Epic Pharmacy Circuit Clinical Newsletter Edition 2, 2021

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2021 Edition 2

clinical initiatives, research and current updates in treatment

Burnout and Patient Safety Smita Dey-Chatterjee, Epic Pharmacy Murdoch Our healthcare system is continuously being bombarded with growing pressures – from an increasing and aging population, the burden of chronic diseases, funding cuts, and global crises such as COVID-19. In face of these major challenges, burnout in the healthcare industry has garnered national and international attention.

So, what is burnout syndrome? Work-related burnout refers to emotional, mental, and physical exhaustion, and results from prolonged workplace stress. It results in a sense of

cynicism and detachment from the job, decreased satisfaction, and a reduced sense of accomplishment.¹ One way researchers check for burnout is by using the Maslach Burnout Inventory (MBI) which looks for symptoms seen in Table 1.

What causes burnout and why does it matter? The cause is both multifactorial and complex. [See Figure 1]. The continuous giving of self to others and repeated exposure of others’ suffering in a high-stress and under-resourced

environment are among the most common reasons healthcare staff are prone to burnout.³ It has been linked to increased absenteeism, job turnover and various illnesses such as cardiovascular disease and depression.⁴ Medication errors, failure to recognise lifethreatening signs and symptoms, and hospital-acquired infections have also been linked to poor staff wellbeing and burnout.3,5,6 Studies have found rates of burnout in doctors to vary between 41% and 76% and in nurses to vary between 20 - 40%.7,8

Table 1. Characteristics of burnout²

Exhaustion

Depersonalisation

Inefficacy

Wearing out

Cynicism

Reduced personal accomplishment

Loss of energy

Negative or inappropriate attitudes toward job, patients, coworkers

Reduced productivity/capability

Depletion

Indifference

Low morale

Debilitation

Irritability

Inability to cope

Fatigue

Loss of idealism

Tendency to negatively evaluate one’s work

Can be emotional or physical

Withdrawal

Feeling insufficient to perform one’s job

Inability to express empathy or grief Detachment

Medication safety Medications are one of the most common healthcare interventions and are associated with a high incidence of errors and adverse events. A literature review conducted in Australia found medication incidents to be the second most frequently reported incident in acute care.⁹ The Australian Commission on Safety and Quality in Health Care states that “up to 50% of medication errors are potentially avoidable”.¹⁰

Healthcare professionals prescribing, supplying and administration of medicine whilst fatigued can lead to adverse events that are preventable. A recent study found up to 48% of physicians experiencing emotional burnout self-reported medical errors which included ordering the wrong medication.¹¹ Nurses reported that up to 75% of their medication administration errors have been due to fatigue, exhaustion and burnout.¹² Medication

administration errors included incorrect preparation, inadequate monitoring of effects, overlooking allergies, giving the wrong medication or dose, and administering medications via the wrong route or at the wrong time.¹³ Indeed, burnout in staff significantly increases the risk of medication errors with a clear way forward in reducing these incidents being the implementation of strategies aimed at reducing burnout.2,3,14 Continued on page 2


What can we do to manage burnout?

Figure 1. Drivers of burnout²

Addressing burnout and promoting wellness needs to be proactively managed at an individual and organisational level. Strong organisational support with innovative work culture has been associated with lower burnout scores.15 Implementing strategies such as encouraging true collaboration between healthcare professionals and empowering employee decision-making is a great start. Other individual interventions include:2,16 •

Recognising the warning signs. Awareness of early warning signs (feeling burdened, exasperated, stressed or irritable) for yourself and your colleagues is important. We know that a little bit of stress at work can motivate functional behaviour but too much stress can lead to burnout. If you notice these signs weekly or more, it is time to contact your Employee Assist Program (EAP). Do not postpone talking to someone and asking for help.

Speaking to your supervisor and evaluating your options. Discuss professional goals, realistic job expectations and ways to reduce workflow interruptions. Having a mentor and knowing where to seek professional guidance is also valuable.

