Chloe Hava
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[post_content] => From 1 May, Spravato (esketamine) will be subsidised under the Pharmaceutical Benefits Scheme (PBS) for adults with treatment-resistant depression, intended for use alongside a newly initiated oral antidepressant.
Up to 30,000 Australians are anticipated to access esketamine via the PBS, paying only $7.70 per dose with a pensioner or concession card, or $31.60 per dose for general patients.
[caption id="attachment_29259" align="alignright" width="233"]
Professor Malcolm Hopwood[/caption]
Australian Pharmacist spoke with Professor Malcolm Hopwood, Ramsay Health Care Professor of Psychiatry at the University of Melbourne, about the treatment process and how pharmacists will be involved.
How effective is esketamine in managing treatment resistant depression?
The largest clinical trials on esketamine efficacy found that about 50% of patients who had not responded to two or three antidepressants did respond to esketamine, Prof Hopwood said.
‘If you compare that to trialing one of the usual medicines, the response rate for the third or fourth [medicine] is probably only about 15%,’ he said. ‘So it’s quite a jump up in terms of response rate.’
Who is eligible to be prescribed esketamine nasal spray?
Those diagnosed with treatment-resistant depression, defined as major depressive disorder that has not responded sufficiently to at least two different antidepressants, each administered at an adequate dose and duration, for the treatment of the current moderate to severe depressive episode.
Who is not a good candidate for this treatment?
Esketamine is currently not indicated for bipolar depression. And caution should be taken for patients with psychotic depression, Prof Hopwood said.Â
‘[This is] because ketamine, when used in much higher doses, has psychogenic potential,’ Prof Hopwood said.
There is also a precautionary note in the product information around patients with marked hepatic or renal impairment.
‘In terms of drug-drug interactions, it should not be used together with an irreversible monoamine oxidase inhibitor, which these days is only Parnate,’ he said. ‘While not widely used now, it's an important interaction to be aware of.’
What’s the duration of therapy?
Esketamine is initially administered twice weekly for the first 4 weeks, Prof Hopwood said.
‘By the end of that 4-week period, we've usually got a sense whether you're a responder or not.’
Treatment usually stops in non-responders, with responders moving to a once-weekly treatment regimen.
‘Eventually, fortnightly treatment for a 6-month maintenance period is what we recommend,’ Prof Hopwood said.
Is re-treatment recommended?
Given that depression is a highly recurrent condition, it is likely some patients will relapse post treatment. And re-treatment with esketamine could prove beneficial, Prof Hopwood said.
‘There is some data about re-treatment … [with] evidence showing that responders do seem to have a good response rate the second time around,’ he said. ‘That will be permitted under this funding scheme.’
How is esketamine supplied?
Patients cannot be in possession of the spray until they are in the clinic for administration under supervision, Prof Hopwood said.Â
‘Esketamine needs to be administered in an approved treatment center that involves close supervision for side effects such as dissociation and hypertension,’ he said.Â
Appropriate pharmacist handling of a Schedule 8 medicine is also required.
‘In our facility, we are fortunate to have an on-site pharmacist who dispenses [the medicine] to a nurse, and then the patient self-administers,’ Prof Hopwood said.Â
‘But the patient neither brings the medicine to the clinic or takes it away. The intent … is to reduce the risk of diversion.’
Facilities that do not have an on-site pharmacist must establish and demonstrate a connection with a local community pharmacy to qualify as an approved treatment centre.
Is talk therapy involved in the session?
Treatment with esketamine does not involve psychotherapy. However, there is a small body of research currently looking at ketamine-facilitated psychotherapy, Prof Hopwood said.
‘We still don't know whether that offers additional benefit for many patients, [but] if esketamine proves an effective treatment for their depression, they may be able to utilise psychotherapy much more effectively – which they might not be able to do when severely depressed.’
What are the estimated costs of esketamine sessions?
The estimated cost is $300–$350 per treatment session, Prof Hopwood said.
In most clinics, the doctor will see the patient on treatment occasions, but less so as treatment becomes established.
‘If the doctor does visit before the treatment is administered, then they can claim through Medicare as per usual,’ he said. ‘But the nursing and pharmacy [costs] will not be covered.’
Are patients supposed to disassociate when they take esketamine?
Dissociation with treatment is frequent, albeit mild and transient for most patients, Prof Hopwood said.
‘For up to half an hour they [may] feel a little dreamy and not unpleasant,’ he said.Â
Some evidence suggests that mild dissociative effects may be required for the drug to be effective in the treatment of depression, although this is not definitive, Prof Hopwood said.
‘We monitor patients during that time and keep them safe,’ he said. ‘Most of them simply want to lie there and listen to music or just bliss out for a short period of time.’Â
While there is no reversal agent for esketamine, any periods of distress are typically short lived.
‘We've had a very small number of patients distressed, consistent with the trials,’ Prof Hopwood said. ‘And they've generally responded to quite simple reassurance.’
Patients’ blood pressure is also monitored ‘It's rarely severe enough that intervention is required, but there can be a transient increase, as we've known from the use of ketamine as an anaesthetic,’ he said.
Where should pharmacists refer interested patients?
GPs are an important resource for knowing where the available treatment centers are, Prof Hopwood said.Â
‘There is a list of those available, and I predict that number may increase over time now that esketamine is funded.’
There are high levels of patient interest in esketamine and psychedelics, Prof Hopwood said.
‘So it's important they receive accurate, quality information that includes realistic expectations about the likelihood of treatment response and what's involved,’ he said. ‘And pharmacists are very well placed to provide that kind of information.’
What is preferable: esketamine or psychedelics?
Since 1 July 2023, patients with treatment-resistant depression have legally been allowed to receive treatment with psilocybin and MDMA, under specific conditions. Â
There is a degree of overlap between the patient populations considered suitable for ketamine and psychedelic therapy, Prof Hopwood said.
‘Most of the current guidance, including from The Royal Australian and New Zealand College of Psychiatrists, would say that psychedelic therapy is still more at a research level,’ he said.Â
‘Whereas, esketamine, reflected in the funding, has reached a higher level of evidence at this point.Â
‘So I would certainly see it as coming before psychedelic therapy in any hierarchy.’
To find out more about the use of psilocybin for treatment-resistant depression, read Australian Pharmacist's CPD article on the therapeutic potential of psychedelics.
[post_title] => PBS-backed esketamine rolls out for depression with S8 controls
[post_excerpt] => Esketamine will soon be funded for treatment-resistant depression, requiring pharmacists to adhere to strict supply and handling conditions.
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[title_attribute] => PBS-backed esketamine rolls out for depression with S8 controls
[title] => PBS-backed esketamine rolls out for depression with S8 controls
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[post_content] => Aside from administering medicines by injection, Queensland-based community pharmacist Fiona Watson MPS loves tearing up a Latin dance floor.
Tell us about your pharmacy career.
I had a varied early career, moving to North Queensland for a year shortly after I graduated as well as locuming around Australia for a while.
This gave me a great introduction to community pharmacy and a lot of different experiences – both good and bad. When locuming, you develop a clear idea of the factors that contribute to a well-run pharmacy.
I then moved to the United Kingdom where I completed a Certificate in Clinical Pharmacy. You can tell how old I am because I was one of the last pharmacists able to register in the UK with only a month under supervision.
I was a ‘rotational resident pharmacist’, living on-site at the hospital. I covered renal, gastro, cardiology, oncology, aged care, palliative care and surgery wards.
We worked on call overnight, and could get called upon to help with all sorts of different situations – one of the most interesting being calculating the correct dose for the antidote to antifreeze.
More recently, I was very fortunate to be given the opportunity to go into partnership with my mum and sister, both pharmacists, as the managing partner at Redland Bay Wholelife Pharmacy and Healthfoods.
What medicines do you administer by injection?
About 10 years ago, I became a trained vaccinator administering thousands of vaccines during the COVID-19 pandemic.
When Queensland allowed pharmacists to expand the range of medicines they could administer, I completed the Medication Administration course, as I believe this is an essential skill for pharmacists to have.
So many new medications are injectable, and for some patients self-administration just isn’t an option. We were one of the first pharmacies in our area to offer long-acting injectable buprenorphine services, which can be a life-changing option for patients.
Tell us about your administering injections beyond vaccines.
The majority of pharmacists I work with at Redland Bay are trained vaccinators and have completed medicines administration courses. When we come across a new medication that requires administration by injection we collate the available information from the manufacturer and ensure everyone has read it. Many companies, such as Novartis with inclisiran (Leqvio), have reps who are happy to provide additional training.
Once you are comfortable with subcutaneous injections, it’s a matter of familiarising yourself with the different types of devices available. It seemed a logical step for us to provide this service. We have great consult room facilities and it brings variety to our role.
What role do you see pharmacists playing in cardiovascular care in future?
The sky is the limit. We’re on the cusp of a fundamental change in the way Australians receive health care and I hope to see pharmacists embrace the opportunities this will bring.
There’s a workforce crisis and an ageing population, so we need to become more efficient and accessible. If you think about how much the role of a nurse practitioner has changed in the last 10–15 years, you can see where pharmacists have even greater potential. A patient with a diagnosis of heart failure should be able to be titrated to optimum therapy by a pharmacist in a community pharmacy. A patient should have their HbA1c or lipids checked in the pharmacy, with appropriate therapy initiated or adjusted. We should also be actively involved in screening and chronic disease management.
Pharmacy is an incredibly rewarding and enjoyable career, and now is an especially exciting time to be a pharmacist. There is just so much opportunity.Â
Day in the life of Fiona Watson MPS, Community pharmacist at Redland Bay Wholelife Pharmacy, QLD.
| 5.00am |
Hit the gym I get up and do a HIIT or Muay Thai class most mornings for positive effects on my mental health. Passionate about preventative health care, I see the long-term effects of patients’ lifestyle choices every day. |
| 8.00am |
Open the pharmacy Every day is different. At least two pharmacists are rostered on, ensuring we give each patient the time they need while providing a wide range of different services. |
| 9.00am |
Vaccination service Embarking on a cruise in 2 months, a couple in their 60s asks about COVID-19 vaccines. More than 12 months since their last vaccine they are happy to be vaccinated on the spot. Not wanting more than one vaccine at a time, we book them in for a follow-up appointment in a month for the shingles vaccination. |
| 10.00am |
Collaborative care A local GP phones about a recently discharged mutual patient who’s not coping well on his new medicines. We spend some time with the patient doing a medicine review and setting up his profile for a dose administration aid. |
| 1.00pm |
Lunchtime It’s important that all staff, especially pharmacists, prioritise their breaks. We all need a little downtime to reset and refresh. |
| 1.30pm |
Medicines injection A regular patient comes in for her second dose of inclisiran (Leqvio) after I administered her first 3 months ago. She is happy with the more convenient option than visiting her GP. |
| 3.00pm |
Infection control In a call from our pharmacy car park, we learn a patient has tested positive for COVID-19 and has an e-script. We dispense and counsel over the phone and then deliver out to their car (with appropriate precautions). |
| 6.30pm |
OCP continuance A stressed young woman, with a 2-week wait for a GP appointment, has run out of her pill. She is relieved when seen by a colleague who prescribes Estelle under the Queensland Hormonal Contraceptive Pilot. I dispense it. |
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[post_content] => Vaccination coverage in older Australians remains alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
Older Australians are highly susceptible to serious complications from influenza and COVID-19. But the vaccination rates in patients aged 75 and over are nowhere where they need to be to protect this vulnerable patient cohort from harm, including hospitalisations and death.
The national influenza vaccination rate of patients aged 65 and over currently sits at 7.2%. And in the last 12 months, only 37.7% of Australians aged 75 and over received a COVID-19 vaccination.
