Dr Jonathan Steel discusses the NICE guideline on medicines adherence and explains the role of GPs in helping patients to make an informed decision about prescribed drugs

The decision to develop a NICE guideline on medicines adherence was made for a number of reasons: the economic cost of medicines wastage, the sub-optimal clinical outcome that results from poor behaviour in medicine taking, and a growing evidence base that clinicians can make a difference.1,2 Constructing a guideline on medicines adherence proved far more challenging than one on a specific disease. This was partly because of the:

  • broad nature of the subject and conflicting evidence base
  • lack of an existing framework or pathway to steer the guideline development group
  • multi-professional involvement.

Economic and clinical impact

The prescription of medicines is central to medical care and drug costs amount to around 10% of NHS expenditure. Between 2006 and 2007, the NHS in England spent £10.6 billion on drugs, around three quarters of which was in primary care.2 Studies of different medical conditions have found that between 30% and 50% of patients do not take their prescription medicines.2 The estimated drug cost of unused or unwanted medicines to the NHS is around £100 million annually.3 For patients, the clinical cost of not taking medicines as prescribed potentially increases morbidity and mortality. A Cochrane review concluded that improving medicine taking may have a far greater impact on clinical outcomes than any treatment itself.4

Terminology

The use of the same and appropriate terminology is fundamental to understanding medicines-taking behaviour:2

  • Compliance—commonly used and implies that the patient complies with the doctor’s orders; most doctors no longer practise medicine in such a paternalistic way
  • Adherence—a better term that describes the extent to which the patient’s behaviour matches advice from the prescriber
  • Concordance—a complex concept that is not practical in everyday general practice; it covers the process of incorporating patient beliefs and preferences in the decision-making process and includes wider supportive care for the patient.

Why is medicines adherence poor?

There are two broad reasons for patients not taking a medicine—can’t or won’t:1,2

  • ‘Can’t take’ or unintentional non-adherence occurs when the patient wants to follow the agreed treatment but is prevented from doing so by barriers beyond their control. Examples include poor recall or difficulties in understanding the instructions, problems with using the treatment, inability to pay for the treatment, or forgetting to take it
  • ‘Won’t take’ or intentional non-adherence occurs when the patient decides not to follow advice on recommended treatment. This is perceptual and is based upon the patient’s beliefs about medicines in general and the prescribed medicine specifically.

There is a large body of sociological and psychological literature reviewing how patients take medicines. This literature indicates that patients use their own ‘evidence base’ to decide how and when to take them. Patients stop and start medicines to determine their effect, adjust doses according to their understanding of how medicines work, and make their own judgements on the balance of benefits and side-effects.5 One of the most striking aspects of this research is that patients generally do not report to doctors how they take their medicines and doctors do not routinely ask.6

Accepting that patients are probably not taking their medicines correctly, the NICE guideline has broken down medicines adherence into the component parts of a process (see Figure 1).7 The GP can then select the relevant step for each consultation and improve adherence.

Figure 1: Why don’t some patients use their medicines as prescribed?

www.nice.org.uk/CG76
National Institute for Health and Care Excellence (NICE) (2009) CG76. Medicines adherence: Involving patients in decisions about prescribed medicines and supporting adherence. London: NICE. Reproduced with permission. Available from www.nice.org.uk/CG76

Improving adherence rates

At first glance of the quick reference guide,7 as sent to all GPs, many of the recommendations seem obvious and even condescending, and are easy to ignore, but GPs have to acknowledge that however effective they think they are in consultations, medicine adherence rates are poor, and there is probably room for improvement. The hope is that doctors see adherence as a true clinical issue and not merely that the patient is causing the problem.

Computers are an effective tool for assessing adherence. The medication screens usually display the interval between prescriptions and the date of the last prescription. This will prompt the GP into exploring the reasons behind non-adherence to medicine.

Unintentional non-adherence

There are a number of solutions to practical difficulties, including:1,2

  • patient recording of medicine taking
  • self monitoring of condition
  • simplifying the dosage regimen
  • using alternative packaging
  • multi-compartment medicines system (e.g. Dosette box—although there is currently no evidence that they work).

