As the peak body for all pharmacists practising across Australia’s health system, PSA highlights opportunities to support pharmacists as medicine experts to improve the quality use of medicines and medicine safety in all areas of practice.

PSA’s submission highlights opportunities to improve patient access to equitable healthcare and medicine safety by strengthening the role of pharmacists with sustainable funding models, calling for:

• Equitably funding pharmacist services, including annual indexation, rural and after-
  hours loading.
• Lifting remuneration to align with other health professions delivering vaccinations
  under the National Immunisation Program.
• Investing in First Nations health by funding the Integrating Pharmacists within
  Aboriginal Community Controlled Health Services (IPAC) program as recommended by
  the Medical Services Advisory Committee.
• Making medicines expertise and support more accessible to Australians living with
  chronic illness by doubling the Workforce Incentive Program funding for general
  practices that embed pharmacists, and funding pharmacists to participate in
  multidisciplinary case conferencing.
• Further supporting professional pharmacy practice by funding measures that bring
  standards and guidelines in line with growing scope of practice.

PSA National President, Associate Professor Fei Sim FPS, says that unlocking the full potential of pharmacists is critical to meeting the country’s growing health needs.

“Pharmacists are ready and willing to do more for our patients – now we need the tools and
support to do so sustainably,” she says.

“This budget is an opportunity to address long standing inequalities in funding, giving pharmacists the recognition that they deserve.

“Every day, Australians turn to their local pharmacist for timely, expert care. With investment in services, education, and workforce sustainability, we can continue to strengthen and scale up the services we provide, improving patient access to care and reducing pressure on the health system.

“Our message to government is clear, invest in pharmacists, and we will deliver better health outcomes for all Australians.”

PSA’s 2024-25 Federal Budget submission is available in full here: Budget Submissions.

Text by: PSA.

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For the first time, eligible patients will be able to obtain medicines for UTIs and hormonal contraceptives at Pharmaceutical Benefits Scheme (PBS) pricing, improving affordability and accessibility.

‘Breaking down healthcare barriers’

PSA National President Associate Professor Fei Sim FPS, who has co-chaired the Access, Care and Outcome Subcommittee under the federal government’s Women’s Health Advisory Council since 2023, describes the announcement as a significant step forward in breaking down healthcare barriers, particularly in rural and regional areas.

“Women deserve to receive timely, high-quality care, and pharmacists are trained and ready to support them in managing their health,” says Associate Professor Sim.

‘Announcement takes pharmacy programs further’

Associate Professor Sim emphasises the critical role pharmacists already play in enabling women to access treatment for UTIs and repeat prescriptions for hormonal contraceptives.

“This announcement will take these programs one step further, allowing pharmacists to initiate hormonal contraceptives and supply medications under the PBS for the first time,” she says.

With bipartisan support, cements pharmacists’ role as trust, accessible healthcare providers, reinforcing their ability to deliver essential women’s health services.

“Community pharmacists are trusted, accessible healthcare professionals.

“These policy changes are a game changer for women around the country,” says Associate Professor Sim.

PSA committed to pharmacy education and training

PSA is committed to equipping pharmacists with high-quality education and training to ensure safe and effective care under the new policies.

“PSA is proud to support these initiatives with high-quality education and training for pharmacists, building the capacity and expertise of our profession as we scale up our health care services for women across Australia.

“PSA looks forward to working closely with governments and healthcare stakeholders to ensure the success of these trials and to continue strengthening pharmacists’ role in women’s healthcare across Australia,” says Associate Professor Sim.

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Backed by a $174.5 million investment, the vaccine will be offered through the National Immunisation Program (NIP) starting 3 February.

RSV or respiratory syncytial virus is a leading cause of infant hospitalisation in Australia and results in around 12,000 hospital admissions each year for babies with severe cases.

RACGP President Dr Michael Wright emphasises the significance of this initiative for Australian families.

“The decision from the Federal Government will save lives and is good news for families,” he said.

“It will help keep babies safe and save expectant families money.

“The vaccine will be available in practices around Australia, and will have a great impact on reducing the number of severe infections in newborns and babies.”

Dr Write urges all pregnant women to take advantage of the free vaccine, highlighting its critical role in protecting newborns.

“RSV is not just a relatively harmless illness, and particularly for our kids it can be devastating,” he said. 

“The unfortunate reality is that around half of RSV notifications are in kids aged under five and what some families may not realise is that almost all infants will experience an RSV infection.

“So, we must do all we can to ensure their immune systems are ready, this vaccine will help keep them as safe as possible.”

