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[post_content] => The popular weight-loss drug has been approved to treat cardiovascular disease in patients who are overweight or obese.
The Therapeutic Goods Administration (TGA) approval is based on results from the SELECT double-blind, randomised, placebo-controlled trial – a global study conducted in 41 countries, including Australia, with over 17,000 participants.
Australian Pharmacist spoke with Professor Stephen Nicholls, lead of the Australian arm of the SELECT trial, about the significance of this new indication and what pharmacists need to know.
What impact does a Wegovy have on cardiovascular risk?
It has been well known for many years that being overweight or obese is a major risk factor for heart disease, said Prof Nicholls.
[caption id="attachment_28714" align="alignnone" width="700"]
Professor Stephen Nicholls[/caption]
‘And in people who have had a heart attack, the presence of overweight or obesity is associated with a worse risk of having another event – but there's nothing specifically that we've been able to do for these people.’
For decades, clinical trials for weight loss drugs have shown no benefit in reducing cardiovascular risk in these patients.
‘But here you have a trial where we specifically targeted people who were overweight, and it reduced their risk,’ he said.
Participants in the SELECT trial had cardiovascular disease, overweight or obesity, but without diabetes, said Professor Stephen Nicholls.
‘The trial found that giving them semaglutide reduced their risk of having another event by 20%,’ he said. ‘That's a game changer – both for the drug and the field.’
What makes a patient eligible for Wegovy for cardiovascular disease?
The new TGA indication for Wegovy is as a complementary therapy for reducing major adverse cardiovascular events such as cardiovascular death, heart attack, or non-fatal stroke in adults with:
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[post_content] => Checking a patient's photo identification (ID) can be both a useful – and mandatory – practice.
Australian Pharmacist explores the instances where minimum practice and legal obligations require pharmacists to verify photo ID.
Signing a statutory declaration as a witness
Under the Statutory Declarations Regulations 2023 and various state/territory regulations, pharmacists are approved to witness a Commonwealth statutory declaration.
The Statutory Declarations Act 1959 contains surprisingly little guidance on the responsibility of a witness. While the Act does not require witnesses to confirm a declarant’s identity or validity of their statement, there is an expectation witnesses are confident the person making the declaration is not acting fraudulently or under coercion.
Whether to increase confidence in a person’s identity, allay doubts or improve workflow, if the declarant is not known to them, pharmacists should request photo ID – or may choose to refuse to witness the Commonwealth statutory declaration altogether.
This approach also helps with consistency, as different types of declarations have different identity verification requirements. For example, in Victoria, the Oaths and Affirmations Act 2018 says a witness must not sign a statutory declaration unless the authorised witness has taken reasonable steps to ensure the declarant is the person named in the statutory declaration.
If the witness doesn’t know the declarant personally, the quickest and most reliable form of proof is always likely to be photo ID.
Signing a patient up for Active Script Lists
Following the implementation of the Active Script List (ASL) functionality, the Active Script List Release 1 – Privacy Framework was released in May 2021 – requiring pharmacists to verify a patient’s identity for ASL registration.
To confirm a patient's identity, pharmacists are legally required to check both a current government-issued photo ID and a Medicare or Department of Veteran Affairs card.
If the patient doesn't have a photo ID, pharmacists can either verify 100 points of other ID (along with their Medicare or DVA card) – or apply the ‘known patient model’.
The threshold for the ‘known patient model’ may surprise you. The patient must already be familiar to the individual pharmacist and have had at least four prescriptions filled in their name at that pharmacy in the past year.
Prescribing pseudoephedrine
Due to the potential for misuse, in most jurisdictions, pharmacists are required to sight or record certain details when prescribing medicines containing pseudoephedrine as Pharmacist Only medicines – including identity verification.
But the requirements vary from state to state.
For example in South Australia, pharmacists must not supply pseudoephedrine unless patients provide a form of photo ID or their birth certificate.
In NSW, the Poisons and Therapeutic Goods Regulation 2008 requires pharmacists to record a unique reference number, the supplier’s name, the patient’s name and address, and the product name, strength, quantity, and supply date. Importantly, if the recipient’s identity is unknown, pharmacists must record the unique reference number of a form of photo ID. And the implications of failing to do so are dire – resulting in up to 20 penalty units, 3 months' imprisonment – or both.
Establishing patient identity for enrolment in opioid dependence therapy
Critical to patient safety in opioid dependence therapy is correct identification, as administering a dose to the wrong patient can lead to a fatal overdose.
Positive patient identification is critical to validating someone’s identity accurately when establishing a person in the program, particularly when biometric data is collected.
Biometric identification systems, such as iris scanning, can be helpful in pharmacotherapy programs such as opioid dependence treatment for verifying patient identity, reducing the risk of diversion and dramatically streamlining workflow.
Photo identification at the time of establishing the profile can be valuable in supporting this. Most jurisdictions also have workaround options to establish patient identity (e.g. photo of patient signed by the prescriber) where photo identification is not available.
Dispensing controlled drugs (S8)
If a patient is not known to a pharmacy or their Medicare card details are unspecified, asking for photo identification can be useful to confirm identity when dispensing controlled substances.
This can be helpful in establishing the prescription is for a real person and reduce the risk of someone accessing Controlled Drugs through impersonation.
While this will be normal practice for many pharmacists, some may be surprised at specific requirements in their state and territory poisons regulations.. For example, in:
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[post_content] => Over the weekend, the Albanese Government announced a $573 million commitment to national women’s health initiatives, to bipartisan support.
So what is actually happening? And when?
Australian Pharmacist takes a ‘deep dive’ to help pharmacists navigate these life-changing initiatives for women.
Two new oral contraceptive pills listed on the PBS
What: oral contraceptive pills (OCP) Yaz (drospirenone/
Co-lead for Access, Care and Outcomes Subcommittee and PSA National President Associate Professor Fei Sim FPS and moderator Ms Sophie Scott OAM[/caption]
‘Patients who meet the eligibility criteria will be able to access these medicines at a PBS-subsidised price, making access more affordable and equitable.’
Three new MHTs also set to be included on the PBS
What: the menopausal hormone therapies (MHTs) Estrogel (estradiol), Prometrium (progesterone) and Estrogel Pro (estragio/progesterone) will also be listed on the PBS – marking the first MHT listings in 20 years.
When: from 1 March 2025
Why: various MHTs, including strengths of Estalis (estradiol /norethisterone acetate) and Estradot (estradiol) transdermal patches, have been in short supply for months, forcing women to pay hundreds of dollars annually for substitutions under Section 19A of the Therapeutic Goods Act or newer, unsubsidised MHTs.
The TGA has also warned that supply shortages of some PBS-listed menopause treatments will persist throughout 2025.
PBAC recommended the listing of Prometrium, Estrogel and Estrogel Pro as General Schedule unrestricted benefit listings, with corresponding General Schedule restricted benefit listings for 60-day maximum dispensed quantities.
These new PBS subsidies also follow a 2024 Parliamentary Inquiry recommendation to make newer menopause therapies more affordable and accessible.
And because these medications match the body’s own hormones more closely, many women find they experience fewer or milder side effects compared to older therapies.
Impact: the new PBS subsidies mean women will soon be able to pay substantially less for modern menopause therapy – reducing the cost from around $650 per year to as little as $7.70 or $31.60 a month for around 150,000 women.
‘Prometrium, Estrogel and Estrogel Pro are all commonly used hormone replacement therapy,’ said PSA National President Associate Professor Fei Sim FPS.
‘Having them on the PBS means they will be subsidised for women who need them, better supporting women experiencing perimenopause and menopause.’
A national approach for OCP access and treating uncomplicated UTIs directly from pharmacies
What: national OCP and urinary tract infection (UTI) pharmacy trials, allowing pharmacists to initiate PBS medicines for the first time ever.
When: early 2026. At this stage, these trials are part of Labor’s election platform, however the coalition has vowed to match this measure.
Why: the nation-wide trials are designed to boost access to treatment for uncomplicated UTIs and hormonal contraception through community pharmacists at PBS medicine cost.
Impact: around 250,000 concession cardholders will be able to consult a trained pharmacist free of charge. And if medication is required, they will only need to pay the standard cost of the medicine.
Enabling appropriately trained pharmacists to prescribe treatment for uncomplicated UTI and contraceptives under the PBS will allow for equitable, affordable healthcare for women and girls, said A/Prof Sim.
‘We all know that when experiencing symptoms of UTI, timely treatment is critical,’ she said.
Previously, when prescribing and management of these acute conditions were undertaken, patients often faced additional out-of-pocket costs to see a pharmacist versus a GP.
‘[Allowing] pharmacists to prescribe treatment under the PBS means there is no discrimination with care,’ she added.
Widened access to long-term contraceptives at a lower cost
When: unknown at this stage. The coalition has vowed to match this measure.
Why: only 6% of Australian women use an Intrauterine device (IUD), with 5% opting for the contraceptive implant – partly due to a lack of awareness about these options.
Access is further impacted by difficulties finding trained GPs, coupled with long waiting times, for insertions.
While a slight Medicare rebate increase was introduced in 2022, it doesn’t cover the costs and time required for IUD insertion – discouraging many GPs from offering the service. The high cost of training also makes it challenging for GPs to gain the necessary qualifications.
Impact: the new women’s health package improves access to IUDs and implants by increasing clinician rebates and introducing Medicare coverage for nurse practitioner insertions. It also incentivises GPs to bulk bill insertions, eliminating out-of-pocket costs for women. Eight training centers will also be established across Australia to enhance clinician skills and confidence in IUD insertion.
‘This should make it more affordable and much easier for women to find a clinician to insert it,’ said Danielle Mazza, Director, SPHERE NHMRC Centre of Research Excellence in Women's Sexual and Reproductive Health in Primary Care.
New Medicare support for menopause
What: a new Medicare rebate for menopause health assessments
When: from 1 July 2025
It is unclear when funding to train health professionals, a first-ever clinical guideline for menopause and a national awareness campaign will be introduced. But the coalition has vowed to follow through with these initiatives if reelected.
Why: as one caller to 774 ABC Radio Melbourne put it this week, ‘women are just used to putting up with stuff.’
‘I've always had the feeling that once you hit 65, once supposedly you’ve had your kids and you've helped a bit with the grandchildren that basically medically you're just forgotten,’ the caller continued.
The menopause initiative should help to shift that narrative, designed to support women experiencing menopause and perimenopause to receive appropriate care from their GP, and help to ensure informed conversations with trained healthcare professionals.
Impact: a 2024 Parliamentary inquiry into menopause found GPs have limited knowledge and perimenopause and menopause and are often unable to recognise symptoms.
Boosting healthcare education and knowledge, along with empowering women to advocate for their own health, should help to address this.
More clinics to address endometriosis and pelvic pain
What: 11 new clinics dedicated to endometriosis and pelvic pain will be opened, along with 33 existing clinics receiving more staff to provide specialist support for menopause
When: an unspecified date after the federal election. The coalition has vowed to match these initiatives if elected.
Why: endometriosis affects around one in 7 Australian women by age 44–49, often leading to severe pelvic pain, fertility issues, irritable bowel syndrome or mental health issues. Yet despite advancements in medicines and surgical treatments, there is still a high rate of recurrence.
A Victorian inquiry into women's pain and health also found that the pain women experience is often overlooked.
Impact: through more healthcare avenues, women can benefit from improved access to diagnostic, treatment and referral services for endometriosis and pelvic pain.
The announcement will break down barriers to healthcare access, especially in regional, rural and remote areas, reflecting the recommendations and work of the National Women’s Health Council, said A/Prof Sim, who co-chairs the Access, Care and Outcomes Subcommittee.
‘These are the recommendations our Council has been calling for,’ she added.
A summary of these announcements is below:
| What | When | Detail |
| Listing of two additional oral contraceptive pills on the PBS | 1 March 2025 | Yaz and Yasmin will be listed on the PBS as unrestricted benefits |
| Listing of three additional menopausal hormone therapies on PBS | 1 March 2025 | Estrogel, Prometrium and Estrogel Pro will be listed on the PBS as unrestricted benefits |
| Pharmacy trials of OCP prescribing and treating uncomplicated UTIs | Early 2026* | Free-of-charge UTI and OCP consultations in community pharmacies for concession card holders, with prescribed medicines available via the PBS |
| Increased access to long-term contraceptives | Unknown* | Increased rebates and new Medicare rebates for IUD and hormonal implant insertions. Eight training centres to be established to increase clinician skill and confidence |
| Medicare support for menopause | From 1 July 2025 | New Medicare rebate for menopause health assessments Training, guidelines and a public awareness campaign will also be developed |
| Additional endometriosis and pelvic pain clinics | Unknown* | 11 new clinics (in addition to 33 currently existing) dedicated to endometriosis and pelvic pain |
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[post_content] => PSA has long advocated for nationally consistent vaccine regulations, allowing pharmacist immunisers in all practice settings to be able to administer all vaccines to patients of all ages.
With South Australia recently becoming the first jurisdiction to authorise and administer all vaccines to all patients, will other jurisdictions follow suit?
Australian Pharmacist investigates what this means for South Australian pharmacists, patients and our national approach to vaccination.
