research proposal

Right Direction Medication Reviews and Tutoring (RDMT) is a small business structured as a sole proprietorship that delivers medication review services funded under the Sixth Community Pharmacy Agreement (Pharmacy Guild of Australia, 2016b). This business started through collaboration with a small medical practice in the Prospect region of Adelaide which has extended into the Northern suburbs. The primary activity of the business is the supply of a home medicines review (HMR) service to patients referred from these medical practices.

HMRs involve a comprehensive medication review conducted by an Accredited Pharmacist at a client's residential address (Australian Association of Consultant Pharmacy, 2016a). The main objective of this service is to enhance the quality use of medicines and reduce the potential for preventable drug-related problems. The review achieves this by utilising the extensive knowledge-base of Accredited Pharmacists to detect and address drug-related problems, recommend best practice approaches by collaborating with general practitioners (GP), and provide up-to-date medication information to improve the client's and other health professionals' knowledge and understanding of medications (Pharmacy Guild of Australia, 2016b). The process of a HMR requires intense collaboration between GPs and Accredited Pharmacists as outlined in Figure 1.

Figure 1: Brief Overview of the HMR Process (Pharmaceutical Society of Australia, 2010; Pharmacy Guild of Australia, 2016b)

A primary goal for RDMT is to determine if investment should be increased to expand HMR business operations (e.g. intensify marketing efforts). However, RDMT needs to consider the question of the likelihood for uptake of HMR services by patients and their respective medical practices.

HMR revenue is currently dependent on funding through the Sixth Community Pharmacy Agreement negotiated between the Pharmacy Guild of Australia and the Australian Government (Department of Health and Pharmacy Guild of Australia, 2015). There appeared to be some interest in HMRs after introduction of the foundation program in the Third Community Pharmacy Agreement signed in 2000 (Pharmacy Guild of Australia, 2016a). That agreement provided AU$114 million for the delivery of a suite of medication review programs, which included HMRs. The current sixth agreement specifically outlines AU$14.5 million for this program in the first year of its delivery, with subsequent budget allocation to occur as part of a AU$178.3 million budget for the contemporary spectrum of medication review programs.

The HMR component of the negotiated Agreement has recently been capped due to a budget blowout during the Fifth Community Pharmacy Agreement (Pharmacy Guild of Australia, 2016b). Under the Sixth Community Pharmacy Agreement, service providers can only submit a maximum 20 HMRs per calendar month. This cap has significant implications for service providers as a result of budgetary pressure on Government.

The number of HMR services completed across the length of the Fifth Community Pharmacy Agreement (July 2010 to March 2015) was 639,891 (Department of Health, 2016). Although precise costing is unavailable, using the VALMER study value as a conservative baseline (i.e. AU$183.60 paid for each service by HMR providers in 2010), this means total expenditure can be estimated to have been over AU$117.5 million for only the HMR component of medication review programs (Stafford, et al., 2010). This is compared to the intended AU$52.11 million intention outlined in the agreement. However, the capping effect has appeared to bring the program back into budget, with 66,192 HMRs completed in the first year of the Sixth Community Pharmacy Agreement, charged at the known AU$210.93 per HMR service (Department of Health, 2016). This means the HMR program has so far expended AU$13,961,878.56 which is within the budgeted AU$14.5 million. This trend may affect the ability of HMR service providers to expand.

Dependence on the Australian Government for remuneration of HMR services under the capped program may mean expansion efforts for individual service providers are severely limited. This paper proposes this to be the casse because the home medicines review service industry is mature, fragmented and in monopolistic competition. There were 7080 service providers in Australia who submitted claims during the Fifth Community Pharmacy Agreement (PricewaterhouseCoopers, 2015). However, the capping effect, imitable nature of HMRs, and their widespread knowledge means the profitability of HMR service providers is limited and makes the industry unattractive. This is supported by Porter which suggests, given Government is one of the most consolidated buyers possible, there is likely to be downward pressure on HMR service prices and little opportunity for differentiation or cost advantages due to the standardised nature of the service (Porter, 2008). This has a number of implications for current service providers.

