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National Collaborating Centre for Primary Care (UK). Medicines Adherence: Involving Patients in Decisions About Prescribed Medicines and Supporting Adherence [Internet]. London: Royal College of General Practitioners (UK); 2009 Jan. (NICE Clinical Guidelines, No. 76.)

Cover of Medicines Adherence

Medicines Adherence: Involving Patients in Decisions About Prescribed Medicines and Supporting Adherence [Internet].

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1Guidance

The following guidance is based on the best available evidence. These recommendations apply to all healthcare professionals who prescribe or dispense medicines or who have a role in making decisions about medicines with patients. Healthcare professionals are reminded of their duty under the Disability Discrimination Act (2005) to make reasonable adjustments to ensure that all people have the same opportunity for health.

1.1. Recommendations

Patient involvement in decisions about medicines

Communication

Good communication between healthcare professionals and patients is needed for involvement of patients in decisions about medicines and for supporting adherence. Some patients may find it easier to communicate with their healthcare professional than others.

1.1.1.

Healthcare professionals should adapt their consultation style to the needs of individual patients so that all patients have the opportunity to be involved in decisions about their medicines at the level they wish.

1.1.2.

Consider any factors such as physical or learning disabilities, sight or hearing problems and difficulties with reading or speaking English, which may affect the patient’s involvement in the consultation.

1.1.3.

Establish the most effective way of communicating with each patient and, if necessary, consider ways of making information accessible and understandable (for example, using pictures, symbols, large print, different languages, an interpreter or a patient advocate).

1.1.4.

Encourage patients to ask about their condition and treatment.

1.1.5.

Ask patients open ended questions because these are more likely to uncover patients’ concerns.

1.1.6.

Be aware that the consultation skills needed for increasing patient involvement can be improved.

Increasing patient involvement

Patient involvement in the decision making process requires that healthcare professionals acknowledge patients’ views about their condition and its treatment, and that both healthcare professional and patient have a role in making decisions about treatment. Simple interventions to increase patient involvement do not necessarily increase the overall length of consultation and may be justified by benefits, particularly over the course of a long term condition.

1.1.7.

Offer all patients the opportunity to be involved in making decisions about prescribed medicines. Establish what level of involvement in decision making the patient would like.

1.1.8.

Discuss with the patient why they might benefit from the treatment. Clearly explain the disease or condition and how the medicine will influence this.

1.1.9.

Explain the medical aims of the treatment to patients and openly discuss the pros and cons of proposed medicines. The discussion should be at the level preferred by the patient.

1.1.10.

Clarify what the patient hopes the treatment will achieve.

1.1.11.

Avoid making assumptions about patient preferences about treatment. Talk to the patient to find out their preferences, and note any non verbal cues that may indicate you need to explore the patient’s perspective further.

1.1.12.

Healthcare professionals have a duty to help patients to make decisions about their treatment based on an understanding of the likely benefits and risks rather than on misconceptions.

1.1.13.

Accept that patients may have different views from healthcare professionals about the balance of risks, benefits and side effects of medicines.

1.1.14.

Be aware that increasing patient involvement may mean that the patient decides not to take or to stop taking a medicine. If in the healthcare professional’s view this could have an adverse effect, then the information provided to the patient on risks and benefits and the patient’s decision should be recorded.

1.1.15.

Accept that the patient has the right to decide not to take a medicine, even if you do not agree with the decision, as long as the patient has the capacity to make an informed decision and has been provided with the information needed to make such a decision.

1.1.16.

Assess the patient’s capacity to make each decision using the principles in the Mental Capacity Act (2005) (www​.opsi.gov.uk/ACTS​/acts2005/ukpga_20050009_en_1). To lack capacity patients must: (a) have an impairment of or disturbance or malfunction of brain and mind, and (b) demonstrate lack of capacity to:

  • understand the information relevant to the decision
  • retain information for long enough to use it in the decision
  • use or weigh information as part of the process of making the decision
  • communicate the decision (whether by talking, using sign language or any other means).
1.1.17.

If the patient has specific concerns, record a summary of the discussion, because this may be helpful in future consultations.

1.1.18.

Encourage and support patients, families and carers to keep an up to date list of all medicines the patient is taking. The list should include the names and dosages of prescription and non prescription medicines and herbal and nutritional supplements. If the patient has any allergic or adverse reactions to medicines, these should be noted.

Understanding the patient’s knowledge, beliefs and concerns about medicines

There is evidence that patients make decisions about medicines based on their understanding of their condition and the possible treatments, their view of their own need for the medicine and their concerns about the medicine.

