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[post_content] => Mid-winter will be a busy time of year for pharmacists, with a range of practice, fee and career pathway updates kicking off on 1 July 2024.
Australian Pharmacist takes a look at the changes pharmacists will experience from next week.
1. Vaping ban comes into effect
The third tranche of vaping reform included in the Therapeutic Goods and other Legislation (Vaping Reforms) Bill 2024 will see all vape sales banned from general retailers from 1 July. Passing through the Senate this morning, the Bill limits the supply of all vapes strictly to community pharmacies from Monday.
These vaping products must adhere to quality and product standards including:
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[post_content] => Rabies causes an estimated 59,000 deaths annually, with almost half (40%) deaths occurring in children under 15. But underreporting could mean this death rate is much higher.
Post COVID-19, there has been an increase in rabies cases – with the abandonment of pets and a reduction in human-dog interaction leading to heightened aggression in dogs – who are responsible for most human rabies cases. Rabies hotspots include Asia, Africa and India, but 150 countries are considered high-risk rabies territories.
As we approach the winter school holidays and Australians escape the cold by heading overseas, pharmacists in New South Wales can now protect patients against the disease.
PSA advocacy was the key driver for the change to the NSW Pharmacist Vaccination Standards to allow pharmacists to administer the rabies vaccine, with the NSW Branch Committee working closely with the Ministry of Health to drive the change, said PSA NSW State Manager Amanda Fairjones MPS.
[caption id="attachment_25121" align="alignright" width="298"]
PSA NSW branch State Manager Amanda Fairjones MPS[/caption]
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for,’ she said. ‘People were asking for it but we were unable to provide it.’
Having the vaccine available provides a great opportunity for pharmacists to sit down and have a chat to people about their travel vaccination needs, said Karen Carter FPS, Partner of Carter's Pharmacy Gunnedah and Owner Narrabri Pharmacy Narrabri in north-west NSW.
‘Because of the regime with some vaccines, we need to have them all done on one day or a week apart,’ she said. ‘ Now we can organise a vaccine regime to be completed at the pharmacy, rather than having to send patients back to their GP for part of it.’
Who is the vaccine indicated for?
Under the NSW Pharmacist Vaccination Standards, pharmacists can administer the rabies vaccine for pre-exposure prophylaxis treatment via intramuscular injection to people 5 years and over who are not immunocompromised.
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for. People were asking for it but we were unable to provide it.'
amanda fairjones MPS
The Australian Immunisation Handbook (AIH), recommends pre-exposure rabies vaccine for:
Karen Carter FPS[/caption]
Post-exposure prophylaxis includes wound management, administration of rabies vaccine doses and human rabies immunoglobulin, taking into account:
If a prescriber writes a prescription for a vaccine – including the rabies vaccine – pharmacists are able to administer it in all states and territories other than Tasmania and South Australia.
However, in the case of the rabies vaccine, in Tasmania, authorised pharmacist immunisers can administer the rabies vaccine when prescribed by a medical or nurse practitioner.
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As winter kicked off, Australia was hit by a massive COVID-19 wave – fuelled by the new Omicron FLiRT subvariant.
There have been 93,049 cases of COVID-19 reported since April 2024. Case numbers are highest among those most at risk, with notifications peaking in the 75–79 (6,655), 80–84 (6,524) and 85+ (12,607) age brackets.
However, with limited testing and reporting COVID-19 cases, this figure does not tell the full story.
‘We’re looking at six to 10 times as many people actually infected as the case numbers are showing,’ said Professor Adrian Esterman, chair of biostatistics and epidemiology at the University of South Australia.
At the same time, reported influenza cases are also increasing. During the first week of June, influenza notifications to the Department of Health increased by 22% to 251 cases. This rise pushed the influenza case numbers above the seasonal threshold for the first time in 2024.
While these respiratory diseases circulate among the community – vaccination rates are waning.
While 2024 influenza vaccination in pharmacies has slightly increased compared to this time last year (87,232 versus 83,326 for the week 9–16 June) – there has been a significant decrease since 2022, when vaccination rates reached a high of 181,202 in the same period.
To boost vaccination rates among older Australians – whether in the community or in residential aged care facilities (RACFs) – three community pharmacists shared their top tips with Australian Pharmacist.
How to overcome vaccination fatigue
According to community pharmacist Yves Cruz, based in the New South Wales South Coast town of Nowra, 2024 has been particularly challenging for COVID-19 vaccine uptake.
‘What I have experienced is that people think 3, 4 or 5 doses is enough for them,’ he said.
However, Mr Cruz thinks leveraging trusting relationships with patients can help to overcome hesitancy.
‘If the people trust their pharmacist, I find they are willing to get the vaccine – even if they have reservations,’ he said.
‘Through communication and providing [evidence-based] information, this can help to remove their doubts.’
Queensland-based pharmacist Alicia Slight has similarly encountered some resistance to COVID-19 boosters, which she promptly addresses with factual information.
‘I use the Australian Technical Advisory Group on Immunisation (ATAGI) table to help navigate the conversation, and also describe [COVID-19 booster doses] as akin to having a yearly flu vaccine,’ she said. ‘I win over [around] three quarters of the fence sitters with a straightforward explanation and by not being too pushy on the matter.’
How to Get involved in outreach programs
As of 13 June 2024, there were 4,147 active COVID-19 cases reported in 487 active outbreaks in RACFs across Australia.
But only 40.3% of those in RACFs had received a COVID-19 booster dose in the last 6 months.
National Immunisation Program vaccines can now be administered off-site in RACFs under NIPVIP. Mark Butler, federal Minister for Health and Aged Care, has strongly advised pharmacists to get involved in these programs.
Since 29 April 2024, pharmacists have also been able to receive funding to deliver National Immunisation Program vaccines to patients in RACFs. From next month (1 July) NIPVIP payments will also be indexed in line with Medicare Benefits Schedule indexation.
‘Community pharmacists play a vital role in our healthcare system – and they will play an even bigger role by administering free, lifesaving vaccines to eligible patients living in aged care homes and disability homes,’ he said.
Pharmacists should also be actively engaged with community outreach as this enhances the uptake of vaccinations, said Dr Brian Chia MPS, community pharmacist, lecturer in Pharmacy and Pharmacology at the University of South Australia and member of the South Australian PSA Early Career working group.
‘This is not limited to COVID-19 or influenza vaccinations, but the scope for many other vaccinations pharmacists can provide,’ he said.
How to promote co-administration
For Mr Chia, promoting co-administration is key to ensuring vulnerable older patients are protected against both influenza and COVID-19 this season.
[caption id="attachment_26579" align="alignright" width="318"]
Dr Brian Chia MPS[/caption]
‘Whenever they come in for a COVID-19 vaccine, I usually ask them, “have you had your flu shot?”,’ he said.
‘A lot of patients are not aware that you can actually get the vaccines at the same time, and many of them say “if I can get them together, it will make my life so much more convenient”.’
Mr Cruz takes the opportunity to discuss influenza and COVID-19 vaccines when patients come in for a Shingrix vaccine – which is highly sought after by older Australians in his community.
‘Once we talk about shingles vaccine, we open up about the importance of flu and COVID-19 vaccines,’ he said. ‘Most of the time, this is successful. The majority of our loyal customers aged 65 years and over have received the COVID-19, influenza and shingles vaccines, and now we're starting to give the pneumococcal vaccine.’
How to leverage pharmacy’s accessibility
Community pharmacies are one of the most accessible vaccine providers around. But not all patients are aware of what vaccinations pharmacists can provide, and how simple the process is.
‘I had a patient who came in with a prescription for Boostrix and Vaxigrip Tetra,’ said Mr Chia.
‘I told a patient, “do you know you can actually walk in, we can provide you with these vaccinations? And it doesn't take more than 15 minutes.’
