The Therapeutic Goods Administration (TGA) has granted approval for semaglutide 2.4mg (Wegovy) as an adjunct therapy to reduce major adverse CVD events, including cardiovascular death, non-fatal heart attacks, and non-fatal strokes.

The approval follows findings from the SELECT trial, a global study involving more than 17,000 participants across 41 countries, including Australia.

Results published in late 2023 showed that Wegovy reduced cardiovascular events by 20% in people with pre-existing heart disease who were overweight or obese but did not have diabetes.

Professor Stephen Nicholls, lead of the Australian arm of the SELECT trial and Director of the Victorian Heart Institute at Monash University, emphasises the significance of the approval.

“This approval highlights the critical role of overweight and obesity as major drivers of heart disease — on par with cholesterol, blood pressure, diabetes and smoking,” he says.

“It reinforces that these risks can be actively reduced with targeted therapies.

“The SELECT trial demonstrated that the cardiovascular benefits of semaglutide extend beyond weight loss.

“This drug also positively impacts inflammation, blood lipids and blood pressure, which are all crucial in preventing heart attacks and strokes.

“What this tells us is that if you have heart disease and are overweight or obese, not only are you at a higher risk of another cardiovascular event, but that risk can now be significantly reduced.

“This is a groundbreaking result for patients.”

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Led by Monash University and published in the Medical Journal of Australia, the recommendations address the unique challenges faced by some 39,000 people living with this chronic neurological condition.

Senior author Associate Professor Mastura Monif, a neurologist and researcher from the Monash University School of Translational Medicine and head of Alfred Health’s Neuroimmunology Service, said although Australia’s Therapeutic Goods Administration (TGA) adopted an international MS guideline in 2009 (which was last updated in 2015), specific and recent consensus recommendations were needed to guide best practice on locally available therapies and local practices.

“New disease-modifying therapies are more effective and better tolerated,” says Associate Professor Monif.

“But it’s a much more complex treatment landscape than it was 20 years ago, and there is new evidence being generated all the time on many aspects of the disease.

“It is really important that the approach used is focused on both the effectiveness and safety for the individual so they can get the best possible outcome.”

Developed by more than 30 experts from the Australian and New Zealand Association of Neurologists working group — including MS specialists, nurses, allied health professionals, and patient advocacy groups — the statement covers pre-assessment, therapy selection, monitoring, symptom management, and special considerations such as pregnancy and infections.

MS Australia CEO Rohan Greenland welcomes the guidelines as an “invaluable resource, especially for generalist clinicians navigating this rapidly evolving field”.

“They provide a clear and ready reference to best-practice evidence and expert consensus – an important milestone in MS care in Australia,” he says.

First author Dr Jessica Shipley, an MS and Neuroimmunology fellow at Alfred Health, says the recommendations are for everyone involved in managing MS, regardless of healthcare setting or location.

“These recommendations will be a valuable resource for everyone from GPs,  to neurologists, doctors in training, medical students, allied health professionals, nursing staff, and consumers or patients,” says Dr Shipley.

The recommendations can be found here:

• Part 1: Consensus recommendations on MS management in Australia and New Zealand.
• Part 2: Consensus recommendations ons MS management in Australia and New Zealand.

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According to a statement released by the Guild, the current approach is not only making if harder for pharmacists to do their jobs but is also failing patients, with supply issues impacting vital medicines for diabetes, menopause and mental health.

‘Current approach too short-term and reactive’

Adding comment, the National President of the Guild, Trent Twomey says the current approach to the medicine shortage is too short-term and reactive.

“It doesn’t address the root cause of shortages, and patients continue to suffer,” he says.

“Information sharing and greater awareness of existing and forecasted supply disruptions is crucial to making sure Australian patients have the medicine they need.”

Since the disbanding of the Medicine Shortage Working Party in 2021, the Guild has consistently urged the government to reinstate the forum, which was formed during the COVID-19 pandemic.

This forum included representatives from all levels of the supply chain and provided for information sharing and
greater awareness of existing and forecasted shortages.

Unlike the Therapeutic Goods Administration (TGA) Medicine Shortage Action Groups, formed in response to critical shortages, the former Medicine Shortage Working Party facilitated broader discussions around general policies and mitigation strategies for anticipated or localised shortages.

Need to focus on the big picture

“The TGA’s reactive approach means that not all industry stakeholders are represented, leading to inconsistent information being shared across the supply chain,” says Mr Twomey.

“The Government can, and should, focus on the big picture – to reduce the impact being felt by vulnerable Australians who need these essential medicines.”

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ZANTAC is a histamine-2 receptor antagonist over-the-counter (OTC) medicine for the treatment of gastro-oesophageal reflux symptoms such as heartburn and acid indigestion.

In September 2019, the Therapeutic Goods Administration removed all medicines containing ranitidine from the Australian market over concerns about the level of nitrosamine impurities in ranitidine products, specifically N-Nitrosodimethylamine (NDMA).