Pharmacists can now self-determine their scope of practice
In South Australia, pharmacists were previously authorised to administer vaccines under the Vaccine Administration Code (VAC), which wasn’t fit for purpose for pharmacists operating outside public health settings, said PSA SA/NT State Manager Helen Stone MPS.
‘The VAC had been initially formulated for nurse immunisers, with pharmacists included in 2015 to enable us to provide influenza vaccines in South Australia,’ she said. ‘But it became obvious during the pandemic that it wasn't fit for purpose.’
The recent legislation change includes a removal of pharmacists from the VAC, allowing trained pharmacists to continue to have authority to both administer the vaccines they provided under the VAC along with additional vaccines.
[caption id="attachment_28651" align="alignnone" width="533"]
From centre: PSA SA/NT President Manya Angley FPS, Matthew Gillespie and Minister for Health and Wellbeing Chris Picton MP[/caption]
This means pharmacist immunisers in South Australia can now administer all vaccines included in the Australian Immunisation Handbook (AIH), or as determined by the Minister.
With these barriers now removed, pharmacists can now self-determine their vaccination scope of practice, said Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
‘Pharmacists are required to plan their annual professional development, and PSA recommends an annual update with our annual refresher courses,’ he said.
‘The responsibility now is on pharmacists, as it is for all immunisers, to start to close the gap on our immunisation rates, particularly for the most vulnerable.’
Unnecessary admin will be removed
Beyond widening the variety of vaccines pharmacists can administer and to whom, the legislation change will also help to reduce the duplication of administration work for pharmacists, said Ms Stone.
‘To be able to offer vaccination services in South Australia, pharmacists previously had to file a lot of paperwork,’ she said.
This included registering a pharmacy as an approved organisation and updating this information to the Pharmacy Regulation Authority SA (PRASA) as well as the Communicable Disease Control Branch (CDCB).
‘Now, only PRASA registration is required to operate a pharmacy in SA, reducing administrative burden,’ said Ms Stone.
‘Pharmacists also need to register with the Vaccine Distribution Center (VDC) to place an order and access the National Immunisation Program (NIP) stock.’
Travel health and private vaccines will be the first step
By widening access to vaccines, patients in South Australia will now have the opportunity to access travel and private vaccines such as hepatitis A and B, typhoid, cholera and rabies.
Several vaccines recommended in AIH are not covered under the NIP, but that doesn’t mean they are not important – particularly for those who are travelling, said Mr Campbell.
‘We know the awareness of what vaccines patients will need when travelling to certain countries is not high,’ he said. ‘We want to make sure people know they can come to the pharmacy now in South Australia and receive the right vaccines for the area they are going to.’
However, access to NIP stock for pharmacist-administered vaccines remains restricted to patients who are 5 years and older. So while there is no longer an age limit for pharmacist- administered vaccines, out-of-pocket costs will still apply, said Ms Stone.
‘For children under 5 years, if eligible for an NIP vaccine, pharmacists might refer them on to a GP [at this stage] so they can access a funded vaccine,’ she said.
In discussions with the federal Department of Health, PSA has requested for an expansion to the funding schedule to cover all vaccines on the NIP for pharmacist administration, said Mr Campbell.
‘PSA will continue our advocacy to extend NIP access to all vaccines for all eligible people, he added.
This includes an expansion of the program to children who are under 5 years of age, which is particularly crucial with childhood vaccination rates decreasing across Australia.
More opportunities for pharmacists will open up
Combined with the recent determination in South Australia allowing pharmacists to administer medicines by injection, this opens up the potential for a full clinical service for people who need assistance with administering medicines, said Ms Stone.
‘It might be that a patient was recently discharged from hospital and they need to inject Clexane or a 6-monthly injection of denosumab, for example,’ she said.
‘There's lots of newer medicines on the market that are injectable, and not everybody feels comfortable injecting themselves, so pharmacists might decide that they want to offer a comprehensive service around medicine administration.’
With the authority to administer all vaccines to patients of all ages, pharmacists may also benefit from a wider variety of roles – including in GP clinics and public health units.
Having pharmacists as part of a broader care team that can administer all vaccines should help to increase vaccination rates – particularly in areas where access to care is limited.
‘There are towns where the pharmacy is the only health provider, so this will be one of many new services that all pharmacists will be able to deliver to support access,’ said Mr Campbell.
But rather than focusing on pharmacists replacing other vaccine providers, broadening the legislation is designed to improve access in accordance with the ‘No Wrong Door’ principle.
‘Pharmacists are trained immunisers who should be able to immunise against any condition, as other providers can,’ he said.
The legislation change will future proof us for the next pandemic
Invariably, a new variant of a virus or other pathogen will spread that could become a future pandemic. So when a vaccine is developed to safeguard the population, this regulation change allows a fast-tracked pathway to vaccine access, said Mr Campbell.
‘There won’t be any legislative instrument changes, parliamentary decisions or emergency measures that need to be made to allow that to happen,’ he said.
This will allow pharmacists to administer new vaccines without red tape roadblocks in place.
‘When there's a vaccine that becomes available that's not in the AIH, we can provide advice to the Minister in terms of the pharmacy profession's response to any emerging trend,’ said Ms Stone.
This allows pharmacists to focus on patient care.
‘When a new vaccine comes in, pharmacists can focus on, “Who is this recommended for? What do I need to know about this vaccine? What do I need to know about that condition?” to support the patient in front of them, rather than being concerned about the nuanced details of a legal instrument,’ said Mr Campbell.
Other jurisdictions are expected to follow suit
It’s hoped that other jurisdictions will follow South Australia's lead and remove vaccination red tape, as soon as practical, said Mr Campbell.
‘Harmonisation that allows access to care, when a health professional has the education and training and it is within their scope, was one of the clear recommendations during the Scope of Practice Review,’ he said.
This should improve patients’ ability to make informed decisions and have access to the vaccines they need.
‘Currently, patients might see a pharmacist for some vaccines and another provider for others. So this is a much more crisp and simple message,’ said Mr Cambell.
‘In the future, people will see pharmacies and know they can get access to all immunisations they are eligible for and recommended to receive.’
PSA is currently in discussions with every state and territory, calling on them to similarly remove barriers and allow pharmacists to provide all vaccines to patients of all ages, said Mr Campbell.
‘We've also approached the federal government around funding the NIP for an expanded age access for pharmacist-administered vaccines,’ he said. ‘People shouldn't be penalised for choosing to get immunised in a pharmacy, if that's the place they choose.’
[post_title] => This state enacted a game-changing vaccine legislation change
[post_excerpt] => This bold legislation move will remove red tape and broaden vaccine access. But will other jurisdictions to follow suit?
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[post_content] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
Think you’ve mastered cold chain protocol? Think again. PSA’s Pharmacist-to-Pharmacist Advice Line receives more calls than you may think about risks to cold chain and possible breaches.
So what problems do pharmacists call with? PSA’s expert pharmacist advisors have rounded up some of their most pressing queries… and how they helped pharmacists find a resolution.
1. Do I still have to manually measure the fridge temperature if I have a data logger?
Yes!
A pharmacist who recently contacted the Pharmacist-to-Pharmacist Advice Line was surprised to learn during an audit that despite having a temperature data logger for her pharmacy’s vaccine fridge, she was not compliant with cold chain regulations, said Pooja Jadeja MPS.
[caption id="attachment_28631" align="alignright" width="209"]
Pooja Jadeja MPS[/caption]
‘Pharmacies are often under the impression that when they've passed Quality Care Pharmacy Program (QCPP) requirements, that they are up to date,’ she said.
‘But QCPP compliance doesn’t factor in this national guidelines requirement. And during an [regulatory] audit, they are informed that they have to manually log the maximum/minimum temperatures twice a day in order to be compliant with the “Strive for 5” National Vaccine Storage Guidelines.’
So why do pharmacists need to manually record this data when they have an automated process in place?
‘Data loggers are generally linked to the pharmacy email [account], and with the plethora of emails coming through, pharmacists often miss alerts and aren't checking maximum/minimum temperatures on a daily basis,’ said Ms Jadeja.
‘Doing a manual check at the beginning and end of the day will identify a cold chain breach in a timely manner so that action can be taken accordingly.’
When a pharmacy is deemed non-compliant with the Strive for 5, they will need to sift through their data logs to prove their vaccine fridge has been within the required temperature range.
‘They would have to go in and check the data logger temperatures’ she said. ‘Then put a plan in place to ensure they are checking [temperatures] regularly, and submit that to the [health department] with evidence to show they have taken steps to record manual readings,’ she said.
2. What happens to NIP stock if the power goes out?
Severe storms hit Sydney and regional New South Wales in mid-January, leading to mass power outages.
One affected premise happened to be a small pharmacy, which went on to experience a cold chain breach.
‘The power outage went for over 15 minutes, so they had to dispose of all of their vaccine stock, including [National Immunisation Program] stock, and some private vaccines,’ said Ms Jadeja.
But before disposing of the vaccines, Ms Jadeja advised the pharmacy to declare the NIP stock that was affected by the cold chain breach.
‘Any cold chain breach of NIP stock must be reported to the relevant state or territory health department and [depending on the jurisdiction] disposed of immediately,’ she said. ‘Then the pharmacy can place an order for new NIP stock.’
Before discarding NIP stock, contact your jurisdiction's health department or check health department guidance specific to your state of territory.
For any other vaccines or refrigerated medicine, a record must be kept on the length of the breach and what temperature the fridge reached.
‘This can be checked with either the fridge maximum/minimum temperature log at the front or via the data logger,’ said Ms Jajeda.
Pharmacists must consult the product manufacturer about next steps.
‘In 99% of cases, vaccines have to be disposed of, and that's a loss the pharmacy takes,’ she said.
‘But other medicines may be okay for a certain period of time at a higher temperature, depending on how high the temperature went and how long it stayed at that temperature.’
3. Can vaccines be removed from their packing and stored in a basket in the fridge?
In short: it’s a very bad idea.
Vaccine packaging can be relatively bulky, particularly if it includes outer cartons, pre-filled syringes or vials with diluents, taking up valuable refrigeration space.
So what’s the harm in taking the product out of its original packing to fit more into the vaccine fridge?
One pharmacist found out exactly why this is not advisable post-audit.
‘When vaccines are exposed to light, this can degrade the vaccine and cause it to lose potency,’ said Ms Jadeja. ‘So this pharmacist had to throw out all the vaccines that had been removed from the packaging.’
According to Strive for 5 National Vaccine Storage Guidelines, the outer carton not only protects vials or syringes from light and temperature fluctuations when the refrigerator door is opened, but also includes critical information such as the batch number, expiry date, and product inserts – which may be important for reference and monitoring.
4. What’s the worst-case scenario in the event of a cold chain breach?
When one pharmacy’s fridge temperature was compromised, the team only realised a week later after checking the data logger that a significant cold chain breach had occurred.
From there, the pharmacy had to check how long the fridge temperature was affected and what temperature it reached to determine if each vaccine is still viable and effective, said PSA NSW State Manager Amanda Fairjones MPS.
‘Pharmacists should consult the vaccine manufacturer and ask if they have data to show the vaccine is still effective at 8° C, and at a maximum of 15°C, for example.’
In the case of a cold chain breach, pharmacists must report it to their local public health unit and isolate affected vaccines with a ‘DO NOT USE’ sign, and if possible, transfer them to another vaccine fridge while maintaining +2°C to +8°C.
Download and review the data log, keeping the logger in place if power fails.
But if push comes to shove, pharmacists may have to revaccinate patients who were immunised during the duration of the cold chain breach.
Getting on top of the issue early can help to prevent the unfortunate event of a media notification, as was the case with Holy Family Medical Centre in Sydney’s inner west.
More than 1,200 of the practice’s patients, including hundreds of children under 5 years of age receiving their first vaccinations, were advised that vaccines administered over a 4.5-year period might have been less effective due to improper storage.
This can not only undermine confidence in a business, but in vaccination more broadly.
Did you know you need to do an annual self-audit of cold chain?
To comply with national cold chain requirements, pharmacists must complete a Vaccine storage self-audit at least every 12 months.
‘This is something pharmacists should do [annually] to identify any gaps in their cold chain management protocol, which will ensure that they remain compliant with cold chain management,’ said Ms Jadeja.
The self-audit tool covers storage procedures, fridge certification requirements and having the cold chain breach protocol on display in the pharmacy.
‘It just ensures your pharmacy is ready for any incident that may occur, because you can't plan for incidents,’ she said.
And if you are based in New South Wales, you may be paid a visit by an auditor sooner rather than later.
Because vaping regulations changed in 2024, with vaping products downscheduled to Pharmacist Only medicines, pharmacists are being audited more frequently.
‘These audits are designed to educate pharmacists on how to [prescribe] vapes in a compliant manner,’ said Ms Jadeja. ‘While they're checking vaping products are stored correctly and whether we know how to do the [Special Access Scheme] approvals, they're also checking everything else, including cold chain storage.’
For advice on all things pharmacy, ring PSA’s Pharmacist-to-Pharmacist Advice Line between 8.30am to 5.00pm AEST on 1300 369 772.
This article was updated on 6 February 2025 clarify what pharmacists should do in the event of compromised NIP stock due to a cold chain breach.