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The Australian Institute of Health and Welfare’s (AIHW) Health System Spending on Disease and Injury in Australia 2022–23 report shows disease-related healthcare spending rose from $159.3 billion in 2021–22 to $172.3 billion in 2022–23, an 8.2% increase in current prices.

Chronic diseases accounted for nearly half of the spending—$82 billion—with cancer, cardiovascular diseases, and musculoskeletal disorders consistently dominating costs over the last decade. Among cancers, prostate, non-melanoma skin, breast, and bowel cancers represented the top areas of expenditure.

‘We need to invest in prevention’

PHAA CEO Adjunct Professor Terry Slevin says the findings underscore the urgent need to prioritise prevention.

“In addition to the harms of these preventable diseases, each person living with such conditions experiences pain, suffering, a lower quality of life, and, in too many cases, premature death,” Adj Prof Slevin said.

“This reinforces the need to invest in prevention.”

Currently, just 2% of health spending goes toward public health initiatives.

Adj Prof Slevin calls on the federal government to raise this to 5% of total health expenditure to mitigate rising costs and improve long-term health outcomes.

“We strongly encourage the Australian Government to boost investment to 5% of total health expenditure on prevention.

“This will help ease pressures on our hospital systems in the future, but also means people will live healthier, and for longer,” he said.

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Health and Aged Care Minister Mark Butler, speaking with journalist David Speers in an interview for the ABC’s 7.30¹ current affairs program in early May, described vaping as “a public health menace particularly impacting younger Australians”, referring to the strong action his government has taken to reduce smoking and stamp out vaping.

“Following public consultation led by the Therapeutic Goods Administration in December 2022, the government is proposing stronger regulation and enforcement of all e-cigarettes, including controls on their importation, contents and packaging,” Mr Butler said in a statement.² “The government will work with states and territories to stamp out the growing black market in illegal vaping.”

He added that this would include:

• Stopping the import of non-prescription vapes.
• Increasing the minimum quality standards for vapes, including by restricting flavours, colours and other ingredients.
• Requiring pharmaceutical-like packaging.
• Reducing the allowed nicotine concentrations and volumes.
• Banning all single-use, disposable vapes.

With vaping issues the focus of increased media attention recently³ and with the government’s proposed legislation changes around smoking and vaping – part of the measures included in a $737 million fund allocation in the 2023-24 budget “to protect Australians against the harm caused by tobacco and vaping products”² – it’s important for pharmacists to be abreast of the changes and how they affect pharmacies.

“Vaping was sold to governments and communities around the world as a therapeutic product to help long-term smokers quit,” Mr Butler said. “It was not sold as a recreational product – especially not one targeted to our kids, but that’s what it has become.

“Australia needs to reclaim its position as a world leader in tobacco control.

“These reform measures will help protect the health of Australians while reducing the pressure on our health system, and critically, they’ll help to achieve a reduction in smoking rates to five per cent or less by 2030.”

Nicotine vaping laws 

Currently in Australia, NVPs can be lawfully obtained only through a pharmacy with a prescription from a medical professional. This law came into effect on 1 October 2021 when the nicotine vaping laws were changed in response to “a significant increase in the use of NVPs by young people in Australia and in many countries”.⁴

The TGA said in a 2021 statement:⁵ “There is evidence that [NVPs] act as a ‘gateway’ to smoking in youth, and exposure to nicotine in adolescents may have long-term consequences for brain development. The changes strike a balance between the need to prevent young people from taking up [NVPs], while allowing current smokers to access these products for smoking cessation on their doctor’s advice.”

Since 1 October 2021, all NVPs have been Schedule 4 (prescription only) medicines, meaning “consumers require a prescription for all purchases of NVPs”, including “purchases from pharmacies and overseas”.⁵

NVPs 

According to the TGA, no NVPs currently on the market are approved by the TGA or registered in the Australian Register of Therapeutic Goods (ARTG). This means NVPs are considered “unapproved medicines”.⁵ The only way to dispense NVPs is to follow the established pathways set out by the TGA.

“The main pathways for Australians to dispense unapproved NVPs are the Authorised Prescriber (AP) scheme and Special Access Scheme Category B (SAS B),” the TGA said in a 2022 statement.⁵

In 2021, the TGA also introduced a new standard specifically for unapproved and export-only NVPs. This is known as the ‘Therapeutic goods standard for nicotine vaping products order 2021’ (TGO 110) and came into effect on 1 October 2021. It includes “minimum safety and quality requirements for unapproved NVPs”.⁵

So, how does this relate to pharmacies?

