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THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING
AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT
FULL FINAL REPORT
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
THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING
AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT
FULL FINAL REPORT
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 (see Appendix A).
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.
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Project team
Lead researchers
Dr Anne-Marie Feyer, PricewaterhouseCoopers
Professor SI (Charlie) Benrimoj, Faculty of Pharmacy, University of Sydney
Quality and assurance partner
John Cannings, PricewaterhouseCoopers
Project director
Carrie Schulman, PricewaterhouseCoopers
Project managers
Rebecca Jessop, PricewaterhouseCoopers
Mary Mitchelhill, PricewaterhouseCoopers
Research team
Deanna Pyper, PricewaterhouseCoopers
Brian Sabet, PricewaterhouseCoopers
Jeremy Solomon, PricewaterhouseCoopers
Elle Feletto, Faculty of Pharmacy, University of Sydney
Data management team
Monica Brabant, PricewaterhouseCoopers
Michael Allwright, PricewaterhouseCoopers
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Acronyms
Acronym Explanation
AGPN Australian General Practice Network
APCC Australian Primary Care Collaborative
BMQ Beliefs about Medications Questionnaire
CI Confidence Interval
CPS Cognitive Pharmaceutical Services
CPD Continuing Professional Development
DAA Dose Administration Aids
DoHA Department of Health and Ageing
EOI Expression of interest
GP General Practitioner
Guild Pharmacy Guild of Australia
HMR Home Medicines Review
IT Information technology
KSA Knowledge, skills and abilities
MUR Medication Use Reviews
MARS Medication Adherence Report Scale
NSW New South Wales
NT Northern Territory
PhARIA Pharmacy Access/Remoteness Index of Australia
PSA Pharmaceutical Society of Australia
PwC PricewaterhouseCoopers
QLD Queensland
RCT Randomised controlled trial
SD Standard Deviation
SEIFA Socio-Economic Indexes for Areas
SA South Australia
TAS Tasmania
USA United States of America
VIC Victoria
WA Western Australia
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Table of contents
1. Background and rationale for the research ..................................................................................7
1.1. Project background .................................................................................................. 7
1.2. Definition of medication compliance ......................................................................... 7
1.3. The impact of non-compliance ................................................................................. 8
1.3.1. Health impacts of non-compliance .......................................................................................... 8
1.3.2. Economic costs of non-compliance ......................................................................................... 9
1.4. Measures of compliance .......................................................................................... 9
1.5. Predictors and barriers of non-compliance ............................................................. 10
1.6. Improving medication compliance .......................................................................... 11
1.6.1. Strategies for improving medication compliance ................................................................... 11
1.6.2. Behaviour change ................................................................................................................. 11
1.6.3. Behaviour change in community pharmacies ........................................................................ 12
1.7. Rationale for the research ...................................................................................... 12
1.8. Purpose of the research ......................................................................................... 13
1.9. Research project outline ........................................................................................ 14
1.10. Purpose of the report ............................................................................................. 15
1.11. Roadmap to the report ........................................................................................... 15
2. Approach to the design of the trial .............................................................................................16
2.1. Background ............................................................................................................ 16
2.2. Committee consultations ........................................................................................ 16
2.2.1. Advisory Panel ...................................................................................................................... 16
2.2.2. Reference Group ................................................................................................................... 17
2.2.3. Community Pharmacy Working Group .................................................................................. 17
2.3. Literature review .................................................................................................... 17
2.3.1. Search strategy ..................................................................................................................... 18
2.3.2. Literature search criteria ........................................................................................................ 18
2.4. Stakeholder consultation ........................................................................................ 19
2.4.1. Purpose of stakeholder consultations .................................................................................... 19
2.4.2. Key stakeholder groups and organisations ........................................................................... 19
2.4.3. Themes from stakeholder consultations ................................................................................ 19
3. Trial design .................................................................................................................................21
3.1. Guiding principles of the study ............................................................................... 21
3.1.1. An evidence-based approach ................................................................................................ 21
3.1.2. Practical adult learning theory ............................................................................................... 21
3.1.3. Organisational change .......................................................................................................... 22
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3.2. Overview of the four-stage patient intervention ...................................................... 23
3.2.1. Stage 1: Sign up for the trial .................................................................................................. 24
3.2.2. Stage 2: Explore medication taking behaviour ...................................................................... 24
3.2.3. Stage 3: Collaborate and commit to next steps ..................................................................... 25
3.2.4. Stage 4: Follow through ........................................................................................................ 25
3.3. Reimbursement of pharmacists .............................................................................. 26
3.4. Timeframes for the research project ....................................................................... 26
3.5. Ethics approval ...................................................................................................... 27
4. Pilot .............................................................................................................................................28
4.1. Objectives of the pilot ............................................................................................. 28
4.2. Pilot approach ........................................................................................................ 28
4.2.1. Pharmacy recruitment to the pilot .......................................................................................... 28
4.2.2. Pharmacy education .............................................................................................................. 29
4.2.3. Patient recruitment ................................................................................................................ 29
4.2.4. Intervention, data collection and support ............................................................................... 30
4.3. Key findings of the pilot .......................................................................................... 31
4.4. Pilot conclusions .................................................................................................... 34
5. Trial methodology .......................................................................................................................35
5.1. Overview of trial activities and timelines ................................................................. 35
5.2. Sampling framework .............................................................................................. 36
5.2.1. Development of the pharmacy sampling framework for the national trial .............................. 37
5.2.2. Patient distribution ................................................................................................................. 38
5.3. Recruitment process .............................................................................................. 38
5.3.1. Pharmacy recruitment process .............................................................................................. 38
5.3.2. Pharmacy recruitment ........................................................................................................... 40
5.4. Education and training of pharmacists ................................................................... 41
5.4.1. Education workshops ............................................................................................................ 42
5.4.2. Site visits and teleconference education ............................................................................... 43
5.5. Patient recruitment ................................................................................................. 44
5.6. Pharmacy resources, support and communication ................................................. 45
5.6.1. Pharmacy resources ............................................................................................................. 45
5.6.2. Additional pharmacy support ................................................................................................. 45
5.6.3. Pharmacy communication ..................................................................................................... 45
5.7. Pharmacy data collection ....................................................................................... 46
5.7.1. Pharmacy demographic survey ............................................................................................. 46
5.7.2. Pharmacy survey ................................................................................................................... 46
5.8. Patient data collection ............................................................................................ 46
5.8.1. Patient characteristics questionnaire ..................................................................................... 46
5.8.2. Patient questionnaire ............................................................................................................. 47
5.8.3. Patient strategy card ............................................................................................................. 47
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5.8.4. Patient satisfaction questionnaire .......................................................................................... 47
5.9. Data management processes ................................................................................ 48
5.9.1. Access database ................................................................................................................... 48
5.9.2. Data quality ........................................................................................................................... 48
5.10. Statistical analysis .................................................................................................. 49
6. Results ........................................................................................................................................50
6.1. Recruitment and retention ...................................................................................... 50
6.1.1. Pharmacy recruitment and retention ..................................................................................... 50
6.1.2. Patient recruitment and retention .......................................................................................... 51
6.1.3. Missing and excluded data .................................................................................................... 52
6.2. Demographics ........................................................................................................ 52
6.2.1. Pharmacy demographics ....................................................................................................... 52
6.2.2. Patient demographics ............................................................................................................ 54
6.3. Baseline results ...................................................................................................... 54
6.3.1. Medication compliance .......................................................................................................... 54
6.3.2. Beliefs about medication and readiness to change ............................................................... 55
6.4. Trial outcomes ....................................................................................................... 56
6.4.1. Compliance measure outcomes ............................................................................................ 56
6.4.2. Beliefs about medication outcomes ....................................................................................... 57
6.4.3. Readiness to change outcomes ............................................................................................ 58
6.5. Characteristics associated with improved outcomes .............................................. 59
6.6. Pharmacist education............................................................................................. 59
6.7. Strategies delivered by pharmacists ....................................................................... 60
6.8. Pharmacist satisfaction .......................................................................................... 61
6.8.1. Education satisfaction ........................................................................................................... 61
6.8.2. End of trial satisfaction .......................................................................................................... 61
6.8.3. Impact of the trial ................................................................................................................... 62
6.8.4. Pharmacy readiness .............................................................................................................. 64
6.9. Patient satisfaction ................................................................................................. 65
6.10. Completers vs. non-completers .............................................................................. 66
6.10.1. Comparison of pharmacy completers vs. non-completers ..................................................... 66
6.10.2. Comparison of patient completers vs. non-completers .......................................................... 67
6.10.3. Reasons for patient drop-out ................................................................................................. 68
6.11. Economic Analysis ................................................................................................. 69
6.11.1. Service delivery costs ............................................................................................................ 69
6.11.2. Service establishment costs .................................................................................................. 71
6.11.3. Honorarium costs .................................................................................................................. 72
6.11.4. Estimated total cost per patient ............................................................................................. 72
6.11.5. Effectiveness of the intervention............................................................................................ 72
6.11.6. Benefits of the intervention .................................................................................................... 72
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7. Implementation of a national medication compliance service in community pharmacy: Implications of the national trial ................................................................................................................................76
7.1. Key findings of the medication compliance service ................................................ 76
7.2. Strengths and limitations of the Study .................................................................... 79
7.3. Recommendations ................................................................................................. 80
7.3.1. Recommendations emerging from an evidence-based approach ......................................... 80
7.3.2. Recommendations emerging from practical use of adult learning theory .............................. 80
7.3.3. Recommendations emerging from Organisational Change theory ........................................ 81
7.3.4. Recommendations emerging from behaviour change theory ................................................ 83
7.4. Conclusion ............................................................................................................. 84
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1. Background and rationale for the research
1.1. Project background
Non-compliance with medication regimens is a challenging and complex problem, resulting in poorer health outcomes and increased health care costs. Recent literature on medication compliance within Australia reveals that approximately 50% of patients fail to comply with their medication regimen (Pharmaceutical Society of Australia, 2006). These findings are consistent with those found internationally. A review on medication compliance in the United States of America (USA) revealed that 50-70% of patients do not comply with their prescribed medication (Wertheimer & Santella, 2003). This problem is further exacerbated by the fact that medication non-compliance is a hidden problem, often undisclosed by patients and unrecognised by prescribers.
To further investigate this complex problem, the Pharmacy Guild of Australia (the Guild) engaged PricewaterhouseCoopers (PwC) in collaboration with the University of Sydney, to undertake a study to develop and evaluate strategies implemented in community pharmacies to improve medication compliance (the Improving Medication Compliance Trial). 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 focus of this project was to develop and implement a professional service in community pharmacies that aimed to improve a patient’s medication compliance.
This section provides an overview of the Improving Medication Compliance project, including:
• definitions of medication compliance
• impact and costs of medication non-compliance
• measures of medication compliance
• predictors and barriers to compliance
• rationale for the research
• aims and objectives of the study.
1.2. Definition of medication compliance
Medication compliance is a term used to describe the extent to which a patient’s behaviour matches agreed recommendations from the prescriber (Cochrane, 1996). In reviewing the literature, it is evident that medication compliance is often used interchangeably with adherence and concordance (Playle & Keeley, 1998). It is recognised that many health researchers use the term adherence in preference to compliance; however the term compliance will be used throughout this report.
Figure 1 illustrates the pathway for non-compliance, highlighting the difference between primary and secondary non-compliance, as well as intentional and unintentional non-compliance (Pharmaceutical Society of Australia, 2006). Primary non-compliance refers to patients who do not initially fill their prescription. Secondary non-compliance refers to patients who, after initially filling their prescription, fail to repeat, refill or take this medication correctly. It is secondary non-compliance that pharmacists may have the greatest impact on.
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Figure 1: The non-compliance pathway
Prescription not filledPRIMARY NON-COMPLIANCE
Decision to prescribePatient receives the advice/
recommendation to use a given Rx
Prescription filledThe initial prescription is filled by the
patient
Not refilledSECONDARY NON-COMPLIANCE
Not takenSECONDARY NON-COMPLIANCE
INTENTIONALNON-COMPLIANCE
UNINTENTIONALNON-COMPLIANCE
INTENTIONALNON-COMPLIANCE
UNINTENTIONALNON-COMPLIANCE
Prescription not filledPRIMARY NON-COMPLIANCE
Decision to prescribePatient receives the advice/
recommendation to use a given Rx
Prescription filledThe initial prescription is filled by the
patient
Not refilledSECONDARY NON-COMPLIANCE
Not takenSECONDARY NON-COMPLIANCE
INTENTIONALNON-COMPLIANCE
UNINTENTIONALNON-COMPLIANCE
INTENTIONALNON-COMPLIANCE
UNINTENTIONALNON-COMPLIANCE
INTENTIONALNON-COMPLIANCE
UNINTENTIONALNON-COMPLIANCE
INTENTIONALNON-COMPLIANCE
UNINTENTIONALNON-COMPLIANCE
The literature examines both intentional and unintentional non-compliance. Intentional non-compliance involves a well thought out, purposeful decision to omit or cease to take a medication dose, for example based on the patients beliefs about medication or their disease. Unintentional non-compliance involves patients omitting to take a medication, for example as they are away from home and do not have access to their medications or simply forget to take their medication (Pharmaceutical Society of Australia, 2006). Research has shown that approximately 40% of non-compliant patients are unintentionally non-compliant (Vik, Maxwell, Hogan, Patten, Johnson, & Romonko-Slack, 2005).
1.3. The impact of non-compliance
Patient non-compliance to medication regimens has many implications for both the individual patient and the health care system (Aslani, Krass, Chen, Whitehead, & Rose, 2006), in terms of health outcomes and economic costs.
1.3.1. Health impacts of non-compliance
Poor compliance to medication regimens compromises the effectiveness of treatments, increases the risks of complications and reduces a patients’ quality of life (World Health Organisation, 2003).
In a review of asthma literature (World Health Organisation, 2003), poor compliance resulted in a more intense relapse of symptoms, resistance to therapies and decreased quality of life for the patient. Similar results have been demonstrated in studies investigating hypertension. One such study (Psaty, 1990) found that patients who stopped using beta-blockers were 4.5 times more likely to experience complications for coronary heart disease than those who complied with the medication.
This research demonstrates the importance of enhancing patients’ compliance with medication regimens to improve their health outcomes. According to several recent literature reviews (Haynes, H, Garg, & Montague, 2005; Horne, Weinman, Barber, Elliott, & Morgan, 2005) “increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments”.
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1.3.2. Economic costs of non-compliance
The economic costs of non-compliance are high both in Australia and internationally. In a report by the Australian Council for Safety and Quality in Health Care (2002), inappropriate use of medicines cost the Australian public hospital system approximately $380 million per year. Furthermore, a study (Dartnell, Anderson, Chohan, Galbraith, Lyon, & Nestor, 1996) found that the cost of hospital admissions in Australia, which were attributable to non-compliance, was approximately $1 million per year.
International literature is in line with these findings, for example it is estimated that the impact of non-compliance on healthcare costs in the USA alone is between US$77 and US$300 billion a year and contributes to approximately 25% of hospital admissions (Ashburn, 1981).
The literature on medication compliance highlights the dramatic consequences of non-compliance. Efforts to assist patients to improve their compliance with medication regimens’ represent an opportunity to improve population health and the efficiency of the health care system. The importance of improving medication compliance is further recognised in the National Medicines Policy, where quality use of medicines is one of the central objectives.
1.4. Measures of compliance
Tools for measuring patient medication compliance are important for identifying patients who are non-compliant and may require assistance to improve their medication taking behaviour. Accurate information about compliance is needed to be able to apply a patient centred, targeted approach to the implementation of strategies to improve compliance (Svarstad, Chewning, Sleath, & Claesson, 1999). From the literature, it is recognised that no single method is considered to be completely valid and reliable. It is important therefore, to use multiple methods, ie a variety of compliance indicators / tools to enable measurement of the different dimensions of medication compliance.
Measures of compliance can be categorised as either direct or indirect measures. Direct measures refer to those measures of compliance which observes the ingestion of the medication, whereas indirect measures refer to assumed ingestion based on self-report or monitoring (Horne et al., 2005).
Table 1 provides an overview of the different measures of compliance identified from the literature.
Table 1: Measures of indirect medication compliance
Description Advantages Disadvantages
Electronic monitoring devices
Electronic monitoring devices, such as the Medication Events Monitoring System, involve dispensing each patient’s medication in a bottle that contains a microprocessor in the cap to record the date and time of each bottle opening.
• Most accurate indirect measure of compliance available
• Often considered the ‘gold standard’ in measuring adherence
• Expensive
• Does not ensure medication ingestion
• Does not provide information about why the patient did not take their medication
MedsIndex
MedsIndex calculates a score out of 100 based on the number of missed doses a client may have had in the given time period as indicated from dispensing data. The lower the MedsIndex score the lower the patient’s assumed medication compliance (see Section 5.8.1 for more detail on MedsIndex).
• Allows pharmacists to approximate whether a patient has been taking their medications
• MedsIndex is not compatible with all dispensing databases within community pharmacies.
• Some reliability concerns exist related to changes in medication and dispensing at other pharmacies.
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Description Advantages Disadvantages
Patient self-report
A number of validated self-report scales have been used to measure medication compliance and beliefs about medication including the Medication Adherence Rating Scale (MARS) and the Beliefs about Medication Questionnaire (BMQ).
• Less expensive
• Provides details about why a patient did not take their medication
• More practical measure
• Self report bias
1.5. Predictors and barriers of non-compliance
Medication compliance for long-term regimens is a complex and multidimensional process. It is influenced by a variety of factors related to the patient, disease, therapy, socio-economic status and the health care system (Playle & Keeley, 1998). These factors are further complicated by the variability of medication-taking behaviour over time.
The barriers and predictors of non-compliance have been examined extensively in the literature. Considerable overlap exists in the findings for both of these concepts and this report differentiates them based on the way the factors are reported and measured in each study. Predictors refer to those factors that have been statistically tested and found to be significantly related to non-compliance. Barriers are identified through qualitative methods and have not been statistically verified.
Predictors and barriers can be further categorised into fixed and modifiable factors. Fixed factors refer to characteristics of the patient that cannot be changed but provide important contextual information regarding risk factors of non-compliance. Fixed factors include patient demographics, such as age, gender, race and socio-economic status, illness and medication history and impaired cognitive function. Modifiable factors can be used to inform the design of strategies for improving medication compliance.
The key modifiable barriers to medication compliance identified in the literature are:
• medication complexity
• patient, pharmacist and prescriber relationship
• patient health and medication beliefs and understanding of their illness and treatment
• access to pharmacists and health care providers
• side-effects of medication
• forgetting to take medication.
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1.6. Improving medication compliance
1.6.1. Strategies for improving medication compliance
The findings from the literature review suggest a number of strategies which could be integrated into community pharmacy practice to improve a patient’s medication compliance. Key strategies identified for possible use in the community pharmacy setting include:
• provision of patient education and information
• reminders and dose administration aids
• follow up
• provision of pharmacist education and information
• medication profiling and simplification of medication regimens
• collaboration between patient, pharmacist and physician and
• pharmacy remuneration.
See the literature review in Appendix C for a detailed review of these strategies and their impact on medication compliance.
