The post TGA crackdown: 70K vapes seized in NSW appeared first on Retail Pharmacy.
]]>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 post ‘Tighter regulations on vaping products critical,’ says RACGP appeared first on Retail Pharmacy.
]]>In a submission made to the TGA, the RACGP is calling for:
Of particular concern here, according to RACGP President Dr Nicole Higgins, are the vaping products sold as non-nicotine products while containing nicotine.
“Many vaping products sold as non-nicotine do, in fact, contain nicotine. This makes it clear that getting people addicted is a core part of Big Nicotine’s marketing strategy,” says Dr Higgins.
Dr Higgins says that the increasing number of young Australians taking up vaping is “deeply concerning”.
“More and more young people who have never smoked cigarettes are now vaping and this is deeply concerning,” she says.
“The RACGP created smoking cessation guidelines, which include using nicotine vaping products to aid smoking cessation and that’s because we believe this is the only legitimate use of these products.”
Dr Higgins says that while the correct use of NVPs is within the realm of aiding smoking cessation, tighter regulations are needed to ensure the health of all Australians and to avoid creating “an impression of a safe alternative to cigarettes”.
“We are at risk of trading one public health disaster for another,” she says.
“The RACGP understands that getting a prescription is harder than walking to the shop, but GPs are here to help, and to work with you to improve your health, without judgement,” Dr Higgins says.
“Your GP can work with you to take control of your health, and save you money, by helping you to access smoking cessation products and develop strategies that work for you.”
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]]>The post Let’s talk CBD appeared first on Retail Pharmacy.
]]>Broadly speaking, two components make up the emerging area of healthcare referred to as medicinal cannabis: THC (or tetrahydrocannabinol), which is intoxicating, and CBD (or cannabidiol) which is not.
According to pharmacist Zeeta Bawa, research assistant and PhD candidate within the Lambert Initiative for Cannabinoid Therapeutics at the Brain and Mind Centre of the University of Sydney, these are “the two most well-studied active ingredients found in the Cannabis sativa plant”.
She adds that while evidence is still emerging, CBD has demonstrated health benefits, including “anxiolytic, anti-inflammatory, antipsychotic, anti-addiction and anticonvulsant properties”.
“CBD can be found in a wide variety of formulations, some of which include oils, capsules, wafers, flower (flos, plant material) and other oral products – for example, tablets, lozenges,” she said.
Dr Joe Kosterich, medical adviser to medicinal cannabis company Little Green Pharma says CBD is “one of the main cannabinoids in the cannabis plant”.
“It comes mainly as an oral form – oils or tablets – but also as dried flower,” he said. “There are [also] some sublingual formulations.”
Medicinal cannabis, and in this case, the use of CBD within Australian healthcare, is governed by tight regulations.
Regulatory authorities the Therapeutic Goods Administration (TGA) and the Australian Register of Therapeutic Goods (ARTG) have set in place restrictions related to the use of medicinal cannabis, which all healthcare professionals need to be aware of.
“Formulations containing mostly CBD have been largely available via Schedule 4 using the Authorised Prescriber (AP) and Special Access (SAS) schemes that are overseen by the TGA,” Ms Bawa said.
“Recently, Schedule 3 access has been approved but no CBD products have been registered with the TGA or are currently available in this schedule. It’s expected that this will happen sometime next year.”
Dr Kosterich adds that the TGA down-scheduled CBD to Schedule 3 in early 2021.
“This only applies to those formulations on the ARTG,” he said. “Currently there are none on this register, thus CBD is Schedule 4 and must be prescribed by a doctor.
“However, as CBD products are not on the ARTG, a doctor must get approval from the TGA to prescribe, in contrast to regular Schedule 4 drugs, which do not require authorisation.”
Despite the current regulations, the use of medicinal cannabis, specifically CBD in this case, is an evolving area of healthcare. As CBD offers health benefits, it’s an area in which pharmacists should be upskilling.
Referring to a summary provided by the TGA, Ms Bawa lists some of the evidence supporting the benefits of CBD for various health conditions:
Ms Bawa continued: “The main uses for CBD have been chronic pain, anxiety, insomnia, neuropathic pain, cancer pain/symptoms and epilepsy. It should be noted that these uses are not always supported by robust evidence from clinical trials. This is not to say that CBD doesn’t work, but that we simply require more randomised controlled trials to confirm efficacy.”
She adds that currently, “CBD is often used when other treatment options are unsuitable or have failed”.
Conversations around CBD oils and products often refer to benefits in reducing inflammation. Ms Bawa says that while CBD has been “seen to help with modulating some of the inflammatory responses and pain associated with inflammation”, more “robust clinical trials are required to confirm these findings in humans”.
