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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The changes aim to reduce the risk of intentional overdose, which, according to the TGA, results in around 225 hospitilisations and 50 deaths per year in Australia.

What do the changes mean for pharmacies? 

While the new rules largely relate to non-pharmacy retailers including supermarkets, petrol stations and convenience stores, pharmacies must also prepare for new pack size restrictions and blister packaging requirements.

As outlined by the TGA, the changes pertaining to pharmacies are as follows:

• The maximum pack size for unsupervised sales in pharmacies (Pharmacy Medicine) is now reduced from 100 to 50 tablets or capsules in most jurisdictions.
• Larger pack sizes of up to 100 tablets or capsules are now required to be Pharmacist Only Medicines, requiring supervision of a pharmacist.
• Paracetamol tablets and capsules sold in pharmacies must now be in blister packaging.

The TGA also states: “It’s important to note that some states and territories may have different restrictions.

“For example, in pharmacies in Queensland and Western Australia paracetamol-containing products in pack sizes larger than 16 capsules or tablets are stored behind the counter.

“However, packets of up to 50 capsules or tablets can be purchased without needing to consult a pharmacist.”

Writing for The Conversation, Natasa Gisev, clinical pharmacist and Scientia Associate Professor at the National Drug and Alcohol Research Centre, UNSW Sydney and Ria Hopkins, Postdoctoral Research Fellow, National Drug and Alcohol Research Centre, UNSW Sydney, state:

“Several paracetamol products are not affected by these changes.

“These include children’s products, slow-release formulations (for example, “osteo” products), and products already behind the pharmacy counter or only available via prescription,” they write.

Impact on non-pharmacy retailers 

As mentioned earlier, the current changes largely affect non-pharmacy retailers, including supermarkets, petrol stations and convenience stores.

Supermarkets, petrol stations and convenience stores will now be required to:

• Limit paracetamol to 16-tablet packs.
• Run down stocks of 20-tablet packs before 1 February, as selling these larger packs becomes illegal after this date.

Non-pharmacy retailers are also encouraged to limit sales of paracetamol to one pack per transaction.

Additionally, the TGA states:

“These restrictions cover paracetamol products and combination products, such as cold and flu medicines that contain paracetamol.

“Any paracetamol tablets and capsules for general sale will also be required to be in blister packaging.”

Pharmacists’ role in patient education

Dr Kate Wang, Senior Lecturer and Pharmacist at RMIT highlights the critical role of pharmacists in ensuring safe paracetamol use.

“The changes to scheduling and packaging of paracetamol presents an opportunity for pharmacists to engage in a discussion with patients to make them aware of the benefits and risks,” she says.

“These conversations can help pharmacists to assess whether patients are taking other medications containing paracetamol, or if they have pre-existing liver conditions that necessitate caution in its use.”

While the changes may add to pharmacists’ workload, Dr Wang stresses the importance of maintaining safe medication practices.

“There may be concerns around an increased workload for pharmacists, who already often face significant workloads,” she says.

“However, pharmacists are the medication experts in frontline healthcare.

“Addressing staff workload concerns should be approached separately without compromising safe practices and patient-centred care.”

For more information and to stay informed about all the latest regulatory updates, visit: ‘Comply with paracetamol pack size changes’. 

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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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On 1 July 2023, the TGA made changes to the classification of psilocybin and MDMA to enable prescribing by authorised psychiatrists for the treatment of certain mental health conditions, including treatment-resistant depression and PTSD. To prescribe, psychiatrists must be approved under the Authorised Prescriber Scheme by the TGA following approval by a Human Research Ethics Committee.

Australian Multidisciplinary Association for Psychedelic Practitioners (AMAPP) is a registered multidisciplinary organisation of qualified health practitioners, including doctors, psychiatrists, psychologists, nurses, paramedics and social workers, who are keen to encourage and promote the safe and judicious introduction of PAT as a recognised, well-regulated and effective treatment in the Australian mental health field.

“To this end, our members, many of whom have extensive experience understanding and working with psychedelic medicines for the treatment of psychiatric disorders, have come together to develop safe, efficient and practical guidelines for the use of PAT as well as educational resources for general practitioners and the public,” said the AMAPP Chairman Dr Anthony Bloch.

‘We feel that the current regulations and recommendations made this year by the TGA and the RANZCP leave a lot to be desired,” said Dr Bloch. “We understand that the TGA decision made earlier this year was both unexpected and perhaps premature, considering the lack of adequate research up until now into psychedelic medicines, but nevertheless, the decision was made, and under certain prescribed circumstances, PAT can now be legally utilised by suitably qualified and trained psychiatrists.”

