“Patients are suffering unnecessarily, enduring heightened pain and distress, because the medications that typically control their symptoms are either unavailable or prohibitively expensive,” says Dr Peter Allcroft, Chair, Palliative Care Australia.

Despite repeated calls for action from the palliative care sector, Palliative Care Australia (PCA) says there has been little progress toward ensuring a stable supply of these life-changing drugs.

“A collective of 7 organisations wrote to parliamentarians in early December [2024] trying to escalate this issue after months and months of slow or no progress, people, including children are dying without adequate pain relief,” says Dr Allcroft.

‘Supply becoming increasingly uncertain’

Most of the affected medicines are vital opioid analgesics that have been used for decades to manage severe pain and other symptoms in palliative care patients.

With their supply becoming increasingly uncertain, clinicians are forced to prescribe less effective alternatives, resulting in less reliable pain relief and risking unwanted side effects.

Adding to the distress is cost, with many of the alternative medications not subsidised through the Pharmaceutical Benefits Scheme (PBS).

One of the most startling examples is hydromorphone SR, which costs the public $182 for 32mg, which a non-PBS-listed alternative is $4209 for 100 tablets.

PCA campaign to resolve the ongoing issue

As part of the ‘better access to palliative care’ campaign leading up to the federal election, PCA has launched an 11 point plan to resolve this ongoing issue.

“Our recommendations centre on establishing a national stockpile of critical medicines, fostering domestic pharmaceutical manufacturing, strengthening the PBS, and empowering the TGA,” says Dr Allcroft.

“Four hundred people die every day of a terminal illness — limited or no access to these critical medications has a ripple effect through families and communities.”

With nearly 20,000 signatures already on the campaign’s petition, advocates hope the issue will be addressed ahead of the federal election, ensuring better quality of life for those in palliative care.

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The study, conducted by researchers from the National Drug & Alcohol Research Centre (NDARC) and the Medicines Intelligence Centre of Research Excellence at UNSW Sydney, revealed a 33% reduction in Pharmaceutical Benefits Scheme (PBS) opioid dispensing claims, primarily for long-acting formulations.

This decline follows the implementation of government measures aimed at curbing opioid use.

However, despite these efforts, private prescriptions for opioids rose by 55%, offsetting around a quarter of the PBS reductions.

“While Australia has reduced its overall consumption of opioid analgesics, our findings indicate a significant rise in private prescriptions, which come with higher out-of-pocket costs for people in pain,” lead author and pharmacoepidemiologist Kendal Chidwick said.

“Reasons for the increase in private market use may include accessing opioids not subsidised under the PBS, or efforts to avoid the PBS restrictions altogether.”

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The Department of Health and Aged Care has reviewed and remade the following instruments, which are effective from 1 April 2024:

• National Health (Listing of Pharmaceutical Benefits) Instrument 2024
• National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024
• National Health (Prescriber bag supplies) Determination 2024

As a result of the review, the National Health (Pharmaceutical Benefits) Regulations 2017 (the regulations) have also been amended.

The main amendments to the regulations are as follows:

Patient Signatures Changes

From 1 April 2024, patients are no longer required to sign and date receipt of a pharmaceutical benefit. Additionally, pharmacists are no longer required to certify why it was not practical to obtain a patient acknowledgement of receipt.

Maximum Quantity or Maximum Repeats

The process for seeking authorisation of increases to maximum quantity or maximum repeats in the new section 30 of the Regulations differs from previous version as follows:

• The prescriber submits details of a proposed prescription to Services Australia rather than submitting the prescription itself or a copy of the prescription.
• The section has been simplified to remove administrative detail about the different channels a prescriber can use to submit details of the proposed prescription to Services Australia.
• As Services Australia will now receive details of proposed prescriptions rather than prescriptions that have already been finalised by the prescriber, provisions requiring the prescriber to alter a prescription where requested by the Minister are now redundant and have been omitted.
• Prescribers can no longer ask the Minister, in practice Services Australia, to send the prescription on to the patient.