1.1.19.

Be aware that patients’ concerns about medicines, and whether they believe they need them, affect how and whether they take their prescribed medicines.

1.1.20.

Ask patients what they know, believe and understand about medicines before prescribing new treatments and when reviewing medicines.

1.1.21.

Ask if the patient has any specific concerns about their medicines, whenever you prescribe, dispense or review medicines. These may include concerns about becoming dependent on medicines and concerns about adverse effects. Address these concerns.

1.1.22.

Be aware that patients may wish to minimise how much medicine they take.

1.1.23.

Be aware that patients may wish to discuss:

  • what will happen if they do not take the medicine suggested by their healthcare professional
  • non pharmacological alternatives to medicines
  • how to reduce and stop medicines they may have been taking for a long time, particularly those known to be associated with withdrawal symptoms
  • how to fit taking the medicine into their daily routine
  • how to make a choice between medicines if they believe they are taking too many medicines.

Providing information

Patients need information about their condition and possible treatments if they are to be involved in making informed decisions about medicines. The format and content of the information provided should meet the needs of individual patients.

1.1.24.

Offer patients information about medicines before the medicines are prescribed.

1.1.25.

Offer patients information that is relevant to their condition, possible treatments and personal circumstances, and that is easy to understand and free from jargon.

1.1.26.

Check that patients have any information they wish about medicines when the medicines are dispensed.

1.1.27.

Discuss information on medicines with the patient rather than just presenting it. The discussion should take into account what the patient understands and believes about the condition and treatment.

1.1.28.

Do not assume that the patient information leaflets (PILs) that patients receive with their medicines will meet each patient’s needs. Address concerns that patients may have after reading the standard PILs.

1.1.29.

Patients differ in the type and amount of information they need and want. Therefore the provision of information should be individualised and is likely to include, but not be limited to:

  • what the medicine is
  • how the medicine is likely to affect their condition (that is, its benefits)
  • likely or significant adverse effects and what to do if they think they are experiencing them
  • how to use the medicine
  • what to do if they miss a dose
  • whether further courses of the medicine will be needed after the first prescription
  • how to get further supplies of medicines.
1.1.30.

Be careful not to make assumptions about a patient’s ability to understand the information provided. Check with the patient that they have understood the information. Information for patients should be clear and logical and, if possible, tailored to the needs of the individual patient.

1.1.31.

Suggest where patients might find reliable information and support after the consultation: for example, by providing written information or directing them to other resources (for example, NHS Choices [www​.nhs.uk]).

1.1.32.

Provide inpatients with the same information as patients in other settings. Information should include:

  • what the medicine is
  • how the medicine is likely to affect their condition (that is, its benefits)
  • likely or significant adverse effects and what to do if they think they are experiencing them
  • how to use the medicine
  • what to do if they miss a dose
  • whether further courses of the medicine will be needed after the first prescription
  • how to get further supply after discharge.

Supporting adherence

Assessing adherence

Patients do not always take their medicines exactly as prescribed, and healthcare professionals are often unaware of how patients take their medicines. The purpose of assessing adherence is not to monitor patients but rather to find out whether patients need more information and support.

1.2.1.

Recognise that non adherence is common and that most patients are non adherent sometimes. Routinely assess adherence in a non judgemental way whenever you prescribe, dispense and review medicines.

1.2.2.

Consider assessing non adherence by asking the patient if they have missed any doses of medicine recently. Make it easier for them to report non adherence by:

  • asking the question in a way that does not apportion blame
  • explaining why you are asking the question
  • mentioning a specific time period such as ‘in the past week’
  • asking about medicine-taking behaviours such as reducing the dose, stopping and starting medicines.
1.2.3.

Consider using records of prescription re ordering, pharmacy patient medication records and return of unused medicines to identify potential non adherence and patients needing additional support.

Interventions to increase adherence

Patients may need support to help them make the most effective use of their medicines. This support may take the form of further information and discussion, or involve practical changes to the type of medicine or the regimen. Any interventions to support adherence should be considered on a case by case basis and should address the concerns and needs of individual patients.

1.2.4.

If a patient is not taking their medicines, discuss with them whether this is because of beliefs and concerns or problems about the medicines (intentional non adherence) or because of practical problems (unintentional non adherence).

1.2.5.

Be aware that although adherence can be improved, no specific intervention can be recommended for all patients. Tailor any intervention to increase adherence to the specific difficulties with adherence the patient is experiencing.

1.2.6.

Find out what form of support the patient would prefer to increase their adherence to medicines. Together, you and your patient should consider options for support.