But boosting immunisation rates in older Australians is more important than ever. The influenza season started earlier and stronger than usual, with 60,594 cases of influenza reported this year.
As of 10 April, there were also 70 active outbreaks of COVID-19 in residential aged care facilities (RACFs). Last year, case numbers were highest among those most at risk, with notifications peaking in the 75–79, 80–84 and 85+ (12,607).
With GPs not always available to address vaccination gaps in aged care, pharmacists are well positioned to step in and provide this essential service.
In the video above, community pharmacist Lachlan Rose MPS outlines the benefits of providing offsite vaccinations in aged care settings, including financial incentives, workplace variety and the protection of one of the most vulnerable populations.
[post_title] => All pharmacists should consider off-site vaccinations in aged care
[post_excerpt] => Vaccination rates in older Australians are alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
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[title_attribute] => All pharmacists should consider off-site vaccinations in aged care
[title] => All pharmacists should consider off-site vaccinations in aged care
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[post_content] => The Fair Work Commission’s Expert Panel for pay equity in the care and community sector has today issued its initial decision on the Gender-based undervaluation – priority awards review – making determinations on the Pharmacy Industry Award 2020, which most community pharmacists are employed under.Â
What did the Expert Panel find?Â
The Expert Panel found that pharmacists covered by the Pharmacy Industry Award 2020 (and several other awards) have been the subject of gender-based undervaluation. Â
As a result, the Expert Panel has determined that findings constitute work value reasons, justifying variation of the modern award minimum wage rates across all categories of pharmacists. Â
What is ‘gender-based undervaluation’?Â
Gender-based undervaluation considers a range of factors to determine whether minimum award pay rates are undervalued because of assumptions based on gender.Â
The range of factors considered extends to historical undervaluing, exercise of ‘invisible skills’, exercise of caring work and workforce qualifications, among others. Â
How does the Expert Panel intend to address the undervaluation?Â
For pharmacists employed by the Pharmacy Industry Award 2020, the Expert Panel has issued a determination that there will be a total increase in the minimum wage rates of 14.1% over three years.Â
This increase will be implemented in three equal phases on:Â
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[post_content] => Case scenario
Malcolm (68 years old, male) visits your pharmacy with a new prescription for sacubitril/valsartan. He mentions he has recently been diagnosed with heart failure with reduced ejection fraction (HFrEF). You review his records and confirm he is still taking metformin/sitagliptin for type 2 diabetes. Malcolm explains that he has taken this for many years, and that his general practitioner has advised him that his blood glucose control needs to be better. He expresses frustration that the shortness of breath from his heart failure limits his ability to exercise and improve his diabetes. Malcolm hopes that starting this new medicine will improve this.
After reading this article, pharmacists should be able to:
|
Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.
Heart failure is a clinical syndrome caused by the inability of the heart muscle to provide adequate cardiac output and/or the presence of increased cardiac pressure. This is due to either a structural or functional abnormality of the heart.1 The clinical syndrome consists of symptoms such as breathlessness and fatigue and may be accompanied by signs of fluid accumulation such as peripheral oedema, elevated jugular venous pressure and pulmonary crackles.1
In many cases, heart failure may be both preventable and treatable. Choice of treatment depends on the type of heart failure present, with management being primarily pharmacological.1
Pharmacists play an essential role in optimising pharmacotherapy for heart failure patients, providing recommendations on safe and effective dose titration and appropriate pharmacological management, as well as providing education, counselling and support for adherence.2
Heart failure remains a global public health issue that affects at least 38Â million people worldwide.2 It is a major cause of hospitalisation in Australia and is associated with significant healthcare costs.3
Heart failure has a poor prognosis and results in markedly reduced quality of life.1 Readmission to hospital is extremely common, with about 1 in 3 patients being readmitted in the first month, and up to 15% of patients dying within the first 6 months, after being discharged from hospital.4 By 12 months post-discharge, approximately 25% of heart failure patients will have died.5
Concerningly, due to population aging and increasing prevalence of comorbidities, heart failure hospitalisations could increase by as much as 50% in the next 25Â years.1
Categorisation of heart failureHeart failure is categorised according to the measurement of the left ventricular ejection fraction (LVEF). Knowing the LVEF at time of diagnosis is crucial, as this guides treatment.1 Heart failure is categorised as either1,6,7:
HFrEF
For HFrEF, there are effective pharmacological therapies, supported by robust, high-quality evidence. These include what has now become known as ‘the four pillars’, and these collectively make up guideline-directed medical therapy for HFrEF. These include9–11:
All patients with HFrEF should be prescribed all four agents (unless contraindicated or not tolerated), with early initiation being associated with the best outcomes.1,9,10 Other therapies are available as HFrEF progresses, however the ‘four pillars’ are the cornerstone of HFrEF treatment.10
HFmrEF
There is limited evidence to support specific recommendations for the pharmacological management of HFmrEF.1 Some studies suggest that patients with HFmrEF may receive similar benefit from a beta blocker, a mineralocorticoid receptor antagonist and a renin angiotensin system inhibitor as in HFrEF, and SGLT2is have been shown to reduce the risk of cardiovascular death and hospitalisation for heart failure.14 The medicines used to treat HFrEF are often used to treat HFmrEF, however the confidence in prognostic benefits is much less.1,14
HFpEF
For the treatment of HFpEF, no medicines have demonstrated a statistically significant benefit on mortality.1 Recommended treatment consists of15:
The use of an SGLT2i in HFpEF has not been shown to improve mortality to the same extent as for HFrEF. However, an SGLT2i is still recommended because major trials have shown they can still offer some benefits.16,17
The EMPEROR-Preserved trial demonstrated a 21% lower relative risk in the composite of cardiovascular death or hospitalisation for heart failure with the use of empagliflozin in the treatment of HFpEF compared with placebo – a result driven primarily by a reduction in risk of hospitalisation rather than mortality.16 Importantly, this benefit was seen regardless of the diabetic status of the patient.16 This benefit was later reinforced by the DELIVER trial which showed a lower risk of its composite primary outcome of worsening heart failure or cardiovascular death with dapagliflozin use, compared to placebo for those with HFmrEF and HFpEF.18 As a result, SGLT2is have received a strong recommendation for the management of HFpEF in treatment guidelines.1
Additionally, mineralocorticoid receptor antagonists are used in clinical practice because they have been associated with a reduction in risk of hospitalisation for HFpEF patients, as demonstrated by the TOPCAT trial.19
A focus on SGLT2isInitially developed as a medicine used for type 2 diabetes, SGLT2is have become a crucial cardiovascular drug class, as demonstrated above by their role in the management of heart failure, and now have renal and cardiovascular indications irrespective of type 2 diabetic status. This is largely due to results of cardiovascular outcome trials mandated by the United States Food and Drug Administration (FDA) in 2008. These trials led to findings that have significantly changed clinical practice.20 They arose from concerns of cardiovascular risks with certain medicines used for type 2 diabetes, evidence suggesting rosiglitazone may increase the risk of myocardial infarction, and in recognition of the high prevalence of cardiovascular disease in these patients.20
SGLT2is lower blood glucose by inhibiting SGLT2 transporters in the proximal tubules of the kidneys to decrease glucose reabsorption, which increases the excretion of glucose in the urine.21 Sodium excretion also occurs because the SGLT2 receptor is close to, and works together with, a sodium/hydrogen exchanger, which is a major receptor responsible for sodium reuptake.22
Although SGLT2is lower blood glucose, blood pressure and contribute to diuresis, their benefits in terms of renal and cardiovascular outcomes cannot be solely attributed to these properties, as similar clinical benefits are not seen with other agents that lower glucose, blood pressure or increase natriuresis to similar or greater extent.23,24 The mechanism of action linked to these benefits is complex, and appears to also be a combination of anti-inflammatory and anti-fibrotic effects, a reduction in epicardial fat and a reduction in hyperinsulinaemia.21
Additional evidence also suggests a reduction in oxidative stress, less coronary microvascular injury and improved contractile performance.23 Emerging clinical evidence may also suggest antiarrhythmic properties, which is particularly important given that ventricular arrhythmias and sudden cardiac death is a major cause of death in heart failure patients.21 Some trials have demonstrated a decrease in sudden cardiac death for patients using a SGLT2i.21
The EMPA-REG OUTCOME trial in 2015 was a landmark study, demonstrating that empagliflozin significantly reduced cardiovascular death among high-risk patients with type 2 diabetes, compared to placebo.25 Importantly, it also suggested renal benefits, with less cases of acute renal failure in the empagliflozin group.25 These findings were later confirmed by the EMPA-Kidney (empagliflozin) and DAPA-CKD (dapagliflozin) trials, which both showed reduced rates of death due to renal disease, slower decline in renal function and delayed time to needing dialysis.26–28
The cardiovascular benefits of these medicines went on to be confirmed in further trials including the DAPA-HF (2019), EMPEROR Reduced (2020), EMPEROR Preserved (2021) and DELIVER (2022) trials.16,18,29,30
Key practice points
Knowledge to practice The use of heart failure guideline-directed medical therapy in HFrEF can have a significant impact on patient outcomes. The combination of the ‘four pillars’ (a heart failure beta blocker, an mineralocorticoid receptor antagonist, a renin angiotensin system inhibitor and an SGLT2i) has the ability to improve life expectancy, delay disease progression, decrease heart failure symptoms and improve quality of life.9,10 All patients with HFrEF should be prescribed all four agents unless a contraindication or intolerance exists preventing their use.32Â
In HFpEF, there are currently no medicines that demonstrate a statistically significant benefit on mortality. However, the use of SGLT2is has been shown to reduce risk of hospitalisation (regardless of diabetic status) and are recommended to be used by guidelines as part of its management, and in the managment of HFmrEF.1,9,14
Heart failure remains a significant health burden, but modern medicines, particularly SGLT2is, can offer significant benefits. Pharmacists play a pivotal role in optimising therapy, ensuring adherence, and providing education to patients. By leveraging their expertise as medication experts, pharmacists can profoundly impact outcomes, improving survival and quality of life for individuals living with heart failure and associated comorbidities.
Case scenario continuedRecognising the benefits of an SGLT2i for both Malcolm’s heart failure and diabetes, you discuss the option of adding an SGLT2i to his regimen, and the potential benefits and risks. Malcolm explains that his main priority is to get his heart failure symptoms under control so that he can play with his grandchildren and exercise comfortably. At Malcolm’s request, you contact his GP, and it is agreed to commence empagliflozin 10 mg daily (after ensuring his eGFR is appropriate). This intervention may help to reduce Malcolm’s risk of death from heart failure, improve his quality of life, delay disease progression, improve diabetic control and assist in helping him achieve his health goals. |
[cpd_submit_answer_button]
Cassie Potts (she/her) BPharm, GradCertChronCondMgt, FANZCAP (Cardiol), AdPhaM is a Senior Clinical Pharmacist with SA Pharmacy and has over 11 years of experience specialising in heart failure as part of the cardiology team at Flinders Medical Centre. She serves on the AdPha Cardiology Leadership Committee and currently practises within the intensive care unit at the Royal Adelaide Hospital.
Hana Numan (she/her) BPharm (NZ), PGDipClinPharm (NZ), MPS (NZ)
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[post_content] => From 1 May, Spravato (esketamine) will be subsidised under the Pharmaceutical Benefits Scheme (PBS) for adults with treatment-resistant depression, intended for use alongside a newly initiated oral antidepressant.
Up to 30,000 Australians are anticipated to access esketamine via the PBS, paying only $7.70 per dose with a pensioner or concession card, or $31.60 per dose for general patients.
[caption id="attachment_29259" align="alignright" width="233"] Professor Malcolm Hopwood[/caption]
Australian Pharmacist spoke with Professor Malcolm Hopwood, Ramsay Health Care Professor of Psychiatry at the University of Melbourne, about the treatment process and how pharmacists will be involved.
