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[post_content] => At one point in time, Menopausal hormone therapy (MHT) was used fairly extensively.
But this has changed since 2002, when the Women's Health Initiative (WHI) published a study linking combined MHT (oestrogen and progestin) with an increased risk of blood clots, stroke, breast cancer and heart attacks.
Almost overnight, women stopped using hormone therapy, said CEO of Jean Hailes for Women's Health, Dr Sarah White.
[caption id="attachment_27901" align="alignright" width="300"]
Dr Sarah White[/caption]
But there are several factors that led to the study results being skewed.
‘It was [based on] an older group of women who started taking hormone therapy late, and it was a different form of hormone therapy, so those results did not stand up and the increased risk in breast cancer was terribly small,’ she said.
The sensationalist reporting did a huge amount of damage, Dr White said.
‘We still have women today who believe that MHT causes breast cancer, and GPs who are nervous about prescribing it.’
While around one in four women who go through menopause will be asymptomatic or have mild symptoms, a quarter will be at the opposite end of the spectrum and experience severe symptoms, said Dr White.
‘We're talking about an inability to sleep, terrible brain fog, anxiety, a loss of confidence, and hot flushes that can be catastrophic,’ she said.
The remaining half of women are on a spectrum of experiencing mildly annoying to must-be-managed symptoms.
‘We have women who are trying to soldier on through some really unpleasant physical and mental effects,’ she said. ‘And it's a bit heartbreaking to think that there's a medication that can help manage a lot of the symptoms and women are worried about taking it when they have no need to be.’
Is MHT underprescribed?
There's ‘no doubt’ that MHT is underused in Australia, said Dr White – with barriers to access a compounding factor.
‘It's not just going to get that doctor's appointment, it's the cost of the MHT,’ she said.
Some forms of MHT are subsidised under the Pharmaceutical Benefits Scheme (PBS), such as estradiol patches, but there has been a global shortage of this therapy in 2024.
But newer medicines such as Prometrium – a progesterone-based treatment matching the hormone the body makes when ovulating – are not, setting women back around $60 per month.
Are all women suitable candidates for MHT?
No, cautioned Dr White.
For example, a person who has had a hormone responsive cancer should have a careful discussion with their GP about whether the risks of MHT outweigh the benefits.
‘If you've had a hormone responsive cancer, then taking a hormone increases the risk of recurrence,’ she said.
Oral combined MHT will increase the ‘baseline’ risk of thrombosis around two-fold – however the baseline risk remains low in most women. Thrombosis risk increases with increasing age, smoking, increased body weight, in those with genetic predisposition to clotting and in certain illnesses. Risk factors should be considered prior to commencing MHT.
MHT treatment should be individualised based on the patient’s needs, clinical features and risk assessment, and reviewed regularly. Women with a personal or family history of venous thrombosis should undergo screening for risk factors to guide the choice of MHT delivery method. In cases where a woman is deemed to be at high risk for developing deep vein thrombosis (DVT), transdermal MHT should be used.
‘That’s why the message is very clear to speak about your individual circumstances with your doctor,’ added Dr White, who said a consultation to discuss the appropriateness of therapy could include:
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[post_content] => The Unleashing the Potential of our Health Workforce – Scope of Practice Review final report and implementation plan is slated for delivery by October 2024.
But many states and territories are forging ahead with expanding pharmacist scope of practice in the interim.
Australian Pharmacist has rounded up some of the most recent updates.
Queensland pharmacy prescribing pilot could go permanent
Ahead of the Queensland state election next week (26 October), incumbent Premier Steven Miles and Health Minister Shannon Fentiman have vowed to make both the Community Pharmacy Scope of Practice Pilot and the Community Pharmacy Hormonal Contraception Pilot permanent if reelected.
Opposition Leader David Crisafulli has since announced intentions to expand both pilots.
Since the scope of practice pilot rolled out in April, trained pharmacists have been able to provide medication management services, autonomous prescribing for specified acute common conditions, and structured prescribing as part of a chronic disease management program.
With Queensland introducing the Community Pharmacy Hormonal Contraception Pilot, making this service permanent would bring Queensland in line with some other states and territories.
Since both pilots kicked off, hundreds of Queenslanders have benefitted from accessing care from their local pharmacy.
Queensland is a largely decentralised state, with more than half (50.7%) of Queensland’s population residing outside of Greater Brisbane.
PSA welcomes the commitment to expanding the scope of practice for pharmacists, said PSA Queensland State Manager Karen Castle MPS.
‘If the scope of practice pilots become permanent, it would have a significant positive impact on the health of Queenslanders and improve access to healthcare, particularly for rural and regional communities where accessing a GP can be challenging,’ she said.
‘Patients already see their pharmacist as a trusted healthcare professional, and this expanded scope will further enhance their role in delivering healthcare, reduce waiting times and improve patient outcomes.
‘As pharmacists expand their practice and the public becomes more aware of the broader services available, we anticipate significant growth in the uptake of services provided by pharmacists.’
Canberrans could soon access more pharmacy services
With the ACT election only days away (19 October), both ACT Labor and the Canberra Liberals have committed to expanding pharmacists' scope of practice.
Pharmacists in the ACT have already been providing consultations for uncomplicated urinary tract infections (UTI) and resupplying OCP under the NSW pilot.
In alignment with NSW, the expanded scope will cover a broader range of common and mild conditions, including ear infections, nausea and vomiting, reflux, acne, muscle pain and wound management.
Certain chronic conditions will also be included.
While PSA ACT Branch President Olivia Collenette MPS said the services will be introduced as a trial, PSA has been advised that there’s no intention to roll back service once it has started.
‘This will be great for Canberrans, where it is the most expensive city in Australia to see a GP,’ Ms Collenette told AP.
‘We have the lowest bulk billing rates in the country and wait times [to see a doctor] are in the weeks. This is all about patient access, ensuring appropriate care is there at the time it's needed.’
Both parties will work to ensure pharmacists can administer vaccines to patients of all ages.
PSA has been advocating for pharmacists to be able to administer all vaccines to all ages in all locations, she said.
‘Pharmacists are trusted healthcare professionals, helping the ACT maintain its above average for Australia vaccination rates,’ Ms Collenette said. ‘Patients have spoken with their feet that they like that pharmacists are providing these services, so we want to ensure they can continue to do so regardless of which vaccine/s they are after.’
Victoria’s scope of practice pilot extended
The Secretary Approval for 12-month Victorian Community Pharmacist Statewide Pilot, due to wrap up this month, was recently extended until June 2025 – ensuring all pharmacists who are already enrolled in the program continue be able to provide services during the evaluation period.
The pilot allows appropriately trained pharmacists to provide certain Schedule 4 medicines for:
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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"]
Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => Case scenario
Sarah, a regular customer in your community pharmacy, presents a prescription for riluzole tablets written by a neurologist for her husband David. It has been several months since David, aged 57, has been seen in the pharmacy. Sarah looks visibly upset and not her usual cheerful self.
After reading this article, pharmacists should be able to:
|
Motor neurone disease (MND) is a group of progressive, degenerative disorders of the motor neurones.1 Motor neurones are nerve cells which control the muscles that enable movement, speech, breathing and swallowing, and their degeneration results in muscle weakness and atrophy.1–3
Patients diagnosed with MND have an average survival time of 2.5 years after diagnosis and usually die of respiratory failure.1–3 The initial symptoms, rate and pattern of disease progression and survival times vary between patients.1 In the vast majority of cases, the cause of the disease is unknown, and there is currently no cure.1,2,4 Multidisciplinary care of patients is required as the disease progresses, and pharmacists can play an important role in patient care.3
The most common type of MND is known as amyotrophic lateral sclerosis (ALS).1,4 In the United States, ALS is also colloquially known as Lou Gehrig’s disease.3,5 Although there are other forms of MND that are not classified as ALS, ALS and MND are generally referred to interchangeably.2 In the United Kingdom, some European countries, Australia and New Zealand, the disease is referred to as MND, but in most other countries it is simply referred to as ALS.5
MND occurs globally. The lifetime risk of MND is approximately 1 in 300–400.4,6 In Australia, on average, two people are diagnosed and two people die from MND each day.2 It is estimated that over 2,000 Australians have MND at any time, of whom 60% are male and 40% female.2 The prevalence in Australia is 8.7 per 100,000, with the highest prevalence in males aged 75–84 years.2 However, 58% of patients are aged under 65 years.2
Australia has a relatively high prevalence compared to other countries; for example, the prevalence rate in Europe is 7.9 per 100,000.2 There is evidence that the prevalence of MND is increasing in some countries.2,6
Although the average survival time following diagnosis is 2.5 years,1 some patients die 3–12 months after diagnosis.4 However, in 5–10% of cases, patients may survive for 10 years or more.2
Aetiology and pathophysiology Various mechanisms, such as protein aggregation, glutamate (a neurotransmitter) toxicity, oxidative stress and free radical or immune-mediated damage, may adversely impact the health of motor neurones in the body; these may contribute to the pathogenesis of MND.1,2 However, the actual causes of MND are largely unknown. In 90% of cases, MND is sporadic where there are no clearly identifiable causes.2 Approximately 10% of cases are inherited (familial) and the genetic mutation responsible for 60% of these cases in Australian families is now known.2 From a clinical perspective, the inherited and sporadic forms of the disease are not distinguishable from each other.2 Knowledge of genetic involvement in MND is increasing with further research, but the relationship between genetic and environmental risks, particularly in sporadic MND, is not well understood.2
Many risk factors have been proposed to be associated with the development of MND. However, the only factors that have been clearly identified are older age, male sex and family history.3,6 Other factors that have been proposed include1,6:
These risk factors may act individually or in combination to contribute to the development of MND. Recent research suggests a six-step process with genes, environment and aging contributing to its development.2,7
Proposed causes of MND, such as high-intensity exercise and blue green algae, often generate media interest, but it should be noted that an association is not the same as causality.2 There may be interactions between non-genetic and genetic risk factors.5,6 More research is required to understand how any underlying genetic mutations cause MND. Genetic testing of patients may become routine practice in the future as more MND-causing gene mutations are discovered in both familial and sporadic forms.2 Also, targeted treatments and strategies which can prevent or delay the onset of disease in patients with an MND-related genetic mutation may be developed in the future, as knowledge of causative factors increases.2
The onset of MND is insidious. The site of initial symptoms varies from patient to patient, with symptoms typically occurring in one muscle group; for example, weakness and wasting of one hand or a unilateral foot drop.1,2
Initial symptoms are usually mild and may include1,2,8:
In some patients, there may be frontotemporal cognitive changes, and emotional responses such as laughing and crying may be easily triggered.