1.2.7.

Address any beliefs and concerns that patients have that result in reduced adherence.

1.2.8.

Because evidence supporting interventions to increase adherence is inconclusive, only use interventions to overcome practical problems associated with non adherence if a specific need is identified. Target the intervention to the need. Interventions might include:

  • suggesting that patients record their medicine taking
  • encouraging patients to monitor their condition
  • simplifying the dosing regimen
  • using alternative packaging for the medicine
  • using a multi compartment medicines system.
1.2.9.

Side effects can be a problem for some patients. If this is the case you should:

  • discuss how the patient would like to deal with side effects
  • discuss the benefits, side effects and long term effects with the patient to allow them to make an informed choice
  • consider adjusting the dosage
  • consider switching to another medicine with a different risk of side effects
  • consider what other strategies might be used (for example, timing of medicines).
1.2.10.

Ask patients if prescriptions charges are a problem for them. If they are, consider possible options to reduce costs.

Reviewing medicines

Patients may use medicines long term. The initial decision to prescribe medicines, the patient’s experience of using the medicines and the patient’s needs for adherence support should be reviewed regularly. The patient’s own list of medicines may be a useful aid in a medicines review.

1.3.1.

Review patient knowledge, understanding and concerns about medicines, and a patient’s view of their need for medicine at intervals agreed with the patient, because these may change over time. Offer repeat information and review to patients, especially when treating long term conditions with multiple medicines.

1.3.2.

Review at regular intervals the decision to prescribe medicines, according to patient choice and need.

1.3.3.

Enquire about adherence when reviewing medicines. If non adherence is identified, clarify possible causes and agree any action with the patient. Any plan should include a date for a follow up review.

1.3.4.

Be aware that patients sometimes evaluate prescribed medicines using their own criteria such as their understanding of their condition or the symptoms most troubling to them. They may, for example, stop and start the medicine or alter the dose and check how this affects their symptoms. Ask the patient whether they have done this.

Communication between healthcare professionals

Patients may be under the care of healthcare professionals from different disciplines and specialties at the same time; responsibility for patients’ care may be transferred between healthcare professionals, and medicines reviews may be carried out by healthcare professionals other than the prescriber. Therefore good communication between healthcare professionals is required to ensure that fragmentation of care does not occur.

1.4.1.

Healthcare professionals involved in prescribing, dispensing or reviewing medicines should ensure that there are robust processes for communicating with other healthcare professionals involved in the patient’s care.

1.4.2.

On transfer between services (for example, between hospitals and care homes or on discharge from hospital), give all patients and subsequent healthcare or other providers a written report containing:

  • the patient’s diagnosis
  • a list of all medicines the patient should be taking
  • clear identification of any new medicines that were started
  • clear identification of any medicines that were stopped, with reasons
  • clear information on which medicines should be continued after transfer from that service and for how long
  • any known adverse reactions and allergies the patient has experienced
  • any potential difficulties with adherence and any actions taken (for example, provision of a multi compartment medicines system).
1.4.3.

Healthcare professionals involved in reviewing medicines should inform the prescriber of the review and its outcome. This is particularly important if the review involves discussion of difficulties with adherence and further review is necessary.

1.2. Aim of the guideline

Clinical guidelines are defined as ‘systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances.’

This guideline gives recommendations to clinicians and others on how to involve adults and carers in decisions about prescribed medicine.

1.3. How the guideline is set out

Both the evidence statements and narratives of the research studies on which our recommendations are based are found within each topic section. The evidence statements precede the narrative for each topic. Also included in each chapter is a brief explanation of why the GDG made the specific recommendations. The evidence tables with details of the research studies that describe the studies reviewed are found in Appendix C.

1.4. Scope

The guideline was developed in accordance with a scope given by the National Institute for Health and Clinical Excellence (NICE, ‘the Institute’). The scope set the remit of the guideline and specified those aspects of the identification and management of medicines adherence to be included and excluded. The scope was published in April 2007 and is reproduced here in Appendix A.

During development the guideline title was Medicines Concordance. Stakeholder comment during consultation indicated that retaining the term concordance in the title was potentially misleading and unhelpful to healthcare professionals. NICE Guidance Executive agreed to the title Medicines Adherence: involving patients in decisions about prescribed medicines and supporting adherence as this more clearly explains the content of the guideline.

Whom the guideline is intended for

This guideline is of relevance to those who work in or use the National Health Service (NHS) in England and Wales:

Population

Groups that will be covered

  1. Adults, including those with co morbidities, learning disabilities or language and/or cultural differences.

Groups that will not be covered

Children and young people. However, the guideline recommendations may be considered for a child or young person who is deemed competent to express a view on their prescription.