The evidence base does not indicate which of the above interventions are likely to be the most successful. They are all very obvious as are the methods for dealing with side-effects, such as changing dosage timing or dosage schedule, reducing dose, or switching to another medicine, alongside a re-evaluation of the need for the medicine.

Intentional non-adherence

Elucidating the practical barriers to non-adherence is less challenging than understanding a patient’s beliefs. The latter depends upon the core of good general practice, consultation skills, and relationship with the patient. As condescending as it may sound, not all patients are the same and some will find it difficult to discuss their beliefs with a healthcare professional. It may be necessary to overcome communication difficulties by adapting the consultation style and tone to suit their needs. As communication is a two-way process, this may involve using pictures, models, large text, interpreters, or advocates.

The NICE guideline recommends asking the patient open-ended questions and to not appear judgemental.1,2 Patients should be encouraged to ask questions. Openly exploring the management options allows the patient to express their preference and they should be supported even if the healthcare professional does not believe that they have made the best choice.

At the heart of understanding the patient perspective is the necessity–concerns framework.8 This simple yet very useful framework looks at the balance between the patient’s doubts around the personal necessity for this specific medicine and their concerns regarding potential adverse effects. During a consultation, healthcare professionals should encourage the patient to understand the need for the medicine, and reduce their concerns by discussing potential adverse effects. This will lead to a better acceptance of the shared prescribing decision.

A feature of medicine today is the wealth of information available to patients. This information has two components: content and delivery. Information can be delivered through a variety of methods: written (leaflets, websites, and newspapers), video, dialogue in the consultation, or through self-help lines. Different patients acquire information in different ways, just as people have different learning styles (auditory, visual, and kinaesthetic). Ascertaining which style suits the patient can lead to informed decisions. It is important to provide unbiased information; studies show that the majority of patients find that the information they receive from the doctor as the most valuable.

For those who say all of this will take a lot of time, the evidence shows that improving consultation outcome doesn’t necessarily increase consultation length.2

Quality and outcomes framework

Medicines management forms part of the quality and outcomes framework (QOF) (see Table 1).9 Achievement of points for Medicines 11 and Medicines 12 does not require the review to be face to face, however, an effective clinical medicines review is best performed during a consultation. This should include:

  • a review of the reason to prescribe
  • the effects of the medicine from the patient’s perspective as well as its effect on the medical condition
  • discussion of side-effects and possible interventions
  • reassessment of patient beliefs regarding medicine taking (these change over time).

Patients evaluate their medicines in their own way and an open style is best. A good medicines review will lead to better adherence and a better clinical outcome.

Table 1: QOF 2009/10 indicators related to medication review9

No. Indicator Points
Medicines 6 The practice meets the primary care organisation prescribing adviser at least annually and agrees up to three actions related to prescribing 4
Medicines 10 The practice meets the primary care organisation prescribing adviser at least annually, has agreed up to three actions related to prescribing and subsequently provided evidence of change 4
Medicines 11 A medication review is recorded in the notes in the preceding 15 months for all patients being prescribed four or more repeat medicines. Standard 80% 7
Medicines 12 A medication review is recorded in the notes in the preceding 15 months for all patients being prescribed repeat medicines. Standard 80% 8

Auditing medicines adherence

Audit can be used as an effective tool in encouraging changes in clinical behaviour. It is quite easy to construct a medicines-adherence audit.

Fluoxetine adherence audit
In my practice we looked at three aspects of fluoxetine adherence:

  • When was the first prescription taken?
  • What was the duration of treatment (expected to be for 6 months)?
  • Was the medicine taken once daily?

