Adherence to treatment: practice, education and research in Danish community pharmacy.

OBJECTIVE: To describe the practice, education and research concerning medication adherence in Danish community pharmacy.
METHODS: The authors supplemented their expertise in the area of medication adherence through their contacts with other educators and researchers as well as by conducting searches in the Danish Pharmacy Practice Evidence Database, which provides annually updated literature reviews on intervention research in Danish pharmacy practice. PRACTICE: Medication adherence is the focus of and/or is supported by a large number of services and initiatives used in pharmacy practice such as governmental funding, IT-supported medicine administration systems, dose-dispensing systems, theme years in pharmacies on adherence and concordance, standards for counselling at the counter, pharmacist counselling, medication reviews and inhaler technique assessment. Education: In Denmark, pharmacy and pharmaconomist students are extensively trained in the theory and practice of adherence to therapy. Pharmacy staff can choose from a variety of continuing education and post-graduate programmes which address patient adherence. RESEARCH: Nine ongoing and recently completed studies are described. Early research in Denmark comprised primarily smaller, qualitative studies centred on user perspectives, whereas later research has shifted the focus towards larger, quantitative, controlled studies and action-oriented studies focusing on patient groups with chronic diseases (such as diabetes, asthma, coronary vascular diseases).
CONCLUSIONS: Our analysis has documented that Danish pharmaceutical education and research has focused strongly on adherence to treatment for more than three decades. Adherence initiatives in Danish community pharmacies have developed substantially in the past 5-10 years, and, as pharmacies have prioritised their role in health care and patient safety, this development can be expected to continue in future years.

INTRODUCTION

The consequences of poor adherence to long-term therapies include poor health outcomes and increased health care costs. Adherence can be defined as “… the extent to which a person’s behaviour – taking medication, following a diet and/or lifestyle changes, corresponds with agreed recommendations from a health care practitioner”.1,2

This article describes the initiatives taken in the Danish primary health care sector, specifically community pharmacy, concerning medication adherence practice, education and research.

METHODS

The information concerning policy and practice is based firstly on the authors’ extensive knowledge, and secondly, on a mapping of pharmacy practice activities in Nordic countries conducted in 2008 for the Nordic Pharmacy Association.3

The results in the research section are based on searches in 1) the Danish Pharmacy Practice Evidence Database and 2) PubMed. The Danish Pharmacy Practice Evidence Database has been developed and is operated and annually updated by Pharmakon (the Danish College of Pharmacy Practice- www.pharmakon.com). It is an electronic searchable database, comprising literature reviews (published in English and Scandinavian languages) and Danish reports in key pharmacy practice areas, with emphasis on primary care.4,5 The following keywords were used in the Pubmed search: (compliance OR adherence OR concordance) AND (intervention* OR (clinical trial)) AND medication or medicines or drugs AND ((primary care) or (pharmacist OR pharmacists OR pharmacy OR pharmacies). As a second strategy, input was sought from researchers in key organizations: Pharmakon, Association of Danish Pharmacies, and the Faculty of Pharmaceutical Sciences.

RESULTS AND DISCUSSION

Danish community pharmacy practice

In 2007 Denmark’s population of 5.5 million spent approximately EUR 550 per inhabitant on medicines.6 Community pharmacies in Denmark are privately owned, but as they are an important part of the health care system, the state closely regulates their premises, tasks, competency requirements, prices and profit margins All Danish pharmacies are members of the Association of Danish Pharmacies. Pharmaconomists (formerly referred to as pharmacy assistants) may dispense prescriptions and advise customers in a pharmacy.6

Adherence standards and guidelines

Community pharmacies in Denmark play a key role in providing the public with information and counselling in the use of medicines, self-care and disease prevention. They provide medicines and medicine-related services in accordance with national laws and regulations, the WHO-approved Guidelines for Good Pharmacy Practice and Danish quality standards for pharmacies.