MND may be categorised according to the features of lower and upper motor neurone damage (see Table 1).2,4
Diagnosis of MND is not straightforward, as initial symptoms may be confused with those of other diseases. The average time from the appearance of first symptoms to diagnosis is 12 months.2 Several tests can be conducted to confirm the diagnosis and rule out other diseases; these tests may include8:
There are three main phenotypes of MND based on the sites of symptoms and involvement of upper and lower motor neurones:
Differentiation between the different MND clinical phenotypes is often blurred, and as the disease progresses, there may be considerable overlap, resulting in more generalised muscle wasting and weakness.2 Patients exhibit different initial symptoms depending on the exact combination of nerves that are damaged, and as the disease progresses, the features of the disease become mixed.8 However, certain symptoms, such as loss of the senses, loss of bladder and bowel control, confusion or loss of mental functions, are rarely found in any patients with MND.8
Delays in diagnosis may result from various factors.11 This may include patients not seeking immediate diagnosis, initial misdiagnosis, referral to non-neurological specialists and delayed referral to a neurologist.11 General practitioners will probably only encounter one patient with MND in their careers.1,11 Differential diagnoses may include a variety of other neurological conditions, including Kennedy’s disease, an inherited disorder which progresses very slowly, involves only lower motor neurones and exhibits similar symptoms to those of MND.1,2
A diagnosis of MND, a debilitating and fatal disease, will have an enormous impact on the patient and the patient’s family.5 It is a difficult time for all, and many questions will arise. Because the symptoms and progression of the disease vary so much from one patient to another, it is impossible to predict exactly what will happen following diagnosis.8
Because there is no curative therapy currently available, the focus of treatment for patients with MND is coordinated multidisciplinary care with timely interventions to help manage symptoms as they develop.2,10
Pharmacological therapies
Currently there are only two neuroprotective, disease-modifying therapies available globally, both of which have only very limited effects on the course of the disease.2
Riluzole is available on the Pharmaceutical Benefits Scheme (PBS) for eligible patients (authority required). The exact mechanism of action is unknown, but it is thought to target glutamate by inhibiting its accumulation and neurotransmission.6,12 Tablets containing 50 mg (Rilutek, Pharmacor Riluzole, Riluzole Sandoz, APO-Riluzole) are available, as well as a liquid containing 5 mg/mL (Teglutik) for ease of swallowing or use via a percutaneous endoscopic gastrostomy (PEG) tube.3 The dosage is 50 mg twice daily, taken at the same time each day, 1 hour before or 2 hours after food.3 In the initial clinical trials comparing riluzole with placebo, there was no clinically significant benefit on muscle strength, but survival for patients was increased by up to 3 months compared with placebo.13,14 However, recent analyses of population studies may indicate that survival for patients taking riluzole may be extended by as much as 6–19 months.9,13
Riluzole is generally well tolerated, but common adverse effects may include nausea, dizziness, headache, abdominal pain, weakness, drowsiness and vomiting.2,12 Aminotransferases may become elevated, and regular liver function tests are recommended.1,4,12 Some cases of fatal hepatic failure and pancreatitis have been reported.14
Treatment should be initiated as early as possible after diagnosis. Realistic expectations for treatment effects and potential adverse effects should be discussed with both patients and carers.15
Edaravone (Radicava) has recently been approved for use in Australia; however, it is not yet available, as it is pending PBS listing (as of September 2024). In a small number of patients, it provides limited extensions in survival time. It works by suppressing oxidative stress as a free radical scavenger, although its exact mechanism in MND is yet to be elucidated.2,9 Edaravone is administered as an intravenous infusion, and treatment should be initiated within 2 years of disease onset.2,3
Numerous other pharmacological therapies have been investigated but have not been proven to be effective in mitigating MND, and currently there is insufficient evidence to recommend them. Some of these include2:
Other pharmacological therapies are used to manage individual symptoms such as pain, anxiety, depression, insomnia, cramps, mucosal secretions, drooling (sialorrhea), spasticity, dysphagia, constipation, emotional lability and fatigue.1,3,9 Anticoagulants are not routinely recommended for prevention of venous thromboembolism in MND unless there are additional risk factors.3
Non-pharmacological therapies
As various symptoms develop, interventions will be required for each. Nutritional management is important throughout the disease.9,15 Nutritional status should be monitored regularly, and high-calorie diets can be used to improve nutrition. PEG feeding may be required in some patients; PEG tubes should be placed before respiratory insufficiency develops.8
Similarly, respiratory management is important, and respiration should be monitored regularly.1,9 To treat respiratory insufficiency, non-invasive positive-pressure ventilation can be used to improve survival and quality of life.1,9,15
Difficulties with speech (dysarthria) may require the use of special communication devices.9
Patients are generally cared for at home by family members. MND clinics housing multidisciplinary health professionals are available around Australia to support patients and their carers.10 The clinics are often held in outpatient clinics at a hospital and are usually staffed by a neurologist, other specialist doctors, nurses and allied health professionals.1,2,10
Care of patients requires involvement of various health professionals, not all of whom may be based at a clinic. This may include a general practitioner, neurologist, nurse, psychologist, physiotherapist, speech therapist, occupational therapist and dietitian.8,10
Pharmacists can have positive impacts in the management of MND and have been shown to play an important role in multidisciplinary clinics. A US study reported that pharmacists contributed to optimising medicine use, minimising medicine-induced adverse effects and supporting patient and carer education.16 Additionally, pharmacists can assist by providing advice regarding non-pharmacological management of symptoms as well as vaccines such as influenza and pneumococcal vaccines.3 Pharmacists may also participate in the provision of palliative care as required in the terminal stages of the disease.3 Above all, pharmacists should be compassionate with both patients and their carers.4
Information and support for patients and carers are available from MND Australia and from the various state MND associations.
The care of patients with MND requires a multidisciplinary team. Multidisciplinary teams benefit from a pharmacist’s involvement, as they can compassionately assist patients and carers by providing advice regarding symptom management, medicine use and adverse reactions.
MND is a fatal disorder of motor neurones. The rate and pattern of the disease varies in each patient, as does the survival time. In 90% of cases the cause is unknown, but regardless there is no known cure. Management of MND requires a multidisciplinary approach. A pharmacist’s knowledge of medicines and symptom management can help improve a patient’s quality of life.
Case scenario continuedYou dispense the riluzole prescription and provide advice to Sarah about this medicine. Sarah informs you that David has just been diagnosed with MND and tells you what the neurologist has explained so far before she starts to cry. With compassion, you ask how both she and David are coping. You assure her that you and your staff are there to assist and support them. You offer home delivery of any medicines required for either of them. You counsel her on how the riluzole tablets are to be administered and what to expect. Additionally, you check that Sarah has been provided with information on MND clinics, state-based support services, MND support organisations and where she can find more information about MND. |
Dr Barry L Werth BPharm (Hons), MBA, PhD, MPS is a member of the Lived Experience Research Advisory Panel and the Research Collective at MND Australia and is a pharmaceutical industry consultant.
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
[post_title] => Prescribing pioneer
[post_excerpt] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
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[post_content] => At one point in time, Menopausal hormone therapy (MHT) was used fairly extensively.
But this has changed since 2002, when the Women's Health Initiative (WHI) published a study linking combined MHT (oestrogen and progestin) with an increased risk of blood clots, stroke, breast cancer and heart attacks.
Almost overnight, women stopped using hormone therapy, said CEO of Jean Hailes for Women's Health, Dr Sarah White.
[caption id="attachment_27901" align="alignright" width="300"] Dr Sarah White[/caption]
But there are several factors that led to the study results being skewed.
‘It was [based on] an older group of women who started taking hormone therapy late, and it was a different form of hormone therapy, so those results did not stand up and the increased risk in breast cancer was terribly small,’ she said.
The sensationalist reporting did a huge amount of damage, Dr White said.
‘We still have women today who believe that MHT causes breast cancer, and GPs who are nervous about prescribing it.’
While around one in four women who go through menopause will be asymptomatic or have mild symptoms, a quarter will be at the opposite end of the spectrum and experience severe symptoms, said Dr White.
‘We're talking about an inability to sleep, terrible brain fog, anxiety, a loss of confidence, and hot flushes that can be catastrophic,’ she said.