[post_title] => Don’t let a cold chain breach take you by surprise
[post_excerpt] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
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[post_content] => The popular weight-loss drug has been approved to treat cardiovascular disease in patients who are overweight or obese.
The Therapeutic Goods Administration (TGA) approval is based on results from the SELECT double-blind, randomised, placebo-controlled trial – a global study conducted in 41 countries, including Australia, with over 17,000 participants.
Australian Pharmacist spoke with Professor Stephen Nicholls, lead of the Australian arm of the SELECT trial, about the significance of this new indication and what pharmacists need to know.
What impact does a Wegovy have on cardiovascular risk?
It has been well known for many years that being overweight or obese is a major risk factor for heart disease, said Prof Nicholls.
[caption id="attachment_28714" align="alignnone" width="700"] Professor Stephen Nicholls[/caption]
‘And in people who have had a heart attack, the presence of overweight or obesity is associated with a worse risk of having another event – but there's nothing specifically that we've been able to do for these people.’
For decades, clinical trials for weight loss drugs have shown no benefit in reducing cardiovascular risk in these patients.
‘But here you have a trial where we specifically targeted people who were overweight, and it reduced their risk,’ he said.
Participants in the SELECT trial had cardiovascular disease, overweight or obesity, but without diabetes, said Professor Stephen Nicholls.
‘The trial found that giving them semaglutide reduced their risk of having another event by 20%,’ he said. ‘That's a game changer – both for the drug and the field.’
What makes a patient eligible for Wegovy for cardiovascular disease?
The new TGA indication for Wegovy is as a complementary therapy for reducing major adverse cardiovascular events such as cardiovascular death, heart attack, or non-fatal stroke in adults with:
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[post_content] => Checking a patient's photo identification (ID) can be both a useful – and mandatory – practice.
Australian Pharmacist explores the instances where minimum practice and legal obligations require pharmacists to verify photo ID.
Signing a statutory declaration as a witness
Under the Statutory Declarations Regulations 2023 and various state/territory regulations, pharmacists are approved to witness a Commonwealth statutory declaration.
The Statutory Declarations Act 1959 contains surprisingly little guidance on the responsibility of a witness. While the Act does not require witnesses to confirm a declarant’s identity or validity of their statement, there is an expectation witnesses are confident the person making the declaration is not acting fraudulently or under coercion.
Whether to increase confidence in a person’s identity, allay doubts or improve workflow, if the declarant is not known to them, pharmacists should request photo ID – or may choose to refuse to witness the Commonwealth statutory declaration altogether.
This approach also helps with consistency, as different types of declarations have different identity verification requirements. For example, in Victoria, the Oaths and Affirmations Act 2018 says a witness must not sign a statutory declaration unless the authorised witness has taken reasonable steps to ensure the declarant is the person named in the statutory declaration.
If the witness doesn’t know the declarant personally, the quickest and most reliable form of proof is always likely to be photo ID.
Signing a patient up for Active Script Lists
Following the implementation of the Active Script List (ASL) functionality, the Active Script List Release 1 – Privacy Framework was released in May 2021 – requiring pharmacists to verify a patient’s identity for ASL registration.
To confirm a patient's identity, pharmacists are legally required to check both a current government-issued photo ID and a Medicare or Department of Veteran Affairs card.
If the patient doesn't have a photo ID, pharmacists can either verify 100 points of other ID (along with their Medicare or DVA card) – or apply the ‘known patient model’.
The threshold for the ‘known patient model’ may surprise you. The patient must already be familiar to the individual pharmacist and have had at least four prescriptions filled in their name at that pharmacy in the past year.
Prescribing pseudoephedrine
Due to the potential for misuse, in most jurisdictions, pharmacists are required to sight or record certain details when prescribing medicines containing pseudoephedrine as Pharmacist Only medicines – including identity verification.
But the requirements vary from state to state.
For example in South Australia, pharmacists must not supply pseudoephedrine unless patients provide a form of photo ID or their birth certificate.
In NSW, the Poisons and Therapeutic Goods Regulation 2008 requires pharmacists to record a unique reference number, the supplier’s name, the patient’s name and address, and the product name, strength, quantity, and supply date. Importantly, if the recipient’s identity is unknown, pharmacists must record the unique reference number of a form of photo ID. And the implications of failing to do so are dire – resulting in up to 20 penalty units, 3 months' imprisonment – or both.
Establishing patient identity for enrolment in opioid dependence therapy
Critical to patient safety in opioid dependence therapy is correct identification, as administering a dose to the wrong patient can lead to a fatal overdose.
Positive patient identification is critical to validating someone’s identity accurately when establishing a person in the program, particularly when biometric data is collected.
Biometric identification systems, such as iris scanning, can be helpful in pharmacotherapy programs such as opioid dependence treatment for verifying patient identity, reducing the risk of diversion and dramatically streamlining workflow.
Photo identification at the time of establishing the profile can be valuable in supporting this. Most jurisdictions also have workaround options to establish patient identity (e.g. photo of patient signed by the prescriber) where photo identification is not available.
Dispensing controlled drugs (S8)
If a patient is not known to a pharmacy or their Medicare card details are unspecified, asking for photo identification can be useful to confirm identity when dispensing controlled substances.
This can be helpful in establishing the prescription is for a real person and reduce the risk of someone accessing Controlled Drugs through impersonation.
While this will be normal practice for many pharmacists, some may be surprised at specific requirements in their state and territory poisons regulations.. For example, in:
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[post_content] => Over the weekend, the Albanese Government announced a $573 million commitment to national women’s health initiatives, to bipartisan support.
So what is actually happening? And when?
Australian Pharmacist takes a ‘deep dive’ to help pharmacists navigate these life-changing initiatives for women.
Two new oral contraceptive pills listed on the PBS
What: oral contraceptive pills (OCP) Yaz (drospirenone/Three new MHTs also set to be included on the PBS
What: the menopausal hormone therapies (MHTs) Estrogel (estradiol), Prometrium (progesterone) and Estrogel Pro (estragio/progesterone) will also be listed on the PBS – marking the first MHT listings in 20 years.
When: from 1 March 2025
Why: various MHTs, including strengths of Estalis (estradiol /norethisterone acetate) and Estradot (estradiol) transdermal patches, have been in short supply for months, forcing women to pay hundreds of dollars annually for substitutions under Section 19A of the Therapeutic Goods Act or newer, unsubsidised MHTs.
The TGA has also warned that supply shortages of some PBS-listed menopause treatments will persist throughout 2025.
PBAC recommended the listing of Prometrium, Estrogel and Estrogel Pro as General Schedule unrestricted benefit listings, with corresponding General Schedule restricted benefit listings for 60-day maximum dispensed quantities.
These new PBS subsidies also follow a 2024 Parliamentary Inquiry recommendation to make newer menopause therapies more affordable and accessible.
And because these medications match the body’s own hormones more closely, many women find they experience fewer or milder side effects compared to older therapies.
Impact: the new PBS subsidies mean women will soon be able to pay substantially less for modern menopause therapy – reducing the cost from around $650 per year to as little as $7.70 or $31.60 a month for around 150,000 women.
‘Prometrium, Estrogel and Estrogel Pro are all commonly used hormone replacement therapy,’ said PSA National President Associate Professor Fei Sim FPS.
‘Having them on the PBS means they will be subsidised for women who need them, better supporting women experiencing perimenopause and menopause.’
A national approach for OCP access and treating uncomplicated UTIs directly from pharmacies
What: national OCP and urinary tract infection (UTI) pharmacy trials, allowing pharmacists to initiate PBS medicines for the first time ever.
When: early 2026. At this stage, these trials are part of Labor’s election platform, however the coalition has vowed to match this measure.
Why: the nation-wide trials are designed to boost access to treatment for uncomplicated UTIs and hormonal contraception through community pharmacists at PBS medicine cost.
Impact: around 250,000 concession cardholders will be able to consult a trained pharmacist free of charge. And if medication is required, they will only need to pay the standard cost of the medicine.
Enabling appropriately trained pharmacists to prescribe treatment for uncomplicated UTI and contraceptives under the PBS will allow for equitable, affordable healthcare for women and girls, said A/Prof Sim.
‘We all know that when experiencing symptoms of UTI, timely treatment is critical,’ she said.
Previously, when prescribing and management of these acute conditions were undertaken, patients often faced additional out-of-pocket costs to see a pharmacist versus a GP.
‘[Allowing] pharmacists to prescribe treatment under the PBS means there is no discrimination with care,’ she added.
Widened access to long-term contraceptives at a lower cost
When: unknown at this stage. The coalition has vowed to match this measure.
Why: only 6% of Australian women use an Intrauterine device (IUD), with 5% opting for the contraceptive implant – partly due to a lack of awareness about these options.
Access is further impacted by difficulties finding trained GPs, coupled with long waiting times, for insertions.
While a slight Medicare rebate increase was introduced in 2022, it doesn’t cover the costs and time required for IUD insertion – discouraging many GPs from offering the service. The high cost of training also makes it challenging for GPs to gain the necessary qualifications.
Impact: the new women’s health package improves access to IUDs and implants by increasing clinician rebates and introducing Medicare coverage for nurse practitioner insertions. It also incentivises GPs to bulk bill insertions, eliminating out-of-pocket costs for women. Eight training centers will also be established across Australia to enhance clinician skills and confidence in IUD insertion.
‘This should make it more affordable and much easier for women to find a clinician to insert it,’ said Danielle Mazza, Director, SPHERE NHMRC Centre of Research Excellence in Women's Sexual and Reproductive Health in Primary Care.
New Medicare support for menopause
What: a new Medicare rebate for menopause health assessments
When: from 1 July 2025
It is unclear when funding to train health professionals, a first-ever clinical guideline for menopause and a national awareness campaign will be introduced. But the coalition has vowed to follow through with these initiatives if reelected.
Why: as one caller to 774 ABC Radio Melbourne put it this week, ‘women are just used to putting up with stuff.’
‘I've always had the feeling that once you hit 65, once supposedly you’ve had your kids and you've helped a bit with the grandchildren that basically medically you're just forgotten,’ the caller continued.
The menopause initiative should help to shift that narrative, designed to support women experiencing menopause and perimenopause to receive appropriate care from their GP, and help to ensure informed conversations with trained healthcare professionals.
Impact: a 2024 Parliamentary inquiry into menopause found GPs have limited knowledge and perimenopause and menopause and are often unable to recognise symptoms.
Boosting healthcare education and knowledge, along with empowering women to advocate for their own health, should help to address this.
More clinics to address endometriosis and pelvic pain
What: 11 new clinics dedicated to endometriosis and pelvic pain will be opened, along with 33 existing clinics receiving more staff to provide specialist support for menopause
When: an unspecified date after the federal election. The coalition has vowed to match these initiatives if elected.
Why: endometriosis affects around one in 7 Australian women by age 44–49, often leading to severe pelvic pain, fertility issues, irritable bowel syndrome or mental health issues. Yet despite advancements in medicines and surgical treatments, there is still a high rate of recurrence.
A Victorian inquiry into women's pain and health also found that the pain women experience is often overlooked.
Impact: through more healthcare avenues, women can benefit from improved access to diagnostic, treatment and referral services for endometriosis and pelvic pain.
The announcement will break down barriers to healthcare access, especially in regional, rural and remote areas, reflecting the recommendations and work of the National Women’s Health Council, said A/Prof Sim, who co-chairs the Access, Care and Outcomes Subcommittee.
‘These are the recommendations our Council has been calling for,’ she added.
A summary of these announcements is below:
| What | When | Detail |
| Listing of two additional oral contraceptive pills on the PBS | 1 March 2025 | Yaz and Yasmin will be listed on the PBS as unrestricted benefits |
| Listing of three additional menopausal hormone therapies on PBS | 1 March 2025 | Estrogel, Prometrium and Estrogel Pro will be listed on the PBS as unrestricted benefits |
| Pharmacy trials of OCP prescribing and treating uncomplicated UTIs | Early 2026* | Free-of-charge UTI and OCP consultations in community pharmacies for concession card holders, with prescribed medicines available via the PBS |
| Increased access to long-term contraceptives | Unknown* | Increased rebates and new Medicare rebates for IUD and hormonal implant insertions. Eight training centres to be established to increase clinician skill and confidence |
| Medicare support for menopause | From 1 July 2025 | New Medicare rebate for menopause health assessments Training, guidelines and a public awareness campaign will also be developed |
| Additional endometriosis and pelvic pain clinics | Unknown* | 11 new clinics (in addition to 33 currently existing) dedicated to endometriosis and pelvic pain |
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[post_content] => PSA has long advocated for nationally consistent vaccine regulations, allowing pharmacist immunisers in all practice settings to be able to administer all vaccines to patients of all ages.
With South Australia recently becoming the first jurisdiction to authorise and administer all vaccines to all patients, will other jurisdictions follow suit?
Australian Pharmacist investigates what this means for South Australian pharmacists, patients and our national approach to vaccination.
Pharmacists can now self-determine their scope of practice
In South Australia, pharmacists were previously authorised to administer vaccines under the Vaccine Administration Code (VAC), which wasn’t fit for purpose for pharmacists operating outside public health settings, said PSA SA/NT State Manager Helen Stone MPS.