For Ms Slight, offering both appointments and walk-in vaccinations is a key driver for increasing uptake of influenza vaccines.
‘We also offer vaccination to patients when they hand in and pick up prescriptions – providing a constant reminder of our service [leads to] so many happy to get vaccinated then and there,’ she said.
During any vaccination, Ms Slight also shows patients their Australian Immunisation Register to highlight any upcoming or outstanding vaccinations, such as COVID-19, pneumococcal, DTPa or shingles.
‘I then arrange for those vaccinations to be administered – either on the same day or with an appropriate interval – depending on what needs to be done,’ she said. ‘Very rarely do I get resistance to this process.’
[post_title] => Vaccination rates wane as COVID-19 and influenza cases ramp up
[post_excerpt] => Vaccination rates are rapidly slipping in vulnerable older Australians. Three pharmacists share their advice for turning this around.
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[title_attribute] => Vaccination rates wane as COVID-19 and influenza cases ramp up
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[post_content] => NSW Health has issued an alert following a stream of newborn and infant presentations with symptoms of anticholinergic syndrome.
Colic preparations containing the toxic belladonna plant are the suspected culprit.
Other jurisdictions have reported similar incidents, with Queensland Health also issuing an alert after two infants presented to a Brisbane metropolitan hospital with suspected belladonna toxicity.
So what do pharmacists need to look out for? Australian Pharmacist delves into the signs and symptoms of colic, the recommended treatment options, how anticholinergic syndrome manifests and advice for struggling parents.
How, and when, does colic present?
Colic is defined as repeated, unexplained, inconsolable episodes of crying that persist for more than 3 hours per day, with parents unable to comfort their children.
The crying typically onsets suddenly at a similar time each day – more frequently occurring in the afternoons or evenings.
Other symptoms can include:
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[post_content] => Four areas to consider when manipulating or repackaging commercial products.
Compounding has been part of the pharmacist’s role since time immemorial. It remains an important part of practice, allowing pharmacists to offer personalised medicines to patients. Compounding ranges from formulating with raw ingredients to reformulating commercial products. It may also be necessary for pharmacists to repackage commercial products to suit a patient’s needs.
The Australian Pharmaceutical Formulary and Handbook (APF) is the primary reference for pharmacists extemporaneously preparing medicines. The most recent edition, APF26 print and updated APF digital, released in February, contains important updates to guidance on compounding formulations and on manipulating or repackaging commercial products. Some of these updates require a practice change, while other aspects of the guidance affirm expectations of practice that are not always upheld, usually inadvertently.
PSA Senior Professional Practice Pharmacist Carolyn Allen MPS says the changes ‘place a major emphasis on quality assurance processes and procedures’.
‘Revision of the APF compounding guidance has involved extensive stakeholder consultation in order to align the APF with other relevant compounding standards and guidelines wherever possible,’ she says. ‘This will provide pharmacists with consistent guidance across all areas of compounding practice.’
Here are four areas to consider.
1. How do you assign expiry dates for repackaged commercial products?
It may be necessary to remove a medicine from its original packaging to meet the needs of a patient, for example when packing a dose administration aid (DAA), or when preparing a staged supply.1
During this process, medicines can be affected by environmental factors, including light, heat and humidity. There is also the potential for physical contamination, such as by dust, skin flakes or pieces of packaging.
Before repackaging a medicine, pharmacists must complete a risk assessment to determine whether it is appropriate and supports the safe and effective use of the product.
The risk assessment should include (but is not limited to) assessing:
Removing a product from its original primary packaging invalidates the expiry date provided by the manufacturer, Ms Allen notes. The repackaged product must be labelled in accordance with legal and professional requirements, including an appropriate expiry date and storage conditions, and a number or code that links the repackaged product with the manufacturer’s batch number.
APF includes new tables with guidance, including recommended maximum expiry dates, for the repackaging of both non-sterile and sterile commercial products.
To determine an appropriate expiry date, pharmacists should consider ‘factors that influence the quality and stability of the product,’ according to the APF. This includes ‘the properties of the active ingredient and dosage form, the storage requirements for the product, the environmental conditions (e.g. heat, humidity, light) during repackaging and storage, and the risk of microbial and other contamination’.
For example, APF specifies that a packed DAA should be assigned a maximum expiry of 8 weeks. In addition, the expiry should be no later than the manufacturer’s original expiry date of any individual medicine in the DAA and no later than the known period of stability of any individual medicine in the DAA (e.g. some brands of levothyroxine can be stored in a DAA for a maximum of 14 days below 25 °C). Medicines that are not stable when removed from the manufacturer’s primary packaging should not be repackaged (e.g. dabigatran capsules).2
Adding flavourings to oral mixtures can make them more palatable, particularly for children. But, adding flavours to commercial products, if not in accordance with the manufacturer’s instructions, is considered compounding.
The APF chapter Good compounding practice sets out the quality assurance requirements that must be followed, including conducting a risk assessment, completing a compounding record form and assigning an appropriate expiry date.
‘Pharmacists need to assure themselves that the flavour is a pharmaceutical grade ingredient and that it will not change the physical, chemical or microbiological stability of the existing formulation,’ Ms Allen says.
‘For example, citrus-based flavours, can change the pH of a formulation that requires a pH>8.’
While the APF advises that it is usually preferable to use pure drug powder as the source of active ingredient, commercial products such as injections, tablets, capsules and creams are sometimes used as ingredients in compounded medicines.
‘This is a manipulation that is not in accordance with the manufacturer’s instructions,’ Ms Allen says. ‘That means this activity must meet the requirements of the APF Good compounding practice chapter.’
For example, when crushing commercial tablets to prepare an oral liquid, a compounding risk assessment must first be performed. The supplied formulation must be recorded in the patient’s medication record and endorsed on the prescription and duplicate (or the electronic prescription administration record). Pharmacists should also consider the impact that crushing a tablet might have on the efficacy of the medicine, for example enteric-coated tablets. ‘The enteric coating on a tablet dissolves in the intestine, rather than the stomach,’ Ms Allen says. ‘This is to prevent the active ingredient from being released into the stomach, where it could be unstable in stomach acid or damage the stomach lining.’ For example, proton pump inhibitors (PPIs) are acid labile, so PPI tablets are enteric coated, she explains.
‘Crushing tablets negates the enteric coating, and consequently the active ingredient may not be effective or may damage the stomach lining if made into an oral liquid.’
Preparing eye drops is considered ‘complex’ compounding and must be done in a sterile environment with the right facilities.
APF includes a dedicated chapter on compounding sterile medicines, with guidance for pharmacists on how to comply with the principles of good manufacturing practice that apply to sterile compounding.
This is particularly important given there have been reports of pharmacists compounding eye drops without the appropriate facilities or equipment for preparing sterile medicines.3
‘Eye drops must be sterile,’ Ms Allen says. ‘The compounding, manipulation or repackaging of eye drops must meet the requirements of the new APF Compounding sterile medicines chapter, to reduce the risk of microbial contamination. For example, diluting eye drops should be performed in a laminar flow cabinet, pharmaceutical isolator or equivalent device with Grade A (ISO class 5) air quality.
‘The compounder must wear appropriate sterile garb and use a validated aseptic technique,’ she says. ‘In addition, the diluent used must maintain the quality, safety and efficacy of the eye drop. An expiry date and in-use expiry should be assigned in accordance with APF expiry date guidance.’
Top tips for the safe and effective manipulation of commercial productsCompiled by Claire Antrobus MPS, PSA’s Manager – Practice Support
4. If the manipulation is not considered to be compounding:
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[post_content] => Mid-winter will be a busy time of year for pharmacists, with a range of practice, fee and career pathway updates kicking off on 1 July 2024.
Australian Pharmacist takes a look at the changes pharmacists will experience from next week.
