Arthritis, asthma, back pain, cancer, cardiovascular disease, chronic obstructive pulmonary disease, diabetes and mental health conditions are the eight most common chronic conditions affecting Australians. In 2018, half of Australians are estimated to have at least one of these eight conditions (1). Chronic conditions account for 61% of Australia’s total disease burden and 37% of hospitalisations (1). These conditions are long lasting, cause persistent negative effects on people’s quality of life and require ongoing care from multiple healthcare professionals (HCPs). Here we will look at how the role of pharmacists is expanding to involve more patient centric activities aimed at easing the burden of chronic disease management.

Pharmacists are highly skilled yet often underutilised in the primary health care sector (2). Recognising this untapped potential, many countries including Australia have started to equip community pharmacists with additional patient-centred responsibilities (3). In recent years Australian pharmacies began to offer a broader range of services to the public including smoking cessation and weight management programs, as well as administering flu vaccines. There is now growing support to further extend the role of pharmacists in primary care. Community pharmacists with relevant experience and training could potentially provide a range of services to support treatment of chronic conditions including medication review, monitoring medication related side effects, managing adverse drug reactions and provision of additional patient counselling for people taking new medicines or with special needs (4).

A Successful Collaborative Healthcare Model

Countries with comparable healthcare systems to that of Australia such as the United Kingdom have made substantial steps to enhance community pharmacy services and pharmacists’ roles in primary care. For example, in 2015, England’s National Health Service launched a scheme placing clinical pharmacists in general practice (5). This scheme was developed to support GPs struggling to cope with unprecedented workloads causing some patients to wait weeks for appointments (5). Services provided by clinical practice-based pharmacists as part of this scheme include face-to-face review of all medicines, review of medicines over the phone, responding to questions about prescribed medicines and to have the supply of a repeat prescription reauthorised. The scheme has successfully demonstrated that collaboration between general practitioners and pharmacists can improve patient care resulting in it being extended to cover 40% of GP surgeries across England (6).

Canada is another country where pharmacists’ scope of practice has been significantly expanded over the past 12 years demonstrating that system change is possible (7). Canada has made significant inroads to introducing a range of new pharmacy services which allow pharmacists to provide more effective care to consumers. For example, pharmacists in all but two provinces can now renew or extend prescriptions. Additionally, Canadian pharmacists in some provinces can now make therapeutic substitutions, order and interpret lab tests, administer drugs by injection, change drug dosage and prescribe for minor ailments (7).

Evolving Primary Care Model for Australia

In 2016, the Australian government introduced the Pharmacy Trial Program, which focused in three areas: improved medication management for Aboriginal and Torres Strait Islanders through pharmacist advice and culturally appropriate services; pharmacy based screening and referral for diabetes; and improved continuity in the management of patients’ medications when they are discharged from hospital (8). The Victorian government has also implemented an ongoing 18-month pilot scheme to integrate pharmacists into four general practice teams allowing them to renew prescriptions and make dose adjustments to medication (9).

Another pilot initiative by the Capital Health Network in the Australian Capital Territory involved placement of part-time, non-dispensing pharmacists in three general practices for six months (10). This study aimed to describe the variety of activities undertaken by pharmacists. It was found the pharmacists’ activities related to quality of practice, administration, medication review and patient education. Importantly, these pilot schemes along with further large randomised controlled trials are required to collect clinical outcomes and determine which activities conducted by pharmacists are most beneficial, cost-effective and welcomed by GPs and patients (10). Collecting this data will add to the body of evidence to prove the value of expanding the role of pharmacists in primary care.

In Australia efforts are in place to ensure that by 2023 pharmacists’ roles are optimised, they are practicing to full scope and are more highly valued in the healthcare system (7).

CRC has the expertise to manage Medical Affairs projects involving the pharmacy channel, particularly where it represents a major role in client commercialisation plans.