Healthcare setting

All consultations with healthcare professionals in any NHS setting that relate to the initiation or review of prescribed medicine.

Areas that will be covered

  1. Shared decision-making about medicines and medicine-taking as reported by the patient or carer. The guideline will focus on the barriers (such as communication difficulties, cultural issues, low health literacy and physical limitations), facilitators (including structural or procedural factors), beliefs and health behaviours that influence decision-making and adherence.
  2. Shared decision-making about medicines and medicine-taking as reported by the healthcare professional. The guideline will focus on the barriers (such as communication difficulties, cultural issues and time), facilitators (including structural or procedural factors), beliefs and health behaviours that influence decision-making and adherence.
  3. The effectiveness and cost-effectiveness of interventions to facilitate the process of shared decision-making about medicines (looking at time of intervention – before, during, or after the consultation with the healthcare professional; and mode of delivery). The target of the intervention may be the patient, the carer, the prescriber, any healthcare professional providing ongoing support or a combination of these.
  4. The effectiveness and cost-effectiveness of interventions to promote adherence in medicine-taking (looking at time of intervention – before, during, or after the consultation with the healthcare professional; and mode of delivery). The target of the intervention may be the patient, the carer, the prescriber, the dispenser or any other healthcare professional providing ongoing support or a combination of these.
  5. The evidence on single or multiple medicines as it relates to issues around decision-making and adherence.
  6. The skills and competencies required by prescribers to involve patient in decisions regarding prescribed medicines.

Areas outside the remit of the guideline

The administration of medicines will not be covered. Administration is defined as giving a medicine by introduction into the body (for example, orally or by injection), or by external application (for example application of an impregnated dressing).

1.5. Guideline Limitations

Guideline limitations are as follows:

  • NICE clinical guidelines usually do not cover issues of service delivery, organisation or provision (unless specified in the remit from the Department of Health).
  • NICE is primarily concerned with health services and so recommendations are not provided for social services and the voluntary sector. However, the guideline may address important issues in how NHS clinicians interface with these sectors.
  • Generally, the guideline does not cover rare, complex, complicated or unusual conditions.
  • It is not possible in the development of a clinical guideline to complete extensive systematic literature reviews of all pharmacological toxicity. NICE expects the guidelines to be read alongside the summaries of product characteristics.

1.6. Responsibility and support for guideline development

1.6.1. The National Collaborating Centre for Primary Care (NCC-PC)

The NCC-PC is a partnership of primary care professional associations and was formed as a collaborating centre to develop guidelines under contract to NICE. It is entirely funded by NICE. The NCC-PC is contracted to develop four guidelines at any one time, although there is some overlap at start and finish. Unlike many of the other centres which focus on a particular clinical area, the NCC-PC has a broad range of topics relevant to primary care. However, it does not develop guidelines exclusively for primary care. Each guideline may, depending on the scope, provide guidance to other health sectors in addition to primary care.

The Royal College of General Practitioners (RCGP) acts as the host organisation. The Royal Pharmaceutical Society and the Community Practitioners and Health Visitors’ Association are partner members with representation from other professional and lay bodies on the Board. The RCGP holds the contract with the Institute for the NCC-PC.

1.6.2. The development team

The development team had the responsibility for this guideline throughout its development. They were responsible for preparing information for the Guideline Development Group (GDG), for drafting the guideline and for responding to consultation comments. The development team working on this guideline consisted of the:

  • Guideline lead
    who is a senior member of the NCC-PC team who has overall responsibility for the guideline
  • Information scientist
    who searched the bibliographic databases for evidence to answer the questions posed by the GDG
  • Reviewer (Health Services Research Fellow)
    with knowledge of the field, who appraised the literature and abstracted and distilled the relevant evidence for the GDG
  • Health economist
    who reviewed the economic evidence and assisted the GDG in considering cost-effectiveness
  • Project manager
    who was responsible for organising and planning the development, for meetings and minutes and for liaising with the Institute and external bodies
  • Chair
    who was responsible for chairing and facilitating the working of the GDG meetings

The members of the development team attended the GDG meetings and participated in them. The development team also met regularly with the Chair of the GDG during the development of the guideline to review progress and plan work.

Other guidelines normally have a Clinical Advisor who is someone with an academic understanding of the research in the area and its practical implications to the service, who advises the development team on searches and the interpretation of the literature. Due to the conceptual nature of the guideline topic and the different academic stances on explaining such behaviour, the development team chose not to have a formal Clinical Advisor.