The dependency of HMR service providers on Government funding for revenue significantly contributes to making the industry unattractive. At the rate of HMR services completed under the current agreement, industry profitability is likely to significantly decline as there would be 330,960 reviews completed over the 5 year agreement compared to the previous agreement level of 639,891. This means the business problem RDMT faces is the probability for uptake of HMRs services by patients and their respective medical practices may decline or stagnate. However, is it possible for RDMT to identify other sources of revenue than Government remuneration for its core HMR service?

There are a number of research problems associated with the outlined business problem. For example, an understanding of the basis for limited HMR service uptake since the introduction of the cap could clarify a post-cap approach. Also, knowledge about the willingness of GPs to participate in the HMR identification process could clarify useful marketing efforts.

However, this proposal considers the core research problem is: 'Are there alternative sources of funding for medication reviews other than Government?'

This paper proposes there are sources for funding for medication reviews other than Government, but the extent of payment may not reach levels of the Government remunerated level per HMR service (i.e. AU$213.67 in 2016-2017).

The key objectives of the research are:

1. To determine if there is a willingness to pay (WTP) for HMRs by the general public.

2. If there is a WTP, find the likely level of payment.

3. If there is no WTP, discover the underlying drivers of this decision.

4. To identify the current level of awareness of the HMR service by the general public.

5. Discover which consumer attitudes or preferences to HMR services are most and least important based on rank items.

6. Identify if researched preference and attitude items can be simplified to meaningful factors.

7. Determine any statistically significant associations between any simplified factors from 6. or any individual items, and the WTP for medication review services.

8. Determine any statistically significant associations between the current level of awareness of the HMR service and the WTP for medication review services.

Given these research objectives, the following questions should be answered by the research:

· Is there a WTP for HMRs by the general public?

· If there is a WTP, what is the likely level of payment?

· If there is no WTP, what are the likely reasons?

· What is the current level of awareness of the HMR service by the general public?

· What is the level of importance of general consumer attitudes or preferences to medication review services?

· Can any researched preference and attitude items be simplified to meaningful factors?

· Are there any statistically significant associations between any simplified factors or any individual items and the WTP for medication review services?

· Is there any statistically significant associations between the current level of awareness of the HMR service and the WTP for medication review services?

There appears to be a paucity of research into the question of willingness of the Australian public to pay for medication management services. An exhaustive search of Cochrane, PubMed, Business Source Complete, Medline, Elsevier, Science Direct, Google Scholar, Informit databases and the Adelaide University Library advanced search engine did not identify peer-reviewed articles into the question of WTP for any medication management review program in Australia. On review of research compiled by the Australian Association of Consultant Pharmacy and the research and development programme projects conducted under community pharmacy agreements by the Pharmacy Guild of Australia, there were no studies that directly investigated the WTP for medication management review programs (Australian Association of Consultant Pharmacy, 2016b; Pharmacy Guild of Australia, 2016c).

The underlying reason for the lack of Australian studies into the WTP for HMRs is unclear. However, some insight may be available from consideration of Canadian or United States (US)-based medication management service programs.

Tsao at al. investigated the WTP for medication management (MM) services by residents of British Columbia, Canada (Tsao, et al., 2015). Although Canada has a similar Medicare system to Australia, unlike Australia's nationally administered Pharmaceutical Benefits Scheme, its provinces and territories apply Government-funded insurance schemes to fund prescription medications (Government of Canada, 2016). In the British Columbian case, this is Pharmacare which also covers medication management services such as medication reviews (British Columbia Government, 2016a; British Columbia Government, 2016b). The Australian model uses Community Pharmacy Agreements and the Pharmacy Guild of Australia to manage claiming amounts and process (Pharmacy Guild of Australia, 2016a). The nature of medication review services is similar to the Australian pharmacy-based MedsCheck, and do not require a home-visit for remuneration under its claimable three streams (i.e. MR-S, MR-PC and MR-F) (British Columbia Government, 2016b). However, the Pharmacare medication review scheme has follow-up components and there appears to be no cap on the scheme. It is important to recognise this medication review series is fundamentally distinct to the Australian HMR for comparison.