References:

1. Australian Institute of Health and Welfare. 2018. Australia’s Health in Brief.
2. Freeman C. et al. Integrating a pharmacist into the general practice environment: opinions of pharmacist’s, general practitioner’s, health care consumer’s and practice managers. BMC Health Service Research.
3. Mossialos E. et al. From “Retailers” To Health Care Providers: Transforming The Role Of Community Pharmacists In Chronic Disease Management. Health Policy.
4. Paola S. 2017. SHPA calls for prescribing pilot, role in CPA negotiations. Australian Journal of Pharmacy. Available at: https://bit.ly/2CVGOQH
5. Barnes E. et al. 2017. New role for clinical pharmacists in general practice. Medicines Optimisation.
6. NHS England. 2018. More clinical pharmacists set to boost GP services for patients and practices. https://bit.ly/2DFcKW7
7. Pharmacists in 2023: A discussion paper. 2018. Pharmaceutical Society of Australia. Available at: https://bit.ly/2NM79F8
8. The Department of Health. Pharmacy Trial Program. 2017. Available at: https://bit.ly/2eHQFwp
9. Paola S. 2017. Can pharmacists manage chronic disease? Available at: https://bit.ly/2jdsnw5
10. Deeks L. S. 2018. What can pharmacists do in general practice? A pilot trial. Available at: https://bit.ly/2D4dEij

CRC Australia and FarmaForce were proud to host the 2^nd annual ‘Biopharma Women of Influence Luncheon’ in the beautiful surrounds of the QVB Tea Room in Sydney on Thursday 30^th August.

The event, hosted by CRC’s General Manager Jimena Hurtado, provided an opportunity for senior female pharmaceutical and medical device industry executives to network with their peers and share their knowledge and experience.

The event featured guest speaker Dr Libby Weaver, an internationally acclaimed nutritionist, biochemist and wellbeing expert, as well as The iQ Group Global’s Organisational Performance Coach, Kellie Rigg, who shared some top tips for enhancing performance.

Libby’s message felt particularly appropriate for the busy professionals present whom she encourages to take time to focus on health, wellness and practicing self-care.

CRC Australia and FarmaForce would like to thank everyone who attended and contributed to making the event a success.

Photos from the event are below.

Over three days from 21st – 23rd of August, ARCS Australia hosted their annual conference at Sydney’s Randwick Race Course. The event brought together expert speakers from across regulatory, clinical research and medical affairs to discuss a broad range of topics currently impacting the healthcare industry. Clinical Research Corporation (CRC) was a proud sponsor of the event and enjoyed the opportunity to network and engage in discussion about industry hot topics and emerging healthcare challenges.

Day One

The conference began with concurrent keynote sessions titled ‘The Australian and international regulatory affairs landscape’ and ‘Public policy and its role in the timely access to emerging medicines and medical technologies’. CRC opted to attend the latter where speakers discussed whether current policy and legal frameworks for reimbursement are appropriate to manage public access to emerging innovative treatments.

A key conclusion from this discussion was that early planning and communication among all parties including government, industry, regulators, payers, health care providers and patients is essential to achieve timely access to emerging innovative therapies.

The conference consisted of concurrent sessions, which on day one included a series about ‘What Australian-based life science companies need to know about commercialisation’. Industry experts provided insights on developing commercial strategy based on a thorough understanding of product positioning, clinical program development, regulatory strategy as well as pricing, reimbursement and market access.

As part of this session, CRC’s Head of Medical Affairs, Athena Kolivos presented on ‘The science, politics and art of drug reimbursement in Australia’. The presentation started with the evolution of reimbursement from product to patient focus. It also described demonstrating cost effectiveness as the ‘4th hurdle’ and emphasised the importance of implementing market access strategy early, years ahead of a reimbursement submission aligned with clinical and regulatory strategies. Highlighted were various challenges in demonstrating therapy value followed by insights on how to proactively address these with solid evidence, effective stakeholder relationships and related communications to maximise the probability of reimbursement success.

Day Two

The opening session focused on digital health strategy and how best to organise healthcare and life sciences data to make it accessible, secure and useful for patient care. Speakers emphasised the importance of providing tools and digital infrastructure to convert raw healthcare data to medical insights that are usable for healthcare providers (HCPs) and patients.

The day continued with a series of sessions focused on the changes and challenges associated with precision medicines. Experts in the clinical application of these innovative therapies provided insights into the benefits of early or more accurate diagnosis and treatment with targeted medications and gene therapies. A multidisciplinary panel discussed the challenges for clinical research, regulatory affairs and reimbursement strategies for the introduction of companion diagnostics and precision medicines to the Australian healthcare system.

Day Three

During the final day, topics for discussion included patient engagement in clinical trials, improving pharmacovigilance standards and the evolving role of medical affairs. CRC provides tailored, strategic medical affairs solutions for our clients in the pharmaceutical and medical device industries so naturally we focused our attention on relevant sessions starting with ‘Launch excellence: unlocking the strategic value of medical affairs’.