The remaining half of women are on a spectrum of experiencing mildly annoying to must-be-managed symptoms.
‘We have women who are trying to soldier on through some really unpleasant physical and mental effects,’ she said. ‘And it's a bit heartbreaking to think that there's a medication that can help manage a lot of the symptoms and women are worried about taking it when they have no need to be.’
Is MHT underprescribed?
There's ‘no doubt’ that MHT is underused in Australia, said Dr White – with barriers to access a compounding factor.
‘It's not just going to get that doctor's appointment, it's the cost of the MHT,’ she said.
Some forms of MHT are subsidised under the Pharmaceutical Benefits Scheme (PBS), such as estradiol patches, but there has been a global shortage of this therapy in 2024.
But newer medicines such as Prometrium – a progesterone-based treatment matching the hormone the body makes when ovulating – are not, setting women back around $60 per month.
Are all women suitable candidates for MHT?
No, cautioned Dr White.
For example, a person who has had a hormone responsive cancer should have a careful discussion with their GP about whether the risks of MHT outweigh the benefits.
‘If you've had a hormone responsive cancer, then taking a hormone increases the risk of recurrence,’ she said.
Oral combined MHT will increase the ‘baseline’ risk of thrombosis around two-fold – however the baseline risk remains low in most women. Thrombosis risk increases with increasing age, smoking, increased body weight, in those with genetic predisposition to clotting and in certain illnesses. Risk factors should be considered prior to commencing MHT.
MHT treatment should be individualised based on the patient’s needs, clinical features and risk assessment, and reviewed regularly. Women with a personal or family history of venous thrombosis should undergo screening for risk factors to guide the choice of MHT delivery method. In cases where a woman is deemed to be at high risk for developing deep vein thrombosis (DVT), transdermal MHT should be used.
‘That’s why the message is very clear to speak about your individual circumstances with your doctor,’ added Dr White, who said a consultation to discuss the appropriateness of therapy could include:
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[post_content] => The Unleashing the Potential of our Health Workforce – Scope of Practice Review final report and implementation plan is slated for delivery by October 2024.
But many states and territories are forging ahead with expanding pharmacist scope of practice in the interim.
Australian Pharmacist has rounded up some of the most recent updates.
Queensland pharmacy prescribing pilot could go permanent
Ahead of the Queensland state election next week (26 October), incumbent Premier Steven Miles and Health Minister Shannon Fentiman have vowed to make both the Community Pharmacy Scope of Practice Pilot and the Community Pharmacy Hormonal Contraception Pilot permanent if reelected.
Opposition Leader David Crisafulli has since announced intentions to expand both pilots.
Since the scope of practice pilot rolled out in April, trained pharmacists have been able to provide medication management services, autonomous prescribing for specified acute common conditions, and structured prescribing as part of a chronic disease management program.
With Queensland introducing the Community Pharmacy Hormonal Contraception Pilot, making this service permanent would bring Queensland in line with some other states and territories.
Since both pilots kicked off, hundreds of Queenslanders have benefitted from accessing care from their local pharmacy.
Queensland is a largely decentralised state, with more than half (50.7%) of Queensland’s population residing outside of Greater Brisbane.
PSA welcomes the commitment to expanding the scope of practice for pharmacists, said PSA Queensland State Manager Karen Castle MPS.
‘If the scope of practice pilots become permanent, it would have a significant positive impact on the health of Queenslanders and improve access to healthcare, particularly for rural and regional communities where accessing a GP can be challenging,’ she said.
‘Patients already see their pharmacist as a trusted healthcare professional, and this expanded scope will further enhance their role in delivering healthcare, reduce waiting times and improve patient outcomes.
‘As pharmacists expand their practice and the public becomes more aware of the broader services available, we anticipate significant growth in the uptake of services provided by pharmacists.’
Canberrans could soon access more pharmacy services
With the ACT election only days away (19 October), both ACT Labor and the Canberra Liberals have committed to expanding pharmacists' scope of practice.
Pharmacists in the ACT have already been providing consultations for uncomplicated urinary tract infections (UTI) and resupplying OCP under the NSW pilot.
In alignment with NSW, the expanded scope will cover a broader range of common and mild conditions, including ear infections, nausea and vomiting, reflux, acne, muscle pain and wound management.
Certain chronic conditions will also be included.
While PSA ACT Branch President Olivia Collenette MPS said the services will be introduced as a trial, PSA has been advised that there’s no intention to roll back service once it has started.
‘This will be great for Canberrans, where it is the most expensive city in Australia to see a GP,’ Ms Collenette told AP.
‘We have the lowest bulk billing rates in the country and wait times [to see a doctor] are in the weeks. This is all about patient access, ensuring appropriate care is there at the time it's needed.’
Both parties will work to ensure pharmacists can administer vaccines to patients of all ages.
PSA has been advocating for pharmacists to be able to administer all vaccines to all ages in all locations, she said.
‘Pharmacists are trusted healthcare professionals, helping the ACT maintain its above average for Australia vaccination rates,’ Ms Collenette said. ‘Patients have spoken with their feet that they like that pharmacists are providing these services, so we want to ensure they can continue to do so regardless of which vaccine/s they are after.’
Victoria’s scope of practice pilot extended
The Secretary Approval for 12-month Victorian Community Pharmacist Statewide Pilot, due to wrap up this month, was recently extended until June 2025 – ensuring all pharmacists who are already enrolled in the program continue be able to provide services during the evaluation period.
The pilot allows appropriately trained pharmacists to provide certain Schedule 4 medicines for:
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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"] Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => Case scenario
Sarah, a regular customer in your community pharmacy, presents a prescription for riluzole tablets written by a neurologist for her husband David. It has been several months since David, aged 57, has been seen in the pharmacy. Sarah looks visibly upset and not her usual cheerful self.
After reading this article, pharmacists should be able to:
|
Motor neurone disease (MND) is a group of progressive, degenerative disorders of the motor neurones.1 Motor neurones are nerve cells which control the muscles that enable movement, speech, breathing and swallowing, and their degeneration results in muscle weakness and atrophy.1–3
Patients diagnosed with MND have an average survival time of 2.5 years after diagnosis and usually die of respiratory failure.1–3 The initial symptoms, rate and pattern of disease progression and survival times vary between patients.1 In the vast majority of cases, the cause of the disease is unknown, and there is currently no cure.1,2,4 Multidisciplinary care of patients is required as the disease progresses, and pharmacists can play an important role in patient care.3
The most common type of MND is known as amyotrophic lateral sclerosis (ALS).1,4 In the United States, ALS is also colloquially known as Lou Gehrig’s disease.3,5 Although there are other forms of MND that are not classified as ALS, ALS and MND are generally referred to interchangeably.2 In the United Kingdom, some European countries, Australia and New Zealand, the disease is referred to as MND, but in most other countries it is simply referred to as ALS.5
MND occurs globally. The lifetime risk of MND is approximately 1 in 300–400.4,6 In Australia, on average, two people are diagnosed and two people die from MND each day.2 It is estimated that over 2,000 Australians have MND at any time, of whom 60% are male and 40% female.2 The prevalence in Australia is 8.7 per 100,000, with the highest prevalence in males aged 75–84 years.2 However, 58% of patients are aged under 65 years.2
Australia has a relatively high prevalence compared to other countries; for example, the prevalence rate in Europe is 7.9 per 100,000.2 There is evidence that the prevalence of MND is increasing in some countries.2,6
Although the average survival time following diagnosis is 2.5 years,1 some patients die 3–12 months after diagnosis.4 However, in 5–10% of cases, patients may survive for 10 years or more.2
Aetiology and pathophysiology Various mechanisms, such as protein aggregation, glutamate (a neurotransmitter) toxicity, oxidative stress and free radical or immune-mediated damage, may adversely impact the health of motor neurones in the body; these may contribute to the pathogenesis of MND.1,2 However, the actual causes of MND are largely unknown. In 90% of cases, MND is sporadic where there are no clearly identifiable causes.2 Approximately 10% of cases are inherited (familial) and the genetic mutation responsible for 60% of these cases in Australian families is now known.2 From a clinical perspective, the inherited and sporadic forms of the disease are not distinguishable from each other.2 Knowledge of genetic involvement in MND is increasing with further research, but the relationship between genetic and environmental risks, particularly in sporadic MND, is not well understood.2
Many risk factors have been proposed to be associated with the development of MND. However, the only factors that have been clearly identified are older age, male sex and family history.3,6 Other factors that have been proposed include1,6:
These risk factors may act individually or in combination to contribute to the development of MND. Recent research suggests a six-step process with genes, environment and aging contributing to its development.2,7
Proposed causes of MND, such as high-intensity exercise and blue green algae, often generate media interest, but it should be noted that an association is not the same as causality.2 There may be interactions between non-genetic and genetic risk factors.5,6 More research is required to understand how any underlying genetic mutations cause MND. Genetic testing of patients may become routine practice in the future as more MND-causing gene mutations are discovered in both familial and sporadic forms.2 Also, targeted treatments and strategies which can prevent or delay the onset of disease in patients with an MND-related genetic mutation may be developed in the future, as knowledge of causative factors increases.2
The onset of MND is insidious. The site of initial symptoms varies from patient to patient, with symptoms typically occurring in one muscle group; for example, weakness and wasting of one hand or a unilateral foot drop.1,2
Initial symptoms are usually mild and may include1,2,8:
In some patients, there may be frontotemporal cognitive changes, and emotional responses such as laughing and crying may be easily triggered.
