INTRODUCTION

Adherence to therapy is a challenge not only for patients, but also for health practitioners and researchers. Despite efforts to educate patients and provide interventions to address factors contributing to non-adherence, non-adherence and non persistence to therapy remain high, both across different populations and disease states. Adherence and persistence are influenced by many factors, and a single intervention is unable to address all issues resulting in non-adherence in all populations. A lack of consensus about the use and definitions of adherence (and compliance), the absence of a gold standard to measure adherence and the use of, primarily, self-report methods also introduce a bias in the results and further complicate adherence research and the assessment of interventions provided.

In addressing non-adherence and non persistence, a multidisciplinary approach to patient care is advocated. However to achieve this, health practitioners must be appropriately educated about how to identify barriers to adherence and support adherence. More importantly, there need to be national policies that promote patient adherence to therapy and support both research and interventions delivered by health practitioners. This article describes the education, research, practice and policy in the area of adherence to therapy in Australia with a focus on community pharmacists as the health practitioners.

METHODS

Adherence Education

All Australian pharmacy schools were contacted to collect information about their adherence programs.

Research in Adherence

Study Selection and Review

The databases MEDLINE and International Pharmaceutical Abstracts were searched, with the search being limited to Australia and the time period 2000-2008, as it is only in that past 9 years that adherence monitoring services and government and professional pharmacy organisation initiatives have emerged in the Australian setting. The following key words were used: “community pharmacist” or “pharmacist” or “community pharmacy” or “pharmacy” AND “adherence” or “compliance”; “pharmaceutical care” or “pharmaceutical services” or “disease state management” AND community pharmacist” or “pharmacist” or “community pharmacy” or “pharmacy”. Searches were also conducted based on the names of key Australian researchers in the areas of cognitive pharmaceutical services and disease state management. A hand search of the bibliographies of retrieved articles, as well as a search of the Research and Development projects funded through the Pharmacy Guild of Australia (http://beta.guild.org.au/research/funded_projects.a sp) was also conducted.

Each retrieved article was then reviewed based on the study design, description of the interventions provided, and outcome measures evaluated (with a focus on adherence measures).

The study was included if it was an intervention program delivered in a community pharmacy by the pharmacist to patients with a chronic disease; the intervention either directly or indirectly addressed adherence assessment, monitoring and support and adherence was either a direct study outcome measure or was measured indirectly. All study designs were included.

A total of 11 studies met the inclusion criteria and were reviewed.

RESULTS AND DISCUSSION

Adherence Education

Nine of the 16 Australian institutions responded. The majority offer a Bachelor of Pharmacy program which is a four-year undergraduate degree. Some institutions also offer the Master of Pharmacy degree, which is a two-year postgraduate degree. However, students completing either the Bachelor or Masters programs are still required to complete a 12 month pharmacy graduate training program prior to being eligible to register as pharmacists. The content of the degree programs is not prescribed by state or federal regulations or guidelines. However, all programs are accredited through the New Zealand and Australian Pharmacy Schools Accreditation Committee (NAPSAC).

Patient medication adherence, including definitions, causes of non-adherence and non persistence, measures of adherence, strategies to promote adherence and persistence and psychological models of non-adherence are taught in almost all of the Pharmacy degree programs across Australia. Table 1 provides examples of the curriculum content. The institutions appear to have similar programs though named differently, assessed differently and taught at various levels in the degree.

Research Intervention Program Characteristics

Several studies demonstrated a positive impact of the community pharmacy delivered service on medication adherence1-8, measured predominantly by the use of validated self report questionnaires.9,10 No studies used the Medication Events Measuring System (MEMS) considered the gold standard for adherence measurement, possibly due to the cost of the devices.

The majority of studies used a parallel, controlled, repeated measures design (with 2 or more post-intervention data collection points) to strengthen the research design. In all studies the community pharmacy was recruited first, and the pharmacists then recruited patients (Table 2). Two studies reported using a randomised controlled design1,5 these were randomised at the pharmacy and not the patient level. It is recognised that conducting a true randomised controlled trial with a community pharmacy setting is not easy. Some studies experienced difficulty recruiting pharmacists, who in turn had difficulties recruiting patients.3,11 The low recruitment and high attrition rates compromise the research design and make statistical analyses difficult.