The TGA says pharmacies may source unapproved NVPs from “Australian sponsors and/or wholesalers or directly from overseas” and can “hold the unapproved NVPs in your dispensary until you receive a prescription” from an AP or under an SAS.⁵ However, pharmacies are advised to check with the NVP sponsor or wholesaler “about conformance to TGO 110 prior to ordering the products”.⁵ The TGA warns pharmacists that only products that conform to TGO 110 requirements should be dispensed.⁵

According to the TGA, “pharmacists can dispense a prescription for NVPs with evidence of an AP or SAS B approval, subject to any applicable state or territory restrictions or requirements”.⁵

Only via pharmacies on prescription 

Referring to this year’s vaping law changes, Minister Butler said on the 7.30 program: “The only way companies will be able to import vapes is to demonstrate that they’ll be for sale through a pharmacy on prescription by a health professional and that they comply with new standards.

“No more bubble gum flavours, no more pink unicorns on the wrappers – they’ve got to be pharmaceutical style with plain flavours, and not disposable.

“There’ll be products that are assessed against standards set in place by the TGA. At the end of the day, a sponsor needs to submit a product for approval … if there are products in the marketplace that comply with the standards, they need to be free of chemicals that the TGA lists as particularly dangerous [and] they need to be at particular nicotine levels – as well as all the other things I’ve set out around flavouring and presentation.

“If they’re compliant with those standards and can be prescribed by doctors as a smoking cessation device to help people with nicotine addiction, that’s something that will be able to be imported and sold through pharmacies only.

“Vaping is an emerging technology and we’ve got the chance to nip this in the bud. It’s going to be difficult because it really has flourished over the last two or three years.”

For more information, visit:

• tga.gov.au/resources/resource/guidance/nicotine-vaping-products-information-pharmacists
• my.psa.org.au/s/article/Guidelines-for-pharmacists-providing-smoking-cessation-support

References 

1. abc.net.au/news/2023-05-02/health-minister-mark-butler-declares-crackdown-on/102294676
2. health.gov.au/ministers/the-hon-mark-butler-mp/media/taking-action-on-smoking-and-vaping
3. abc.net.au/news/2023-05-03/vaping-changes-australia-how-will-it-work/102294626
4. tga.gov.au/news/blog/nicotine-vaping-laws-are-changing
5. tga.gov.au/resources/resource/guidance/nicotine-vaping-products-information-pharmacists

This feature was originally published in the July issue of Retail Pharmacy magazine. 

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NostraData says pharmacists have legitimate reasons to be worried, considering the inadequate understanding of the real impact the 60DD will have on pharmacies and their viability as small business owners.

The reduced dispensing fees directly impact pharmacies’ ability to provide care for their patients, says NostraData, particularly services that may currently be offered at little or no charge, such as home deliveries and dose administration aid packing.

A survey of more than 200 general practitioners (GPs) revealed a high level of awareness and support for the 60-day reform, with more than 90% backing the change, yet pharmacists are left grappling with uncertainty due to the lack of clarity provided by the government.

Time and cost savings to patients are key benefits identified by the health profession, but the potential consequences for community pharmacy dispensing income are significant, according to NostraData.

Prescribers intending to issue 60-day scripts for patients exceed 78%, indicating a potentially faster and more substantial impact on pharmacy revenue than projected by health department models.

NostraData says the latest government report fails to provide references to modelling or other input data to support the assumption that uptake by prescribers and patients will fall within the range of 45-63% over four years, as mentioned on page 28 of the Impact Analysis report (OFFICE OF IMPACT ANALYSIS ID: 22-03771).

Although the report makes passing references to “previous studies” regarding maximum dispense quantity uptake, these references lack proper citations, raising concerns about the evidence and transparency of the assumptions made by the Department of Health, according to NostraData.

In a recent statement, NostraData says the firm firmly believes that the Department of Health’s assumptions must be challenged, and the information and rationale behind their projections must be made available through comprehensive consultation.

The concerns raised by pharmacists, who serve as small business owners, should not be dismissed, says NostraData, as their ability to remain viable is directly impacted by changes in prescribing practices.

While GPs intend to gradually trial 60-day prescribing, NostraData says it’s crucial to address the legitimate concerns of small business owner pharmacists and ensure that their viability is not compromised by the introduction of this reform. It’s also essential that policy development is informed with the right information and consultation with the right stakeholders.

Collaborative efforts between the government, healthcare professionals, and the pharmacy sector are essential to develop a comprehensive understanding of the potential impact and implement safeguards to ensure that there aren’t unintended consequences that leave patients or pharmacies worse off from this measure.