At present, there are no official Danish adherence policies on medication non-adherence. However, medication is a key topic in The Strategy for Chronic Conditions.7 The strategy, which focusses on the organisation and provision of health care and on patient self-management is currently being implemented at regional level. Moreover, the Danish Society for Patient Safety has developed medication safety strategies in which adherence is a focus, and which is expected to attract more attention in the future.8

The Association of Danish Pharmacies launched its “Standard for Counselling at the Counter” in 2007.7 The standard sets out three different levels for counselling at the counter: A ‘basic’, ‘extended’ and an ‘advanced’ level. At the basic level, the standard requires pharmacy staff to invite all customers purchasing medicines for themselves to a ‘dialogue’, by asking questions and giving information about the medicine. At the extended level, the pharmacy staff should, in addition, ask questions about customers’ specific risks and provide relevant counselling according to the customer’s needs. At the advanced level, pharmacy staff is required to also assess symptoms and identify ‘alarm signals’ in order to help the customer prevent medicine-related problems. Pseudo-customer studies have been used to investigate whether customers receive counselling in accordance with the standard’s basic level.9

Occasional services delivered with temporary funding

In 2005-06, several policy papers highlighting the need to focus on adherence to medicines were published.10,11 The Medication Reimbursement Committee report led to a parliamentary decision to allocate DKK 10 million (EUR 1.33 million) annually over a period of four years to adherence research.12 During the first years (2005-2007) of the existence of this fund – known popularly as the ‘adherence pool’ – special emphasis was placed on (dis)continuing medicine treatment and particularly vulnerable groups. The invitation for applications in 2009 focused on how to increase adherence and on studies regarding dose-dispensing systems. To support appropriate decision-making and prioritizing in the funding programme, The Danish Institute for Rational Pharmacotherapy (IRF) published two reports, one on the concept of adherence and problems with non-adherence13 and one on evidence for adherence interventions.14 IRF also frequently publishes reviews and meta-analyses relevant to the adherence area.15 Pharmacy projects supported by grants from this programme are shown in Table 1. About half of all the projects take or have taken place in a primary health care setting.

Table 1

The 2005-2007 adherence pool projects, which involved community pharmacists

	Setting	Project title
2005 pool	Pharmakon, The Danish College of Pharmacy Practice	Better medicine use in home care and in nursing homes
2006 pool	The Faculty of Pharmaceutical Sciences, University of Copenhagen	1. Optimal medicine use among ethnic minority Danes.
		2. Evaluation of the health economics aspects of individually optimizing the medicine use of asthmatics via text messaging – a controlled study
2007 pool	The Faculty of Pharmaceutical Sciences, University of Copenhagen	Medisam – a collaborative model for medication reviews and coordination between patients, physicians and pharmacists
	Community pharmacy	Community pharmacy-based pharmaceutical care programme for improving the adherence of elderly poly-pharmacy patients

Since the 1990s, the Association of Danish Pharmacies has organized common “theme years” (such as diabetes, asthma, patient safety, better use of medicines) in all community pharmacies.16,17 In 2007, a specific adherence campaign was included, and in 2008 adherence and concordance were the common theme of all campaigns. For a description of tools developed for the theme years, see Table 2.

Table 2

Adherence campaigns in Danish Pharmacy – Theme Years 2007 and 2008

Counselling at the counter:	2007: Adherence in general as one of four campaigns 2008: Adherence and concordance as an overall theme in all four campaigns: Lipid lowering drugs Chronic Obstructive Pulmonary Disease Reminder techniques Depression
Marketing activities	Newspaper national advertising Window display “Great Reminder Day”, including badges and free dosing aids (2007)
Materials and tools for the public	Introduced in 2007: Brochure: “Medication Safety” Customer card: “Did you remember your medicines?” Free text message reminder service Adherence information on customer computers in pharmacies Introduced in 2008: Brochure: “Reminder techniques” Menu card: “Reminder techniques and dosing aids” Patient Interview or Self assessment tool: “How are you doing with your medicines?”
Learning resources for staff	2007 Training leaflet: “Communication about adherence” 2008 Dialogue tool for adherence communication PowerPoint presentations and patient cases Adherence and concordance booklet
Cognitive services featured	Medication review Medication check (brown bag service) Dose dispensing Peak flow measurement Medication review in nursing homes

Funded and/or mandated routine services (focusing on adherence)

At national drug policy level, a number of IT-supported medicine administration systems that facilitate adherence to treatment have been implemented. These include automated dose-dispensing in primary care, personal medication profiles, a national prescription server, health portals with information on medicines, a national database on interactions and interaction-checking facilities for patients and professionals.