1. Vaping ban comes into effect
The third tranche of vaping reform included in the Therapeutic Goods and other Legislation (Vaping Reforms) Bill 2024 will see all vape sales banned from general retailers from 1 July. Passing through the Senate this morning, the Bill limits the supply of all vapes strictly to community pharmacies from Monday.
These vaping products must adhere to quality and product standards including:
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[post_content] => Rabies causes an estimated 59,000 deaths annually, with almost half (40%) deaths occurring in children under 15. But underreporting could mean this death rate is much higher.
Post COVID-19, there has been an increase in rabies cases – with the abandonment of pets and a reduction in human-dog interaction leading to heightened aggression in dogs – who are responsible for most human rabies cases. Rabies hotspots include Asia, Africa and India, but 150 countries are considered high-risk rabies territories.
As we approach the winter school holidays and Australians escape the cold by heading overseas, pharmacists in New South Wales can now protect patients against the disease.
PSA advocacy was the key driver for the change to the NSW Pharmacist Vaccination Standards to allow pharmacists to administer the rabies vaccine, with the NSW Branch Committee working closely with the Ministry of Health to drive the change, said PSA NSW State Manager Amanda Fairjones MPS.
[caption id="attachment_25121" align="alignright" width="298"] PSA NSW branch State Manager Amanda Fairjones MPS[/caption]
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for,’ she said. ‘People were asking for it but we were unable to provide it.’
Having the vaccine available provides a great opportunity for pharmacists to sit down and have a chat to people about their travel vaccination needs, said Karen Carter FPS, Partner of Carter's Pharmacy Gunnedah and Owner Narrabri Pharmacy Narrabri in north-west NSW.
‘Because of the regime with some vaccines, we need to have them all done on one day or a week apart,’ she said. ‘ Now we can organise a vaccine regime to be completed at the pharmacy, rather than having to send patients back to their GP for part of it.’
Who is the vaccine indicated for?
Under the NSW Pharmacist Vaccination Standards, pharmacists can administer the rabies vaccine for pre-exposure prophylaxis treatment via intramuscular injection to people 5 years and over who are not immunocompromised.
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for. People were asking for it but we were unable to provide it.'
amanda fairjones MPS
The Australian Immunisation Handbook (AIH), recommends pre-exposure rabies vaccine for:
Karen Carter FPS[/caption]
Post-exposure prophylaxis includes wound management, administration of rabies vaccine doses and human rabies immunoglobulin, taking into account:
If a prescriber writes a prescription for a vaccine – including the rabies vaccine – pharmacists are able to administer it in all states and territories other than Tasmania and South Australia.
However, in the case of the rabies vaccine, in Tasmania, authorised pharmacist immunisers can administer the rabies vaccine when prescribed by a medical or nurse practitioner.
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As winter kicked off, Australia was hit by a massive COVID-19 wave – fuelled by the new Omicron FLiRT subvariant.
There have been 93,049 cases of COVID-19 reported since April 2024. Case numbers are highest among those most at risk, with notifications peaking in the 75–79 (6,655), 80–84 (6,524) and 85+ (12,607) age brackets.
However, with limited testing and reporting COVID-19 cases, this figure does not tell the full story.
‘We’re looking at six to 10 times as many people actually infected as the case numbers are showing,’ said Professor Adrian Esterman, chair of biostatistics and epidemiology at the University of South Australia.
At the same time, reported influenza cases are also increasing. During the first week of June, influenza notifications to the Department of Health increased by 22% to 251 cases. This rise pushed the influenza case numbers above the seasonal threshold for the first time in 2024.
While these respiratory diseases circulate among the community – vaccination rates are waning.
While 2024 influenza vaccination in pharmacies has slightly increased compared to this time last year (87,232 versus 83,326 for the week 9–16 June) – there has been a significant decrease since 2022, when vaccination rates reached a high of 181,202 in the same period.
To boost vaccination rates among older Australians – whether in the community or in residential aged care facilities (RACFs) – three community pharmacists shared their top tips with Australian Pharmacist.
How to overcome vaccination fatigue
According to community pharmacist Yves Cruz, based in the New South Wales South Coast town of Nowra, 2024 has been particularly challenging for COVID-19 vaccine uptake.
‘What I have experienced is that people think 3, 4 or 5 doses is enough for them,’ he said.
However, Mr Cruz thinks leveraging trusting relationships with patients can help to overcome hesitancy.
‘If the people trust their pharmacist, I find they are willing to get the vaccine – even if they have reservations,’ he said.
‘Through communication and providing [evidence-based] information, this can help to remove their doubts.’
Queensland-based pharmacist Alicia Slight has similarly encountered some resistance to COVID-19 boosters, which she promptly addresses with factual information.
‘I use the Australian Technical Advisory Group on Immunisation (ATAGI) table to help navigate the conversation, and also describe [COVID-19 booster doses] as akin to having a yearly flu vaccine,’ she said. ‘I win over [around] three quarters of the fence sitters with a straightforward explanation and by not being too pushy on the matter.’
How to Get involved in outreach programs
As of 13 June 2024, there were 4,147 active COVID-19 cases reported in 487 active outbreaks in RACFs across Australia.
But only 40.3% of those in RACFs had received a COVID-19 booster dose in the last 6 months.
National Immunisation Program vaccines can now be administered off-site in RACFs under NIPVIP. Mark Butler, federal Minister for Health and Aged Care, has strongly advised pharmacists to get involved in these programs.
Since 29 April 2024, pharmacists have also been able to receive funding to deliver National Immunisation Program vaccines to patients in RACFs. From next month (1 July) NIPVIP payments will also be indexed in line with Medicare Benefits Schedule indexation.
‘Community pharmacists play a vital role in our healthcare system – and they will play an even bigger role by administering free, lifesaving vaccines to eligible patients living in aged care homes and disability homes,’ he said.
Pharmacists should also be actively engaged with community outreach as this enhances the uptake of vaccinations, said Dr Brian Chia MPS, community pharmacist, lecturer in Pharmacy and Pharmacology at the University of South Australia and member of the South Australian PSA Early Career working group.
‘This is not limited to COVID-19 or influenza vaccinations, but the scope for many other vaccinations pharmacists can provide,’ he said.
How to promote co-administration
For Mr Chia, promoting co-administration is key to ensuring vulnerable older patients are protected against both influenza and COVID-19 this season.
[caption id="attachment_26579" align="alignright" width="318"] Dr Brian Chia MPS[/caption]
‘Whenever they come in for a COVID-19 vaccine, I usually ask them, “have you had your flu shot?”,’ he said.
‘A lot of patients are not aware that you can actually get the vaccines at the same time, and many of them say “if I can get them together, it will make my life so much more convenient”.’
Mr Cruz takes the opportunity to discuss influenza and COVID-19 vaccines when patients come in for a Shingrix vaccine – which is highly sought after by older Australians in his community.
‘Once we talk about shingles vaccine, we open up about the importance of flu and COVID-19 vaccines,’ he said. ‘Most of the time, this is successful. The majority of our loyal customers aged 65 years and over have received the COVID-19, influenza and shingles vaccines, and now we're starting to give the pneumococcal vaccine.’
How to leverage pharmacy’s accessibility
Community pharmacies are one of the most accessible vaccine providers around. But not all patients are aware of what vaccinations pharmacists can provide, and how simple the process is.
‘I had a patient who came in with a prescription for Boostrix and Vaxigrip Tetra,’ said Mr Chia.
‘I told a patient, “do you know you can actually walk in, we can provide you with these vaccinations? And it doesn't take more than 15 minutes.’
For Ms Slight, offering both appointments and walk-in vaccinations is a key driver for increasing uptake of influenza vaccines.
‘We also offer vaccination to patients when they hand in and pick up prescriptions – providing a constant reminder of our service [leads to] so many happy to get vaccinated then and there,’ she said.