‘The VAC had been initially formulated for nurse immunisers, with pharmacists included in 2015 to enable us to provide influenza vaccines in South Australia,’ she said. ‘But it became obvious during the pandemic that it wasn't fit for purpose.’
The recent legislation change includes a removal of pharmacists from the VAC, allowing trained pharmacists to continue to have authority to both administer the vaccines they provided under the VAC along with additional vaccines.
[caption id="attachment_28651" align="alignnone" width="533"] From centre: PSA SA/NT President Manya Angley FPS, Matthew Gillespie and Minister for Health and Wellbeing Chris Picton MP[/caption]
This means pharmacist immunisers in South Australia can now administer all vaccines included in the Australian Immunisation Handbook (AIH), or as determined by the Minister.
With these barriers now removed, pharmacists can now self-determine their vaccination scope of practice, said Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
‘Pharmacists are required to plan their annual professional development, and PSA recommends an annual update with our annual refresher courses,’ he said.
‘The responsibility now is on pharmacists, as it is for all immunisers, to start to close the gap on our immunisation rates, particularly for the most vulnerable.’
Unnecessary admin will be removed
Beyond widening the variety of vaccines pharmacists can administer and to whom, the legislation change will also help to reduce the duplication of administration work for pharmacists, said Ms Stone.
‘To be able to offer vaccination services in South Australia, pharmacists previously had to file a lot of paperwork,’ she said.
This included registering a pharmacy as an approved organisation and updating this information to the Pharmacy Regulation Authority SA (PRASA) as well as the Communicable Disease Control Branch (CDCB).
‘Now, only PRASA registration is required to operate a pharmacy in SA, reducing administrative burden,’ said Ms Stone.
‘Pharmacists also need to register with the Vaccine Distribution Center (VDC) to place an order and access the National Immunisation Program (NIP) stock.’
Travel health and private vaccines will be the first step
By widening access to vaccines, patients in South Australia will now have the opportunity to access travel and private vaccines such as hepatitis A and B, typhoid, cholera and rabies.
Several vaccines recommended in AIH are not covered under the NIP, but that doesn’t mean they are not important – particularly for those who are travelling, said Mr Campbell.
‘We know the awareness of what vaccines patients will need when travelling to certain countries is not high,’ he said. ‘We want to make sure people know they can come to the pharmacy now in South Australia and receive the right vaccines for the area they are going to.’
However, access to NIP stock for pharmacist-administered vaccines remains restricted to patients who are 5 years and older. So while there is no longer an age limit for pharmacist- administered vaccines, out-of-pocket costs will still apply, said Ms Stone.
‘For children under 5 years, if eligible for an NIP vaccine, pharmacists might refer them on to a GP [at this stage] so they can access a funded vaccine,’ she said.
In discussions with the federal Department of Health, PSA has requested for an expansion to the funding schedule to cover all vaccines on the NIP for pharmacist administration, said Mr Campbell.
‘PSA will continue our advocacy to extend NIP access to all vaccines for all eligible people, he added.
This includes an expansion of the program to children who are under 5 years of age, which is particularly crucial with childhood vaccination rates decreasing across Australia.
More opportunities for pharmacists will open up
Combined with the recent determination in South Australia allowing pharmacists to administer medicines by injection, this opens up the potential for a full clinical service for people who need assistance with administering medicines, said Ms Stone.
‘It might be that a patient was recently discharged from hospital and they need to inject Clexane or a 6-monthly injection of denosumab, for example,’ she said.
‘There's lots of newer medicines on the market that are injectable, and not everybody feels comfortable injecting themselves, so pharmacists might decide that they want to offer a comprehensive service around medicine administration.’
With the authority to administer all vaccines to patients of all ages, pharmacists may also benefit from a wider variety of roles – including in GP clinics and public health units.
Having pharmacists as part of a broader care team that can administer all vaccines should help to increase vaccination rates – particularly in areas where access to care is limited.
‘There are towns where the pharmacy is the only health provider, so this will be one of many new services that all pharmacists will be able to deliver to support access,’ said Mr Campbell.
But rather than focusing on pharmacists replacing other vaccine providers, broadening the legislation is designed to improve access in accordance with the ‘No Wrong Door’ principle.
‘Pharmacists are trained immunisers who should be able to immunise against any condition, as other providers can,’ he said.
The legislation change will future proof us for the next pandemic
Invariably, a new variant of a virus or other pathogen will spread that could become a future pandemic. So when a vaccine is developed to safeguard the population, this regulation change allows a fast-tracked pathway to vaccine access, said Mr Campbell.
‘There won’t be any legislative instrument changes, parliamentary decisions or emergency measures that need to be made to allow that to happen,’ he said.
This will allow pharmacists to administer new vaccines without red tape roadblocks in place.
‘When there's a vaccine that becomes available that's not in the AIH, we can provide advice to the Minister in terms of the pharmacy profession's response to any emerging trend,’ said Ms Stone.
This allows pharmacists to focus on patient care.
‘When a new vaccine comes in, pharmacists can focus on, “Who is this recommended for? What do I need to know about this vaccine? What do I need to know about that condition?” to support the patient in front of them, rather than being concerned about the nuanced details of a legal instrument,’ said Mr Campbell.
Other jurisdictions are expected to follow suit
It’s hoped that other jurisdictions will follow South Australia's lead and remove vaccination red tape, as soon as practical, said Mr Campbell.
‘Harmonisation that allows access to care, when a health professional has the education and training and it is within their scope, was one of the clear recommendations during the Scope of Practice Review,’ he said.
This should improve patients’ ability to make informed decisions and have access to the vaccines they need.
‘Currently, patients might see a pharmacist for some vaccines and another provider for others. So this is a much more crisp and simple message,’ said Mr Cambell.
‘In the future, people will see pharmacies and know they can get access to all immunisations they are eligible for and recommended to receive.’
PSA is currently in discussions with every state and territory, calling on them to similarly remove barriers and allow pharmacists to provide all vaccines to patients of all ages, said Mr Campbell.
‘We've also approached the federal government around funding the NIP for an expanded age access for pharmacist-administered vaccines,’ he said. ‘People shouldn't be penalised for choosing to get immunised in a pharmacy, if that's the place they choose.’
[post_title] => This state enacted a game-changing vaccine legislation change
[post_excerpt] => This bold legislation move will remove red tape and broaden vaccine access. But will other jurisdictions to follow suit?
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[post_content] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
Think you’ve mastered cold chain protocol? Think again. PSA’s Pharmacist-to-Pharmacist Advice Line receives more calls than you may think about risks to cold chain and possible breaches.
So what problems do pharmacists call with? PSA’s expert pharmacist advisors have rounded up some of their most pressing queries… and how they helped pharmacists find a resolution.
1. Do I still have to manually measure the fridge temperature if I have a data logger?
Yes!
A pharmacist who recently contacted the Pharmacist-to-Pharmacist Advice Line was surprised to learn during an audit that despite having a temperature data logger for her pharmacy’s vaccine fridge, she was not compliant with cold chain regulations, said Pooja Jadeja MPS.
[caption id="attachment_28631" align="alignright" width="209"] Pooja Jadeja MPS[/caption]
‘Pharmacies are often under the impression that when they've passed Quality Care Pharmacy Program (QCPP) requirements, that they are up to date,’ she said.
‘But QCPP compliance doesn’t factor in this national guidelines requirement. And during an [regulatory] audit, they are informed that they have to manually log the maximum/minimum temperatures twice a day in order to be compliant with the “Strive for 5” National Vaccine Storage Guidelines.’
So why do pharmacists need to manually record this data when they have an automated process in place?
‘Data loggers are generally linked to the pharmacy email [account], and with the plethora of emails coming through, pharmacists often miss alerts and aren't checking maximum/minimum temperatures on a daily basis,’ said Ms Jadeja.
‘Doing a manual check at the beginning and end of the day will identify a cold chain breach in a timely manner so that action can be taken accordingly.’
When a pharmacy is deemed non-compliant with the Strive for 5, they will need to sift through their data logs to prove their vaccine fridge has been within the required temperature range.
‘They would have to go in and check the data logger temperatures’ she said. ‘Then put a plan in place to ensure they are checking [temperatures] regularly, and submit that to the [health department] with evidence to show they have taken steps to record manual readings,’ she said.
2. What happens to NIP stock if the power goes out?
Severe storms hit Sydney and regional New South Wales in mid-January, leading to mass power outages.
One affected premise happened to be a small pharmacy, which went on to experience a cold chain breach.
‘The power outage went for over 15 minutes, so they had to dispose of all of their vaccine stock, including [National Immunisation Program] stock, and some private vaccines,’ said Ms Jadeja.
But before disposing of the vaccines, Ms Jadeja advised the pharmacy to declare the NIP stock that was affected by the cold chain breach.
‘Any cold chain breach of NIP stock must be reported to the relevant state or territory health department and [depending on the jurisdiction] disposed of immediately,’ she said. ‘Then the pharmacy can place an order for new NIP stock.’
Before discarding NIP stock, contact your jurisdiction's health department or check health department guidance specific to your state of territory.
For any other vaccines or refrigerated medicine, a record must be kept on the length of the breach and what temperature the fridge reached.
‘This can be checked with either the fridge maximum/minimum temperature log at the front or via the data logger,’ said Ms Jajeda.
Pharmacists must consult the product manufacturer about next steps.
‘In 99% of cases, vaccines have to be disposed of, and that's a loss the pharmacy takes,’ she said.
‘But other medicines may be okay for a certain period of time at a higher temperature, depending on how high the temperature went and how long it stayed at that temperature.’
3. Can vaccines be removed from their packing and stored in a basket in the fridge?
In short: it’s a very bad idea.
Vaccine packaging can be relatively bulky, particularly if it includes outer cartons, pre-filled syringes or vials with diluents, taking up valuable refrigeration space.
So what’s the harm in taking the product out of its original packing to fit more into the vaccine fridge?
One pharmacist found out exactly why this is not advisable post-audit.
‘When vaccines are exposed to light, this can degrade the vaccine and cause it to lose potency,’ said Ms Jadeja. ‘So this pharmacist had to throw out all the vaccines that had been removed from the packaging.’
According to Strive for 5 National Vaccine Storage Guidelines, the outer carton not only protects vials or syringes from light and temperature fluctuations when the refrigerator door is opened, but also includes critical information such as the batch number, expiry date, and product inserts – which may be important for reference and monitoring.
4. What’s the worst-case scenario in the event of a cold chain breach?
When one pharmacy’s fridge temperature was compromised, the team only realised a week later after checking the data logger that a significant cold chain breach had occurred.
From there, the pharmacy had to check how long the fridge temperature was affected and what temperature it reached to determine if each vaccine is still viable and effective, said PSA NSW State Manager Amanda Fairjones MPS.
‘Pharmacists should consult the vaccine manufacturer and ask if they have data to show the vaccine is still effective at 8° C, and at a maximum of 15°C, for example.’
In the case of a cold chain breach, pharmacists must report it to their local public health unit and isolate affected vaccines with a ‘DO NOT USE’ sign, and if possible, transfer them to another vaccine fridge while maintaining +2°C to +8°C.
Download and review the data log, keeping the logger in place if power fails.
But if push comes to shove, pharmacists may have to revaccinate patients who were immunised during the duration of the cold chain breach.
Getting on top of the issue early can help to prevent the unfortunate event of a media notification, as was the case with Holy Family Medical Centre in Sydney’s inner west.
More than 1,200 of the practice’s patients, including hundreds of children under 5 years of age receiving their first vaccinations, were advised that vaccines administered over a 4.5-year period might have been less effective due to improper storage.
This can not only undermine confidence in a business, but in vaccination more broadly.
Did you know you need to do an annual self-audit of cold chain?
To comply with national cold chain requirements, pharmacists must complete a Vaccine storage self-audit at least every 12 months.
‘This is something pharmacists should do [annually] to identify any gaps in their cold chain management protocol, which will ensure that they remain compliant with cold chain management,’ said Ms Jadeja.
The self-audit tool covers storage procedures, fridge certification requirements and having the cold chain breach protocol on display in the pharmacy.
‘It just ensures your pharmacy is ready for any incident that may occur, because you can't plan for incidents,’ she said.
And if you are based in New South Wales, you may be paid a visit by an auditor sooner rather than later.
Because vaping regulations changed in 2024, with vaping products downscheduled to Pharmacist Only medicines, pharmacists are being audited more frequently.
‘These audits are designed to educate pharmacists on how to [prescribe] vapes in a compliant manner,’ said Ms Jadeja. ‘While they're checking vaping products are stored correctly and whether we know how to do the [Special Access Scheme] approvals, they're also checking everything else, including cold chain storage.’
For advice on all things pharmacy, ring PSA’s Pharmacist-to-Pharmacist Advice Line between 8.30am to 5.00pm AEST on 1300 369 772.
This article was updated on 6 February 2025 clarify what pharmacists should do in the event of compromised NIP stock due to a cold chain breach.
[post_title] => Don’t let a cold chain breach take you by surprise
[post_excerpt] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
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[post_content] => The popular weight-loss drug has been approved to treat cardiovascular disease in patients who are overweight or obese.