1.6.2. Behaviour change
In addition to the evidence-based and best practice strategies, a community pharmacy compliance service should be based on relevant behaviour change theories and models. Compliance to medication is a variable behaviour, and thus improving poor compliance relies on changing that behaviour. For example, behaviour change research suggests that patient motivation and readiness to change greatly influences the way a patient takes their medication. To help patients improve their medication compliance, it is important to identify and understand the patient’s readiness or motivation to change their behaviour (Rollnick, Mason, & Butler, 1999) .
Figure 2 illustrates the Stages of Change model, which can be used to identify a patient’s readiness to change. In this model, patients are shown to move through five stages when trying to change their behaviour: pre-contemplation; contemplation; preparation; action; and maintenance. Figure 2 demonstrates how people move through the stages in a cyclical manner (Rollnick et al., 1999).
Figure 2: Stages of change model
Pre-Contemplation
Contemplation
Preparation
Action
Maintenance
Exit
Relapse
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Research has shown that a patient will be more ready to change their behaviour if they feel the change is important and they have the confidence that they can do it. Figure 3 illustrates how importance and confidence interact to determine an individual’s readiness to change.
Figure 3: Importance and confidence to change
Low High
High
Importance
Confidence
Ready
The research on behaviour change suggests that influencing patients’ medication taking behaviour relies on community pharmacists delivering a patient-centred and tailored approach to meet the individual needs of patients. A multi-component intervention, combining numerous strategies, may therefore be more effective than implementing a single strategy. This recommendation is supported by several literature reviews, including Haynes, Garg and Montage (2005) and McDonald, Garg and Haynes (2002).
1.6.3. Behaviour change in community pharmacies
The successful delivery of a medication compliance professional service relies on the readiness of pharmacists to change their behaviour. In this setting, readiness to change refers to an organisation’s plan for change and its ability to execute it (Roberts, Benrimoj, Dunphy and Palmer, 2007). This readiness to change begins with the pharmacist’s perceptions of the benefits of change, the risk of failing to change and the demands of an externally imposed change. Applying Rollnick et al’s (1999) model of health behaviour change, pharmacists need to assess the need for the change (importance) and have the resources such as time and skill (confidence) to effectively carry out the change.
1.7. Rationale for the research
The community pharmacy profession is in the midst of a significant transformation, shifting the focus of pharmacists away from solely supplying products towards the implementation of professional services. This shift is evidenced by the increasing literature (Roughhead, Semple, & Vitry, 2002) identifying community pharmacists as important members of the clinical service provider team in improving medication compliance, as well as the value of Cognitive Pharmaceutical Services (CPS).
CPS, often referred to as Pharmaceutical Care, is defined as clinical and professional assistance delivered by the community pharmacist, for the purpose of promoting effective and safe medication taking behaviour (Albrecht, Roberts, Benrimoj, Williams, Chen, & Aslani, 2006). CPS focuses on providing patient-centred care to improve health service delivery to patients.
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Community pharmacists are well placed to improve medication compliance, as they:
• are often the last point of contact after patient consultation with a physician and they can play an important role in reinforcing information and correcting misunderstandings (Crawford, 2008; Denham & Barnett, 1998)
• have extensive pharmaceutical knowledge and can assist patients with medication related concerns
• are more easily accessible than physicians, with patients not requiring an appointment
• work in an informal atmosphere, facilitating trusting relationships and allowing patients to ask more questions and express their concerns (Knight, 2000)
• provide an advanced level of care by identifying and implementing existing resources, such as dose administration aids (Pharmaceutical Society of Australia, 2006).
Pharmacists are ideally positioned and skilled to provide a CPS which focuses on improving medication compliance (Aslani et al., 2006). An investigation of the effectiveness of a professional pharmacy service for improving patient medication compliance is therefore a critical step to implementing a valuable and remunerable pharmacy delivered compliance service (Aslani et al., 2006) and to support a national rollout.
1.8. Purpose of the research
The purpose of the research project was to develop, implement and evaluate a professional service in the community pharmacy which aimed to improve a patient’s medication compliance. The research was based on the implementation of a professional pharmacy service in community pharmacy, in addition to patient-related health outcomes that relate to the implementation of the service.
The objectives of the research were to:
• improve medication compliance among users of regular medicines
• facilitate the implementation of a professional pharmacy service for medication compliance
• provide the Guild with a implementation considerations and recommendations to support a national rollout.
Based on the objectives, two hypotheses were developed:
1. That an effective compliance service can be developed and implemented in the community pharmacy setting
2. That a significant improvement in patient compliance will be seen as a result of the pharmacist intervention.
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1.9. Research project outline
The Improving Medication Compliance research project consisted of six stages:
• Stage 1: Project initiation – included liaison with the Guild, Advisory Panel and committees and a comprehensive literature review.
• Stage 2: Strategy development – included key stakeholder consultation, trial design and ethics approval.
• Stage 3: Conduct pilot – involved piloting the medication compliance service and implementation of the intervention.
• Stage 4: Trial implementation – the implementation of the medication compliance trial.
• Stage 5: Trial analysis.
• Stage 6: Final report and implementation considerations.
An outline of the research project is illustrated in Figure 4.
Figure 4: Outline of the research project
Trial designStakeholder consultations conducted to
design and agree trial design and intervention.
Ethics approvalEthics approval obtained from University of
Sydney.
Analysis of trial results Cost / benefit analysis & business
case
Literature review
Identification of reliable predictors and barriers to medication compliance, and evidence based strategies for improving medication compliance.
Pilot
Implementation of the two month pilot for testing and selection of interventions for use in the trial
Final report and recommendations for national implementationRecommendations made regarding appropriate and effective service delivery models
Recruitment of pharmacies132 pharmacies expressed interest, with 91 pharmacies successfully consenting. Of this, 66 pharmacies successfully completed the trial.
Recruitment of patientsPharmacists were responsible for recruiting patients to the trial.
Data collectionPatient data was collected at baseline (zero months), mid point (three
months) and end point (six months).
Stage 1: Project initiation5 weeks
Stage 2: Strategy development
2 month
Stage 3:
Conduct pilot3 months
Stage 4: Trial implementation
6 months
Stage 5: Analyse trial results2 months
Stage 6: Final report
2 months
Recruitment and training of pharmacies
93 pharmacies were represented at the education workshop. 97 pharmacies received a site visit or a teleconference
September 2008
October 2008
January 2009
January 2010
Feb/Mar 2010
April 2010
May 2009
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1.10. Purpose of the report
This is the Full Final Report for the Improving Medication Compliance research project. This report comprises the Executive Summary, the Full Final Report (this report) and Appendices (attached).
The primary purpose of the Full Final Report is to present a comprehensive and detailed description of the approach and findings of the research project, along with all necessary technical details to substantiate the rigour of the project.
1.11. Roadmap to the report
The final report is comprised of eight sections, including the executive summary:
• Section 2 provides the background to the project and rationale for the research, including the objectives and hypotheses of the study.
• Section 3 provides the approach to the design of the trial, including the committees, literature review and consultations conducted to inform the development of the trial.
• Section 4 provides a detailed description of the trial design, including the four-stage patient intervention, pharmacy reimbursement, timeframes and ethics approval.
• Section 5 provides an overview of the pilot, including key findings which informed the national trial.
• Section 6 provides the detailed description of the trial methodology, including the approach to recruitment and selection, education and training, data collection and data analysis.
• Section 7 provides the key findings and results from the trial, as well as the results from the economic analysis.
• Section 8 provides a discussion of the key findings from the trial, as well as important considerations, study limitations and study conclusions.
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2. Approach to the design of the trial
2.1. Background
The project initiation (Stage 1) and strategy development stage (Stage 2) of the research project consisted of three key activities, which guided the design of the Improving Medication Compliance Trial (the trial). These included:
• consultation with three advisory committees, including the Advisory Panel, Reference Group and Community Pharmacy Working Group
• a comprehensive literature review
• key stakeholder consultations.
2.2. Committee consultations
2.2.1. Advisory Panel
The Advisory Panel was established to provide a representative group of key stakeholders to oversee the implementation of medication compliance strategies into the community pharmacy. Member representation consisted of the Guild, Pharmaceutical Society of Australia (PSA), Australian General Practice Network (AGPN), Australian Psychological Society, Department of Health and Ageing (DoHA) and the Consumer’s Health Forum.
The role of the Advisory Panel was to:
• oversee the project from all aspects of member representation
• act as an advisor to the project on behalf of the Guild
• review aspects of the project on commencement, as the project progressed and on completion.
Four Advisory Panel meetings were held in November 2008, April 2009, August 2009 and March 2010. The members of the Advisory Panel are provided in Table 2.
Table 2: Advisory Panel members
Name Organisation
Toni Riley Pharmacy Guild of Australia
Paul Feldman Department of Health and Ageing
Gilbert Yeates Pharmaceutical Society of Australia
Dr Helen Lindner Australian Psychological Society
Dr Guan Yeo Australian General Practice Network
Roma Cecere Healthlinks
Alison Marcus Consumers Health Forum
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2.2.2. Reference Group
The Reference Group consisted of key pharmacy and healthcare provider experts and was established to provide additional support and guidance regarding the research methodology and strategies. The role of the Reference Group was to:
• act as a multi-disciplinary expert resource for the project team
• review and advise on pilot and trial implementation
• assist in recruitment of pharmacies to the pilot and trial
• review and advise on analysis, findings and major deliverables throughout the project
• provide advice regarding barriers to the delivery of a community pharmacy professional services program for medication compliance and the implementation of a national program.
Four meetings of the Reference Group were held in September 2008, December 2008, April 2009 and April 2010. See Appendix B for the list of members and terms of reference.
2.2.3. Community Pharmacy Working Group
The Community Pharmacy Working Group consisted of a representative group of local practising community pharmacists and was established to provide practical advice on the operational aspects of implementation of a medication compliance service into community pharmacies and other associated activities, such as recruitment and use of MedsIndex.
The role of the Community Pharmacy Working Group was to:
• provide practical advice and a deep understanding on the operational aspects of delivery of a community pharmacy professional service for medication compliance
• meet at key stages to provide practical advice for recruitment, implementation, behaviour change, and interpretation of findings in a community pharmacy setting
• participate in the pilot and/or trial and act as local champions in each state to provide local advice and support to the participating pharmacists.
Two meetings of the Community Pharmacy Working Group were held in December 2008 and April 2009. See Appendix B for a list of members and terms of reference.
2.3. Literature review
This section outlines the literature review methodology that was used as part of the research design. The literature review was undertaken to:
• identify reliable predictors of non-compliance and examine the reasons behind poor medication taking behaviours
• examine models of behaviour and factors that influence behaviour change and a patient’s readiness to change, to improve compliance with medications
• review strategies for improving medication compliance
• examine the role of the community pharmacists in delivery of a compliance service and the ability of these services to be integrated into the community pharmacy setting.
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The literature review methodology ensured that the literature was identified that could best inform the design of the trial according to an explicit search strategy, using defined literature search criteria.
2.3.1. Search strategy
The literature search strategy included examination of both peer reviewed journals and other published literature. The following approaches were used to identify relevant literature:
• Electronic database search – Medline, CINAHL, PsycINFO, ScienceDirect, Pubmed, Web of Science, The Cochrane Library and CIAP databases were searched using the terms listed in Table 3.
• Internet searches – A number of medication and compliance websites were searched, including the Guild, DoHA and the Australian Institute of Health and Welfare. Other search engines including Google and Google Scholar were also search using a variety of the common key words.
• Scanning of reference lists – The reference lists of articles and reports obtained through the above databases and search engines were scanned to identify other potentially relevant literature.
2.3.2. Literature search criteria
The literature search involved a detailed examination of the material that had been identified using the subject and text words listed in Table 3.
Table 3: Keywords used during database search
Keyword search criteria: medication compliance
Adherence, cognitive pharmaceutical service, compliance, community pharmacist, concordance, cost, cost-benefit, cost-effectiveness, cost-of-illness, health-care, medication management, medication regimen, patient, pharmaco-economics, treatment.
Keyword search criteria: barriers
Barriers, barriers to change, barriers to compliance, change management, community pharmacy service, (compliance OR adherence OR concordance), (compliance OR noncompliance OR non-compliance), cost-effectiveness, cost-benefit, health care, medication management, patient, pharmaceutical care, predictors.
Keyword search criteria: predictors
Cognitive pharmaceutical service, (Compliance OR adherence OR concordance), (compliance OR noncompliance OR non-compliance), health care, intervention, medication, medication regimen, patient, pharmacy, pharmacists, strategies.
Keyword search criteria: behaviour change
Behaviour change, medication behaviour, medication taking behaviour, health behaviour, heath prevention, health promotion, stages of change, change models, theory of change, trans-theoretical model, health belief model, changing health behaviour, compliance, adherence behaviour, medication beliefs, patient activation, self-efficacy.
Key findings of the literature review are summarised in the Background and Rationale for the Research discussion in Section 2 above. The complete literature review is included in Appendix C.
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2.4. Stakeholder consultation
Stakeholder consultations were conducted with key groups and individual stakeholders who were identified as integral to informing the design of the Improving Medication Compliance trial, maximising participation in the trial, and thereby increasing the opportunity for success.
2.4.1. Purpose of stakeholder consultations
The purpose of the stakeholder consultations were to:
• allow stakeholder groups to be consulted, informed and engaged in the research project
• incorporate the potential roles and needs of the stakeholder groups in the study design
• gather input on the trial design and receive feedback on implementation considerations
• identify and understand key success factors for the long term viability of the service.
2.4.2. Key stakeholder groups and organisations
Two stakeholder workshops were held in Canberra and Melbourne during October 2008. Stakeholders who were unable to attend either of the workshops were individually consulted, either via telephone or face-to-face interviews. The following are a list of organisations and stakeholder groups who were involved in the consultation workshops and interviews:
• Department of Health and Ageing
• The National Prescribing Service
• Medicines Australia
• AGPN
• Divisions of General Practice
• PSA
• Australian Medical Association
• National Heart Foundation
• Carers Australia
• National Asthma Council of Australia
• The Royal College of Nursing
• Australian Practice Nurses Association
• Community pharmacists
2.4.3. Themes from stakeholder consultations
Several key themes and considerations for the trial design were identified during the consultations, as described in Table 4.
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Table 4: Key themes and considerations identified during stakeholder consultations
Themes Considerations
Importance of collaboration and communication
• To improve medication compliance, there needs to be collaboration and clear communication across all members of the health care team.
• Providing a team care orientated approach is essential to the success of compliance interventions including patients, General Practitioners (GP), pharmacists, carers and family.
Need for simple and consistent messages
• Given the number of projects focusing on improving medication compliance being run by the Guild, it is important that the messages delivered to patients, GPs and pharmacists are clear, simple and consistent to reduce confusion.
Focus on patient centred medication compliance strategies
• The patient is the most important person and thus compliance strategies must be patient centred. This includes educating patients about the importance and benefits of medication compliance as well as ensuring that the patients are part of the team.
Workforce issues • Trial design needs to consider workforce issues including available time and staff, appropriate space and adequate training. The trial must be workable and fit into both the pharmacists and GPs everyday practice.
Support for pharmacists • Sufficient support needs to be provided to community pharmacists participating in the Improving Medication Compliance trial in order for them to provide an effective and efficient service. This includes appropriate and easy to access remuneration, education and training, timely and regular feedback and general support.
Impact of information technology (IT) systems
• Improving medication compliance in the community pharmacy setting relies on accurate and fast IT systems. Consideration needs to be given to IT which supports pharmacists in delivering a medication compliance service.
Impact of generic medications
• Generic medication may complicate the use of medicines and increase the chance of confusion and misuse.
Engaging GPs • To ensure GPs are appropriately engaged in the research project, continued information and collaboration throughout the project is essential.
Impact of rural and remote locations
• There are a number of additional barriers for those in rural and remote locations. These include language and cultural barriers, difficulty accessing pharmacies and lack of transport.
The findings of the consultations with advisory committees, literature review, and key stakeholder consultations formed the basis of the design of the pilot and trial as described in the following section of this report.
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3. Trial design
The medication compliance service trialled in this study was underpinned by four key theoretical principles. These principles, through the activities undertaken in Stage 1 and Stage 2 of the research project informed the design and implementation of the intervention.
This section describes:
• the guiding principles of the study
• the integrated patient and pharmacy intervention
• the four-stage patient intervention:
− Stage 1: Sign up for the trial.
− Stage 2: Explore medication taking behaviour.
− Stage 3: Collaborate and commit to next steps.
− Stage 4: Follow through
• the reimbursement of pharmacies for participation
• timeframes for the research project
• ethics approval.
3.1. Guiding principles of the study
3.1.1. An evidence-based approach
The medication compliance service was designed based on a systematic review of current literature, using what was known about compliance, behaviour change, organisational change and pharmacy-based professional services. Both the pharmacy and patient interventions were based on empirical data feedback loops, whereby information from the literature, key stakeholder interviews, Advisory Panel and the experiences of pharmacists in the pilot, informed the development and subsequent modification of the interventions. The patient compliance intervention was informed by the professional expertise of the community pharmacist, a focus on customising the intervention to the individual patient, and the systematic collection and review of data to inform future modifications in strategies.
3.1.2. Practical adult learning theory
Key principles of adult learning theory were used in the design of the education workshops and the implementation of the medication compliance service in community pharmacies. The workshops were designed as train-the-trainer sessions with at least two pharmacy staff attending for follow up reinforcement. Information in the workshops was delivered using multi-sensory learning to cater for the different learning styles of participants through a combination of oral and visual didactic lecture style training, interactive demonstrations and role plays supported by written workbooks.
Training included information delivered by peer ‘champions’ on the benefits to the participating pharmacy both in terms of the professional difference made in the lives of their patients, patient loyalty and the financial returns to the pharmacy. These champions had been part of the pilot phase and were therefore able to share their experiences. Reinforcement of training was done via site visits to the pharmacy by the research team, phone follow up and feedback. The use of adult learning theory was important to the initial engagement of community pharmacists.
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3.1.3. Organisational change
Successful implementation of the medication compliance service relied upon the integration of key organisational change principles. The key principles of organisational change which informed the design and implementation of the community pharmacy medication compliance service, as trialled in this study, included:
• A ‘whole of pharmacy’ approach.
• Consideration of the unique organisational and job design of each pharmacy, including management support and informal leadership by pharmacy representatives responsible for delivery of the service.
• Customising the compliance service to suit the processes and systems in each pharmacy, eg customising training to the dispensing software and utilising existing systems and processes for the follow up of patients.
• Providing practical tools, such as streamlined forms and carbonless copies for record-keeping.
• Providing multiple modes of communication, including a toll free phone line, dedicated fax number, website, teleconferences and monthly newsletters between the pharmacies and the training organisation.
• Creating feedback loops through affirmative communication, reminders by exception for missing data, and celebrating success.
Behaviour change Principles and theories of stages of behaviour change were fundamental, both to engaging with busy pharmacists to change their interactions with clients, as well as understanding and changing patient behaviour to improve patient outcomes in compliance. Achieving behaviour change requires an understanding of the pharmacists’ and patients’ stage of change, their readiness and motivation to change and then the development of a targeted approach appropriate for that individual.
Given the importance of behaviour change at both the patient and pharmacy level, the national trial was comprised of two integrated but distinct interventions, illustrated in Figure 5. The key activities of the pharmacist intervention are discussed in Section 5.
