Pharmacy Trial Program
More information about the Pharmacy Trial Program can be found on the Department of Health website.
Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) Randomised Controlled Trial
Severe and Persistent Mental Illness (SPMI) refers to any mental illness that has a continuous and significant effect on a person’s daily life, such as schizophrenia, severe and recurrent depression, and bipolar disorder. In Australia, there are an estimated 9,000 premature deaths annually amongst consumers living with SPMI. However, this mortality rate is generally due to health conditions experienced by the general population, such as cardiovascular and respiratory diseases. Urgent attention is therefore required to address associated physical health concerns of this vulnerable population.
Medications are a common treatment option for managing mental and physical illnesses, which are mostly obtained from community pharmacies. Pharmacists, as accessible health professionals, are well positioned to improve mental health and associated physical healthcare, resolve any associated medication-related problems, including medication adherence, and signpost consumers to other health professionals and services.
The Bridging the Gap between Physical and Mental Illness in Community Pharmacy (PharMIbridge) Randomised Control Trial (RCT) is a collaboration between Griffith University, The University of Sydney, the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia aimed at enhancing the way community pharmacists support people living with SPMI.
The PharMIbridge RCT will test the effectiveness of a person-centred, goal-oriented and flexible pharmacist-led support service for consumers living with SPMI, compared to a standard in-pharmacy medication review service. Changes in consumer medication adherence and health outcomes (including quality of life, physical health and mental wellbeing), as well as the confidence and knowledge of community pharmacists’ to support this population, will be assessed. Additionally, the acceptability and cost-effectiveness of the new service will be evaluated.
Pharmacy Diabetes Screening Trial
In Australia, the prevalence of type 2 diabetes is estimated to have risen from 1.5% to 4.4% between 1989-90 and 2014-15. Within these estimates, the numbers of people with undiagnosed diabetes is unknown but estimated to be between 250,000 and 1,000,000. The high prevalence of undiagnosed diabetes, highlights the need for more effective screening of the general population to facilitate increased risk identification, diagnosis and earlier interventions to reduce the risk of developing diabetes complications. Over a decade ago, Krass et al. demonstrated the capacity for detection of undiagnosed individuals via screening interventions in Australian community pharmacy, the more cost-effective approach being sequential screening comprising a paper-based test, followed by point of care testing for those with identified risk factors.
The trial will compare the clinical and cost effectiveness of three different pharmacy-based Diabetes Screening interventions based on AUSDRISK™ assessment tool alone compared with additional point-of-care (POC) testing HbA1c or small capillary blood glucose test (scBGT) in patients with AUSDRISK™ score of greater than or equal to 12.
This is a cluster randomised controlled trial which will involve 363 pharmacies across Australia recruiting 10,240 patients per arm. Patients will be aged 35-74 years and without diabetes or impaired blood sugar control, and will receive one of the three intervention models based on the pharmacy location. Patients referred for further investigation will subsequently be followed up by researchers to enable a comparison of the rate of newly detected diabetes in each arm, the trial’s primary endpoint. The secondary outcomes to be assessed are the proportion of people referred to the GP; and the proportion of people who take up the referral to the GP and the difference in proportions of newly diagnosed cases of pre-diabetes.
An economic analysis will investigate the relative cost-effectiveness of these interventions. It is hypothesised that the addition of either HbA1c POC test or scBGT POC test to AUSDRISK™ screening followed by a referral to GP, if appropriate, is cost-effective in comparison to AUSDRISK™ screening alone from a health service funder perspective, having regard to trial-based costs and clinical outcomes (i.e. new cases of diabetes and prediabetes). The trial also aims to identify the barriers and facilitators to implementing the Diabetes Health Check screening service, including workflow and efficiencies in providing the service to the at-risk groups.
Krass I, Carter R, Mitchell B, et al Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy
Indigenous Medication Review Service Feasibility Study
Healthcare that is culturally appropriate, flexible and responsive is needed to support safe medication use by Aboriginal and Torres Strait Islander peoples, especially those with long-term conditions.
Griffith University, the National Aboriginal Community Controlled Health Organisation (NACCHO), and the Pharmacy Guild of Australia have partnered to evaluate the feasibility of a culturally responsive, individualised medication review service delivered collaboratively by community pharmacists and Aboriginal and Torres Strait Islander health services (both Aboriginal Community Controlled Health Services and government Indigenous Health Services). Researchers will develop, pilot and evaluate the service to ensure it is acceptable and deliverable across remote, rural and urban settings.
A total of 540 adults with a long-term condition, or who are pregnant, or within two years postpartum AND who are at risk of medication-related problems will work with pharmacists and staff from nine Aboriginal and Torres Strait Islander health services across Queensland, New South Wales and Northern Territory to resolve medication-related problems. Feedback from participants, health service staff, communities, community pharmacy staff, and experts will refine service development, training and outcome measures for a future randomised controlled trial.
This feasibility study is funded by the Australian Government Department of Health as part of the Sixth Community Pharmacy Agreement.
Getting Asthma Under Control Using the Skills of the Community Pharmacist
Asthma affects approximately 10% of the Australian population and when assessed, half of these people have poorly controlled asthma. The PTP – ARC (Getting asthma under control using the skills of the community pharmacist) project addresses the need to improve clinical outcomes for the Australian population at risk of uncontrolled asthma, by extending the role of pharmacists in the delivery of primary health care services through community pharmacies. The trial is a culmination of 16 years of asthma research.
The project is a collaboration between the Woolcock Institute of Medical Research (lead organisation), University of Sydney, Curtin University, University of Tasmania, the Pharmaceutical Society of Australia, The Pharmacy Guild of Australia, National Asthma Council Australia and the George Institute for Global Health. Thus at this stage pharmacies will only be recruited from New South Wales, Western Australia and Tasmania. It is hoped that other states will be involved in the future.
The objective of PTP-ARC is to compare the efficacy and cost effectiveness of a pharmacist-delivered asthma service comprising of consultations with the pharmacist over a 12-month period for people with uncontrolled asthma (Group A) versus a “low-level” pharmacy intervention comprising identification of uncontrolled asthma with referral to the GP (Group B) and “usual primary care” in general practice (group C).
The proposed intervention will target three key factors associated poor asthma control:
Poor adherence, characterised by underuse of preventer medication and/or overuse of reliever medication
Suboptimal inhaler technique and/or
Uncontrolled allergic rhinitis.
The pharmacist-delivered asthma service will be tested for efficacy using a cluster randomized controlled design. The trial will recruit over 840 Australians with poorly controlled asthma from 80 participating pharmacies and approximately 20 GP practices throughout New South Wales, Western Australia and Tasmania. An economic analysis will investigate the relative cost-effectiveness of this service. The trial in community pharmacy will commence in July 2018 and will be completed by October 2019.
Group A pharmacies will contact the person with asthma a total of 4 times in 12 months. Group B will contact the person with asthma a total of 3 times in 12 months. Pharmacists will be remunerated for their time.
This trial program is funded by the Australian Government Department of Health as part of the Sixth Community Pharmacy Agreement.