Prescriber Bag Changes

Where there is more than one item in a group in the Prescriber Bag Determination Schedule, prescribers may only order the maximum quantity of an item if they do not already have the maximum quantity on hand for the other items within that group.

Regulation 49

Under regulation 49 (previously referred to as regulation 24), original and repeat supplies of pharmaceutical benefits can be supplied at the one time if a medical practitioner, a midwife or a nurse practitioner is first satisfied that certain conditions apply, then endorses the PBS prescription ‘one supply’ or ‘1 supply’ (the words ‘Regulation 49’, ‘Reg 49’, ‘Section 49’, ‘Regulation 24’ or ‘Reg 24’ are also valid for this purpose).

For further information regarding the legislation changes and examples, refer to the Explanatory Statement to the National Health (Pharmaceutical Benefits) Amendment (2024 Measures No. 1) Regulations 2024.

Any questions regarding these Legislative Instruments can be sent to PBS@health.gov.au

Pharmaceutical Benefits Scheme
Department of Health and Aged Care
www.pbs.gov.au

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The 60DD policy will double the amount of medicines that pharmacists can dispense for stable conditions, on the Pharmaceutical Benefits Scheme (PBS), from 30 to 60 days – saving patients at least $180 a year and more if they’re taking multiple medicines, says the RACGP.

“This is progressive policy, and it puts patients first,” says RACGP President Dr Nicole Higgins.

“60-day dispensing will make a big difference for some of the most vulnerable people in our communities, who are struggling with rising costs.

“It will save patients at least $180 a year, and more if they’re taking multiple medicines, as well as reducing trips to get medicine, and freeing up GP appointments for other people who need them.

“Many people living with chronic and ongoing conditions in Australia will see immediate benefits.”

Dr Higgins adds that “the government is reinvesting all saving from [the 60DD] back into community pharmacy, plus providing an extra $148.2 million to help regional and rural pharmacies adjust to the change”.

“This is important and the RACGP welcomed it,” she says.

“Australia needs a strong and sustainable primary care sector, with GPs working in teams with other specialists, pharmacists, allied health and nurses, for the best outcomes for our patients.

“Because everyone needs access to high-quality care, no matter where they live or what they earn.”

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This means patients won’t have to pay up to $200 a month in out-of-pocket costs and will simply pay the usual PBS co-payment – up to $30 for everyone with a Medicare card or $7.30 for concession card holders.

These co-payments will contribute towards the PBS Safety Net threshold.

Amounting to a $377 million Government investment in community pharmacies, this change will provide much-needed cost-of-living relief for tens of thousands of Australians receiving treatment for opioid dependency.

The Government says transition arrangements will apply until 30 November 2023. This will ensure that private clinics, non-PBS pharmacies and other dosing sites can still provide these medicines to patients while they transition to a PBS-approved pharmacy.

Click here for more.

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Under the arrangements, people who already have a current prescription for Fiasp will be able to access Fiasp for the next six months.

People who have used Fiasp previously, and do not have a current prescription are encouraged to see their doctor before April 1 to ensure they are able to access Fiasp over the next 6 months or to discuss longer term treatment alternatives.

“The Government will continue to act in the best interests of Australians living with type 1 diabetes,” Minister Butler said.

Diabetes Australia Group CEO Justine Cain thanked Minister Butler for his quick intervention to allow continued access to the insulin for around 15,000 Australians living with diabetes.

“Living with diabetes can be very difficult and people should be able to access the best available insulins and medicines, at an affordable price, to have their best quality of life and reduce the impact of diabetes-related complications,” Ms Cain said.

“Minister Butler has demonstrated that the Albanese Government understands how important it is to give people living with type 1 diabetes access to the affordable medicines and technologies they need to manage the condition.

“Diabetes Australia actively made our concerns known to the Government about the significant impact of Novo Nordisk’s decision to delist from Fiasp from the PBS.

“We are very grateful that Minister Butler listened and acted to help the thousands of people living with diabetes who were going to be impacted.

Ms Cain said she hoped the Government and Novo Nordisk could come to an agreement that would see Fiasp remain on the PBS for the foreseeable future.