“The efficacy data of inflammation has largely come from pre-clinical and animal trials, which are an early marker of efficacy in inflammation,” she said.
Pharmacist and herbalist Gerald Quigley says that given its role within the inflammatory response pathways and the fact that “inflammation is the root cause of so many chronic diseases”, there’s an opportunity for CBD to help in this space.
He adds that evidence supports the role of CBD in aiding inflammatory conditions such as polymyalgia, fibromyalgia, osteoarthritis and rheumatoid arthritis.
“If you look at some mental health conditions that may involve inflammation in the brain, then CBD will play a role there,” he said. “In fact, … [CBD] has been used in an autism spectrum disorder study … there are some children whose autism has been resolved … so we know that it works as an anti-inflammatory.”
Similarly, when it comes to pain management, Ms Bawa says more “randomised controlled trials are required to truly understand the analgesic effects of CBD in various types of pain”.
“It’s important to [remember] that pain is a complex condition that varies in aetiology,” she said. “It’s not a one-dimensional condition, and therefore the treatment of pain is not simple either.”
Ms Bawa continued: “Despite the lack of robust clinical evidence, it [CBD] has certainly been prescribed a great deal for pain, and there’s a lot of interest in CBD as an alternative therapy. Some patients may find relief from their pain with CBD, while others may not.
“Currently, CBD is used on a case-by-case basis and is considered a last resort therapy or an ‘add-on’ therapy when conventional treatment options haven’t managed to control pain sufficiently. I recommend that patients speak to their doctors about using CBD for pain.”
While more clinical studies are needed, Dr Kosterich says numerous studies in the US have shown “reduced use of opiates when medicinal cannabis is introduced”, which may be a better alternative here, given the fact that “CBD is non-intoxicating and non-addictive”, he says.
“It’s important to point out that these studies generally include CBD and combinations of CBD and THC,” Dr Kosterich said. “It’s certainly the case that for some people, they can reduce other pain medications, and that reduction can be all the way down to stopping [this medication]. Currently in Australia, it [medicinal cannabis] can only be prescribed when other treatments have failed or caused adverse effects.”
Regarding the management of stress and anxiety, Ms Bawa says that “CBD has demonstrated anxiolytic effects in some clinical trials in doses of 300mg and above”.
“[This] is promising,” she said. “However, there are very few trials to confirm these effects … As I’ve mentioned, further high-quality trials are required to clarify the anxiolytic effects of CBD.”
Dr Kosterich says CBD, and combinations of CBD and THC, are “a viable option” for the management of stress/anxiety, as they are for pain management – and have “a more benign side effect profile than many currently used medications”.
“And [they’re ] non-addictive,” he said.
Ms Bawa says “CBD generally has a good safety profile”, but she cautions that “it can interact with a number of medications”.
“This will, of course, depend on the dose and frequency of CBD use,” she said. “CBD can affect a number of enzymes in the liver, which will affect how various substances are metabolised. Therefore, care should be taken if patients are using other medications.”
In terms of drug interactions, Ms Bawa says CBD has been known to interact with “clobazam and sodium valproate”.
“CBD can also interact with warfarin, and recent research by the Lambert Initiative for Cannabinoid Therapeutics found a CBD and citalopram interaction,” she said.
According to Mr Quigley, CBD is generally safe and doesn’t have any significant side effects.
“It appears that the biggest issue with CBD and CBD oil is taste,” he said.
Ms Bawa agreed: “CBD is generally well tolerated, [although] some of the side effects of CBD can include fatigue, sedation and gastrointestinal upsets, including nausea, vomiting and diarrhoea,” she said. “However, these effects tend to happen at higher doses, and will depend on the dose and frequency of use.”
According to Dr Kosterich, CBD is also contraindicated in pregnancy and lactation, while “care needs to be taken in those with liver or kidney issues – albeit CBD is non-toxic to these organs”.
Reiterating the warnings regarding warfarin use, he says those considering CBD who are on warfarin will “need their INR levels monitored” as would be the case “with the addition of any new medication”. He adds that “care needs to be taken when adding it [CBD] to current medications that perform a similar role”.
“However, one can start at a low dose and titrate upwards slowly, in some instances while reducing other medications, if appropriate,” Dr Kosterich said. “In clinical practice, drug interactions are rarely a problem.”
When CBD products that comply with TGA regulations and are listed on the ARTG become available, this will be a space in which community pharmacies will have a role. It’s pertinent, therefore, for pharmacists to upskill in this area.
“It’s important for pharmacists to keep up to date with all of this,” Mr Quigley said. “I think they need to start learning about cannabis … they need to become educated in the latest work being done so that when these things come on the market, they’re ready to go because there’ll be people coming from everywhere wanting to give it [CBD] a try.”
