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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"]
Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
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[post_excerpt] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
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[post_content] => Novo Nordisk has announced the discontinuation of earlier generation insulin products over a 2-year period, which will leave many patients struggling to adjust to new medicine strengths and devices.
The product discontinuations include:
Cindy Tolba MPS[/caption]
‘No other product presentation for Mixtard 30/70 will be available,’ she said.
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[post_content] => When the Commonwealth’s legislated vaping reforms come into effect tomorrow, pharmacists need to adhere to a new set of regulations for Schedule 3 prescribing and Schedule 4 supply.
Ahead of the 1 October start date, PSA has updated their Professional Practice Guidelines for Pharmacists for Nicotine Dependence support.
Here’s what you need to know about changes to consultation guidelines and supply of nicotine containing vapes.
How are therapeutic vaping goods regulated and stocked?
Therapeutic vaping goods that are imported, manufactured or supplied in Australia must be notified to the TGA by the sponsor as complying with the applicable quality and safety standards, said Mandy Edlington, Assistant Secretary of the Vaping Legislative Reform Branch at the Therapeutic Goods Administration (TGA) in a webinar held on Thursday night.
‘Pharmacists and prescribers can refer to the TGA’s Notified vape list to determine what therapeutic vapes are available for supply in Australia, and the TGA is undertaking post-notification surveillance to ensure vapes included on that list are compliant with standards,’ said Ms Edlington. ‘Non-compliant vapes will be the subject of a determination and removed from the list.’
While the TGA’s Special Access Scheme does not normally allow for pre-ordering of stock, there is a difference when it comes to S3 or S4 vaping products, said PSA Victorian State Manager Jarrod McMaugh MPS.
‘Because it's expected that we have stock available at the time the person deems appropriate, we can keep them [in stock],’ he said. ‘But we should limit how much we keep and they should be out of view.’
What are pharmacists’ obligations under the new S3 pathway?
S3 therapeutic vapes, prescribed under Special Access Scheme (SAS) Category C (SAS-C) are restricted to patients 18 years or over – subject to strict conditions and compliance with state and territory laws.
‘A prescription will continue to be needed for patients who are under 18 years of age, subject to state and territory requirements, and patients who require a higher nicotine concentration, of more than 20 mg per mL,’ said Ms Edlington.
Pharmacists must sight identification at every encounter to confirm patients’ identity and age.
‘[Even] if you know the person very well or have sold them vaping products 6 months in a row, you must still check their ID,’ added Mr McMaugh.
It’s also essential to confirm the person prescribed or supplied the vape is who they say they are.
‘From 1 October, provision of S3 or S4 vaping products is in-person to the person themselves,’ he said.
The legislation recognises that there may be circumstances where it's necessary to provide vaping products to the carer of the patient, said Ms Edlington.
‘We haven't adopted social security legislation in order to confine what is precisely meant by “carer”, [but] it’s the responsibility of the person to demonstrate that they could be considered a carer,’ she said.
Before prescribing an S3 vaping product, pharmacists must be satisfied that it is clinically appropriate for smoking cessation or the management of nicotine dependence, said Ms Edlington.
Pharmacists must also provide professional advice to the patient in relation to alternative registered therapies, appropriate dosage frequency, and interaction with other medicines.
‘[They must] ensure the quantity of goods supplied does not exceed more than 1 month supply at any one time,’ said Ms Edlington.
If an S3 vaping consultation ends with a vaping product being provided, it should be considered as last line, with pharmacists obligated to talk to patients about all first-line options – whether nicotine replacement therapy (NRT), or prescription medicines, said Mr McMaugh.
Contact details about cessation support services should also be provided to the patient. ‘The therapeutic vape is not is not going to work in isolation,’ added Ms Edlington.
What paperwork is required?
SAS-C notifications must be made by pharmacists within 28 days for each instance of supply of a therapeutic vaping good substance – whether S3 or S4, said Ms Edlington.
PSA’s guidelines recommend that the SAS-C form is completed in real-time during the consultation.
‘If your workflow becomes disordered and you lose track of them, and then you get audited, the regulatory process can be quite severe and expensive,’ added Mr McMaugh.
PSA’s guidelines also recommend documenting S3 vaping consultations.
‘This helps you understand what was previously provided to this person, as far as advice and products,’ he said.
‘If you have the information about that person in your dispensing system, it may also upload to their My Health Record.’
Pharmacists will not have a mechanism from 1 October to determine if a person has visited another pharmacy for an S3 vaping product already, said Mr McMaugh.
[But] it is possible state-based governments might decide to include this in their real-time prescription monitoring,’ he said.
What is involved in S4 supply?
Pharmacists must have evidence of a prescriber’s Authorised Prescriber (AP) status to fill an S4 vaping script, and can use the TGA’s SAS and AP portal to validate this status online.
Under the SAS-C and the SAS-B schemes, pharmacists must verify the SAS reference number by using the online validation tool.