“We hope that over the next six months the Department of Health and Novo Nordisk continue discussions and reach an agreement that benefits people living with diabetes, she said.

“I’d also like to acknowledge Australia’s diabetes community, including the Australian Diabetes Society,  the Australian Diabetes Educators Association, JDRF Australia, the Australia and New Zealand Society for Paediatric Endocrinology and Diabetes and the Australian Diabetes in Pregnancy Society, as well as the thousands of passionate and committed diabetes advocates.

“When Australia’s diabetes community is united in the fight for change, we can achieve anything.”

Text by: Diabetes Australia

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The Budget allocation is welcomed by the Pharmacy Guild of Australia, with National President Trent Twomey describing the move as a great step forward for patients across Australia who are battling with the rising costs of living.

This decision, says Professor Twomey, “fulfills an election commitment by the Government” and is the “result of strong advocacy by the pharmacy profession on behalf of patients across the country”.

“As primary healthcare workers, community pharmacists have for some time been hearing patients say they simply cannot afford their medicines,” Professor Twomey said.

“This is a good first step in increasing the universality of the access to medicines for all Australians, while also helping to address cost-of-living pressures.”

Extra Government-funded university places 

Professor Twomey also welcomes the Budget measure announced to create an extra 20,000 Government-funded university places across Australia, including for student pharmacists.

“It is significant that a focus of the newly-created university places is the health sector, which has been severely affected by the workforce shortage,” Professor Twomey said.

“This is a strong initiative that will help ease some of the crisis we are seeing across a wide range of health professions, particularly pharmacy.

“There will be additional places for student pharmacists as well as more subsided places for nurses. This is a recognition by the Government of the severe impact the workforce shortages are having on this sector.”

Under the scheme, universities will be required to allocate the new places to disadvantaged students from poorer backgrounds, Indigenous Australians, and students in rural and remote areas.

The National President of the National Australian Pharmacy Students’ Association, Flynn Swift, also welcomes the move and says it is a recognition of the importance of ensuring more students are able to study for the pharmacy profession.

“The workforce shortage is a real and ongoing issue and the only way to address is to start acting now,” Mr Swift said.

“This is a very sound and proactive initiative.”

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Welcoming the decision, the National President of the Pharmacy Guild of Australia, Professor Trent Twomey says this legislation is the result of strong advocacy by the Guild on behalf of patients.

“As primary healthcare workers, community pharmacists have for some time been hearing patients say they simply cannot afford their medicines,” Professor Twomey said.

“Increasingly, people are being faced with the horrible decision of having to decide who in the family will go without their medicines in order to put food on the table or pay their bills.

“The Guild and community pharmacies have advocated strongly on behalf of patients for a reduction of the cost of medicines and today we thank the Federal Government for taking action that was promised as part of Labor’s election commitment.

“The reduction in the co-payment is a 30% saving on the cost of each prescription. It means an individual will save $150 a year for one monthly script, or $300-$450 a year for two to three scripts a month. This is an annual saving of almost $200 million, which will be put back into the pockets of Australians.”

Professor Twomey says making medicines more affordable will help reduce medication non-adherence, either by taking less of the medicine than prescribed or not having the prescription filled at all.

“This will help reduce medicine non-adherence which directly contributes to higher healthcare costs, including preventable hospital admissions and readmission,” he said.

“In addition to increasing the universality of the access to medicines, this is a big step in addressing the cost of living pressures and I congratulate the Government on acting so quickly to fulfil this election promise.”

The Guild partnered with a coalition of health bodies including the Australian Patients Association, Chronic Pain Australia and Musculoskeletal Australia to advocate on behalf of their patients.

CEO of the Australian Patients Association Stephen Mason says the success of the campaign will benefit thousands of needy patients who cannot afford their prescription medications but will now benefit when the cuts commence on 1 January 2023.

Musculoskeletal Australia (MSK) CEO Rob Anderson says MSK has heard from people contacting its National Helpline that, with regular housing interest rate increases and the increasing cost of living pressures, they are struggling to afford the medicines they need to manage their conditions.

The reduction in the patient co-payment is a priority and MSK applauds the Government for the steps taken with the passing of this legislation.