However, according to Dr Bloch: “The current regulatory system is virtually unworkable, overly cautious and cumbersome and needs to evolve with the help and input from those practitioners who have appropriate knowledge and experience working in the psychedelic field.”

AMAPP is proposing an urgent meeting of “minds and regulators” so that all those interested and invested in this work can come together and develop fairer and more progressive guidelines and regulations. According to the group, what is most important is equitable and reasonable patient access to these treatments, as well as more flexibility and sharing of the treatment roles and responsibilities by the psychiatrists and the therapists involved.

AMAPP argues that a number of other issues also need to be sorted out and agreed upon, such as appropriate advertising, clinic locations and types, the need for uniform national standards, as well as the future collection of accurate treatment and research data.

“We are proposing that everyone invested in PAT, the TGA, state health departments, HREC’s, Academic institutions, the RANZCP, and all the professional organisations representing our members get together and formulate ways of significantly improving the current inadequate state of play. Failure to address these issues may push desperate, vulnerable patients to unregulated therapists where real harm is more likely.”

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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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Pfizer Australia and BioNTech SE have announced that the Therapeutic Goods Administration (TGA) has approved the companies’ to release a new COVID-19 vaccine in individuals 5 years and older.¹

The Omicron XBB sublineages account for the majority of COVID-19 cases globally.² The 1.5-adapted monovalent COVID-19 vaccine is targeted towards XBB-related COVID-19. Although Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccines provide some protection against a range of outcomes from XBB-related COVID-1,^3,4 evidence suggests that the vaccine is better matched to currently circulating strains with help to improve protection against symptomatic and severe COVID-19.⁵

“We welcome the TGA’s decision and commend them for their careful assessment of the latest version of Comirnaty. This decision reaffirms our commitment to bring a high-qualityvaccine against this virus to Australians,” said Dr Krishan Thiru, Pfizer Australia & New Zealand Medical Director.

“In 2022, COVID-19 was one of Australia’s leading causes of death, behind heart diseaseand dementia.6 With today’s decision, an updated vaccine will shortly become available that helps address multiple Omicron XBB-related sublineages, which currently account for the vast majority of COVID-19 cases globally.”

“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiratory viruses, we remain committed to providing COVID-19 vaccines that are that are better matched to relevant circulating virus variants or sublineages to people worldwide,” said Prof. Ugur

Sahin, M.D., CEO and Co-founder of BioNTech. “The new variant-adapted monovalent vaccine aims to further improve protection against severe illness and hospitalisation caused by Omicron XBB descendent sublineages that are antigenically distant from prior Omicron strains.”

The TGA’s decision was based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of Pfizer and BioNTech’s COVID-19 vaccines.

COVID-19 vaccines are free of charge for Australians and are available in pharmacies and general practices across Australia.

References:

1. Australian Government Department of Health and Aged Care. ARTG Public Summary documents

COMIRNATY Omicron XBB.1.5 (raxtozinameran). Available at:tga.gov.au/resources/artg?keywords=XBB+1.5. Accessed October 2023.

2. World Health Organization. COVID-19 Weekly Epidemiological Update: Edition 158 published 1 September 2023. Available at: who.int/publications/m/item/weekly-epidemiological-update-on-covid-19—1-september-2023

3. Link-Gelles R, Ciesla AA, Roper LE, et al. Early estimates of bivalent mRNA booster dose vaccine

effectiveness in preventing symptomatic SARS-CoV-2 infection attributable to Omicron BA.5– and

XBB/XBB.1.5–related sublineages among immunocompetent adults — Increasing community access to testing program, United States, December 2022–January 2023. MMWR Morb Mortal Wkly

Rep 2023;72:119–124. doi: dx.doi.org/10.15585/mmwr.mm7205e1

4. Link-Gelles R, Weber ZA, Reese SE, et al. Estimates of bivalent mRNA vaccine durability in preventing COVID-19–associated hospitalization and critical illness among adults with and without immunocompromising conditions — VISION Network, September 2022–April 2023. MMWR Morb Mortal Wkly Rep 2023;72:579–588. DOI: dx.doi.org/10.15585/mmwr.mm7221a3

5. Khoury DS, Docken SS, Subbarao K, Kent SJ, Davenport MP, Cromer D. Predicting the efficacy of variant-modified COVID-19 vaccine boosters. Nature Medicine. 2023 Mar;29(3):574-8. Available at: pubmed.ncbi.nlm.nih.gov/36864253/

6. Australian Bureau of Statistics. (2022). Causes of Death, Australia. ABS. abs.gov.au/statistics/health/causes-death/causes-death-australia/latest-release.

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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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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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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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