‘If pharmacists have any concerns in relation to the lawful supply of those goods under the Act using SAS-B or SAS-C pathways by a medical or nurse practitioner, they should contact the prescriber,’ said Ms Edlington.
If pharmacists receive a prescription for a S4 vaping product, they should check that the prescriber has filled in an SAS-B or SAS-C form before dispensing the product.
‘If it doesn't exist, you should contact the prescriber. If they've got all the information, you can complete the form for them [but] you will be taking on extra paperwork for which you are not remunerated,’ he said. ‘[But] don't complete an SAS-C form for a vaping prescription without speaking to the prescriber first.’
How should pharmacists tailor an S3 vaping consultation?
In all S3 vaping consultations, pharmacists need to understand why a person wants to quit vaping or smoking and what outcome they are seeking, said Mr McMaugh.
‘[For example] if they are looking to cut down or quit, we need to say “as you reduce your dose yourself, you need to allow yourself to have some withdrawal symptoms”,’ he said.
‘Without experiencing some withdrawal symptoms, patients won’t experience receptor down regulation, and will still wind up with withdrawal symptoms in the future.’
It’s also important to help patients avoid relapse, which entails advising them against cutting down too quickly.
‘If withdrawal issues are a problem, they can increase the dose back up in response to that,’ said Mr McMaugh.
If a patient indicates they are running out of their 20 mg per mL supply before the month is up, they should be referred to their GP.
‘GPs have access to greater strengths and can provide [patients] with extra support,’ he added.
If a person presents for an S3 vaping consultation for vaping rather than smoking cessation, it’s important to keep in mind that existing NRT products are still off-label for this indication.
What does a behavioural intervention comprise?
Evidence-based behavioural intervention for smoking and/or vaping cessation includes four to six sessions over a month, or longer if required, said Dr Eileen Cole, GP lead at Victoria’s Quit Centre.
If pharmacists make a referral for a patient via the Quit Centre online referral process, the pre-quit call back model includes questions about patients’:
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[post_content] => Early next week (Tuesday 1 October), the next stage of the Commonwealth’s legislated vaping reforms comes into effect, including a Schedule 3 entry for nicotine-containing therapeutic vapes.
PSA’s updated guidelines for pharmacists providing nicotine dependence support are set to be released tomorrow (Thursday 26 September), followed by a national webinar on the same evening.
Ahead of the release of these guidelines, Australian Pharmacist put some of your burning questions to Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
Here’s a sneak peek at what tomorrow night’s webinar will cover.
1. Vapes cannot be collected by third parties – including a person’s husband or wife
A change to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 means pharmacists are not permitted to provide third-party or distance supply of either Schedule 3 or Schedule 4 therapeutic vapes.
All therapeutic vaping products must be handed to the individual who it is intended for, with even spouses precluded. This requirement is unique, and pharmacists will need to consider how to ensure this requirement is upheld.
‘The guidelines cover the circumstances where a carer may collect them, but it does need to be in person,’ said Mr Campbell.
However, in most cases, a family member will not meet the definition of carer.
2. Pharmacists must refer people seeking care
Pharmacists who choose not to prescribe or dispense therapeutic vapes have an obligation to refer patients for care whether that be other nicotine dependence support or how they might access therapeutic vapes
‘As health professionals, we have an obligation to support people who are legitimately seeking care said Mr Campbell
‘For some people, this could be a positive conversation around first-line therapies for smoking or nicotine cessation. For others, this may require referral to another health provider.’
Other options include referral to Quitline, a GP for a prescription or a participating pharmacy.
‘Because there are no published list of pharmacies, GPs or nurse practitioners that are participating, pharmacists may simply not know of any local pharmacies or local prescribers to refer to,’ said Mr Campbell.
‘But we still have a duty of care to make sure there are care options for that person, and that the patient is offered access to nicotine dependence advice, other treatment, first-line recommendations or a referral.’
3. All pharmacists need to be familiar with the updated guidelines, even in pharmacies and states which don't have Schedule 3 therapeutic vapes
Updates to the guidelines highlight obligations not only for pharmacists providing Schedule 3 nicotine vaping products, but also those who choose to dispense on prescription only, or not stock them at all.
‘Although there’s not much evidence in terms of cessation strategies for vaping, heat-not-burn tobacco or nicotine pouches, the guidelines will still support a pharmacist in having those discussions with patients,’ said Mr Campbell.
Schedule 3 therapeutic vaping products may also not be available in all jurisdictions, with both Western Australia and Tasmania planning to introduce legislation to prevent supply of vapes without a prescription from a doctor or nurse practitioner.
4. Prescribing Schedule 3 therapeutic vapes will take time to meet patient clinical needs and regulatory requirements
Prescribing vapes under Schedule 3 will take longer than most other Pharmacist Only medicines as the therapeutics and regulatory compliance obligations are more substantial.