MND may be categorised according to the features of lower and upper motor neurone damage (see Table 1).2,4
Diagnosis of MND is not straightforward, as initial symptoms may be confused with those of other diseases. The average time from the appearance of first symptoms to diagnosis is 12 months.2 Several tests can be conducted to confirm the diagnosis and rule out other diseases; these tests may include8:
There are three main phenotypes of MND based on the sites of symptoms and involvement of upper and lower motor neurones:
Differentiation between the different MND clinical phenotypes is often blurred, and as the disease progresses, there may be considerable overlap, resulting in more generalised muscle wasting and weakness.2 Patients exhibit different initial symptoms depending on the exact combination of nerves that are damaged, and as the disease progresses, the features of the disease become mixed.8 However, certain symptoms, such as loss of the senses, loss of bladder and bowel control, confusion or loss of mental functions, are rarely found in any patients with MND.8
Delays in diagnosis may result from various factors.11 This may include patients not seeking immediate diagnosis, initial misdiagnosis, referral to non-neurological specialists and delayed referral to a neurologist.11 General practitioners will probably only encounter one patient with MND in their careers.1,11 Differential diagnoses may include a variety of other neurological conditions, including Kennedy’s disease, an inherited disorder which progresses very slowly, involves only lower motor neurones and exhibits similar symptoms to those of MND.1,2
A diagnosis of MND, a debilitating and fatal disease, will have an enormous impact on the patient and the patient’s family.5 It is a difficult time for all, and many questions will arise. Because the symptoms and progression of the disease vary so much from one patient to another, it is impossible to predict exactly what will happen following diagnosis.8
Because there is no curative therapy currently available, the focus of treatment for patients with MND is coordinated multidisciplinary care with timely interventions to help manage symptoms as they develop.2,10
Pharmacological therapies
Currently there are only two neuroprotective, disease-modifying therapies available globally, both of which have only very limited effects on the course of the disease.2
Riluzole is available on the Pharmaceutical Benefits Scheme (PBS) for eligible patients (authority required). The exact mechanism of action is unknown, but it is thought to target glutamate by inhibiting its accumulation and neurotransmission.6,12 Tablets containing 50 mg (Rilutek, Pharmacor Riluzole, Riluzole Sandoz, APO-Riluzole) are available, as well as a liquid containing 5 mg/mL (Teglutik) for ease of swallowing or use via a percutaneous endoscopic gastrostomy (PEG) tube.3 The dosage is 50 mg twice daily, taken at the same time each day, 1 hour before or 2 hours after food.3 In the initial clinical trials comparing riluzole with placebo, there was no clinically significant benefit on muscle strength, but survival for patients was increased by up to 3 months compared with placebo.13,14 However, recent analyses of population studies may indicate that survival for patients taking riluzole may be extended by as much as 6–19 months.9,13
Riluzole is generally well tolerated, but common adverse effects may include nausea, dizziness, headache, abdominal pain, weakness, drowsiness and vomiting.2,12 Aminotransferases may become elevated, and regular liver function tests are recommended.1,4,12 Some cases of fatal hepatic failure and pancreatitis have been reported.14
Treatment should be initiated as early as possible after diagnosis. Realistic expectations for treatment effects and potential adverse effects should be discussed with both patients and carers.15
Edaravone (Radicava) has recently been approved for use in Australia; however, it is not yet available, as it is pending PBS listing (as of September 2024). In a small number of patients, it provides limited extensions in survival time. It works by suppressing oxidative stress as a free radical scavenger, although its exact mechanism in MND is yet to be elucidated.2,9 Edaravone is administered as an intravenous infusion, and treatment should be initiated within 2 years of disease onset.2,3
Numerous other pharmacological therapies have been investigated but have not been proven to be effective in mitigating MND, and currently there is insufficient evidence to recommend them. Some of these include2:
Other pharmacological therapies are used to manage individual symptoms such as pain, anxiety, depression, insomnia, cramps, mucosal secretions, drooling (sialorrhea), spasticity, dysphagia, constipation, emotional lability and fatigue.1,3,9 Anticoagulants are not routinely recommended for prevention of venous thromboembolism in MND unless there are additional risk factors.3
Non-pharmacological therapies
As various symptoms develop, interventions will be required for each. Nutritional management is important throughout the disease.9,15 Nutritional status should be monitored regularly, and high-calorie diets can be used to improve nutrition. PEG feeding may be required in some patients; PEG tubes should be placed before respiratory insufficiency develops.8
Similarly, respiratory management is important, and respiration should be monitored regularly.1,9 To treat respiratory insufficiency, non-invasive positive-pressure ventilation can be used to improve survival and quality of life.1,9,15
Difficulties with speech (dysarthria) may require the use of special communication devices.9
Patients are generally cared for at home by family members. MND clinics housing multidisciplinary health professionals are available around Australia to support patients and their carers.10 The clinics are often held in outpatient clinics at a hospital and are usually staffed by a neurologist, other specialist doctors, nurses and allied health professionals.1,2,10
Care of patients requires involvement of various health professionals, not all of whom may be based at a clinic. This may include a general practitioner, neurologist, nurse, psychologist, physiotherapist, speech therapist, occupational therapist and dietitian.8,10
Pharmacists can have positive impacts in the management of MND and have been shown to play an important role in multidisciplinary clinics. A US study reported that pharmacists contributed to optimising medicine use, minimising medicine-induced adverse effects and supporting patient and carer education.16 Additionally, pharmacists can assist by providing advice regarding non-pharmacological management of symptoms as well as vaccines such as influenza and pneumococcal vaccines.3 Pharmacists may also participate in the provision of palliative care as required in the terminal stages of the disease.3 Above all, pharmacists should be compassionate with both patients and their carers.4
Information and support for patients and carers are available from MND Australia and from the various state MND associations.
The care of patients with MND requires a multidisciplinary team. Multidisciplinary teams benefit from a pharmacist’s involvement, as they can compassionately assist patients and carers by providing advice regarding symptom management, medicine use and adverse reactions.
MND is a fatal disorder of motor neurones. The rate and pattern of the disease varies in each patient, as does the survival time. In 90% of cases the cause is unknown, but regardless there is no known cure. Management of MND requires a multidisciplinary approach. A pharmacist’s knowledge of medicines and symptom management can help improve a patient’s quality of life.
Case scenario continuedYou dispense the riluzole prescription and provide advice to Sarah about this medicine. Sarah informs you that David has just been diagnosed with MND and tells you what the neurologist has explained so far before she starts to cry. With compassion, you ask how both she and David are coping. You assure her that you and your staff are there to assist and support them. You offer home delivery of any medicines required for either of them. You counsel her on how the riluzole tablets are to be administered and what to expect. Additionally, you check that Sarah has been provided with information on MND clinics, state-based support services, MND support organisations and where she can find more information about MND. |
Dr Barry L Werth BPharm (Hons), MBA, PhD, MPS is a member of the Lived Experience Research Advisory Panel and the Research Collective at MND Australia and is a pharmaceutical industry consultant.
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
[post_title] => Prescribing pioneer
[post_excerpt] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
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[post_content] => At one point in time, Menopausal hormone therapy (MHT) was used fairly extensively.
But this has changed since 2002, when the Women's Health Initiative (WHI) published a study linking combined MHT (oestrogen and progestin) with an increased risk of blood clots, stroke, breast cancer and heart attacks.
Almost overnight, women stopped using hormone therapy, said CEO of Jean Hailes for Women's Health, Dr Sarah White.
[caption id="attachment_27901" align="alignright" width="300"] Dr Sarah White[/caption]
But there are several factors that led to the study results being skewed.
‘It was [based on] an older group of women who started taking hormone therapy late, and it was a different form of hormone therapy, so those results did not stand up and the increased risk in breast cancer was terribly small,’ she said.
The sensationalist reporting did a huge amount of damage, Dr White said.
‘We still have women today who believe that MHT causes breast cancer, and GPs who are nervous about prescribing it.’
While around one in four women who go through menopause will be asymptomatic or have mild symptoms, a quarter will be at the opposite end of the spectrum and experience severe symptoms, said Dr White.
‘We're talking about an inability to sleep, terrible brain fog, anxiety, a loss of confidence, and hot flushes that can be catastrophic,’ she said.
The remaining half of women are on a spectrum of experiencing mildly annoying to must-be-managed symptoms.
‘We have women who are trying to soldier on through some really unpleasant physical and mental effects,’ she said. ‘And it's a bit heartbreaking to think that there's a medication that can help manage a lot of the symptoms and women are worried about taking it when they have no need to be.’
Is MHT underprescribed?
There's ‘no doubt’ that MHT is underused in Australia, said Dr White – with barriers to access a compounding factor.
‘It's not just going to get that doctor's appointment, it's the cost of the MHT,’ she said.
Some forms of MHT are subsidised under the Pharmaceutical Benefits Scheme (PBS), such as estradiol patches, but there has been a global shortage of this therapy in 2024.
But newer medicines such as Prometrium – a progesterone-based treatment matching the hormone the body makes when ovulating – are not, setting women back around $60 per month.
Are all women suitable candidates for MHT?
No, cautioned Dr White.
For example, a person who has had a hormone responsive cancer should have a careful discussion with their GP about whether the risks of MHT outweigh the benefits.
‘If you've had a hormone responsive cancer, then taking a hormone increases the risk of recurrence,’ she said.
