion should be brought to the encounter – rather than simply saying ‘you can’t have that’, said Prof Roughead.
‘It’s not just ceasing a medicine. It’s ceasing a medicine and starting other things that you might need to help you be well, whether it be an exercise program or psychological services,’ she said.
Pharmacists can bridge communication and healthcare gaps in RACFs
With the Aged Care On-site Pharmacist (ACOP) program kicking off on 1 July 2024, pharmacists can improve the approach to healthcare by simply getting to know people – a skill well-honed by pharmacists in other settings, said Prof Roughead.
This includes understanding patient preferences and non-pharmacological activities that might support them.
‘If we can build a system where we can create relationships, particularly in a virtual world … we’re all going to be safer and we’re all going to feel better,’ she said.
‘That’s got to be the strength of an embedded pharmacist in aged care, that day-to-day knowledge of what the patient’s likes and dislikes are and how they’ve been managed over a continuum, as opposed to a visit that might happen once a year,’ added Mr Waller.
As the custodian of the pharmacy profession’s Professional Practice Standards and an education and training provider, PSA has continued to invest and embark into practice support training and education for pharmacists to become ACOP credentialed, said PSA National President Associated Professor Fei Sim.
The training covers all elements of this role – from professionalism, to understanding the governance of an RACF, collaborative practice, providing person-centred medication management and working within a multidisciplinary team to improve the safe and quality use of medicines.
‘Pharmacists undertaking the training program would then acquire the necessary credentials, qualifications and skill set to be able to undertake the role as an aged care on-site pharmacist,’ she said.
‘We’re also providing ongoing resources and clinical updates for credentialed pharmacists so they can be kept up to date with their knowledge and skills to undertake the role.’
With any new areas of practice, there is a great need for mentoring and networking for like-minded pharmacists who work in the same area to forge bonds, said A/Prof Sim. ‘That’s why PSA created the Consultant Pharmacists CSI group [and] an annual Consultant Pharmacist Conference, focusing on supporting and meeting the learning needs of credentialed pharmacists.’
[post_title] => Giving a voice back to elderly patients
[post_excerpt] => Yesterday’s National Medicine Symposium delivered a stark critique of how our health system is failing older patients – and how to fix it.
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[post_content] => Mpox cases are surging in Australia. An expert reveals how pharmacists can address the rising spread.
When mpox was first reported in Australia in May 2022, case numbers remained relatively low for the better part of 2 years.
However, in 2024 there has been a significant spike in case numbers in several Australian states and territories, with New South Wales, Victoria and Western Australia all seeing rising locally acquired notifications.
In September, it was reported that mpox cases grew a staggering 570% since July 2024 –with over 724 cases recorded this year. Yet vaccination rates remain low.
Meanwhile, cases of clade Ib – which has a much higher fatality rate than clade IIb strain spreading in Australia – have been detected in numerous countries around the world, most recently the United States. The worldwide spread of the new clade led the World Health Organisation to declare the mpox outbreak a public health emergency of international concern.
At this stage, pharmacists can only administer the mpox vaccine in Victoria and the Northern Territory.
However, pharmacists in all jurisdictions have an essential role in raising awareness of vaccine eligibility and dosing schedule, when to get vaccinated and where to get tested – all of which can help to bring down rising case numbers.
Watch the video below to hear sexual health expert Dr Tom Morley explain how pharmacists can go about this in a culturally safe way.
https://www.youtube.com/watch?v=ZPzbadkq8sM
[post_title] => Curbing the spread as mpox cases skyrocket
[post_excerpt] => Mpox cases are surging both in Australia and around the world. An expert reveals how pharmacists can address the rising spread.
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[post_date] => 2024-11-18 09:28:17
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[post_content] => Constipation can be an embarrassing topic to discuss with your patients. But irregular bowel movements can not only be uncomfortable, but can lead to other health conditions and severely impact a patient’s quality of life.
[caption id="attachment_28205" align="alignright" width="150"] This CPD activity is sponsored by Reckitt. All content is the true, accurate and independent opinion of the speakers and the views expressed are entirely their own.[/caption]
Constipation is a common problem in the community,1 that can significantly impact quality of life if not properly managed.2 It’s also a common reason for primary care visits and referrals to gastroenterologists.3 Unfortunately, many patients are choosing laxatives without the help and advice of a health professional1 so may be choosing products that don’t work effectively5 or choosing to use laxatives when addressing dietary, lifestyle or medicine regimens may be the most appropriate course of action. In this CPD accredited podcast, listen to Priceline Health Services Manager Brett Macfarlane and Senior Clinical Pharmacist – Gastroenterology at the Royal Melbourne Hospital Stephanie Dimovski discuss the problem of constipation and how pharmacists can assist patients in managing this condition. They will address the importance of identifying whether insufficient fibre and fluid intake may be contributing and whether making dietary and exercise recommendations is enough to restore normal bowel habits.