During a Schedule 3 vaping consultation, pharmacists must:
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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"] Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
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[post_excerpt] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
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[post_content] => Novo Nordisk has announced the discontinuation of earlier generation insulin products over a 2-year period, which will leave many patients struggling to adjust to new medicine strengths and devices.
The product discontinuations include:
Cindy Tolba MPS[/caption]
‘No other product presentation for Mixtard 30/70 will be available,’ she said.
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[post_content] => When the Commonwealth’s legislated vaping reforms come into effect tomorrow, pharmacists need to adhere to a new set of regulations for Schedule 3 prescribing and Schedule 4 supply.
Ahead of the 1 October start date, PSA has updated their Professional Practice Guidelines for Pharmacists for Nicotine Dependence support.
Here’s what you need to know about changes to consultation guidelines and supply of nicotine containing vapes.
How are therapeutic vaping goods regulated and stocked?
Therapeutic vaping goods that are imported, manufactured or supplied in Australia must be notified to the TGA by the sponsor as complying with the applicable quality and safety standards, said Mandy Edlington, Assistant Secretary of the Vaping Legislative Reform Branch at the Therapeutic Goods Administration (TGA) in a webinar held on Thursday night.
‘Pharmacists and prescribers can refer to the TGA’s Notified vape list to determine what therapeutic vapes are available for supply in Australia, and the TGA is undertaking post-notification surveillance to ensure vapes included on that list are compliant with standards,’ said Ms Edlington. ‘Non-compliant vapes will be the subject of a determination and removed from the list.’
While the TGA’s Special Access Scheme does not normally allow for pre-ordering of stock, there is a difference when it comes to S3 or S4 vaping products, said PSA Victorian State Manager Jarrod McMaugh MPS.
‘Because it's expected that we have stock available at the time the person deems appropriate, we can keep them [in stock],’ he said. ‘But we should limit how much we keep and they should be out of view.’
What are pharmacists’ obligations under the new S3 pathway?
S3 therapeutic vapes, prescribed under Special Access Scheme (SAS) Category C (SAS-C) are restricted to patients 18 years or over – subject to strict conditions and compliance with state and territory laws.
‘A prescription will continue to be needed for patients who are under 18 years of age, subject to state and territory requirements, and patients who require a higher nicotine concentration, of more than 20 mg per mL,’ said Ms Edlington.
Pharmacists must sight identification at every encounter to confirm patients’ identity and age.
‘[Even] if you know the person very well or have sold them vaping products 6 months in a row, you must still check their ID,’ added Mr McMaugh.
It’s also essential to confirm the person prescribed or supplied the vape is who they say they are.
‘From 1 October, provision of S3 or S4 vaping products is in-person to the person themselves,’ he said.
The legislation recognises that there may be circumstances where it's necessary to provide vaping products to the carer of the patient, said Ms Edlington.
‘We haven't adopted social security legislation in order to confine what is precisely meant by “carer”, [but] it’s the responsibility of the person to demonstrate that they could be considered a carer,’ she said.
Before prescribing an S3 vaping product, pharmacists must be satisfied that it is clinically appropriate for smoking cessation or the management of nicotine dependence, said Ms Edlington.
Pharmacists must also provide professional advice to the patient in relation to alternative registered therapies, appropriate dosage frequency, and interaction with other medicines.
‘[They must] ensure the quantity of goods supplied does not exceed more than 1 month supply at any one time,’ said Ms Edlington.
If an S3 vaping consultation ends with a vaping product being provided, it should be considered as last line, with pharmacists obligated to talk to patients about all first-line options – whether nicotine replacement therapy (NRT), or prescription medicines, said Mr McMaugh.
Contact details about cessation support services should also be provided to the patient. ‘The therapeutic vape is not is not going to work in isolation,’ added Ms Edlington.
What paperwork is required?
SAS-C notifications must be made by pharmacists within 28 days for each instance of supply of a therapeutic vaping good substance – whether S3 or S4, said Ms Edlington.
PSA’s guidelines recommend that the SAS-C form is completed in real-time during the consultation.
‘If your workflow becomes disordered and you lose track of them, and then you get audited, the regulatory process can be quite severe and expensive,’ added Mr McMaugh.
PSA’s guidelines also recommend documenting S3 vaping consultations.
‘This helps you understand what was previously provided to this person, as far as advice and products,’ he said.
‘If you have the information about that person in your dispensing system, it may also upload to their My Health Record.’
Pharmacists will not have a mechanism from 1 October to determine if a person has visited another pharmacy for an S3 vaping product already, said Mr McMaugh.
[But] it is possible state-based governments might decide to include this in their real-time prescription monitoring,’ he said.
What is involved in S4 supply?
Pharmacists must have evidence of a prescriber’s Authorised Prescriber (AP) status to fill an S4 vaping script, and can use the TGA’s SAS and AP portal to validate this status online.
Under the SAS-C and the SAS-B schemes, pharmacists must verify the SAS reference number by using the online validation tool.