1.6.3. The Guideline Development Group (GDG)

A Chair was chosen for the group and his primary role was to facilitate and chair the GDG meetings.

The GDG consisted of a diverse multidisciplinary group with an interest and/or expertise in medicines adherence. The Chair, a general practitioner with special interest in epilepsy identified by the NCC-PC, oversaw the work of the group.

Nominations for group members were invited from various stakeholder organisations, selected to ensure appropriate combination of members including healthcare professionals and patient representatives.

Each GDG member was expected to act as an individual expert in their own right and not as a representative of their parent organisation, although they were encouraged to keep their nominating organisation informed of the process.

Nominees who were not selected for the GDG were invited to act as Expert Peer Reviewers and were sent drafts of the guideline by the Institute during the consultation periods and invited to submit comments using the same process as stakeholders.

In accordance with guidance from NICE, all GDG members’ interests were recorded on a standard declaration form that covered consultancies, fee-paid work, share-holdings, fellowships, and support from the healthcare industry. Details of these can be seen in Appendix E.

The names of GDG members appear listed below.

Full GDG members

Dr Henry Smithson (Chair)

General Practitioner; Senior Clinical University Teacher, Academic Unit of Primary Medical Care, Sheffield

Professor Rob Horne

Professor of Behavioural Medicine, Head of Department of Practice and Policy, The School of Pharmacy, University of London

Dr John Benson

Senior Lecturer in General Practice, General Practice and Primary Care Research Unit, Department of Public Health and Primary Care, University of Cambridge

Mr Shaun Johnson

Patient representative; Mind Link National Advisory Panel; Trustee, LAMP (the Leicestershire Action for Mental Health Project)

Mrs Alison Bowser

Patient representative; independent patient advocate; patient representative for Medicines and Healthcare products Regulatory Authority, Cornwall and Isles of Scilly Primary Care Trust and Royal College of General Practitioners

Dr Mahendra Patel

Lecturer/Research Fellow, Institute of Pharmaceutical Innovation, University of Bradford

Mr Stephen Hemingway

Senior Lecturer in Mental Health, University of Huddersfield

Mrs Bunis Packham

Nurse Consultant – Thrombosis and Anticoagulation, Barnet and Chase Farm Hospitals NHS Trust

Mr Jim Blair

Senior Lecturer in Learning Disabilities, Kingston University/St George’s University of London; Interim Consultant Nurse (Learning Disabilities) St George’s Healthcare NHS Trust

Professor Peter Crome

Professor of Geriatric Medicine, Keele University; Honorary Consultant Geriatrician, North Staffordshire Combined Healthcare NHS Trust

Dr Peter Haddad

Consultant Psychiatrist, Greater Manchester West Mental Health NHS Foundation Trust; Honorary Senior Lecturer in Psychiatry, University of Manchester

Dr Jonathan Steel

General Practitioner, Gloucestershire; Chairman, GP Network, Royal College of Physicians

Dr Sean Kelly

Consultant Physician and Gastroenterologist, York Hospital; Honorary Senior Lecturer, Hull York Medical School

Dr Wendy Clyne

Assistant Director, Medicines Partnership Programme, NPC Plus, Keele University

National Collaborating Centre for Primary Care

Dr Norma O’Flynn

Guideline Lead and Clinical Director

Ms Elizabeth Shaw

Guideline Lead (until February 2007) and Deputy Chief Executive (until February 2008)

Ms Vanessa Nunes

Senior Health Services Research Fellow/Project Manager

Ms Julie Neilson

Health Services Research Fellow

Ms Stefanie Kuntze

Health Economist (until October 2008)

Dr Neil Calvert

Senior Health Economist

1.6.4. Guideline Development Group meetings

The GDG met on 12 occasions (with one two day GDG meeting), at approximately 2 monthly intervals over a period of 11 months and 6 weekly intervals over a period of 6 months to review the evidence identified by the project team, to comment on its quality and completeness and to develop recommendations for clinical practice based on the available evidence. The final recommendations were agreed by the full GDG.

1.7. Research recommendations

The Guideline Development Group has made the following recommendations for research, based on its review of evidence, to improve NICE guidance and patient care in the future.

The GDG noted the generally poor quality of research in the area of medicines adherence and the potential clinical and economic gains that would accrue from the development of cost-effective, equitable and patient-centred interventions to support adherence to appropriate prescriptions The GDG believe that there is an urgent need to provide specific adherence funding streams to support structured programmes of research particularly where the health gains from medicines adherence are likely to be high.