In 2001, Denmark adopted legislation to implement automated dose-dispensing (ADD) (which is defined as the filling of a medication into a dose container adapted to the specific use of the medication at a system to support correct medicine-taking in primary care. ADD can be ordered from all pharmacies, and is the adherence service most extensively provided by Danish pharmacies (more than 40,000 users in 2008).19 The service is provided mainly to elderly poly-pharmacy patients and requires collaboration with other health care professionals.

In 2004, the Personal Medication Profile (PEM) was launched on the national health website www.sundhed.dk as a facility for all Danish residents. The profile gives individual medicine users, general practitioners (GPs), pharmacists and, from 2009, primary care nurses, an overview of medicines bought by patients. The data quality of dosing information is still not optimal in the PEM, though, often resulting in adherence profiles of poor quality.20 However, the PEM is a valuable tool for medication reviews and, after system improvements, will have definite potential as an adherence support tool.21 The PEM is now being developed into an integrated medication record.22

More than 70% of prescriptions in Denmark are dispensed as e-prescriptions, and, since 2007, physicians have been able to send e-prescriptions either to a pharmacy or to a national prescription server, from which all pharmacies can download them. In principle, pharmacies can check whether prescribed medicines have been collected, thus enabling follow-up on primary non-adherence.

Since 1991, pharmacies in Denmark have been required to offer a generic substitute unless the physician has marked the prescription ‘No Substitution’. The system has generated substantial savings for the national health insurance system and patients, but is also criticized for its potentially negative impact on adherence and safety.23,24 In small pharmacy-based projects, 20-44% of patients report that they sometimes find substitution confusing.25,26

A so-called “sms-service” has been offered by Danish Pharmacies since 2007. The service was introduced during the theme years as a text message reminder service for adherence support and is now offered as part of patient counselling or nationwide via the website www.apoteket.dk.

Since April 2005 the government has reimbursed an inhaler technique assessment service, the first reimbursed cognitive service in Denmark, which aims at optimizing inhalation techniques. Every pharmacy is required to provide the service. Between May 2006 to April 2007, Danish pharmacies provided the service approximately 40,000 times.27 The service is feasible28 and has resulted in a reduction of inhalation errors by 80%.29

Extended services funded or mandated (focused on adherence)

Danish pharmacists can offer patients a consultation comprising a medication review, a patient interview and follow-up as the basis for a pharmaceutical care service to optimize patient therapy outcomes. The service targets poly-pharmacy patients. The service requires collaboration with the patient’s GP if the pharmacist recommends therapy adjustments. Research has documented the cost-effectiveness and benefit of the service for patient health and adherence.30-32 A pharmacist consultation takes about 75 minutes and is currently paid for by the customer (at a price of approximately EUR 50). Data on number of services delivered are not published.

A medication check can be offered by Danish pharmacies. Customers bring their medicines to the pharmacy to check which should be discarded and to get advice on use and storage. The service is estimated to take 20-30 minutes and is currently paid for by the customer (approximately EUR 1520). Data on number of services delivered are not published.

Danish pharmacies offer four services to nursing homes: medication review, dose-dispensing, quality assurance and staff training, the quality of which has been documented in research projects.33-35 Although the service package perspective is broader than adherence, it focuses on the appropriate implementation of regimens including dose-dispensing and prevention of medication errors.

Pharmacist and pharmaconomist training in adherence

Denmark has only one institution, the Faculty of Pharmaceutical Sciences (University of Copenhagen) that confers an MSc degree in pharmacy. In 2008, the Faculty had 1,100 bachelor’s and master’s students and 110 PhD students. About 70 students attend one of the Faculty’s three continuing education master’s programmes (Master in Industrial Drug Development, Master in Pharmaceutical Regulatory Affairs or Master in Drug Management).