To be included on the ARTG, the TGA evaluates all registered medicines for safety and efficacy. Aspen Pharmacare Australia, the sponsor of ZANTAC tablets, has worked with the TGA to demonstrate that ZANTAC is stable throughout its shelf life and that nitrosamines are controlled within internationally established acceptable intake limits applied to the maximum daily dose, ensuring all requirements are met for the inclusion of ZANTAC as a registered medicine on the ARTG.

“As one of Australia’s largest pharmaceutical companies, Aspen is committed to delivering products that healthcare professionals can confidently recommend to their patients and customers,” says Aspen Pharmacare Australia Head of Consumer OTC Alison Holland.

“Aspen is pleased that ZANTAC has been reinstated on the ARTG. We’ve worked closely with the TGA and feel that this is a positive development for healthcare professionals, as it provides more options for their patients seeking relief from heartburn and acid indigestion.”

ZANTAC 150mg tablets are indicated for effective 12-hour relief and ZANTAC Double Strength 300mg tablets for 24-hour relief from heartburn and acid indigestion due to gastro-oesophageal reflux.

ZANTAC 150mg and ZANTAC Double Strength 300mg tablets is available from major pharmacy and grocery outlets nationally, without a prescription.

Always read the label and follow the directions for use.

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The warrants were executed as part of ongoing investigations into the alleged importation of unapproved nicotine vaping products.

It’s reported the seized products are alleged to be prescription medicines that were not included, or otherwise exempt from inclusion, in the Australian Register of Therapeutic Goods (ARTG).

According to the TGA, the products will be tested for scheduled and other dangerous ingredients.

Nicotine vaping products that are not imported or supplied under a TGA-approved pathway pose a significant public health risk, according to the TGA, with many tested by the TGA laboratories found to contain dangerous and undeclared chemicals.

On 2 May 2023, the Minister for Health and Aged Care announced that the Australian Government is taking strong action to combat the supply of unlawful vaping products.

The TGA says it’s continuing to work collaboratively with the Australian Border Force to disrupt the importation of unlawful nicotine vaping products.

Nicotine vaping products are a prescription-only medicine. Appropriate treatment options involving prescription medicines should only be determined by a healthcare professional.

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The Therapeutic Goods Administration (TGA) has approved an application from MS Health to amend restrictions on the prescribing of MS-2 Step, which is indicated in females of childbearing age for the medical termination of an intrauterine pregnancy, up to 63 days of gestation.

The changes to prescribing requirements include:

• MS-2 Step can now be prescribed by any healthcare practitioner with appropriate qualifications and training, without the need for certification – this may include nurse practitioners.
• Restrictions on dispensing that limited access to registered pharmacists have also been lifted.

These changes have been welcomed by the Pharmaceutical Society of Australia (PSA) with PSA National President Dr Fei Sim FPS noting that this move will significantly improve women’s access to healthcare.

“This move will improve the access to care for women, making MS-2 step available in more pharmacies and in more communities in Australia,” says Dr Sim.

“This approach recognises that pharmacists are medicine experts and that dispensing MS-2 Step and counselling patients on its use is already within the scope of practice of pharmacists.

“By removing unnecessary red tape, pharmacists can help more Australian women access reproductive care, in line with international experience.

“Pharmacists follow a robust process to ensure all medicines are dispensed safely and effectively,” she says.

Monash University’s Professor Danielle Mazza this decision will help to “destigmatise and increase access to abortion” in Australia.

“[The changes will] bring Australia into line with countries such as Canada, which in 2017 completely deregulated mifepristone providing evidence not only of continued safety but also a marked increase in the number of providers,” says Professor Mazza.

“Restrictive arrangements since medical abortion became available in Australia in 2012 led to access problems, particularly for women who had limited incomes and/or lived in rural and regional areas.

“Previously, GPs have had to undertake mandatory training and register before they could provide the abortion pill, then re-register every three years. As a result, only about 10% of GPs in Australia are registered to prescribe.

“The removal of the need for pharmacists to register to dispense mifepristone means that now all pharmacies will be able to stock and dispense this medication and women won’t have to hunt around to try and find a local pharmacy that does.

“The TGA’s decision will encourage GPs to provide medical abortion, offering women a safe option to use at home. It also enables nurse practitioners to prescribe the abortion pill.

“This recognises their capacity to deliver women’s sexual and reproductive health care and makes medical abortion more available in areas where women don’t have access to a GP who provides this service.”

The Royal Australian College of General Practitioners (RACGP) has also welcomed the changes with RACGP President Dr Nicole Higgins saying that it’s a significant step forward to improve access to holistic reproductive care.

“This is a huge step forward to improve access, particularly for those living in rural and remote communities,” says Dr Higgins.