The central theme underpinning this guideline is that adherence to medicines taking is a variable behaviour that should be based on informed choice and shared decision making, principally between the patient and the practitioner. Medicines carry the potential for harm as well as benefit and there are questions about what constitutes good prescribing and good medicine-taking. The key research agenda therefore relates to behaviour change for practitioners and patients to support the best use of medicines. The research recommendations from this guideline are for research programmes which are described below under the themes of A): Developing effective, equitable interventions to support adherence to appropriately prescribed medicines B) Informed choice and shared decision making, C) Support processes: prescribing-related consultations and medicines usage review and D) Groups for special consideration- vulnerable groups.

A. Developing effective, equitable interventions to support adherence to appropriately prescribed medicines

Research Questions

  1. What are the most clinically effective and cost-effective methods for identifying and addressing the perceptual barriers (such as beliefs and concerns about medicines) which influence motivation to start and continue with treatment and the practical barriers (such as limitations in personal capacity and resources), which limit an individuals’ ability to implement intentions to adhere to medicines?

Why this is important

Systematic reviews of adherence interventions show that although adherence can be improved, the effects were generally modest and there is considerable room for improvement. Few previous interventions have been systematically developed, using appropriate theoretical models, nor have they have been modelled and piloted with assessment of process variables as well as outcomes. We now know why previous interventions have failed, but also how we can improve the content, development and testing of new approaches. The challenges for research in medicines adherence are similar to those for other health-related behaviours such as smoking cessation, exercise and diet: how to influence and change behaviour. Interventions should be developed using an appropriate theoretical framework with a phased approach to testing that includes assessment of process (i.e. the things that are targeted for change) as well as outcomes and a need for an individual approach, as recommended in the Medical Research Council Framework. There are particular questions relating to vulnerable groups (see Section C). Interventions may need to address adherence when initiating treatment (for newly prescribed medicine), but also over the course of treatment through maintenance of appropriate adherence patterns, preventing sub-optimal adherence and changing sub-optimal adherence, once patterns have developed. Interventions targeted at the individual patient level are likely to be more effective if they address both motivational factors and capacity limitations).

A systematic programme of adherence research across long-term conditions is essential to guide the delivery of recommendations for medicines use within NHS NSFs and address a fundamental inefficiency in healthcare delivery. The potential benefits are likely to include: better care tailored to patient needs, higher rates of adherence to appropriate medicines, fewer unwanted and unused prescriptions, more effective management of long-term conditions, increased patient safety and satisfaction and fewer emergency admissions.

B. Informed choice and shared decision making

Research questions

  1. What are the most clinically effective and cost-effective ways of communicating the potential benefits and risks of medicines to promote informed choice?
  2. What are the strengths, weaknesses and consequences of different approaches to joint decision-making, seen from the vantage point of various stakeholders (e.g. prescribers, patients, funders)?

Why is this important?

The principles of informed choice and shared decision-making have largely been developed from theoretical and conceptual models. The competencies listed for shared decision- making consist of a number of different skills and patients have shown that they may be valued differently by different people. While the right of patients to be involved in treatment decisions is accepted, the practice of shared decision making may result in practitioners and patients playing different roles than they have to date in health care consultations. This may have implications for responsibility and accountability. Information asymmetries also need to be addressed and this may require structural changes to health services and their delivery. Patient related outcomes need to be included.

C. Support processes: prescribing-related consultations and medicines usage review

Research Questions

  1. How can we enable new and existing prescribers to identify individuals at risk of nonadherence or those who are a priority for medicines review and adherence support. How can we best provide it?
  2. How can practitioners and patients be supported to improve the quality of prescribing-related consultations and medicine use reviews so that they facilitate informed choice and optimal adherence to medicine?
  3. How can we facilitate the open disclosure of medicine-taking behaviours within consultations relating to medicines prescribing and review? How can we equip health practitioners to respond appropriately and effectively?
  4. What are the effects of non-prescriber medicine reviews (e.g. by pharmacists) on patients, prescribers and outcomes? How can the process of medicine review be enhanced or improved to address issues of informed choice and adherence?

Why this is important?

Nonadherence is often a hidden problem. Many patients are reluctant to express doubts and concerns about medicines because they fear that it will displease the practitioner. We need better methods for overcoming this problem and promoting open discussions about medicines and adherence. There is a new and growing agenda relating to non-medical prescribers (pharmacists, nurses etc.) This is a key context issue and there are a range of questions relating to patient perspectives on new prescribers and to new and existing prescribers’ perceptions and skills. The effects of new prescribers on patient adherence to medicines should be included in any research agendas designed to evaluate new prescribers. The inclusion of formal procedures for medicine review within the pharmacy contract in England provides an opportunity for improved medicine support for patients. We need a better understanding of the effects of non-prescriber medicine review on medicines usage and outcomes and of how reviews might be improved to benefit patients and society.