Pharmacy students learn about adherence issues in several courses during their bachelor’s and master’s programmes (see Table 3), during their six-month pharmacy internship and during an elective course on quality-assured medicine use. Overall, the courses deal with patient adherence definitions, models and theories on adherence, methods for identifying non-adherence, strategies to improve adherence and the economic consequences of non-adherence.

Table 3

Medication adherence taught at the Faculty of Pharmaceutical Sciences, University of Copenhagen

Degree (year)	Course	Content	Assessment
Bachelor (1)	Introductory pharmacy course – one-hour lecture and four-hour pharmacy visit	Definition of compliance/adherence, patient perspectives on medicine use	Report, presentation and exam
Master (1)	Social Pharmacy course – three hours followed by report writing	Definition of compliance and adherence, user perspective on drug utilization, rational pharmacotherapy, drug-related problems, patient autonomy.	Synopsis and written exam
		Students carry out interviews or do a survey with patients and/or health care professionals on adherence issues
Master (2)	Pharmacy internship – six months including two weeks of theory lectures and class room teaching in the Faculty – approx. one week on adherence-related issues	Definition of adherence, patient empowerment, communication theory and skills, drug-related problems, medication reviews, motivational interviewing, patient interviews (students watch two interviews in the auditorium – with a patient and with a person who needs motivation – and carry out patient interviews themselves in a patient’s home)	Written port-folio exam
Master (3)	Elective course in Quality Assurance of Drug Therapy (18 lectures and 21 class-room sessions each lasting 3 hours)	The aim of the course is to give the student insight into clinical pharmaceutical activities in the primary health care sector; to provide insight into quality assurance of drug therapy; to enhance the students’ understanding of drug-related problems, adverse drug reactions, drug-related morbidity and other unintended drug reactions; and to focus on patient safety aspects (medication errors, etc.)	Reports, oral presentation and defence
		Adherence issues are dealt with throughout the entire course.
Post-graduate programme	Master in Drug Management – six 40-hour courses	Courses deal with approaches to and theories on pharmaceuticals in health care, leadership in health care, project planning in health care, clinical pharmacy and pharmacotherapy, counselling in medicine use and evaluation and documentation of medicine use.	Reports or oral presentations

During the pharmacy internship, students can join a research project in which adherence is studied and analysed – the ‘Medisam study’, which is further described in the research section below.36,37 It is founded on the belief that pharmacy practice research, pharmacy practice and student learning are closely connected and interwoven.

The pharmaconomist education is a three-year programme consisting of practical training periods and eight theoretical courses.38 Concordance and adherence theory of is taught in the third course during the first year, by assignments in the practical training period and, later on, during multidisciplinary courses.

Post-graduate programmes

The Master in Drug Management (MDM) programme deals with adherence issues. The programme aim is to ensure the quality of drug utilization in society and to increase patient safety. The MDM programme is a one-year degree programme for pharmacists and others with a health care-related background. The programme offers six compulsory courses (30 European Credit Transfer System credits (ECTS), where one ECTS corresponds to 27-28 student working hours). All courses (except for the leadership course) include adherence-related issues. Students can also opt to include adherence issues in their final thesis, a solution chosen by all three students (in pharmacy) who have completed the programme to date.39-41

In 2007 a certificate programme for Danish pharmaconomists was established - “Postgraduate education in clinical pharmacy and public health”- with a total of 30 ECTS corresponding to six months full-time study to be completed over a period of two to six years. The programme comprises five courses, two of which (clinical pharmacy and pharmacotherapy) have adherence and behaviour change as major subjects, and participants are trained in motivational interviewing and self-management enhancement.

Continuing education

In Denmark, there are no mandatory requirements for continuing education, but the pharmacy has to keep documentation of staff qualifications for inspection and quality audits. Most professional continuing education programmes for pharmacists and pharmaconomists are offered by or in collaboration with Pharmakon. Many two-day courses in pharmacotherapy are offered in relation to theme years, and these include the pharmacy’s role in detecting and resolving adherence problems.