‘If pharmacists have any concerns in relation to the lawful supply of those goods under the Act using SAS-B or SAS-C pathways by a medical or nurse practitioner, they should contact the prescriber,’ said Ms Edlington.
If pharmacists receive a prescription for a S4 vaping product, they should check that the prescriber has filled in an SAS-B or SAS-C form before dispensing the product.
‘If it doesn't exist, you should contact the prescriber. If they've got all the information, you can complete the form for them [but] you will be taking on extra paperwork for which you are not remunerated,’ he said. ‘[But] don't complete an SAS-C form for a vaping prescription without speaking to the prescriber first.’
How should pharmacists tailor an S3 vaping consultation?
In all S3 vaping consultations, pharmacists need to understand why a person wants to quit vaping or smoking and what outcome they are seeking, said Mr McMaugh.
‘[For example] if they are looking to cut down or quit, we need to say “as you reduce your dose yourself, you need to allow yourself to have some withdrawal symptoms”,’ he said.
‘Without experiencing some withdrawal symptoms, patients won’t experience receptor down regulation, and will still wind up with withdrawal symptoms in the future.’
It’s also important to help patients avoid relapse, which entails advising them against cutting down too quickly.
‘If withdrawal issues are a problem, they can increase the dose back up in response to that,’ said Mr McMaugh.
If a patient indicates they are running out of their 20 mg per mL supply before the month is up, they should be referred to their GP.
‘GPs have access to greater strengths and can provide [patients] with extra support,’ he added.
If a person presents for an S3 vaping consultation for vaping rather than smoking cessation, it’s important to keep in mind that existing NRT products are still off-label for this indication.
What does a behavioural intervention comprise?
Evidence-based behavioural intervention for smoking and/or vaping cessation includes four to six sessions over a month, or longer if required, said Dr Eileen Cole, GP lead at Victoria’s Quit Centre.
If pharmacists make a referral for a patient via the Quit Centre online referral process, the pre-quit call back model includes questions about patients’:
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[post_content] => Early next week (Tuesday 1 October), the next stage of the Commonwealth’s legislated vaping reforms comes into effect, including a Schedule 3 entry for nicotine-containing therapeutic vapes.
PSA’s updated guidelines for pharmacists providing nicotine dependence support are set to be released tomorrow (Thursday 26 September), followed by a national webinar on the same evening.
Ahead of the release of these guidelines, Australian Pharmacist put some of your burning questions to Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
Here’s a sneak peek at what tomorrow night’s webinar will cover.
1. Vapes cannot be collected by third parties – including a person’s husband or wife
A change to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 means pharmacists are not permitted to provide third-party or distance supply of either Schedule 3 or Schedule 4 therapeutic vapes.
All therapeutic vaping products must be handed to the individual who it is intended for, with even spouses precluded. This requirement is unique, and pharmacists will need to consider how to ensure this requirement is upheld.
‘The guidelines cover the circumstances where a carer may collect them, but it does need to be in person,’ said Mr Campbell.
However, in most cases, a family member will not meet the definition of carer.
2. Pharmacists must refer people seeking care
Pharmacists who choose not to prescribe or dispense therapeutic vapes have an obligation to refer patients for care whether that be other nicotine dependence support or how they might access therapeutic vapes
‘As health professionals, we have an obligation to support people who are legitimately seeking care said Mr Campbell
‘For some people, this could be a positive conversation around first-line therapies for smoking or nicotine cessation. For others, this may require referral to another health provider.’
Other options include referral to Quitline, a GP for a prescription or a participating pharmacy.
‘Because there are no published list of pharmacies, GPs or nurse practitioners that are participating, pharmacists may simply not know of any local pharmacies or local prescribers to refer to,’ said Mr Campbell.
‘But we still have a duty of care to make sure there are care options for that person, and that the patient is offered access to nicotine dependence advice, other treatment, first-line recommendations or a referral.’
3. All pharmacists need to be familiar with the updated guidelines, even in pharmacies and states which don't have Schedule 3 therapeutic vapes
Updates to the guidelines highlight obligations not only for pharmacists providing Schedule 3 nicotine vaping products, but also those who choose to dispense on prescription only, or not stock them at all.
‘Although there’s not much evidence in terms of cessation strategies for vaping, heat-not-burn tobacco or nicotine pouches, the guidelines will still support a pharmacist in having those discussions with patients,’ said Mr Campbell.
Schedule 3 therapeutic vaping products may also not be available in all jurisdictions, with both Western Australia and Tasmania planning to introduce legislation to prevent supply of vapes without a prescription from a doctor or nurse practitioner.
4. Prescribing Schedule 3 therapeutic vapes will take time to meet patient clinical needs and regulatory requirements
Prescribing vapes under Schedule 3 will take longer than most other Pharmacist Only medicines as the therapeutics and regulatory compliance obligations are more substantial.