Figure 5: Patient and pharmacist interventions
Ongoing support and reinforcement
Pharmacist training and education
IMPROVED COMPLIANCE
Patient intervention
Pharmacist Intervention
Sign up
Sign up for the Trial
Stage 1Explore
Explore medication-taking behaviour and attitude
Stage 2Collaborate
Collaborate and commit to next steps
Stage 3
Follow through
Stage 4Follow through
• Invite the patient to come up • Record the patient’s
Delivery of patient intervention
Pharmacy recruitment and selection
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3.2. Overview of the four-stage patient intervention
Figure 6 overviews the steps undertaken in the four stages, further detail on each of the stages is provided below.
Figure 6: Overview of the four stage process
Sign up
Sign up for the Trial
Stage 1Explore
Explore medication-taking behaviour and attitude
Stage 2Collaborate
Collaborate and commit to next steps
Stage 3
Follow through
Stage 4Follow through
• Review dispensing database and identify patients using MedsIndex
• Contact identified patient and provide them with information about the trial
• Confirm that patient is willing to participate
• Get patient consent signed
• Introduce questionnaire and provide guidance to patient on how to complete the questionnaire
• Discuss with the patient their reasons for not taking their medication as prescribed
• Use motivational interviewing to build rapport, clarifying and confirm, encourage open dialogue and listen to responses
• Invite the patient to come up with a strategy
• Based on listening –consider the patient’s stage of change readiness
• Discuss options with patient and ask about their confidence to follow through –continue until a strategy is agreed in which the patient expresses confidence
• Assist patient in completing the Reminder card
• Record the patient’s estimated stage of change on the Strategy card and return all paperwork to the PwC researchers.
• Complete summary letter and send to GP (if agreed in consent)
• Set up reminder flags in system
• Execute patient reminders
The timeline of the four-stage patient intervention is illustrated in Figure 7.
Figure 7: Timeline for the four-stage patient intervention
OnwardsOnwardsStage 1
Start 3 months 6 months
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3.2.1. Stage 1: Sign up for the trial
In Stage 1, pharmacists were required to identify patients who were non-compliant with their long-term medication regimens, make contact with these patients to inform them of and obtain their consent to the trial. The key activities and tools for Stage 1 are outlined in Table 5 below.
Table 5: Actions and tools for stage one
Activity Description Tools
1 GP Letter Pharmacists had the option to send the GP information letter to their top prescribers in the area. This was an optional step, based on the outcomes of the pilot, discussed in Section 4.
GP information letter (Appendix D)
2 Identify eligible patients
Pharmacists identified patients who were eligible to participate in the trial through a review of their dispensing database using the MedsIndex software program (see Section 5.8.1 for more details on MedsIndex as the measure of compliance). A benchmark MedsIndex score of less than or equal to 85 was used to identify patients to recruit to the trial.
MedsIndex
3 Inform patients of trial
Pharmacists made contact with the identified patient, either proactively or opportunistically as they presented to the pharmacy. Patients were informed of the trial and invited to participate.
Patient information letter (Appendix E)
4 Obtain patient consent
Once the patient indicated their willingness to participate, the pharmacist obtained informed consent from the patient.
Patient consent form (Appendix E)
3.2.2. Stage 2: Explore medication taking behaviour
In Stage 2, pharmacists were required to explore patients’ attitudes and medication-taking behaviours, using ‘motivational interviewing’, including the reasons for not taking their medication as prescribed. In this stage, pharmacists were expected to use the knowledge obtained from the pharmacy education (see Section 5.4 for details on pharmacy education) to identify barriers to medication compliance and identify the patient’s stage of behaviour change. The key activities and tools for Stage 2 are outlined in Table 6.
Table 6: Actions and tools for stage two
Activity Description Tools
1 Patient completes questionnaires
After patient consent, the patient completes the patient characteristics form and patient questionnaire (see Section 5.8 for more details on the data collection forms).
Patient characteristics form and questionnaire (Appendix F)
2 Discuss patient’s medication taking behaviour
The pharmacist discussed with patients their reasons for not taking their medications as prescribed, to identify barriers to medication compliance.
Not applicable
3 Assess patient’s stage of change
Pharmacist identified and began to understand the patient’s readiness or motivation to change their behaviour.
Stages of change (see Section 1.6.2)
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3.2.3. Stage 3: Collaborate and commit to next steps
In Stage 3, pharmacists collaborated with their patients to select and agree on appropriate strategies that were tailored to their needs. Pharmacists also assessed a patients’ readiness to change, identified through the patient questionnaire and discussion. The types of strategies used include:
• Patient diary
• Patient education
• Medication Profiling
• Referral to GP
• Dose Administration Aids (DAA)
• Home Medicines Review (HMR)
• Reminders
• Celebrating success.
The key activities and tools for stage three are outlined in Table 7.
Table 7: Actions and tools for stage three
Activity Description Tools
1 Agree on strategies Pharmacist collaborated with the patient to agree on strategies to assist the patient improve their medication compliance
Patient strategy card (Appendix F)
2 Record strategies Once the strategy(s) were selected, the selected strategies, MedsIndex score and readiness to change were recorded on the patient strategy card.
Patient strategy card (Appendix F)
3.2.4. Stage 4: Follow through
The final stage of the intervention required both the patient and the pharmacist to follow through on the agreed strategies. Additionally, the pharmacist was required to follow-up with the patients at three and six months after the commencement of the trial. Follow-up involved monitoring and management of the strategies through a discussion with the patient and collection of data about their medication taking behaviour using the questionnaires and tools described in Stage 2 and Stage 3. The key activities and tools for stage four are outlined in Table 8.
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Table 8: Actions and tools for stage four
Activity Description Tools
1 Send GP summary letter Send GP summary letter to patient’s GP, if they have provided consent.
GP summary letter template
2 Agree return date Agree a return date with the patient to complete the follow through with the patient and record on the strategy card
Patient Strategy Card
3 Three month follow-up with patient
Undertake the three month follow-up activities with the patient including reviewing the effectiveness of the strategy and recording on the patient strategy card.
Patient Strategy Card
4 Six month follow-up Undertake six-month follow-up activities with the patient including the patient questionnaire, strategy card and patient satisfaction survey.
Patient Questionnaire
Patient Strategy Card
Patient Satisfaction Survey
3.3. Reimbursement of pharmacists
As part of the trial design, pharmacies were reimbursed for their participation in the trial:
• one time payment of $250.00 for their attendance at the education workshop, to cover out of pocket expenses for attending the workshop
• an honorarium payment of $50.00 per patient recruited, paid at the completion of the trial, in recognition of the time and effort invested in the trial.
3.4. Timeframes for the research project
The research project commenced in August 2008 and concluded in April 2010.
The trial, including pharmacy recruitment and education, was implemented over a period of eight months from April 2009 to December 2009, with the patient medication compliance intervention implemented over a period of six months from June 2009 to December 2009. Figure 8 provides further detail on the timing of key activities for the research project.
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Figure 8: Timeline for key research project activities
Stage 3 Stage 4 Stage 6Stage 5Stage 1
Project initiation Conduct pilot Trial ImplementationAnalyse
Trial ResultsDraft and
final report
Start-up meeting
Start-up meeting
Plan PilotPlan Pilot
Literature ReviewLiterature ReviewConduct pilot (2
months)
Conduct pilot (2 months)
Baseline data collection
Baseline data collection
Recruitment and education of pharmacies
Recruitment and education of pharmacies
Mid-point (3-month) data collection
Mid-point (3-month) data collection
End trial (6-month) data collection
End trial (6-month) data collection
Development of recommendations and considerations
Development of recommendations and considerations
Trial analysis and economic evaluation
Trial analysis and economic evaluation
Draft reportDraft report
Final reportFinal report
5 weeks5 weeks 4 months4 months 8 months8 months 2 months2 months 2 months2 months
Oct 2008
April2009
Dec 2009
Feb 2010
April 2010
1 Sep 2008
Activity 1
Activity 2
Activity 7 Activity 9 Activity 13 Activity 15
Activity 16Activity 14Activity 10Activity 8
Activity 11
Project plan complete
Agreement to pilot design and timeframe
Recruitment of nationally representative sample of pharmacists and patients.
Collection, cleaning and storage of midpoint data
Successful testing of interventions for the trial
Literature review complete
Regular updates and communication with the GuildRegular updates and communication with the Guild
Activity 12
All post-trial data collected
Final report complete
Draft report complete
• WS 7: Stakeholder feedback on draft
• WS 8: Advisory panel feedback on draft
• WS 9: Guild feedback on draft
• Present results as requested by Guild
• WS 4: Guild presents results
• WS 5: Advisory panel presents results
• WS 6: Stakeholders results & implementation
• Project initiation meeting
• WS 1: Advisory panel project overview
Stage 2
Strategy development
Stakeholder workshops
Stakeholder workshops
Agree trial designAgree trial design
2 months2 months
Dec 2008
Activity 3
Activity 4
Ethics approval granted
Collection, cleaning and storage of baseline data
Ethics Committee Approval
Ethics Committee Approval
Activity 5
Trial tools and design
Trial tools and design
Activity 5
3.5. Ethics approval
The Improving Medication Compliance research project was conducted with ethics approval from the University of Sydney Ethics Committee on 18 December 2008 (Reference number: 12-2008/11530).
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4. Pilot
4.1. Objectives of the pilot
To test the trial hypotheses and trial design, a pilot was carried out prior to the implementation of the national trial. The pilot’s primary aim was to test the processes for the intervention, the tools for data collection and the patient compliance strategies for appropriateness. The results of the pilot informed refinement of the education program, the patient intervention, data collection tools and methods for the national trial.
4.2. Pilot approach
The approach to the pilot involved the following key activities:
• pharmacy recruitment
• pharmacy education
• patient recruitment
• intervention, data collection and support
• analysis and findings from the pilot.
Figure 9 illustrates the pilot activities which are described in greater detail below.
Figure 9: Summary of key activities undertaken in the Pilot
December 2008 January 2009 February 2009 March 2009 April 2009
PHARMACY RECRUITMENT
EDUCATION WORKSHOPS
SITE VISTSPHARMACY
TELE-CONFERENCE
SATISFACTION SURVEY
General pharmacy support
January
PATIENT RECRUITMENT
4.2.1. Pharmacy recruitment to the pilot
A convenience sample of 15 community pharmacies from New South Wales (NSW), Victoria (VIC) and Queensland (QLD) were recruited to participate in the pilot with the help of Reference Group members. As outlined in Table 9, thirteen pharmacies participated in the pilot after two pharmacies dropped-out.
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Table 9 Pharmacy recruitment to the pilot
State Pharmacies recruited Pharmacy drop-out
NSW 4 1
VIC 8 1
QLD 3 0
Total 15 2
4.2.2. Pharmacy education
Pharmacies received education and training in the use of the data collection tools and protocols of the pilot via two main methods: education workshops and site visit training by members of the research team. Education workshops were held in Brisbane, Sydney and Melbourne and were attended by a total of 15 pharmacies. The training covered:
• use of MedsIndex
• identification of patients using MedsIndex
• approach to recruitment of patients
• ongoing monitoring and follow-up with patients, including collaboration with GPs
• use of the data collection tools.
One pharmacy withdrew from the pilot after attending the education workshop due to a lack of staff resources to carry out the pilot.
Following the education workshop, each of the remaining 14 pilot pharmacies were visited by a member of the research team. The purposes of the site visits was to consolidate learnings from the workshop, tailor the intervention to suit the individual pharmacy practice (eg dispensing software) and discuss any issues or questions the pharmacist had about the intervention.
One additional pharmacy dropped out after the site visit due to difficulties using MedsIndex (which was not integrated into their dispensing software), leaving 13 pharmacies remaining in the Pilot.
4.2.3. Patient recruitment
The inclusion criteria for patients in the pilot were:
• at least 18 years of age
• fluent in spoken English
• taking at least one regular medication
• low level of compliance (ie a benchmark MedsIndex score of 85 or less).
Patients were recruited via two main methods: (1) opportunistically, on presentation to the pharmacy to have a prescription filled; and (2) proactively from the pharmacy database via a telephone request.
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Some pharmacies used alternative recruitment methods for the pilot such as sending letters out to patients on the dispensing list and advertising within the pharmacy. Divisions of General Practice, local to participating pharmacies, were notified about the pilot and the possible inclusion of their patients.
Each pharmacist was asked to recruit six patients to test the tools and protocols. The participating pharmacies recruited a total of 40 patients, which was 44% of the recruitment goal of 90 patients (see Table 10).
Table 10: Patient recruitment to the pilot
State Patients recruited Number of pharmacies who recruited patients
NSW 12 2
VIC 24 7
QLD 4 1
Total 40 10
Of the 13 pharmacies in the pilot, three pharmacies did not recruit any patients (23%). These pharmacies used dispensing software that did not interface with MedsIndex making identification of non-compliant patient’s difficult (see Table 12 for further detail).
4.2.4. Intervention, data collection and support
The pilot consisted of a three month data collection period. Pharmacists in the pilot were required to complete the following forms:
• the pharmacy consent form
• a pharmacy demographics questionnaire
• a patient record sheet which was used to collect data on selected strategies and MedsIndex scores.
The patient intervention comprised the four stage process (as described in Section 3.1). As part of the patient intervention, patients were required to complete:
• the patient consent form
• demographics questionnaire
• patient reminder and confidence cards
• the patient medication questionnaire, which was used to collect information on compliance patterns and beliefs about their medication.
Pharmacies participating in the pilot were provided with a range of resources to support them in the pilot. See section 5.6 for a description of the additional pharmacy support.
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4.3. Key findings of the pilot
Data collected in the pilot were analysed to identify improvements in the pharmacy and patient interventions for implementation in the national trial. Key findings of the pilot are discussed under the two trial hypotheses:
• Pharmacy intervention – an effective compliance service can be developed and implemented in the community pharmacy setting (Table 11).
• Patient intervention – a significant improvement in patient compliance will be seen as a result of the pharmacist intervention (Table 12).
Table 11: Key findings – pharmacist intervention
Findings – pharmacy recruitment Action
The pilot demonstrated the importance of keeping pharmacies engaged throughout the recruitment process through to implementation.
Developed a comprehensive recruitment and communications strategy for the national trial.
The convenience sample used in the pilot was not relevant to the national trial
A sampling approach based on the Pharmacy Access / Remoteness Index of Australia (PhARIA) and the Socio Economic Indexes for Areas (SEIFA) categories was developed to obtain a representative sample of pharmacies.
The pharmacy drop out rate of 13% in the pilot highlighted the need to oversample in the trial.
Established a recruitment goal for the national trial of 105 pharmacies. To try and maintain that figure over the life of the trial, an oversample of 140 pharmacies was required.
Findings – education workshop Action
The logistics of the education workshops worked well, key industry speakers were influential and the format of the workshops was appropriate.
Learnings about workshop logistics and format were fed into the organisation of workshops for the national trial.
Internal review and feedback from pilot participants identified parts of the workshop that required greater clarity, review and streamlining to make the content and delivery more efficient and to have greater impact.
Feedback from pharmacists highlighted the need for MedsIndex training as most of the pharmacists had not used the tool before.
Reviewed and edited the workshop curriculum to:
• create clear learning objectives
• review and streamline content where possible and reduced training time from five hours to approximately four hours
• have a greater focus on MedsIndex training
• include instructions for next steps and timelines to improve clarity.
The pilot highlighted the importance of clearly stating the benefits of pharmacy participation to increase and maintain engagement throughout the trial.
Workshop curriculum was expanded to include benefits and business case for community pharmacy participation in the trial eg Continuing Professional Development (CPD) points, improved patient loyalty, increased scripts filled, future of professional pharmacy services, etc.
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Findings – site visit Action
The pilot demonstrated the importance of site visits in building relationships with pharmacy staff. The site visits also provided an opportunity to enhance the whole of pharmacy approach by training staff who did not attend the education workshop.
A refined site visit checklist and agenda for site visits were developed to make site visits more efficient and effective. A detailed resources plan for the trial site visits was implemented to maximise efficiencies.
Findings – patient recruitment Action
Pharmacists identified the following barriers during patient recruitment: the use of MedsIndex, resistance from patients, resistance of patients to having GPs notified, time pressures, etc.
In addition to increasing MedsIndex training in workshops and site visits, greater emphasis in the education curriculum for the trial was put on the importance of ‘motivational interviewing’ skills.
Recognising that not all pharmacies would be able to complete the trial, the sample size was revised and protocols were developed for ‘incomplete data’.
Findings – follow-up support Action
Telephone support for pharmacist was more extensive than anticipated demonstrating the importance of ongoing prompting and support from the research team for successful recruitment/retention and data collection during the trial.
A detailed communications plan for pharmacy follow-up (eg number of follow-up calls, use of fax streams, teleconferences and website and other methods for follow-up) was developed to provide support to the national trial.
Emphasis was placed on clear messaging, and required actions and deadlines in communications to pharmacies during the trial.
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Table 12: Key findings – patient intervention
Findings – Stage 1: Sign up and recruitment Action
Pharmacies using the dispensing database ‘Minfos’ experienced significant difficulties using MedsIndex to identify non-compliant patients. Of the four pilot pharmacies using ‘Minfos’ only one recruited patients.
‘Minfos’ users were not excluded from the national trial but were warned about the difficulties they would experience in identifying potential patients for the Trial. Please note, this issues were later resolved and Minfos pharmacies participated in the trial.
Pharmacists reported that some patients did not consent to the pilot as they did not want the pharmacist contacting their GP.
This was discussed with the Advisory Panel and it was agreed that patients who do not consent to the pharmacist contacting their GP could remain in the trial, ie notification of GPs was recommended as good practice but not mandatory to patient participation in the trial.
Findings – Stage 2: Explore medication taking behaviour
Action
Pharmacists reported that there was too much paperwork and too much data to be collected on the patient information sheet and patient questionnaire. This resulted in some patients withdrawing from the pilot.
Patient forms were reviewed and streamlined where possible to make them more succinct.
Communication to pharmacists elaborated on the purpose of the forms and the need to collect complete data for research purposes.
Patient forms were well received by pharmacists as a useful tool for discussion with patients, although patients routinely needed help to complete them.
Education workshops for the trial had a greater focus on in-pharmacy resourcing. Pharmacists were encouraged to determine what role pharmacy assistants or other staff could play in the trial. For example, some pharmacies had their assistants help patients to complete the patient forms.
Some pharmacists reported mixed findings regarding the use of the consulting / counselling room. Some patients found it daunting to be taken to the counselling room while others preferred the privacy.
Pharmacists were encouraged to assess the patient’s preferences when considering using a consulting room.
Findings – Stage 3: Collaborate and commit to next steps
Action
Few pharmacies adequately completed the required forms for this stage of the intervention eg recording strategies and reminder cards.
Forms were reviewed and streamlined for the trial eg combined confidence scale into the reminder card.
There was limited variation in the strategies used to improve patient medication compliance. The strategy most selected by pharmacists and patients was ‘patient education’ and ‘reminders’. It was unclear what the reasons were for this limited variation in use.
Greater detail about strategies was provided in the education workshops for the trial.
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Findings – Stage 4: Follow through Action
The pharmacist was required to initiate getting patients back to the pharmacy for follow-up, for example, reminder calls were necessary.
Given the short length of the pilot, pharmacists had limited time to follow-up with patients. Not all patients completed the follow through stage.
Follow-up activities were specified and built into the education workshop so that pharmacists understood their role in following up with the patient.
Significant effort was required by the research team to get pilot data back from the pharmacies.