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Commissioned by the Pharmacy Guild of Australia and conducted by Insightfully from 6-7 April, the poll included 2500 people across Australia and revealed that 84% of Australians don’t want the proposal to proceed – 47% said they don’t think the 60-day dispensing policy should go ahead and 37% said they don’t think it should go ahead if it worsens medicine shortages.

The poll revealed that 86% of regional Australians don’t think that the 60-day dispensing should go ahead if it will result in medicine shortages.

“If the Federal Government proceeds with this proposal, everyday prescription medicine will be put into severe shortages lasting months, not days or weeks,” says National President of the Pharmacy Guild of Australia Professor Trent Twomey.

“I am very concerned for Australian patients and big shortages will hit common medicines that treat cholesterol, blood pressure, diabetes, depression, anxiety, epilepsy and Parkinson’s disease to name just a few.

“The research is crystal clear, Australians do not support a policy if it means pharmacy shelves are bare and patients miss out on vital medicine that they need.

“We are calling on the Federal Government to reconsider.

“I don’t want to see a Hunger Games stand-off in any community in Australia where some patients get double the medicine they need, while others get nothing.

“We want to work with the Government to deliver cheaper medicine for millions of patients through our proposal to drop the PBS co-payment to $19, helping all Australians in this cost of living crisis,” he said.

Accidental overdose also a concern 

Another concern expressed by the Pharmacy Guilts relates to concerns around accidental overdose with more medicines sitting in homes.

The Guild says that the 60-day dispensing policy will mean more medications are sitting in family homes, which may increase the risk of accidental overdose, including for children.

According to the recent poll, 51% of Australians agree with this concern and oppose the plan for 60-day dispensing should it increase the risk of accidental overdose.

This follows the Therapeutic Goods Administration (TGA) interim decision on 3 February 2023 to reduce the maximum pack sizes for paracetamol products due to the incidence of serious injury and death from intentional paracetamol overdose and a shortage of paracetamol medication.

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The Royal Australian College of General Practitioners (RACGP) says the May Budget is an opportunity for the Government to do this, by acting on reforms that include:

• Extending the length of prescriptions to save patients time and money.
• Allowing a larger supply of medicines in one go. They say a two-month supply would halve dispensing fees.
• Investigating the benefits of removing the $1 discount rule, which caps discounts on medicines.
• Overhauling Australia’s anti-competitive pharmacy ownership and location laws, which they say inflate costs for patients.
• Making prescribing faster and easier for GPs, so they have more time for patient care by streamlining the Pharmaceutical Benefits Schedule (PBS) prescribing system, which they says is unnecessarily complex.

‘Health system crisis must be tackled from all sides’ 

“We have a cost-of-living crisis and a health system crisis on our hands, and people across Australia are feeling the crunch and struggling to access or afford the healthcare and medicines they need,” says RACGP President Dr Nicole Higgins.

The health system crisis must be tackled from all sides, says Dr Higgins, including by making medicines cheaper and easier to access.

Dr Higgins says the solution to this is simple reforms that the Government “can and should make to save patients’ money and time”. These reforms, she adds, will also free up GPs “so we can see more patients”.

“This includes extending the length of prescriptions. If GPs could give longer prescriptions of 15 months instead of the usual 6 months to suitable patients, it would make a big difference. GPs should have the flexibility to decide what’s right for their patients,” says Dr Higgins.

“Another easy way to lower costs is to allow patients to get a larger supply of medicines in one go by increasing the supply interval for certain medicines.

“This will save the government money on dispensing fees which could in turn be used to further subsidise patient care.

“These reforms are an easy way to help those most in need, including people who are older and those with chronic conditions who often need multiple medicines.

“It will save money for individual patients, as well as significant savings for the overall health budget and taxpayers.

“We also support further investigation of the benefits to patients in changing the $1 discount rule. This prevents pharmacies from discounting medicines that cost more than the current co-payment of $30 by more than $1. Other countries like New Zealand don’t have this rule, so pharmacies can offer significant discounts on some medicines,” she says.

PBS prescribing system reforms needed

Dr Higgins also calls for changes to the PBS prescribing system to reduce administration time and free up GPs to see patients.

“The current PBS authority system is time-consuming and an administrative burden for GPs, with questionable if any benefits for patients,” she says.

“If this system was updated and streamlined it would result in shorter consults, lower Medicare billings, and GPs would have more time to spend with patients, rather than cumbersome administration.