During a Schedule 3 vaping consultation, pharmacists must:
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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"] Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
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[post_content] => Novo Nordisk has announced the discontinuation of earlier generation insulin products over a 2-year period, which will leave many patients struggling to adjust to new medicine strengths and devices.
The product discontinuations include:
Cindy Tolba MPS[/caption]
‘No other product presentation for Mixtard 30/70 will be available,’ she said.
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[post_content] => When the Commonwealth’s legislated vaping reforms come into effect tomorrow, pharmacists need to adhere to a new set of regulations for Schedule 3 prescribing and Schedule 4 supply.
Ahead of the 1 October start date, PSA has updated their Professional Practice Guidelines for Pharmacists for Nicotine Dependence support.
Here’s what you need to know about changes to consultation guidelines and supply of nicotine containing vapes.
How are therapeutic vaping goods regulated and stocked?
Therapeutic vaping goods that are imported, manufactured or supplied in Australia must be notified to the TGA by the sponsor as complying with the applicable quality and safety standards, said Mandy Edlington, Assistant Secretary of the Vaping Legislative Reform Branch at the Therapeutic Goods Administration (TGA) in a webinar held on Thursday night.
‘Pharmacists and prescribers can refer to the TGA’s Notified vape list to determine what therapeutic vapes are available for supply in Australia, and the TGA is undertaking post-notification surveillance to ensure vapes included on that list are compliant with standards,’ said Ms Edlington. ‘Non-compliant vapes will be the subject of a determination and removed from the list.’
While the TGA’s Special Access Scheme does not normally allow for pre-ordering of stock, there is a difference when it comes to S3 or S4 vaping products, said PSA Victorian State Manager Jarrod McMaugh MPS.
‘Because it's expected that we have stock available at the time the person deems appropriate, we can keep them [in stock],’ he said. ‘But we should limit how much we keep and they should be out of view.’
What are pharmacists’ obligations under the new S3 pathway?
S3 therapeutic vapes, prescribed under Special Access Scheme (SAS) Category C (SAS-C) are restricted to patients 18 years or over – subject to strict conditions and compliance with state and territory laws.
‘A prescription will continue to be needed for patients who are under 18 years of age, subject to state and territory requirements, and patients who require a higher nicotine concentration, of more than 20 mg per mL,’ said Ms Edlington.
Pharmacists must sight identification at every encounter to confirm patients’ identity and age.
‘[Even] if you know the person very well or have sold them vaping products 6 months in a row, you must still check their ID,’ added Mr McMaugh.
It’s also essential to confirm the person prescribed or supplied the vape is who they say they are.
‘From 1 October, provision of S3 or S4 vaping products is in-person to the person themselves,’ he said.
The legislation recognises that there may be circumstances where it's necessary to provide vaping products to the carer of the patient, said Ms Edlington.
‘We haven't adopted social security legislation in order to confine what is precisely meant by “carer”, [but] it’s the responsibility of the person to demonstrate that they could be considered a carer,’ she said.
Before prescribing an S3 vaping product, pharmacists must be satisfied that it is clinically appropriate for smoking cessation or the management of nicotine dependence, said Ms Edlington.
Pharmacists must also provide professional advice to the patient in relation to alternative registered therapies, appropriate dosage frequency, and interaction with other medicines.
‘[They must] ensure the quantity of goods supplied does not exceed more than 1 month supply at any one time,’ said Ms Edlington.
If an S3 vaping consultation ends with a vaping product being provided, it should be considered as last line, with pharmacists obligated to talk to patients about all first-line options – whether nicotine replacement therapy (NRT), or prescription medicines, said Mr McMaugh.
Contact details about cessation support services should also be provided to the patient. ‘The therapeutic vape is not is not going to work in isolation,’ added Ms Edlington.
What paperwork is required?
SAS-C notifications must be made by pharmacists within 28 days for each instance of supply of a therapeutic vaping good substance – whether S3 or S4, said Ms Edlington.
PSA’s guidelines recommend that the SAS-C form is completed in real-time during the consultation.
‘If your workflow becomes disordered and you lose track of them, and then you get audited, the regulatory process can be quite severe and expensive,’ added Mr McMaugh.
PSA’s guidelines also recommend documenting S3 vaping consultations.
‘This helps you understand what was previously provided to this person, as far as advice and products,’ he said.
‘If you have the information about that person in your dispensing system, it may also upload to their My Health Record.’
Pharmacists will not have a mechanism from 1 October to determine if a person has visited another pharmacy for an S3 vaping product already, said Mr McMaugh.
[But] it is possible state-based governments might decide to include this in their real-time prescription monitoring,’ he said.
What is involved in S4 supply?
Pharmacists must have evidence of a prescriber’s Authorised Prescriber (AP) status to fill an S4 vaping script, and can use the TGA’s SAS and AP portal to validate this status online.
Under the SAS-C and the SAS-B schemes, pharmacists must verify the SAS reference number by using the online validation tool.