Cultivating positive relationships. Positive interactions with supervisors and co-workers has been shown to reduce depersonalisation and increase feelings of personal accomplishment. Connecting with fellow colleagues in ways that are not linked to your clinical duties has also shown to improve wellbeing.

Actively thinking about your worklife balance. This has been linked to a greater sense of job satisfaction, and reduced absenteeism. Aim to do more of what you love when you are not at work.

Exercising and improving quality of sleep. Stress not only affects us mentally but also physically. Exercise and good quality sleep improves executive decision-making and resilience.

Practicing mindful selfcompassion. Fostering a non-

judgemental attitude towards yourself can help reduce stress and restore hope. Some ways this can be achieved are through mindful journaling, yoga, and spiritual practices such as prayers and meditation. The implementation of these strategies will not only reduce burnout and improve staff wellbeing but in doing so, also improve patient safety.

References are available on request.

Biosimilars Rachel Taylor, Epic Pharmacy Port Macquarie Recently, Mabthera® (rituximab) and Avastin® (bevacizumab), two familiar brands of monoclonal antibody medications, have been removed from the Pharmaceutical Benefits Scheme (PBS) in Australia by their manufacturer. These medicines have subsequently been replaced with biosimilar medicines. This change gives rise to the questions: What is a biosimilar? Is it the same as a generic medicine? And are they still effective and safe to use in our patients?

1. What is a biosimilar? Biosimilar medicines are highly similar in terms of quality, safety and efficacy to the reference biological medicine. The reference biological medicine is the first

brand to market. Biosimilar medicines can be used to treat the same disease, in the same way, as the reference biological medicine.¹

A generic medicine has exactly the same active ingredients as the original medicine. A biosimilar medicine is highly similar to the original biological medicine.¹

atorvastatin, has a molecular mass of 558 g/mol or daltons.² Atorvastatin has a defined chemical structure, and it can be duplicated as exact copies in a laboratory. By comparison, rituximab is a monoclonal antibody, with a molecular mass of 145,000 daltons.³ Nearly 300 times the size of the atorvastatin. It is a complex molecule made of two heavy chains of 451 amino acids and two light chains of 213 amino acids.³ (See Figure 1)

There are several reasons why a biosimilar is not identical to the originator molecule. One reason is the molecular size and complexity of biological medicines. For example, a large oral drug molecule, such as

In addition, monoclonal antibodies and other biological molecules are grown by a particular line of cells. They aren’t created in a test tube using basic chemical ingredients, they’re actually produced by a biological system.

2. Is a biosimilar the same as a generic medicine?


Therefore, the size of biosimilars and the extraordinary complexity of their manufacturing process is something that sets them well apart from generic drug molecules.⁴ Due to the manufacturing process used to produce monoclonal antibodies, it is noteworthy that there are already minor differences between batches of the same reference biological molecule. The inherent variability of the process and the cell lines means that the resulting products are also variable to each other. No two batches of a biological medicine (even from the same manufacturer) are ever exactly the same. (See Figure 2)

3. Are biosimilars safe and effective? The Therapeutic Goods Administration (TGA) is a regulatory system that governs medicines use in Australia. As with all medicines in Australia, before a medicine is registered and allowed for use within the Australian market, a biosimilar medicine must undergo rigorous testing and evaluation by the TGA to assess that it is safe and efficacious for use1, 4. The company that manufactures the biosimilar product must provide very specific test results for the molecule, and for each subsequent batch of the molecule, for it to be acceptable for use in the Australian population¹. This is demonstrated through laboratory, animal and human studies. (See Figure 3)

Figure 1. Comparison of drug molecular mass

Source: https://www.sciencedirect.com/science/article/pii/S1359634913700016

Figure 2. Steps in the production of biological and biosimilar medicines

Source: Based on IAPO (2013). Briefing paper on biological and biosimilar medicines. International Alliance of Patients’ Organizations, London. From https://www1.health.gov.au/internet/main/ publishing.nsf/Content/biosimilar-hp-what-are-biosimilar-medicines# accessed 30/6/2021

are reimbursed the same amount on the PBS. As the cost to develop, test and license biosimilars is less, this price sets the benchmark for all other brands. This presents significant cost savings to the PBS.⁵

Figure 3. How are they regulated?