How effective is esketamine in managing treatment resistant depression?
The largest clinical trials on esketamine efficacy found that about 50% of patients who had not responded to two or three antidepressants did respond to esketamine, Prof Hopwood said.
‘If you compare that to trialing one of the usual medicines, the response rate for the third or fourth [medicine] is probably only about 15%,’ he said. ‘So it’s quite a jump up in terms of response rate.’
Who is eligible to be prescribed esketamine nasal spray?
Those diagnosed with treatment-resistant depression, defined as major depressive disorder that has not responded sufficiently to at least two different antidepressants, each administered at an adequate dose and duration, for the treatment of the current moderate to severe depressive episode.
Who is not a good candidate for this treatment?
Esketamine is currently not indicated for bipolar depression. And caution should be taken for patients with psychotic depression, Prof Hopwood said.Â
‘[This is] because ketamine, when used in much higher doses, has psychogenic potential,’ Prof Hopwood said.
There is also a precautionary note in the product information around patients with marked hepatic or renal impairment.
‘In terms of drug-drug interactions, it should not be used together with an irreversible monoamine oxidase inhibitor, which these days is only Parnate,’ he said. ‘While not widely used now, it's an important interaction to be aware of.’
What’s the duration of therapy?
Esketamine is initially administered twice weekly for the first 4 weeks, Prof Hopwood said.
‘By the end of that 4-week period, we've usually got a sense whether you're a responder or not.’
Treatment usually stops in non-responders, with responders moving to a once-weekly treatment regimen.
‘Eventually, fortnightly treatment for a 6-month maintenance period is what we recommend,’ Prof Hopwood said.
Is re-treatment recommended?
Given that depression is a highly recurrent condition, it is likely some patients will relapse post treatment. And re-treatment with esketamine could prove beneficial, Prof Hopwood said.
‘There is some data about re-treatment … [with] evidence showing that responders do seem to have a good response rate the second time around,’ he said. ‘That will be permitted under this funding scheme.’
How is esketamine supplied?
Patients cannot be in possession of the spray until they are in the clinic for administration under supervision, Prof Hopwood said.Â
‘Esketamine needs to be administered in an approved treatment center that involves close supervision for side effects such as dissociation and hypertension,’ he said.Â
Appropriate pharmacist handling of a Schedule 8 medicine is also required.
‘In our facility, we are fortunate to have an on-site pharmacist who dispenses [the medicine] to a nurse, and then the patient self-administers,’ Prof Hopwood said.Â
‘But the patient neither brings the medicine to the clinic or takes it away. The intent … is to reduce the risk of diversion.’
Facilities that do not have an on-site pharmacist must establish and demonstrate a connection with a local community pharmacy to qualify as an approved treatment centre.
Is talk therapy involved in the session?
Treatment with esketamine does not involve psychotherapy. However, there is a small body of research currently looking at ketamine-facilitated psychotherapy, Prof Hopwood said.
‘We still don't know whether that offers additional benefit for many patients, [but] if esketamine proves an effective treatment for their depression, they may be able to utilise psychotherapy much more effectively – which they might not be able to do when severely depressed.’
What are the estimated costs of esketamine sessions?
The estimated cost is $300–$350 per treatment session, Prof Hopwood said.
In most clinics, the doctor will see the patient on treatment occasions, but less so as treatment becomes established.
‘If the doctor does visit before the treatment is administered, then they can claim through Medicare as per usual,’ he said. ‘But the nursing and pharmacy [costs] will not be covered.’
Are patients supposed to disassociate when they take esketamine?
Dissociation with treatment is frequent, albeit mild and transient for most patients, Prof Hopwood said.
‘For up to half an hour they [may] feel a little dreamy and not unpleasant,’ he said.Â
Some evidence suggests that mild dissociative effects may be required for the drug to be effective in the treatment of depression, although this is not definitive, Prof Hopwood said.
‘We monitor patients during that time and keep them safe,’ he said. ‘Most of them simply want to lie there and listen to music or just bliss out for a short period of time.’Â
While there is no reversal agent for esketamine, any periods of distress are typically short lived.
‘We've had a very small number of patients distressed, consistent with the trials,’ Prof Hopwood said. ‘And they've generally responded to quite simple reassurance.’
Patients’ blood pressure is also monitored ‘It's rarely severe enough that intervention is required, but there can be a transient increase, as we've known from the use of ketamine as an anaesthetic,’ he said.
Where should pharmacists refer interested patients?
GPs are an important resource for knowing where the available treatment centers are, Prof Hopwood said.Â
‘There is a list of those available, and I predict that number may increase over time now that esketamine is funded.’
There are high levels of patient interest in esketamine and psychedelics, Prof Hopwood said.
‘So it's important they receive accurate, quality information that includes realistic expectations about the likelihood of treatment response and what's involved,’ he said. ‘And pharmacists are very well placed to provide that kind of information.’
What is preferable: esketamine or psychedelics?
Since 1 July 2023, patients with treatment-resistant depression have legally been allowed to receive treatment with psilocybin and MDMA, under specific conditions. Â
There is a degree of overlap between the patient populations considered suitable for ketamine and psychedelic therapy, Prof Hopwood said.
‘Most of the current guidance, including from The Royal Australian and New Zealand College of Psychiatrists, would say that psychedelic therapy is still more at a research level,’ he said.Â
‘Whereas, esketamine, reflected in the funding, has reached a higher level of evidence at this point.Â
‘So I would certainly see it as coming before psychedelic therapy in any hierarchy.’
To find out more about the use of psilocybin for treatment-resistant depression, read Australian Pharmacist's CPD article on the therapeutic potential of psychedelics.
[post_title] => PBS-backed esketamine rolls out for depression with S8 controls
[post_excerpt] => Esketamine will soon be funded for treatment-resistant depression, requiring pharmacists to adhere to strict supply and handling conditions.
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[post_content] => Aside from administering medicines by injection, Queensland-based community pharmacist Fiona Watson MPS loves tearing up a Latin dance floor.
Tell us about your pharmacy career.
I had a varied early career, moving to North Queensland for a year shortly after I graduated as well as locuming around Australia for a while.
This gave me a great introduction to community pharmacy and a lot of different experiences – both good and bad. When locuming, you develop a clear idea of the factors that contribute to a well-run pharmacy.
I then moved to the United Kingdom where I completed a Certificate in Clinical Pharmacy. You can tell how old I am because I was one of the last pharmacists able to register in the UK with only a month under supervision.
I was a ‘rotational resident pharmacist’, living on-site at the hospital. I covered renal, gastro, cardiology, oncology, aged care, palliative care and surgery wards.
We worked on call overnight, and could get called upon to help with all sorts of different situations – one of the most interesting being calculating the correct dose for the antidote to antifreeze.
More recently, I was very fortunate to be given the opportunity to go into partnership with my mum and sister, both pharmacists, as the managing partner at Redland Bay Wholelife Pharmacy and Healthfoods.
What medicines do you administer by injection?
About 10 years ago, I became a trained vaccinator administering thousands of vaccines during the COVID-19 pandemic.
When Queensland allowed pharmacists to expand the range of medicines they could administer, I completed the Medication Administration course, as I believe this is an essential skill for pharmacists to have.
So many new medications are injectable, and for some patients self-administration just isn’t an option. We were one of the first pharmacies in our area to offer long-acting injectable buprenorphine services, which can be a life-changing option for patients.
Tell us about your administering injections beyond vaccines.
The majority of pharmacists I work with at Redland Bay are trained vaccinators and have completed medicines administration courses. When we come across a new medication that requires administration by injection we collate the available information from the manufacturer and ensure everyone has read it. Many companies, such as Novartis with inclisiran (Leqvio), have reps who are happy to provide additional training.
Once you are comfortable with subcutaneous injections, it’s a matter of familiarising yourself with the different types of devices available. It seemed a logical step for us to provide this service. We have great consult room facilities and it brings variety to our role.
What role do you see pharmacists playing in cardiovascular care in future?
The sky is the limit. We’re on the cusp of a fundamental change in the way Australians receive health care and I hope to see pharmacists embrace the opportunities this will bring.
There’s a workforce crisis and an ageing population, so we need to become more efficient and accessible. If you think about how much the role of a nurse practitioner has changed in the last 10–15 years, you can see where pharmacists have even greater potential. A patient with a diagnosis of heart failure should be able to be titrated to optimum therapy by a pharmacist in a community pharmacy. A patient should have their HbA1c or lipids checked in the pharmacy, with appropriate therapy initiated or adjusted. We should also be actively involved in screening and chronic disease management.
Pharmacy is an incredibly rewarding and enjoyable career, and now is an especially exciting time to be a pharmacist. There is just so much opportunity.Â
Day in the life of Fiona Watson MPS, Community pharmacist at Redland Bay Wholelife Pharmacy, QLD.
| 5.00am |
Hit the gym I get up and do a HIIT or Muay Thai class most mornings for positive effects on my mental health. Passionate about preventative health care, I see the long-term effects of patients’ lifestyle choices every day. |
| 8.00am |
Open the pharmacy Every day is different. At least two pharmacists are rostered on, ensuring we give each patient the time they need while providing a wide range of different services. |
| 9.00am |
Vaccination service Embarking on a cruise in 2 months, a couple in their 60s asks about COVID-19 vaccines. More than 12 months since their last vaccine they are happy to be vaccinated on the spot. Not wanting more than one vaccine at a time, we book them in for a follow-up appointment in a month for the shingles vaccination. |
| 10.00am |
Collaborative care A local GP phones about a recently discharged mutual patient who’s not coping well on his new medicines. We spend some time with the patient doing a medicine review and setting up his profile for a dose administration aid. |
| 1.00pm |
Lunchtime It’s important that all staff, especially pharmacists, prioritise their breaks. We all need a little downtime to reset and refresh. |
| 1.30pm |
Medicines injection A regular patient comes in for her second dose of inclisiran (Leqvio) after I administered her first 3 months ago. She is happy with the more convenient option than visiting her GP. |
| 3.00pm |
Infection control In a call from our pharmacy car park, we learn a patient has tested positive for COVID-19 and has an e-script. We dispense and counsel over the phone and then deliver out to their car (with appropriate precautions). |
| 6.30pm |
OCP continuance A stressed young woman, with a 2-week wait for a GP appointment, has run out of her pill. She is relieved when seen by a colleague who prescribes Estelle under the Queensland Hormonal Contraceptive Pilot. I dispense it. |
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[post_content] => Vaccination coverage in older Australians remains alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
Older Australians are highly susceptible to serious complications from influenza and COVID-19. But the vaccination rates in patients aged 75 and over are nowhere where they need to be to protect this vulnerable patient cohort from harm, including hospitalisations and death.
The national influenza vaccination rate of patients aged 65 and over currently sits at 7.2%. And in the last 12 months, only 37.7% of Australians aged 75 and over received a COVID-19 vaccination.
But boosting immunisation rates in older Australians is more important than ever. The influenza season started earlier and stronger than usual, with 60,594 cases of influenza reported this year.
As of 10 April, there were also 70 active outbreaks of COVID-19 in residential aged care facilities (RACFs). Last year, case numbers were highest among those most at risk, with notifications peaking in the 75–79, 80–84 and 85+ (12,607).
With GPs not always available to address vaccination gaps in aged care, pharmacists are well positioned to step in and provide this essential service.
In the video above, community pharmacist Lachlan Rose MPS outlines the benefits of providing offsite vaccinations in aged care settings, including financial incentives, workplace variety and the protection of one of the most vulnerable populations.