“As a GP in a regional centre, I know all too well that there are significant barriers to reproductive care in rural and remote areas. These services are vital, and they must be affordable and accessible for everyone who needs them.

“The TGA’s changes will enable greater access to medical abortion for women throughout Australia and will reduce unnecessary red tape for the GPs who provide these essential services.”

The TGA states that in noting these revised restrictions, a new warning/instruction has been included in the Product Information, which provides information about circumstances where a person should be referred to a medical practitioner.

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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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In response to the Therapeutic Goods Administration notice to cancel and recall medicines that contain pholcodine, Consumer Health Products (CHP) Australia wants to provide further clarity and information to actively support the community.
Pholcodine is an ingredient that is only present in medicines that treat non-productive or DRY cough – it is not found in medicines indicated to treat “wet” or “chesty” coughs.

This recall is taking place at a pharmacy level and relates to medicines containing pholcodine having the possible association with extremely rare but serious anaphylactic reactions to medicines called neuromuscular blocking agents (NMBA) used in anaesthesia.

The relevant companies are working actively to manage the removal of their products, which must be completed by the end of March. CHP Australia and its members take consumer safety very seriously, and we are working closely with the TGA to ensure even extremely rare complications can be mitigated.

Pholcodine has been used worldwide since the 1950s and there is long-term data supporting its efficacy as a cough suppressant to treat dry cough. Following the conclusion of a 2022 French study (the ALPHO study) into the possible relationship between pholcodine use and anaphylactic reactions to NMBAs, the TGA reviewed the safety of registered medicines containing pholcodine. The available data from the ALPHO study showed use of pholcodine in the 12 months before general anaesthesia with NMBAs is a risk factor for developing anaphylaxis under anaesthesia. However, the relationship between pholcodine and NMBAs has been under investigation for many years, and there is a great deal of uncertainty about triggers and other sensitising agents.

In their review, the TGA concluded that, while rare, the seriousness of the safety risks outweighed the benefits of the medicine.

We encourage those with questions or concerns about dry cough products to speak with their healthcare professional. To alleviate unnecessary anxiety or confusion for the Australian public, please refer to the factsheet below.

FACT SHEET:

1.         The risk of developing anaphylactic reactions to NMBAs during anaesthesia is very low[1].

2.       The TGA has only announced a pharmacy level recall of pholcodine containing products.  This is not a consumer level recall, which means that product will be removed from shelves and consumers are not required to return product to their pharmacy. If consumers wish to dispose of unused product, they should do so safely.

3.       The recall does not take immediate effect following the TGA’s press release.  Companies that distribute pholcodine containing products are required by the TGA to initiate individual recalls by 8 March.  The recall process is a formal process that requires the TGA to approve communications from distributors to relevant stakeholders, which may take time to implement.  Therefore, retailers and consumers can expect to hear directly from distributors of pholcodine products shortly.

4.       The TGA’s Media Release on Tuesday 28 February 2023 stated that “Up to 9 February this year, the TGA has also received 50 reports of Australian cases of suspected pholcodine-related anaphylactic reactions to neuromuscular blockers, including one fatality”. As qualification, the TGA received these 50 reports referred to over an 8-year period.  The reports relate to anaphylactic reactions where pholcodine is mentioned.  There were only 8 cases of confirmed prior pholcodine usage.

[1]https://www.aimspress.com/article/doi/10.3934/medsci.2022005

Text by: CHP Australia

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MDMA will be allowed for the treatment of post-traumatic stress disorder, while psilocybin will be used for treatment-resistant depression.These are the only conditions where there is currently sufficient evidence for potential benefits in certain patients.

Prescribing will be limited to psychiatrists, given their specialised qualifications and expertise to diagnose and treat patients with serious mental health conditions, with therapies that are not yet well established. To prescribe, psychiatrists will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee. The Authorised Prescriber Scheme allows prescribing permissions to be granted under strict controls that ensure the safety of patients.

The decision acknowledges the current lack of options for patients with specific treatment-resistant mental illnesses. It means that psilocybin and MDMA can be used therapeutically in a controlled medical setting. However, patients may be vulnerable during psychedelic-assisted psychotherapy, requiring controls to protect these patients.

For these specific uses, psilocybin and MDMA will be listed as Schedule 8 (Controlled Drugs) medicines in the Poisons Standard. For all other uses, they will remain in Schedule 9 (Prohibited Substances) which largely restricts their supply to clinical trials.

The decision follows applications made to the TGA to reclassify the substances in the Poisons Standard, extensive public consultation, a report from an expert panel, and advice received from the Advisory Committee on Medicines Scheduling.

There are currently no approved products containing psilocybin or MDMA that the TGA has evaluated for quality, safety and efficacy. However, this amendment will allow authorised psychiatrists to access and legally supply a specified ’unapproved’ medicine containing these substances to patients under their care for these specific uses.

Text by: TGA

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