Education materials and communication plans for the trial were refined to outline for the pharmacists what the data collection requirements and timelines were. A full communication strategy including individual pharmacy phone follow up, fax reminders, national teleconferences and newsletters were also put into place.
4.4. Pilot conclusions
Overall the Pilot was well received by patients and pharmacists. Patients were generally receptive to the questionnaires and compliance strategies and pharmacists reported a positive experience of building relationships with their clients. The key findings of the Pilot informed significant changes to the national trial design:
• The education workshop curriculum was reviewed and edited.
• Analysis of pilot study data was a valuable exercise to determine the disparities in interpretation of data collection tools by pharmacists and patients and their correct use. As a consequence, pharmacist and patient data collection tools and accompanying instructions were refined.
• Limitations experienced with the MedsIndex tool were a key learning that resulted in significant changes to the education workshop and site visit agenda during the national trial. Additionally, conversations were held with each of the major community pharmacy dispensing software companies to confirm the status of integration of MedsIndex into software packages and collect the documentation of procedures required to use MedsIndex with each software package.
• A comprehensive communication strategy and other methods were developed to manage the significant support pharmacists would require over the life of the trial.
The implications of the Pilot were extensive and formed the ground work for the implementation of the national trial methodology.
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5. Trial methodology
The specific objectives of the Improving Medication Compliance trial were to investigate the role of community pharmacists in improving medication compliance among users of regular medicines by developing, implementing and evaluating a professional pharmacy service for medication compliance.
This section describes the methodology for the Improving Medication Compliance Trial, including:
• procedures and timelines
• sampling framework, reimbursement and recruitment
• training and education
• resources, support and communication
• patient and pharmacy data collection
• data management and analysis.
5.1. Overview of trial activities and timelines
Conducted over an eight month period, from April 2009 until December 2009, the pharmacy intervention had four key activities which are illustrated in the process diagram below. The development, implementation and evaluation of these activities are described in this section. Each of the key activities highlighted in Figure 10 will be described in detail in this section.
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Figure 10: Key activities in the pharmacy intervention
Support activities
Ph
arm
acy
recru
itm
ent and
sele
ctio
n
Pha
rma
cis
t tr
ain
ing
and
ed
uca
tion
Deliv
ery
of th
e
patie
nt
inte
rven
tion
Pharmacy notified of selection (based on
sampling framework)
Pharmacy's expression of
interest
Pharmacy completes
baseline data collection
Attendance at education
workshop
Did pharmacy attend?
Site visit
Tele-conference
No
Yes
3 month patient follow-up and
research support
6 month patient follow-up and
research support
National teleconference
END
Toll free phone line, dedicated fax number and confidential email support
On
go
ing s
uppo
rt
to p
harm
acie
s
Recruitment and delivery of patient
intervention
Pharmacy completed end of
trial data collection
National teleconference
National teleconference
Monthly newsletters, reminder faxes, telephone calls and website
5.2. Sampling framework
The aim of the sampling framework was to ensure that the trial was representative of Australian community pharmacies. To minimise sampling bias, pharmacies were stratified in two ways:
• by PhARIA which was used to minimise sampling bias from pharmacy location and to ensure inclusion of rural and remote community pharmacies
• by SEIFA which was used to provide information on the relationship between socio-economic status, education and health outcomes.
PhARIA is a standardised measurement of the physical and professional remoteness of pharmacies throughout Australia. Pharmacies within Australia can be classified into category one (highly accessible) to category six (very remote) based on their geographic location.
For the purposes of the research project, PhARIA categories were combined into two groups:
• PhARIA categories one to two
• PhARIA categories three to six.
SEIFA is an analytical tool created by the Australian Bureau of Statistics which is used to rank geographical areas across Australia in terms of their relative socio-economic conditions. SEIFA is a broad measure of socio-economic disadvantage, consisting of ten SEIFA deciles, with the lowest socio-economic areas categorised as one and the highest socio-economic areas categorised as ten.
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For the purposes of the research project, SEIFA categories were then combined to highlight:
• relative disadvantage (groups one to four)
• relative midpoint in the scale (groups five to six).
• relative advantage (groups six to ten).
To obtain the necessary statistical power required, the target number of pharmacies for the national trial was estimated to be approximately 105 pharmacies across all jurisdictions. The sampling methodology for the trial is similar to that used by Berbatis, Sunderland, Mills and Bulsara (2003) for the National Pharmacy Database research project.
5.2.1. Development of the pharmacy sampling framework for the national trial
Table 13 outlines the total number of community pharmacies in Australia, categorised into PhARIA and SEIFA categories.
Table 13: Stratification of total pharmacies in Australia based on PhARIA and SEIFA*
SEIFA
1-4
SEIFA
5-6
SEIFA
7-10
PhARIA 1-2 790 (16%) 835 (16%) 2,810 (55%)
PhARIA 3-6 462(9%) 118 (3%) 60 (1%)
Total 5,075 *Based on pharmacy identification numbers provided by the Department of Health and Ageing, received December 2008
The target sample of 105 pharmacies was then distributed according to the percentages described in Table 13, the resulting stratification of the 105 pharmacies is outlined in Table 14.
Table 14: Stratification of the 105 trial pharmacies based on PhARIA and SEIFA
SEIFA
1-4
SEIFA
5-6
SEIFA
7-10
PhARIA 1-2 16 (15%) 17 (16%) 58 (55%)
PhARIA 3-6 10 (10%) 3 (3%) 1 (1%)
Total pharmacies 105
Based on the pilot results and given the nature of research projects, it was expected that there would be pharmacies that would pull out of the trial across the six month period. To accommodate the anticipated pharmacy attrition, the research team sought to recruit approximately 140 pharmacies to the trial to maintain a representative sample of 105 pharmacies over the life of the trial.
The sampling framework for the national trial, based on 140 pharmacies, is outlined in Table 15.
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Table 15: The sampling framework for the national trial based
SEIFA
1-4
SEIFA
5-6
SEIFA
7-10
PhARIA 1-2 22 (16%) 23 (16%) 78 (56%)
PhARIA 3-6 13 (9%) 3 (2%) 1 (1%)
Total pharmacies 140
5.2.2. Patient distribution
Community pharmacists’ recruited patients from their customer pool either proactively or opportunistically as they presented to the pharmacy to have their prescriptions filled. Each participating pharmacy was asked to recruit between ten and fifteen patients to the trial in order to reach the patient target.
5.3. Recruitment process
As described above, the aim of the recruitment process was to have a nationally representative sample of pharmacies and patients across all jurisdictions by PhARIA and SEIFA categories. The pharmacy and patient recruitment processes are described below.
5.3.1. Pharmacy recruitment process
The sampling framework, described in Section 5.2, formed the basis for recruiting and selecting the pharmacies for the trial. The procedure for recruiting and obtaining the target sample of 140 pharmacies included four key steps:
1. Expressions of interest
2. Pharmacy selection
3. Completion of ‘consent bundle one’
4. Completion of ‘consent bundle two’.
Step 1: Expressions of interest
Pharmacists were recruited via an expression of interest (EOI) process. An EOI letter (Appendix G) was distributed to pharmacies across Australia, requesting that they express their interest in participating in the trial. The EOI was sent to community pharmacies across Australia using four methods, which included:
• emailing the EOI letter to all community pharmacies who were members of the Guild
• faxing the EOI letter to over 4,000 community pharmacies (for whom the researchers had fax contact details)
• placing the EOI letter on the Guilds website
• including the EOI letter in the Guilds research and development newsletter.
Approximately 259 community pharmacies expressed interest in participating in the trial.
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Step 2: Pharmacy selection
Of the total number of 259 pharmacies who expressed interest, twelve did not meet the recommended trial criteria because it was not possible to integrate the MedsIndex tool with their dispensing software. Without a functional MedsIndex tool, identification of non-compliant patients for recruitment was very difficult as discovered in the Pilot. Of these twelve pharmacies, eight chose to withdraw from the trial once they were advised of the anticipated difficulties they would experience during the patient recruitment stage of the trial. All EOI pharmacies were then categorised based on the PhARIA and SEIFA sampling framework as described in Table 16.
Table 16: All EOI pharmacies stratified by PhARIA and SEIFA
SEIFA
1-4
SEIFA
5-6
SEIFA
7-10
PhARIA 1-2 37 (14%) 38 (15%) 155 (60%)
PhARIA 3-6 18 (7%) 8 (3%) 3 (1%)
Total pharmacies 259
Pharmacies were then selected for the trial based on the sampling framework described in Table 15. For the categories within the sampling framework that were overrepresented, pharmacies were randomly selected using an excel randomisation function. A total of 132 pharmacies were selected.
Step 3: Consent bundle one
Once pharmacies were selected, a follow-up telephone call informed them they had been selected for the trial and a ‘consent bundle’ was sent out. Consent bundle one included the following (see Appendix H):
• Letter of invitation: informed pharmacies of their selection to the trial and provided further information on the detail of the trial
• Next steps information sheet: informed pharmacies about the initial actions required prior to the commencement of the education workshops
• Pharmacist frequently asked questions: provided answers to common questions regarding the trial
• Pharmacy consent form: included both an original copy and a pharmacy copy
• Pharmacy demographic survey: collected core information regarding the pharmacy and its characteristics
• Education workshop preference form: regarding preferred attendance at an education workshop.
Following distribution of the pharmacy consent bundle one, an additional follow-up telephone call was undertaken with pharmacies who had not returned their consent forms to discuss the information and follow-up whether the pharmacy was willing to take part. From these phone calls it became apparent that a number of pharmacies who had expressed interest, for a number of reasons, were unable to participate in the trial. Additional pharmacies were selected and sent consent forms in order to fill the sample
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Step 4: Consent bundle two
Once the information from consent bundle one had been received, pharmacies were sent consent bundle two which included confirmation of inclusion in the trial and information regarding workshop attendance and information on next steps for the trial.
5.3.2. Pharmacy recruitment
The location of the 132 recruited pharmacies are presented in Figure 11.
Figure 11: Map of recruited pharmacies at start of trial
Key: consented pharmacyKey: consented pharmacy
Participating pharmacies were then categorised, based on PhARIA and SEIFA, for comparison with the sampling framework (see Table 15) to ensure recruited pharmacies were representative of Australian community pharmacies. The results are presented in Table 17.
Table 17: Participating pharmacies stratified by PhARIA and SEIFA
SEIFA
1-4
SEIFA
5-6
SEIFA
7-10
PhARIA 1-2 19 (14%) 24 (18%) 73 (55%)
PhARIA 3-6 9 (7%) 6 (5%) 1 (1%)
Total pharmacies 132
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5.4. Education and training of pharmacists
A core component of the pharmacist intervention was the delivery of education and training. According to principles of change management and behaviour change, the successful implementation of the compliance service relies on engaged and trained pharmacists who are confident in delivering the service. Education and training was provided to all pharmacies participating in the trial. The purpose of the education was to provide participating pharmacies with:
• current information on medication compliance (based on key findings in the literature review), including the impact and extent of non-compliance, importance of medication compliance and the role of community pharmacies in improving compliance
• facilitating and improving medication compliance through behaviour change and the use of motivational interviewing
• training on use of MedsIndex to identify patients who are non-compliant
• training on delivery of the Improving Medication Compliance service to their patients (intervention design)
• training on accurate and complete documentation of the service and patient data relative to the research protocols
• summary of key activities and timelines for the trial.
Education and training was provided to community pharmacies via a number of methods, which were:
• attendance at an education workshop
• site visit from a research team member
• teleconference with the research team
• a combination of the above mentioned education methods.
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5.4.1. Education workshops
Ninety-three or 70% of the participating pharmacies attended an off-site workshop held at PwC offices in one of five regional locations – Sydney, Melbourne, Brisbane, Adelaide and Perth. An additional workshop was held in Wagga Wagga. Eight education workshops in total were held in May and June 2009. To facilitate a consistent delivery of training across all workshops, a core group of the research team delivered the training (see Appendix I for education materials).
The focus of the education workshops was to improve the pharmacists’ perceptions of the importance of a medication compliance service and to increase their confidence in their ability to deliver the service/intervention. Key features of the education workshops which assisted the research team to achieve this included:
1. The education workshops were delivered as train-the-trainer sessions, supported by practical materials and workbooks that were used to assist the pharmacy representatives to provide training to other staff within their pharmacy. Pharmacies were also encouraged to send at least two staff who would be involved in the day-to-day delivery of the compliance service, to enable follow-up reinforcement and support the medication compliance service to be more easily integrated back into their pharmacy setting.
2. Practical training was provided on the tools and materials designed to support pharmacists in delivering the service to improve the pharmacists’ confidence in using the tools. For example, training was provided on using MedsIndex to identify non-compliant patients and on administering the validated and normed scales. The workshops included the use of didactic lecture style training, demonstrations and role plays. Pharmacists were also provided with personalised training during the pharmacy site visits.
3. Education workshops were supported by easy to use written materials designed to cue the main implementation steps for pharmacies. For example, a step-by-step workbook, reminder cards, checklists, self-explanatory forms and non-carbonated copy forms for recording strategies and progress.
4. Education workshops were delivered using adult learning principles of multi-sensory learning to cater for the different learning styles of participants. This was achieved through the use of a combination of oral and visual didactic lecture style training, interactive demonstrations and role plays. This type of learning also reinforces the new knowledge and skills of the training program.
5. Information was delivered by peer ‘champions’ on the benefits to pharmacies, in terms of the professional difference made in the lives of their patients, patient loyalty and the potential for financial returns. This approach helped increase the perceived importance of the trial amongst participating pharmacists.
6. There was a focus on behaviour change tools and techniques, including stages of change, motivational interviewing and change readiness. For example, a core component of the education workshop was training and practice in motivational interviewing, which incorporates a series of communication techniques which pharmacists were asked to use to interact with their patients in the delivery of the compliance service.
7. Representatives from the National Prescribing Service, the Guild and other representative bodies were invited to attend and participate in the education workshops to facilitate a collaborative approach and provide additional support at the local level.
8. CPD points were provided to practicing pharmacists who attended and participated in the education workshops.
A total of 140 pharmacist and pharmacy staff attended representing the 93 pharmacies. Table 18 is a summary of attendance at each of the eight education workshops.
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Table 18: Attendance at each of the eight education workshops
Education workshop Pharmacies represented Pharmacy staff
Sydney workshop one 16 35
Sydney workshop two 21 22
Melbourne workshop one 10 14
Melbourne workshop two 7 12
Perth workshop 8 14
Brisbane workshop 21 31
Adelaide workshop 6 9
Wagga Wagga workshop 4 3
Total 93 pharmacies 140 participants
Those pharmacies who were unable to attend the workshops received training via site visits or teleconference, using the same training material from the workshops.
5.4.2. Site visits and teleconference education
The majority (74%) of participating pharmacies also received site visits or teleconference education to reinforce the workshop education and assist pharmacy staff with the process of data collection, tailored to suit their individual pharmacy.
Teleconferences were provided to pharmacies unable to attend the education workshops, particularly for pharmacies in remote locations. The teleconferences utilised the education workbooks and followed the same structure as the education workshops.
Site visits to pharmacies by the research team were used to reinforce the new knowledge and skills gained in the education workshops and teleconferences. The site visits also provided the opportunity to assist pharmacists in modifying the compliance service to suit their individual pharmacy.
Table 19 provides a summary of the number of pharmacies who received a site visit or participated in a teleconference.
Table 19: Site visits and teleconference education
State Pharmacies who participated in a site visit or
teleconference
New South Wales 27
Victoria 19
Western Australia 9
Queensland 27
South Australia 8
Tasmania 6
Northern Territory 1
Total 97 pharmacies
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5.5. Patient recruitment
Pharmacies were asked to recruit approximately 10 to 15 patients to the trial. To assist with recruitment, pharmacies were provided with leaflets and information sheets for patients (see Appendix E). Pharmacists used their dispensing systems and MedsIndex to screen for patients with an indication of medication non-compliance and identify those patients suitable to be invited to participate in the trial.
Patients were recruited to the trial upon presentation to the pharmacy to have a prescription refilled or via a telephone request by a member of the pharmacy staff. The eligibility and exclusions criteria for patient recruitment into the trial were as follows.
• to be considered eligible for the trial, a patient must:
− be aged 18 years and over
− be able to return for follow-up visits
− be currently on long term chronic medication
− have MedsIndex score of 85 or below (patients with a MedsIndex score of greater than 85 could be included in the study at the discretion of the pharmacist, ie if there was a clinical indication for improving compliance)
• ineligibility for participation in the trial included those patients who:
− did not speak English well enough to communicate with the pharmacist or sign the consent form
− did not complete and sign the patient consent form (Appendix E).
Once the pharmacist had confirmed the patient’s willingness to participate, they introduced the baseline patient forms for discussion and completion. The patient was required to complete the:
• patient consent form which included both a patient copy and a pharmacy copy
• patient characteristics survey which collected demographic information about the patient
• patient questionnaire which explores the patient’s beliefs and attitudes towards medications
• patient strategy card once the pharmacist and the patient had agreed on strategies to improve the patient’s medication compliance and agreed a return date for follow through.
During the initial patient recruitment period, it was apparent that pharmacies would fall short of the recruitment target. Pharmacists required additional support to help them recruit their patient quota of 10 to 15 patients per pharmacy. Additional support from the research team comprised of:
• regular phone contact with pharmacy staff to discuss any problems with patient recruitment and identify ways to overcome these
• regular project newsletters to all pharmacies outlining recruitment progress and sharing useful recruitment tips from other pharmacies
• teleconferences for all participating pharmacies to ask questions, share ideas and tips on patient recruitment
• further phone calls were made to pharmacies that had reached or were close to their patient quota of 10 to 15 recruited patients. These pharmacies were informed they could recruit up to 25 patients to compensate for the recruitment shortfall in other pharmacies.
These additional measures assisted pharmacies to recruit 798 patients.
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5.6. Pharmacy resources, support and communication
5.6.1. Pharmacy resources
Following the pharmacy education, a variety of communication activities and materials were provided to support pharmacies in the trial. These resources included:
• an improving medication compliance education workbook, to enable further training and ongoing reference in the pharmacy
• checklists and timelines to aid pharmacists to track completion of each step in the trial
• a ‘patient pack’ which included sufficient patients forms for approximately 15-20 patient participants
• a CD-ROM which included:
− invoice templates
− reference materials and additional reading (eg MedsIndex information and user guides for each of the dispensing software programs)
− additional patient forms if needed
5.6.2. Additional pharmacy support
Additional support was provided to pharmacists throughout the trial by the research team, including:
• 1800 telephone support line, available Monday to Friday from 8:00am to 6:00pm (EST)
• dedicated and confidential fax line
• dedicated and confidential email address
• website for discussions, frequently asked questions and updates
• national teleconferences held every two-months allowing pharmacists to share success stories and gain additional support.
5.6.3. Pharmacy communication
Throughout the trial, the research team used a range of different communication methods to inform pharmacists of trial progress, upcoming requirements and timeframes, follow-up missing information and data, and to provide ongoing support. These communication methods included:
• regular phone calls
• faxes and mail-outs
• regular newsletters (Appendix J)
• national teleconferences held every two months.