Oral combined MHT will increase the ‘baseline’ risk of thrombosis around two-fold – however the baseline risk remains low in most women. Thrombosis risk increases with increasing age, smoking, increased body weight, in those with genetic predisposition to clotting and in certain illnesses. Risk factors should be considered prior to commencing MHT.
MHT treatment should be individualised based on the patient’s needs, clinical features and risk assessment, and reviewed regularly. Women with a personal or family history of venous thrombosis should undergo screening for risk factors to guide the choice of MHT delivery method. In cases where a woman is deemed to be at high risk for developing deep vein thrombosis (DVT), transdermal MHT should be used.
‘That’s why the message is very clear to speak about your individual circumstances with your doctor,’ added Dr White, who said a consultation to discuss the appropriateness of therapy could include:
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[post_content] => The Unleashing the Potential of our Health Workforce – Scope of Practice Review final report and implementation plan is slated for delivery by October 2024.
But many states and territories are forging ahead with expanding pharmacist scope of practice in the interim.
Australian Pharmacist has rounded up some of the most recent updates.
Queensland pharmacy prescribing pilot could go permanent
Ahead of the Queensland state election next week (26 October), incumbent Premier Steven Miles and Health Minister Shannon Fentiman have vowed to make both the Community Pharmacy Scope of Practice Pilot and the Community Pharmacy Hormonal Contraception Pilot permanent if reelected.
Opposition Leader David Crisafulli has since announced intentions to expand both pilots.
Since the scope of practice pilot rolled out in April, trained pharmacists have been able to provide medication management services, autonomous prescribing for specified acute common conditions, and structured prescribing as part of a chronic disease management program.
With Queensland introducing the Community Pharmacy Hormonal Contraception Pilot, making this service permanent would bring Queensland in line with some other states and territories.
Since both pilots kicked off, hundreds of Queenslanders have benefitted from accessing care from their local pharmacy.
Queensland is a largely decentralised state, with more than half (50.7%) of Queensland’s population residing outside of Greater Brisbane.
PSA welcomes the commitment to expanding the scope of practice for pharmacists, said PSA Queensland State Manager Karen Castle MPS.
‘If the scope of practice pilots become permanent, it would have a significant positive impact on the health of Queenslanders and improve access to healthcare, particularly for rural and regional communities where accessing a GP can be challenging,’ she said.
‘Patients already see their pharmacist as a trusted healthcare professional, and this expanded scope will further enhance their role in delivering healthcare, reduce waiting times and improve patient outcomes.
‘As pharmacists expand their practice and the public becomes more aware of the broader services available, we anticipate significant growth in the uptake of services provided by pharmacists.’
Canberrans could soon access more pharmacy services
With the ACT election only days away (19 October), both ACT Labor and the Canberra Liberals have committed to expanding pharmacists' scope of practice.
Pharmacists in the ACT have already been providing consultations for uncomplicated urinary tract infections (UTI) and resupplying OCP under the NSW pilot.
In alignment with NSW, the expanded scope will cover a broader range of common and mild conditions, including ear infections, nausea and vomiting, reflux, acne, muscle pain and wound management.
Certain chronic conditions will also be included.
While PSA ACT Branch President Olivia Collenette MPS said the services will be introduced as a trial, PSA has been advised that there’s no intention to roll back service once it has started.
‘This will be great for Canberrans, where it is the most expensive city in Australia to see a GP,’ Ms Collenette told AP.
‘We have the lowest bulk billing rates in the country and wait times [to see a doctor] are in the weeks. This is all about patient access, ensuring appropriate care is there at the time it's needed.’
Both parties will work to ensure pharmacists can administer vaccines to patients of all ages.
PSA has been advocating for pharmacists to be able to administer all vaccines to all ages in all locations, she said.
‘Pharmacists are trusted healthcare professionals, helping the ACT maintain its above average for Australia vaccination rates,’ Ms Collenette said. ‘Patients have spoken with their feet that they like that pharmacists are providing these services, so we want to ensure they can continue to do so regardless of which vaccine/s they are after.’
Victoria’s scope of practice pilot extended
The Secretary Approval for 12-month Victorian Community Pharmacist Statewide Pilot, due to wrap up this month, was recently extended until June 2025 – ensuring all pharmacists who are already enrolled in the program continue be able to provide services during the evaluation period.
The pilot allows appropriately trained pharmacists to provide certain Schedule 4 medicines for:
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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"] Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => Case scenario
Sarah, a regular customer in your community pharmacy, presents a prescription for riluzole tablets written by a neurologist for her husband David. It has been several months since David, aged 57, has been seen in the pharmacy. Sarah looks visibly upset and not her usual cheerful self.
After reading this article, pharmacists should be able to:
|
Motor neurone disease (MND) is a group of progressive, degenerative disorders of the motor neurones.1 Motor neurones are nerve cells which control the muscles that enable movement, speech, breathing and swallowing, and their degeneration results in muscle weakness and atrophy.1–3
Patients diagnosed with MND have an average survival time of 2.5 years after diagnosis and usually die of respiratory failure.1–3 The initial symptoms, rate and pattern of disease progression and survival times vary between patients.1 In the vast majority of cases, the cause of the disease is unknown, and there is currently no cure.1,2,4 Multidisciplinary care of patients is required as the disease progresses, and pharmacists can play an important role in patient care.3
The most common type of MND is known as amyotrophic lateral sclerosis (ALS).1,4 In the United States, ALS is also colloquially known as Lou Gehrig’s disease.3,5 Although there are other forms of MND that are not classified as ALS, ALS and MND are generally referred to interchangeably.2 In the United Kingdom, some European countries, Australia and New Zealand, the disease is referred to as MND, but in most other countries it is simply referred to as ALS.5
MND occurs globally. The lifetime risk of MND is approximately 1 in 300–400.4,6 In Australia, on average, two people are diagnosed and two people die from MND each day.2 It is estimated that over 2,000 Australians have MND at any time, of whom 60% are male and 40% female.2 The prevalence in Australia is 8.7 per 100,000, with the highest prevalence in males aged 75–84 years.2 However, 58% of patients are aged under 65 years.2
Australia has a relatively high prevalence compared to other countries; for example, the prevalence rate in Europe is 7.9 per 100,000.2 There is evidence that the prevalence of MND is increasing in some countries.2,6
Although the average survival time following diagnosis is 2.5 years,1 some patients die 3–12 months after diagnosis.4 However, in 5–10% of cases, patients may survive for 10 years or more.2
Aetiology and pathophysiology Various mechanisms, such as protein aggregation, glutamate (a neurotransmitter) toxicity, oxidative stress and free radical or immune-mediated damage, may adversely impact the health of motor neurones in the body; these may contribute to the pathogenesis of MND.1,2 However, the actual causes of MND are largely unknown. In 90% of cases, MND is sporadic where there are no clearly identifiable causes.2 Approximately 10% of cases are inherited (familial) and the genetic mutation responsible for 60% of these cases in Australian families is now known.2 From a clinical perspective, the inherited and sporadic forms of the disease are not distinguishable from each other.2 Knowledge of genetic involvement in MND is increasing with further research, but the relationship between genetic and environmental risks, particularly in sporadic MND, is not well understood.2
Many risk factors have been proposed to be associated with the development of MND. However, the only factors that have been clearly identified are older age, male sex and family history.3,6 Other factors that have been proposed include1,6:
These risk factors may act individually or in combination to contribute to the development of MND. Recent research suggests a six-step process with genes, environment and aging contributing to its development.2,7
Proposed causes of MND, such as high-intensity exercise and blue green algae, often generate media interest, but it should be noted that an association is not the same as causality.2 There may be interactions between non-genetic and genetic risk factors.5,6 More research is required to understand how any underlying genetic mutations cause MND. Genetic testing of patients may become routine practice in the future as more MND-causing gene mutations are discovered in both familial and sporadic forms.2 Also, targeted treatments and strategies which can prevent or delay the onset of disease in patients with an MND-related genetic mutation may be developed in the future, as knowledge of causative factors increases.2
The onset of MND is insidious. The site of initial symptoms varies from patient to patient, with symptoms typically occurring in one muscle group; for example, weakness and wasting of one hand or a unilateral foot drop.1,2
Initial symptoms are usually mild and may include1,2,8:
In some patients, there may be frontotemporal cognitive changes, and emotional responses such as laughing and crying may be easily triggered.