The Therapeutic Goods Administration (TGA) approval is based on results from the SELECT double-blind, randomised, placebo-controlled trial – a global study conducted in 41 countries, including Australia, with over 17,000 participants.
Australian Pharmacist spoke with Professor Stephen Nicholls, lead of the Australian arm of the SELECT trial, about the significance of this new indication and what pharmacists need to know.
What impact does a Wegovy have on cardiovascular risk?
It has been well known for many years that being overweight or obese is a major risk factor for heart disease, said Prof Nicholls.
[caption id="attachment_28714" align="alignnone" width="700"] Professor Stephen Nicholls[/caption]
‘And in people who have had a heart attack, the presence of overweight or obesity is associated with a worse risk of having another event – but there's nothing specifically that we've been able to do for these people.’
For decades, clinical trials for weight loss drugs have shown no benefit in reducing cardiovascular risk in these patients.
‘But here you have a trial where we specifically targeted people who were overweight, and it reduced their risk,’ he said.
Participants in the SELECT trial had cardiovascular disease, overweight or obesity, but without diabetes, said Professor Stephen Nicholls.
‘The trial found that giving them semaglutide reduced their risk of having another event by 20%,’ he said. ‘That's a game changer – both for the drug and the field.’
What makes a patient eligible for Wegovy for cardiovascular disease?
The new TGA indication for Wegovy is as a complementary therapy for reducing major adverse cardiovascular events such as cardiovascular death, heart attack, or non-fatal stroke in adults with:
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[post_content] => Checking a patient's photo identification (ID) can be both a useful – and mandatory – practice.
Australian Pharmacist explores the instances where minimum practice and legal obligations require pharmacists to verify photo ID.
Signing a statutory declaration as a witness
Under the Statutory Declarations Regulations 2023 and various state/territory regulations, pharmacists are approved to witness a Commonwealth statutory declaration.
The Statutory Declarations Act 1959 contains surprisingly little guidance on the responsibility of a witness. While the Act does not require witnesses to confirm a declarant’s identity or validity of their statement, there is an expectation witnesses are confident the person making the declaration is not acting fraudulently or under coercion.
Whether to increase confidence in a person’s identity, allay doubts or improve workflow, if the declarant is not known to them, pharmacists should request photo ID – or may choose to refuse to witness the Commonwealth statutory declaration altogether.
This approach also helps with consistency, as different types of declarations have different identity verification requirements. For example, in Victoria, the Oaths and Affirmations Act 2018 says a witness must not sign a statutory declaration unless the authorised witness has taken reasonable steps to ensure the declarant is the person named in the statutory declaration.
If the witness doesn’t know the declarant personally, the quickest and most reliable form of proof is always likely to be photo ID.
Signing a patient up for Active Script Lists
Following the implementation of the Active Script List (ASL) functionality, the Active Script List Release 1 – Privacy Framework was released in May 2021 – requiring pharmacists to verify a patient’s identity for ASL registration.
To confirm a patient's identity, pharmacists are legally required to check both a current government-issued photo ID and a Medicare or Department of Veteran Affairs card.
If the patient doesn't have a photo ID, pharmacists can either verify 100 points of other ID (along with their Medicare or DVA card) – or apply the ‘known patient model’.
The threshold for the ‘known patient model’ may surprise you. The patient must already be familiar to the individual pharmacist and have had at least four prescriptions filled in their name at that pharmacy in the past year.
Prescribing pseudoephedrine
Due to the potential for misuse, in most jurisdictions, pharmacists are required to sight or record certain details when prescribing medicines containing pseudoephedrine as Pharmacist Only medicines – including identity verification.
But the requirements vary from state to state.
For example in South Australia, pharmacists must not supply pseudoephedrine unless patients provide a form of photo ID or their birth certificate.
In NSW, the Poisons and Therapeutic Goods Regulation 2008 requires pharmacists to record a unique reference number, the supplier’s name, the patient’s name and address, and the product name, strength, quantity, and supply date. Importantly, if the recipient’s identity is unknown, pharmacists must record the unique reference number of a form of photo ID. And the implications of failing to do so are dire – resulting in up to 20 penalty units, 3 months' imprisonment – or both.
Establishing patient identity for enrolment in opioid dependence therapy
Critical to patient safety in opioid dependence therapy is correct identification, as administering a dose to the wrong patient can lead to a fatal overdose.
Positive patient identification is critical to validating someone’s identity accurately when establishing a person in the program, particularly when biometric data is collected.
Biometric identification systems, such as iris scanning, can be helpful in pharmacotherapy programs such as opioid dependence treatment for verifying patient identity, reducing the risk of diversion and dramatically streamlining workflow.
Photo identification at the time of establishing the profile can be valuable in supporting this. Most jurisdictions also have workaround options to establish patient identity (e.g. photo of patient signed by the prescriber) where photo identification is not available.
Dispensing controlled drugs (S8)
If a patient is not known to a pharmacy or their Medicare card details are unspecified, asking for photo identification can be useful to confirm identity when dispensing controlled substances.
This can be helpful in establishing the prescription is for a real person and reduce the risk of someone accessing Controlled Drugs through impersonation.
While this will be normal practice for many pharmacists, some may be surprised at specific requirements in their state and territory poisons regulations.. For example, in:
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[post_content] => Over the weekend, the Albanese Government announced a $573 million commitment to national women’s health initiatives, to bipartisan support.
So what is actually happening? And when?
Australian Pharmacist takes a ‘deep dive’ to help pharmacists navigate these life-changing initiatives for women.
Two new oral contraceptive pills listed on the PBS
What: oral contraceptive pills (OCP) Yaz (drospirenone/Three new MHTs also set to be included on the PBS
What: the menopausal hormone therapies (MHTs) Estrogel (estradiol), Prometrium (progesterone) and Estrogel Pro (estragio/progesterone) will also be listed on the PBS – marking the first MHT listings in 20 years.
When: from 1 March 2025
Why: various MHTs, including strengths of Estalis (estradiol /norethisterone acetate) and Estradot (estradiol) transdermal patches, have been in short supply for months, forcing women to pay hundreds of dollars annually for substitutions under Section 19A of the Therapeutic Goods Act or newer, unsubsidised MHTs.
The TGA has also warned that supply shortages of some PBS-listed menopause treatments will persist throughout 2025.
PBAC recommended the listing of Prometrium, Estrogel and Estrogel Pro as General Schedule unrestricted benefit listings, with corresponding General Schedule restricted benefit listings for 60-day maximum dispensed quantities.
These new PBS subsidies also follow a 2024 Parliamentary Inquiry recommendation to make newer menopause therapies more affordable and accessible.
And because these medications match the body’s own hormones more closely, many women find they experience fewer or milder side effects compared to older therapies.
Impact: the new PBS subsidies mean women will soon be able to pay substantially less for modern menopause therapy – reducing the cost from around $650 per year to as little as $7.70 or $31.60 a month for around 150,000 women.
‘Prometrium, Estrogel and Estrogel Pro are all commonly used hormone replacement therapy,’ said PSA National President Associate Professor Fei Sim FPS.
‘Having them on the PBS means they will be subsidised for women who need them, better supporting women experiencing perimenopause and menopause.’
A national approach for OCP access and treating uncomplicated UTIs directly from pharmacies
What: national OCP and urinary tract infection (UTI) pharmacy trials, allowing pharmacists to initiate PBS medicines for the first time ever.
When: early 2026. At this stage, these trials are part of Labor’s election platform, however the coalition has vowed to match this measure.
Why: the nation-wide trials are designed to boost access to treatment for uncomplicated UTIs and hormonal contraception through community pharmacists at PBS medicine cost.
Impact: around 250,000 concession cardholders will be able to consult a trained pharmacist free of charge. And if medication is required, they will only need to pay the standard cost of the medicine.
Enabling appropriately trained pharmacists to prescribe treatment for uncomplicated UTI and contraceptives under the PBS will allow for equitable, affordable healthcare for women and girls, said A/Prof Sim.
‘We all know that when experiencing symptoms of UTI, timely treatment is critical,’ she said.
Previously, when prescribing and management of these acute conditions were undertaken, patients often faced additional out-of-pocket costs to see a pharmacist versus a GP.
‘[Allowing] pharmacists to prescribe treatment under the PBS means there is no discrimination with care,’ she added.
Widened access to long-term contraceptives at a lower cost
When: unknown at this stage. The coalition has vowed to match this measure.
Why: only 6% of Australian women use an Intrauterine device (IUD), with 5% opting for the contraceptive implant – partly due to a lack of awareness about these options.
Access is further impacted by difficulties finding trained GPs, coupled with long waiting times, for insertions.
While a slight Medicare rebate increase was introduced in 2022, it doesn’t cover the costs and time required for IUD insertion – discouraging many GPs from offering the service. The high cost of training also makes it challenging for GPs to gain the necessary qualifications.
Impact: the new women’s health package improves access to IUDs and implants by increasing clinician rebates and introducing Medicare coverage for nurse practitioner insertions. It also incentivises GPs to bulk bill insertions, eliminating out-of-pocket costs for women. Eight training centers will also be established across Australia to enhance clinician skills and confidence in IUD insertion.
‘This should make it more affordable and much easier for women to find a clinician to insert it,’ said Danielle Mazza, Director, SPHERE NHMRC Centre of Research Excellence in Women's Sexual and Reproductive Health in Primary Care.
New Medicare support for menopause
What: a new Medicare rebate for menopause health assessments
When: from 1 July 2025
It is unclear when funding to train health professionals, a first-ever clinical guideline for menopause and a national awareness campaign will be introduced. But the coalition has vowed to follow through with these initiatives if reelected.
Why: as one caller to 774 ABC Radio Melbourne put it this week, ‘women are just used to putting up with stuff.’
‘I've always had the feeling that once you hit 65, once supposedly you’ve had your kids and you've helped a bit with the grandchildren that basically medically you're just forgotten,’ the caller continued.
The menopause initiative should help to shift that narrative, designed to support women experiencing menopause and perimenopause to receive appropriate care from their GP, and help to ensure informed conversations with trained healthcare professionals.
Impact: a 2024 Parliamentary inquiry into menopause found GPs have limited knowledge and perimenopause and menopause and are often unable to recognise symptoms.
Boosting healthcare education and knowledge, along with empowering women to advocate for their own health, should help to address this.
More clinics to address endometriosis and pelvic pain
What: 11 new clinics dedicated to endometriosis and pelvic pain will be opened, along with 33 existing clinics receiving more staff to provide specialist support for menopause
When: an unspecified date after the federal election. The coalition has vowed to match these initiatives if elected.
Why: endometriosis affects around one in 7 Australian women by age 44–49, often leading to severe pelvic pain, fertility issues, irritable bowel syndrome or mental health issues. Yet despite advancements in medicines and surgical treatments, there is still a high rate of recurrence.
A Victorian inquiry into women's pain and health also found that the pain women experience is often overlooked.
Impact: through more healthcare avenues, women can benefit from improved access to diagnostic, treatment and referral services for endometriosis and pelvic pain.
The announcement will break down barriers to healthcare access, especially in regional, rural and remote areas, reflecting the recommendations and work of the National Women’s Health Council, said A/Prof Sim, who co-chairs the Access, Care and Outcomes Subcommittee.
‘These are the recommendations our Council has been calling for,’ she added.
A summary of these announcements is below:
| What | When | Detail |
| Listing of two additional oral contraceptive pills on the PBS | 1 March 2025 | Yaz and Yasmin will be listed on the PBS as unrestricted benefits |
| Listing of three additional menopausal hormone therapies on PBS | 1 March 2025 | Estrogel, Prometrium and Estrogel Pro will be listed on the PBS as unrestricted benefits |
| Pharmacy trials of OCP prescribing and treating uncomplicated UTIs | Early 2026* | Free-of-charge UTI and OCP consultations in community pharmacies for concession card holders, with prescribed medicines available via the PBS |
| Increased access to long-term contraceptives | Unknown* | Increased rebates and new Medicare rebates for IUD and hormonal implant insertions. Eight training centres to be established to increase clinician skill and confidence |
| Medicare support for menopause | From 1 July 2025 | New Medicare rebate for menopause health assessments Training, guidelines and a public awareness campaign will also be developed |
| Additional endometriosis and pelvic pain clinics | Unknown* | 11 new clinics (in addition to 33 currently existing) dedicated to endometriosis and pelvic pain |
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[post_content] => PSA has long advocated for nationally consistent vaccine regulations, allowing pharmacist immunisers in all practice settings to be able to administer all vaccines to patients of all ages.
With South Australia recently becoming the first jurisdiction to authorise and administer all vaccines to all patients, will other jurisdictions follow suit?
Australian Pharmacist investigates what this means for South Australian pharmacists, patients and our national approach to vaccination.
Pharmacists can now self-determine their scope of practice
In South Australia, pharmacists were previously authorised to administer vaccines under the Vaccine Administration Code (VAC), which wasn’t fit for purpose for pharmacists operating outside public health settings, said PSA SA/NT State Manager Helen Stone MPS.
‘The VAC had been initially formulated for nurse immunisers, with pharmacists included in 2015 to enable us to provide influenza vaccines in South Australia,’ she said. ‘But it became obvious during the pandemic that it wasn't fit for purpose.’