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5.7. Pharmacy data collection
Data collection at the pharmacy level consisted of the pharmacy demographic survey and pharmacy survey, each of which is described in further detail below:
5.7.1. Pharmacy demographic survey
The pharmacy demographic questionnaire (Appendix K) consisted of selected questions from the Guild’s Community Pharmacy Census. It included questions about the pharmacy, including:
• ownership details and trading hours
• professional services currently offered within the pharmacy
• size of pharmacy and number of staff
• revenue and number of scripts filled.
The pharmacy demographic survey had a response rate of 99%.
5.7.2. Pharmacy survey
Participating pharmacies who completed the trial received the end of trial pharmacy survey. Pharmacies who withdrew from the trial prior to completion received an adapted version of pharmacy survey.
The pharmacy survey (Appendix K) consisted of 31 questions which collected information on the:
• pharmacist’s readiness to change
• costs involved and time taken to deliver the medication compliance professional service
• pharmacist’s experiences and satisfaction with the trial.
The pharmacy surveys had a response rate of 58%.
5.8. Patient data collection
Data collection at the patient level is described:
Type of data collection Timing Section
Patient characteristics questionnaire Baseline 5.8.1
Patient questionnaire Baseline, end of trial 5.8.2
Patient strategy card Baseline, mid trial, end of trial 5.8.3
Patient satisfaction questionnaire End of trial 5.8.4
5.8.1. Patient characteristics questionnaire
The patient characteristics questionnaire collects information about the patients’ demographics, including their sex, age, country of birth and preferred language (Appendix F).
The patient characteristics questionnaire had a response rate of 100%.
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5.8.2. Patient questionnaire
The patient questionnaire comprises the Medication Adherence Report Scale (MARS) (Horne et al., 2005) and Beliefs about Medications Questionnaire (BMQ) (Horne, Weinman, & Hankins, 1999):
• MARS is a five-item validated self–report questionnaire which measures patients’ compliance patterns and reasons for non-compliance by asking respondents how often frequently they engage in types of non-adherent behaviours (Appendix F).
• BMQ is an eighteen-item validated self–report questionnaire which assesses patients’ beliefs about the necessity of prescribed medication for controlling their illness and their concerns about the potential adverse consequences of taking the medication (Appendix F).
The patient questionnaire had a response rate of 100% at baseline and 62% at the end of the trial.
5.8.3. Patient strategy card
The patient strategy card was developed by the research team to record (Appendix F):
• the patients medication(s) and MedsIndex score
• the date the patient will return to the pharmacy for follow up
• the strategy(s) which were agreed upon by the patient and pharmacist and a brief description of the strategy(s)
• the patients’ readiness to implement the strategy(s), by recording the patients’ confidence in using the selected strategy(s) and how important they believe the change is
• the patients’ stage of change, as assessed by the pharmacist.
MedsIndex
The MedsIndex score is the empirical measure of medication compliance used in the trial. The MedsIndex score was used to identify patients who may have a compliance issue and to monitor changes in patients’ compliance over time.
MedsIndex provides a score out of 100 which is calculated and is based on the number of missed doses a client may have had in the given time period. The lower the MedsIndex score the lower the patient’s presumed medication compliance. Pharmacists were asked to record the patients MedsIndex score on the patient strategy card and / or provide the MedsIndex print out.
The patient strategy card had a response rate of 100% at baseline, 84% at mid point and 69% at the end of the trial.
5.8.4. Patient satisfaction questionnaire
The patient satisfaction questionnaire was used to measure the patients’ satisfaction with the medication compliance service and their participation in the trial, along with information on any costs involved in the service (Appendix F).
The patient satisfaction questionnaire had a response rate of 71%.
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5.9. Data management processes
5.9.1. Access database
Due to the large number of forms received from each pharmacy and client, there was a need for an efficient data management system to be constructed. A database was built so all information could be stored in a coherent manner for analysis. The database was developed in Microsoft Access, using a split database architecture, ie with a front end user interface in Access and all back end datasets stored in Microsoft SQL Server. This approach enabled multiple users to enter data at the same time and improved data security. Using the functionality within MS Access and Access Visual Basic, a series of Access data entry forms were created based on the data collection forms.
The following principles were followed in designing the database:
• Data validations were applied to ensure the user could only enter certain information (eg Yes/No dropdowns containing “Yes” and “No”, but no other variation).
• A series of business rules were developed to minimise errors in data entry (for example pharmacy start dates on the trial could not be after a certain date).
• The database was engineered to produce a series of automated reports, which enabled the research team to keep track of how many hard copy forms had been received, how many pharmacies and clients were in the trial and how many had dropped out.
• The database had built in safety components to give the user the option to cancel or save information entered. The architecture was built in such a way that the user could drill down to each data entry forms for each pharmacy by selecting from a dropdown menu.
• The datasets containing information entered were created and stored using Microsoft SQL Server. These tables corresponded to the level of information entered – for example some information was collected at the pharmacy level, with single records for each pharmacy demographic. So a “Pharmacy” dataset was created. Other information was collected on a patient level, feeding into a “Patient” dataset. These datasets could then be re-merged later for the purpose of analysis.
5.9.2. Data quality
Data quality assurance checks were conducted, which involved comparison of hard copy data received and the data entered into the database (Table 20):
Table 20: Data quality checks
Form Quality checks
Pharmacy characteristics survey Double entry of all characteristics, then cross checked performance
Pharmacy consent form Double entry of all consents, then cross check performed
Patient characteristics survey Double entry of all consents, then cross check performed
Patient questionnaire (Start of trial)
Patient questionnaire (End of trial)
Double entry of all questionnaires, then cross check performed
10% checked (1 in 10 patients)
Strategy cards (Start of trial)
Strategy cards (Mid trial)
Strategy cards (End of trial)
20% checked (1 in 5 patients)
20% checked (1 in 5 patients)
20% checked (1 in 5 patients)
Patient satisfaction survey 10% checked (1 in 10 patients)
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5.10. Statistical analysis
All data were entered into a computerised database, Microsoft Access 2003. All analyses were done using SAS Version 9.1 for windows, with descriptives compiled for all variables. Baseline, three-month and six-month values were compared using paired t-tests. Multiple regression analyses, with backward selection, were used to compare characteristics of completers versus non-completers in the trial. Frequency counts were computed for strategies, satisfaction and readiness to change. Finally, time and resources were documented and used to calculate a net cost of the service per pharmacy over the trial period. The approach to calculating the costs reflected the consideration that intervention delivered was a ‘package of care’, as distinct from a single input service occasion.
All tests were two-sided, with a 5-percent type-I error rate (α).
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6. Results
6.1. Recruitment and retention
6.1.1. Pharmacy recruitment and retention
Section 5.3 described the process for recruiting pharmacies to the trial using a sampling framework to ensure a nationally representative sample of pharmacies and patients. Based on this framework, 132 pharmacies were selected to participate in the trial, of which 124 received education (attendance at workshop, teleconference and/or site visit in the pharmacy – see Section 5.4 for detail).
Following the education, 33 pharmacies withdrew from the trial due to lack of staff and pharmacy resources or difficulty using MedsIndex.
A total of 91 pharmacies collected baseline patient data and were therefore considered enrolled in the trial. Of these, 66 pharmacies successfully completed the trial (ie had at least one patient who participated in the six month visit). Final end of trial data were obtained from 66 pharmacies.
Figure 12 illustrates the process for recruiting pharmacies and outlines the retention of pharmacies during each stage of the trial.
Figure 12: Process for the recruitment and retention of pharmacies
259 pharmacies expressed interest
91 participating
pharmacies
91 pharmacies at base-line visit
79 pharmacies at three month visit
12 pharmacies withdrew prior to completing the three
month visit
66 pharmacies at six month visit
13 pharmacies withdrew prior to completing the six
month visit
124 pharmacies received education
8 pharmacies withdraw prior to receiving education
33 pharmacies withdrew after receiving education or were unable to recruit
132 pharmacies selected and consented
based on sampling framework
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Reasons for drop-out were provided by twelve of the 25 pharmacies who dropped-out following baseline data collection. The most commonly cited reason for drop-out was time constraints (eleven out of twelve pharmacies). According to one pharmacist:
“There was so much happening in the pharmacy that it was not possible to get time to recruit patients”.
Other commonly cited reasons for pharmacy drop out, following the commencement of the trial, included:
• Lack of resources and available staff (five out of twelve pharmacies):
“There were not enough staff to recruit patients and we were too busy in the pharmacy”.
• Difficulty recruiting patients due to compliance or resistance (four out of twelve pharmacies):
“Most patients were compliant and of the few that fit the criteria there was little time for getting them in and recruited”.
• Difficulty using MedsIndex program (three out of eleven pharmacies).
Two pharmacies reported that a lack of interest in the trial contributed to their withdrawal from the trial.
6.1.2. Patient recruitment and retention
From the 798 patients who consented to the trial, a total of 732 patients met the eligibility criteria and were included in trial. 68 patients were ineligible due to MedsIndex scores above 90 and/or incomplete baseline data. Of the 732 participating patients, 612 patients (84%) returned for the three month pharmacy visit and 476 patients (65%) returned for the six month follow up visit. Figure 13 illustrates the process for recruiting patients and outlines the retention of patients during each stage of the trial.
Figure 13: Process for the recruitment and retention of patients
798 patients were consented to the trial
732 participating patients
66 ineligible patients:• MedsIndex scores > 90• Incomplete baseline data
732 patients at baseline visit
612 patients at three month visit
120 patients withdrew
476 patients at six month visit
136 patients withdrew
476 patients
completed trial
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6.1.3. Missing and excluded data
There may be variation in the denominators (n) presented throughout the results section due to missing data for either/both pharmacies and patients at each stage of the trial.
In addition, 69 patients had MedsIndex scores which were not based on matching medications. In other words, increased or decreased MedsIndex scores were due to changes in medication type rather than genuine changes from the trial intervention.
To ensure that the scores were recorded consistently and were comparable across time, MedsIndex scores were categorised into four groups:
• Matching single medication – where MedsIndex scores were recorded for a matching single medication across the trial. In other words, MedsIndex scores for the same single medication were recorded at each of the three follow-up visits.
• Non-matching single medication – where MedsIndex scores were recorded for a different single medications across the trial. In other words, MedsIndex scores were not provided for the same single medication at each of the three follow-up visits.
• Matching multiple medications – where MedsIndex scores were recorded for matching multiple medications across the trial. In other words, MedsIndex scores for the same multiple medications were recorded at each of the three follow-up visits.
• Non-matching multiple medications - where MedsIndex scores were recorded for different multiple medications across the trial. In other words, MedsIndex scores were not provided for the same multiple medications at each of the three follow-up visits.
To monitor changes in patient compliance over time, only matching medication(s) were used. Non-matching MedsIndex scores were removed from the relevant analyses, resulting in variation in the denominators for some results.
6.2. Demographics
6.2.1. Pharmacy demographics
A summary of the demographic characteristics of the participating 91 pharmacies are presented in Table 21. The sample of pharmacies recruited for this study included a reasonable distribution of pharmacies in terms of size, geographic location and socio-economic status and were typical of the average pharmacy in Australia.
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Table 21: Demographic characteristics of pharmacies
Variable description Statistic
N (%)
PhARIA rating Category 1-2
Category 3-6
76 (83.5%)
15 (16.5%)
SEIFA Category 1-2
Category 3-6
Category 7-10
14 (15.4%)
21 (23.1%)
56 (62.5%)
State New South Wales (NSW)
Victoria (VIC)
Queensland (QLD)
Tasmania (TAS)
South Australia (SA)
Western Australia (WA)
Northern Territory (NT)
39 (42.9%)
14 (15.4%)
21 (23.1%)
2 (2.2%)
7 (7.7%)
7 (7.7%)
1 (1.1%)
Pharmacy type Brand
Independent
Missing
33 (36.3%)
55 (60.4%)
3 (3.3%)
Days open per week Five days
Six days
Seven days
Missing
4 (4.4%)
43 (47.3%)
42 (46.2%)
2 (2.2%)
Weekly number of prescriptions dispensed
300 or less
301 to 800
801 to 1200
1201 to 2000
2001 to 3000
Greater than 3000
Missing
2 (2.2%)
35 (38.5%)
23 (25.3%)
21 (23.1%)
3 (3.3%)
2 (2.2%)
5 (5.5%)
Dispensing database Amfac
Aquarius
Winifred
Lots
Minfos
Corrum
Other
7 (7.7%)
7 (7.7%)
42 (46.2%)
16 (17.6%)
8 (8.8%)
3 (3.3%)
8 (8.8%)
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6.2.2. Patient demographics
A summary of the demographic characteristics of 732 patients are presented in Table 22. The majority of patients were aged 51 or above (85%) and 57% of patients were female. The majority of patients were born in Australia (74%) and their preferred language was English (94%).
In addition, 16% of patients delayed filling their prescription due to the cost of the medication and 20% of patients received some assistance with complying with their medication regimen.
Table 22: Demographic characteristics of patients
Variable description Statistic
N (%)
Age of patient 18 to 25 years
26 to 30 years
31 to 40 years
41 to 50 years
51 to 60 years
60 years and above
11 (1.5%)
11 (1.5%)
22 (3.0%)
66 (9.1%)
112 (15.4%)
504 (69.4%)
Sex of patient Female
Male
410 (56.6%)
315 (43.4%)
Country of birth Australia
Other
540 (74.2%)
188 (25.8%)
Preferred language English
Other
686 (94.1%)
43 (5.9%)
Delays filling prescription due to cost
Yes
No
115 (15.8%)
613 (84.2%)
Receives assistance with medication regimen
Yes
No
142 (19.6%)
581 (80.4%)
6.3. Baseline results
6.3.1. Medication compliance
As described in Section 5.8, medication compliance was measured using two indicators of compliance.
The empirical measure of compliance was obtained using the software program MedsIndex. The MedsIndex score is calculated out of 100 based on the number of missed doses a client may have in the given period (see Section 5.8 for more detail), with higher MedsIndex scores indicating higher medication compliance. At baseline, the average MedsIndex score was 65.5.
Self-reported compliance was measured using the MARS, which assessed patients’ compliance patterns. A total score is computed for MARS by summing the scores for each of the five items, with higher scores indicating higher patterns of compliance. At baseline, the average MARS score was 22 (out of a possible 25). Table 23 provides a summary of patients’ medication compliance at baseline.
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Table 23: Medication compliance at baseline
Variable description Statistics
N Mean (SD)
MedsIndex Medication compliance 732 65.5 (17.85)
Medication Adherence Rating Scale (MARS)
Self-report compliance 717 22.0 (3.13)
6.3.2. Beliefs about medication and readiness to change
Research on behaviour change has demonstrated that patients’ belief about their medication can have a major influence on medication compliance. The BMQ was used to assess patients’ beliefs about their prescribed medication. The BMQ is comprised of four scales which measure patients’:
• belief about the necessity of prescribed medication for controlling their illness (necessity scale)
• concerns about the potential adverse consequences of taking the medication (concerns scale)
• beliefs about harm of medicines in general (harm scale)
• beliefs about overuse of medicines in general (overuse scale).
A total score for each of the scales is computed by summing the scores for each of the items, which ranges from five to twenty-five for the necessity and concerns scales, and from four to twenty for the harm and overuse scales. Higher scores indicate stronger beliefs in the concepts. Table 24 shows the mean scores for each of the four BMQ scales.
In addition to the BMQ, patients’ readiness to change was also measured using two questions developed to assess patients’:
• confidence in using the selected strategy(s)
• belief about the importance of changing their behaviour.
A lower score on both scales indicates greater confidence in using the strategies and stronger beliefs about the importance of changing their behaviour. Table 24 shows the mean scores for both scales.
Table 24: Beliefs about medications, confidence and importance at baseline
Variable description Statistics
N Mean (SD)
BMQ BMQ Specific – necessity scale
BMQ Specific – concerns scale
BMQ General – harm scale
BMQ General – overuse scale
718 10.0 (3.8)
719 17.2 (4.1)
721 13.8 (3.1)
712 14.8 (2.6)
Readiness to Change Confidence scale
Importance scale
717 2.8 (1.61)
717 2.8 (1.75)
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6.4. Trial outcomes
6.4.1. Compliance measure outcomes
Figure 14 illustrates the improvement in medication compliance, as measured by MedsIndex, over the six-month trial. The average MedsIndex score increased from 65.5 at baseline, to 77.2 at three-months and 81.3 at six-months.
Figure 14: Mean MedsIndex scores across the trial (confidence intervals)
Me
dsIn
de
x S
co
re
6465
6667
6869
70
7172
73
747576
77
7879
8081
8283
Time
Baseline 3 months 6 months
Three paired sample t-tests were conducted to test the significance of the improvements in MedsIndex over the trial, comparing three-month vs. baseline, six-month vs. baseline and six-month vs. three-month. Normality and outlier assumptions were verified using histograms. All scores were approximately normally distributed and no outliers were detected (See Appendix L).
Table 25 provides the results of each of the paired samples t-tests for MedsIndex. This table shows that there was a significant increase in medication compliance from baseline to three-months (p<.0001), three-months to six-months (p<.0001) and baseline to six months (p<.0001). From baseline to six-months the average MedsIndex score rose by 16%, from 65.5 to 81.3. A significant improvement in medication compliance was also found for self-reported compliance, as measured by MARS (p=.0004).
All significant paired t-tests remained significant with Bonferroni correction.
The results of the paired samples t-tests for both MedsIndex and MARS provide strong evidence that a pharmacist-led and patient-centred compliance intervention can improve patients’ medication compliance.
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Table 25: MedsIndex measure outcomes
Compliance measure Statistics
N Mean diff (95% CI1)
P-Value
MedsIndex
3 month – baseline
6 month – baseline
3 month – 6 month
559 12.1 (10.53 13.67)
437 16.0 (14.21 17.89)
440 4.2 (2.88 5.51)
<.0001
<.0001
<.0001
MARS
6 month – baseline
432 0.6 (0.27 0.93)
0.0004
6.4.2. Beliefs about medication outcomes
As described in Section 6.3.2, the BMQ is comprised of four scales measuring perceived necessity of medication, concerns about adverse consequences, belief of general harm and overuse of medicines. Results of the paired t-tests revealed that over the six month trial, there was no significant difference in three of the four subscales (Table 26). The results showed a significant difference in the overuse scale between baseline and six-months (p=0.0005), with patients beliefs about overuse of medications becoming stronger at six-months.
Table 26: Belief about medication outcomes
Compliance measure Statistics
n Mean diff (95% CI) P-Value
BMQ Specific
Necessity scale (6 month – baseline)
Concerns scale (6 month – baseline)
431 -0.3 (-0.68 0.06)
427 0.4 (-0.03 0.86)
0.1012
0.0675
BMQ General
Harm scale (6 month – baseline)
Overuse scale (6 month – baseline)
432 0.2 (-0.12 0.53)
421 0.5 (0.23 0.82)
0.2182
0.0005
1 Confidence Interval (CI)
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6.4.3. Readiness to change outcomes
Figure 15 illustrates that over the six month trial patients reported increased confidence in using the selected strategies and stronger belief about the importance of changing their behaviour.
Figure 15: Mean confidence and importance scores across the trial (confidence intervals)
Sco
re
2.9
2.8
2.7
2.6
2.5
2.4
2.3
2.2
2.1
2.0
1.9
Time
Baseline 3 months 6 months
Confidence
Importance
Six paired samples t-tests were conducted to test the significance of the improvements in confidence and importance scores over the trial, comparing three-month vs. baseline, six-month vs. baseline and six-month vs. three-month. Normality and outlier assumptions were verified using histograms. All scores were approximately normally distributed and no outliers were detected (See Appendix L).