During any vaccination, Ms Slight also shows patients their Australian Immunisation Register to highlight any upcoming or outstanding vaccinations, such as COVID-19, pneumococcal, DTPa or shingles.
‘I then arrange for those vaccinations to be administered – either on the same day or with an appropriate interval – depending on what needs to be done,’ she said. ‘Very rarely do I get resistance to this process.’
[post_title] => Vaccination rates wane as COVID-19 and influenza cases ramp up
[post_excerpt] => Vaccination rates are rapidly slipping in vulnerable older Australians. Three pharmacists share their advice for turning this around.
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[title_attribute] => Vaccination rates wane as COVID-19 and influenza cases ramp up
[title] => Vaccination rates wane as COVID-19 and influenza cases ramp up
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[post_content] => NSW Health has issued an alert following a stream of newborn and infant presentations with symptoms of anticholinergic syndrome.
Colic preparations containing the toxic belladonna plant are the suspected culprit.
Other jurisdictions have reported similar incidents, with Queensland Health also issuing an alert after two infants presented to a Brisbane metropolitan hospital with suspected belladonna toxicity.
So what do pharmacists need to look out for? Australian Pharmacist delves into the signs and symptoms of colic, the recommended treatment options, how anticholinergic syndrome manifests and advice for struggling parents.
How, and when, does colic present?
Colic is defined as repeated, unexplained, inconsolable episodes of crying that persist for more than 3 hours per day, with parents unable to comfort their children.
The crying typically onsets suddenly at a similar time each day – more frequently occurring in the afternoons or evenings.
Other symptoms can include:
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[post_content] => Four areas to consider when manipulating or repackaging commercial products.
Compounding has been part of the pharmacist’s role since time immemorial. It remains an important part of practice, allowing pharmacists to offer personalised medicines to patients. Compounding ranges from formulating with raw ingredients to reformulating commercial products. It may also be necessary for pharmacists to repackage commercial products to suit a patient’s needs.
The Australian Pharmaceutical Formulary and Handbook (APF) is the primary reference for pharmacists extemporaneously preparing medicines. The most recent edition, APF26 print and updated APF digital, released in February, contains important updates to guidance on compounding formulations and on manipulating or repackaging commercial products. Some of these updates require a practice change, while other aspects of the guidance affirm expectations of practice that are not always upheld, usually inadvertently.
PSA Senior Professional Practice Pharmacist Carolyn Allen MPS says the changes ‘place a major emphasis on quality assurance processes and procedures’.
‘Revision of the APF compounding guidance has involved extensive stakeholder consultation in order to align the APF with other relevant compounding standards and guidelines wherever possible,’ she says. ‘This will provide pharmacists with consistent guidance across all areas of compounding practice.’
Here are four areas to consider.
1. How do you assign expiry dates for repackaged commercial products?
It may be necessary to remove a medicine from its original packaging to meet the needs of a patient, for example when packing a dose administration aid (DAA), or when preparing a staged supply.1
During this process, medicines can be affected by environmental factors, including light, heat and humidity. There is also the potential for physical contamination, such as by dust, skin flakes or pieces of packaging.
Before repackaging a medicine, pharmacists must complete a risk assessment to determine whether it is appropriate and supports the safe and effective use of the product.
The risk assessment should include (but is not limited to) assessing:
Removing a product from its original primary packaging invalidates the expiry date provided by the manufacturer, Ms Allen notes. The repackaged product must be labelled in accordance with legal and professional requirements, including an appropriate expiry date and storage conditions, and a number or code that links the repackaged product with the manufacturer’s batch number.
APF includes new tables with guidance, including recommended maximum expiry dates, for the repackaging of both non-sterile and sterile commercial products.
To determine an appropriate expiry date, pharmacists should consider ‘factors that influence the quality and stability of the product,’ according to the APF. This includes ‘the properties of the active ingredient and dosage form, the storage requirements for the product, the environmental conditions (e.g. heat, humidity, light) during repackaging and storage, and the risk of microbial and other contamination’.
For example, APF specifies that a packed DAA should be assigned a maximum expiry of 8 weeks. In addition, the expiry should be no later than the manufacturer’s original expiry date of any individual medicine in the DAA and no later than the known period of stability of any individual medicine in the DAA (e.g. some brands of levothyroxine can be stored in a DAA for a maximum of 14 days below 25 °C). Medicines that are not stable when removed from the manufacturer’s primary packaging should not be repackaged (e.g. dabigatran capsules).2
Adding flavourings to oral mixtures can make them more palatable, particularly for children. But, adding flavours to commercial products, if not in accordance with the manufacturer’s instructions, is considered compounding.
The APF chapter Good compounding practice sets out the quality assurance requirements that must be followed, including conducting a risk assessment, completing a compounding record form and assigning an appropriate expiry date.
‘Pharmacists need to assure themselves that the flavour is a pharmaceutical grade ingredient and that it will not change the physical, chemical or microbiological stability of the existing formulation,’ Ms Allen says.
‘For example, citrus-based flavours, can change the pH of a formulation that requires a pH>8.’
While the APF advises that it is usually preferable to use pure drug powder as the source of active ingredient, commercial products such as injections, tablets, capsules and creams are sometimes used as ingredients in compounded medicines.
‘This is a manipulation that is not in accordance with the manufacturer’s instructions,’ Ms Allen says. ‘That means this activity must meet the requirements of the APF Good compounding practice chapter.’
For example, when crushing commercial tablets to prepare an oral liquid, a compounding risk assessment must first be performed. The supplied formulation must be recorded in the patient’s medication record and endorsed on the prescription and duplicate (or the electronic prescription administration record). Pharmacists should also consider the impact that crushing a tablet might have on the efficacy of the medicine, for example enteric-coated tablets. ‘The enteric coating on a tablet dissolves in the intestine, rather than the stomach,’ Ms Allen says. ‘This is to prevent the active ingredient from being released into the stomach, where it could be unstable in stomach acid or damage the stomach lining.’ For example, proton pump inhibitors (PPIs) are acid labile, so PPI tablets are enteric coated, she explains.
‘Crushing tablets negates the enteric coating, and consequently the active ingredient may not be effective or may damage the stomach lining if made into an oral liquid.’
Preparing eye drops is considered ‘complex’ compounding and must be done in a sterile environment with the right facilities.
APF includes a dedicated chapter on compounding sterile medicines, with guidance for pharmacists on how to comply with the principles of good manufacturing practice that apply to sterile compounding.
This is particularly important given there have been reports of pharmacists compounding eye drops without the appropriate facilities or equipment for preparing sterile medicines.3
‘Eye drops must be sterile,’ Ms Allen says. ‘The compounding, manipulation or repackaging of eye drops must meet the requirements of the new APF Compounding sterile medicines chapter, to reduce the risk of microbial contamination. For example, diluting eye drops should be performed in a laminar flow cabinet, pharmaceutical isolator or equivalent device with Grade A (ISO class 5) air quality.
‘The compounder must wear appropriate sterile garb and use a validated aseptic technique,’ she says. ‘In addition, the diluent used must maintain the quality, safety and efficacy of the eye drop. An expiry date and in-use expiry should be assigned in accordance with APF expiry date guidance.’
Top tips for the safe and effective manipulation of commercial productsCompiled by Claire Antrobus MPS, PSA’s Manager – Practice Support
4. If the manipulation is not considered to be compounding:
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[post_content] => Mid-winter will be a busy time of year for pharmacists, with a range of practice, fee and career pathway updates kicking off on 1 July 2024.
Australian Pharmacist takes a look at the changes pharmacists will experience from next week.
1. Vaping ban comes into effect
The third tranche of vaping reform included in the Therapeutic Goods and other Legislation (Vaping Reforms) Bill 2024 will see all vape sales banned from general retailers from 1 July. Passing through the Senate this morning, the Bill limits the supply of all vapes strictly to community pharmacies from Monday.