Tsao at al. conducted a cross-sectional online survey and quantitative analysis by sourcing respondents from Ipsos Reid Canada, a marketing research firm (Ipsos, 2016). They concluded there is a WTP for MM service interventions out-of-pocket to an average level of CAD$24.55. The study also noted that this WTP was greater for those who previously experienced MM services. Although this research indicates a willingness of sourced British Columbian residents to pay, there are problems with comparing this to Australian-based medication review services.

The sourced respondents from Tsao et al. had a mean age of 45 years and the study, apart from the focus group stage, was entirely conducted online and through email correspondence. This may bring the reliability and validity of findings into doubt as the ad hoc recruitment method may introduce systematic error into the study. Indeed, O'Connell is critical of survey results from marketing research panels and makes the argument they do not mirror the general population (O'Connell, 2010). However, US-based studies are also available for comparative purposes.

Farris et al., Hong et al., Friedrich et al., and Barner and Branvold assess WTP in the US using in-pharmacy medication review services similar to Australian offerings. However, given the vastly different healthcare system of the US, such comparison may not be as smooth as the Canadian model. Also, the home visit component of the home medicines review appears to be absent from US-based services.

Unlike the Australian Medicare system, the US version is a federal insurance-based funding scheme generally available only to the elderly (USA.gov, 2016). The Medicare Modernization Act of 2003 legislated medication therapy management (MTM) provision by pharmacy organizations to Medicare enrolled patients (108th Congress, 2003). This involves an in-person interview session in the community pharmacy setting similar to the Australian MedsCheck. There is no indication in the legislation or from the American Pharmacy Association that MTM services must be delivered in the home-based setting (American Pharmacists Association, 2016). However, remuneration of MTM services to pharmacy organizations is not standardised and fees are determined by suppliers who invoice the relevant patient's insurance fund. This has implications for WTP assessments.

Farris et al.'s study analysed the Iowa Priority Brown Bag Medication Review program (Farris, et al., 2004). At the time of the study, the non-for-profit Iowa Priority Prescription Savings Program incorporated this medication review component which involved presentation of currently used medications in a 'brown bag' to the reviewing doctor or pharmacist. This study determined WTP by surveying a stratified random sample of 1000 Iowa Priority Program enrolees. From the sample, 500 had the medication review the other 500 did not. A frequency count was reported for WTP. Of the 43.5% usable response rate, 175 respondents reported obtaining a review. From this cohort, 48.1% were willing to pay some part of the cost for an initial review and 28.6% for an annual review. The payment level was under US$40 per review with the median level of payment being between US$1-$10. This approach differed from that of Hong et al.

Another study into WTP for MTM services was conducted by Hong et al. (Hong, et al., 2011). This study conducted a discrete choice experiment among 355 Medicare Beneficiaries across Memphis. This involved offering the beneficiaries hypothetical MTM service bundles which used 3 different cost levels ($30, $60 and $90) and 7 attributes. Conjoint analysis was applied to estimate the marginal WTP for each attribute level. The study reported a decline in marginal WTP for MTM services performed in a home setting (-US$15.88) compared to an in-pharmacy (US$13.31) medication review. This appeared to be the most relevant WTP research available to this paper's WTP objectives despite it citing the $40 level found by Barner and Branvold.

A convenience sample of menopause suffering patients were sourced by the pharmacists who participated in Barner and Branvold's study (Barner & Branvold, 2005). The patients had to be on prescribed hormone replacement therapy (HRT) supplied at the survey administering pharmacy. The survey typically involved questions using Likert scales which used independent variables generally associated with WTP as the dependent variable (e.g. income and disease severity such as menopause symptoms). The survey was divided into 3 sections which covered menopause symptoms and HRT, satisfaction with physician services and perceptions, and WTP for pharmacist consultations. The study's respondents had a median WTP of US$40 per half-hour for initial consultations, and between US$20-40 per half-hour for follow-up consultations. This study represents the highest WTP of the identified research, but clearly with a convenience sampling method and the specific use of menopause suffering patients it is likely results cannot be generalised to the US population level. And any comparison would assume comparability of the Australian and US population which may be suspect.