All but one2 of the studies had a disease focus for the interventions which were delivered by the community pharmacists. The majority focused on asthma1,6-8,12,13 with diabetes as the next most common disease state.4,14,15 Other areas included depression16 and cardiovascular disease.3,11 Improving adherence was not the primary outcome of any of the studies, but rather a means to produce better disease or risk factor control. All studies included some elements of patient education about the disease, therapy and monitoring, as well as lifestyle factors. In most cases the interventions included an assessment of patient’s beliefs and knowledge, patient goal setting, with a review of the goals at the planned patient visits to the pharmacy when the pharmacist would provide tailored strategies to optimise medication taking and improve therapeutic outcomes. The types of interventions implemented by researchers highlights the complex nature of adherence behaviour and the need for multiple strategies to support behaviour change. However, in one study, the pharmacists only delivered the intervention on a single occasion.6

In all reported studies, participating community pharmacists who delivered the interventions received training. In addition, in some studies pharmacists were remunerated for their services.1,8,11,13 Some interventions appeared complicated2 and not all authors provided a detailed description of the interventions delivered or how sustainable and reproducible they were outside the research studies.

POLICY AND PRACTICE OF ADHERENCE SERVICES

Following World Health Organization’s (WHO) leadership, Australia has been very active in the development and implementation of a National Drug Policy. The Australian Government launched its National Medicines Policy (NMP) in 1999. It focuses on four main objectives 1) timely access to medicines that Australians need at a cost that individuals and the community can afford, 2) medicines meeting appropriate standards of quality, safety and efficacy, 3) quality use of medicines, and 4) maintaining a responsible and viable medicines industry.17

The aspect of the NMP which pertains to compliance or adherence to medication is the Quality Use of Medicines (QUM) policy. Its aims are “to optimize the use of medicines to improve health outcomes for all Australians” through the “judicious selection of management options, appropriate choice of medicines where a medicine is considered necessary, and safe and effective use of medicines”.18 While the QUM policy does not specify adherence to medications per se, it is implicit in the notion of effective use of medicines.

Pharmacists in executing their professional responsibilities with respect to QUM have a key role in identifying and addressing non-adherence to medication. This has been recognised by official pharmacy organisations through a number of policies, practice standards and programs over recent years.19,20 For example the Pharmaceutical Society of Australia in its “Framework Document endorsed by all stakeholders in February 2001” for Home Medicines Review (HMR) refers to one of the purposes of HMR which is to identify consumer management issues such as continuing ceased medication; misuse, overuse or underuse of medicine; signs of non-adherence; and misunderstanding, confusion or problems with purpose or use.19 Indeed HMR is one of a number of professional pharmacy programs funded under 3rd (2000-2005) and 4th (2005-2010) Guild Government Agreements which have been introduced to community pharmacy by the Pharmacy Guild of Australia over the past decade.20 Most of these programs address adherence to medication as a component of the service. Services other than HMR include Dose Administration Aids (DAA), Patient Medication Profiling, and the Diabetes Medication Assistance Service (DMAS).

Home Medicines Review (HMR)

Introduced in 2001, the HMR is a consumer focused structured and collaborative health care service which involves the consumer, his/her general practitioner, his/her pharmacy and other relevant health care professionals. The program targets consumers at risk of medication related problems such as those on multiple medications or multiple daily doses, those with suspected non-adherence or inability to manage medication related therapeutic devices or recently discharged from hospital. The GP initiates the service by writing a referral to the local pharmacy and provides relevant clinical information including diagnoses, recent laboratory results and a list of prescribed medications to inform the pharmacist conducting the review. In the next phase, the pharmacist conducts an interview preferably in the consumer’s home and uses this as an opportunity to identify and address any gaps in consumer understanding of their medicines and barriers to medication adherence. Following this the pharmacist prepares a report for the GP with their findings and recommendations. The GP then discusses the report with their patient and considers any recommendations for changes to the regimen for the patient. A medication plan is produced by the GP and once agreed with the patient, a copy is sent to the preferred community pharmacist. The pharmacy is remunerated for each HMR (AUD 180; [92EUR]) and the GP receives a fee (AUD 134; [68EUR]). The service aims to improve the appropriate use of medicines and thereby improve patient outcomes.20 There are currently 1794 pharmacists in Australia accredited to deliver home medicines reviews.21 The data from Medicare Australia indicate that 189,108 HMRs have been claimed by health professionals.22

Dose Administration Aids (DAA)