These vaping products must adhere to quality and product standards including:
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[post_content] => Rabies causes an estimated 59,000 deaths annually, with almost half (40%) deaths occurring in children under 15. But underreporting could mean this death rate is much higher.
Post COVID-19, there has been an increase in rabies cases – with the abandonment of pets and a reduction in human-dog interaction leading to heightened aggression in dogs – who are responsible for most human rabies cases. Rabies hotspots include Asia, Africa and India, but 150 countries are considered high-risk rabies territories.
As we approach the winter school holidays and Australians escape the cold by heading overseas, pharmacists in New South Wales can now protect patients against the disease.
PSA advocacy was the key driver for the change to the NSW Pharmacist Vaccination Standards to allow pharmacists to administer the rabies vaccine, with the NSW Branch Committee working closely with the Ministry of Health to drive the change, said PSA NSW State Manager Amanda Fairjones MPS.
[caption id="attachment_25121" align="alignright" width="298"] PSA NSW branch State Manager Amanda Fairjones MPS[/caption]
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for,’ she said. ‘People were asking for it but we were unable to provide it.’
Having the vaccine available provides a great opportunity for pharmacists to sit down and have a chat to people about their travel vaccination needs, said Karen Carter FPS, Partner of Carter's Pharmacy Gunnedah and Owner Narrabri Pharmacy Narrabri in north-west NSW.
‘Because of the regime with some vaccines, we need to have them all done on one day or a week apart,’ she said. ‘ Now we can organise a vaccine regime to be completed at the pharmacy, rather than having to send patients back to their GP for part of it.’
Who is the vaccine indicated for?
Under the NSW Pharmacist Vaccination Standards, pharmacists can administer the rabies vaccine for pre-exposure prophylaxis treatment via intramuscular injection to people 5 years and over who are not immunocompromised.
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for. People were asking for it but we were unable to provide it.'
amanda fairjones MPS
The Australian Immunisation Handbook (AIH), recommends pre-exposure rabies vaccine for:
Karen Carter FPS[/caption]
Post-exposure prophylaxis includes wound management, administration of rabies vaccine doses and human rabies immunoglobulin, taking into account:
If a prescriber writes a prescription for a vaccine – including the rabies vaccine – pharmacists are able to administer it in all states and territories other than Tasmania and South Australia.
However, in the case of the rabies vaccine, in Tasmania, authorised pharmacist immunisers can administer the rabies vaccine when prescribed by a medical or nurse practitioner.
[post_title] => Some pharmacists can now protect travellers against rabies [post_excerpt] => With rabies cases increasing worldwide, patients in this jurisdiction can now receive prophylactic protection before they head off overseas. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => regulation-change-allows-some-pharmacists-to-protect-travellers-against-rabies [to_ping] => [pinged] => [post_modified] => 2024-06-24 15:09:43 [post_modified_gmt] => 2024-06-24 05:09:43 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.australianpharmacist.com.au/?p=26595 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [title_attribute] => Some pharmacists can now protect travellers against rabies [title] => Some pharmacists can now protect travellers against rabies [href] => https://www.australianpharmacist.com.au/regulation-change-allows-some-pharmacists-to-protect-travellers-against-rabies/ [module_atts:td_module:private] => Array ( ) [td_review:protected] => Array ( ) [is_review:protected] => [post_thumb_id:protected] => 26604 )td_module_mega_menu Object
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As winter kicked off, Australia was hit by a massive COVID-19 wave – fuelled by the new Omicron FLiRT subvariant.
There have been 93,049 cases of COVID-19 reported since April 2024. Case numbers are highest among those most at risk, with notifications peaking in the 75–79 (6,655), 80–84 (6,524) and 85+ (12,607) age brackets.
However, with limited testing and reporting COVID-19 cases, this figure does not tell the full story.
‘We’re looking at six to 10 times as many people actually infected as the case numbers are showing,’ said Professor Adrian Esterman, chair of biostatistics and epidemiology at the University of South Australia.
At the same time, reported influenza cases are also increasing. During the first week of June, influenza notifications to the Department of Health increased by 22% to 251 cases. This rise pushed the influenza case numbers above the seasonal threshold for the first time in 2024.
While these respiratory diseases circulate among the community – vaccination rates are waning.
While 2024 influenza vaccination in pharmacies has slightly increased compared to this time last year (87,232 versus 83,326 for the week 9–16 June) – there has been a significant decrease since 2022, when vaccination rates reached a high of 181,202 in the same period.
To boost vaccination rates among older Australians – whether in the community or in residential aged care facilities (RACFs) – three community pharmacists shared their top tips with Australian Pharmacist.
How to overcome vaccination fatigue
According to community pharmacist Yves Cruz, based in the New South Wales South Coast town of Nowra, 2024 has been particularly challenging for COVID-19 vaccine uptake.
‘What I have experienced is that people think 3, 4 or 5 doses is enough for them,’ he said.
However, Mr Cruz thinks leveraging trusting relationships with patients can help to overcome hesitancy.
‘If the people trust their pharmacist, I find they are willing to get the vaccine – even if they have reservations,’ he said.
‘Through communication and providing [evidence-based] information, this can help to remove their doubts.’
Queensland-based pharmacist Alicia Slight has similarly encountered some resistance to COVID-19 boosters, which she promptly addresses with factual information.
‘I use the Australian Technical Advisory Group on Immunisation (ATAGI) table to help navigate the conversation, and also describe [COVID-19 booster doses] as akin to having a yearly flu vaccine,’ she said. ‘I win over [around] three quarters of the fence sitters with a straightforward explanation and by not being too pushy on the matter.’
How to Get involved in outreach programs
As of 13 June 2024, there were 4,147 active COVID-19 cases reported in 487 active outbreaks in RACFs across Australia.
But only 40.3% of those in RACFs had received a COVID-19 booster dose in the last 6 months.
National Immunisation Program vaccines can now be administered off-site in RACFs under NIPVIP. Mark Butler, federal Minister for Health and Aged Care, has strongly advised pharmacists to get involved in these programs.
Since 29 April 2024, pharmacists have also been able to receive funding to deliver National Immunisation Program vaccines to patients in RACFs. From next month (1 July) NIPVIP payments will also be indexed in line with Medicare Benefits Schedule indexation.
‘Community pharmacists play a vital role in our healthcare system – and they will play an even bigger role by administering free, lifesaving vaccines to eligible patients living in aged care homes and disability homes,’ he said.
Pharmacists should also be actively engaged with community outreach as this enhances the uptake of vaccinations, said Dr Brian Chia MPS, community pharmacist, lecturer in Pharmacy and Pharmacology at the University of South Australia and member of the South Australian PSA Early Career working group.
‘This is not limited to COVID-19 or influenza vaccinations, but the scope for many other vaccinations pharmacists can provide,’ he said.
How to promote co-administration
For Mr Chia, promoting co-administration is key to ensuring vulnerable older patients are protected against both influenza and COVID-19 this season.
[caption id="attachment_26579" align="alignright" width="318"] Dr Brian Chia MPS[/caption]
‘Whenever they come in for a COVID-19 vaccine, I usually ask them, “have you had your flu shot?”,’ he said.
‘A lot of patients are not aware that you can actually get the vaccines at the same time, and many of them say “if I can get them together, it will make my life so much more convenient”.’
Mr Cruz takes the opportunity to discuss influenza and COVID-19 vaccines when patients come in for a Shingrix vaccine – which is highly sought after by older Australians in his community.
‘Once we talk about shingles vaccine, we open up about the importance of flu and COVID-19 vaccines,’ he said. ‘Most of the time, this is successful. The majority of our loyal customers aged 65 years and over have received the COVID-19, influenza and shingles vaccines, and now we're starting to give the pneumococcal vaccine.’