[post_title] => All pharmacists should consider off-site vaccinations in aged care
[post_excerpt] => Vaccination rates in older Australians are alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
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[title_attribute] => All pharmacists should consider off-site vaccinations in aged care
[title] => All pharmacists should consider off-site vaccinations in aged care
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[post_content] => The Fair Work Commission’s Expert Panel for pay equity in the care and community sector has today issued its initial decision on the Gender-based undervaluation – priority awards review – making determinations on the Pharmacy Industry Award 2020, which most community pharmacists are employed under.Â
What did the Expert Panel find?Â
The Expert Panel found that pharmacists covered by the Pharmacy Industry Award 2020 (and several other awards) have been the subject of gender-based undervaluation. Â
As a result, the Expert Panel has determined that findings constitute work value reasons, justifying variation of the modern award minimum wage rates across all categories of pharmacists. Â
What is ‘gender-based undervaluation’?Â
Gender-based undervaluation considers a range of factors to determine whether minimum award pay rates are undervalued because of assumptions based on gender.Â
The range of factors considered extends to historical undervaluing, exercise of ‘invisible skills’, exercise of caring work and workforce qualifications, among others. Â
How does the Expert Panel intend to address the undervaluation?Â
For pharmacists employed by the Pharmacy Industry Award 2020, the Expert Panel has issued a determination that there will be a total increase in the minimum wage rates of 14.1% over three years.Â
This increase will be implemented in three equal phases on:Â
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[post_content] => Case scenario
Malcolm (68 years old, male) visits your pharmacy with a new prescription for sacubitril/valsartan. He mentions he has recently been diagnosed with heart failure with reduced ejection fraction (HFrEF). You review his records and confirm he is still taking metformin/sitagliptin for type 2 diabetes. Malcolm explains that he has taken this for many years, and that his general practitioner has advised him that his blood glucose control needs to be better. He expresses frustration that the shortness of breath from his heart failure limits his ability to exercise and improve his diabetes. Malcolm hopes that starting this new medicine will improve this.
After reading this article, pharmacists should be able to:
|
Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.
Heart failure is a clinical syndrome caused by the inability of the heart muscle to provide adequate cardiac output and/or the presence of increased cardiac pressure. This is due to either a structural or functional abnormality of the heart.1 The clinical syndrome consists of symptoms such as breathlessness and fatigue and may be accompanied by signs of fluid accumulation such as peripheral oedema, elevated jugular venous pressure and pulmonary crackles.1
In many cases, heart failure may be both preventable and treatable. Choice of treatment depends on the type of heart failure present, with management being primarily pharmacological.1
Pharmacists play an essential role in optimising pharmacotherapy for heart failure patients, providing recommendations on safe and effective dose titration and appropriate pharmacological management, as well as providing education, counselling and support for adherence.2
Heart failure remains a global public health issue that affects at least 38Â million people worldwide.2 It is a major cause of hospitalisation in Australia and is associated with significant healthcare costs.3
Heart failure has a poor prognosis and results in markedly reduced quality of life.1 Readmission to hospital is extremely common, with about 1 in 3 patients being readmitted in the first month, and up to 15% of patients dying within the first 6 months, after being discharged from hospital.4 By 12 months post-discharge, approximately 25% of heart failure patients will have died.5
Concerningly, due to population aging and increasing prevalence of comorbidities, heart failure hospitalisations could increase by as much as 50% in the next 25Â years.1
Categorisation of heart failureHeart failure is categorised according to the measurement of the left ventricular ejection fraction (LVEF). Knowing the LVEF at time of diagnosis is crucial, as this guides treatment.1 Heart failure is categorised as either1,6,7:
HFrEF
For HFrEF, there are effective pharmacological therapies, supported by robust, high-quality evidence. These include what has now become known as ‘the four pillars’, and these collectively make up guideline-directed medical therapy for HFrEF. These include9–11:
All patients with HFrEF should be prescribed all four agents (unless contraindicated or not tolerated), with early initiation being associated with the best outcomes.1,9,10 Other therapies are available as HFrEF progresses, however the ‘four pillars’ are the cornerstone of HFrEF treatment.10
HFmrEF
There is limited evidence to support specific recommendations for the pharmacological management of HFmrEF.1 Some studies suggest that patients with HFmrEF may receive similar benefit from a beta blocker, a mineralocorticoid receptor antagonist and a renin angiotensin system inhibitor as in HFrEF, and SGLT2is have been shown to reduce the risk of cardiovascular death and hospitalisation for heart failure.14 The medicines used to treat HFrEF are often used to treat HFmrEF, however the confidence in prognostic benefits is much less.1,14
HFpEF
For the treatment of HFpEF, no medicines have demonstrated a statistically significant benefit on mortality.1 Recommended treatment consists of15:
The use of an SGLT2i in HFpEF has not been shown to improve mortality to the same extent as for HFrEF. However, an SGLT2i is still recommended because major trials have shown they can still offer some benefits.16,17
The EMPEROR-Preserved trial demonstrated a 21% lower relative risk in the composite of cardiovascular death or hospitalisation for heart failure with the use of empagliflozin in the treatment of HFpEF compared with placebo – a result driven primarily by a reduction in risk of hospitalisation rather than mortality.16 Importantly, this benefit was seen regardless of the diabetic status of the patient.16 This benefit was later reinforced by the DELIVER trial which showed a lower risk of its composite primary outcome of worsening heart failure or cardiovascular death with dapagliflozin use, compared to placebo for those with HFmrEF and HFpEF.18 As a result, SGLT2is have received a strong recommendation for the management of HFpEF in treatment guidelines.1
Additionally, mineralocorticoid receptor antagonists are used in clinical practice because they have been associated with a reduction in risk of hospitalisation for HFpEF patients, as demonstrated by the TOPCAT trial.19
A focus on SGLT2isInitially developed as a medicine used for type 2 diabetes, SGLT2is have become a crucial cardiovascular drug class, as demonstrated above by their role in the management of heart failure, and now have renal and cardiovascular indications irrespective of type 2 diabetic status. This is largely due to results of cardiovascular outcome trials mandated by the United States Food and Drug Administration (FDA) in 2008. These trials led to findings that have significantly changed clinical practice.20 They arose from concerns of cardiovascular risks with certain medicines used for type 2 diabetes, evidence suggesting rosiglitazone may increase the risk of myocardial infarction, and in recognition of the high prevalence of cardiovascular disease in these patients.20
SGLT2is lower blood glucose by inhibiting SGLT2 transporters in the proximal tubules of the kidneys to decrease glucose reabsorption, which increases the excretion of glucose in the urine.21 Sodium excretion also occurs because the SGLT2 receptor is close to, and works together with, a sodium/hydrogen exchanger, which is a major receptor responsible for sodium reuptake.22
Although SGLT2is lower blood glucose, blood pressure and contribute to diuresis, their benefits in terms of renal and cardiovascular outcomes cannot be solely attributed to these properties, as similar clinical benefits are not seen with other agents that lower glucose, blood pressure or increase natriuresis to similar or greater extent.23,24 The mechanism of action linked to these benefits is complex, and appears to also be a combination of anti-inflammatory and anti-fibrotic effects, a reduction in epicardial fat and a reduction in hyperinsulinaemia.21
Additional evidence also suggests a reduction in oxidative stress, less coronary microvascular injury and improved contractile performance.23 Emerging clinical evidence may also suggest antiarrhythmic properties, which is particularly important given that ventricular arrhythmias and sudden cardiac death is a major cause of death in heart failure patients.21 Some trials have demonstrated a decrease in sudden cardiac death for patients using a SGLT2i.21
The EMPA-REG OUTCOME trial in 2015 was a landmark study, demonstrating that empagliflozin significantly reduced cardiovascular death among high-risk patients with type 2 diabetes, compared to placebo.25 Importantly, it also suggested renal benefits, with less cases of acute renal failure in the empagliflozin group.25 These findings were later confirmed by the EMPA-Kidney (empagliflozin) and DAPA-CKD (dapagliflozin) trials, which both showed reduced rates of death due to renal disease, slower decline in renal function and delayed time to needing dialysis.26–28
The cardiovascular benefits of these medicines went on to be confirmed in further trials including the DAPA-HF (2019), EMPEROR Reduced (2020), EMPEROR Preserved (2021) and DELIVER (2022) trials.16,18,29,30
Key practice points
Knowledge to practice The use of heart failure guideline-directed medical therapy in HFrEF can have a significant impact on patient outcomes. The combination of the ‘four pillars’ (a heart failure beta blocker, an mineralocorticoid receptor antagonist, a renin angiotensin system inhibitor and an SGLT2i) has the ability to improve life expectancy, delay disease progression, decrease heart failure symptoms and improve quality of life.9,10 All patients with HFrEF should be prescribed all four agents unless a contraindication or intolerance exists preventing their use.32Â
In HFpEF, there are currently no medicines that demonstrate a statistically significant benefit on mortality. However, the use of SGLT2is has been shown to reduce risk of hospitalisation (regardless of diabetic status) and are recommended to be used by guidelines as part of its management, and in the managment of HFmrEF.1,9,14
Heart failure remains a significant health burden, but modern medicines, particularly SGLT2is, can offer significant benefits. Pharmacists play a pivotal role in optimising therapy, ensuring adherence, and providing education to patients. By leveraging their expertise as medication experts, pharmacists can profoundly impact outcomes, improving survival and quality of life for individuals living with heart failure and associated comorbidities.
Case scenario continuedRecognising the benefits of an SGLT2i for both Malcolm’s heart failure and diabetes, you discuss the option of adding an SGLT2i to his regimen, and the potential benefits and risks. Malcolm explains that his main priority is to get his heart failure symptoms under control so that he can play with his grandchildren and exercise comfortably. At Malcolm’s request, you contact his GP, and it is agreed to commence empagliflozin 10 mg daily (after ensuring his eGFR is appropriate). This intervention may help to reduce Malcolm’s risk of death from heart failure, improve his quality of life, delay disease progression, improve diabetic control and assist in helping him achieve his health goals. |
[cpd_submit_answer_button]
Cassie Potts (she/her) BPharm, GradCertChronCondMgt, FANZCAP (Cardiol), AdPhaM is a Senior Clinical Pharmacist with SA Pharmacy and has over 11 years of experience specialising in heart failure as part of the cardiology team at Flinders Medical Centre. She serves on the AdPha Cardiology Leadership Committee and currently practises within the intensive care unit at the Royal Adelaide Hospital.
Hana Numan (she/her) BPharm (NZ), PGDipClinPharm (NZ), MPS (NZ)
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[post_content] => From 1 May, Spravato (esketamine) will be subsidised under the Pharmaceutical Benefits Scheme (PBS) for adults with treatment-resistant depression, intended for use alongside a newly initiated oral antidepressant.
Up to 30,000 Australians are anticipated to access esketamine via the PBS, paying only $7.70 per dose with a pensioner or concession card, or $31.60 per dose for general patients.
[caption id="attachment_29259" align="alignright" width="233"] Professor Malcolm Hopwood[/caption]
Australian Pharmacist spoke with Professor Malcolm Hopwood, Ramsay Health Care Professor of Psychiatry at the University of Melbourne, about the treatment process and how pharmacists will be involved.
How effective is esketamine in managing treatment resistant depression?
The largest clinical trials on esketamine efficacy found that about 50% of patients who had not responded to two or three antidepressants did respond to esketamine, Prof Hopwood said.
‘If you compare that to trialing one of the usual medicines, the response rate for the third or fourth [medicine] is probably only about 15%,’ he said. ‘So it’s quite a jump up in terms of response rate.’
Who is eligible to be prescribed esketamine nasal spray?
Those diagnosed with treatment-resistant depression, defined as major depressive disorder that has not responded sufficiently to at least two different antidepressants, each administered at an adequate dose and duration, for the treatment of the current moderate to severe depressive episode.
Who is not a good candidate for this treatment?