Some takeaway points: Biosimilar medicines are highly similar versions of a reference biological medication. Source: Australian Government Department of Health. How are biosimilar medicines regulated and monitored? March 2017. https://www1.health.gov.au/internet/main/publishing.nsf/Content/ biosimilar-how-are-biosimilar-medicines-assessed-and-monitored

Why biosimilars? One of the reasons that use of generic and biosimilar medicines are encouraged in Australia is that there is a cost saving for the PBS from use of such drugs. All drugs start with an originator molecule that receives a certain amount of time under patent i.e. the pharmaceutical company that develops the drug, and holds the patent, is the only one allowed to manufacture and market the drug and, ultimately, profit from it for a certain amount of time. This incentivises new drug discovery for pharmaceutical companies, as they are

required to invest considerable time and expense into the development, testing and marketing of a new medicine in order for it to reach the market. Once the patent on the item has expired, generic and biosimilar medicines can be freely developed, which encourages market competition, usually driving the price down. When a biosimilar is first listed on the PBS, the originator product is subject to a mandatory price reduction of 25% (i.e. what the government will pay for the drug). Further price reductions may apply as the government pays the same price for all brands of the same medicine i.e. the original biological medicine and its biosimilars

Biosimilar medicines are not identical to the reference biological medication, and no two batches of a biological medication are ever exactly the same. Drugs such as insulin, monoclonal antibodies for use in treating rheumatoid arthritis and cancer, and hormones are all available on the PBS as biosimilar agents. Any minor differences between biosimilar medicines and the reference biological medication have been assessed and the safety, effectiveness and quality are assured. They are considered to be therapeutically equivalent.

References are available on request.


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What’s New New in Osteoporosis Justine Forbes – Hollywood Private Hospital Romosozumab (marketed as Evenity by AMGEN), is a new monoclonal antibody that has recently been listed by the PBS for severe osteoporosis. Initially marketed for postmenopausal women, the PBS has listed it for use in both men and women, in those who have a BMD T-score below -3.0, have had 2 or more fractures due to minimal trauma, and who have recently had a new fracture despite being on another antiresorptive agent for the last 12 months.1,2 Romosozumab binds to and inhibits sclerostin – a protein found in osteocytes. By inhibiting sclerostin activity, romosozumab both increases bone formation and decreases bone resorption.

The most common side effects reported with romosozumab include headaches and arthralgia. Hypocalcaemia can occur if calcium and vitamin D replacement therapy are not provided, especially in the case of renal impairment.5 Uncommon side effects include osteonecrosis of the jaw and atypical femoral fractures. In rare cases, romosozumab may increase the risk of myocardial infarction and stroke. Patients should be assessed for cardiovascular risk and considered whether benefit of treatment outweighs the risk before treatment is initiated. If stroke or MI occurs during therapy, romosozumab should be discontinued.5,6 References are available on request.

Similar drugs on the market (denosumab, bisphosphonates) decrease bone resorption only. Significant anti-fracture benefit has been demonstrated in clinical trials, with faster improvements in T-scores over denosumab alone.³ The drug is administered, by subcutaneous injection (210mg) each month for a total of 12 months. Calcium and vitamin D levels should be checked and maintained during treatment. It is recommended that denosumab be started for ongoing prevention of fractures after the one year course of romosozumab has been completed as it was found to be clinically beneficial to rebuild the bones before transitioning to an anti-resorptive alone.3,4

If you have any queries regarding Circuit content and authors please contact the Epic Pharmacy Practice Unit by email: circuit.editor@epicpharmacy.com.au Every effort has been made to ensure this newsletter is free from error or omission.

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