With the introduction of increasingly innovative therapies, the medical affairs function has evolved to include activities that are critical to driving strategy from pre-launch to beyond commercialisation of a new therapy. Another related topic of discussion was the increasing demand for medical science liaisons (MSLs), the growing importance of their role and how to measure MSL related outcomes. The demand for MSLs is driven in part by the evolving needs of HCPs who require access to scientific and technical expertise for increasingly complex medications to facilitate and support confident prescribing decisions.

CRC’s mission is to develop and implement strategic medical affairs solutions to maximise our client’s competitive advantage throughout the entire drug development life cycle.

Creating healthcare products to truly help improve the lives of patients should start with an understanding of their needs and the challenges they face in daily life (1). Now more than ever people have access to vast amounts of health related information due in part to advancing technology giving rise to increasingly health literate patients who are empowered to influence health care decisions (2). For their part, healthcare industry stakeholders are now recognising the benefits of involving patients throughout the product development lifecycle (2).

For example, the FDA recently launched the Patient Focused Drug Development Initiative to gain patient perspectives for more effectively informing evaluation of the risk: benefit profile of new therapies (1). While healthcare companies have traditionally involved patients mostly during postlaunch activities such as disease awareness campaigns, development of education resources and patient support programs, some companies are now engaging patients as early as the research selection phase and throughout clinical trial development, regulatory approval, reimbursement and treatment decisions (2).

There are many ways in which patients can ‘get behind their disease’ to influence improved access to quality and affordable care. Here we discuss two examples where the actions of patients and patient advocates have effectively influenced positive healthcare system changes.

Health care professionals advocating for patients

Patient advocates often have professional experience in the health industry such as in nursing and may use their knowledge of a specific disease area to help patients understand the potential benefits of various treatment options, support services and other aspects of healthcare. In this example, a team of diabetes nurse educators helped patients from Aboriginal and Torres Strait Islander communities living with type 2 diabetes to take charge of their condition (3).

A program run by the nurse educators provided patients access to continuous glucose monitoring (CGM) devices, allowing them to track the effects of food, exercise and medications on their glucose levels. As a result, patients who used CGM could access detailed graphs of their glucose levels allowing them to learn how certain foods and behaviours influenced changes in their levels throughout the day. Using CGM empowered patients to learn how to bring their glucose levels under control. The nurse educators observed many benefits among patients using CGM and have gone on to advocate for extending the program to younger patients and those with gestational diabetes (3).

Patients influencing access to therapy

Patients with rare cancers may have limited treatment options or struggle to access adequate treatment and support, which can negatively impact patient outcomes. In some cases where treatments are available, they may not be funded by payers, meaning patients need to find a way to self-fund expensive treatment or risk dying earlier from their disease. In this example one patient with a rare form of blood cancer campaigned for a decade to gain access to a potentially life saving therapy (4). Even after gaining compassionate access she continued advocating to achieve subsidised access among the wider patient community. The patient attended global conferences, lobbied politicians, rallied support from leading haematologists and a patient organisation and eventually completed a reimbursement submission (5). As a result, over one thousand patients in Australia with rare types of leukaemia will gain reimbursed access to the therapy through the Pharmaceutical Benefits Scheme (PBS) from August 2018 (6).

CRC’s experienced team provides innovative Medical Affairs solutions to assist our clients in gaining valuable patient insights that can be used to develop patient focused initiatives in achieving business goals.

References:

1. Lowe et al. Increasing Patient Involvement in Drug Development. 2016. Value in Health.
2. Ings S. Pharma’s response to the patient voice. 2018. Envision Pharma. Available at: https://bit.ly/2AUBDjb
3. Helping diabetes patients ‘see’ their blood sugar levels aids treatment. Available at: https://bit.ly/2vG0cuV
4. Life-saving drug subsidies for thousands of patients battling rare cancers. 2018. Available at: https://bit.ly/2nzzwrw
5. Australians living with MPN step closer to accessing Pegasys treatment. 2017. Available at: https://bit.ly/2OwZzek
6. PBS list: https://bit.ly/2nwwQuz

It is National Diabetes Week from July 8^th – 14^th and Diabetes Australia has launched the “It’s About Time” campaign to raise awareness about the importance of early detection and treatment of all types of diabetes (1). There are an estimated 451 million people with diabetes worldwide including 1.7 million Australians, the majority (up to 90%) of whom have type 2 diabetes (2, 3). The prevalence of diabetes worldwide is expected to grow to over 690 million people by 2045 (2).