Esketamine is currently not indicated for bipolar depression. And caution should be taken for patients with psychotic depression, Prof Hopwood said.Â
‘[This is] because ketamine, when used in much higher doses, has psychogenic potential,’ Prof Hopwood said.
There is also a precautionary note in the product information around patients with marked hepatic or renal impairment.
‘In terms of drug-drug interactions, it should not be used together with an irreversible monoamine oxidase inhibitor, which these days is only Parnate,’ he said. ‘While not widely used now, it's an important interaction to be aware of.’
What’s the duration of therapy?
Esketamine is initially administered twice weekly for the first 4 weeks, Prof Hopwood said.
‘By the end of that 4-week period, we've usually got a sense whether you're a responder or not.’
Treatment usually stops in non-responders, with responders moving to a once-weekly treatment regimen.
‘Eventually, fortnightly treatment for a 6-month maintenance period is what we recommend,’ Prof Hopwood said.
Is re-treatment recommended?
Given that depression is a highly recurrent condition, it is likely some patients will relapse post treatment. And re-treatment with esketamine could prove beneficial, Prof Hopwood said.
‘There is some data about re-treatment … [with] evidence showing that responders do seem to have a good response rate the second time around,’ he said. ‘That will be permitted under this funding scheme.’
How is esketamine supplied?
Patients cannot be in possession of the spray until they are in the clinic for administration under supervision, Prof Hopwood said.Â
‘Esketamine needs to be administered in an approved treatment center that involves close supervision for side effects such as dissociation and hypertension,’ he said.Â
Appropriate pharmacist handling of a Schedule 8 medicine is also required.
‘In our facility, we are fortunate to have an on-site pharmacist who dispenses [the medicine] to a nurse, and then the patient self-administers,’ Prof Hopwood said.Â
‘But the patient neither brings the medicine to the clinic or takes it away. The intent … is to reduce the risk of diversion.’
Facilities that do not have an on-site pharmacist must establish and demonstrate a connection with a local community pharmacy to qualify as an approved treatment centre.
Is talk therapy involved in the session?
Treatment with esketamine does not involve psychotherapy. However, there is a small body of research currently looking at ketamine-facilitated psychotherapy, Prof Hopwood said.
‘We still don't know whether that offers additional benefit for many patients, [but] if esketamine proves an effective treatment for their depression, they may be able to utilise psychotherapy much more effectively – which they might not be able to do when severely depressed.’
What are the estimated costs of esketamine sessions?
The estimated cost is $300–$350 per treatment session, Prof Hopwood said.
In most clinics, the doctor will see the patient on treatment occasions, but less so as treatment becomes established.
‘If the doctor does visit before the treatment is administered, then they can claim through Medicare as per usual,’ he said. ‘But the nursing and pharmacy [costs] will not be covered.’
Are patients supposed to disassociate when they take esketamine?
Dissociation with treatment is frequent, albeit mild and transient for most patients, Prof Hopwood said.
‘For up to half an hour they [may] feel a little dreamy and not unpleasant,’ he said.Â
Some evidence suggests that mild dissociative effects may be required for the drug to be effective in the treatment of depression, although this is not definitive, Prof Hopwood said.
‘We monitor patients during that time and keep them safe,’ he said. ‘Most of them simply want to lie there and listen to music or just bliss out for a short period of time.’Â
While there is no reversal agent for esketamine, any periods of distress are typically short lived.
‘We've had a very small number of patients distressed, consistent with the trials,’ Prof Hopwood said. ‘And they've generally responded to quite simple reassurance.’
Patients’ blood pressure is also monitored ‘It's rarely severe enough that intervention is required, but there can be a transient increase, as we've known from the use of ketamine as an anaesthetic,’ he said.
Where should pharmacists refer interested patients?
GPs are an important resource for knowing where the available treatment centers are, Prof Hopwood said.Â
‘There is a list of those available, and I predict that number may increase over time now that esketamine is funded.’
There are high levels of patient interest in esketamine and psychedelics, Prof Hopwood said.
‘So it's important they receive accurate, quality information that includes realistic expectations about the likelihood of treatment response and what's involved,’ he said. ‘And pharmacists are very well placed to provide that kind of information.’
What is preferable: esketamine or psychedelics?
Since 1 July 2023, patients with treatment-resistant depression have legally been allowed to receive treatment with psilocybin and MDMA, under specific conditions. Â
There is a degree of overlap between the patient populations considered suitable for ketamine and psychedelic therapy, Prof Hopwood said.
‘Most of the current guidance, including from The Royal Australian and New Zealand College of Psychiatrists, would say that psychedelic therapy is still more at a research level,’ he said.Â
‘Whereas, esketamine, reflected in the funding, has reached a higher level of evidence at this point.Â
‘So I would certainly see it as coming before psychedelic therapy in any hierarchy.’
To find out more about the use of psilocybin for treatment-resistant depression, read Australian Pharmacist's CPD article on the therapeutic potential of psychedelics.
[post_title] => PBS-backed esketamine rolls out for depression with S8 controls
[post_excerpt] => Esketamine will soon be funded for treatment-resistant depression, requiring pharmacists to adhere to strict supply and handling conditions.
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[title_attribute] => PBS-backed esketamine rolls out for depression with S8 controls
[title] => PBS-backed esketamine rolls out for depression with S8 controls
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[post_content] => Aside from administering medicines by injection, Queensland-based community pharmacist Fiona Watson MPS loves tearing up a Latin dance floor.
Tell us about your pharmacy career.
I had a varied early career, moving to North Queensland for a year shortly after I graduated as well as locuming around Australia for a while.
This gave me a great introduction to community pharmacy and a lot of different experiences – both good and bad. When locuming, you develop a clear idea of the factors that contribute to a well-run pharmacy.
I then moved to the United Kingdom where I completed a Certificate in Clinical Pharmacy. You can tell how old I am because I was one of the last pharmacists able to register in the UK with only a month under supervision.
I was a ‘rotational resident pharmacist’, living on-site at the hospital. I covered renal, gastro, cardiology, oncology, aged care, palliative care and surgery wards.
We worked on call overnight, and could get called upon to help with all sorts of different situations – one of the most interesting being calculating the correct dose for the antidote to antifreeze.
More recently, I was very fortunate to be given the opportunity to go into partnership with my mum and sister, both pharmacists, as the managing partner at Redland Bay Wholelife Pharmacy and Healthfoods.
What medicines do you administer by injection?
About 10 years ago, I became a trained vaccinator administering thousands of vaccines during the COVID-19 pandemic.
When Queensland allowed pharmacists to expand the range of medicines they could administer, I completed the Medication Administration course, as I believe this is an essential skill for pharmacists to have.
So many new medications are injectable, and for some patients self-administration just isn’t an option. We were one of the first pharmacies in our area to offer long-acting injectable buprenorphine services, which can be a life-changing option for patients.
Tell us about your administering injections beyond vaccines.
The majority of pharmacists I work with at Redland Bay are trained vaccinators and have completed medicines administration courses. When we come across a new medication that requires administration by injection we collate the available information from the manufacturer and ensure everyone has read it. Many companies, such as Novartis with inclisiran (Leqvio), have reps who are happy to provide additional training.
Once you are comfortable with subcutaneous injections, it’s a matter of familiarising yourself with the different types of devices available. It seemed a logical step for us to provide this service. We have great consult room facilities and it brings variety to our role.
What role do you see pharmacists playing in cardiovascular care in future?
The sky is the limit. We’re on the cusp of a fundamental change in the way Australians receive health care and I hope to see pharmacists embrace the opportunities this will bring.
There’s a workforce crisis and an ageing population, so we need to become more efficient and accessible. If you think about how much the role of a nurse practitioner has changed in the last 10–15 years, you can see where pharmacists have even greater potential. A patient with a diagnosis of heart failure should be able to be titrated to optimum therapy by a pharmacist in a community pharmacy. A patient should have their HbA1c or lipids checked in the pharmacy, with appropriate therapy initiated or adjusted. We should also be actively involved in screening and chronic disease management.
Pharmacy is an incredibly rewarding and enjoyable career, and now is an especially exciting time to be a pharmacist. There is just so much opportunity.Â
Day in the life of Fiona Watson MPS, Community pharmacist at Redland Bay Wholelife Pharmacy, QLD.
| 5.00am |
Hit the gym I get up and do a HIIT or Muay Thai class most mornings for positive effects on my mental health. Passionate about preventative health care, I see the long-term effects of patients’ lifestyle choices every day. |
| 8.00am |
Open the pharmacy Every day is different. At least two pharmacists are rostered on, ensuring we give each patient the time they need while providing a wide range of different services. |
| 9.00am |
Vaccination service Embarking on a cruise in 2 months, a couple in their 60s asks about COVID-19 vaccines. More than 12 months since their last vaccine they are happy to be vaccinated on the spot. Not wanting more than one vaccine at a time, we book them in for a follow-up appointment in a month for the shingles vaccination. |
| 10.00am |
Collaborative care A local GP phones about a recently discharged mutual patient who’s not coping well on his new medicines. We spend some time with the patient doing a medicine review and setting up his profile for a dose administration aid. |
| 1.00pm |
Lunchtime It’s important that all staff, especially pharmacists, prioritise their breaks. We all need a little downtime to reset and refresh. |
| 1.30pm |
Medicines injection A regular patient comes in for her second dose of inclisiran (Leqvio) after I administered her first 3 months ago. She is happy with the more convenient option than visiting her GP. |
| 3.00pm |
Infection control In a call from our pharmacy car park, we learn a patient has tested positive for COVID-19 and has an e-script. We dispense and counsel over the phone and then deliver out to their car (with appropriate precautions). |
| 6.30pm |
OCP continuance A stressed young woman, with a 2-week wait for a GP appointment, has run out of her pill. She is relieved when seen by a colleague who prescribes Estelle under the Queensland Hormonal Contraceptive Pilot. I dispense it. |
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[post_content] => Vaccination coverage in older Australians remains alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
Older Australians are highly susceptible to serious complications from influenza and COVID-19. But the vaccination rates in patients aged 75 and over are nowhere where they need to be to protect this vulnerable patient cohort from harm, including hospitalisations and death.
The national influenza vaccination rate of patients aged 65 and over currently sits at 7.2%. And in the last 12 months, only 37.7% of Australians aged 75 and over received a COVID-19 vaccination.
But boosting immunisation rates in older Australians is more important than ever. The influenza season started earlier and stronger than usual, with 60,594 cases of influenza reported this year.
As of 10 April, there were also 70 active outbreaks of COVID-19 in residential aged care facilities (RACFs). Last year, case numbers were highest among those most at risk, with notifications peaking in the 75–79, 80–84 and 85+ (12,607).
With GPs not always available to address vaccination gaps in aged care, pharmacists are well positioned to step in and provide this essential service.
In the video above, community pharmacist Lachlan Rose MPS outlines the benefits of providing offsite vaccinations in aged care settings, including financial incentives, workplace variety and the protection of one of the most vulnerable populations.