MND may be categorised according to the features of lower and upper motor neurone damage (see Table 1).2,4
Diagnosis of MND is not straightforward, as initial symptoms may be confused with those of other diseases. The average time from the appearance of first symptoms to diagnosis is 12 months.2 Several tests can be conducted to confirm the diagnosis and rule out other diseases; these tests may include8:
There are three main phenotypes of MND based on the sites of symptoms and involvement of upper and lower motor neurones:
Differentiation between the different MND clinical phenotypes is often blurred, and as the disease progresses, there may be considerable overlap, resulting in more generalised muscle wasting and weakness.2 Patients exhibit different initial symptoms depending on the exact combination of nerves that are damaged, and as the disease progresses, the features of the disease become mixed.8 However, certain symptoms, such as loss of the senses, loss of bladder and bowel control, confusion or loss of mental functions, are rarely found in any patients with MND.8
Delays in diagnosis may result from various factors.11 This may include patients not seeking immediate diagnosis, initial misdiagnosis, referral to non-neurological specialists and delayed referral to a neurologist.11 General practitioners will probably only encounter one patient with MND in their careers.1,11 Differential diagnoses may include a variety of other neurological conditions, including Kennedy’s disease, an inherited disorder which progresses very slowly, involves only lower motor neurones and exhibits similar symptoms to those of MND.1,2
A diagnosis of MND, a debilitating and fatal disease, will have an enormous impact on the patient and the patient’s family.5 It is a difficult time for all, and many questions will arise. Because the symptoms and progression of the disease vary so much from one patient to another, it is impossible to predict exactly what will happen following diagnosis.8
Because there is no curative therapy currently available, the focus of treatment for patients with MND is coordinated multidisciplinary care with timely interventions to help manage symptoms as they develop.2,10
Pharmacological therapies
Currently there are only two neuroprotective, disease-modifying therapies available globally, both of which have only very limited effects on the course of the disease.2
Riluzole is available on the Pharmaceutical Benefits Scheme (PBS) for eligible patients (authority required). The exact mechanism of action is unknown, but it is thought to target glutamate by inhibiting its accumulation and neurotransmission.6,12 Tablets containing 50 mg (Rilutek, Pharmacor Riluzole, Riluzole Sandoz, APO-Riluzole) are available, as well as a liquid containing 5 mg/mL (Teglutik) for ease of swallowing or use via a percutaneous endoscopic gastrostomy (PEG) tube.3 The dosage is 50 mg twice daily, taken at the same time each day, 1 hour before or 2 hours after food.3 In the initial clinical trials comparing riluzole with placebo, there was no clinically significant benefit on muscle strength, but survival for patients was increased by up to 3 months compared with placebo.13,14 However, recent analyses of population studies may indicate that survival for patients taking riluzole may be extended by as much as 6–19 months.9,13
Riluzole is generally well tolerated, but common adverse effects may include nausea, dizziness, headache, abdominal pain, weakness, drowsiness and vomiting.2,12 Aminotransferases may become elevated, and regular liver function tests are recommended.1,4,12 Some cases of fatal hepatic failure and pancreatitis have been reported.14
Treatment should be initiated as early as possible after diagnosis. Realistic expectations for treatment effects and potential adverse effects should be discussed with both patients and carers.15
Edaravone (Radicava) has recently been approved for use in Australia; however, it is not yet available, as it is pending PBS listing (as of September 2024). In a small number of patients, it provides limited extensions in survival time. It works by suppressing oxidative stress as a free radical scavenger, although its exact mechanism in MND is yet to be elucidated.2,9 Edaravone is administered as an intravenous infusion, and treatment should be initiated within 2 years of disease onset.2,3
Numerous other pharmacological therapies have been investigated but have not been proven to be effective in mitigating MND, and currently there is insufficient evidence to recommend them. Some of these include2:
Other pharmacological therapies are used to manage individual symptoms such as pain, anxiety, depression, insomnia, cramps, mucosal secretions, drooling (sialorrhea), spasticity, dysphagia, constipation, emotional lability and fatigue.1,3,9 Anticoagulants are not routinely recommended for prevention of venous thromboembolism in MND unless there are additional risk factors.3
Non-pharmacological therapies
As various symptoms develop, interventions will be required for each. Nutritional management is important throughout the disease.9,15 Nutritional status should be monitored regularly, and high-calorie diets can be used to improve nutrition. PEG feeding may be required in some patients; PEG tubes should be placed before respiratory insufficiency develops.8
Similarly, respiratory management is important, and respiration should be monitored regularly.1,9 To treat respiratory insufficiency, non-invasive positive-pressure ventilation can be used to improve survival and quality of life.1,9,15
Difficulties with speech (dysarthria) may require the use of special communication devices.9
Patients are generally cared for at home by family members. MND clinics housing multidisciplinary health professionals are available around Australia to support patients and their carers.10 The clinics are often held in outpatient clinics at a hospital and are usually staffed by a neurologist, other specialist doctors, nurses and allied health professionals.1,2,10
Care of patients requires involvement of various health professionals, not all of whom may be based at a clinic. This may include a general practitioner, neurologist, nurse, psychologist, physiotherapist, speech therapist, occupational therapist and dietitian.8,10
Pharmacists can have positive impacts in the management of MND and have been shown to play an important role in multidisciplinary clinics. A US study reported that pharmacists contributed to optimising medicine use, minimising medicine-induced adverse effects and supporting patient and carer education.16 Additionally, pharmacists can assist by providing advice regarding non-pharmacological management of symptoms as well as vaccines such as influenza and pneumococcal vaccines.3 Pharmacists may also participate in the provision of palliative care as required in the terminal stages of the disease.3 Above all, pharmacists should be compassionate with both patients and their carers.4
Information and support for patients and carers are available from MND Australia and from the various state MND associations.
The care of patients with MND requires a multidisciplinary team. Multidisciplinary teams benefit from a pharmacist’s involvement, as they can compassionately assist patients and carers by providing advice regarding symptom management, medicine use and adverse reactions.
MND is a fatal disorder of motor neurones. The rate and pattern of the disease varies in each patient, as does the survival time. In 90% of cases the cause is unknown, but regardless there is no known cure. Management of MND requires a multidisciplinary approach. A pharmacist’s knowledge of medicines and symptom management can help improve a patient’s quality of life.
Case scenario continuedYou dispense the riluzole prescription and provide advice to Sarah about this medicine. Sarah informs you that David has just been diagnosed with MND and tells you what the neurologist has explained so far before she starts to cry. With compassion, you ask how both she and David are coping. You assure her that you and your staff are there to assist and support them. You offer home delivery of any medicines required for either of them. You counsel her on how the riluzole tablets are to be administered and what to expect. Additionally, you check that Sarah has been provided with information on MND clinics, state-based support services, MND support organisations and where she can find more information about MND. |
Dr Barry L Werth BPharm (Hons), MBA, PhD, MPS is a member of the Lived Experience Research Advisory Panel and the Research Collective at MND Australia and is a pharmaceutical industry consultant.
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
[post_title] => Prescribing pioneer
[post_excerpt] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
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[post_content] => At one point in time, Menopausal hormone therapy (MHT) was used fairly extensively.
But this has changed since 2002, when the Women's Health Initiative (WHI) published a study linking combined MHT (oestrogen and progestin) with an increased risk of blood clots, stroke, breast cancer and heart attacks.
Almost overnight, women stopped using hormone therapy, said CEO of Jean Hailes for Women's Health, Dr Sarah White.
[caption id="attachment_27901" align="alignright" width="300"] Dr Sarah White[/caption]
But there are several factors that led to the study results being skewed.
‘It was [based on] an older group of women who started taking hormone therapy late, and it was a different form of hormone therapy, so those results did not stand up and the increased risk in breast cancer was terribly small,’ she said.
The sensationalist reporting did a huge amount of damage, Dr White said.
‘We still have women today who believe that MHT causes breast cancer, and GPs who are nervous about prescribing it.’
While around one in four women who go through menopause will be asymptomatic or have mild symptoms, a quarter will be at the opposite end of the spectrum and experience severe symptoms, said Dr White.
‘We're talking about an inability to sleep, terrible brain fog, anxiety, a loss of confidence, and hot flushes that can be catastrophic,’ she said.
The remaining half of women are on a spectrum of experiencing mildly annoying to must-be-managed symptoms.
‘We have women who are trying to soldier on through some really unpleasant physical and mental effects,’ she said. ‘And it's a bit heartbreaking to think that there's a medication that can help manage a lot of the symptoms and women are worried about taking it when they have no need to be.’
Is MHT underprescribed?
There's ‘no doubt’ that MHT is underused in Australia, said Dr White – with barriers to access a compounding factor.
‘It's not just going to get that doctor's appointment, it's the cost of the MHT,’ she said.
Some forms of MHT are subsidised under the Pharmaceutical Benefits Scheme (PBS), such as estradiol patches, but there has been a global shortage of this therapy in 2024.
But newer medicines such as Prometrium – a progesterone-based treatment matching the hormone the body makes when ovulating – are not, setting women back around $60 per month.
Are all women suitable candidates for MHT?
No, cautioned Dr White.
For example, a person who has had a hormone responsive cancer should have a careful discussion with their GP about whether the risks of MHT outweigh the benefits.
‘If you've had a hormone responsive cancer, then taking a hormone increases the risk of recurrence,’ she said.
Oral combined MHT will increase the ‘baseline’ risk of thrombosis around two-fold – however the baseline risk remains low in most women. Thrombosis risk increases with increasing age, smoking, increased body weight, in those with genetic predisposition to clotting and in certain illnesses. Risk factors should be considered prior to commencing MHT.
MHT treatment should be individualised based on the patient’s needs, clinical features and risk assessment, and reviewed regularly. Women with a personal or family history of venous thrombosis should undergo screening for risk factors to guide the choice of MHT delivery method. In cases where a woman is deemed to be at high risk for developing deep vein thrombosis (DVT), transdermal MHT should be used.
‘That’s why the message is very clear to speak about your individual circumstances with your doctor,’ added Dr White, who said a consultation to discuss the appropriateness of therapy could include:
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[post_content] => The Unleashing the Potential of our Health Workforce – Scope of Practice Review final report and implementation plan is slated for delivery by October 2024.
But many states and territories are forging ahead with expanding pharmacist scope of practice in the interim.
Australian Pharmacist has rounded up some of the most recent updates.
Queensland pharmacy prescribing pilot could go permanent
Ahead of the Queensland state election next week (26 October), incumbent Premier Steven Miles and Health Minister Shannon Fentiman have vowed to make both the Community Pharmacy Scope of Practice Pilot and the Community Pharmacy Hormonal Contraception Pilot permanent if reelected.