After reading this article, pharmacists should be able to:
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[post_date] => 2024-11-13 12:50:58
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[post_content] => The Therapeutic Goods Administration (TGA) has worked with Phenergan manufacturer Sanofi to develop a new contraindication for the medicine in children under 6.
The decision to restrict use of the medicine in this age cohort – commonly used to treat allergies, travel sickness and nausea – is based on a thorough evaluation of new scientific evidence that the risks outweigh the benefits, a spokesperson for Sanofi told Australian Pharmacist.
‘Following recent evaluations made by Sanofi Consumer Healthcare Pty Ltd, including a benefit-risk assessment, the research has shown a causal association between promethazine and safety concerns,’ said this spokesperson.
The sponsor-initiated update was prompted by advice from the TGA Advisory Committee on Medicines (ACM) – first-generation oral sedating antihistamines – do not use in children, said a spokesperson from the TGA.
‘Further review by the sponsor of cumulative safety data in children 2 to 5 years of age demonstrated sufficient evidence of a causal association between promethazine and psychiatric and central nervous system adverse events in this age group,’ the TGA spokesperson told AP.
The contraindication comes after Medsafe, the New Zealand Medicines and Medical Devices Safety Authority, moved to contraindicate the use of the medicine in children under 6 due to the potential for fatal respiratory depression, psychiatric and central nervous system (CNS) events.
AP understands that the contraindication will affect other products. A spokesperson for AFT said a variation has been submitted to update the product information and label on Allersoothe Elixir with a change to the age indication from children 2 years and older to children 6 years and older. This submission is pending approval.
Will the packaging change?
Not immediately.
New labels for promethazine-containing products will be rolled out in 2025 due to production and logistics lead times, said the Sanofi spokesperson.
‘No immediate action is required regarding current stock. There is no need to set aside existing medications, as this communication does not constitute a recall,’ said the spokesperson. ‘Similarly, the revised labels do not create any changes in the ordering process.
The product information for Phenergan has been updated and is available here.
What should pharmacists do if they get a Phenergan script for an 18 month old infant?
The use of promethazine in children under 6 years of age is now both contraindicated and off label, said Peter Guthrey MPS, PSA Senior Pharmacist – strategic policy.
‘This means that if you choose to dispense, both the prescriber and dispenser carry the full indemnity risk, and you need to get the patient to provide informed consent,’ he said.
Should a parent present with a script for promethazine for use in a child under 6 years of age, pharmacists should contact the prescriber to discuss the risks and benefits, noting that it's contraindicated.
Is there any situation where it would be appropriate to dispense Phenergan to a young child?
It would need to be a pretty compelling case, where the benefit to a child outweighed the risk of respiratory depression, psychiatric or CNS events, said Mr Guthrey.
‘Given it’s a documented contraindication, it'd be pretty hard to demonstrate the medicine is ‘‘safe and therapeutically appropriate’’,’ he said.
‘It is going to be difficult to find a situation where supply is clinically justified and pharmacists have met their obligations to patient safety.’
What about prescribing Phenergan as a Schedule 3 medicine?
If a parent requests promethazine as a Schedule 3 medicine for someone under the age of 6 years, generally alternate products or advice for treatment should be provided following a discussion.
‘While a pharmacist prescribing promethazine as a Pharmacist Only Medicine is lawful for children aged 2-5 years, it is still contraindicated,’ said Mr Guthrey. ‘There would be very few, if any, situations where prescribing the medicine where contraindicated would be warranted.’
What about phenylephrine?
There are some combination phenylephrine products indicated for children under 6 years of age for nasal congestion. However, there is plenty of evidence showing that oral phenylephrine products are ineffective as a nasal decongestant.
In fact, the United States Food and Drug Administration (FDA) recently announced it will move to ban oral phenylephrine products because they simply don't work.
‘Based on our review of available data, and consistent with the advice of the advisory committee, we are taking this next step in the process to propose removing oral phenylephrine because it is not effective as a nasal decongestant,’ said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research.
While a spokesperson for the TGA told Australian Pharmacist back in July that there are ‘no plans’ to review the effectiveness of oral phenylephrine, it will continue to monitor the outcomes of the FDA review.
What advice should pharmacists provide?
For children with allergies, non-sedating antihistamines are first line.
The best thing parents can do when a child under 6 years of age has cough or cold symptoms is to wait it out, with a review by a medical practitioner when appropriate.
‘It's about reassurance to parents that the cough in itself isn't harmful, and that kids don’t always need medicines for a cold – they need time and supportive therapy,’ said Mr Guthrey.
It’s important that pharmacists give parents confidence that they're doing the right thing by not treating the cough, and providing symptomatic relief for fever and chills – ensuring they are appropriately counselled on when review by a medical practitioner may be appropriate.
For more information, refer to the Australian Pharmaceutical Formulary and Handbook treatment guidelines on:
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[post_content] => With cases of Respiratory syncytial virus (RSV) spiking this year, the federal government announced yesterday (10 November) that free vaccination would be offered to eligible pregnant people and babies.