‘If pharmacists have any concerns in relation to the lawful supply of those goods under the Act using SAS-B or SAS-C pathways by a medical or nurse practitioner, they should contact the prescriber,’ said Ms Edlington.
If pharmacists receive a prescription for a S4 vaping product, they should check that the prescriber has filled in an SAS-B or SAS-C form before dispensing the product.
‘If it doesn't exist, you should contact the prescriber. If they've got all the information, you can complete the form for them [but] you will be taking on extra paperwork for which you are not remunerated,’ he said. ‘[But] don't complete an SAS-C form for a vaping prescription without speaking to the prescriber first.’
How should pharmacists tailor an S3 vaping consultation?
In all S3 vaping consultations, pharmacists need to understand why a person wants to quit vaping or smoking and what outcome they are seeking, said Mr McMaugh.
‘[For example] if they are looking to cut down or quit, we need to say “as you reduce your dose yourself, you need to allow yourself to have some withdrawal symptoms”,’ he said.
‘Without experiencing some withdrawal symptoms, patients won’t experience receptor down regulation, and will still wind up with withdrawal symptoms in the future.’
It’s also important to help patients avoid relapse, which entails advising them against cutting down too quickly.
‘If withdrawal issues are a problem, they can increase the dose back up in response to that,’ said Mr McMaugh.
If a patient indicates they are running out of their 20 mg per mL supply before the month is up, they should be referred to their GP.
‘GPs have access to greater strengths and can provide [patients] with extra support,’ he added.
If a person presents for an S3 vaping consultation for vaping rather than smoking cessation, it’s important to keep in mind that existing NRT products are still off-label for this indication.
What does a behavioural intervention comprise?
Evidence-based behavioural intervention for smoking and/or vaping cessation includes four to six sessions over a month, or longer if required, said Dr Eileen Cole, GP lead at Victoria’s Quit Centre.
If pharmacists make a referral for a patient via the Quit Centre online referral process, the pre-quit call back model includes questions about patients’:
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[post_content] => Early next week (Tuesday 1 October), the next stage of the Commonwealth’s legislated vaping reforms comes into effect, including a Schedule 3 entry for nicotine-containing therapeutic vapes.
PSA’s updated guidelines for pharmacists providing nicotine dependence support are set to be released tomorrow (Thursday 26 September), followed by a national webinar on the same evening.
Ahead of the release of these guidelines, Australian Pharmacist put some of your burning questions to Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
Here’s a sneak peek at what tomorrow night’s webinar will cover.
1. Vapes cannot be collected by third parties – including a person’s husband or wife
A change to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 means pharmacists are not permitted to provide third-party or distance supply of either Schedule 3 or Schedule 4 therapeutic vapes.
All therapeutic vaping products must be handed to the individual who it is intended for, with even spouses precluded. This requirement is unique, and pharmacists will need to consider how to ensure this requirement is upheld.
‘The guidelines cover the circumstances where a carer may collect them, but it does need to be in person,’ said Mr Campbell.
However, in most cases, a family member will not meet the definition of carer.
2. Pharmacists must refer people seeking care
Pharmacists who choose not to prescribe or dispense therapeutic vapes have an obligation to refer patients for care whether that be other nicotine dependence support or how they might access therapeutic vapes
‘As health professionals, we have an obligation to support people who are legitimately seeking care said Mr Campbell
‘For some people, this could be a positive conversation around first-line therapies for smoking or nicotine cessation. For others, this may require referral to another health provider.’
Other options include referral to Quitline, a GP for a prescription or a participating pharmacy.
‘Because there are no published list of pharmacies, GPs or nurse practitioners that are participating, pharmacists may simply not know of any local pharmacies or local prescribers to refer to,’ said Mr Campbell.
‘But we still have a duty of care to make sure there are care options for that person, and that the patient is offered access to nicotine dependence advice, other treatment, first-line recommendations or a referral.’
3. All pharmacists need to be familiar with the updated guidelines, even in pharmacies and states which don't have Schedule 3 therapeutic vapes
Updates to the guidelines highlight obligations not only for pharmacists providing Schedule 3 nicotine vaping products, but also those who choose to dispense on prescription only, or not stock them at all.
‘Although there’s not much evidence in terms of cessation strategies for vaping, heat-not-burn tobacco or nicotine pouches, the guidelines will still support a pharmacist in having those discussions with patients,’ said Mr Campbell.
Schedule 3 therapeutic vaping products may also not be available in all jurisdictions, with both Western Australia and Tasmania planning to introduce legislation to prevent supply of vapes without a prescription from a doctor or nurse practitioner.
4. Prescribing Schedule 3 therapeutic vapes will take time to meet patient clinical needs and regulatory requirements
Prescribing vapes under Schedule 3 will take longer than most other Pharmacist Only medicines as the therapeutics and regulatory compliance obligations are more substantial.