The final US-based study this review considers is that of Friedrich et al (Friedrich, et al., 2010). Their research involved supplying a written survey to a convenience sample of patients at grocery store chain pharmacies (i.e. Jewel-Osco) in the Chicago metropolitan area. A survey question was directed to extracting WTP by allowing survey participants to state a range between $0 and $100. The average price patients were willing to pay for Jewel-Osco's MTM services was $17.57. But, as for Barner and Branvold, a convenience sampling method may mean results cannot be generalised to the population level.

The WTP for HMRs in Australia is unknown and the presented Canadian and US perspectives into the question may not be representative of this specific medication review type. Canadian and US-based medication review providers do not have a program requirement to visit patients in the home-based setting (108th Congress, 2003; British Columbia Government, 2016b). With respect to WTP, the Hong et al. study provided the only identifiable outcome measure that may be generalised to this context which was a reduction of US$15.88 in marginal WTP (Hong, et al., 2011). However, the reliability and validity of this assertion for the Australian HMR is in doubt. This supports the view that there is a paucity of research to support or refute a WTP proposition for HMRs.

White and Clark found in both the qualitative and quantitative aspects of their research that awareness of HMRs was very low in Australia (White & Clark, 2010). The quantitative component suggested that 20% of non-previous recipients of HMRs were aware of the program prior to their research. The findings of White and Clark are consistent with a PwC report on the Fifth Community Pharmacy Agreement which suggests that most consumers had very low awareness of all medication management programs, how they could be accessed and the value those programs could provide them (PricewaterhouseCoopers, 2015). The PwC report into the Fifth Community Pharmacy Agreement also noted that a barrier for consumer awareness and access of HMRs was a lack of awareness by GPs.

Although HMRs have been delivered for over 15 years, the level of awareness of consumers and GPs does not seem to have significantly progressed over this timeframe. As suspected by both White and Clark, and PwC the lack of awareness of the HMR program may act as a barrier to referrals which could affect their uptake. Any research into the program should ideally assess the current level of awareness given this could affect any proposed funding allocation decisions.

Numerous literature sources reveal many possible attitude and preference items that can potentially affect the uptake of HMR services.

White, Klinner and Carter applied a qualitative method to determine consumer perspective items of the Australian HMR service (White, et al., 2012). Their study found that information acquisition, reassurance, coordination of care, feeling valued and cared about, and relationships were identifiable benefit items. However, concerns about upsetting the GP, pride, interdependence, an unknown pharmacist, home privacy and safety concerns and information supply and inclusion of carers in the process were relevant barrier items.

Furthermore, qualitative research by Campbell Consulting and Research into HMRs used trust, longevity of participant relationship with their GP and community pharmacies, patterns of medication use, prior experience of adverse reactions to medications, source of medication information and who people expect to provide clarification on medications as attitude items (Campbell Research and Consulting, 2008). This research found that overall, most HMR consumers' did not view a need for the service, but agreed for it to take place on suggestion by their GP. This suggests that attitudes of GPs should be considered with respect to the HMR uptake question.

This view is supported by a semi-structured focus group qualitative approach used by White and Clark (White & Clark, 2010). This study applied questionnaire items to undergo segmentation across nine parameters including gender, age, disease state, geographic location, ethnic background, context-community versus hospital, previous experience of an HMR, independence with respect to medical decision-making and attitude towards healthcare professionals. They reported the key issues identified were low awareness of the HMR program, high satisfaction and positive perceptions of the HMR service.

The presented Australian-based literature into consumer attitudes and preferences for the HMR program had some commonalities. However, unique items were identified across each study. There also appears to be no standard for assessing consumer attitudes or preferences that should be applied to specifically assess HMR services. Therefore, use of common items identified from previous qualitative research is considered relevant to apply for the purpose of assessing their level of importance and any association with WTP for HMRs, should that be the case.

The conducted research will have a cross-sectional study design consisting of both quantitative and qualitative approaches to acquire primary data, and a literature review to consider secondary data. The use of these approaches will minimise the respective weaknesses of the deductive and inductive method. For example, quantitative analysis can provide an assessment for generalisation of any findings to the population and qualitative analysis can better investigate the perceptions of HMRs by consideration of social contexts.