D. Overarching issues Groups for special consideration, vulnerable groups

Consideration of vulnerable groups cuts across the above themes and is relevant for all research questions. Work in this area requires systematic reviews of the available literature followed by empirical studies. Specific questions are:

  1. What are the effects of social disadvantage and ethnicity on informed choice, shared decision making and adherence to prescribed medicines?
  2. How do the perceptions and life circumstances of different age groups (children, young adults, elderly people) influence informed choice, shared decision making and adherence. What are the implications for interventions to support these?
  3. What are the particular barriers to medicines use for people with multiple pathologies (and their informal carers) and what interventions are required?

Why this is important

Perceptions of medicines and the value an individual places on sharing decisions with their practitioner have been found to differ by groups such as the elderly and severity of condition. Research into the factors and impact on adherence could inform clinicians and shape clinical care.

1.8. Acknowledgements

We gratefully acknowledge the contributions of the following people

All the staff at the National Collaborating Centre for Primary Care for their assistance in the preparation of the final guideline in particular Dr Kathy DeMott, Ms Laura Sawyer and Mrs Nancy Turnbull.

The staff at NICE who have helped us with this guideline in particular Dr Anne-Louise Clayton, Ms Sarah Willet and Dr Tim Stokes.

All of the stakeholders who took time to comment on the guideline.

Professor Rona Campbell and Professor Nicky Britten for providing access to the draft report from their HTA funded work with Pound P, Morgan M, Yardley L, Pope C, and Daker-White G on metaethnography and medicine.

1.9. Glossary

Adherence

Adherence – ‘the extent to which the patient’s behaviour matches agreed recommendations from the prescriber’. Adherence emphasises the need for agreement and that the patient is free to decide whether or not to adhere to the prescriber’s recommendation.

Compliance

Compliance – ‘the extent to which the patient’s behaviour matches the prescribers’ recommendations’.

Concordance

Concordance – this is a recent term whose meaning has changed. It was initially applied to the consultation process in which prescriber and patient agree therapeutic decisions that incorporate their respective views, but now includes patient support in medicine-taking as well as prescribing communication. Concordance reflects social values but does not address medicine-taking and may not lead to improved adherence

Cost-benefit analysis

A type of economic evaluation where both costs and benefits of healthcare treatment are measured in the same monetary units. If benefits exceed costs, the evaluation would recommend providing the treatment.

Cost-consequences analysis

A type of economic evaluation where various health outcomes are reported in addition to cost for each intervention, but there is no overall measure of health gain.

Cost-effectiveness analysis

An economic study design in which consequences of different interventions are measured using a single outcome, usually in ‘natural’ units (for example, life-years gained, deaths avoided, heart attacks avoided, cases detected). Alternative interventions are then compared in terms of additional cost per additional unit of effectiveness.

Cost-effectiveness model

An explicit mathematical framework, which is used to represent clinical decision problems and incorporate evidence from a variety of sources in order to estimate the costs and health outcomes. See also Markov model.

Cost-minimisation analysis

An economic evaluation that finds the least costly alternative therapy after the proposed interventions has been demonstrated to be no worse than its main comparator(s) in terms of effectiveness and toxicity.

Cost-utility analysis

A form of cost-effectiveness analysis in which the units of effectiveness are quality-adjusted life-years (QALYs).

Decision analysis

A systematic way of reaching decisions, based on evidence from research. This evidence is translated into probabilities, and then into diagrams or decision trees which direct the clinician through a succession of possible scenarios, actions and outcomes.

Decision problem

A clear specification of the interventions, patient populations and outcome measures and perspective adopted in an evaluation, with an explicit justification, relating these to the decision which the analysis is to inform.

Discounting

Costs and benefits incurred today have a higher value than costs and benefits occurring in the future. Discounting health benefits reflects individual preference for benefits to be experienced in the present rather than the future. Discounting costs reflects individual preference for costs to be experienced in the future rather than the present. For NICE economic evaluations, health outcomes will be discounted at 3.5% and costs at 3.5% per annum, following the recommendations of the UK Treasury.

Dispensing professional

Professional trained in dispensing medicine, generally a pharmacist or a general practitioner in a dispensing practice

Dominance

An intervention is said to be dominated if there is an alternative intervention that is both less costly and more effective. See also extended dominance.