[post_title] => All pharmacists should consider off-site vaccinations in aged care
[post_excerpt] => Vaccination rates in older Australians are alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
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[title_attribute] => All pharmacists should consider off-site vaccinations in aged care
[title] => All pharmacists should consider off-site vaccinations in aged care
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[post_content] => The Fair Work Commission’s Expert Panel for pay equity in the care and community sector has today issued its initial decision on the Gender-based undervaluation – priority awards review – making determinations on the Pharmacy Industry Award 2020, which most community pharmacists are employed under.Â
What did the Expert Panel find?Â
The Expert Panel found that pharmacists covered by the Pharmacy Industry Award 2020 (and several other awards) have been the subject of gender-based undervaluation. Â
As a result, the Expert Panel has determined that findings constitute work value reasons, justifying variation of the modern award minimum wage rates across all categories of pharmacists. Â
What is ‘gender-based undervaluation’?Â
Gender-based undervaluation considers a range of factors to determine whether minimum award pay rates are undervalued because of assumptions based on gender.Â
The range of factors considered extends to historical undervaluing, exercise of ‘invisible skills’, exercise of caring work and workforce qualifications, among others. Â
How does the Expert Panel intend to address the undervaluation?Â
For pharmacists employed by the Pharmacy Industry Award 2020, the Expert Panel has issued a determination that there will be a total increase in the minimum wage rates of 14.1% over three years.Â
This increase will be implemented in three equal phases on:Â
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[post_content] => Case scenario
Malcolm (68 years old, male) visits your pharmacy with a new prescription for sacubitril/valsartan. He mentions he has recently been diagnosed with heart failure with reduced ejection fraction (HFrEF). You review his records and confirm he is still taking metformin/sitagliptin for type 2 diabetes. Malcolm explains that he has taken this for many years, and that his general practitioner has advised him that his blood glucose control needs to be better. He expresses frustration that the shortness of breath from his heart failure limits his ability to exercise and improve his diabetes. Malcolm hopes that starting this new medicine will improve this.
After reading this article, pharmacists should be able to:
|
Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.
Heart failure is a clinical syndrome caused by the inability of the heart muscle to provide adequate cardiac output and/or the presence of increased cardiac pressure. This is due to either a structural or functional abnormality of the heart.1 The clinical syndrome consists of symptoms such as breathlessness and fatigue and may be accompanied by signs of fluid accumulation such as peripheral oedema, elevated jugular venous pressure and pulmonary crackles.1
In many cases, heart failure may be both preventable and treatable. Choice of treatment depends on the type of heart failure present, with management being primarily pharmacological.1
Pharmacists play an essential role in optimising pharmacotherapy for heart failure patients, providing recommendations on safe and effective dose titration and appropriate pharmacological management, as well as providing education, counselling and support for adherence.2
Heart failure remains a global public health issue that affects at least 38Â million people worldwide.2 It is a major cause of hospitalisation in Australia and is associated with significant healthcare costs.3
Heart failure has a poor prognosis and results in markedly reduced quality of life.1 Readmission to hospital is extremely common, with about 1 in 3 patients being readmitted in the first month, and up to 15% of patients dying within the first 6 months, after being discharged from hospital.4 By 12 months post-discharge, approximately 25% of heart failure patients will have died.5
Concerningly, due to population aging and increasing prevalence of comorbidities, heart failure hospitalisations could increase by as much as 50% in the next 25Â years.1
Categorisation of heart failureHeart failure is categorised according to the measurement of the left ventricular ejection fraction (LVEF). Knowing the LVEF at time of diagnosis is crucial, as this guides treatment.1 Heart failure is categorised as either1,6,7:
HFrEF
For HFrEF, there are effective pharmacological therapies, supported by robust, high-quality evidence. These include what has now become known as ‘the four pillars’, and these collectively make up guideline-directed medical therapy for HFrEF. These include9–11:
All patients with HFrEF should be prescribed all four agents (unless contraindicated or not tolerated), with early initiation being associated with the best outcomes.1,9,10 Other therapies are available as HFrEF progresses, however the ‘four pillars’ are the cornerstone of HFrEF treatment.10
HFmrEF
There is limited evidence to support specific recommendations for the pharmacological management of HFmrEF.1 Some studies suggest that patients with HFmrEF may receive similar benefit from a beta blocker, a mineralocorticoid receptor antagonist and a renin angiotensin system inhibitor as in HFrEF, and SGLT2is have been shown to reduce the risk of cardiovascular death and hospitalisation for heart failure.14 The medicines used to treat HFrEF are often used to treat HFmrEF, however the confidence in prognostic benefits is much less.1,14
HFpEF
For the treatment of HFpEF, no medicines have demonstrated a statistically significant benefit on mortality.1 Recommended treatment consists of15:
The use of an SGLT2i in HFpEF has not been shown to improve mortality to the same extent as for HFrEF. However, an SGLT2i is still recommended because major trials have shown they can still offer some benefits.16,17
The EMPEROR-Preserved trial demonstrated a 21% lower relative risk in the composite of cardiovascular death or hospitalisation for heart failure with the use of empagliflozin in the treatment of HFpEF compared with placebo – a result driven primarily by a reduction in risk of hospitalisation rather than mortality.16 Importantly, this benefit was seen regardless of the diabetic status of the patient.16 This benefit was later reinforced by the DELIVER trial which showed a lower risk of its composite primary outcome of worsening heart failure or cardiovascular death with dapagliflozin use, compared to placebo for those with HFmrEF and HFpEF.18 As a result, SGLT2is have received a strong recommendation for the management of HFpEF in treatment guidelines.1
Additionally, mineralocorticoid receptor antagonists are used in clinical practice because they have been associated with a reduction in risk of hospitalisation for HFpEF patients, as demonstrated by the TOPCAT trial.19
A focus on SGLT2isInitially developed as a medicine used for type 2 diabetes, SGLT2is have become a crucial cardiovascular drug class, as demonstrated above by their role in the management of heart failure, and now have renal and cardiovascular indications irrespective of type 2 diabetic status. This is largely due to results of cardiovascular outcome trials mandated by the United States Food and Drug Administration (FDA) in 2008. These trials led to findings that have significantly changed clinical practice.20 They arose from concerns of cardiovascular risks with certain medicines used for type 2 diabetes, evidence suggesting rosiglitazone may increase the risk of myocardial infarction, and in recognition of the high prevalence of cardiovascular disease in these patients.20
SGLT2is lower blood glucose by inhibiting SGLT2 transporters in the proximal tubules of the kidneys to decrease glucose reabsorption, which increases the excretion of glucose in the urine.21 Sodium excretion also occurs because the SGLT2 receptor is close to, and works together with, a sodium/hydrogen exchanger, which is a major receptor responsible for sodium reuptake.22
Although SGLT2is lower blood glucose, blood pressure and contribute to diuresis, their benefits in terms of renal and cardiovascular outcomes cannot be solely attributed to these properties, as similar clinical benefits are not seen with other agents that lower glucose, blood pressure or increase natriuresis to similar or greater extent.23,24 The mechanism of action linked to these benefits is complex, and appears to also be a combination of anti-inflammatory and anti-fibrotic effects, a reduction in epicardial fat and a reduction in hyperinsulinaemia.21
Additional evidence also suggests a reduction in oxidative stress, less coronary microvascular injury and improved contractile performance.23 Emerging clinical evidence may also suggest antiarrhythmic properties, which is particularly important given that ventricular arrhythmias and sudden cardiac death is a major cause of death in heart failure patients.21 Some trials have demonstrated a decrease in sudden cardiac death for patients using a SGLT2i.21
The EMPA-REG OUTCOME trial in 2015 was a landmark study, demonstrating that empagliflozin significantly reduced cardiovascular death among high-risk patients with type 2 diabetes, compared to placebo.25 Importantly, it also suggested renal benefits, with less cases of acute renal failure in the empagliflozin group.25 These findings were later confirmed by the EMPA-Kidney (empagliflozin) and DAPA-CKD (dapagliflozin) trials, which both showed reduced rates of death due to renal disease, slower decline in renal function and delayed time to needing dialysis.26–28
The cardiovascular benefits of these medicines went on to be confirmed in further trials including the DAPA-HF (2019), EMPEROR Reduced (2020), EMPEROR Preserved (2021) and DELIVER (2022) trials.16,18,29,30
Key practice points
Knowledge to practice The use of heart failure guideline-directed medical therapy in HFrEF can have a significant impact on patient outcomes. The combination of the ‘four pillars’ (a heart failure beta blocker, an mineralocorticoid receptor antagonist, a renin angiotensin system inhibitor and an SGLT2i) has the ability to improve life expectancy, delay disease progression, decrease heart failure symptoms and improve quality of life.9,10 All patients with HFrEF should be prescribed all four agents unless a contraindication or intolerance exists preventing their use.32Â
In HFpEF, there are currently no medicines that demonstrate a statistically significant benefit on mortality. However, the use of SGLT2is has been shown to reduce risk of hospitalisation (regardless of diabetic status) and are recommended to be used by guidelines as part of its management, and in the managment of HFmrEF.1,9,14
Heart failure remains a significant health burden, but modern medicines, particularly SGLT2is, can offer significant benefits. Pharmacists play a pivotal role in optimising therapy, ensuring adherence, and providing education to patients. By leveraging their expertise as medication experts, pharmacists can profoundly impact outcomes, improving survival and quality of life for individuals living with heart failure and associated comorbidities.
Case scenario continuedRecognising the benefits of an SGLT2i for both Malcolm’s heart failure and diabetes, you discuss the option of adding an SGLT2i to his regimen, and the potential benefits and risks. Malcolm explains that his main priority is to get his heart failure symptoms under control so that he can play with his grandchildren and exercise comfortably. At Malcolm’s request, you contact his GP, and it is agreed to commence empagliflozin 10 mg daily (after ensuring his eGFR is appropriate). This intervention may help to reduce Malcolm’s risk of death from heart failure, improve his quality of life, delay disease progression, improve diabetic control and assist in helping him achieve his health goals. |
[cpd_submit_answer_button]
Cassie Potts (she/her) BPharm, GradCertChronCondMgt, FANZCAP (Cardiol), AdPhaM is a Senior Clinical Pharmacist with SA Pharmacy and has over 11 years of experience specialising in heart failure as part of the cardiology team at Flinders Medical Centre. She serves on the AdPha Cardiology Leadership Committee and currently practises within the intensive care unit at the Royal Adelaide Hospital.
Hana Numan (she/her) BPharm (NZ), PGDipClinPharm (NZ), MPS (NZ)
[post_title] => SGLT2 inhibitors in heart failure [post_excerpt] => Heart failure remains a significant health burden, but modern medicines, particularly SGLT2is, can offer significant benefits. Pharmacists play a pivotal role in optimising therapy, ensuring adherence, and providing education to patients. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => sglt2-inhibitors-in-heart-failure [to_ping] => [pinged] => [post_modified] => 2025-04-16 15:42:24 [post_modified_gmt] => 2025-04-16 05:42:24 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.australianpharmacist.com.au/?p=28725 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [title_attribute] => SGLT2 inhibitors in heart failure [title] => SGLT2 inhibitors in heart failure [href] => https://www.australianpharmacist.com.au/sglt2-inhibitors-in-heart-failure/ [module_atts:td_module:private] => Array ( ) [td_review:protected] => Array ( [td_post_template] => single_template_4 ) [is_review:protected] => [post_thumb_id:protected] => 29161 [authorType] => )td_module_mega_menu Object
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[post_content] => From 1 May, Spravato (esketamine) will be subsidised under the Pharmaceutical Benefits Scheme (PBS) for adults with treatment-resistant depression, intended for use alongside a newly initiated oral antidepressant.
Up to 30,000 Australians are anticipated to access esketamine via the PBS, paying only $7.70 per dose with a pensioner or concession card, or $31.60 per dose for general patients.
[caption id="attachment_29259" align="alignright" width="233"] Professor Malcolm Hopwood[/caption]
Australian Pharmacist spoke with Professor Malcolm Hopwood, Ramsay Health Care Professor of Psychiatry at the University of Melbourne, about the treatment process and how pharmacists will be involved.
How effective is esketamine in managing treatment resistant depression?
The largest clinical trials on esketamine efficacy found that about 50% of patients who had not responded to two or three antidepressants did respond to esketamine, Prof Hopwood said.
‘If you compare that to trialing one of the usual medicines, the response rate for the third or fourth [medicine] is probably only about 15%,’ he said. ‘So it’s quite a jump up in terms of response rate.’