A literature review will be conducted to initially collect secondary data to gain deep insight about the theoretical basis of WTP, level of awareness, and consumer attitudes and preferences for HMR services.

The literature used in the review will be reconciled using NVivo Pro 11 software. A research journal and log will be maintained throughout the project. The literature review will inform and justify this research. It will also search for patterns and themes to allow critical evaluation of the research approach. Any identified knowledge gaps on WTP, level of awareness, and consumer attitudes and preferences for HMR services will be presented.

Ideally, a random sampling of community pharmacy and medical practices will be conducted across metropolitan Adelaide using a sourced list from a relevant database (e.g. Yellow pages or Google search). Every fifth listing from these sources up to a maximum of 30 sites will be allocated a value using a random number generator with Excel software between 0 and 100. The sites with a numerical value on Excel random number generator closest to 0 will be consulted for participation in the study to allow access of researchers to their patient populations as the priority. This will occur until all sites have been exhausted for participation in the study or the required number of participants has been reached. Based on Cochran's (1977) formula, a minimum total of approximately 385 (384.16) usable responses will need to be sourced (Cochran, 1977). This level would provide acceptable accuracy for a 5% margin of error, use of a 95% confidence interval, and 50% as an estimate of the variance of the Adelaide population.

In the event the necessary number of respondents cannot be reached by this method, a contingent convenience sampling using quota sampling principles of a relevant email database will be applied (e.g. University of Adelaide database). This timing of this decision will be determined in agreement with the research supervisor. If personal or university-based email databases exhaust respondent possibilities, employment of a marketing firm may be necessary.

The online survey questionnaire will be constructed using the Qualtrics platform and consist of two parts. The initial section will contain a set of demographic questions (e.g. age, gender, income level). The second set will include questions containing items to examine WTP, level of awareness, and consumer attitudes and preferences for HMR services. A total of 30 questions will be issued in the survey and contain nominal, interval, simple attitude and Likert scales. The survey will also contain open-ended questions without pre-set choices for relevant items to provide supporting qualitative data. The survey will be targeted to take no longer than 10 minutes.

The completed survey will be uploaded on tablet hardware and the researcher will complete the survey on sample unit engagement at the pharmacy or medical practice site.

The qualitative component of this research will ideally be conducted as two focus groups. A convenience sampling approach using quota sampling principles will be applied to supply the two groups where one group will be for previous recipients of HMRs and the other group will be for non-recipients of HMRs. The sampling units will be general adult members of the public sourced on the initial approach at community pharmacy or medical practice sites. In the event conducting focus groups may prove impractical, one-on-one interviews will be offered and appointment times made at an agreed site for willing participants (e.g. home, cafe or room booking at the University of Adelaide).

The interviews or focus groups will involve a single moderator and apply a questioning approach that will narrow to the willingness to pay for HMRs. Exploratory questions will also be asked to provide insight into the research questions including awareness and consumer and preference items. These sessions will be voice recorded and time controlled for maximum 30 minute sessions.

After completing data acquisition activities, analysis will be conducted by the following methods to present any findings for WTP, level of awareness, and consumer attitudes and preferences for HMR services.

On closing the online survey, quantitative data analysis will be conducted using Qualtrics, SPSS and Excel software.

The initial demographic questions will be analysed using descriptive statistics principles. Frequency tables, histograms and crosstab functions will be generated. A key output will be the number of respondents willing to pay for HMRs and the level of that payment.

For the second section of the questionnaire, analysis will incorporate a broader set of analytical tools. Interval items will be analysed with independent sample t-tests against demographic items to determine any differences (e.g. gender differences in attitudes to or preferences for HMR services). Also, Pearson's correlations will be run to examine potential associations between level of awareness and consumer attitudes and preference items, and WTP.

Finally, exploratory factor analysis will be performed on preference and attitude items to identify if they can be reduced to specific and meaningful factors. The relevant factor will be classified according to the observed nature of the reduction (e.g. GP-focussed, side effect averse). Should any meaningful factors be discovered, regression analysis will be performed where the reduced factors will be used as independent variables and WTP the dependent variable.