Table 27 provides the results of each of the paired samples t-tests for confidence and importance. This table shows that there was a significant increase in confidence scores from baseline to three-months (p<.0001), three-months to six-months (p<.0001) and baseline to six months (p<.0001). Significant improvements were also found for importance scores from baseline to three-months (p<.0001) and baseline to six-months (p<.0001), but not for three-months to six months (p=0.0703).
As discussed in Section 1.6.2, confidence and importance contribute to an individual’s readiness to change. The results of the paired samples t-tests therefore suggest that over the six-month trial patients became more motivated and ready to change.
Table 27: Readiness to change outcomes
Compliance measure Statistics
n Mean diff (95% CI) P-Value
Confidence
3 month – baseline
6 month – baseline
3 month – 6 month
618 -0.3 (-0.45 -0.23)
520 -0.6 (-0.76 -0.48)
503 -0.3 (-0.40 -0.16)
<0.0001
<0.0001
<0.0001
Importance
3 month – baseline
6 month – baseline
3 month – 6 month
615 -0.5 (-0.63 -0.35)
520 -0.6 (-0.80 -0.46)
501 -0.1 (-0.26 0.01)
<0.0001
<0.0001
0.0703
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6.5. Characteristics associated with improved outcomes
A multiple regression analysis was carried out to examine the relationship between characteristics of the patient and the pharmacy with improved medication compliance (as measured by MedsIndex). From the literature, thirteen independent baseline variables were selected:
• Patient characteristics: age, sex, country of birth, preferred language, concerns about cost, receiving assistance with medication regimen, confidence, importance and completion status.
• Pharmacy characteristics: location (PhARIA), socio-economic status (SEIFA), weekly number of prescriptions dispensed and designated professional services area.
Correlations between MedsIndex and the covariates were very low (less than 9%). No significant correlations between covariates were found. No variable was retained by the backward selection procedure. These results suggest that none of the patient or pharmacy characteristics were significant predictors of improved medication compliance over the six-month trial (as measured by MedsIndex).
The generalised effect of the intervention suggests that a pharmacist-led compliance service may be effective for all patients who have difficulty complying with their long term medication regimens and targeting patients on any other basis than poor compliance was not supported.
See Appendix L for the detailed multiple regressions results, including fitting the full model and reducing the model using backward elimination.
6.6. Pharmacist education
All pharmacies participating in the trial received education and training, via:
• attendance at an education workshop
• site visit from a research team member
• both education workshop and site visit
• teleconference with the research team.
Table 28 shows the comparison between pharmacies that did and did not complete the six-month trial based on the education they received. Results show that a greater proportion of pharmacies completed the trial when they received the education workshop and site visit combination (40% withdrew v 60% completed), with the exception of the more remote pharmacies involved in the teleconference only.
These teleconferences were conducted with four of the more remote pharmacies who were unable to travel to the education workshops or receive a site visit. The results in Table 28 suggest that teleconferences may be effective in reaching remote pharmacies who have experience in receiving education in this format.
Table 28: Education received and pharmacy withdrawal
Attended education workshop and received
site visit
Attended education workshop only
Received site visit only Teleconference only
Withdrew Completed Withdrew Completed Withdrew Completed Withdrew Completed
27 / 68
(40%)
41 / 68
(60%)
11 / 20
(55%)
9 / 20
(45%)
17 / 32
(53%)
15 / 32
(47%)
1 / 4
(25%)
3 / 4
(75%)
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6.7. Strategies delivered by pharmacists
As described in Section 1.6, research on behaviour change suggests that influencing patients’ medication taking behaviour relies on community pharmacists delivering a patient-centred and tailored approach. Pharmacists in the trial were therefore asked to select the type and number of strategies based on the individual needs of their patients (see Section 1.6.1).
Table 29 breaks down the number of patients who received a single strategy versus patients who received multiple strategies at baseline, three month and six month follow-up. At baseline, there were approximately an equal number of patients who received single versus multiple strategies. By the end of trial, pharmacists were more likely to deliver a single strategy (67%).
Table 29: Number of patients receiving single or multiple strategies at each stage of the trial
Time Received single strategies
n / N (%)
Received multiple strategies
n / N (%)
Baseline (0 months) 374 / 732 (51%) 358 / 732 (49%)
Mid-point (3 months) 358 / 617 (58%) 292 / 617 (42%)
End-point (6 months) 338 / 506 (67%) 198 / 506 (33%)
There were a total of 1,314 strategies delivered by pharmacists at baseline for the 732 patients in the trial. Table 30 shows that the most common strategy used at baseline was patient education to assist patients understand their medications and the importance of taking them. The second most common strategy used at baseline was patient reminders to help minimise the patients’ risk of forgetting to take their medication or taking them incorrectly.
The number of strategies delivered by pharmacists was reduced to 1,028 and 785 at three-months and six-months respectively. The general trend of strategies utilised remained similar across the entire six month trial, with the exception of patient reminders, which increased slightly at the three-month and six-month follow-ups. The increasing use of reminders is consistent with the Stages of Change model (see Section 1.6.2), suggesting that patients are moving through the stages of change towards maintenance.
Table 30: Strategies used at baseline, mid- and end-point
Strategy used
(As self-nominated by pharmacist)
Number of times used at baseline
Number of times used three-months
Number of times used at six-months
Dose administration aids 169 (13%) 129 (13%) 111 (14%)
Patient medication profiling 133 (10%) 76 (7%) 58 (7%)
Home medicines review 98 (7%) 68 (7%) 37 (5%)
Patient education2 420 (32%) 330 (32%) 245 (31%)
Reminders 244 (19%) 221 (21%) 189 (24%)
Simplification of regimen 113 (9%) 90 (9%) 69 (9%)
Referral to GP 65 (5%) 58 (6%) 36 (5%)
Logbook / Patient diary 72 (5%) 56 (5%) 40 (5%)
Total 1,314 1,028 785
2 Education provided was specific to the trial, ie related to medication compliance, rather than general patient
education.
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6.8. Pharmacist satisfaction
6.8.1. Education satisfaction
As described in Section 5.4.1, eight education workshops were held across Australia and were attended by 140 staff from 93 pharmacies. At the conclusion of the education workshops, participants were given a survey which asked them to indicate the extent to which their learning needs were met. The response rate of the survey was 89%.
Overall, the results of the survey were positive, with 94% (116/124) of participants reporting that the learning objectives of the education workshop were entirely met. In addition, 90% (112/124) of participants reported that their own learning objectives were entirely met and 89% (110/124) reported that the education was entirely relevant to their own practice (Figure 16).
Figure 16: Pharmacy satisfaction with education workshop
Degree to which education was relevant to own practice
Degree to which own learning objectives were met
Extent to which learning objectives were met
Degree to which education was relevant to own practice
Degree to which own learning objectives were met
Extent to which learning objectives were met
94%94% 90%90% 89%89%
Not metPartially metEntirely met
Not metPartially metEntirely met
Not metPartially metEntirely met
Not metPartially metEntirely met
Not metPartially metEntirely met
Not metPartially metEntirely met
6.8.2. End of trial satisfaction
At the completion of the six month trial, pharmacists were asked to complete a final survey, which included five satisfaction questions rated on a five-point likert scale where 1 = very satisfied and 5 = very dissatisfied.
Overall, pharmacists reported positive experiences in the trial, with seventy-three percent (43 / 59) of pharmacists reporting that they were satisfied or very satisfied with the trial. Figure 17 illustrates pharmacists’ satisfaction with various aspects of the trial:
• Ninety-two per cent (55/60) of pharmacists were satisfied or very satisfied with the strategies used to improve their patients’ medication compliance.
• Eighty per cent (48/60) of pharmacists were satisfied or very satisfied with their patients’ participation and interaction throughout the trial.
• Eighty-three per cent (50/60) of pharmacists were satisfied or very satisfied with the overall support they were given throughout the trial.
• Fifty-two per cent (31/60) of pharmacists were satisfied or very satisfied with the remuneration they received for participating in the trial.
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Figure 17: End of trial pharmacist satisfaction
0
5
10
15
20
25
30
35
40
45
Very di
ssat
isfie
d
Dissa
tisfie
d
Neu
tral
Satisf
ied
Very sa
tisfie
d
Stretegies
Patient interaction
Overall support
Remmuneration
Strategies
Pharmacists were also asked how effective they thought the service was in improving their patients’ medication compliance. Seventy-two percent (43 / 60) of pharmacists reported that they thought the service was effective to very effective. Only one pharmacist said they thought the service was ineffective in improving patient compliance. Eighty-nine percent (50 / 56) of pharmacists said they would continue to offer the medication compliance service in their pharmacy.
6.8.3. Impact of the trial
Throughout the trial, pharmacists provided ongoing feedback about their progress and their experiences of the trial. Figure 18 provides some quotes from pharmacists on how they became more confident in delivering the trial, ways in which they had modified the service to suit the needs of their pharmacy and their general experience. The newsletters in Appendix J also outline some experiences of the participating pharmacists.
FULL FINAL REPORT
Figure 18: Experiences and feedback from participating pharmacists
“We could see that MedsIndex scores
looked to be improving -which was motivating”
“Patients found the trial experience to be positive and it became easier to collect data
as the trial progressed, as patients were familiar with the
forms and process”
“Pop-up messages and instructions on the
patients computer file made it easier for other pharmacy staff to assist
with follow-up”
“Patients became empowered to ask their
GPs to simplify their medications”
“Making follow-up appointments with the
patients worked well for getting them back into the
pharmacy”
“Asking the patient to fill out any forms while
they were waiting for their scripts worked
well”
“We are much more interactive with patients. They are coming back knowing they can and
should ask us all questions”
“I am more aware of patient compliance. I watch out for people’s
MedsIndex scores and am in a better position to act on problems”
“I can see the value in the service professionally, but
the implementation is costly and time
consuming”
“It formalised what we normally do, but made
more time for the process and gave us feedback from
our customers”
“We are building a larger consultation room and
intend to provide services to improve patient compliance and
perceptions of various medications”
“We sit down and have to have a face to face consultation with all of
our patients everyday so this service has and will continue to be
part of our pharmacy work”
“The service highlights the importance of reviewing compliance and making
patients aware”
“We will use the MedsIndex tool to
help identify patients who may
require assistance with
their medication”
“We have become more personal with patients and are spending more time to discuss medication issues or problems
relating to compliance and offering avenues of
assistance”
“It formalised what we normally do, but made more
time for the process and gave us feedback from our
customers”
“This service is invaluable”
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A thematic analysis was conducted for pharmacists’ responses to the three open-ended satisfaction questions, “Will you continue to provide this service in your pharmacy?”, “Has your involvement in the project altered the way you practice as a community pharmacist?” and “Do you have any other comments about the trial or the service you provided?”
The thematic analysis revealed a number of key themes regarding the Improving Medication Compliance Service, which are provided in Table 31. Overall, the comments were very positive.
Table 31: Thematic analysis of pharmacist comments to end of trial survey
Theme Description
Improved relationships with patients
Pharmacists reported improved relationships with their patients, as well as the value of spending time developing this relationship.
“We are much more interactive with patients. They are coming back knowing they can and should ask us all questions”.
“We understand the value of providing one-on-one consultation when compliance is poor. The time spent with pharmacists seems to be the critical element”.
Importance of medication compliance
Pharmacists reported an increased awareness of the importance of medication compliance.
“I am more aware of patient compliance. I watch out for people’s MedsIndex scores and am in a better position to act on problems”.
Greater confidence and improved knowledge
Pharmacists reported greater confidence in talking to their patients about medication compliance, as well as improved knowledge about how to address poor compliance.
“This project has given me more confidence to talk to and discuss with patients. I am being more proactive, with better questioning and interviewing techniques”.
Need for reimbursement
Pharmacists reported that the service can be time consuming and thus there is a need for reimbursement (ie fee for service payment) to be able to successfully implement and maintain the compliance service in the future.
“I can see the value in the service professionally, but the implementation is costly and time consuming”.
Formalised what is already being done
Pharmacists reported that the trial was valuable as it formalised what was already being done within the pharmacy.
“It formalised what we normally do, but made more time for the process and gave us feedback from our customers”.
Incorporate compliance service into pharmacy practice
Pharmacists reported that they saw the effectiveness of the compliance service and can see the benefit of incorporating the service into their pharmacy practice.
“We are building a larger consultation room and intend to provide services to improve patient compliance and perceptions of various medications”.
6.8.4. Pharmacy readiness
In addition to the satisfaction questions, participating pharmacists were asked a series of questions which were aimed at gauging their readiness to implement the medication compliance service in their pharmacy (see Appendix L for the full results to the eighteen questions). Results from the pharmacy readiness questions are outlined below:
• Ninety-three per cent (55/59) of pharmacists reported that they had the knowledge, tools and training needed to implement the new compliance service, whilst 97% (57/59) reported that they had the skills needed to approach patients and discuss their medication compliance
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• Eighty-eight per cent (52/62) of pharmacists reported that there was a fit between the medication compliance service and their pharmacy’s future vision.
• Eighty-seven per cent (54/62) of pharmacists reported that the physical environment of their pharmacy was appropriate for the implementation of the compliance service.
• Eighty-five per cent (50/59) of pharmacists reported that they were provided with adequate support and encouragement from the owners and/or management needed to implement the new service.
• Ninety-five per cent (59/62) reported motivation from non-financial benefits such as professional satisfaction and improved reputation, whilst 48% (30/62) of pharmacists reported that they were motivated in the trial by a belief in the financial benefits of delivering the medication compliance service.
The successful delivery of compliance interventions relies on the readiness of pharmacists to deliver an effective compliance service within their particular pharmacy setting. The positive results amongst participating pharmacies indicate an overall readiness and motivation to implement a medication compliance service.
6.9. Patient satisfaction
At the completion of the six month trial, patients were asked to complete a satisfaction survey, rated on a five-point likert scale where 1 = very satisfied and 5 = very dissatisfied. Overall, patients reported very positive experiences in the trial. Figure 19 illustrates patient satisfaction for the six month trial:
• Ninety-nine percent (515 / 522) of patients were satisfied or very satisfied with the medication compliance service they received from their pharmacy.
• Ninety-eight percent (510 / 522) of patients were satisfied or very satisfied with the discussion they had with their pharmacist about the factors which influence the way they take their medication.
• Ninety-seven percent (503 / 522) of patients were satisfied or very satisfied with the strategies selected to help them take their medications more effectively.
Finally, 98% (507 / 516) of patients reported that working with their pharmacist is a good way of helping them manage their medications.
Figure 19: End of trial patient satisfaction
0
50
100
150
200
250
300
350
400
Very diss
atisfie
d
Dissa
tisfie
d
Neu
tral
Satisfie
d
Very sa
tisfie
d
Overall satisfaction
Satisfaction with discussion
Satisfaction with strategies
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A thematic analysis was conducted on patients’ responses to the open-ended satisfaction question. Overall, most comments were very positive and indicated a central theme regarding the improved relationship with their pharmacists.
“The pharmacist was helpful and willing to explain the “what’s” and the “how’s” of my medications”.
“It was nice to have someone help me get on to the right track every now and then”.
“When you are on so many medications and making changes with GP/specialist it is good to get info on what you are taking to be able to manage medications for illness. Developing rapport with pharmacists helps when you are reliant on medications for illness”.
“A helpful and engaged pharmacist provides an increased level of confidence about both the medication and the taking of them”.
6.10. Completers vs. non-completers
6.10.1. Comparison of pharmacy completers vs. non-completers
Pharmacy completion status was defined as pharmacies which had at least one patient return for a six month follow-up visit. From the 91 consented and participating pharmacies, a total of 66 pharmacies completed the trial.
Table 32 provides a comparison of pharmacies which completed and did not complete the trial based on pharmacy characteristics. This table illustrates that pharmacies in PhARIA categories three to six were more likely to complete the trial (p < .005), with all pharmacies in categories three to six successfully completing the trial. These results indicate that pharmacies located in remote areas were more likely to complete the trial.
Results also show that pharmacies in classified in lower SEIFA categories (1-2 and 3-6) were more likely to complete the trial (p <0.05), with all pharmacies in categories one to two successfully completing the trial. These results indicate that pharmacies located in more socio-economically disadvantaged areas were more likely to complete the trial.
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Table 32: Comparison of pharmacy completers versus non-completers
Variable description Completers
n / N (%)
Non-completers
n / N (%) P-Value
PhARIA
Category 1-2
Category 3-6
51 / 78 (65.4%)
15 / 15 (100.0%)
27 / 78 (34.6%)
0 / 15 (0.0%)
0.0068
SEIFA
Category 1-2
Category 3-6
Category 7-10
14 / 14 (100.0%)
16 / 22 (72.7%)
36 / 57 (63.2%)
0 / 14 (0.0%)
6 / 22 (27.3%)
21 / 57 (36.8%)
0.0241
State
NSW
NT
QLD
TAS
VIC
WA
SA
31 / 40 (77.5%)
1 / 1 (100.0%)
14 / 21 (66.7%)
2 / 2 (100.0%)
8 / 15 (53.3%)
6 / 7 (85.7%)
4 / 7 (57.1%)
9 / 40 (22.5%)
0 / 1 (0.0%)
7 / 21 (33.3%)
0 / 2 (0.0%)
7 / 15 (46.7%)
1 / 7 (14.3%)
3 / 7 (42.9%)
0.4349
Pharmacy type
Brand
Independent
22 / 33 (66.7%)
42 / 56 (75.0%)
11 / 33 (33.3%)
14 / 56 (25.0%)
0.3982
Weekly number of prescriptions dispensed
800 or less
801 to 2000
Greater than 2000
26 / 38 (68.4%)
32 / 45 (71.1%)
4 / 5 (80.0%)
12 / 38 (31.6%)
13 / 45 (28.9%)
1 / 5 (20.0%)
0.8591
6.10.2. Comparison of patient completers vs. non-completers
Patient completion status was defined as patients who had their MedsIndex scores recorded over the three time points (baseline, three-months and six-months). From the 732 consented patients, a total of 476 patients completed the trial.
Table 33 provides a comparison of completers and non-completers on demographic characteristics recorded at baseline. This table illustrates that there were no significant differences between completers and non-completers on any of the demographic characteristics.
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Table 33: Comparison of patient completers versus non-completers
Variable description Completers
n / N (%)
Non-completers
n / N (%) P-Value
Age
50 and under
51 years and over
77 / 110 (70.0%)
398 / 616 (64.6%)
33 / 110 (30.0%)
218 / 616 (35.4%)
0.2736
Sex
Male
Female
195 / 315 (61.9%)
279 / 410 (68.0%)
120 / 315 (38.1%)
131 / 410 (32.0%)
0.0848
Birth Country
Australia
Other
361 / 540 (66.8%)
115 / 188 (61.2%)
179 / 540 (33.2%)
73 / 118 (38.8 %)
0.1585
Language
English
Other
445 / 686 (64.9%)
31 / 43 (72.1%)
241 / 686 (35.1%)
12 / 43 (27.9%)
0.3344
Delays filling prescription due to cost
Yes
No
79 / 115 (68.7%)
397 / 613 (64.8%)
36 / 115 (31.3%)
216 / 613 (35.2%)
0.4160
Receives assistance with medication regimen
Yes
No
86 / 142 (60.6%)
386 /581 (66.4%)
56 / 142 (39.4%)
195 / 581 (33.6%)
0.1875
6.10.3. Reasons for patient drop-out
Patients were considered to have completed the trial if they had attended the pharmacy and had their MedsIndex scores recorded three times during the trial (baseline, three-months and six-months). From the 732 consented patients, a total of 256 patients did not complete the trial. Following the three-month and six-month follow-up, pharmacists’ were asked about the main reason for patient(s) had drop-out of the trial. Responses were provided for 94 patients. The most common reasons for drop-out, as cited by the pharmacists were:
• patient did not return to the pharmacy to complete the follow-up discussion (29%)
• patient had ceased taking the medication (27%)
• patient no longer visits the pharmacy (16%)
• insufficient pharmacist time to follow-up with patient (5%)
• death of the patient (4%)
• patient moved to a nursing home (3%).