“Australia needs to seriously explore alternative models to lower the cost of medicines and increase access and choice for people across Australia. Other models such as supermarket pharmacies, online pharmacies and automated dispensing machines are used widely in other western countries like the US and UK and could make a real difference here, particularly in rural communities,” Dr Higgins says.

‘Too many people missing out’ 

“Everyone deserves access to affordable and high-quality primary care and medicines, no matter their postcode or income,” Dr Higgins says.

“But too many people are missing out, which is causing more people to go to the hospital and more pressure on our overstretched emergency care system.

“The Government needs to stem the bleeding in this Budget by providing urgent relief to Australians facing growing out-of-pocket costs for healthcare. And we are continuing to call for an increase in Medicare rebates, including for longer complex consultations.

“The government should also use the Budget to act on these reforms to make medicines cheaper and easier to access. It is an easy way to help Australians battling rising costs at a time when they really need it, as well as reducing overall healthcare costs, and freeing up GPs to spend more time with patients,” she says.

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Pharmaceutical Society of Australia (PSA) National President Dr Fei Sim says that while pharmacists are working harder than ever to ensure patients have access to the medicines they need, their hands are tied when it comes to supplying prescription medicines to those who have been most affected.

“We have been speaking with pharmacists who are staying open and trying to help patients with intermittent power, water damage and without stable phone and internet lines,” she said.

“They have told us the watered-down arrangements are putting them in the impossible situation of having to deny reasonable requests for lifesaving medicines or risk losing their AHPRA registration by breaking the law.”

Access to medicines is particularly crucial for those on medications that are dangerous to suddenly stop taking, such as antiarrhythmic, anticoagulant, antiepileptic and anti-depressant medication.

“In a disaster situation, it is the patients on these sorts of medicines who will suffer without permanent continued dispensing arrangements in place,” Dr Sim said.

Dr Sim says the current situation “is unacceptable” and that the current arrangements “are simply not fit-for-purpose”.

“Governments need to make sure that all patients have access to their medicines in emergency situations, regardless of what medicines they take,” she said.

“It is vital the full PBS Continued Dispensing list is restored, as it guarantees access to full PBS quantities Australia-wide for people affected by an emergency.

“Without this, the quantity of medicines a pharmacist can supply varies depending on where you are in Australia, which can be as little as only three days’ supply We all know emergencies last longer than that.

“Full continued dispensing is necessary to ensure medicines remain affordable in an emergency. Without PBS subsidy, either the patient or pharmacist has to wear the full cost of the medicine at a time when the individual costs of the disaster are starting to roll in.

“The last thing these pharmacists and patients need is unnecessary bureaucratic red tape getting in the way of emergency patient care.

“After two years when this problem has been solved, it feels like we’ve gone back to Groundhog Day again.

“We cannot wait for the next natural disaster to revisit this issue yet again. Restoring full continued dispensing permanently will help improve our disaster response and protect the post-disaster health of our communities.”

Continued dispensing arrangements came into effect in late 2019 allowing people separated from their medicines and prescriptions to access a standard box of their medicines as a one-off, one-month supply without a prescription.

Despite the initiative successfully running for more than two years without any known safety incidents, the Federal Government reduced the number of eligible medicines from over 900 to only 168 on 30 June 2022.

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The funding announcement was made on World Heart Day (29 September) and has been welcomed by the Heart Foundation’s CEO David Lloyd who says the funding will support Australia’s greatest cardiovascular minds to continue groundbreaking and lifesaving work.

“The Heart Foundation has led the fight against heart disease in Australia for more than 60 years and we warmly welcome the Government’s strong investment in cardiovascular research, noting it will continue to build Australia’s reputation for research excellence and innovation while saving and improving the lives of the many thousands of people touched by heart disease every year,” says Mr Lloyd. 

Heart Foundation Chief Medical Adviser, Professor Garry Jennings AO, says that while the announcement is great news, it’s also important for Australians to know they shouldn’t wait for the results of heart research before taking steps towards a healthy heart.

He says that Australians can start taking positive steps by taking the Heart Foundation’s online Heart Age Calculator or by seeing their GP for a Heart Health Check.  

“The Heart Health Check is available for Australians aged 45 and over (30 and over if First Nations) and is a 20-minute consultation with their GP that has so far helped more than 300,000 Australians understand their heart health since it was introduced in 2019,” says Professor Jennings.

“Our Heart Age Calculator is available online for anyone aged 35 and over and it uses a sophisticated algorithm to calculate the probability of a cardiovascular event occurring in the next five years based on your risk factors.

“It is an easy and accessible gateway to a conversation with your GP, should the calculator’s results give you any concern.” 

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