The proposed interview or focus group elements of this research will focus on identifying any meaningful patterns or themes that emerge during the discussion. Nvivo Pro 11 will be the primary software tool for conducting qualitative data analysis. Recordings or a transcript document of the discussion will be uploaded onto the software for reconciliation with the literature review.

Data reduction will be performed by considering which aspects of discussion were emphasised, minimised or ignored by respondents. Focus Group sources will be de-identified for privacy purposes, and allocated nominal descriptors for case classification (e.g. male 5, female 4). The findings of data reduction will be documented as nodes, cases and relationships in the software. This will be reconciled with the literature review to consider the level of consistency in identified patterns or themes with this study's findings for the purpose of determining if they are new or clarify influences of the social context.

Data displays will be generated to provide a visual interpretation of the data. Word clouds and cluster analysis will be performed to analyse word frequency and use. Project and concept maps will be generated to clarify relationships and associations. Particularly, the concept maps will show how identified patterns and themes influence research questions.

The proposed timeline and the expected duration of each activity for the study is presented in Table 1. The proposed length of the study is 17 weeks. This timeline assumes ethics approval has been granted, full-time status and availability of the researcher and supervisor.

Table 1: Research Project Activities and Timelines.

The HMR research project Gannt chart is a graphical illustration of the timeline details contained in Table 2 which is shown in Figure 2.

Figure 2: HMR Research Project Gannt Chart

This section outlines the proposed costs for the overall research project.  Table 2 shows an assessed total cost of between $2,136 to $3,522 to complete the project based on present estimations. This cost figure is the cash outlay for the project and includes a cost figure for purchases or leasing of a tablet device and if a marketing firm would need to be employed for sampling purposes.

Table 2: Research Project Proposed Budget and Allocations (SHRM, 2016)

This research proposal outlines RDMT's business problem, core research problem and research questions. A methodology, timeframe and budget has been provided to enable the research to occur without significant impediments. This research will provide useful data and recommendations to assist with decisions about HMR business expansion. If the public demonstrates a willingness to pay for HMRs, this may signal the beginning of widespread HMR application in the healthcare system. This would improve the quality use of medicines in Australia and likely be translated into reduced hospital admissions resulting from medication misadventure.

108th Congress, 2003, Medicare Prescription Drug, Improvement, and Modernization Act of 2003, United States Government.

American Pharmacists Association, 2016, Billing for MTM Services- Tips for Pharmacists, viewed online 12 December, 2016, Available at: <https://www.pharmacist.com/sites/default/files/files/mtm_billing_tips.pdf>

Australian Association of Consultant Pharmacy, 2016a, Home Medicines Review, viewed online 12 December, 2016, Available at: <https://www.aacp.com.au/accreditation/mmr/hmr.html>

Australian Association of Consultant Pharmacy, 2016b, Australian Medication Review Journal Publications, viewed online 12 December, 2016, Available at: <https://aacp.com.au/dev/docs/MMR%20Journal%20Articles%20Feb2016.pdf>

Barner, J. C. & Branvold, A., 2005, Patients' Willingness to Pay for Pharmacist-Provided Menopause and Hormone Replacement Therapy Consultations, Research in Social and Administrative Pharmacy in Science Direct, pp. 77-100.

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Friedrich, M., et al., 2010, Patients' Needs and Interests in a Self-Pay Medication Therapy Management Service, J Am Pharm Assoc, pp. 72-77.

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Initiation

Identication of patient who needs a HMR

GP assesses clinical need for HMR

Review

Approved HMR service provider coordinates the HMR with the patient and GP

Accredited Pharmacist conducts the HMR at the patient's home.

Management Plan

GP develops a written medication management plan which is discussed with the patient.

An agreed plan is implemented.

GP refers patient and provides detailed clinical referral report to the provider of the HMR service.

Accredited Pharmacist reviews the information from the HMR and provides a written report outlining findings and management strategies to the GP.

HMR Research Proposal Gannt Chart

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