If non adherence to medication or difficulty in managing the medication regimen are identified as issues, a suitable strategy is to supply the patient with a dose administration aid. In Australia, under the 4th Guild Government Agreement a new pharmacy program, the Dose Administration Aids (DAA) is paying community pharmacists to supply a dose administration aid to eligible community based patients enrolled in the program.23 Currently, the DAA program is in the implementation trial phase. During Phase 1 (July 1 2008 – 30 June 2009) specified data are collected for a minimum of five patients every three months and provided for the evaluation of the DAA Program. Pharmacists are eligible to receive incentive payments totalling AUS$8,900 when participating in Phase 1. The data collected during Phase 1 will be used to review patient eligibility and to develop a service and payment model to trial in Phase 2.24

Patient Medication Profile (PMP)

Another recent program to be introduced into community pharmacy under the 4th Guild Government Agreement is the Patient Medication Profile Program (PMP). Its aim is to assist eligible patients to better understand and manage their medicines and to provide a tool for communication between health care providers, such as pharmacists, GPs, allied health and community health careworkers, and the patient.

The PMP is a comprehensive summary of all regular medicines taken by a patient and must include complete information (brand, strength, dose, dose regimen, directions, prescriber) on all regular prescription medicines (including regular ‘when necessary’ medicines), regular over-the-counter and complementary medicines. It must also include patient details such as the patient’s name and address; date of birth, allergies or previous adverse drug reactions, and pharmacy contact details.

The PMP should provide space for the pharmacist to include additional advice or information and for additional comments to be annotated by different health care providers to facilitate effective inter-professional communication. An integral part of preparing the PMP is a patient consultation with a trained pharmacist which must take place in a suitable counselling area.

As with the DAA, the PMP Program is trialling the service within the community setting in a 2 phase process and will collect evaluation data to establish its benefits and sustainability. During Phase 1, incentives of up to AUD 4,200 [2,150EUR] (excluding Goods and Services Tax) are available to pharmacies for full participation in the PMP Program which comprises the collection and provision of evaluation data for a minimum of five patients every three months between July 2008 and July 2009. Pharmacists are also expected to charge patients AUD 5 [2.6EUR] per PMP per calendar year.25

Diabetes Medication Assistance Service (DMAS)

One of the Better Community Health Initiatives programs of the 4th Guild-Government Community Pharmacy Agreement which addresses medication adherence in a specific disease state is the Diabetes Pilot Program: Diabetes Medication Assistance Service (DMAS). Its aim is to assess the effectiveness and feasibility of a broader implementation of the Diabetes Medication Assistance Service within community pharmacy and its effect on the access to professional health support for eligible patients. The DMAS was trialled under the 3rd Guild-Government Community Pharmacy Agreement in people with type 2 diabetes and demonstrated improved diabetes control, an improved understanding of the long-term management of their diabetes and improved medication adherence.5,15

This service, focused on patients with type 2 diabetes, comprises a cycle of pharmacy visits which follow a defined protocol. Using a patient-centered approach, the pharmacist provides support to the patient to better self manage their diabetes by reviewing self-monitoring of blood glucose (SMBG) results with the patient, providing targeted disease, medication, and lifestyle information; giving adherence support; detecting drug-related problems; and making referrals as appropriate to the GP. At the end of each visit the patient with the help of the pharmacist will set a few key goals to improve self management to be reviewed at the next visit.

The program will be implemented in two stages. Evaluation of Stage 1 will focus on both process and outcome measures. The implementation process will be monitored with data collected on the recruitment rate of both pharmacies and patients. A wide range of clinical (e.g. HbA1c, BP, lipids, 10 year CV risk) and humanistic (quality of life and satisfaction) outcomes will be collected to determine the optimum number of visits to achieve the greatest improvements in diabetes.

Adherence Assessment Tool- MedsIndex®

This tool was developed by the Pharmacy Guild of Australia and launched in 2008. It computes a score out of 100 for up to five chronic medications in the patient computerized medication history by comparing actual refill intervals over expected refill intervals based on the dosage regimen. Thus it enables the pharmacist to identify potential non adherence and propose to their customer to enroll in one of the other professional pharmacy programs such as the DAA or the PMP (Figure 1).26

CONCLUSIONS

Australian pharmacy schools are educating cohorts of students who will have the skills to monitor and support patient medication adherence in the context of contemporary pharmacy practice. This is supported by government policy and fits well into the move to expand community pharmacy services to include chronic disease state management and primary health care. A great deal of research has been conducted in the past 5-10 years on development, implementation and evaluation of disease specific interventions to be delivered by community pharmacists to their patients with chronic diseases, namely asthma, diabetes and cardiovascular diseases. Although these studies have shown a positive impact of the interventions on medication adherence as well as various health outcomes, the long term (more than 12 months) impact of these interventions is unknown, and an area which should be considered for further research.

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Notes