Dosette box

A type of compliance aid. Other terms used are NOMAD, MANRAX and monitored dose system.

Economic evaluation

Comparative analysis of alternative health strategies (interventions or programmes) in terms of both their costs and consequences.

Extended dominance

An intervention is extendedly dominated when it can be dominated by a combination of two alternative interventions (i.e. if x% of the population are treated with intervention A, and y% are treated with intervention C where x + y = 100%, the overall result will be an intervention strategy that is both cheaper and more effective than intervention B). See also dominance.

Extrapolation

In data analysis, predicting the value of a parameter outside the range of observed values.

Forgiveness

The ability of a drug to sustain its pharmacological action after a dose has been missed

GDG

Guideline development group who developed the guideline

Health care professional (HCP)

Any health care professional- specialists, general practitioner, pharmacists, nurse prescribers who are involved in the prescribing of medicines, dispensing of medicines or have designated roles e.g. specialist nurses, in the discussion with patients about those medicines.

Health economics

The study of the allocation of scarce resources among alternative healthcare treatments. Health economists are concerned with both increasing the average level of health in the population and improving the distribution of healthcare resources.

Health-related quality of life

A combination of an individual’s physical, mental and social well-being; not merely the absence of disease.

Informed adherence

Informed adherence refers to an outcome of informed choice in decision to take medicines and supported adherence

Incremental Cost Effectiveness Ratio (ICER)

The difference in costs between two interventions being compared divided by the difference in effects of the two interventions. For instance, if A and B are being compared, then the ICER would be calculated as

Costs of B - costs of A divided by effects of B - effects of A

Life-year

A measure of health outcome that shows the number of years of remaining life expectancy.

Life-years gained

Average years of life gained per person as a result of an intervention.

Markov model

A modelling technique used when a greater number of health states needs to be considered. They are particularly useful for disease in which events can occur repeatedly over time.

Medicines

The term medicines is used in the guideline to apply to drug treatments that patients may take orally or self- administer such as creams to the skin and drops.

Medicine review

A face to face meeting between a professional and a patient to discuss the patients medicines and medicine- taking behaviour

Opportunity cost

The opportunity cost of investing in a healthcare intervention is the value of other healthcare programmes that are foregone or displaced by its introduction. This may be best measured by the health benefits that could have been achieved had the money been spent on the next best alternative healthcare intervention.

Persistence

The length of time from initiation to discontinuation of therapy. Persistence is measured in units of time.

Perspective

(or viewpoint): This determines which costs to include. For NICE evaluations the perspective is from the NHS and includes costs to the NHS and Personal Social Services. Costs to other public bodies and to patients and carers may be considered as an additional factor.

Probabilistic sensitivity analysis

Probability distributions are assigned to the uncertain parameters and are incorporated into evaluation models based on decision analytical techniques (for example, Monte Carlo simulation).

Quality adjusted life-years (QALYS)

An index of survival that is adjusted to account for the person’s quality of life during this time. QALYs have the advantage of incorporating changes in both quantity (longevity/mortality) and quality (morbidity, psychological, functional, social and other factors) of life. Used to measure benefits in cost-utility analysis, QALYS are calculated by estimating the number of years of life gained from a treatment and weighting each year with a quality-of-life score between zero and one.

Shared Decision Making (SDM)

Shared-decision making (SDM) is described as a model of decision making where information exchange is a two way process in the consultation and both deliberation and decision are made by both health care professional and patient.

Specialist

One who has expertise in a particular field of medicine by virtue of additional training and experience.

Time horizon

The time span used in the NICE appraisal that reflects the period over which the main differences between interventions in health effects and use of healthcare resources are expected to be experienced, and taking into account the limitations of supportive evidence.

Unit-dose packaging

Unit-dose packaging is the packaging of a single dose in a non-reusable container.

Utility

This concept is applied in health care to mean the individual’s valuation of their state of well-being deriving from the use of health care interventions. In brief, utility is a measure of the preference for, or desirability of, a specific level of health status or specific health outcome.

Willingness to pay (WTP)

WTP refers to the amount that a decision maker is willing to pay for an additional unit of outcome (e.g. an additional QALY). If the WTP is higher than the ICER, the intervention is cost effective. If not, the intervention is not cost effective.

Copyright © 2009, Royal College of General Practitioners.

All rights reserved. No part of this publication may be reproduced in any form (including photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written permission of the copyright owner. Applications for the copyright owner’s written permission to reproduce any part of this publication should be addressed to the publisher.

Bookshelf ID: NBK55446
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