Before the 2025 winter season, the RSV vaccine will be available under the National Immunisation Program (NIP) for all people in the third trimester of pregnancy via the Australian Infant RSV Immunisation Program.
Which RSV vaccines will pharmacists administer?
The RSV immunisation program will offer two Therapeutic Goods Administration approved protections against severe RSV.
Pharmacists can administer the maternal vaccine, Abrysvo, to pregnant women between 28-36 weeks of gestation.
Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%, a spokesperson from the Department of Health and Aged Care told Australian Pharmacist.
‘This is [through] passive protection by transplacental transfer of RSV-specific antibodies from the mother to the foetus during pregnancy.’
How popular will it be?
Federal Minister for Health and Aged Care Mark Butler said the RSV vaccine rollout has been modelled on the whooping cough vaccine in pregnant women, which is administered at around the same time and has an uptake rate of around 80%.
‘Maternal vaccination provides early protection for newborn children by reducing the risk of severe RSV disease in infants under 6 months of age by around 70%.'
The Department of Health and Aged Care
‘So we have good confidence that there will be a significant uptake of this maternal vaccine by pregnant Australian women,’ he added.
What is covered for pharmacists under the NIP?
According to the Department of Health and Aged Care, both the cost of the maternal RSV vaccine (Abrysvo) and the vaccine administration fee will be covered under the NIP and The National Immunisation Program Vaccinations in Pharmacy (NIPVIP) Program.
Abrysvo NIP vaccine stock will also be available to community pharmacists, said the spokesperson.
What about protection for neonates?
Access has also widened for more babies to receive a protection against RSV soon after birth, particularly those whose mother did not opt to have the vaccine during pregnancy.
Beyfortus (nirsevimab), an antibody therapy for the prevention of RSV-related lower respiratory tract disease, will be available in hospitals, immunisation clinics and general practices for infants before or during their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease throughout their second RSV season can also access the vaccine.
‘Beyfortus is a monoclonal antibody treatment which is administered to babies by injection,’ said Minister Butler. ‘[It can be received] immediately after birth … if their mother has not been vaccinated against RSV.’
Why did the government decide to take action against RSV?
Australia recorded the highest ever number of RSV cases this year, with 165,910 reported notifications.
Most cases were recorded in the 0–4 age cohort, among whom RSV can be fatal, and is the leading cause of hospitalisation for Australian children under five years of age.
The Australian Immunisation Foundation estimates that around 12,000 Australian babies aged 12 months or younger are admitted to hospital with RSV annually. Around 25% of these children will require intensive care.
The inclusion of an RSV vaccine in the NIP is an important step to protect newborn children and infants from severe RSV infection, said the spokesperson.
‘The highest rate of RSV-related hospitalisations is in infants during their first few months of life,’ said the spokesperson.
‘Infants with medical risk factors, such as being born very [premature], under 32 weeks gestational age, have an increased risk of severe disease.
‘Up to 80% of infants who are hospitalised due to RSV are otherwise healthy children with no predisposing conditions.’
What’s the expected impact?
The Immunisation Foundation of Australia has estimated that the nationwide availability of new RSV immunisations will help to keep 10,000 infants out of hospital with related bronchiolitis or pneumonia each year.
‘The immunisations being funded in Australia protect babies against severe RSV and have been shown to slash hospitalisation rates by up to 90 per cent,’ said Catherine Hughes AM, Founder and Director of the Immunisation Foundation of Australia.
Western Australia was the first state to implement an infant RSV immunisation program with Beyfortus. More than 23,000 infants received RSV protection this year, resulting in up to 84% fewer hospitalisations in immunised newborns compared to those who were not RSV protected. In Queensland, where a statewide infant RSV immunisation program commenced in April 2024, similar results were observed.
‘The exceptional results in Western Australia and Queensland contrast sharply with other parts of Australia where hospitals were overwhelmed by babies struggling to breathe due to severe RSV,’ she said.
Will older patients be able to receive the RSV vaccine under the NIP?
No. Well at least, not yet.
Vaccines can only be listed on the NIP after a positive recommendation from the Pharmaceutical Benefits Advisory Committee’s (PBAC) as required by the National Health Act 1953, said the spokesperson.
‘Several vaccine sponsors have made submissions in relation to RSV vaccines for older populations to the PBAC to consider for NIP listing,’ said the spokesperson.
‘The outcomes of these meetings will inform future government considerations regarding the potential listing of RSV vaccines on the NIP for older Australians.’
While a positive PBAC recommendation is an essential requirement in the NIP-listing process, other steps need to be completed before a vaccine can be given final approval for NIP listing, said the spokesperson.
‘These include negotiations with the relevant pharmaceutical company, finalisation of conditions for listing, quality and availability checks and final consideration by the government,’ said the spokesperson. ‘These considerations and decisions of government cannot be preempted.’
[post_title] => Government-funded RSV vaccines to protect infants from severe disease
[post_excerpt] => With cases of RSV spiking in 2024, the federal government announced free vaccination would be offered to eligible pregnant people and babies.
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