President of Chronic Pain Australia, Fiona Hodson says the reduction in the co-payment will be welcome news to the one in five Australians living with chronic pain as medicine affordability is a key issue for these patients who have to manage complex and chronic conditions.

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According to the review anxiety in children with CF is 26% higher than in the general paediatric population, and depression in adults with CF is 27% higher.

Carers of people with CF also had significantly higher rates of both depression and anxiety compared to the global prevalence of both illnesses.

However, the review, which only included studies where a psychometric tool (PT) to specifically assess depression and anxiety was used, also showed that the choice of PT significantly influenced prevalence, indicating a need for future studies to use the optimal PT for each CF population to allow appropriate interpretation and identify those most at risk.

“Our review looked at 94 articles and over 18,000 people with CF worldwide, showing depression and anxiety to be consistently high across all age groups,” the study’s first author Monash Health pharmacist and PhD candidate at Monash’s Centre for Medicine Use and Safety, Louise Lord said.

“However, sub-analysis revealed that the PT used to describe prevalence led to a number of gaps, such as a sparsity of information involving children under 12 with cystic fibrosis, as those in this age group were understudied.”

It’s said that PTs are tools used to assess various individual factors that may predict behaviours and outcomes in various circumstances, including diseases such as cystic fibrosis.

Ms Lord said that the study found that the optimal choice of PT is one that is validated in the CF population and which is recommended by the International Committee on Mental Health in Cystic Fibrosis consensus statements published in 2016.

“The review found that the choice of PT in each study impacted results substantially, emphasising the need for clinicians to be aware of the validity each tool has in the CF population, and in different age groups,” she said.

“For example, the tools that have been validated for depression or anxiety screening in people living with cystic fibrosis include the Patient Health Questionnaire for depression and Generalised Anxiety Disorder 7-item measure for anxiety.

“While there were guidelines for those aged 12 and over with cystic fibrosis, the optimal choice of psychometric tool in those younger than this could not be determined, leading us to conclude that there is still much work to be done to help identify those most at risk, particularly for children under 12 who could be slipping through the gaps,” she said.

There are an estimated 3500-4000 people in Australia living with cystic fibrosis.

The psychological burden, such as depression and anxiety, can result in poorer outcomes such as decreased lung function, more hospitalisations and higher healthcare costs.

The mental health of carers can also affect the outcomes of people with cystic fibrosis.

“New treatments, such as the recently Pharmaceutical Benefits Scheme (PBS) listed elexacaftor/tezacaftor/ivacaftor (Trikafta®), are allowing people with cystic fibrosis to live longer lives, so it is imperative that the quality of life is also optimised,” Ms Lord said.

The review confirms the need for regular screening measures using appropriate psychometric tools.

Future research in this area should help identify those at most risk, as well as focussing on identifying the most appropriate tools for children under 12 years of age.

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The Pharmacy Guild of Australia has criticised this missed opportunity, with National President of the Pharmacy Guild, Professor Trent Twomey saying the Government has squandered an opportunity to help millions of Australians.

“The maximum general co-payment for the PBS is now $42.50 and will keep rising every year hitting $50 by the end of the decade,” says Professor Twomey.

“Research by the Australian Patients Association has found more than 20% of Australians aged 18-64 describe prescription medicines as being unaffordable.

“Cost of living and the affordability of healthcare continue to dominate as issues affecting Australians with more than one in six voters saying they or their families have been unable to purchase medicines due to cost.

“This inevitably translates into preventable hospital presentations and worse population health.

Professor Twomey says that the Government’s decision to lower the PBS Safety Net Threshold “doesn’t go far enough” and adds that “despite constructive discussions with the Government, they decided to ignore the pleas of healthcare professionals”.

“People are struggling to afford essentials and going without their medicines should never be a decision Australians have to make,” says Professor Twomey.

“As community pharmacists at the front line of primary healthcare, we are concerned about the implications for the individuals and their families.

“The Government has the ability to make PBS medicines more affordable for middle-income households. For many households, these medicines are the cost of staying alive,” he says.

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