During a Schedule 3 vaping consultation, pharmacists must:
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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"] Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
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[post_excerpt] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
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[post_content] => Novo Nordisk has announced the discontinuation of earlier generation insulin products over a 2-year period, which will leave many patients struggling to adjust to new medicine strengths and devices.
The product discontinuations include:
Cindy Tolba MPS[/caption]
‘No other product presentation for Mixtard 30/70 will be available,’ she said.
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[post_content] => When the Commonwealth’s legislated vaping reforms come into effect tomorrow, pharmacists need to adhere to a new set of regulations for Schedule 3 prescribing and Schedule 4 supply.
Ahead of the 1 October start date, PSA has updated their Professional Practice Guidelines for Pharmacists for Nicotine Dependence support.
Here’s what you need to know about changes to consultation guidelines and supply of nicotine containing vapes.
How are therapeutic vaping goods regulated and stocked?
Therapeutic vaping goods that are imported, manufactured or supplied in Australia must be notified to the TGA by the sponsor as complying with the applicable quality and safety standards, said Mandy Edlington, Assistant Secretary of the Vaping Legislative Reform Branch at the Therapeutic Goods Administration (TGA) in a webinar held on Thursday night.
‘Pharmacists and prescribers can refer to the TGA’s Notified vape list to determine what therapeutic vapes are available for supply in Australia, and the TGA is undertaking post-notification surveillance to ensure vapes included on that list are compliant with standards,’ said Ms Edlington. ‘Non-compliant vapes will be the subject of a determination and removed from the list.’
While the TGA’s Special Access Scheme does not normally allow for pre-ordering of stock, there is a difference when it comes to S3 or S4 vaping products, said PSA Victorian State Manager Jarrod McMaugh MPS.
‘Because it's expected that we have stock available at the time the person deems appropriate, we can keep them [in stock],’ he said. ‘But we should limit how much we keep and they should be out of view.’
What are pharmacists’ obligations under the new S3 pathway?
S3 therapeutic vapes, prescribed under Special Access Scheme (SAS) Category C (SAS-C) are restricted to patients 18 years or over – subject to strict conditions and compliance with state and territory laws.
‘A prescription will continue to be needed for patients who are under 18 years of age, subject to state and territory requirements, and patients who require a higher nicotine concentration, of more than 20 mg per mL,’ said Ms Edlington.
Pharmacists must sight identification at every encounter to confirm patients’ identity and age.
‘[Even] if you know the person very well or have sold them vaping products 6 months in a row, you must still check their ID,’ added Mr McMaugh.
It’s also essential to confirm the person prescribed or supplied the vape is who they say they are.
‘From 1 October, provision of S3 or S4 vaping products is in-person to the person themselves,’ he said.
The legislation recognises that there may be circumstances where it's necessary to provide vaping products to the carer of the patient, said Ms Edlington.
‘We haven't adopted social security legislation in order to confine what is precisely meant by “carer”, [but] it’s the responsibility of the person to demonstrate that they could be considered a carer,’ she said.
Before prescribing an S3 vaping product, pharmacists must be satisfied that it is clinically appropriate for smoking cessation or the management of nicotine dependence, said Ms Edlington.
Pharmacists must also provide professional advice to the patient in relation to alternative registered therapies, appropriate dosage frequency, and interaction with other medicines.
‘[They must] ensure the quantity of goods supplied does not exceed more than 1 month supply at any one time,’ said Ms Edlington.
If an S3 vaping consultation ends with a vaping product being provided, it should be considered as last line, with pharmacists obligated to talk to patients about all first-line options – whether nicotine replacement therapy (NRT), or prescription medicines, said Mr McMaugh.
Contact details about cessation support services should also be provided to the patient. ‘The therapeutic vape is not is not going to work in isolation,’ added Ms Edlington.
What paperwork is required?
SAS-C notifications must be made by pharmacists within 28 days for each instance of supply of a therapeutic vaping good substance – whether S3 or S4, said Ms Edlington.
PSA’s guidelines recommend that the SAS-C form is completed in real-time during the consultation.
‘If your workflow becomes disordered and you lose track of them, and then you get audited, the regulatory process can be quite severe and expensive,’ added Mr McMaugh.
PSA’s guidelines also recommend documenting S3 vaping consultations.
‘This helps you understand what was previously provided to this person, as far as advice and products,’ he said.
‘If you have the information about that person in your dispensing system, it may also upload to their My Health Record.’
Pharmacists will not have a mechanism from 1 October to determine if a person has visited another pharmacy for an S3 vaping product already, said Mr McMaugh.
[But] it is possible state-based governments might decide to include this in their real-time prescription monitoring,’ he said.
What is involved in S4 supply?
Pharmacists must have evidence of a prescriber’s Authorised Prescriber (AP) status to fill an S4 vaping script, and can use the TGA’s SAS and AP portal to validate this status online.
Under the SAS-C and the SAS-B schemes, pharmacists must verify the SAS reference number by using the online validation tool.