Who is eligible to be prescribed esketamine nasal spray?
Those diagnosed with treatment-resistant depression, defined as major depressive disorder that has not responded sufficiently to at least two different antidepressants, each administered at an adequate dose and duration, for the treatment of the current moderate to severe depressive episode.
Who is not a good candidate for this treatment?
Esketamine is currently not indicated for bipolar depression. And caution should be taken for patients with psychotic depression, Prof Hopwood said.Â
‘[This is] because ketamine, when used in much higher doses, has psychogenic potential,’ Prof Hopwood said.
There is also a precautionary note in the product information around patients with marked hepatic or renal impairment.
‘In terms of drug-drug interactions, it should not be used together with an irreversible monoamine oxidase inhibitor, which these days is only Parnate,’ he said. ‘While not widely used now, it's an important interaction to be aware of.’
What’s the duration of therapy?
Esketamine is initially administered twice weekly for the first 4 weeks, Prof Hopwood said.
‘By the end of that 4-week period, we've usually got a sense whether you're a responder or not.’
Treatment usually stops in non-responders, with responders moving to a once-weekly treatment regimen.
‘Eventually, fortnightly treatment for a 6-month maintenance period is what we recommend,’ Prof Hopwood said.
Is re-treatment recommended?
Given that depression is a highly recurrent condition, it is likely some patients will relapse post treatment. And re-treatment with esketamine could prove beneficial, Prof Hopwood said.
‘There is some data about re-treatment … [with] evidence showing that responders do seem to have a good response rate the second time around,’ he said. ‘That will be permitted under this funding scheme.’
How is esketamine supplied?
Patients cannot be in possession of the spray until they are in the clinic for administration under supervision, Prof Hopwood said.Â
‘Esketamine needs to be administered in an approved treatment center that involves close supervision for side effects such as dissociation and hypertension,’ he said.Â
Appropriate pharmacist handling of a Schedule 8 medicine is also required.
‘In our facility, we are fortunate to have an on-site pharmacist who dispenses [the medicine] to a nurse, and then the patient self-administers,’ Prof Hopwood said.Â
‘But the patient neither brings the medicine to the clinic or takes it away. The intent … is to reduce the risk of diversion.’
Facilities that do not have an on-site pharmacist must establish and demonstrate a connection with a local community pharmacy to qualify as an approved treatment centre.
Is talk therapy involved in the session?
Treatment with esketamine does not involve psychotherapy. However, there is a small body of research currently looking at ketamine-facilitated psychotherapy, Prof Hopwood said.
‘We still don't know whether that offers additional benefit for many patients, [but] if esketamine proves an effective treatment for their depression, they may be able to utilise psychotherapy much more effectively – which they might not be able to do when severely depressed.’
What are the estimated costs of esketamine sessions?
The estimated cost is $300–$350 per treatment session, Prof Hopwood said.
In most clinics, the doctor will see the patient on treatment occasions, but less so as treatment becomes established.
‘If the doctor does visit before the treatment is administered, then they can claim through Medicare as per usual,’ he said. ‘But the nursing and pharmacy [costs] will not be covered.’
Are patients supposed to disassociate when they take esketamine?
Dissociation with treatment is frequent, albeit mild and transient for most patients, Prof Hopwood said.
‘For up to half an hour they [may] feel a little dreamy and not unpleasant,’ he said.Â
Some evidence suggests that mild dissociative effects may be required for the drug to be effective in the treatment of depression, although this is not definitive, Prof Hopwood said.
‘We monitor patients during that time and keep them safe,’ he said. ‘Most of them simply want to lie there and listen to music or just bliss out for a short period of time.’Â
While there is no reversal agent for esketamine, any periods of distress are typically short lived.
‘We've had a very small number of patients distressed, consistent with the trials,’ Prof Hopwood said. ‘And they've generally responded to quite simple reassurance.’
Patients’ blood pressure is also monitored ‘It's rarely severe enough that intervention is required, but there can be a transient increase, as we've known from the use of ketamine as an anaesthetic,’ he said.
Where should pharmacists refer interested patients?
GPs are an important resource for knowing where the available treatment centers are, Prof Hopwood said.Â
‘There is a list of those available, and I predict that number may increase over time now that esketamine is funded.’
There are high levels of patient interest in esketamine and psychedelics, Prof Hopwood said.
‘So it's important they receive accurate, quality information that includes realistic expectations about the likelihood of treatment response and what's involved,’ he said. ‘And pharmacists are very well placed to provide that kind of information.’
What is preferable: esketamine or psychedelics?
Since 1 July 2023, patients with treatment-resistant depression have legally been allowed to receive treatment with psilocybin and MDMA, under specific conditions. Â
There is a degree of overlap between the patient populations considered suitable for ketamine and psychedelic therapy, Prof Hopwood said.
‘Most of the current guidance, including from The Royal Australian and New Zealand College of Psychiatrists, would say that psychedelic therapy is still more at a research level,’ he said.Â
‘Whereas, esketamine, reflected in the funding, has reached a higher level of evidence at this point.Â
‘So I would certainly see it as coming before psychedelic therapy in any hierarchy.’
To find out more about the use of psilocybin for treatment-resistant depression, read Australian Pharmacist's CPD article on the therapeutic potential of psychedelics.
[post_title] => PBS-backed esketamine rolls out for depression with S8 controls
[post_excerpt] => Esketamine will soon be funded for treatment-resistant depression, requiring pharmacists to adhere to strict supply and handling conditions.
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[title_attribute] => PBS-backed esketamine rolls out for depression with S8 controls
[title] => PBS-backed esketamine rolls out for depression with S8 controls
[href] => https://www.australianpharmacist.com.au/pbs-backed-esketamine-rolls-out-for-depression-with-s8-controls/
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[post_content] => Aside from administering medicines by injection, Queensland-based community pharmacist Fiona Watson MPS loves tearing up a Latin dance floor.
Tell us about your pharmacy career.
I had a varied early career, moving to North Queensland for a year shortly after I graduated as well as locuming around Australia for a while.
This gave me a great introduction to community pharmacy and a lot of different experiences – both good and bad. When locuming, you develop a clear idea of the factors that contribute to a well-run pharmacy.
I then moved to the United Kingdom where I completed a Certificate in Clinical Pharmacy. You can tell how old I am because I was one of the last pharmacists able to register in the UK with only a month under supervision.
I was a ‘rotational resident pharmacist’, living on-site at the hospital. I covered renal, gastro, cardiology, oncology, aged care, palliative care and surgery wards.
We worked on call overnight, and could get called upon to help with all sorts of different situations – one of the most interesting being calculating the correct dose for the antidote to antifreeze.
More recently, I was very fortunate to be given the opportunity to go into partnership with my mum and sister, both pharmacists, as the managing partner at Redland Bay Wholelife Pharmacy and Healthfoods.
What medicines do you administer by injection?
About 10 years ago, I became a trained vaccinator administering thousands of vaccines during the COVID-19 pandemic.
When Queensland allowed pharmacists to expand the range of medicines they could administer, I completed the Medication Administration course, as I believe this is an essential skill for pharmacists to have.
So many new medications are injectable, and for some patients self-administration just isn’t an option. We were one of the first pharmacies in our area to offer long-acting injectable buprenorphine services, which can be a life-changing option for patients.
Tell us about your administering injections beyond vaccines.
The majority of pharmacists I work with at Redland Bay are trained vaccinators and have completed medicines administration courses. When we come across a new medication that requires administration by injection we collate the available information from the manufacturer and ensure everyone has read it. Many companies, such as Novartis with inclisiran (Leqvio), have reps who are happy to provide additional training.
Once you are comfortable with subcutaneous injections, it’s a matter of familiarising yourself with the different types of devices available. It seemed a logical step for us to provide this service. We have great consult room facilities and it brings variety to our role.
What role do you see pharmacists playing in cardiovascular care in future?
The sky is the limit. We’re on the cusp of a fundamental change in the way Australians receive health care and I hope to see pharmacists embrace the opportunities this will bring.
There’s a workforce crisis and an ageing population, so we need to become more efficient and accessible. If you think about how much the role of a nurse practitioner has changed in the last 10–15 years, you can see where pharmacists have even greater potential. A patient with a diagnosis of heart failure should be able to be titrated to optimum therapy by a pharmacist in a community pharmacy. A patient should have their HbA1c or lipids checked in the pharmacy, with appropriate therapy initiated or adjusted. We should also be actively involved in screening and chronic disease management.
Pharmacy is an incredibly rewarding and enjoyable career, and now is an especially exciting time to be a pharmacist. There is just so much opportunity.Â
Day in the life of Fiona Watson MPS, Community pharmacist at Redland Bay Wholelife Pharmacy, QLD.
| 5.00am |
Hit the gym I get up and do a HIIT or Muay Thai class most mornings for positive effects on my mental health. Passionate about preventative health care, I see the long-term effects of patients’ lifestyle choices every day. |
| 8.00am |
Open the pharmacy Every day is different. At least two pharmacists are rostered on, ensuring we give each patient the time they need while providing a wide range of different services. |
| 9.00am |
Vaccination service Embarking on a cruise in 2 months, a couple in their 60s asks about COVID-19 vaccines. More than 12 months since their last vaccine they are happy to be vaccinated on the spot. Not wanting more than one vaccine at a time, we book them in for a follow-up appointment in a month for the shingles vaccination. |
| 10.00am |
Collaborative care A local GP phones about a recently discharged mutual patient who’s not coping well on his new medicines. We spend some time with the patient doing a medicine review and setting up his profile for a dose administration aid. |
| 1.00pm |
Lunchtime It’s important that all staff, especially pharmacists, prioritise their breaks. We all need a little downtime to reset and refresh. |
| 1.30pm |
Medicines injection A regular patient comes in for her second dose of inclisiran (Leqvio) after I administered her first 3 months ago. She is happy with the more convenient option than visiting her GP. |
| 3.00pm |
Infection control In a call from our pharmacy car park, we learn a patient has tested positive for COVID-19 and has an e-script. We dispense and counsel over the phone and then deliver out to their car (with appropriate precautions). |
| 6.30pm |
OCP continuance A stressed young woman, with a 2-week wait for a GP appointment, has run out of her pill. She is relieved when seen by a colleague who prescribes Estelle under the Queensland Hormonal Contraceptive Pilot. I dispense it. |
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[post_content] => Vaccination coverage in older Australians remains alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
Older Australians are highly susceptible to serious complications from influenza and COVID-19. But the vaccination rates in patients aged 75 and over are nowhere where they need to be to protect this vulnerable patient cohort from harm, including hospitalisations and death.
The national influenza vaccination rate of patients aged 65 and over currently sits at 7.2%. And in the last 12 months, only 37.7% of Australians aged 75 and over received a COVID-19 vaccination.
But boosting immunisation rates in older Australians is more important than ever. The influenza season started earlier and stronger than usual, with 60,594 cases of influenza reported this year.
As of 10 April, there were also 70 active outbreaks of COVID-19 in residential aged care facilities (RACFs). Last year, case numbers were highest among those most at risk, with notifications peaking in the 75–79, 80–84 and 85+ (12,607).
With GPs not always available to address vaccination gaps in aged care, pharmacists are well positioned to step in and provide this essential service.
In the video above, community pharmacist Lachlan Rose MPS outlines the benefits of providing offsite vaccinations in aged care settings, including financial incentives, workplace variety and the protection of one of the most vulnerable populations.
[post_title] => All pharmacists should consider off-site vaccinations in aged care
[post_excerpt] => Vaccination rates in older Australians are alarmingly low. Off-site services provided by pharmacists are key to closing the gap in aged care.