The recent legislation change includes a removal of pharmacists from the VAC, allowing trained pharmacists to continue to have authority to both administer the vaccines they provided under the VAC along with additional vaccines.
[caption id="attachment_28651" align="alignnone" width="533"] From centre: PSA SA/NT President Manya Angley FPS, Matthew Gillespie and Minister for Health and Wellbeing Chris Picton MP[/caption]
This means pharmacist immunisers in South Australia can now administer all vaccines included in the Australian Immunisation Handbook (AIH), or as determined by the Minister.
With these barriers now removed, pharmacists can now self-determine their vaccination scope of practice, said Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
‘Pharmacists are required to plan their annual professional development, and PSA recommends an annual update with our annual refresher courses,’ he said.
‘The responsibility now is on pharmacists, as it is for all immunisers, to start to close the gap on our immunisation rates, particularly for the most vulnerable.’
Unnecessary admin will be removed
Beyond widening the variety of vaccines pharmacists can administer and to whom, the legislation change will also help to reduce the duplication of administration work for pharmacists, said Ms Stone.
‘To be able to offer vaccination services in South Australia, pharmacists previously had to file a lot of paperwork,’ she said.
This included registering a pharmacy as an approved organisation and updating this information to the Pharmacy Regulation Authority SA (PRASA) as well as the Communicable Disease Control Branch (CDCB).
‘Now, only PRASA registration is required to operate a pharmacy in SA, reducing administrative burden,’ said Ms Stone.
‘Pharmacists also need to register with the Vaccine Distribution Center (VDC) to place an order and access the National Immunisation Program (NIP) stock.’
Travel health and private vaccines will be the first step
By widening access to vaccines, patients in South Australia will now have the opportunity to access travel and private vaccines such as hepatitis A and B, typhoid, cholera and rabies.
Several vaccines recommended in AIH are not covered under the NIP, but that doesn’t mean they are not important – particularly for those who are travelling, said Mr Campbell.
‘We know the awareness of what vaccines patients will need when travelling to certain countries is not high,’ he said. ‘We want to make sure people know they can come to the pharmacy now in South Australia and receive the right vaccines for the area they are going to.’
However, access to NIP stock for pharmacist-administered vaccines remains restricted to patients who are 5 years and older. So while there is no longer an age limit for pharmacist- administered vaccines, out-of-pocket costs will still apply, said Ms Stone.
‘For children under 5 years, if eligible for an NIP vaccine, pharmacists might refer them on to a GP [at this stage] so they can access a funded vaccine,’ she said.
In discussions with the federal Department of Health, PSA has requested for an expansion to the funding schedule to cover all vaccines on the NIP for pharmacist administration, said Mr Campbell.
‘PSA will continue our advocacy to extend NIP access to all vaccines for all eligible people, he added.
This includes an expansion of the program to children who are under 5 years of age, which is particularly crucial with childhood vaccination rates decreasing across Australia.
More opportunities for pharmacists will open up
Combined with the recent determination in South Australia allowing pharmacists to administer medicines by injection, this opens up the potential for a full clinical service for people who need assistance with administering medicines, said Ms Stone.
‘It might be that a patient was recently discharged from hospital and they need to inject Clexane or a 6-monthly injection of denosumab, for example,’ she said.
‘There's lots of newer medicines on the market that are injectable, and not everybody feels comfortable injecting themselves, so pharmacists might decide that they want to offer a comprehensive service around medicine administration.’
With the authority to administer all vaccines to patients of all ages, pharmacists may also benefit from a wider variety of roles – including in GP clinics and public health units.
Having pharmacists as part of a broader care team that can administer all vaccines should help to increase vaccination rates – particularly in areas where access to care is limited.
‘There are towns where the pharmacy is the only health provider, so this will be one of many new services that all pharmacists will be able to deliver to support access,’ said Mr Campbell.
But rather than focusing on pharmacists replacing other vaccine providers, broadening the legislation is designed to improve access in accordance with the ‘No Wrong Door’ principle.
‘Pharmacists are trained immunisers who should be able to immunise against any condition, as other providers can,’ he said.
The legislation change will future proof us for the next pandemic
Invariably, a new variant of a virus or other pathogen will spread that could become a future pandemic. So when a vaccine is developed to safeguard the population, this regulation change allows a fast-tracked pathway to vaccine access, said Mr Campbell.
‘There won’t be any legislative instrument changes, parliamentary decisions or emergency measures that need to be made to allow that to happen,’ he said.
This will allow pharmacists to administer new vaccines without red tape roadblocks in place.
‘When there's a vaccine that becomes available that's not in the AIH, we can provide advice to the Minister in terms of the pharmacy profession's response to any emerging trend,’ said Ms Stone.
This allows pharmacists to focus on patient care.
‘When a new vaccine comes in, pharmacists can focus on, “Who is this recommended for? What do I need to know about this vaccine? What do I need to know about that condition?” to support the patient in front of them, rather than being concerned about the nuanced details of a legal instrument,’ said Mr Campbell.
Other jurisdictions are expected to follow suit
It’s hoped that other jurisdictions will follow South Australia's lead and remove vaccination red tape, as soon as practical, said Mr Campbell.
‘Harmonisation that allows access to care, when a health professional has the education and training and it is within their scope, was one of the clear recommendations during the Scope of Practice Review,’ he said.
This should improve patients’ ability to make informed decisions and have access to the vaccines they need.
‘Currently, patients might see a pharmacist for some vaccines and another provider for others. So this is a much more crisp and simple message,’ said Mr Cambell.
‘In the future, people will see pharmacies and know they can get access to all immunisations they are eligible for and recommended to receive.’
PSA is currently in discussions with every state and territory, calling on them to similarly remove barriers and allow pharmacists to provide all vaccines to patients of all ages, said Mr Campbell.
‘We've also approached the federal government around funding the NIP for an expanded age access for pharmacist-administered vaccines,’ he said. ‘People shouldn't be penalised for choosing to get immunised in a pharmacy, if that's the place they choose.’
[post_title] => This state enacted a game-changing vaccine legislation change
[post_excerpt] => This bold legislation move will remove red tape and broaden vaccine access. But will other jurisdictions to follow suit?
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[post_content] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
Think you’ve mastered cold chain protocol? Think again. PSA’s Pharmacist-to-Pharmacist Advice Line receives more calls than you may think about risks to cold chain and possible breaches.
So what problems do pharmacists call with? PSA’s expert pharmacist advisors have rounded up some of their most pressing queries… and how they helped pharmacists find a resolution.
1. Do I still have to manually measure the fridge temperature if I have a data logger?
Yes!
A pharmacist who recently contacted the Pharmacist-to-Pharmacist Advice Line was surprised to learn during an audit that despite having a temperature data logger for her pharmacy’s vaccine fridge, she was not compliant with cold chain regulations, said Pooja Jadeja MPS.
[caption id="attachment_28631" align="alignright" width="209"] Pooja Jadeja MPS[/caption]
‘Pharmacies are often under the impression that when they've passed Quality Care Pharmacy Program (QCPP) requirements, that they are up to date,’ she said.
‘But QCPP compliance doesn’t factor in this national guidelines requirement. And during an [regulatory] audit, they are informed that they have to manually log the maximum/minimum temperatures twice a day in order to be compliant with the “Strive for 5” National Vaccine Storage Guidelines.’
So why do pharmacists need to manually record this data when they have an automated process in place?
‘Data loggers are generally linked to the pharmacy email [account], and with the plethora of emails coming through, pharmacists often miss alerts and aren't checking maximum/minimum temperatures on a daily basis,’ said Ms Jadeja.
‘Doing a manual check at the beginning and end of the day will identify a cold chain breach in a timely manner so that action can be taken accordingly.’
When a pharmacy is deemed non-compliant with the Strive for 5, they will need to sift through their data logs to prove their vaccine fridge has been within the required temperature range.
‘They would have to go in and check the data logger temperatures’ she said. ‘Then put a plan in place to ensure they are checking [temperatures] regularly, and submit that to the [health department] with evidence to show they have taken steps to record manual readings,’ she said.
2. What happens to NIP stock if the power goes out?
Severe storms hit Sydney and regional New South Wales in mid-January, leading to mass power outages.
One affected premise happened to be a small pharmacy, which went on to experience a cold chain breach.
‘The power outage went for over 15 minutes, so they had to dispose of all of their vaccine stock, including [National Immunisation Program] stock, and some private vaccines,’ said Ms Jadeja.
But before disposing of the vaccines, Ms Jadeja advised the pharmacy to declare the NIP stock that was affected by the cold chain breach.
‘Any cold chain breach of NIP stock must be reported to the relevant state or territory health department and [depending on the jurisdiction] disposed of immediately,’ she said. ‘Then the pharmacy can place an order for new NIP stock.’
Before discarding NIP stock, contact your jurisdiction's health department or check health department guidance specific to your state of territory.
For any other vaccines or refrigerated medicine, a record must be kept on the length of the breach and what temperature the fridge reached.
‘This can be checked with either the fridge maximum/minimum temperature log at the front or via the data logger,’ said Ms Jajeda.
Pharmacists must consult the product manufacturer about next steps.
‘In 99% of cases, vaccines have to be disposed of, and that's a loss the pharmacy takes,’ she said.
‘But other medicines may be okay for a certain period of time at a higher temperature, depending on how high the temperature went and how long it stayed at that temperature.’
3. Can vaccines be removed from their packing and stored in a basket in the fridge?
In short: it’s a very bad idea.
Vaccine packaging can be relatively bulky, particularly if it includes outer cartons, pre-filled syringes or vials with diluents, taking up valuable refrigeration space.
So what’s the harm in taking the product out of its original packing to fit more into the vaccine fridge?
One pharmacist found out exactly why this is not advisable post-audit.
‘When vaccines are exposed to light, this can degrade the vaccine and cause it to lose potency,’ said Ms Jadeja. ‘So this pharmacist had to throw out all the vaccines that had been removed from the packaging.’
According to Strive for 5 National Vaccine Storage Guidelines, the outer carton not only protects vials or syringes from light and temperature fluctuations when the refrigerator door is opened, but also includes critical information such as the batch number, expiry date, and product inserts – which may be important for reference and monitoring.
4. What’s the worst-case scenario in the event of a cold chain breach?
When one pharmacy’s fridge temperature was compromised, the team only realised a week later after checking the data logger that a significant cold chain breach had occurred.
From there, the pharmacy had to check how long the fridge temperature was affected and what temperature it reached to determine if each vaccine is still viable and effective, said PSA NSW State Manager Amanda Fairjones MPS.
‘Pharmacists should consult the vaccine manufacturer and ask if they have data to show the vaccine is still effective at 8° C, and at a maximum of 15°C, for example.’
In the case of a cold chain breach, pharmacists must report it to their local public health unit and isolate affected vaccines with a ‘DO NOT USE’ sign, and if possible, transfer them to another vaccine fridge while maintaining +2°C to +8°C.
Download and review the data log, keeping the logger in place if power fails.
But if push comes to shove, pharmacists may have to revaccinate patients who were immunised during the duration of the cold chain breach.
Getting on top of the issue early can help to prevent the unfortunate event of a media notification, as was the case with Holy Family Medical Centre in Sydney’s inner west.
More than 1,200 of the practice’s patients, including hundreds of children under 5 years of age receiving their first vaccinations, were advised that vaccines administered over a 4.5-year period might have been less effective due to improper storage.
This can not only undermine confidence in a business, but in vaccination more broadly.
Did you know you need to do an annual self-audit of cold chain?
To comply with national cold chain requirements, pharmacists must complete a Vaccine storage self-audit at least every 12 months.
‘This is something pharmacists should do [annually] to identify any gaps in their cold chain management protocol, which will ensure that they remain compliant with cold chain management,’ said Ms Jadeja.
The self-audit tool covers storage procedures, fridge certification requirements and having the cold chain breach protocol on display in the pharmacy.
‘It just ensures your pharmacy is ready for any incident that may occur, because you can't plan for incidents,’ she said.
And if you are based in New South Wales, you may be paid a visit by an auditor sooner rather than later.
Because vaping regulations changed in 2024, with vaping products downscheduled to Pharmacist Only medicines, pharmacists are being audited more frequently.
‘These audits are designed to educate pharmacists on how to [prescribe] vapes in a compliant manner,’ said Ms Jadeja. ‘While they're checking vaping products are stored correctly and whether we know how to do the [Special Access Scheme] approvals, they're also checking everything else, including cold chain storage.’
For advice on all things pharmacy, ring PSA’s Pharmacist-to-Pharmacist Advice Line between 8.30am to 5.00pm AEST on 1300 369 772.
This article was updated on 6 February 2025 clarify what pharmacists should do in the event of compromised NIP stock due to a cold chain breach.
[post_title] => Don’t let a cold chain breach take you by surprise
[post_excerpt] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
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[post_content] => The popular weight-loss drug has been approved to treat cardiovascular disease in patients who are overweight or obese.
The Therapeutic Goods Administration (TGA) approval is based on results from the SELECT double-blind, randomised, placebo-controlled trial – a global study conducted in 41 countries, including Australia, with over 17,000 participants.