He adds that it will also be important for pharmacists to “be supportive and engaging in customers’ requests”.
“[As pharmacists],” he said, “we should be able to confidently inform people, bearing in mind their history, their medications, their particular issues, their pain, and what effect [CBD] is having.”
Ms Bawa said: “Medicinal cannabis is an emerging area of pharmacy practice, and there’s a need for pharmacists to have knowledge about this drug class. This need is emphasised given the recent legislation, which will permit the Schedule 3 supply of low-dose CBD products.”
She continued: “In terms of Schedule 4 CBD supply, pharmacists should approach this medication as they would any other: Are the prescribed dose, frequency and indications suitable? Are there any drug interactions, contraindications or precautions? What counselling point should you provide?
“In terms of Schedule 3 CBD supply, pharmacists will be able to supply these products based on the indications approved by the TGA (these are yet to be determined). Over-the-counter supply of CBD by pharmacists will not be suitable for complex or unstable chronic conditions, and these customers will need to be referred to their doctor for further advice.
“I believe pharmacists will play a critical role in educating customers on CBD products and the available evidence, whether pharmacists decide to participate in supply or not.”
To read the feature in full, as it appears in the December issue of Retail Pharmacy magazine, visit: retailpharmacymagazine.com.au/magazine/retail-pharmacy-december-2022
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]]>The post Covid-19 rapid antigen for use at home appeared first on Retail Pharmacy.
]]>Individual tests will require TGA approval and inclusion in the Australian Register of Therapeutic Goods (ARTG) as for all other testing kits. The TGA has already commenced the review of data and information for self-tests for those suppliers who have responded to the registration of interest process.
The Pharmacy Guild of Australia says rapid antigen self-testing kits will become another tool in the fight to suppress Covid-19 in Australia with National President, Trent Twomey, welcoming the move by the TGA.
Mr Twomey expects that upon approval, test kits would be widely available through community pharmacies across Australia.
“We need to utilise all available resources in this once-in-a-century fight against this pandemic,” says Mr Twomey.
“As the Federal Minister for Health, Greg Hunt, has made clear, all necessary checks and balances must be undertaken to ensure safety and effectiveness of these tests; and also the regulatory process will involve State and Territory Governments.
“Community pharmacists have helped accelerate vaccinations against Covid-19, especially now that Moderna vaccine stocks are available.
“Pharmacists will continue to deliver resources to the community in the fight against Covid and the effort to restore our Australian way of life – at least to a ‘new normal’,” says Mr Twomey said.
The TGA says it will continue to work with suppliers and manufacturers of self-tests to ensure:
The TGA advises that it is important that the appropriate systems are in place, including by State and Territories, to ensure the reliable use of these tests at home occurs at the earliest possible time, including enabling any consumer who has a positive rapid antigen test result is supported to immediately have a confirmatory PCR test at a Covid-19 testing centre.
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]]>The post TGA announces OTC access for low dose CBD appeared first on Retail Pharmacy.
]]>According to a statement released by the TGA this decision allows approved low-dose CBD-containing products (up to a maximum of 150mg/day) for use in adults, to be supplied OTC by a pharmacist, without prescription.
The caveat is that this decision limits OTC supply of CBD-containing products to only those that have been approved by the TGA and included on the Australian Register of Therapeutic Goods (ARTG).
According to the TGA, the final decision was made following an earlier TGA safety review of low dose CBD, which indicated that the known adverse events of CBD at low doses were not serious.
There are reportedly no TGA approved products on the ARTG that meet the Schedule 3 criteria at this time.
The TGA says that sponsoring companies can now lodge an application to the TGA for inclusion of Schedule 3 CBD preparations on the ARTG.
For more information on this can be found here.
Painaustralia has reportedly cautiously welcomed this decision by the TGA as changes that provide more accessible and affordable pain management options are necessary, according to CEO of Painaustralia, Carol Bennett.
“While the number of people living with pain in Australia rises, there will still be significant gaps in access to, and understanding of, best practice holistic pain management,” says Ms Bennett.
“With the recent restrictions applied to opioids in Australia making pharmacological pain treatments less accessible, the Schedule 3 listing of CBD and ready availability in pharmacies will add another drug to the list of available treatments.
“The missing piece of the puzzle remains access to multidisciplinary treatment.”
Painaustralia is reportedly advocating for a National Action Plan for pain management to ensure a national and holistic policy framework that supports consumers, health professionals and the wider community.