In Australia, the total annual cost burden of diabetes including healthcare and indirect costs caused by loss of productivity and missed days of work is estimated at $14.6 billion (1). Yet even with substantial healthcare resources dedicated to diabetes care and the availability of effective, affordable monitoring devices and medications, many people still experience serious complications related to poor management of blood glucose. There is a looming population health crisis associated with the increasing type 2 diabetes disease burden.

Here we discuss the potential for digital health interventions to improve the management and treatment of diabetes.

Challenges of diabetes management

Diabetes is a complex chronic condition which affects not only people’s physical health but also their cognitive, psychological, emotional and social well-being. Effective diabetes management requires a combination of input from healthcare professionals and self-management by the individual to monitor and control their blood glucose, take medications and follow a healthy lifestyle. Incorporating strict glucose monitoring and control into their daily lives is challenging for many people.

Poor diabetes management is associated with the risk of developing long-term complications such as damage to the eyes, kidneys, nerves and heart. Measurement of glycated haemoglobin (HbA1c) is the current gold standard test used by doctors to assess glucose levels over a 2-3 month period and predict the risk of developing long-term complications (5). Yet this test does not reflect the potential daily highs and lows in blood glucose experienced by an individual (5). This means people with a normal HbA1c may still experience daily fluctuations in blood glucose which could impact their long-term health (5).

However, the added support offered by digital diabetes management tools for everyday living could be routinely introduced to potentially revolutionise diabetes care in helping people to take control of their glucose levels.

Digital innovation for diabetes care

Indeed, technological advances have powered the re-invention of industries such as banking, music, retail, travel, publishing and transportation to become more efficient and consumer friendly. Digital interventions in the healthcare industry such as the introduction of electronic medical records, telehealth and mobile applications to track health related data are becoming increasingly popular, although mainstream adoption of digital healthcare tools has been slow.

As technology advances, there is increasing potential to use digital solutions to improve diabetes care and enable people to take a more proactive approach to self-management. Importantly, there is growing evidence to support the value of digital interventions such as smart phones, mobile applications, wearable devices and telehealth for diabetes management (6-9). In particular, a variety of digital health solutions are available with applications for health data collection and analysis, prediction of poor diabetes management, delivery of patient education and reinforcement of health choices and successful disease management.

The functions offered by mobile applications include monitoring blood glucose measurements, carbohydrate intake, medications, exercise, sleep and stress levels, the tracking of which is beneficial for the health of people with diabetes. Some apps are designed to send personalised self-management support (e.g. encouragement, education, reminders and recommendations) based on an individual’s tracked health data, while others may enable sharing of this data with health care professionals.

A recent analysis of multiple studies showed that clinically relevant improvements were gained using mobile technologies particularly in patient self-management of type 2 diabetes (7). Another study reported that mobile phone app strategies were associated with significant reduction of HbA1c levels among app users (8).

Diabetes is a chronic condition requiring vigilant monitoring and management of daily blood glucose fluctuations, which can seem to be a relentless task. Digital tools could assist people with diabetes to monitor and make adjustments to their day-to-day behaviour based on improved visibility and understanding of their own healthcare data, which could potentially ease the burden of diabetes self-management.

CRC’s expert team has extensive medical affairs experience in diabetes and across many other therapeutic areas. We develop and deliver strategic solutions that are tailored to maximise our clients’ commercial success.

References:

1. Diabetes Australia. National Diabetes Week 2018. Available at: https://bit.ly/2IloTRS
2. Cho N. H., et al. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. 2018. Diabetes Research and Clinical Practice. https://www.ncbi.nlm.nih.gov/pubmed/29496507
3. Diabetes Australia. 2018. Available at: https://www.diabetesaustralia.com.au/about-diabetes
4. Diabetes Australia2018. Available at: https://www.diabetesaustralia.com.au/diabetes-globally
5. Diabetes Australia2018. Available at: https://www.diabetesaustralia.com.au/type-2-diabetes
6. Adolfsson P., et al. Selecting the appropriate continuous glucose monitoring system – a practical approach. 2018. European Endocrinology.
7. Kitsiou S. et al. Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews. 2017. PLOS One.
8. Cui M., et al. T2DM Self-Management via Smartphone Applications: A Systematic Review and Meta-Analysis. 2016. PLOS One.
9. Kaufman N. and Khurana I. Using digital health technology to prevent and treat diabetes. 2016. Diabetes Technology and Therapeutics.