Australian Pharmacist spoke with Professor Stephen Nicholls, lead of the Australian arm of the SELECT trial, about the significance of this new indication and what pharmacists need to know.
What impact does a Wegovy have on cardiovascular risk?
It has been well known for many years that being overweight or obese is a major risk factor for heart disease, said Prof Nicholls.
[caption id="attachment_28714" align="alignnone" width="700"] Professor Stephen Nicholls[/caption]
‘And in people who have had a heart attack, the presence of overweight or obesity is associated with a worse risk of having another event – but there's nothing specifically that we've been able to do for these people.’
For decades, clinical trials for weight loss drugs have shown no benefit in reducing cardiovascular risk in these patients.
‘But here you have a trial where we specifically targeted people who were overweight, and it reduced their risk,’ he said.
Participants in the SELECT trial had cardiovascular disease, overweight or obesity, but without diabetes, said Professor Stephen Nicholls.
‘The trial found that giving them semaglutide reduced their risk of having another event by 20%,’ he said. ‘That's a game changer – both for the drug and the field.’
What makes a patient eligible for Wegovy for cardiovascular disease?
The new TGA indication for Wegovy is as a complementary therapy for reducing major adverse cardiovascular events such as cardiovascular death, heart attack, or non-fatal stroke in adults with:
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[post_content] => Checking a patient's photo identification (ID) can be both a useful – and mandatory – practice.
Australian Pharmacist explores the instances where minimum practice and legal obligations require pharmacists to verify photo ID.
Signing a statutory declaration as a witness
Under the Statutory Declarations Regulations 2023 and various state/territory regulations, pharmacists are approved to witness a Commonwealth statutory declaration.
The Statutory Declarations Act 1959 contains surprisingly little guidance on the responsibility of a witness. While the Act does not require witnesses to confirm a declarant’s identity or validity of their statement, there is an expectation witnesses are confident the person making the declaration is not acting fraudulently or under coercion.
Whether to increase confidence in a person’s identity, allay doubts or improve workflow, if the declarant is not known to them, pharmacists should request photo ID – or may choose to refuse to witness the Commonwealth statutory declaration altogether.
This approach also helps with consistency, as different types of declarations have different identity verification requirements. For example, in Victoria, the Oaths and Affirmations Act 2018 says a witness must not sign a statutory declaration unless the authorised witness has taken reasonable steps to ensure the declarant is the person named in the statutory declaration.
If the witness doesn’t know the declarant personally, the quickest and most reliable form of proof is always likely to be photo ID.
Signing a patient up for Active Script Lists
Following the implementation of the Active Script List (ASL) functionality, the Active Script List Release 1 – Privacy Framework was released in May 2021 – requiring pharmacists to verify a patient’s identity for ASL registration.
To confirm a patient's identity, pharmacists are legally required to check both a current government-issued photo ID and a Medicare or Department of Veteran Affairs card.
If the patient doesn't have a photo ID, pharmacists can either verify 100 points of other ID (along with their Medicare or DVA card) – or apply the ‘known patient model’.
The threshold for the ‘known patient model’ may surprise you. The patient must already be familiar to the individual pharmacist and have had at least four prescriptions filled in their name at that pharmacy in the past year.
Prescribing pseudoephedrine
Due to the potential for misuse, in most jurisdictions, pharmacists are required to sight or record certain details when prescribing medicines containing pseudoephedrine as Pharmacist Only medicines – including identity verification.
But the requirements vary from state to state.
For example in South Australia, pharmacists must not supply pseudoephedrine unless patients provide a form of photo ID or their birth certificate.
In NSW, the Poisons and Therapeutic Goods Regulation 2008 requires pharmacists to record a unique reference number, the supplier’s name, the patient’s name and address, and the product name, strength, quantity, and supply date. Importantly, if the recipient’s identity is unknown, pharmacists must record the unique reference number of a form of photo ID. And the implications of failing to do so are dire – resulting in up to 20 penalty units, 3 months' imprisonment – or both.
Establishing patient identity for enrolment in opioid dependence therapy
Critical to patient safety in opioid dependence therapy is correct identification, as administering a dose to the wrong patient can lead to a fatal overdose.
Positive patient identification is critical to validating someone’s identity accurately when establishing a person in the program, particularly when biometric data is collected.
Biometric identification systems, such as iris scanning, can be helpful in pharmacotherapy programs such as opioid dependence treatment for verifying patient identity, reducing the risk of diversion and dramatically streamlining workflow.
Photo identification at the time of establishing the profile can be valuable in supporting this. Most jurisdictions also have workaround options to establish patient identity (e.g. photo of patient signed by the prescriber) where photo identification is not available.
Dispensing controlled drugs (S8)
If a patient is not known to a pharmacy or their Medicare card details are unspecified, asking for photo identification can be useful to confirm identity when dispensing controlled substances.
This can be helpful in establishing the prescription is for a real person and reduce the risk of someone accessing Controlled Drugs through impersonation.
While this will be normal practice for many pharmacists, some may be surprised at specific requirements in their state and territory poisons regulations.. For example, in:
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[post_content] => Over the weekend, the Albanese Government announced a $573 million commitment to national women’s health initiatives, to bipartisan support.
So what is actually happening? And when?
Australian Pharmacist takes a ‘deep dive’ to help pharmacists navigate these life-changing initiatives for women.
Two new oral contraceptive pills listed on the PBS
What: oral contraceptive pills (OCP) Yaz (drospirenone/Three new MHTs also set to be included on the PBS
What: the menopausal hormone therapies (MHTs) Estrogel (estradiol), Prometrium (progesterone) and Estrogel Pro (estragio/progesterone) will also be listed on the PBS – marking the first MHT listings in 20 years.
When: from 1 March 2025
Why: various MHTs, including strengths of Estalis (estradiol /norethisterone acetate) and Estradot (estradiol) transdermal patches, have been in short supply for months, forcing women to pay hundreds of dollars annually for substitutions under Section 19A of the Therapeutic Goods Act or newer, unsubsidised MHTs.
The TGA has also warned that supply shortages of some PBS-listed menopause treatments will persist throughout 2025.
PBAC recommended the listing of Prometrium, Estrogel and Estrogel Pro as General Schedule unrestricted benefit listings, with corresponding General Schedule restricted benefit listings for 60-day maximum dispensed quantities.
These new PBS subsidies also follow a 2024 Parliamentary Inquiry recommendation to make newer menopause therapies more affordable and accessible.
And because these medications match the body’s own hormones more closely, many women find they experience fewer or milder side effects compared to older therapies.
Impact: the new PBS subsidies mean women will soon be able to pay substantially less for modern menopause therapy – reducing the cost from around $650 per year to as little as $7.70 or $31.60 a month for around 150,000 women.
‘Prometrium, Estrogel and Estrogel Pro are all commonly used hormone replacement therapy,’ said PSA National President Associate Professor Fei Sim FPS.
‘Having them on the PBS means they will be subsidised for women who need them, better supporting women experiencing perimenopause and menopause.’
A national approach for OCP access and treating uncomplicated UTIs directly from pharmacies
What: national OCP and urinary tract infection (UTI) pharmacy trials, allowing pharmacists to initiate PBS medicines for the first time ever.
When: early 2026. At this stage, these trials are part of Labor’s election platform, however the coalition has vowed to match this measure.
Why: the nation-wide trials are designed to boost access to treatment for uncomplicated UTIs and hormonal contraception through community pharmacists at PBS medicine cost.
Impact: around 250,000 concession cardholders will be able to consult a trained pharmacist free of charge. And if medication is required, they will only need to pay the standard cost of the medicine.
Enabling appropriately trained pharmacists to prescribe treatment for uncomplicated UTI and contraceptives under the PBS will allow for equitable, affordable healthcare for women and girls, said A/Prof Sim.
‘We all know that when experiencing symptoms of UTI, timely treatment is critical,’ she said.
Previously, when prescribing and management of these acute conditions were undertaken, patients often faced additional out-of-pocket costs to see a pharmacist versus a GP.
‘[Allowing] pharmacists to prescribe treatment under the PBS means there is no discrimination with care,’ she added.
Widened access to long-term contraceptives at a lower cost
When: unknown at this stage. The coalition has vowed to match this measure.
Why: only 6% of Australian women use an Intrauterine device (IUD), with 5% opting for the contraceptive implant – partly due to a lack of awareness about these options.
Access is further impacted by difficulties finding trained GPs, coupled with long waiting times, for insertions.
While a slight Medicare rebate increase was introduced in 2022, it doesn’t cover the costs and time required for IUD insertion – discouraging many GPs from offering the service. The high cost of training also makes it challenging for GPs to gain the necessary qualifications.
Impact: the new women’s health package improves access to IUDs and implants by increasing clinician rebates and introducing Medicare coverage for nurse practitioner insertions. It also incentivises GPs to bulk bill insertions, eliminating out-of-pocket costs for women. Eight training centers will also be established across Australia to enhance clinician skills and confidence in IUD insertion.
‘This should make it more affordable and much easier for women to find a clinician to insert it,’ said Danielle Mazza, Director, SPHERE NHMRC Centre of Research Excellence in Women's Sexual and Reproductive Health in Primary Care.
New Medicare support for menopause
What: a new Medicare rebate for menopause health assessments
When: from 1 July 2025
It is unclear when funding to train health professionals, a first-ever clinical guideline for menopause and a national awareness campaign will be introduced. But the coalition has vowed to follow through with these initiatives if reelected.
Why: as one caller to 774 ABC Radio Melbourne put it this week, ‘women are just used to putting up with stuff.’
‘I've always had the feeling that once you hit 65, once supposedly you’ve had your kids and you've helped a bit with the grandchildren that basically medically you're just forgotten,’ the caller continued.
The menopause initiative should help to shift that narrative, designed to support women experiencing menopause and perimenopause to receive appropriate care from their GP, and help to ensure informed conversations with trained healthcare professionals.
Impact: a 2024 Parliamentary inquiry into menopause found GPs have limited knowledge and perimenopause and menopause and are often unable to recognise symptoms.
Boosting healthcare education and knowledge, along with empowering women to advocate for their own health, should help to address this.
More clinics to address endometriosis and pelvic pain
What: 11 new clinics dedicated to endometriosis and pelvic pain will be opened, along with 33 existing clinics receiving more staff to provide specialist support for menopause
When: an unspecified date after the federal election. The coalition has vowed to match these initiatives if elected.
Why: endometriosis affects around one in 7 Australian women by age 44–49, often leading to severe pelvic pain, fertility issues, irritable bowel syndrome or mental health issues. Yet despite advancements in medicines and surgical treatments, there is still a high rate of recurrence.
A Victorian inquiry into women's pain and health also found that the pain women experience is often overlooked.
Impact: through more healthcare avenues, women can benefit from improved access to diagnostic, treatment and referral services for endometriosis and pelvic pain.
The announcement will break down barriers to healthcare access, especially in regional, rural and remote areas, reflecting the recommendations and work of the National Women’s Health Council, said A/Prof Sim, who co-chairs the Access, Care and Outcomes Subcommittee.
‘These are the recommendations our Council has been calling for,’ she added.
A summary of these announcements is below:
| What | When | Detail |
| Listing of two additional oral contraceptive pills on the PBS | 1 March 2025 | Yaz and Yasmin will be listed on the PBS as unrestricted benefits |
| Listing of three additional menopausal hormone therapies on PBS | 1 March 2025 | Estrogel, Prometrium and Estrogel Pro will be listed on the PBS as unrestricted benefits |
| Pharmacy trials of OCP prescribing and treating uncomplicated UTIs | Early 2026* | Free-of-charge UTI and OCP consultations in community pharmacies for concession card holders, with prescribed medicines available via the PBS |
| Increased access to long-term contraceptives | Unknown* | Increased rebates and new Medicare rebates for IUD and hormonal implant insertions. Eight training centres to be established to increase clinician skill and confidence |
| Medicare support for menopause | From 1 July 2025 | New Medicare rebate for menopause health assessments Training, guidelines and a public awareness campaign will also be developed |
| Additional endometriosis and pelvic pain clinics | Unknown* | 11 new clinics (in addition to 33 currently existing) dedicated to endometriosis and pelvic pain |
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[post_content] => PSA has long advocated for nationally consistent vaccine regulations, allowing pharmacist immunisers in all practice settings to be able to administer all vaccines to patients of all ages.
With South Australia recently becoming the first jurisdiction to authorise and administer all vaccines to all patients, will other jurisdictions follow suit?
Australian Pharmacist investigates what this means for South Australian pharmacists, patients and our national approach to vaccination.
Pharmacists can now self-determine their scope of practice
In South Australia, pharmacists were previously authorised to administer vaccines under the Vaccine Administration Code (VAC), which wasn’t fit for purpose for pharmacists operating outside public health settings, said PSA SA/NT State Manager Helen Stone MPS.
‘The VAC had been initially formulated for nurse immunisers, with pharmacists included in 2015 to enable us to provide influenza vaccines in South Australia,’ she said. ‘But it became obvious during the pandemic that it wasn't fit for purpose.’
The recent legislation change includes a removal of pharmacists from the VAC, allowing trained pharmacists to continue to have authority to both administer the vaccines they provided under the VAC along with additional vaccines.