How to leverage pharmacy’s accessibility
Community pharmacies are one of the most accessible vaccine providers around. But not all patients are aware of what vaccinations pharmacists can provide, and how simple the process is.
‘I had a patient who came in with a prescription for Boostrix and Vaxigrip Tetra,’ said Mr Chia.
‘I told a patient, “do you know you can actually walk in, we can provide you with these vaccinations? And it doesn't take more than 15 minutes.’
For Ms Slight, offering both appointments and walk-in vaccinations is a key driver for increasing uptake of influenza vaccines.
‘We also offer vaccination to patients when they hand in and pick up prescriptions – providing a constant reminder of our service [leads to] so many happy to get vaccinated then and there,’ she said.
During any vaccination, Ms Slight also shows patients their Australian Immunisation Register to highlight any upcoming or outstanding vaccinations, such as COVID-19, pneumococcal, DTPa or shingles.
‘I then arrange for those vaccinations to be administered – either on the same day or with an appropriate interval – depending on what needs to be done,’ she said. ‘Very rarely do I get resistance to this process.’
[post_title] => Vaccination rates wane as COVID-19 and influenza cases ramp up
[post_excerpt] => Vaccination rates are rapidly slipping in vulnerable older Australians. Three pharmacists share their advice for turning this around.
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[title_attribute] => Vaccination rates wane as COVID-19 and influenza cases ramp up
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[post_content] => NSW Health has issued an alert following a stream of newborn and infant presentations with symptoms of anticholinergic syndrome.
Colic preparations containing the toxic belladonna plant are the suspected culprit.
Other jurisdictions have reported similar incidents, with Queensland Health also issuing an alert after two infants presented to a Brisbane metropolitan hospital with suspected belladonna toxicity.
So what do pharmacists need to look out for? Australian Pharmacist delves into the signs and symptoms of colic, the recommended treatment options, how anticholinergic syndrome manifests and advice for struggling parents.
How, and when, does colic present?
Colic is defined as repeated, unexplained, inconsolable episodes of crying that persist for more than 3 hours per day, with parents unable to comfort their children.
The crying typically onsets suddenly at a similar time each day – more frequently occurring in the afternoons or evenings.
Other symptoms can include:
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[post_content] => Four areas to consider when manipulating or repackaging commercial products.
Compounding has been part of the pharmacist’s role since time immemorial. It remains an important part of practice, allowing pharmacists to offer personalised medicines to patients. Compounding ranges from formulating with raw ingredients to reformulating commercial products. It may also be necessary for pharmacists to repackage commercial products to suit a patient’s needs.
The Australian Pharmaceutical Formulary and Handbook (APF) is the primary reference for pharmacists extemporaneously preparing medicines. The most recent edition, APF26 print and updated APF digital, released in February, contains important updates to guidance on compounding formulations and on manipulating or repackaging commercial products. Some of these updates require a practice change, while other aspects of the guidance affirm expectations of practice that are not always upheld, usually inadvertently.
PSA Senior Professional Practice Pharmacist Carolyn Allen MPS says the changes ‘place a major emphasis on quality assurance processes and procedures’.
‘Revision of the APF compounding guidance has involved extensive stakeholder consultation in order to align the APF with other relevant compounding standards and guidelines wherever possible,’ she says. ‘This will provide pharmacists with consistent guidance across all areas of compounding practice.’
Here are four areas to consider.
1. How do you assign expiry dates for repackaged commercial products?
It may be necessary to remove a medicine from its original packaging to meet the needs of a patient, for example when packing a dose administration aid (DAA), or when preparing a staged supply.1
During this process, medicines can be affected by environmental factors, including light, heat and humidity. There is also the potential for physical contamination, such as by dust, skin flakes or pieces of packaging.
Before repackaging a medicine, pharmacists must complete a risk assessment to determine whether it is appropriate and supports the safe and effective use of the product.
The risk assessment should include (but is not limited to) assessing:
Removing a product from its original primary packaging invalidates the expiry date provided by the manufacturer, Ms Allen notes. The repackaged product must be labelled in accordance with legal and professional requirements, including an appropriate expiry date and storage conditions, and a number or code that links the repackaged product with the manufacturer’s batch number.
APF includes new tables with guidance, including recommended maximum expiry dates, for the repackaging of both non-sterile and sterile commercial products.
To determine an appropriate expiry date, pharmacists should consider ‘factors that influence the quality and stability of the product,’ according to the APF. This includes ‘the properties of the active ingredient and dosage form, the storage requirements for the product, the environmental conditions (e.g. heat, humidity, light) during repackaging and storage, and the risk of microbial and other contamination’.
For example, APF specifies that a packed DAA should be assigned a maximum expiry of 8 weeks. In addition, the expiry should be no later than the manufacturer’s original expiry date of any individual medicine in the DAA and no later than the known period of stability of any individual medicine in the DAA (e.g. some brands of levothyroxine can be stored in a DAA for a maximum of 14 days below 25 °C). Medicines that are not stable when removed from the manufacturer’s primary packaging should not be repackaged (e.g. dabigatran capsules).2
Adding flavourings to oral mixtures can make them more palatable, particularly for children. But, adding flavours to commercial products, if not in accordance with the manufacturer’s instructions, is considered compounding.
The APF chapter Good compounding practice sets out the quality assurance requirements that must be followed, including conducting a risk assessment, completing a compounding record form and assigning an appropriate expiry date.
‘Pharmacists need to assure themselves that the flavour is a pharmaceutical grade ingredient and that it will not change the physical, chemical or microbiological stability of the existing formulation,’ Ms Allen says.
‘For example, citrus-based flavours, can change the pH of a formulation that requires a pH>8.’
While the APF advises that it is usually preferable to use pure drug powder as the source of active ingredient, commercial products such as injections, tablets, capsules and creams are sometimes used as ingredients in compounded medicines.
‘This is a manipulation that is not in accordance with the manufacturer’s instructions,’ Ms Allen says. ‘That means this activity must meet the requirements of the APF Good compounding practice chapter.’
For example, when crushing commercial tablets to prepare an oral liquid, a compounding risk assessment must first be performed. The supplied formulation must be recorded in the patient’s medication record and endorsed on the prescription and duplicate (or the electronic prescription administration record). Pharmacists should also consider the impact that crushing a tablet might have on the efficacy of the medicine, for example enteric-coated tablets. ‘The enteric coating on a tablet dissolves in the intestine, rather than the stomach,’ Ms Allen says. ‘This is to prevent the active ingredient from being released into the stomach, where it could be unstable in stomach acid or damage the stomach lining.’ For example, proton pump inhibitors (PPIs) are acid labile, so PPI tablets are enteric coated, she explains.
‘Crushing tablets negates the enteric coating, and consequently the active ingredient may not be effective or may damage the stomach lining if made into an oral liquid.’
Preparing eye drops is considered ‘complex’ compounding and must be done in a sterile environment with the right facilities.
APF includes a dedicated chapter on compounding sterile medicines, with guidance for pharmacists on how to comply with the principles of good manufacturing practice that apply to sterile compounding.
This is particularly important given there have been reports of pharmacists compounding eye drops without the appropriate facilities or equipment for preparing sterile medicines.3
‘Eye drops must be sterile,’ Ms Allen says. ‘The compounding, manipulation or repackaging of eye drops must meet the requirements of the new APF Compounding sterile medicines chapter, to reduce the risk of microbial contamination. For example, diluting eye drops should be performed in a laminar flow cabinet, pharmaceutical isolator or equivalent device with Grade A (ISO class 5) air quality.
‘The compounder must wear appropriate sterile garb and use a validated aseptic technique,’ she says. ‘In addition, the diluent used must maintain the quality, safety and efficacy of the eye drop. An expiry date and in-use expiry should be assigned in accordance with APF expiry date guidance.’