‘If pharmacists have any concerns in relation to the lawful supply of those goods under the Act using SAS-B or SAS-C pathways by a medical or nurse practitioner, they should contact the prescriber,’ said Ms Edlington.
If pharmacists receive a prescription for a S4 vaping product, they should check that the prescriber has filled in an SAS-B or SAS-C form before dispensing the product.
‘If it doesn't exist, you should contact the prescriber. If they've got all the information, you can complete the form for them [but] you will be taking on extra paperwork for which you are not remunerated,’ he said. ‘[But] don't complete an SAS-C form for a vaping prescription without speaking to the prescriber first.’
How should pharmacists tailor an S3 vaping consultation?
In all S3 vaping consultations, pharmacists need to understand why a person wants to quit vaping or smoking and what outcome they are seeking, said Mr McMaugh.
‘[For example] if they are looking to cut down or quit, we need to say “as you reduce your dose yourself, you need to allow yourself to have some withdrawal symptoms”,’ he said.
‘Without experiencing some withdrawal symptoms, patients won’t experience receptor down regulation, and will still wind up with withdrawal symptoms in the future.’
It’s also important to help patients avoid relapse, which entails advising them against cutting down too quickly.
‘If withdrawal issues are a problem, they can increase the dose back up in response to that,’ said Mr McMaugh.
If a patient indicates they are running out of their 20 mg per mL supply before the month is up, they should be referred to their GP.
‘GPs have access to greater strengths and can provide [patients] with extra support,’ he added.
If a person presents for an S3 vaping consultation for vaping rather than smoking cessation, it’s important to keep in mind that existing NRT products are still off-label for this indication.
What does a behavioural intervention comprise?
Evidence-based behavioural intervention for smoking and/or vaping cessation includes four to six sessions over a month, or longer if required, said Dr Eileen Cole, GP lead at Victoria’s Quit Centre.
If pharmacists make a referral for a patient via the Quit Centre online referral process, the pre-quit call back model includes questions about patients’:
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[post_content] => Early next week (Tuesday 1 October), the next stage of the Commonwealth’s legislated vaping reforms comes into effect, including a Schedule 3 entry for nicotine-containing therapeutic vapes.
PSA’s updated guidelines for pharmacists providing nicotine dependence support are set to be released tomorrow (Thursday 26 September), followed by a national webinar on the same evening.
Ahead of the release of these guidelines, Australian Pharmacist put some of your burning questions to Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
Here’s a sneak peek at what tomorrow night’s webinar will cover.
1. Vapes cannot be collected by third parties – including a person’s husband or wife
A change to the Therapeutic Goods and Other Legislation Amendment (Vaping Reforms) Act 2024 means pharmacists are not permitted to provide third-party or distance supply of either Schedule 3 or Schedule 4 therapeutic vapes.
All therapeutic vaping products must be handed to the individual who it is intended for, with even spouses precluded. This requirement is unique, and pharmacists will need to consider how to ensure this requirement is upheld.
‘The guidelines cover the circumstances where a carer may collect them, but it does need to be in person,’ said Mr Campbell.
However, in most cases, a family member will not meet the definition of carer.
2. Pharmacists must refer people seeking care
Pharmacists who choose not to prescribe or dispense therapeutic vapes have an obligation to refer patients for care whether that be other nicotine dependence support or how they might access therapeutic vapes
‘As health professionals, we have an obligation to support people who are legitimately seeking care said Mr Campbell
‘For some people, this could be a positive conversation around first-line therapies for smoking or nicotine cessation. For others, this may require referral to another health provider.’
Other options include referral to Quitline, a GP for a prescription or a participating pharmacy.
‘Because there are no published list of pharmacies, GPs or nurse practitioners that are participating, pharmacists may simply not know of any local pharmacies or local prescribers to refer to,’ said Mr Campbell.
‘But we still have a duty of care to make sure there are care options for that person, and that the patient is offered access to nicotine dependence advice, other treatment, first-line recommendations or a referral.’
3. All pharmacists need to be familiar with the updated guidelines, even in pharmacies and states which don't have Schedule 3 therapeutic vapes
Updates to the guidelines highlight obligations not only for pharmacists providing Schedule 3 nicotine vaping products, but also those who choose to dispense on prescription only, or not stock them at all.
‘Although there’s not much evidence in terms of cessation strategies for vaping, heat-not-burn tobacco or nicotine pouches, the guidelines will still support a pharmacist in having those discussions with patients,’ said Mr Campbell.
Schedule 3 therapeutic vaping products may also not be available in all jurisdictions, with both Western Australia and Tasmania planning to introduce legislation to prevent supply of vapes without a prescription from a doctor or nurse practitioner.
4. Prescribing Schedule 3 therapeutic vapes will take time to meet patient clinical needs and regulatory requirements
Prescribing vapes under Schedule 3 will take longer than most other Pharmacist Only medicines as the therapeutics and regulatory compliance obligations are more substantial.
During a Schedule 3 vaping consultation, pharmacists must:
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