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6.11. Economic Analysis
This section examines the economic implications of the medication compliance service. The primary focus of the analysis was to consider the cost of the delivery of a service, such as that developed in this trial, considered against the population health benefit that might accrue if it were to be a service rolled out nationally in community pharmacy settings.
These results are based on responses from 61 pharmacies.
6.11.1. Service delivery costs
All ‘completing’ pharmacies who participated in the trial for six months (N=66) were asked to provide self report information on the time spent on the various activities associated with the delivery of the service evaluated in the trial (see Appendix L for the specific information collected). Special attention was given to separating out activities that were entirely a function of participating in the trial (for example, completing surveys for the research) and activities that were part of the service being delivered or preparation for delivery. A strength of the data obtained is that there is inbuilt recognition of the changing time demands of various activities over the period of the trial, as the pharmacy staff acquired mastery of the service. For instance, the support required by pharmacists in the early days of the trial with recruitment and management of patients became less intensive over time, which in turn was factored into the estimated service costs reported by pharmacies.
Perhaps first and foremost, the nature of the service being costed needs to be recognised. The medication compliance intervention trialled constitutes a ‘package of care’, as distinct from a single input service occasion. Moreover, it is the package of care that constitutes the ‘service’ which yields the sorts of benefits to patients described above. Accordingly, service delivery costs have been considered in terms of the costs of staff time required to deliver the service overall, as a package of care on a per patient basis. These include the costs of pharmacy staff time involved in receiving the education (ie education workshop, site visits, training other staff), as well as delivering the three occasions of service over the six-month period.
The costs are calculated based on the following factors:
• the category of staff employed in the pharmacy (ie pharmacy manager, pharmacist in-charge, pharmacist, pharmacist graduate and pharmacy assistant)
• the amount of time involved (minutes)
• the hourly cost of staff time.
Proportion of pharmacy staff involved
Throughout the education, participants were encouraged to involve whole-of-pharmacy in the preparation and delivery of the medication compliance service, to facilitate the integration of the service into the pharmacy’s day-to-day practice.
Table 34 presents the proportion of time spent by category of staff, broken down into education activities and service delivery activities. According to this table:
• Pharmacy Managers (44%) and Pharmacy Assistants (19%) were most likely to attend the education workshops and/or be involved in site visits
• Pharmacy Managers were also most likely to be involved in the delivery of the compliance service (75%)
• Pharmacists, Pharmacy Graduates and Pharmacy Assistants were more likely to be involved in service delivery than in the education.
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Table 34: Proportion of time spent by task and by pharmacy staff
Staff Education in hrs
N % (hours)
Service delivery in mins
N % (mins)
Pharmacy Manager 46 43.7% (297.3) 35 75.1% (405.8)
Pharmacist In-charge 13 12.0% (81.7) 12 24.9% (134.8)
Pharmacist 16 13.5% (92.1) 14 34.4 % (185.8)
Pharmacy Graduate 10 12.3% (83.5) 8 17.1% (92.5)
Pharmacy Assistant 24 18.6% (126.5) 16 31.0% (167.5)
Other staff 0 0.0% (0) 1 1.0% (5.5)
Total time spent 100% (608.8) 100% (540.5)
Time spent by staff
Table 35 provides an overview of the mean time spent on education and service delivery, by each level of pharmacy staff. For example, on average Pharmacy Managers spent approximately 6.5 hours on education (either receiving or training other staff) and approximately 40 minutes delivering the service.
Table 35: Mean time spent by task and by pharmacy staff
Staff Education in hrs
N mean (std)
Service delivery in mins
N mean (std)
Pharmacy Manager 46 6.5 (4.06) 39 39.3 (14.7)
Pharmacist In-charge 13 6.3 (6.65) 14 34.8 (18.8)
Pharmacist 16 5.8 (6.0) 17 40.2 (24.0)
Pharmacy Graduate 10 8.35 (7.8) 8 36.1 (14.75)
Pharmacy Assistant 24 5.3 (6.0) 20 24.0 (20.5)
Other staff 0 0 (0) 2 21.75 (2.47)
Total time spent 11.7 (9.31) 59.15 (30.0)
Hourly costs by staff
The hourly costs by staff were estimated using the current state award rates for each category of pharmacy staff. The highest level wage rate was used for each category of staff (eg Pharmacy Manager Level 3) and averaged across all states and territories.
These rates include a 25% on-cost to cover annual holidays, public holidays, sick leave, long-service leave and superannuation contributions.
Table 36: Hourly staff costs
Staff Hourly rate Staff Hourly rate
Pharmacy manager $35.41 Pharmacy Graduate $22.74
Pharmacist in-charge $31.07 Pharmacy Assistant $22.20
Pharmacist $27.93 Other staff $22.20
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Total service delivery costs
Table 37 provides the education costs, service costs and total service delivery costs per pharmacy. These costs are a composite of the average time spent by each category of staff (Table 35), multiplied by the corresponding hourly rates (Table 36).
The mean education and service costs per pharmacy were $407.40 and $287.80 respectively. This resulted in a total service delivery cost of $688.40 per pharmacy. Based on the median number of patients (n = 6) per pharmacy, the total service delivery cost per patient in the study was $114.73.
Table 37: Service delivery costs per pharmacy and per patient
Cost Mean (SD3)
Education cost per pharmacy $407.40
Service cost per pharmacy $287.80
Total cost per pharmacy $688.40
Total cost per patient (cost per pharmacy / 6 patients) $114.73 * One pharmacy was classified as an outlier and was removed from the analysis
It is important to note that the optimal business model is likely to be pharmacy dependent and thus the costs will vary depending on the business model used within the pharmacy (eg senior vs. junior staff time) and education received. The range of total service delivery cost was $17.30 to $381.38 per patient.
6.11.2. Service establishment costs
The following service establishment costs were calculated per pharmacy, based on pharmacists attending a typical education workshop, as well as a subsequent site visit at each pharmacy. Training room and workshop trainer costs were not included in this analysis. Costs associated with a national implementation of the training program would need to be considered.
Based on the median number of patients (n = 6) per pharmacy, the total service establishment cost per patient in the study was $110.88.
Table 38: Service establishment costs
Description of costs Cost
Education and material costs
Reimbursement for pharmacist attendance
Materials and printing
Preparation of training and study materials
Food for participants at training
Postage (15 stamped envelopes)
Site visit to pharmacy
$250.00
$68.80
$50.00
$48.00
$7.50
$241.00
Total cost per pharmacy $665.30
Total cost per patient (cost per pharmacy / 6 patients) $110.88
3 Standard Deviation (SD)
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6.11.3. Honorarium costs
The third cost associated with the medication compliance service was the costs associated with honorarium payments made to the pharmacy for patients receiving the service. Participating pharmacies received a payment of $50 per patient recruited to the study.
6.11.4. Estimated total cost per patient
Table 39 provides the estimated total costs per patient for the compliance service, based on average service delivery costs, service establishment costs and honorarium costs (described above). This cost is an estimation of the total cost of the service per patient, however does not include all costs associated with the delivery of the compliance service. For example, the service establishment costs do not incorporate the cost of trainers or training facilities. In addition, the estimated total costs do not include costs associated with providing ongoing support to pharmacies (as described in Section 5.6). Consideration would need to be given to the costs associated with providing such support for national rollout.
Table 39: Estimated total costs per patient
Cost $ per patient
Average service delivery costs $114.73
Average service establishment costs $110.88
Honorarium costs $50.00
Estimated total cost per patient $275.61
6.11.5. Effectiveness of the intervention
The total cost of the six-month pharmacist-led medication compliance intervention was $275.61 per patient. Over the six-month trial, the intervention improved patients’ average compliance score (as measured by MedsIndex) by 16%, from 65.5 to 81.3.
Therefore, the average total cost associated with improving medication compliance over six-months by an average of 16% per patient in this trial was $275.61.
6.11.6. Benefits of the intervention
This section examines the clinical and financial benefits of a pharmacy-led compliance service, including improved health outcomes and reduced health care costs. It is important to note that the current study focused on a compliance intervention which targeted patients on a broad array of long-term medication regimens, across a number of chronic diseases. As this study did not distinguish between disease states, health outcomes could not accurately be assessed in the trial. To be able to quantify the benefits of a community pharmacy compliance service, a future study should be undertaken to investigate the effect of improved compliance to specific recommended medication regimens, in relation to quality of life and health care costs. This would allow researchers to logically calculate costs associated with improved compliance based on outcomes related to specific disease states.
Additionally, as the trial was conducted over a relatively short time period (six months) substantial changes in health outcomes were not expected. This section therefore draws on current literature which associates improved compliance with health outcomes and health care costs. Based on this literature a number of important findings can be extrapolated to the current study.
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Benefits of improved compliance across disease states
It is well known from the literature that poor compliance to long-term medication regimens severely compromises the effectiveness of treatment, impacting on quality of life, mortality, and health care costs. Interventions which are effective in promoting compliance to long-term medications, irrespective of disease state, have been shown to result in substantial health and economic benefits, through primary prevention (of risk factors) and secondary prevention of adverse health outcomes (World Health Organisation, 2003).
Previous studies investigating the cost-effectiveness and cost-benefits of compliance interventions have consistently found significant health improvements and cost savings that are attributable to relatively low-cost interventions delivered by health professionals. The benefits of low cost interventions to improve compliance have been documented across a wide range of disease states.
A recent meta-analysis of 21 studies which looked at adherence to drug therapy across a wide-array of disease states, showed a significant association between adherence to drug therapy and mortality (Simpson, Eurich, Majumdar, Padwal, Tsuyuki, Varney, & Johnson, 2006). From the analysis, it was revealed that the risk of mortality for compliant patients (defined in the study as ≥ 80% compliant), across disease states, was reduced by half compared to those with poor compliance (defined in the study as < 80% compliant). The current study included direct measures of compliance, with identifiable criteria for classifying patients as compliant/ not compliant, average improvement etc. In the current study, the mean compliance score improved by approximately 16%, from a score of 66.5 (defined by Simpson and colleagues as non-compliant) to 81.3 (defined by Simpson and colleagues as compliant). The findings from Simpson et al (2006) can readily be extrapolated to the current study, suggesting that the risk of mortality amongst patients participating in the trial could be reduced by as much as 50% over an average of three and a half years (range six-months to eleven years).
Benefits of improved compliance for heart failure patients
The potential health and economic benefits of a pharmacist-led compliance service are explored through two scenarios which focus on specific disease states. These scenarios examine the potential cost-benefits of improved compliance for patients taking medications for heart failure and acute myocardial infarction, illustrating the potential reductions in mortality and health care costs for these patients.
The scenario provided in Table 40 extrapolates the costs and benefits observed in the trial to the potential cost/benefit for patients on heart failure medication regimens.
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Table 40: Heart failure scenario
Heart failure scenario
Prevalence and incidence of heart failure
Based on the 2004-05 National Health Survey, approximately 263,000 Australians (1.3% of the population) had heart failure or oedema, with an estimation of around 30,000 new cases diagnosed each year ((Australian Institute of Health and Welfare, 2008). In 2005, heart failure accounted for 2,225 deaths, and was an associated cause of death in a further 14,466 cases. In 2006-07 there were 43,681 hospitalisations due to heart failure.
In a comprehensive study conducted by the University of South Australia (Clark, McLennan, Dawson, Wilkinson, & Stewart, 2004), researchers found that heart failure is costing the health care system more than $1 billion every year, of which $840 million is due to hospitalisation costs.
Pharmacist intervention to improve medication compliance
In a recent study, Murray et al (2007) conducted a three and a half year randomised, controlled trial to investigate whether a pharmacist intervention improves medication compliance and health outcomes for patients with heart failure.
Results of the trial showed a difference of 10.9% in compliance between the control and intervention groups, such that patients receiving the pharmacist intervention had 10.9% improved compliance compared to those patients who received usual care.
The improvement in medication compliance for patients receiving the pharmacist intervention was associated with :
• a 19.4% reduction in emergency department visits and hospitalisation admissions (incidence rate ratio, 0.82 [CI, 0.73 to 0.93])
• a $3,165 reduction in annual direct health care costs per patient (cont.)
Estimated reduced hospitalisations for heart failure patients
Based on the results from Murray et al (2007) and the prevalence of heart failure from the 2004-05 National Health Survey, it can be extrapolated that a 10% improvement in medication compliance will result in a reduction of hospitalisations from 43,681 to approximately 35,207. As the current study found a mean improvement in compliance of 16%, approximately 6% greater than the results of the Murray et al study, it is expected that the incidence of hospitalisations could be further reduced.
20000
25000
30000
35000
40000
45000
Usual care Intervention
19.4%
Hospitalis
ations
(num
be
r)
Estimated reduced healthcare costs for heart failure patients
Considering the cost of $208.53 per patient for establishing and delivering the medication compliance service in the current study, the potential annual cost saved per heart failure patient receiving the service would be approximately $2,956. Hence, the potential annual return on investment for every $1 spent on the medication compliance service for patients with heart failure is $14. This is consistent with the findings of Murray et al (2007).
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Benefits of improved compliance for myocardial infarction patients
The scenario provided in Table 41 outlines the potential reduction in mortality risk for patients in the trial on myocardial infarction medication regimens.
Table 41: Myocardial infarction scenario
Myocardial infarction scenario
Prevalence and incidence of myocardial infarction
Based on the 2004-05 National Health Survey, about 637,900 Australians (3.2% of the population) have coronary heart disease, of which 354,700 people had a myocardial infarction. Coronary heart disease is the largest single cause of death in Australia, accounting for 22,983 deaths in 2007, of which 11,341 were due to acute myocardial infarction (Australian Bureau of Statistics, 2007).
Improvement in medication compliance
Wei, Flynn and MacDonald (2004) conducted a community-based observational study to estimate the effect of adherence to beta-blocker use on subsequent mortality. Results of the study showed that adherence to beta-blocker treatment (defined as greater than or equal to 80%) was significantly associated with a lower relative risk of mortality with unexposed patients (hazard ratio 0.49, 95% CI 0.30-0.80, p <0.01). Within the high-risk subgroup of patients, the adjusted relative risk of mortality was 0.40 (95% CI 0.17-0.93, p=0.03).
Estimated reduced risk of death for compliant myocardial infarction patients
Based on the results from Wei et al (2004) and the incidence of death from the ABS (2007), it can be estimated that the risk of mortality for patients who are compliant with their beta-blocker medication regimens (≥ 80%) was about half that of patients with poor compliance (<80%).
0
20
40
60
80
100
<80% compliant ≥80% compliant
Ris
k o
f m
ort
alit
y
In the current study, medication compliance improved significantly by an overage 16% per patient, from a mean compliance score of 66.5 to 81.3. In other words, on average patients moved from non-compliant (<80%) to compliant with their medication regimens (≥ 80%). It can therefore be extrapolated that the potential reduction in the risk of mortality for compliant patients in the trial, taking at least 80% of beta-blockers for myocardial infarction management is approximately 50% and 40% for unexposed patients and high risk patients respectively.
In summary, current literature investigating interventions aimed at improving compliance to medication regimens have been shown to result in substantial cost-savings due to reduced hospitalisations, mortality and care costs, supporting the implementation of a professional compliance service in the community pharmacy setting.
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7. Implementation of a national medication compliance service in community pharmacy: Implications of the national trial
Results of the present study were very positive and provide support for the national implementation of a patient-centred medication compliance service in the community pharmacy setting. Overall, it is considered that a pharmacist-led medication compliance service, based on the four-stage approach trialled in the study, is suitable for national implementation.
This section provides the key findings of a national medication compliance service in community pharmacies, as well as the key recommendations for operationalising the national implementation of the service.
7.1. Key findings of the medication compliance service
Improved medication compliance can be achieved through a pharmacist-led intervention
The key outcome of the trial was that medication compliance (measured by both MedsIndex and self-report) significantly improved over the six-month trial. The MedsIndex score improved from a mean score of 65.5 to 81.3. On a large sample of patients, this trial showed an average compliance improvement of approximately 16%.
These findings are consistent with previous research regarding the value of pharmacist-led interventions on patient compliance for specific drug types. For example, Murray et al (2007) showed that a pharmacist-intervention with patients on heart failure medication improved their patient’s compliance by an average 10.9%. This study extends such research by demonstrating the positive impact of a compliance service available to all patients on long-term medication regimens, irrespective of disease state / type of medication.
This outstanding result supports the study’s hypothesis that a significant improvement in patient compliance will be seen as a result of the pharmacist intervention.
A medication compliance service should be based on behaviour change principles
Principles of behaviour change were fundamental to the success of the trial, both to 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.
Patient-centred interventions are important in promoting compliance
To achieve these positive results, pharmacists recommended and/or delivered over 1,300 strategies at baseline to the 732 patients in the trial, from the eight general types of strategies described in Section 1.6.1. A further 1,800 strategies were delivered over the remainder of the trial. The most common strategies were patient education, reminders, dose administration aids and patient medication profiling. Results also showed that approximately half of the participating patients received a combination of strategies.
These results support findings from previous research and demonstrate the effectiveness of using a combination of strategies, relevant to the individual patient, which target the various factors influencing compliance. Research examining the barriers to medication compliance suggests that non-compliance with medication regimens is a complex and multi-causal problem (World Health Organisation, 2003). As a result, any single intervention used in isolation is likely to result in only limited improvements in compliance. To be
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more effective, interventions need to have multiple components and the strategies should be tailored to the individual needs of the patient. This was supported in a meta-analysis, conducted by Peterson, Takiya and Finley (2003), who found that the intervention, consisting of a combination of strategies, resulted in an overall increase in compliance across the studies of approximately 4% to 11%.
At an Australian programmatic level, it is important to note that a number of existing pharmaceutical programs, such as HMR, Patient Medication Profiling and DAAs, were utilised by pharmacists as strategies to improve medication compliance. Given the interdependencies of the medication compliance service with programs such as these, consideration would need to be given as to how to successfully integrate the programs if the compliance service were to be rolled out nationally in the community pharmacy setting.
A pharmacist-led compliance service may benefit all patients on long term medications
Results of the multiple regression analysis found no significant relationship between any of the patient or pharmacy characteristics and improved medication compliance (as measured by MedsIndex). This result shows a generalised effect of the intervention and suggests that a pharmacist-led compliance service may be effective for all patients who have difficulty complying with their long term medication regimens.
This finding is consistent with a recent report by PSA (2006), which suggests that compliance services do not need to target patients on any other basis than poor compliance. According to this report, the rates of compliance are often similar in different patient groups. As there are similar barriers to compliance across different disease states, interventions that attempt to overcome these common barriers can be applied to a number of patients with different disease states.