Information on the action plan can be found at: painaustralia.org.au/improving-policy/national-action-plan
For more information on medicinal CBD, visit: retailpharmacymagazine.com.au/the-case-for-marijuana-as-medicine/
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]]>The post Emyria launches Calm-Gut study appeared first on Retail Pharmacy.
]]>The study will complement Emyria’s recent mental health focussed drug development program.
Up to 200 people will be included in the study, expected to last 12 months
Emyria is undertaking this observational study as an important step towards generating evidence of efficacy and safety for routinely prescribed medicinal cannabis for the management of symptoms in patients with irritable bowel syndrome (IBS), a significant unmet medical need.
This study will also inform the development of Emyria’s second cannabinoid-based drug candidate.
Emyria’s Managing Director Michael Winlo says: “We’re pleased to see strong interest in our CALM-GUT study from patients with irritable bowel syndrome. IBS can be a challenging condition to manage and the strong interest demonstrates the need for safe and effective options.
“We were encouraged to initiate this study based on an analysis of our Real-World Evidence and have designed it to support our second drug development program EMD-004. This study will also inform how we can better care for patients with this condition and we’re very pleased to be collaborating with Dr Chris Schneider, a consultant gastroenterologist based in Melbourne, on these projects.”
Professor Alistair Vickery and Dr Chris are leading the study across Victoria, NSW and Western Australia
Emyria’s drug development programs encompass unique clinical evidence packages, intellectual property and strategically developed clinical trial protocols informed by Emyria’s unique Real-World Evidence and observational trial results.
The development programs are intended to support the registration of specific medicines for specific health indications with the Therapeutic Goods Administration’s (TGA) Australian Register of Therapeutic Goods (ARTG).
For more details on CALM-GUT, click here.
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]]>The post High-risk sports supplements to be regulated as medicines appeared first on Retail Pharmacy.
]]>This is a result of the prevalent use of sports supplements among athletes who are not always aware of the risk that comes with them of ingesting poisonous substances.
To protect these consumers, the Therapeutic Goods Administration (TGA) declaration made a legislative instrument under section 7 of the Therapeutic Goods Act 1989 to help protect Australian consumers from the unsafe use of certain sports supplements.
The instrument declares certain sports supplements (those that include higher-risk ingredients or are in the form of a tablet, pill or capsule) to be therapeutic goods, ensuring they are appropriately regulated as medicines.
This means that sports supplements with therapeutic claims containing higher-risk ingredients must be included in the Australian Register of Therapeutic Goods (ARTG) as well as meet legislated requirements that ensure the safety, quality and efficacy for medicines, including advertising.
Sports supplements with therapeutic claims that are presented as tablets, capsules or pills and do not contain higher risk ingredients have three years (by 30 November 2023) to comply with the requirements.
Regulated as medicines means that sports supplements will also need to be manufactured in accordance with good manufacturing practice to ensure the quality of the product, with extra labelling, advertising and evidence requirements.
The declaration follows over 18 months of extensive consultation, including public and targeted stakeholder consultations held between October 2019 and February 2020.
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]]>The post Study finds: Glen 20 surface spray kills COVID-19 appeared first on Retail Pharmacy.
]]>A new study published in The American Journal of Infection Control, evaluating the virucidal efficacy of personal care and surface cleaning and disinfection products against COVID-19 has confirmed that the active ingredients in many leading hygiene products, including Glen 20, are great than 99.9% effective against the virus.
“As we continue to grapple with the global COVID-19 pandemic, infection prevention and control is absolutely critical, says Marketing Directory in Australian and New Zealand at Reckitt Benckiser (RB) Hygiene, Saurabh Jain.
“The outcomes of this study, being founded in scientific evidence, are a positive development in efforts to curb the spread of the virus and our hope is that these findings will be useful to the community of dedicated health and hygiene professionals that are working tirelessly to contain its foothold on society.”
With Glen 20 being a staple disinfectant in many Australian households, Mr Jain adds that RB “is committed to helping protect Australians” against germs viruses such as COVID-19.
“Our vision is to provide Australians with effective, high quality products to help prevent the spread of germs and viruses – these results speak very strongly to this unwavering commitment.”
The laboratory tests examined active ingredients1 in well-known and widely used products, including products from the Lysol family of brands that form part of the RB global hygiene portfolio.
In Australia, this includes Glen 20 Surface Spray Disinfectant, which is listed on the Australian Register of Therapeutic Goods (ARTG) for effective use against the COVID-19 virus.
The study forms part of a wider commitment by RB, a global leader in health and hygiene, to contribute to scientific knowledge around hygiene and the COVID-19 virus and to ensure that all of its communication with stakeholders is evidence-based.
For more information, visit: ajicjournal.org/article/S0196-6553(20)30313-8/pdf
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