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[title_attribute] => All pharmacists should consider off-site vaccinations in aged care
[title] => All pharmacists should consider off-site vaccinations in aged care
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[post_content] => The Fair Work Commission’s Expert Panel for pay equity in the care and community sector has today issued its initial decision on the Gender-based undervaluation – priority awards review – making determinations on the Pharmacy Industry Award 2020, which most community pharmacists are employed under.Â
What did the Expert Panel find?Â
The Expert Panel found that pharmacists covered by the Pharmacy Industry Award 2020 (and several other awards) have been the subject of gender-based undervaluation. Â
As a result, the Expert Panel has determined that findings constitute work value reasons, justifying variation of the modern award minimum wage rates across all categories of pharmacists. Â
What is ‘gender-based undervaluation’?Â
Gender-based undervaluation considers a range of factors to determine whether minimum award pay rates are undervalued because of assumptions based on gender.Â
The range of factors considered extends to historical undervaluing, exercise of ‘invisible skills’, exercise of caring work and workforce qualifications, among others. Â
How does the Expert Panel intend to address the undervaluation?Â
For pharmacists employed by the Pharmacy Industry Award 2020, the Expert Panel has issued a determination that there will be a total increase in the minimum wage rates of 14.1% over three years.Â
This increase will be implemented in three equal phases on:Â
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[post_content] => Case scenario
Malcolm (68 years old, male) visits your pharmacy with a new prescription for sacubitril/valsartan. He mentions he has recently been diagnosed with heart failure with reduced ejection fraction (HFrEF). You review his records and confirm he is still taking metformin/sitagliptin for type 2 diabetes. Malcolm explains that he has taken this for many years, and that his general practitioner has advised him that his blood glucose control needs to be better. He expresses frustration that the shortness of breath from his heart failure limits his ability to exercise and improve his diabetes. Malcolm hopes that starting this new medicine will improve this.
After reading this article, pharmacists should be able to:
|
Already read the CPD in the journal? Scroll to the bottom to SUBMIT ANSWERS.
Heart failure is a clinical syndrome caused by the inability of the heart muscle to provide adequate cardiac output and/or the presence of increased cardiac pressure. This is due to either a structural or functional abnormality of the heart.1 The clinical syndrome consists of symptoms such as breathlessness and fatigue and may be accompanied by signs of fluid accumulation such as peripheral oedema, elevated jugular venous pressure and pulmonary crackles.1
In many cases, heart failure may be both preventable and treatable. Choice of treatment depends on the type of heart failure present, with management being primarily pharmacological.1
Pharmacists play an essential role in optimising pharmacotherapy for heart failure patients, providing recommendations on safe and effective dose titration and appropriate pharmacological management, as well as providing education, counselling and support for adherence.2
Heart failure remains a global public health issue that affects at least 38Â million people worldwide.2 It is a major cause of hospitalisation in Australia and is associated with significant healthcare costs.3
Heart failure has a poor prognosis and results in markedly reduced quality of life.1 Readmission to hospital is extremely common, with about 1 in 3 patients being readmitted in the first month, and up to 15% of patients dying within the first 6 months, after being discharged from hospital.4 By 12 months post-discharge, approximately 25% of heart failure patients will have died.5
Concerningly, due to population aging and increasing prevalence of comorbidities, heart failure hospitalisations could increase by as much as 50% in the next 25Â years.1
Categorisation of heart failureHeart failure is categorised according to the measurement of the left ventricular ejection fraction (LVEF). Knowing the LVEF at time of diagnosis is crucial, as this guides treatment.1 Heart failure is categorised as either1,6,7:
HFrEF
For HFrEF, there are effective pharmacological therapies, supported by robust, high-quality evidence. These include what has now become known as ‘the four pillars’, and these collectively make up guideline-directed medical therapy for HFrEF. These include9–11:
All patients with HFrEF should be prescribed all four agents (unless contraindicated or not tolerated), with early initiation being associated with the best outcomes.1,9,10 Other therapies are available as HFrEF progresses, however the ‘four pillars’ are the cornerstone of HFrEF treatment.10
HFmrEF
There is limited evidence to support specific recommendations for the pharmacological management of HFmrEF.1 Some studies suggest that patients with HFmrEF may receive similar benefit from a beta blocker, a mineralocorticoid receptor antagonist and a renin angiotensin system inhibitor as in HFrEF, and SGLT2is have been shown to reduce the risk of cardiovascular death and hospitalisation for heart failure.14 The medicines used to treat HFrEF are often used to treat HFmrEF, however the confidence in prognostic benefits is much less.1,14
HFpEF
For the treatment of HFpEF, no medicines have demonstrated a statistically significant benefit on mortality.1 Recommended treatment consists of15:
The use of an SGLT2i in HFpEF has not been shown to improve mortality to the same extent as for HFrEF. However, an SGLT2i is still recommended because major trials have shown they can still offer some benefits.16,17
The EMPEROR-Preserved trial demonstrated a 21% lower relative risk in the composite of cardiovascular death or hospitalisation for heart failure with the use of empagliflozin in the treatment of HFpEF compared with placebo – a result driven primarily by a reduction in risk of hospitalisation rather than mortality.16 Importantly, this benefit was seen regardless of the diabetic status of the patient.16 This benefit was later reinforced by the DELIVER trial which showed a lower risk of its composite primary outcome of worsening heart failure or cardiovascular death with dapagliflozin use, compared to placebo for those with HFmrEF and HFpEF.18 As a result, SGLT2is have received a strong recommendation for the management of HFpEF in treatment guidelines.1
Additionally, mineralocorticoid receptor antagonists are used in clinical practice because they have been associated with a reduction in risk of hospitalisation for HFpEF patients, as demonstrated by the TOPCAT trial.19
A focus on SGLT2isInitially developed as a medicine used for type 2 diabetes, SGLT2is have become a crucial cardiovascular drug class, as demonstrated above by their role in the management of heart failure, and now have renal and cardiovascular indications irrespective of type 2 diabetic status. This is largely due to results of cardiovascular outcome trials mandated by the United States Food and Drug Administration (FDA) in 2008. These trials led to findings that have significantly changed clinical practice.20 They arose from concerns of cardiovascular risks with certain medicines used for type 2 diabetes, evidence suggesting rosiglitazone may increase the risk of myocardial infarction, and in recognition of the high prevalence of cardiovascular disease in these patients.20
SGLT2is lower blood glucose by inhibiting SGLT2 transporters in the proximal tubules of the kidneys to decrease glucose reabsorption, which increases the excretion of glucose in the urine.21 Sodium excretion also occurs because the SGLT2 receptor is close to, and works together with, a sodium/hydrogen exchanger, which is a major receptor responsible for sodium reuptake.22
Although SGLT2is lower blood glucose, blood pressure and contribute to diuresis, their benefits in terms of renal and cardiovascular outcomes cannot be solely attributed to these properties, as similar clinical benefits are not seen with other agents that lower glucose, blood pressure or increase natriuresis to similar or greater extent.23,24 The mechanism of action linked to these benefits is complex, and appears to also be a combination of anti-inflammatory and anti-fibrotic effects, a reduction in epicardial fat and a reduction in hyperinsulinaemia.21
Additional evidence also suggests a reduction in oxidative stress, less coronary microvascular injury and improved contractile performance.23 Emerging clinical evidence may also suggest antiarrhythmic properties, which is particularly important given that ventricular arrhythmias and sudden cardiac death is a major cause of death in heart failure patients.21 Some trials have demonstrated a decrease in sudden cardiac death for patients using a SGLT2i.21
The EMPA-REG OUTCOME trial in 2015 was a landmark study, demonstrating that empagliflozin significantly reduced cardiovascular death among high-risk patients with type 2 diabetes, compared to placebo.25 Importantly, it also suggested renal benefits, with less cases of acute renal failure in the empagliflozin group.25 These findings were later confirmed by the EMPA-Kidney (empagliflozin) and DAPA-CKD (dapagliflozin) trials, which both showed reduced rates of death due to renal disease, slower decline in renal function and delayed time to needing dialysis.26–28
The cardiovascular benefits of these medicines went on to be confirmed in further trials including the DAPA-HF (2019), EMPEROR Reduced (2020), EMPEROR Preserved (2021) and DELIVER (2022) trials.16,18,29,30
Key practice points
Knowledge to practice The use of heart failure guideline-directed medical therapy in HFrEF can have a significant impact on patient outcomes. The combination of the ‘four pillars’ (a heart failure beta blocker, an mineralocorticoid receptor antagonist, a renin angiotensin system inhibitor and an SGLT2i) has the ability to improve life expectancy, delay disease progression, decrease heart failure symptoms and improve quality of life.9,10 All patients with HFrEF should be prescribed all four agents unless a contraindication or intolerance exists preventing their use.32Â
In HFpEF, there are currently no medicines that demonstrate a statistically significant benefit on mortality. However, the use of SGLT2is has been shown to reduce risk of hospitalisation (regardless of diabetic status) and are recommended to be used by guidelines as part of its management, and in the managment of HFmrEF.1,9,14
Heart failure remains a significant health burden, but modern medicines, particularly SGLT2is, can offer significant benefits. Pharmacists play a pivotal role in optimising therapy, ensuring adherence, and providing education to patients. By leveraging their expertise as medication experts, pharmacists can profoundly impact outcomes, improving survival and quality of life for individuals living with heart failure and associated comorbidities.
Case scenario continuedRecognising the benefits of an SGLT2i for both Malcolm’s heart failure and diabetes, you discuss the option of adding an SGLT2i to his regimen, and the potential benefits and risks. Malcolm explains that his main priority is to get his heart failure symptoms under control so that he can play with his grandchildren and exercise comfortably. At Malcolm’s request, you contact his GP, and it is agreed to commence empagliflozin 10 mg daily (after ensuring his eGFR is appropriate). This intervention may help to reduce Malcolm’s risk of death from heart failure, improve his quality of life, delay disease progression, improve diabetic control and assist in helping him achieve his health goals. |
[cpd_submit_answer_button]
Cassie Potts (she/her) BPharm, GradCertChronCondMgt, FANZCAP (Cardiol), AdPhaM is a Senior Clinical Pharmacist with SA Pharmacy and has over 11 years of experience specialising in heart failure as part of the cardiology team at Flinders Medical Centre. She serves on the AdPha Cardiology Leadership Committee and currently practises within the intensive care unit at the Royal Adelaide Hospital.
Hana Numan (she/her) BPharm (NZ), PGDipClinPharm (NZ), MPS (NZ)
[post_title] => SGLT2 inhibitors in heart failure [post_excerpt] => Heart failure remains a significant health burden, but modern medicines, particularly SGLT2is, can offer significant benefits. Pharmacists play a pivotal role in optimising therapy, ensuring adherence, and providing education to patients. [post_status] => publish [comment_status] => open [ping_status] => open [post_password] => [post_name] => sglt2-inhibitors-in-heart-failure [to_ping] => [pinged] => [post_modified] => 2025-04-16 15:42:24 [post_modified_gmt] => 2025-04-16 05:42:24 [post_content_filtered] => [post_parent] => 0 [guid] => https://www.australianpharmacist.com.au/?p=28725 [menu_order] => 0 [post_type] => post [post_mime_type] => [comment_count] => 0 [filter] => raw ) [title_attribute] => SGLT2 inhibitors in heart failure [title] => SGLT2 inhibitors in heart failure [href] => https://www.australianpharmacist.com.au/sglt2-inhibitors-in-heart-failure/ [module_atts:td_module:private] => Array ( ) [td_review:protected] => Array ( [td_post_template] => single_template_4 ) [is_review:protected] => [post_thumb_id:protected] => 29161 [authorType] => ) Get your weekly dose of the news and research you need to help advance your practice.
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Australian Pharmacist is the official journal for Pharmaceutical Society of Australia Ltd.