These results suggest that the potential population to benefit from a pharmacist-led compliance service is any non-compliant patient on a long-term medication regimen.
A professional compliance service requires trained and engaged pharmacists
The results of this trial have demonstrated the positive impact that pharmacists can have on patient compliance. Such positive results rely on engaged and empowered community pharmacists, who are appropriately trained and supported to deliver a patient-centred compliance intervention. In this trial, pharmacists received training via a number of methods, including attendance at an education workshop, site visit and/or teleconference with a research team member. Where the initial engagement was not optimal because the pharmacy staff were not able to participate in the face-to-face workshop, engagement appeared to be adversely affected: the majority of pharmacies withdrawing were those who did not attend a workshop.
These results support previous research which has demonstrated that the effectiveness of pharmacist-delivered interventions heavily relies on the ‘buy in’ from community pharmacists. For example, Weinberger et al (2002) suggested that the poor result of the pharmacist education intervention was attributable to poor participation and enthusiasm from the community pharmacists. The successful engagement and involvement of community pharmacists in this trial, was therefore seen to be a key success factor contributing to such significant improvements in compliance.
A pharmacist-led compliance service can be well accepted by patients and pharmacists
Overall, patients reported very positive experiences in the trial with 99% of patients indicating that they were satisfied or very satisfied with the medication compliance service they received from their pharmacy. In addition, 98% of patients reported that working with their pharmacist was a good way of helping them manage their medication. In the words of one patient…
“A helpful and engaged pharmacist provides an increased level of confidence about both the medication and the taking of them”.
Participating pharmacists also reported positive experiences in the trial, with 73% of pharmacists reporting they were satisfied or very satisfied with the trial. In addition, 72% of pharmacists reported they thought the service was effective in improving their patients’ compliance, through improved relationships, increased
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awareness and greater confidence in talking to their patients about compliance. In the words of one pharmacist…
“We understand the value of providing one-on-one consultation when compliance is poor. The time spent with the pharmacist seems to be the critical element”.
These results suggest that pharmacists are ideally positioned and skilled to provide a professional service which focuses on improving medication compliance. Results from the pharmacy readiness survey, also indicate an overall readiness and motivation amongst community pharmacists to implement such a service.
An effective compliance service can be developed and implemented in the community pharmacy setting
An economic analysis was conducted to consider the costs and benefits of the delivery of a pharmacist-led compliance service. 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.
Previous studies investigating the cost-effectiveness and cost-benefits of compliance interventions have consistently found significant health improvements and cost savings that are attributable to relatively low-cost interventions delivered by health professionals. These benefits have been documented across a wide range of disease states. The potential health and economic benefits of the intervention delivered in this trial were explored through scenarios which focused on two specific disease states; heart failure and myocardial infarction.
These scenarios are extrapolated from existing research, to hypothetically model the potential population health benefits that might accrue if the pharmacist-led compliance service were to be rolled out nationally across the community pharmacy setting. Potential benefits for patients on heart failure and myocardial infarction medication regimens include reduced hospitalisation admissions, reduced annual health care costs and reduced risk of mortality. When viewed collectively, the results from the current trial and the evidence provided in the literature, suggests that a pharmacist-led compliance service is effective in both improving patient outcomes and reducing health care costs.
In addition to the health and economic benefits discussed above, delivery of CPS, such as the compliance service trialled in this study, can result in a number of additional benefits for community pharmacists. These benefits include improved:
• customer relationships, such as increased customer loyalty, improved rapport and trust with patients and increased customer satisfaction
• practice and reputation, such as enhanced pharmacy service profile and competitive advantages over other pharmacies
• job satisfaction and professional development, as a result of improved interactions with customers and extended professional roles and knowledge
• financial benefits, related to increased volumes of prescriptions.
Taken together, these results support the study’s central hypothesis that an effective compliance service can be developed and implemented in the community pharmacy setting.
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7.2. Strengths and limitations of the Study
Overall, the trial reported here had a robust methodology and stood up well to statistical scrutiny. Nevertheless, there were several limitations in the study that may have potentially impacted the obtained results. The first limitation was in relation to patient recruitment. In this trial, the recruitment of patients was completed by the participating pharmacies based on the general research requirement to consent a patient to the trial and thus no consistent approach was used. On the one hand, this lack of consistency can be seen as a limitation of the controls applied to the study. On the other hand, given the reported difficulty in recruiting patients in the pilot phase, pharmacists in the trial were encouraged to utilise different strategies to engage with patients, including mail outs, telephone calls, posters and in-pharmacy discussions. This recommendation is in-line with the findings of the study and previous research that suggest a patient-centred approach is necessary for engaging and interacting with patients. In essence then, the recruitment strategy reported here is likely to have more real world applicability, more closely mimicking the sort of approach that would be part of a national roll out.
A second methodological limitation of this study, common in research on medication compliance, was the methods used to measure compliance. The main outcome measure of compliance was obtained using the software program MedsIndex, which calculates a score out of 100 based on the number of missed doses a patient may have had in the given time period. Limitations in the calculation of this score are related to changes in medications and dispensing at other pharmacies. For example, MedsIndex does not take into account a patient who fills a script at an alternative pharmacy or when a patient moves from one medication to another (eg from trade name medication to generic brand medication). However, while the measure may have had some limitations, additional self-report measures of compliance were also used (ie MARS). Results from both measures (MedsIndex and MARS) showed significant improvements in medication compliance over the six-month trial. In addition, measures of patient change readiness also showed a significant improvement in patients’ reported confidence in using compliance strategies (as agreed with their pharmacist), as well as stronger beliefs about the importance of medication compliance for their overall health and wellbeing. The clear convergence of these different data sources strongly supports the interpretations of the Medsindex scores.
The third limitation relates to the economic analysis. The results of the economic analysis provide estimates which should be considered as preliminary rather than definitive. Necessarily, given the paucity of good quality empirical evidence linking increments of medication compliance to health outcomes, estimated economic implications are based on a range of interpolated data, with inherent uncertainty in some of their assumptions. However, the analysis provides evidence for plausible scenarios for considering the costs and benefits of a professional compliance service implemented in the community pharmacy setting. The plausibility of the outlined scenarios rests on the strength of the primary compliance data collected in the trial – one of the largest intervention cohorts thus far reported, and the largest known study examining the impact of strategies to improve compliance within a community pharmacy setting. The trial therefore provides a robust basis for estimating the quantum of compliance improvement that could reasonably be expected.
Finally, the methodological approach of the study would have been strengthened by the inclusion of a control group. Randomised controlled trial approaches (RCT), historically, have been the mainstay of treatment efficacy research, particularly where the quantum of effect is of interest as it was in this instance. Notably, the ecological validity attempted in the trial, namely the integration of the service into business as usual in the participating pharmacies, is not entirely compatible with the RCT approach. Furthermore, the apparent limitation of not including a control condition is offset to a significant extent by several factors. First, none of the ‘treatments’ – ie intervention strategies employed by pharmacists - were new, all being based on substantial previous evidence of efficacy. Second, there is a significant body of national and international research using the RCT approach, and documenting the quantum of effect that can be obtained using the strategies trialled in the present study.
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7.3. Recommendations
The medication compliance service trialled in this study was underpinned by four key theoretical principles, described in Section 3.1. Our findings are best interpreted within those four theoretical principles. Therefore, the recommendations arising from the development, implementation and evaluation of the medication compliance service trialled are presented within the framework of the four theoretical principles.
7.3.1. Recommendations emerging from an evidence-based approach
1) National implementation of the medication compliance service should be based on empirically-supported interventions and that evaluation should be based on objective measures. There are a range of objective measurement tools available in the market; some consideration should be given to the long term benefits of using nationally consistent measures that enable benchmarking of outcomes. Specifically, a national medication compliance service needs empirical tools that measure a patients:
a) compliance, for example based on dispensing data
b) readiness to change, to allow pharmacists to target patients at the appropriate stage of change
c) beliefs about their medication and disease, to inform the selection of appropriate strategies.
2) Patient level record keeping should occur in the pharmacy to allow pharmacists to track patients’ progress over time. This includes changes in compliance, change readiness and the effectiveness of the agreed strategies.
7.3.2. Recommendations emerging from practical use of adult learning theory
3) National rollout of the medication compliance training program should incorporate key features of the training delivered in the study:
a) National training workshops should be delivered as ‘train-the-trainer’ sessions. These workshops should be supported by practical materials and workbooks that can be used to support pharmacy representatives to provide the training to other staff within their pharmacy.
b) National workshops should be delivered using the adult learning principle of multi-sensory learning, to cater for the different learning styles of participating pharmacists. Utilising a combination of oral and visual didactic lecture style training, demonstrations and role playing (such as the training provided in the study) will appeal to the different learning styles of attendees and reinforce the new knowledge and skills of the training program.
c) The national workshops should be offered to allow pharmacies with flexibility to attend. For example, additional workshops should be held in conjunction with major pharmacy conferences, such as the Australian Pharmacy Professional Conference, Pharmacy Australia Congress and Pharmacy Expo, to provide an opportunity for attending pharmacists to up skill and / or earn CPD points.
d) The national workshops should be supported by practical materials that can be used by pharmacists to cue the main implementation steps of the service, for example step-by-step workbooks, reminder cards and self-explanatory forms.
e) Peer champions or mentors should be used to provide support and reinforcement to community pharmacists delivering the compliance service. Consideration should be give to the development and implementation of a mentoring scheme which would allow pharmacists to access the expertise of pharmacists who are experienced in providing such a service. This should occur at a local level, potentially through pharmacy networks.
f) Consideration should also be given to how support and reinforcement, over time, can be provided throughout national implementation. This includes methods for facilitating the transfer of knowledge, skills and experiences between community pharmacies, facilitators, general practitioners and other health professionals, as well as CPD requirements under the National Registration Scheme. Results of this study demonstrate that regular newsletters, national teleconferences and case studies are
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effective ways of providing ongoing support and reinforcement of behaviour change skills in pharmacies.
g) Refresher courses and / or advanced courses should be offered to pharmacies, which include involving program champions, General Practitioners and testimonials from patients. These sessions could also include problem based learning case studies which foster the learning process regarding implementation and delivery of the compliance service.
4) Content of the national training workshops should incorporate:
a) Key messages that highlight the financial and non-financial benefits for community pharmacists and pharmacy owners in delivering a compliance service. Disseminating the benefits of implementing such a service is an important part of motivating pharmacists, managing expectations and reinforcing change.
b) Practical training on the tools and materials used to support pharmacists to deliver the service, including motivational interviewing communication techniques, to improve pharmacists’ confidence in using the tools.
c) Content of the national training workshops need to be consistent with the principles of an evidence-based approach, organisational change and behaviour change.
5) The knowledge, skills and abilities (KSA), covered in the national training program, should be embedded into the professional development of community pharmacists. The KSAs required to implement this service are fundamental to demonstrate the shift of focus from product to patient services in the community pharmacy, and should focus on patient behaviours, beliefs and health outcomes:
a) CPD points should be provided to practicing pharmacists for attendance and participation in the training program.
b) A basic module on patient health beliefs, behaviours and engagement should be provided in advanced pharmacy assistant training programs. The intervention trialled in this study recognised the potential of a whole-of-pharmacy approach: training in the principles underpinning the intervention were delivered at a pharmacy level. Indeed the data clearly indicated that Pharmacy Assistants were frequently involved in the delivery of the service, in keeping with the expectation that patients consider their community pharmacy a setting for care related advice.
c) The core KSAs required to deliver the medication compliance service should be incorporated into the curriculum of university and pre-registration programs.
d) Collaboration between the Guild, PSA, Divisions of General Practice and other representative bodies to provide supportive structures at a local level. In developing the provision of support and structures at a local level, existing local infrastructure and capacity (eg existing programs offered by the Divisions of General Practice) should be recognised and built on.
7.3.3. Recommendations emerging from Organisational Change theory
6) National implementation should employ a targeted approach to selecting pharmacies to deliver a medication compliance service, including readiness (ie motivation, capacity and commitment) to implement the service and potential impact on patient outcomes:
a) National implementation should target pharmacies based on their readiness to deliver the service. Targeting pharmacists who are ready and motivated to implement and offer the compliance service will increase engagement and commitment, providing a more sustainable professional service. As demonstrated in the study, a pharmacy’s readiness to implement the service had a substantial impact on the sustainability of their engagement and commitment throughout the trial.
b) The sample of pharmacies recruited for this study, and delivering the benefits reported here, included a reasonable distribution of pharmacies in terms of size, geographic location and socio-economic status. The results indicated that typical pharmacies are able to achieve the benefits for patients of providing a medication compliance service. This is heartening for population health policy
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because it suggests that specialised pharmacy characteristics are not a substantive driver of the benefits to be realised in community pharmacy delivery of the service.
c) National implementation could consider targeting pharmacies based on the potential impact they will have from a population health perspective. For example, pharmacies in lower socio-economic and more remote areas, where access to services is known to be disadvantaged appeared to be more likely to retain patients in the program.
d) To increase pharmacists’ readiness to implement a compliance service, a communication plan should be developed to raise awareness of the service amongst community pharmacists, general practitioners and other health professionals or representative bodies. This communication plan should include the need for the service, benefits of the service (both financial and non-financial) and implementation considerations. This study provides a solid ground for providing pharmacists with clear information about the need, benefits and considerations of implementing a compliance service.
e) Pharmacists should understand the potential barriers or challenges to delivering the compliance service, and be provided with examples of how other pharmacies have overcome them.
7) Implementation of a compliance service should be based on a whole of pharmacy approach, which can be integrated into normal pharmacy practice:
a) Consideration needs to be given to the organisational and job design features of each pharmacy in assigning roles and responsibilities for the implementation of the program. Pharmacies need to be encouraged to customise aspects of the service to suit their individual pharmacy, including assigning roles and responsibilities of pharmacy staff. For example, consideration needs to be given within each pharmacy regarding the role of pharmacy support staff.
b) National implementation should allow pharmacies to customise the tools and procedures to facilitate the integration of the service into normal pharmacy practice.
c) National implementation requires up-to-date software in pharmacies to facilitate efficient and reliable delivery of the medication compliance service. Consideration needs to be given to technology, equipment and systems to support behaviour change in the national implementation of the medication compliance service.
- For example, software programs should allow pharmacists to identify non-compliant patients, record strategies, track patients’ progress and generate reminders for follow-up.
- Consideration should also be given to the use of MedsIndex, Mirixa and data mining programs to make it easier for pharmacists to identify non-compliant patients.
- Development of a plan to link the service to various eHealth initiatives, in particular electronic prescription programs (eg eRx and Medisecure).
d) Reporting systems should be built into management information systems, to provide pharmacy managers with feedback on how the medication compliance service is progressing in the pharmacy. Such reports would provide management with aggregated patient information, such as the current number of patients on the program, the number of consultations delivered and general changes in patient compliance.
8) A clear implication of the present study, and one predicted on the basis of the evidence, is the dynamic and multifaceted nature of medication compliance. This suggests the additive and even perhaps multiplicative effect of a co-ordinated approach to developing service delivery models in community pharmacy. Therefore, at an Australian programmatic level, the medication compliance service should be integrated with all continuing and new programs under the 5
th Community Pharmacy Agreement, in
particular the staged supply, medication use reviews (MUR) and medication continuance.
9) National implementation of a comprehensive medication compliance service should encourage the use of multi-disciplinary teams and collaboration amongst health professionals, as well as among the community pharmacy community. In this study, the research team provided the ongoing professional support network for participating in the trial, and sharing professional knowledge. Collaboration with other health professionals was acknowledged but not specifically targeted by the study. Anecdotally, collaboration with GPs and other health professionals was challenging. Further consideration is required
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for understanding and promoting collaboration within and beyond community pharmacy. Suggestions include:
a) Establishment of professional networks to underpin service delivery in community pharmacy deserve consideration. Clear lessons are available from approaches in other settings aimed at improving collaboration amongst healthcare professionals. For example, the Australian Primary Care Collaborative (APCC) Program offers a useful framework for encouraging general practitioners and primary health care providers to work together to improve patient clinical outcomes, help maintain good health for those with chronic and complex conditions and promote a culture of quality improvement in primary health care. For example, a key element of the APCC Program was the opportunity to share knowledge and experiences with peers, mobilising change through reinforcing networks. The success of the approach attests to the fundamental benefit of establishing patient care related professional networks. The ongoing extension of the program to an increasingly multidisciplinary base also offers the opportunity to consider the inclusion of community pharmacy.
b) Undertake further research to investigate general practitioner attitudes and awareness of professional services. This would include the perceived benefits of such a service, potential demand and other insights. This would help to identify strategies for improving a multi-disciplinary approach to compliance. In addition, it would be important to consider the existing avenues of delivering multi-disciplinary continuing professional development (eg through the Divisions of General Practice).
10) Consideration should be given to the remuneration and financial reward structures for the implementation of a new compliance service. Results of the study demonstrated that the delivery of the compliance service involved substantial investment in time, equipment and people. It was recognised however, that there are changing time demands of various activities and costs, as pharmacy staff acquired mastery of the service. Consideration regarding how the service provision would be funded is therefore critical to the national implementation of the compliance service.
7.3.4. Recommendations emerging from behaviour change theory
11) According to key principles of behaviour change, community pharmacists providing the medication compliance service should be trained to target patients based on their readiness and stages of change. Targeting patients who are motivated to improve their compliance and who are in the ‘contemplation’ or ‘preparation’ stage of change, will be more receptive to the service provided, which in turn will be motivating for the participating pharmacists. In addition, pharmacists should be asked to reflect on their own readiness and stages of change with respect to modifying their work practices and embracing patient focussed services.
12) Pharmacists should be provided with education on the key behaviour change principles, eg motivational interviewing and readiness to change. These skills should be integrated into university and pre-registration training, as well as into pharmacists’ professional development. This should include:
- assessing patient’s readiness and motivation to change
- conducting motivational interviewing communications
- concepts of importance and confidence of achieving medication compliance
- collaborating on patient-centred strategies
- matching strategies to the patients’ stage of change.
13) Implementation of a nationally consistent four-stage patient medication compliance service based on behaviour change theory is recommended as follows:
- Stage One: Identification of non-compliant patients
- Stage Two: Understanding patients’ health beliefs and readiness to change
- Stage Three: Collaboration with patients to develop personalised strategies
- Stage Four: Reinforcing, monitoring and supporting change.
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In addition, prior to delivering the patient intervention, pharmacists should be trained to complete a self-assessment and reflect on their attitudes and capacity to implement the program.
14) A national awareness campaign should be developed, including:
- Promotional leaflets and pharmacy posters to promote and encourage patients to participate in the medication compliance service.
- Consider messaging in line with affirmative motivational interviewing principles, eg should this be called a ‘compliance’ service?
- Targeting patient support groups and carer organisations, to identify advocates for the service.
7.4. Conclusion
The results of this trial showed a significant improvement in medication compliance amongst patients, as a result of the pharmacist-led compliance intervention. The outstanding results support the study’s hypotheses that an effective compliance service can be developed and implemented in the community pharmacy setting, and that the service will result in a significant improvement in patient compliance.
In summary, national implementation of a compliance service, based on the design and approach to implementation used in this trial, could result in significantly improved compliance for patients on long term medication regimens, with subsequent improvements in health outcomes and reduced costs health care costs.
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