Research in adherence to medication treatment

Adherence research has been part of Danish pharmacy practice since the late 1970s. Most research has been based on qualitative methods (interviews) and conducted from the Royal Danish School of Pharmacy (later the Faculty of Pharmaceutical Sciences, University of Copenhagen). Research has been based on the theory that medicine users’ own perspectives must be included when describing and trying to understand medication adherence and non-adherence, and that non-adherence is not necessarily ‘bad’ and/or due to the patient’s forgetfulness.42-44 Since the 1970s many research projects have thus dealt with users’ everyday experience with medicines (such as perceptions of medicine, adherence, reasons for being adherent/non-adherent).45-58 Most pharmacists have also conducted such studies on a small scale as part of their education.59 In recent years this body of knowledge has supported the shift from an adherence to a concordance orientation and strongly influenced pharmaceutical care projects in Denmark, for instance to put even greater focus on patient empowerment.

After the late 1990s, a shift was experienced in Danish community pharmacy adherence research from the small, qualitative studies mentioned above to larger quantitative, controlled studies carried out under the auspices of two interdisciplinary research centres, The Research Centre for Quality in Medicine Use (FKL) based at the Faculty of Pharmaceutical Sciences (www.fkl-center.dk) and The Apofarma Consortium (www.apofarma.dk). FKL was launched in September 1999 and is an umbrella entity that addresses research needs by analysing associations between medicine use and the population’s health, health behaviours and socio-economic conditions; by exploring users’ experiences, assessments and strategies in medicine use; and by providing interventions in health care aimed at optimizing medicine use. Several studies on medication adherence in a primary setting are operated from the FKL platform. The following is a description of the largest and most influential studies and initiatives.

Therapeutic Outcomes Monitoring (TOM) and medication review

The first Danish study on pharmaceutical care was carried out in the mid-1990s in collaboration with Charles D. Hepler’s team at the University of Florida. Like research done by the other countries in the Pharmaceutical Care Network Europe (PCNE), it offered major insights into the development of a disease-specific pharmaceutical care model with strong emphasis on the user perspective. The study also paved the way for the establishment of the first third-party paid cognitive service in Danish community pharmacies in 2004.60 The TOM study on asthma was followed by another PCNE-based research programme entitled ‘Improving Drug Therapy for the Elderly’ in which a generic pharmaceutical care model was developed and tested.31 Both projects showed positive health outcomes as well as cost-effective benefits.

Safe and Effective Use of Medicines

This research programme comprised projects that developed and tested adherence-enhancing interventions and estimated the frequency of adherence problems among users of anti-hypertensives and anti-diabetics in a Danish community setting.1,61,62 A community pharmacist provided the extensive intervention and a pharmaconomist in the same pharmacy delivered the basic intervention.

The interventions were multidimensional and based on individual patient needs. The intervention model included a concordance-based partnership between patient, pharmacy staff and general practitioner. The programme elements and solutions were: quick screening for non-adherence and identification of problem types, patient story-telling, finding resources in the patient system, patient education, individual coaching and counselling, offers of relevant reminder technology, medication review and follow-up.

The hypertension project included 240 patients and showed that both interventions significantly affected patient-perceived effects on symptoms, blood pressure, knowledge, drug use, health-related quality of life (HRQoL) and satisfaction. The diabetes project included 80 patients and showed positive patient-perceived effects on symptoms, blood pressure, blood glucose, knowledge, drug use, adherence and HRQoL, and quantifiable effects on the pharmacists’ measurements of blood pressure, blood glucose and cholesterol.

