What is CBD?

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.”

Considering the regulations 

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.

CBD: the health benefits

Referring to a summary provided by the TGA, Ms Bawa lists some of the evidence supporting the benefits of CBD for various health conditions:

• “There is reasonable well-established efficacy in paediatric epilepsy and anxiety from randomised controlled trials.
• “There is emerging evidence of efficacy in chronic pain and addictions from randomised controlled trials.
• “There are only pre-clinical/animal studies around the use of CBD for anti-inflammatory or neuroprotective effects.”

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.

CBD precautions

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.”

The role of community pharmacy

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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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:

• Instructions for use are written in a way that all consumers can understand.
• Suppliers having appropriate support available for example, via a You-tube video, 1800 call number, website fact sheets for consumers to seek help or ask questions.
• Usability testing has been successful with untrained, unsupervised users.
• Self-tests perform satisfactorily against variants such as Delta, noting that many tests in the international market were developed prior to the Delta variant becoming predominant.

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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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.

A cautious welcome

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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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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This decision is an interim one made by the Therapeutic Goods Administration in the interests of supporting smoking cessation.

The proposed implementation date of the amendment to the scheduling is the beginning of June 2021.

This decision is supported by the Pharmacy Guild of Australia.

The Guild also supports the delegate’s decision to delay the implementation date in order to provide enough time for the development of resources, including professional standards and clinical guidelines, and for community pharmacies to become familiar with the supply and distribution processes.

The Guild is also of the opinion that the products should be registered on the Australian Register of Therapeutic Goods to address concerns around safety and quality.

This is, however, not likely to occur before mid-year next year.

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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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The Therapeutic Goods Administration annual performance statistics report, released this week, showed 24,000 medicine and vaccine adverse reaction reports were made between July 2018 and June 2019, with pharmacists making the largest contribution among health professionals.

“Of those reports made by health professionals, nearly half were lodged by pharmacists, including hospital pharmacists,” Pharmaceutical Society of Australia National President Associate Professor Chris Freeman said.

“Medicine related side effects are reported to the TGA for assessment and make a vital contribution to medicine safety in this country. PSA’s ‘Medicine safety: take care’ report [January 2019] indicated that 1.2 million Australians experienced an adverse reaction in the [previous] six months.”

What this highlighted, he added, was that “a lot more can be done to encourage adverse event reporting, and pharmacists, as expected, are leading the way in this area”.

“Pharmacists are medicine experts,” he continued. “They also spend a lot of time with consumers talking about their medicine use and any side effects or issues they may have experienced. It’s no surprise that they are more aware of adverse reactions and most likely to report them.”

Products for which therapeutic claims are made are assessed by the TGA and entered on the Australian Register of Therapeutic Goods (ARTG). At June 30, 2019, there were 88,788 therapeutic goods on the ARTG, including 31,987 new products added during the reporting period.

“The number of new listed medicines entered into the ARTG this year was 1,893,” Associate Professor Freeman said.

“Use of medicines is the most common intervention we make in healthcare, which unfortunately means problems with medicine use are also common.

“As the custodians of medicine safety in the healthcare system, the early identification of medicine adverse effects through established reporting systems is vital and this highlights the vital role of pharmacists.

“The TGA report shows the profession takes its responsibility very seriously and prioritises medicine safety.”

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A medicine to treat cancer based on the genetic profile of the tumour, rather than tumour type or location, has now been registered on the Australian Register of Therapeutic Goods.

This is claimed to mark the first ‘tumour agnostic’ approach to cancer treatment in Australia.

MSD has confirmed that Keytruda (pembrolizumab) can now be used to treat eligible patients whose cancer has a specific genetic alteration (a biomarker) known as deficient DNA-mismatch repair (dMMR) or microsatellite instability-high (MSI-H).

These patients must have advanced cancer that has progressed following previous treatment and have no satisfactory alternative treatment options.

Colorectal cancer is one form of cancer that can display the dMMR and/or MSI-H biomarker, and the new indication specifically identifies advanced colorectal cancer patients with this biomarker, whose disease has progressed following treatment with multiple therapies, as eligible for treatment.

This indication was approved under the provisional approval pathway, which provides a six-year window to collect further data to support the drug’s use in MSI-H cancer and to transition to a full registration.

It is estimated that there are more than 20 different tumours types that may display MSI-H and/or dMMR, which can be identified through laboratory tests.

These tumours include colorectal, endometrial, gastric, small intestinal, pancreatic, cholangiocarcinoma, adrenocortical, mesothelioma, small-cell lung, cervical, neuroendocrine, thyroid, urothelial, brain, ovarian, prostate, retroperitoneal, salivary, sarcoma, testicular and tonsillar cancers.

“This is the first tumour agnostic indication made available in Australia,” MSD Australia Managing Director Michael Azrak said. “It marks a shift in treating cancer according to the genetic type of the tumour as opposed to the tumour location.”

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The implant, developed in part with technology created by Professor William Morgan and Professor Dao-Yi Yu at the Perth Lions Eye Institute more than 20 years ago, is now entered in the Australian Register of Therapeutic Goods, to reduce intraocular pressure, or high eye pressure, in patients with primary open-angle glaucoma where previous medical treatments have failed. It is also reimbursed on the Private Health Insurance Prostheses List.

There are approximately 300,000 people in Australia diagnosed with glaucoma, with primary open-angle glaucoma being the most common form. One in 50 Australians will develop glaucoma in their lifetime, and this risk increases with age; one in eight Australians aged more than 80 years will develop it.

There is no cure for glaucoma, and the only proven treatment is to reduce eye pressure. Glaucoma is known as ‘the silent thief of sight’ because it affects side vision before central vision, not readily noticeable in day-to-day life. Generally, there are no symptoms or warning signs in the early stages. Currently, about 50 per cent of people with glaucoma remain undiagnosed, and if left untreated, it can lead to blindness.

The Xen Gel Implant is a tiny gel tube 6mm in length, the size of an eyelash. It becomes soft and flexible when hydrated during a surgical procedure performed by an ophthalmologist specially trained in the Xen procedure. The Xen Gel Implant is inserted into the eye and works by creating a small tunnel that allows the fluid within the eye to drain away and therefore lower eye pressure. The Xen Gel Implant has been shown to reduce eye pressure for more than 12 months.

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