Top tips for the safe and effective manipulation of commercial productsCompiled by Claire Antrobus MPS, PSA’s Manager – Practice Support
4. If the manipulation is not considered to be compounding:
|
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[post_content] => Mid-winter will be a busy time of year for pharmacists, with a range of practice, fee and career pathway updates kicking off on 1 July 2024.
Australian Pharmacist takes a look at the changes pharmacists will experience from next week.
1. Vaping ban comes into effect
The third tranche of vaping reform included in the Therapeutic Goods and other Legislation (Vaping Reforms) Bill 2024 will see all vape sales banned from general retailers from 1 July. Passing through the Senate this morning, the Bill limits the supply of all vapes strictly to community pharmacies from Monday.
These vaping products must adhere to quality and product standards including:
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[post_content] => Rabies causes an estimated 59,000 deaths annually, with almost half (40%) deaths occurring in children under 15. But underreporting could mean this death rate is much higher.
Post COVID-19, there has been an increase in rabies cases – with the abandonment of pets and a reduction in human-dog interaction leading to heightened aggression in dogs – who are responsible for most human rabies cases. Rabies hotspots include Asia, Africa and India, but 150 countries are considered high-risk rabies territories.
As we approach the winter school holidays and Australians escape the cold by heading overseas, pharmacists in New South Wales can now protect patients against the disease.
PSA advocacy was the key driver for the change to the NSW Pharmacist Vaccination Standards to allow pharmacists to administer the rabies vaccine, with the NSW Branch Committee working closely with the Ministry of Health to drive the change, said PSA NSW State Manager Amanda Fairjones MPS.
[caption id="attachment_25121" align="alignright" width="298"] PSA NSW branch State Manager Amanda Fairjones MPS[/caption]
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for,’ she said. ‘People were asking for it but we were unable to provide it.’
Having the vaccine available provides a great opportunity for pharmacists to sit down and have a chat to people about their travel vaccination needs, said Karen Carter FPS, Partner of Carter's Pharmacy Gunnedah and Owner Narrabri Pharmacy Narrabri in north-west NSW.
‘Because of the regime with some vaccines, we need to have them all done on one day or a week apart,’ she said. ‘ Now we can organise a vaccine regime to be completed at the pharmacy, rather than having to send patients back to their GP for part of it.’
Who is the vaccine indicated for?
Under the NSW Pharmacist Vaccination Standards, pharmacists can administer the rabies vaccine for pre-exposure prophylaxis treatment via intramuscular injection to people 5 years and over who are not immunocompromised.
‘When undertaking travel health consultations, our members told us that it was the most common travel vaccine they were referring people back to their GP for. People were asking for it but we were unable to provide it.'
amanda fairjones MPS
The Australian Immunisation Handbook (AIH), recommends pre-exposure rabies vaccine for:
Karen Carter FPS[/caption]
Post-exposure prophylaxis includes wound management, administration of rabies vaccine doses and human rabies immunoglobulin, taking into account:
If a prescriber writes a prescription for a vaccine – including the rabies vaccine – pharmacists are able to administer it in all states and territories other than Tasmania and South Australia.
However, in the case of the rabies vaccine, in Tasmania, authorised pharmacist immunisers can administer the rabies vaccine when prescribed by a medical or nurse practitioner.
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As winter kicked off, Australia was hit by a massive COVID-19 wave – fuelled by the new Omicron FLiRT subvariant.
There have been 93,049 cases of COVID-19 reported since April 2024. Case numbers are highest among those most at risk, with notifications peaking in the 75–79 (6,655), 80–84 (6,524) and 85+ (12,607) age brackets.
However, with limited testing and reporting COVID-19 cases, this figure does not tell the full story.
‘We’re looking at six to 10 times as many people actually infected as the case numbers are showing,’ said Professor Adrian Esterman, chair of biostatistics and epidemiology at the University of South Australia.
At the same time, reported influenza cases are also increasing. During the first week of June, influenza notifications to the Department of Health increased by 22% to 251 cases. This rise pushed the influenza case numbers above the seasonal threshold for the first time in 2024.
While these respiratory diseases circulate among the community – vaccination rates are waning.
While 2024 influenza vaccination in pharmacies has slightly increased compared to this time last year (87,232 versus 83,326 for the week 9–16 June) – there has been a significant decrease since 2022, when vaccination rates reached a high of 181,202 in the same period.
To boost vaccination rates among older Australians – whether in the community or in residential aged care facilities (RACFs) – three community pharmacists shared their top tips with Australian Pharmacist.
How to overcome vaccination fatigue
According to community pharmacist Yves Cruz, based in the New South Wales South Coast town of Nowra, 2024 has been particularly challenging for COVID-19 vaccine uptake.
‘What I have experienced is that people think 3, 4 or 5 doses is enough for them,’ he said.
However, Mr Cruz thinks leveraging trusting relationships with patients can help to overcome hesitancy.
‘If the people trust their pharmacist, I find they are willing to get the vaccine – even if they have reservations,’ he said.
‘Through communication and providing [evidence-based] information, this can help to remove their doubts.’
Queensland-based pharmacist Alicia Slight has similarly encountered some resistance to COVID-19 boosters, which she promptly addresses with factual information.
‘I use the Australian Technical Advisory Group on Immunisation (ATAGI) table to help navigate the conversation, and also describe [COVID-19 booster doses] as akin to having a yearly flu vaccine,’ she said. ‘I win over [around] three quarters of the fence sitters with a straightforward explanation and by not being too pushy on the matter.’
How to Get involved in outreach programs
As of 13 June 2024, there were 4,147 active COVID-19 cases reported in 487 active outbreaks in RACFs across Australia.
But only 40.3% of those in RACFs had received a COVID-19 booster dose in the last 6 months.
National Immunisation Program vaccines can now be administered off-site in RACFs under NIPVIP. Mark Butler, federal Minister for Health and Aged Care, has strongly advised pharmacists to get involved in these programs.
Since 29 April 2024, pharmacists have also been able to receive funding to deliver National Immunisation Program vaccines to patients in RACFs. From next month (1 July) NIPVIP payments will also be indexed in line with Medicare Benefits Schedule indexation.
‘Community pharmacists play a vital role in our healthcare system – and they will play an even bigger role by administering free, lifesaving vaccines to eligible patients living in aged care homes and disability homes,’ he said.
Pharmacists should also be actively engaged with community outreach as this enhances the uptake of vaccinations, said Dr Brian Chia MPS, community pharmacist, lecturer in Pharmacy and Pharmacology at the University of South Australia and member of the South Australian PSA Early Career working group.
‘This is not limited to COVID-19 or influenza vaccinations, but the scope for many other vaccinations pharmacists can provide,’ he said.
How to promote co-administration
For Mr Chia, promoting co-administration is key to ensuring vulnerable older patients are protected against both influenza and COVID-19 this season.
[caption id="attachment_26579" align="alignright" width="318"] Dr Brian Chia MPS[/caption]
‘Whenever they come in for a COVID-19 vaccine, I usually ask them, “have you had your flu shot?”,’ he said.
‘A lot of patients are not aware that you can actually get the vaccines at the same time, and many of them say “if I can get them together, it will make my life so much more convenient”.’
Mr Cruz takes the opportunity to discuss influenza and COVID-19 vaccines when patients come in for a Shingrix vaccine – which is highly sought after by older Australians in his community.
‘Once we talk about shingles vaccine, we open up about the importance of flu and COVID-19 vaccines,’ he said. ‘Most of the time, this is successful. The majority of our loyal customers aged 65 years and over have received the COVID-19, influenza and shingles vaccines, and now we're starting to give the pneumococcal vaccine.’
How to leverage pharmacy’s accessibility
Community pharmacies are one of the most accessible vaccine providers around. But not all patients are aware of what vaccinations pharmacists can provide, and how simple the process is.