The Pharmacy-University study

The Pharmacy-University study36,37,63-65 was a large three-year programme that used research in the 100 internship pharmacies as a strategy for learning and researching in the pharmacy. The overall aim of the programme was to contribute to the quality development of pharmacy practice and pharmacy practice research in the area of pharmaceutical care services. The programme involved researchers, pharmacy students, pharmacy staff, and more than 450 patients (patients with angina pectoris, asthma or type 2 diabetes). It focused on patient’s adherence, comparing questionnaire data from more than 1,500 pharmacy staff concerning their beliefs about patient’s medication adherence with patient’s own description of medication adherence. Data from patients were collected in individual home-based qualitative interviews with the patients. The study showed that one fifth of the angina pectoris patients, almost a third of the type 2 diabetes patients and half of the asthma patients used their medicine inappropriately, the majority of which being non-adherence.36

The Medisam study

In 2008 the internship pharmacies and the university launched a new three-year study, the Medisam study, as a model that patients, general practitioners and pharmacists could use for collaborating on medication review and medication reconciliation. In 2009, 118 type 2 diabetes patients participated, and were interviewed on various issues, including adherence, by pharmacy interns in 24 internship pharmacies throughout Denmark. This study is currently in progress and results have not been published yet.

Automated dose-dispensing

A review showed that there is no evidence that the automated dose-dispensing (ADD) system alone increases adherence or has any health-related effects.66 Interestingly, eight out of nine patients who received ADD-packed medicine were non-adherent in various ways, with intentional non-adherence being the most frequent type of behaviour.67

The Helping Hand

A recent study evaluated a new adherence reminding device named ‘The Helping Hand’. A main finding was that the Helping Hand can improve self-reported adherence among hypertensive patients, mainly in newly diagnosed patients by 6 % or in patients starting a new medication treatment. Blood pressure, though, was not influenced by the device.68

Optimal medicine use among ethnic minority Danes

In this study, 12 ethnic minority pharmacists conducted medication reviews and interviews with 26 ethnic minority patients speaking the pharmacist’s mother tongue. The study identified drug-related problems (including adherence problems), suggested solutions to GPs and mapped patients’ drug-related experiences, perceptions and actions. About 65% of the patients did not adhere to their GP’s advice on how to use medicines, 38% used medicines prescribed to others and 54% used medicines bought in their country of origin.69,70

Transfer of research to practice

The Apofarma Consortium was established in 2007 between the Faculty of Pharmaceutical Sciences, the University of Copenhagen, Pharmakon and the Association of Danish Pharmacies. Its vision is to catalyse a quick process ‘from research to consumer’ in the area of medicine use and practice development. The consortium’s vision and mission are realized through innovative programmes. Especially, programme C on ‘Compliance technologies – technology perspective’ (see Table 4) is particularly relevant in relation to adherence because it involves testing and evaluating technologies to strengthen adherence.

Table 4

Apofarma’s adherence technology programme: ‘Adherence technologies – technology perspective’

· Measuring adherence · Medicine profiles · Reminder technologies ○ Text messaging ○ Telephone reminders ○ MEMS and automatic dispensing machines ○ Individual memory systems · Dose-dispensed medicine ○ Check for adverse effects, automated dose-dispensing ○ Dose packaging · Intelligent medicine packaging · Devices for correct medicine use, e.g. ○ Inhalation technique ○ Injection technique · Diaries ○ Own and internet-based · E-based patient training · Biofeedback ○ Blood pressure ○ Blood sugar ○ Cholesterol

CONCLUSIONS AND FUTURE PERSPECTIVES

In conclusion, our analysis has documented that Danish pharmaceutical education and research has focused strongly on adherence to treatment for more than three decades. Adherence initiatives in Danish community pharmacies have developed substantially in the past five to ten years. This development can be expected to continue in future years, and follow the professional, ethical, and customer-oriented visions in the pharmacy strategy laid down in 2007. Development of professional IT systems is another high-priority area, as is counselling for e-pharmacy.

In the future, the following public health areas can be expected to focus on adherence-related activities: chronic conditions, mental illness, elderly patients, poly-pharmacy patients, nursing homes, home care, dose-dispensing, use of patient educators, counselling and coaching, dose dispensing and other adherence support technology, medication review, sector transitions, medication reconciliation along with more interdisciplinary collaboration and cooperation with regional and local authority administrations and health centres and patient organisations.