Opposition Leader David Crisafulli has since announced intentions to expand both pilots.
Since the scope of practice pilot rolled out in April, trained pharmacists have been able to provide medication management services, autonomous prescribing for specified acute common conditions, and structured prescribing as part of a chronic disease management program.
With Queensland introducing the Community Pharmacy Hormonal Contraception Pilot, making this service permanent would bring Queensland in line with some other states and territories.
Since both pilots kicked off, hundreds of Queenslanders have benefitted from accessing care from their local pharmacy.
Queensland is a largely decentralised state, with more than half (50.7%) of Queensland’s population residing outside of Greater Brisbane.
PSA welcomes the commitment to expanding the scope of practice for pharmacists, said PSA Queensland State Manager Karen Castle MPS.
‘If the scope of practice pilots become permanent, it would have a significant positive impact on the health of Queenslanders and improve access to healthcare, particularly for rural and regional communities where accessing a GP can be challenging,’ she said.
‘Patients already see their pharmacist as a trusted healthcare professional, and this expanded scope will further enhance their role in delivering healthcare, reduce waiting times and improve patient outcomes.
‘As pharmacists expand their practice and the public becomes more aware of the broader services available, we anticipate significant growth in the uptake of services provided by pharmacists.’
Canberrans could soon access more pharmacy services
With the ACT election only days away (19 October), both ACT Labor and the Canberra Liberals have committed to expanding pharmacists' scope of practice.
Pharmacists in the ACT have already been providing consultations for uncomplicated urinary tract infections (UTI) and resupplying OCP under the NSW pilot.
In alignment with NSW, the expanded scope will cover a broader range of common and mild conditions, including ear infections, nausea and vomiting, reflux, acne, muscle pain and wound management.
Certain chronic conditions will also be included.
While PSA ACT Branch President Olivia Collenette MPS said the services will be introduced as a trial, PSA has been advised that there’s no intention to roll back service once it has started.
‘This will be great for Canberrans, where it is the most expensive city in Australia to see a GP,’ Ms Collenette told AP.
‘We have the lowest bulk billing rates in the country and wait times [to see a doctor] are in the weeks. This is all about patient access, ensuring appropriate care is there at the time it's needed.’
Both parties will work to ensure pharmacists can administer vaccines to patients of all ages.
PSA has been advocating for pharmacists to be able to administer all vaccines to all ages in all locations, she said.
‘Pharmacists are trusted healthcare professionals, helping the ACT maintain its above average for Australia vaccination rates,’ Ms Collenette said. ‘Patients have spoken with their feet that they like that pharmacists are providing these services, so we want to ensure they can continue to do so regardless of which vaccine/s they are after.’
Victoria’s scope of practice pilot extended
The Secretary Approval for 12-month Victorian Community Pharmacist Statewide Pilot, due to wrap up this month, was recently extended until June 2025 – ensuring all pharmacists who are already enrolled in the program continue be able to provide services during the evaluation period.
The pilot allows appropriately trained pharmacists to provide certain Schedule 4 medicines for:
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[post_content] => The landscape for glucagon-like peptide-1 receptor agonists (GLP-1RAs) used for weight loss is changing in Australia as demand continues to grow.
Australian Pharmacist explains what options are available, and restricted, for weight loss patients.
Ozempic is out of stock … again
There is no end in sight to the Ozempic shortage, with Novo Nordisk recently informing the Therapeutic Goods Administration (TGA) that supply of the medicine will remain limited for the rest of 2024.
The TGA has continued to ask prescribers not to initiate new patients on Ozempic unless there are no suitable alternatives, with supplies prioritised for patients with type 2 diabetes who are stabilised on the medicine.
Patients who have been using the medicine for weight loss should potentially be switched to an alternative, such as Wegovy which is approved for this indication.
In the experience of Brisbane-based community pharmacist and diabetes educator Rory Johnston MPS, the persistent Ozempic shortages have led to patients seeking the medicine for weight loss being treated with ‘great contempt’ by some healthcare professionals.
[caption id="attachment_27827" align="alignright" width="300"] Rory Johnston MPS[/caption]
There is often a perception that people are simply overweight due to overeating, said Mr Johnston, but there are myriad conditions and medicine classes that can cause patients to gain weight, including:
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[post_content] => Case scenario
Sarah, a regular customer in your community pharmacy, presents a prescription for riluzole tablets written by a neurologist for her husband David. It has been several months since David, aged 57, has been seen in the pharmacy. Sarah looks visibly upset and not her usual cheerful self.
After reading this article, pharmacists should be able to:
|
Motor neurone disease (MND) is a group of progressive, degenerative disorders of the motor neurones.1 Motor neurones are nerve cells which control the muscles that enable movement, speech, breathing and swallowing, and their degeneration results in muscle weakness and atrophy.1–3
Patients diagnosed with MND have an average survival time of 2.5 years after diagnosis and usually die of respiratory failure.1–3 The initial symptoms, rate and pattern of disease progression and survival times vary between patients.1 In the vast majority of cases, the cause of the disease is unknown, and there is currently no cure.1,2,4 Multidisciplinary care of patients is required as the disease progresses, and pharmacists can play an important role in patient care.3
The most common type of MND is known as amyotrophic lateral sclerosis (ALS).1,4 In the United States, ALS is also colloquially known as Lou Gehrig’s disease.3,5 Although there are other forms of MND that are not classified as ALS, ALS and MND are generally referred to interchangeably.2 In the United Kingdom, some European countries, Australia and New Zealand, the disease is referred to as MND, but in most other countries it is simply referred to as ALS.5
MND occurs globally. The lifetime risk of MND is approximately 1 in 300–400.4,6 In Australia, on average, two people are diagnosed and two people die from MND each day.2 It is estimated that over 2,000 Australians have MND at any time, of whom 60% are male and 40% female.2 The prevalence in Australia is 8.7 per 100,000, with the highest prevalence in males aged 75–84 years.2 However, 58% of patients are aged under 65 years.2
Australia has a relatively high prevalence compared to other countries; for example, the prevalence rate in Europe is 7.9 per 100,000.2 There is evidence that the prevalence of MND is increasing in some countries.2,6
Although the average survival time following diagnosis is 2.5 years,1 some patients die 3–12 months after diagnosis.4 However, in 5–10% of cases, patients may survive for 10 years or more.2
Aetiology and pathophysiology Various mechanisms, such as protein aggregation, glutamate (a neurotransmitter) toxicity, oxidative stress and free radical or immune-mediated damage, may adversely impact the health of motor neurones in the body; these may contribute to the pathogenesis of MND.1,2 However, the actual causes of MND are largely unknown. In 90% of cases, MND is sporadic where there are no clearly identifiable causes.2 Approximately 10% of cases are inherited (familial) and the genetic mutation responsible for 60% of these cases in Australian families is now known.2 From a clinical perspective, the inherited and sporadic forms of the disease are not distinguishable from each other.2 Knowledge of genetic involvement in MND is increasing with further research, but the relationship between genetic and environmental risks, particularly in sporadic MND, is not well understood.2
Many risk factors have been proposed to be associated with the development of MND. However, the only factors that have been clearly identified are older age, male sex and family history.3,6 Other factors that have been proposed include1,6:
These risk factors may act individually or in combination to contribute to the development of MND. Recent research suggests a six-step process with genes, environment and aging contributing to its development.2,7
Proposed causes of MND, such as high-intensity exercise and blue green algae, often generate media interest, but it should be noted that an association is not the same as causality.2 There may be interactions between non-genetic and genetic risk factors.5,6 More research is required to understand how any underlying genetic mutations cause MND. Genetic testing of patients may become routine practice in the future as more MND-causing gene mutations are discovered in both familial and sporadic forms.2 Also, targeted treatments and strategies which can prevent or delay the onset of disease in patients with an MND-related genetic mutation may be developed in the future, as knowledge of causative factors increases.2
The onset of MND is insidious. The site of initial symptoms varies from patient to patient, with symptoms typically occurring in one muscle group; for example, weakness and wasting of one hand or a unilateral foot drop.1,2
Initial symptoms are usually mild and may include1,2,8:
In some patients, there may be frontotemporal cognitive changes, and emotional responses such as laughing and crying may be easily triggered.