‘I had a patient who came in with a prescription for Boostrix and Vaxigrip Tetra,’ said Mr Chia.
‘I told a patient, “do you know you can actually walk in, we can provide you with these vaccinations? And it doesn't take more than 15 minutes.’
For Ms Slight, offering both appointments and walk-in vaccinations is a key driver for increasing uptake of influenza vaccines.
‘We also offer vaccination to patients when they hand in and pick up prescriptions – providing a constant reminder of our service [leads to] so many happy to get vaccinated then and there,’ she said.
During any vaccination, Ms Slight also shows patients their Australian Immunisation Register to highlight any upcoming or outstanding vaccinations, such as COVID-19, pneumococcal, DTPa or shingles.
‘I then arrange for those vaccinations to be administered – either on the same day or with an appropriate interval – depending on what needs to be done,’ she said. ‘Very rarely do I get resistance to this process.’
[post_title] => Vaccination rates wane as COVID-19 and influenza cases ramp up
[post_excerpt] => Vaccination rates are rapidly slipping in vulnerable older Australians. Three pharmacists share their advice for turning this around.
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[post_content] => NSW Health has issued an alert following a stream of newborn and infant presentations with symptoms of anticholinergic syndrome.
Colic preparations containing the toxic belladonna plant are the suspected culprit.
Other jurisdictions have reported similar incidents, with Queensland Health also issuing an alert after two infants presented to a Brisbane metropolitan hospital with suspected belladonna toxicity.
So what do pharmacists need to look out for? Australian Pharmacist delves into the signs and symptoms of colic, the recommended treatment options, how anticholinergic syndrome manifests and advice for struggling parents.
How, and when, does colic present?
Colic is defined as repeated, unexplained, inconsolable episodes of crying that persist for more than 3 hours per day, with parents unable to comfort their children.
The crying typically onsets suddenly at a similar time each day – more frequently occurring in the afternoons or evenings.
Other symptoms can include:
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[post_content] => Four areas to consider when manipulating or repackaging commercial products.
Compounding has been part of the pharmacist’s role since time immemorial. It remains an important part of practice, allowing pharmacists to offer personalised medicines to patients. Compounding ranges from formulating with raw ingredients to reformulating commercial products. It may also be necessary for pharmacists to repackage commercial products to suit a patient’s needs.
The Australian Pharmaceutical Formulary and Handbook (APF) is the primary reference for pharmacists extemporaneously preparing medicines. The most recent edition, APF26 print and updated APF digital, released in February, contains important updates to guidance on compounding formulations and on manipulating or repackaging commercial products. Some of these updates require a practice change, while other aspects of the guidance affirm expectations of practice that are not always upheld, usually inadvertently.
PSA Senior Professional Practice Pharmacist Carolyn Allen MPS says the changes ‘place a major emphasis on quality assurance processes and procedures’.
‘Revision of the APF compounding guidance has involved extensive stakeholder consultation in order to align the APF with other relevant compounding standards and guidelines wherever possible,’ she says. ‘This will provide pharmacists with consistent guidance across all areas of compounding practice.’
Here are four areas to consider.
1. How do you assign expiry dates for repackaged commercial products?
It may be necessary to remove a medicine from its original packaging to meet the needs of a patient, for example when packing a dose administration aid (DAA), or when preparing a staged supply.1
During this process, medicines can be affected by environmental factors, including light, heat and humidity. There is also the potential for physical contamination, such as by dust, skin flakes or pieces of packaging.
Before repackaging a medicine, pharmacists must complete a risk assessment to determine whether it is appropriate and supports the safe and effective use of the product.
The risk assessment should include (but is not limited to) assessing:
Removing a product from its original primary packaging invalidates the expiry date provided by the manufacturer, Ms Allen notes. The repackaged product must be labelled in accordance with legal and professional requirements, including an appropriate expiry date and storage conditions, and a number or code that links the repackaged product with the manufacturer’s batch number.
APF includes new tables with guidance, including recommended maximum expiry dates, for the repackaging of both non-sterile and sterile commercial products.
To determine an appropriate expiry date, pharmacists should consider ‘factors that influence the quality and stability of the product,’ according to the APF. This includes ‘the properties of the active ingredient and dosage form, the storage requirements for the product, the environmental conditions (e.g. heat, humidity, light) during repackaging and storage, and the risk of microbial and other contamination’.
For example, APF specifies that a packed DAA should be assigned a maximum expiry of 8 weeks. In addition, the expiry should be no later than the manufacturer’s original expiry date of any individual medicine in the DAA and no later than the known period of stability of any individual medicine in the DAA (e.g. some brands of levothyroxine can be stored in a DAA for a maximum of 14 days below 25 °C). Medicines that are not stable when removed from the manufacturer’s primary packaging should not be repackaged (e.g. dabigatran capsules).2
Adding flavourings to oral mixtures can make them more palatable, particularly for children. But, adding flavours to commercial products, if not in accordance with the manufacturer’s instructions, is considered compounding.
The APF chapter Good compounding practice sets out the quality assurance requirements that must be followed, including conducting a risk assessment, completing a compounding record form and assigning an appropriate expiry date.
‘Pharmacists need to assure themselves that the flavour is a pharmaceutical grade ingredient and that it will not change the physical, chemical or microbiological stability of the existing formulation,’ Ms Allen says.
‘For example, citrus-based flavours, can change the pH of a formulation that requires a pH>8.’
While the APF advises that it is usually preferable to use pure drug powder as the source of active ingredient, commercial products such as injections, tablets, capsules and creams are sometimes used as ingredients in compounded medicines.
‘This is a manipulation that is not in accordance with the manufacturer’s instructions,’ Ms Allen says. ‘That means this activity must meet the requirements of the APF Good compounding practice chapter.’
For example, when crushing commercial tablets to prepare an oral liquid, a compounding risk assessment must first be performed. The supplied formulation must be recorded in the patient’s medication record and endorsed on the prescription and duplicate (or the electronic prescription administration record). Pharmacists should also consider the impact that crushing a tablet might have on the efficacy of the medicine, for example enteric-coated tablets. ‘The enteric coating on a tablet dissolves in the intestine, rather than the stomach,’ Ms Allen says. ‘This is to prevent the active ingredient from being released into the stomach, where it could be unstable in stomach acid or damage the stomach lining.’ For example, proton pump inhibitors (PPIs) are acid labile, so PPI tablets are enteric coated, she explains.
‘Crushing tablets negates the enteric coating, and consequently the active ingredient may not be effective or may damage the stomach lining if made into an oral liquid.’
Preparing eye drops is considered ‘complex’ compounding and must be done in a sterile environment with the right facilities.
APF includes a dedicated chapter on compounding sterile medicines, with guidance for pharmacists on how to comply with the principles of good manufacturing practice that apply to sterile compounding.
This is particularly important given there have been reports of pharmacists compounding eye drops without the appropriate facilities or equipment for preparing sterile medicines.3
‘Eye drops must be sterile,’ Ms Allen says. ‘The compounding, manipulation or repackaging of eye drops must meet the requirements of the new APF Compounding sterile medicines chapter, to reduce the risk of microbial contamination. For example, diluting eye drops should be performed in a laminar flow cabinet, pharmaceutical isolator or equivalent device with Grade A (ISO class 5) air quality.
‘The compounder must wear appropriate sterile garb and use a validated aseptic technique,’ she says. ‘In addition, the diluent used must maintain the quality, safety and efficacy of the eye drop. An expiry date and in-use expiry should be assigned in accordance with APF expiry date guidance.’
Top tips for the safe and effective manipulation of commercial productsCompiled by Claire Antrobus MPS, PSA’s Manager – Practice Support
4. If the manipulation is not considered to be compounding:
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
