National trial to test strategies to improve medication compliance in a community pharmacy setting Researchers: Dr Anne-Marie Feyer, PricewaterhouseCoopers Professor SI (Charlie) Benrimoj, University of Sydney Carrie Schulman, PricewaterhouseCoopers Rebecca Jessop, PricewaterhouseCoopers Deanna Pyper, PricewaterhouseCoopers Brian Sabet, PricewaterhouseCoopers Mary Mitchelhill, PricewaterhouseCoopers EXECUTIVE SUMMARY THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT EXECUTIVE SUMMARY Acknowledgement PricewaterhouseCoopers would like to thank the Department of Health and Ageing for funding this project as part of the Fourth Community Pharmacy Agreement, which has been administered by the Pharmacy Guild of Australia. The researchers would like to make special thanks to the pharmacies, pharmacists and patients who participated in this trial without whom this report would not have been possible. Thanks are also warranted to both the project’s Pharmacy Reference Group and Advisory Groups who helped finalise some of the trials design and participated in workshops and discussions with participating pharmacies throughout the trial. This report was produced with the financial assistance of the Australian Government Department of Health and Ageing. The financial assistance provided must not be taken as endorsement of the contents of this report. The Pharmacy Guild of Australia manages the Fourth Community Pharmacy Agreement Research & Development which supports research and development in the area of pharmacy practice. The funded projects are undertaken by independent researchers and therefore, the views, hypotheses and subsequent findings of the research are not necessarily those of the Pharmacy Guild. 2 EXECUTIVE SUMMARY 1. Executive Summary Background Non-compliance with medication regimens is recognised in Australia and internationally as a pervasive underlying cause of poorer health outcomes and increased health care costs. It is estimated that 50% or more of patients fail to comply with their medication regimen. The Pharmacy Guild of Australia (the Guild) engaged PricewaterhouseCoopers (PwC) in collaboration with the University of Sydney, to carry out a study investigating and evaluating strategies to improve medication compliance within the community pharmacy setting. This project was funded by the Australian Government Department of Health and Ageing as part of the Fourth Community Pharmacy Agreement Research and Development program managed by the Guild. The Final and Full Final Reports provide details on the methodology and results of this 18 month project, as well as recommendations for national implementation. The focus of this study was to develop, implement and evaluate a professional service in community pharmacies that aimed to improve patient medication compliance. The study commenced in August 2008 and concluded in April 2010. To provide an intervention period of six months, the trial was implemented over an eight-month period, from April 2009 to December 2009. The medication compliance service trialled in this study was underpinned by four theoretical principles which informed the design, implementation and evaluation of the intervention. These were: • An evidence based approach • Practical adult learning theory • Organisational change • Behaviour change Given the importance of behaviour change at both the patient and pharmacy level, the national trial was comprised of two integrated but distinct interventions, as illustrated in Figure 1. Figure 1: Patient and pharmacist interventions IMPROVED COMPLIANCE Patient intervention Stage 1 Stage 2 Stage 3 Stage 4 Sign up Explore Collaborate Follow through Sign up for the Trial Explore medication-taking behaviour and attitude Collaborate and commit to next steps Follow through • Invite the patient to come up • Record the patient’s Pharmacist Intervention Pharmacy recruitment and selection Pharmacist training and education Ongoing support and reinforcement Delivery of patient intervention 3 EXECUTIVE SUMMARY Key features of the study design Both the pharmacy and patient interventions were based on the following key design features: 1. Pharmacy recruitment occurred via national expression of interest to community pharmacies in Australia for whom the researcher had fax or email contacts. Pharmacies were randomly recruited to the study from those expressing interest, to fill a sampling framework using SEIFA and PhARIA classification of pharmacies, to obtain a sample which had reasonable national representation on these characteristics. 2. Education and support to community pharmacies were provided throughout the trial, using a variety of communication modes: interactive workshops, site visits to the pharmacy by research teams, fax and newsletter, reminders, teleconferences and a dedicated website. 3. Patients on long term medication regimens were recruited by pharmacies from their existing cohort of patients. 4. Compliance (also described in the literature as adherence and concordance) is the extent to which the patient’s medication taking behaviour was consistent with the recommendations of the prescriber and was measured using the dispensing history in the pharmacy records of patients on long term medication regimens. From the literature, adherence with the prescribed regimen should be measured empirically. Adherence of >80% is defined as being compliant. In this study, patients were screened for a MedsIndex score (based on dispensing data) of less than 85 out of 100 for inclusion in the trial. 5. This study focused on secondary non-compliance, where the script was filled but there was non-compliance to the regimen, and targeting strategies to the patient. The reasons for secondary non-compliance (i.e. prescription not refilled, not taken, intentional and non-intentional) were explored in conversation between the pharmacist and patient. Data regarding the patient’s predictors and barriers to medication taking were collected in a questionnaire completed at baseline and at the end of the trial. 