MND may be categorised according to the features of lower and upper motor neurone damage (see Table 1).2,4
Diagnosis of MND is not straightforward, as initial symptoms may be confused with those of other diseases. The average time from the appearance of first symptoms to diagnosis is 12 months.2 Several tests can be conducted to confirm the diagnosis and rule out other diseases; these tests may include8:
There are three main phenotypes of MND based on the sites of symptoms and involvement of upper and lower motor neurones:
Differentiation between the different MND clinical phenotypes is often blurred, and as the disease progresses, there may be considerable overlap, resulting in more generalised muscle wasting and weakness.2 Patients exhibit different initial symptoms depending on the exact combination of nerves that are damaged, and as the disease progresses, the features of the disease become mixed.8 However, certain symptoms, such as loss of the senses, loss of bladder and bowel control, confusion or loss of mental functions, are rarely found in any patients with MND.8
Delays in diagnosis may result from various factors.11 This may include patients not seeking immediate diagnosis, initial misdiagnosis, referral to non-neurological specialists and delayed referral to a neurologist.11 General practitioners will probably only encounter one patient with MND in their careers.1,11 Differential diagnoses may include a variety of other neurological conditions, including Kennedy’s disease, an inherited disorder which progresses very slowly, involves only lower motor neurones and exhibits similar symptoms to those of MND.1,2
A diagnosis of MND, a debilitating and fatal disease, will have an enormous impact on the patient and the patient’s family.5 It is a difficult time for all, and many questions will arise. Because the symptoms and progression of the disease vary so much from one patient to another, it is impossible to predict exactly what will happen following diagnosis.8
Because there is no curative therapy currently available, the focus of treatment for patients with MND is coordinated multidisciplinary care with timely interventions to help manage symptoms as they develop.2,10
Pharmacological therapies
Currently there are only two neuroprotective, disease-modifying therapies available globally, both of which have only very limited effects on the course of the disease.2
Riluzole is available on the Pharmaceutical Benefits Scheme (PBS) for eligible patients (authority required). The exact mechanism of action is unknown, but it is thought to target glutamate by inhibiting its accumulation and neurotransmission.6,12 Tablets containing 50 mg (Rilutek, Pharmacor Riluzole, Riluzole Sandoz, APO-Riluzole) are available, as well as a liquid containing 5 mg/mL (Teglutik) for ease of swallowing or use via a percutaneous endoscopic gastrostomy (PEG) tube.3 The dosage is 50 mg twice daily, taken at the same time each day, 1 hour before or 2 hours after food.3 In the initial clinical trials comparing riluzole with placebo, there was no clinically significant benefit on muscle strength, but survival for patients was increased by up to 3 months compared with placebo.13,14 However, recent analyses of population studies may indicate that survival for patients taking riluzole may be extended by as much as 6–19 months.9,13
Riluzole is generally well tolerated, but common adverse effects may include nausea, dizziness, headache, abdominal pain, weakness, drowsiness and vomiting.2,12 Aminotransferases may become elevated, and regular liver function tests are recommended.1,4,12 Some cases of fatal hepatic failure and pancreatitis have been reported.14
Treatment should be initiated as early as possible after diagnosis. Realistic expectations for treatment effects and potential adverse effects should be discussed with both patients and carers.15
Edaravone (Radicava) has recently been approved for use in Australia; however, it is not yet available, as it is pending PBS listing (as of September 2024). In a small number of patients, it provides limited extensions in survival time. It works by suppressing oxidative stress as a free radical scavenger, although its exact mechanism in MND is yet to be elucidated.2,9 Edaravone is administered as an intravenous infusion, and treatment should be initiated within 2 years of disease onset.2,3
Numerous other pharmacological therapies have been investigated but have not been proven to be effective in mitigating MND, and currently there is insufficient evidence to recommend them. Some of these include2:
Other pharmacological therapies are used to manage individual symptoms such as pain, anxiety, depression, insomnia, cramps, mucosal secretions, drooling (sialorrhea), spasticity, dysphagia, constipation, emotional lability and fatigue.1,3,9 Anticoagulants are not routinely recommended for prevention of venous thromboembolism in MND unless there are additional risk factors.3
Non-pharmacological therapies
As various symptoms develop, interventions will be required for each. Nutritional management is important throughout the disease.9,15 Nutritional status should be monitored regularly, and high-calorie diets can be used to improve nutrition. PEG feeding may be required in some patients; PEG tubes should be placed before respiratory insufficiency develops.8
Similarly, respiratory management is important, and respiration should be monitored regularly.1,9 To treat respiratory insufficiency, non-invasive positive-pressure ventilation can be used to improve survival and quality of life.1,9,15
Difficulties with speech (dysarthria) may require the use of special communication devices.9
Patients are generally cared for at home by family members. MND clinics housing multidisciplinary health professionals are available around Australia to support patients and their carers.10 The clinics are often held in outpatient clinics at a hospital and are usually staffed by a neurologist, other specialist doctors, nurses and allied health professionals.1,2,10
Care of patients requires involvement of various health professionals, not all of whom may be based at a clinic. This may include a general practitioner, neurologist, nurse, psychologist, physiotherapist, speech therapist, occupational therapist and dietitian.8,10
Pharmacists can have positive impacts in the management of MND and have been shown to play an important role in multidisciplinary clinics. A US study reported that pharmacists contributed to optimising medicine use, minimising medicine-induced adverse effects and supporting patient and carer education.16 Additionally, pharmacists can assist by providing advice regarding non-pharmacological management of symptoms as well as vaccines such as influenza and pneumococcal vaccines.3 Pharmacists may also participate in the provision of palliative care as required in the terminal stages of the disease.3 Above all, pharmacists should be compassionate with both patients and their carers.4
Information and support for patients and carers are available from MND Australia and from the various state MND associations.
The care of patients with MND requires a multidisciplinary team. Multidisciplinary teams benefit from a pharmacist’s involvement, as they can compassionately assist patients and carers by providing advice regarding symptom management, medicine use and adverse reactions.
MND is a fatal disorder of motor neurones. The rate and pattern of the disease varies in each patient, as does the survival time. In 90% of cases the cause is unknown, but regardless there is no known cure. Management of MND requires a multidisciplinary approach. A pharmacist’s knowledge of medicines and symptom management can help improve a patient’s quality of life.
Case scenario continuedYou dispense the riluzole prescription and provide advice to Sarah about this medicine. Sarah informs you that David has just been diagnosed with MND and tells you what the neurologist has explained so far before she starts to cry. With compassion, you ask how both she and David are coping. You assure her that you and your staff are there to assist and support them. You offer home delivery of any medicines required for either of them. You counsel her on how the riluzole tablets are to be administered and what to expect. Additionally, you check that Sarah has been provided with information on MND clinics, state-based support services, MND support organisations and where she can find more information about MND. |
Dr Barry L Werth BPharm (Hons), MBA, PhD, MPS is a member of the Lived Experience Research Advisory Panel and the Research Collective at MND Australia and is a pharmaceutical industry consultant.
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[post_content] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
What made you choose pharmacy as a career?
I started working in a pharmacy in my local town, Sarina, south of Mackay in Queensland. As a junior at 15 years old, I loved it from the get-go. Most of all, I enjoyed being able to help others. Wanting to work in a medical field but not wanting the pressure of becoming a doctor, I decided to pursue pharmacy as a career.
Why did you decide to become one of the very first pharmacist prescribers?
As a rural pharmacist, I was getting frustrated when patients would come in for advice for minor ailments – especially after hours – when unable to get an appointment with a GP.
We were forced to send them to the local emergency department (ED) when referral to a doctor was required, only for them to come back with a prescription for exactly what I would have prescribed, if able. So, when the opportunity came up for the expansion of pharmacy scope via the Queensland Community Pharmacy Scope of Practice Pilot, I was all for it. I thought it was a great idea to help to reduce the burden on the healthcare system and help our community.
Is the pharmacist prescribing training onerous?
The training was the hardest part of my career thus far, but also the most rewarding. When I was at university, I didn’t have three children, a husband or a pharmacy to run – so it was difficult to manage it all. But if I can do it, anyone can if they put their mind to it! I learnt so much and the training significantly expanded my skills so I can be a better pharmacist
to my community.
What do you teach your pharmacy students at JCU?
When James Cook University (JCU) opened up its pharmacy degree in 2021 to include students studying at the Mackay campus, I jumped on board to help out – hoping that we could encourage more pharmacists to stay in the area within the profession to help out with healthcare shortages.
I help tutor pharmacy students locally and support them through their studies and also teach areas of compounding, clinical dispensing and pharmacology.
Last year, I was proud to receive the 2023 JCU Sessional Teaching Award for Outstanding Contributions to Student Learning. This was an honour but a surprise, as I just enjoy working with students to support them and hopefully show them how rewarding a career in community pharmacy can be.
What further scope can pharmacists aim for outside the Queensland pilots?
I really hope the government can see how pharmacists on the ground can help our current crumbling healthcare system. Ambulance ramping and emergency wait times are out of control, and more and more people are presenting to EDs for minor ailments – with GP appointment wait times up to 3 weeks in our local area.
Pharmacists are the most accessible healthcare professionals in Australia, so it makes sense that we should be further utilised to help reduce the burden and pressure on fellow healthcare colleagues.
In the future, it would be ideal if pharmacists had Pharmaceutical Benefits Scheme prescribing rights and access to the Medicare Benefits Schedule so more patients would be able to access our services.
If an opportunity arose, would you encourage a career in rural pharmacy?
Rural pharmacy is very rewarding, so yes! The rapport you build with your patients and colleagues is amazing and I love the rural community to raise my children in. My rural town is my village.
What advice would you give your younger self and early career pharmacists today?
Be kind to yourself and ensure you have a good work-life balance.
A career in pharmacy can be very rewarding and there are now more and more options and specialities that you can expand into as a pharmacist as our scope of practice continues to evolve.
[post_title] => Prescribing pioneer
[post_excerpt] => One of Australia’s first pharmacist prescribers, Therese Lambert MPS is on the lookout for ways to help pharmacists fill healthcare gaps.
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CPD credits
Accreditation Code : CAP2111OTCAW
Group 1 : 0.75 CPD credits
Group 2 : 1.5 CPD credits
This activity has been accredited for 0.75 hours of Group 1 CPD (or 0.75 CPD credits) suitable for inclusion in an individual pharmacist's CPD plan, which can be converted to 0.75 hours of Group 2 CPD (or 1.5 CPD credits) upon successful completion of relevant assessment activities.
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