[caption id="attachment_28651" align="alignnone" width="533"] From centre: PSA SA/NT President Manya Angley FPS, Matthew Gillespie and Minister for Health and Wellbeing Chris Picton MP[/caption]
This means pharmacist immunisers in South Australia can now administer all vaccines included in the Australian Immunisation Handbook (AIH), or as determined by the Minister.
With these barriers now removed, pharmacists can now self-determine their vaccination scope of practice, said Chris Campbell MPS, PSA General Manager Policy and Program Delivery.
‘Pharmacists are required to plan their annual professional development, and PSA recommends an annual update with our annual refresher courses,’ he said.
‘The responsibility now is on pharmacists, as it is for all immunisers, to start to close the gap on our immunisation rates, particularly for the most vulnerable.’
Unnecessary admin will be removed
Beyond widening the variety of vaccines pharmacists can administer and to whom, the legislation change will also help to reduce the duplication of administration work for pharmacists, said Ms Stone.
‘To be able to offer vaccination services in South Australia, pharmacists previously had to file a lot of paperwork,’ she said.
This included registering a pharmacy as an approved organisation and updating this information to the Pharmacy Regulation Authority SA (PRASA) as well as the Communicable Disease Control Branch (CDCB).
‘Now, only PRASA registration is required to operate a pharmacy in SA, reducing administrative burden,’ said Ms Stone.
‘Pharmacists also need to register with the Vaccine Distribution Center (VDC) to place an order and access the National Immunisation Program (NIP) stock.’
Travel health and private vaccines will be the first step
By widening access to vaccines, patients in South Australia will now have the opportunity to access travel and private vaccines such as hepatitis A and B, typhoid, cholera and rabies.
Several vaccines recommended in AIH are not covered under the NIP, but that doesn’t mean they are not important – particularly for those who are travelling, said Mr Campbell.
‘We know the awareness of what vaccines patients will need when travelling to certain countries is not high,’ he said. ‘We want to make sure people know they can come to the pharmacy now in South Australia and receive the right vaccines for the area they are going to.’
However, access to NIP stock for pharmacist-administered vaccines remains restricted to patients who are 5 years and older. So while there is no longer an age limit for pharmacist- administered vaccines, out-of-pocket costs will still apply, said Ms Stone.
‘For children under 5 years, if eligible for an NIP vaccine, pharmacists might refer them on to a GP [at this stage] so they can access a funded vaccine,’ she said.
In discussions with the federal Department of Health, PSA has requested for an expansion to the funding schedule to cover all vaccines on the NIP for pharmacist administration, said Mr Campbell.
‘PSA will continue our advocacy to extend NIP access to all vaccines for all eligible people, he added.
This includes an expansion of the program to children who are under 5 years of age, which is particularly crucial with childhood vaccination rates decreasing across Australia.
More opportunities for pharmacists will open up
Combined with the recent determination in South Australia allowing pharmacists to administer medicines by injection, this opens up the potential for a full clinical service for people who need assistance with administering medicines, said Ms Stone.
‘It might be that a patient was recently discharged from hospital and they need to inject Clexane or a 6-monthly injection of denosumab, for example,’ she said.
‘There's lots of newer medicines on the market that are injectable, and not everybody feels comfortable injecting themselves, so pharmacists might decide that they want to offer a comprehensive service around medicine administration.’
With the authority to administer all vaccines to patients of all ages, pharmacists may also benefit from a wider variety of roles – including in GP clinics and public health units.
Having pharmacists as part of a broader care team that can administer all vaccines should help to increase vaccination rates – particularly in areas where access to care is limited.
‘There are towns where the pharmacy is the only health provider, so this will be one of many new services that all pharmacists will be able to deliver to support access,’ said Mr Campbell.
But rather than focusing on pharmacists replacing other vaccine providers, broadening the legislation is designed to improve access in accordance with the ‘No Wrong Door’ principle.
‘Pharmacists are trained immunisers who should be able to immunise against any condition, as other providers can,’ he said.
The legislation change will future proof us for the next pandemic
Invariably, a new variant of a virus or other pathogen will spread that could become a future pandemic. So when a vaccine is developed to safeguard the population, this regulation change allows a fast-tracked pathway to vaccine access, said Mr Campbell.
‘There won’t be any legislative instrument changes, parliamentary decisions or emergency measures that need to be made to allow that to happen,’ he said.
This will allow pharmacists to administer new vaccines without red tape roadblocks in place.
‘When there's a vaccine that becomes available that's not in the AIH, we can provide advice to the Minister in terms of the pharmacy profession's response to any emerging trend,’ said Ms Stone.
This allows pharmacists to focus on patient care.
‘When a new vaccine comes in, pharmacists can focus on, “Who is this recommended for? What do I need to know about this vaccine? What do I need to know about that condition?” to support the patient in front of them, rather than being concerned about the nuanced details of a legal instrument,’ said Mr Campbell.
Other jurisdictions are expected to follow suit
It’s hoped that other jurisdictions will follow South Australia's lead and remove vaccination red tape, as soon as practical, said Mr Campbell.
‘Harmonisation that allows access to care, when a health professional has the education and training and it is within their scope, was one of the clear recommendations during the Scope of Practice Review,’ he said.
This should improve patients’ ability to make informed decisions and have access to the vaccines they need.
‘Currently, patients might see a pharmacist for some vaccines and another provider for others. So this is a much more crisp and simple message,’ said Mr Cambell.
‘In the future, people will see pharmacies and know they can get access to all immunisations they are eligible for and recommended to receive.’
PSA is currently in discussions with every state and territory, calling on them to similarly remove barriers and allow pharmacists to provide all vaccines to patients of all ages, said Mr Campbell.
‘We've also approached the federal government around funding the NIP for an expanded age access for pharmacist-administered vaccines,’ he said. ‘People shouldn't be penalised for choosing to get immunised in a pharmacy, if that's the place they choose.’
[post_title] => This state enacted a game-changing vaccine legislation change
[post_excerpt] => This bold legislation move will remove red tape and broaden vaccine access. But will other jurisdictions to follow suit?
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[post_content] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
Think you’ve mastered cold chain protocol? Think again. PSA’s Pharmacist-to-Pharmacist Advice Line receives more calls than you may think about risks to cold chain and possible breaches.
So what problems do pharmacists call with? PSA’s expert pharmacist advisors have rounded up some of their most pressing queries… and how they helped pharmacists find a resolution.
1. Do I still have to manually measure the fridge temperature if I have a data logger?
Yes!
A pharmacist who recently contacted the Pharmacist-to-Pharmacist Advice Line was surprised to learn during an audit that despite having a temperature data logger for her pharmacy’s vaccine fridge, she was not compliant with cold chain regulations, said Pooja Jadeja MPS.
[caption id="attachment_28631" align="alignright" width="209"] Pooja Jadeja MPS[/caption]
‘Pharmacies are often under the impression that when they've passed Quality Care Pharmacy Program (QCPP) requirements, that they are up to date,’ she said.
‘But QCPP compliance doesn’t factor in this national guidelines requirement. And during an [regulatory] audit, they are informed that they have to manually log the maximum/minimum temperatures twice a day in order to be compliant with the “Strive for 5” National Vaccine Storage Guidelines.’
So why do pharmacists need to manually record this data when they have an automated process in place?
‘Data loggers are generally linked to the pharmacy email [account], and with the plethora of emails coming through, pharmacists often miss alerts and aren't checking maximum/minimum temperatures on a daily basis,’ said Ms Jadeja.
‘Doing a manual check at the beginning and end of the day will identify a cold chain breach in a timely manner so that action can be taken accordingly.’
When a pharmacy is deemed non-compliant with the Strive for 5, they will need to sift through their data logs to prove their vaccine fridge has been within the required temperature range.
‘They would have to go in and check the data logger temperatures’ she said. ‘Then put a plan in place to ensure they are checking [temperatures] regularly, and submit that to the [health department] with evidence to show they have taken steps to record manual readings,’ she said.
2. What happens to NIP stock if the power goes out?
Severe storms hit Sydney and regional New South Wales in mid-January, leading to mass power outages.
One affected premise happened to be a small pharmacy, which went on to experience a cold chain breach.
‘The power outage went for over 15 minutes, so they had to dispose of all of their vaccine stock, including [National Immunisation Program] stock, and some private vaccines,’ said Ms Jadeja.
But before disposing of the vaccines, Ms Jadeja advised the pharmacy to declare the NIP stock that was affected by the cold chain breach.
‘Any cold chain breach of NIP stock must be reported to the relevant state or territory health department and [depending on the jurisdiction] disposed of immediately,’ she said. ‘Then the pharmacy can place an order for new NIP stock.’
Before discarding NIP stock, contact your jurisdiction's health department or check health department guidance specific to your state of territory.
For any other vaccines or refrigerated medicine, a record must be kept on the length of the breach and what temperature the fridge reached.
‘This can be checked with either the fridge maximum/minimum temperature log at the front or via the data logger,’ said Ms Jajeda.
Pharmacists must consult the product manufacturer about next steps.
‘In 99% of cases, vaccines have to be disposed of, and that's a loss the pharmacy takes,’ she said.
‘But other medicines may be okay for a certain period of time at a higher temperature, depending on how high the temperature went and how long it stayed at that temperature.’
3. Can vaccines be removed from their packing and stored in a basket in the fridge?
In short: it’s a very bad idea.
Vaccine packaging can be relatively bulky, particularly if it includes outer cartons, pre-filled syringes or vials with diluents, taking up valuable refrigeration space.
So what’s the harm in taking the product out of its original packing to fit more into the vaccine fridge?
One pharmacist found out exactly why this is not advisable post-audit.
‘When vaccines are exposed to light, this can degrade the vaccine and cause it to lose potency,’ said Ms Jadeja. ‘So this pharmacist had to throw out all the vaccines that had been removed from the packaging.’
According to Strive for 5 National Vaccine Storage Guidelines, the outer carton not only protects vials or syringes from light and temperature fluctuations when the refrigerator door is opened, but also includes critical information such as the batch number, expiry date, and product inserts – which may be important for reference and monitoring.
4. What’s the worst-case scenario in the event of a cold chain breach?
When one pharmacy’s fridge temperature was compromised, the team only realised a week later after checking the data logger that a significant cold chain breach had occurred.
From there, the pharmacy had to check how long the fridge temperature was affected and what temperature it reached to determine if each vaccine is still viable and effective, said PSA NSW State Manager Amanda Fairjones MPS.
‘Pharmacists should consult the vaccine manufacturer and ask if they have data to show the vaccine is still effective at 8° C, and at a maximum of 15°C, for example.’
In the case of a cold chain breach, pharmacists must report it to their local public health unit and isolate affected vaccines with a ‘DO NOT USE’ sign, and if possible, transfer them to another vaccine fridge while maintaining +2°C to +8°C.
Download and review the data log, keeping the logger in place if power fails.
But if push comes to shove, pharmacists may have to revaccinate patients who were immunised during the duration of the cold chain breach.
Getting on top of the issue early can help to prevent the unfortunate event of a media notification, as was the case with Holy Family Medical Centre in Sydney’s inner west.
More than 1,200 of the practice’s patients, including hundreds of children under 5 years of age receiving their first vaccinations, were advised that vaccines administered over a 4.5-year period might have been less effective due to improper storage.
This can not only undermine confidence in a business, but in vaccination more broadly.
Did you know you need to do an annual self-audit of cold chain?
To comply with national cold chain requirements, pharmacists must complete a Vaccine storage self-audit at least every 12 months.
‘This is something pharmacists should do [annually] to identify any gaps in their cold chain management protocol, which will ensure that they remain compliant with cold chain management,’ said Ms Jadeja.
The self-audit tool covers storage procedures, fridge certification requirements and having the cold chain breach protocol on display in the pharmacy.
‘It just ensures your pharmacy is ready for any incident that may occur, because you can't plan for incidents,’ she said.
And if you are based in New South Wales, you may be paid a visit by an auditor sooner rather than later.
Because vaping regulations changed in 2024, with vaping products downscheduled to Pharmacist Only medicines, pharmacists are being audited more frequently.
‘These audits are designed to educate pharmacists on how to [prescribe] vapes in a compliant manner,’ said Ms Jadeja. ‘While they're checking vaping products are stored correctly and whether we know how to do the [Special Access Scheme] approvals, they're also checking everything else, including cold chain storage.’
For advice on all things pharmacy, ring PSA’s Pharmacist-to-Pharmacist Advice Line between 8.30am to 5.00pm AEST on 1300 369 772.
This article was updated on 6 February 2025 clarify what pharmacists should do in the event of compromised NIP stock due to a cold chain breach.
[post_title] => Don’t let a cold chain breach take you by surprise
[post_excerpt] => From manual temperature checks to proper vaccine packaging, here’s what pharmacists need to know to protect patients, stock – and reputations.
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CPD credits
Accreditation Code : CAP2404SYPCP
Group 1 : 0.5 CPD credits
Group 2 : 1 CPD credits
This activity has been accredited for 0.5 hours of Group 1 CPD (or 0.5 CPD credits) suitable for inclusion in an individual pharmacist's CPD plan, which can be converted to 0.5 hours of Group 2 CPD (or 1 CPD credits) upon successful completion of relevant assessment activities.
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