6. ‘Motivational interviewing’ was used by the pharmacist as a method of collaborating and engaging with the patient, in joint selection of an appropriate strategy or strategies to improve compliance. Strategies included dose administration aids, medication profiling, home medicines review, patient education, reminders, referral to GP, simplification of the medication regimen and patient diaries. 7. The pharmacist assessed the patient’s change readiness (the importance given to compliance and confidence in being able to make a change) as well as the patient’s stage of change (pre-contemplation, contemplation, preparation, action, relapse and maintenance). 8. The intervention was based on three cycles of exploring, collaborating and following through with data collection and adjustment of the strategies, as appropriate, at each cycle. Results and conclusion In total, 132 pharmacies were recruited to the trial based on the study’s sampling framework (using SEIFA and PhARIA classification), with 66 pharmacies successfully completing the trial. Participating pharmacies were able to recruit 732 patients on long term medication regimens to the trial, with 612 (84%) returning for the three-month pharmacy visit and 476 patients (65%) returning for the six-month follow-up visit. The key findings of the trial are summarised below. Improved medication compliance can be achieved through a pharmacist-led intervention – The key outcome of the trial was that medication compliance significantly improved over the sixmonth trial, from 65.5 at baseline, to 77.2 at three-months and 81.3 at six months (average improvement of 16%). Considered in light of the published literature, this level of improvement is outstanding and supports the study’s hypothesis that a significant improvement in compliance can be achieved as a result of the pharmacist intervention. 82 80 MedsIndex Score • 78 76 74 72 70 68 66 64 Baseline 3 months 6 months 4 EXECUTIVE SUMMARY A medication compliance service should be based on behaviour change principles – Principles of behaviour change were fundamental to the success of the trial, in engaging with busy pharmacists to change their interaction with patients, as well as understanding and changing patient behaviour to improve patient outcomes in compliance. At the pharmacy-level, results of the trial showed an overall readiness and motivation amongst pharmacists to implement the compliance service. The results of the trial also showed a significant improvement in patients’ reported confidence in using the compliance strategies, as well as stronger beliefs about the importance of medication compliance. According to behaviour change literature, these results suggest an increased readiness and motivation to change amongst patients during the six-month trial. 1.9 2.0 2.1 2.2 Score • 2.3 2.4 2.5 2.6 Confidence 2.7 Importance 2.8 2.9 Baseline 3 months 6 months Time • Patient-centred interventions are important in promoting compliance – To achieve these results, over 1,300 strategies were delivered by pharmacists at baseline for the 732 patients in the trial (e.g. patient education and reminders, readiness to change-focused discussions and shift in negative medicine beliefs) and a further 1,800 strategies over the remainder of the trial. Approximately half of the patients received a combination of strategies highlighting the importance of patient-centred interventions on medication compliance. • A pharmacist-led compliance service may benefit all patients on long term medications – The compliance service trialled in this study was found to be effective, independent of pharmacy or patient characteristics. This result shows a generalised effect of the intervention and suggests that a pharmacist compliance service may be effective for all patients with difficulties complying with long term medication regimens. • A professional compliance service requires trained and engaged pharmacists – The positive results of the trial relied on motivated community pharmacists who were appropriately trained and supported to deliver the compliance service. The results suggest that where initial engagement with the pharmacists was not optimal, engagement with the patients appeared to be adversely affected. Successful engagement of pharmacists in this trial was a key success factor contributing to the significant improvements in compliance. • A pharmacist-led compliance service can be well accepted by patients and pharmacists – Overall, both patients and pharmacists reported very positive experiences in the trial, with 99% of patients indicating that they were satisfied or very satisfied with the compliance service and 98% reported that working with their pharmacist was a good way of helping them manage their medication. • An effective compliance service can be developed and implemented in the community pharmacy setting – Results of the analysis showed that the average total cost associated with improving medication compliance over the six-month trial, by an average of 16% per patient, was $275.61. This level of improvement in medication compliance has been shown to result in substantial health benefits to patients and economic benefits to health services. Overall, this trial was successful in the design and implementation of a cognitive professional service in the community pharmacy setting, which resulted in a dramatic improvement in patient medication compliance. National implementation of a program based on the design and implementation approach used in this trial could result in significantly improved compliance for patients on long-term medication regimens, improvements in health outcomes and reduced costs to the health system. 5
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