An audit standard of 70% was set in light of the reported 50%–70% non-adherence rate. A computer search revealed 81 new prescriptions for fluoxetine over the previous 3 years. Results of the audit showed that:

  • 10 patients did not take their fluoxetine after the initial prescription, although two reported this (which counts as a shared decision and therefore adherent). This meant that there was a 90% adherent rate to first prescription
  • 71% of patients took the fluoxetine for 6 months
  • of those who stopped before 6 months, and did not report this to us, most had made their own decision to stop in month 3
  • 91% of patients were taking their fluoxetine once daily (NB determined using a repeat prescription as a proxy that medication is being taken).

This audit raised the awareness of medicines adherence among our practice team and informed us to make a note to review the patient’s records 3 months after initiating fluoxetine and ask the patient to come to the practice if they had not received followed up. Our primary care trust has taken up the idea of medicines adherence audits as one of the prescribing actions for the QOF (see Medicines 6 indicator in Table 1, above).

Interdisciplinary working

Other members of the practice team can also help to improve medicines adherence. For example, a dispenser can point out when a patient is not requesting medicines and practice nurses may be aware of adherence issues. While GPs may be best placed to understand the need for a particular medicine, pharmacists often explore patient concerns better than GPs. In hospital practice, the pharmacist is immediately available, but for GPs, the community pharmacist can be rather a distant figure. Information between the two roles needs to be shared in the same way hospital colleagues are expected to share information with us when patients move between services.

The patient pathway (see Figure 2) represents points at which a patient interacts with a prescriber or a dispenser. It serves as a reminder of the flow of information and opportunities that exist to improve adherence through a team-based approach.

Figure 2: Simplified representation of patient pathway

www.nice.org.uk/CG76
National Institute for Health and Care Excellence (NICE) (2009) CG76. Medicines adherence: Involving patients in decisions about prescribed medicines and supporting adherence. London: NICE. Reproduced with permission. Available from www.nice.org.uk/CG76

Conclusion

The NICE guideline is a practical clarification of the concept of medicines adherence. It encourages practitioners to reflect upon their own performance and will help to raise the awareness of adherence among patients, colleagues, and managers. Non-adherence is a waste of resources and leads to suboptimal treatment, and as GPs we can and should do something about it.

NICE implementation tools

NICE has developed the following tools to support implementation of its guideline on Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. They are now available to download from the NICE website: www.nice.org.uk

Slide set

The slides are aimed at supporting organisations to raise awareness of the guideline and resulting implementation issues at a local level, and can be edited to cater for local audiences. This information does not supersede or replace the guidance itself.

Costing statement

A costing statement has been produced to provide an implementation tool to estimate the financial impact to the NHS of implementing this clinical guideline. This statement focuses on the financial impact of the recommendations that require most change in resources to implement in England.

Audit support

This has been developed to support the implementation of the NICE guideline on medicines adherence. The aim is to help NHS organisations with a baseline assessment and to assist with the audit process, thereby helping to ensure that practice is in line with the NICE recommendations. The audit support is based on the key recommendations of the guidance and includes criteria and data collection tools.

Guide to resources

The guide is a selection of resources aimed at helping people put the guideline into practice.

  1. National Institute for Health and Care Excellence. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. Clinical Guideline 76. London: NICE, 2009. Available at: www.nice.org.uk/guidance/CG76/NiceGuidance/pdf/English
  2. National Collaborating Centre for Primary Care. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. London: RCGP, 2009. Available at: www.nice.org.uk/guidance/CG76/Guidance/pdf/English
  3. Department of Health. Pharmacy in England: building on strengths—delivering the future. London: DH, 2008.
  4. Haynes R, Ackloo E, Sahota N et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2008; (2): CD000011.
  5. Pound P, Britten N, Morgan M et al. Resisting medicines: a synthesis of qualitative studies of medicine taking. Soc Sci Med 2005; 61 (1): 133–155.
  6. Crome P, Kelly S, Steel J. Have you taken all your tablets this week? Clinical Medicine 2009; 9 (1): 12–13.
  7. National Institute for Health and Care Excellence. Medicines adherence: Involving patients in decisions about prescribed medicines and supporting adherence. Quick Reference Guide. Clinical Guideline 76. London: NICE, 2009. Available at: www.nice.org.uk/guidance/CG76/QuickRefGuide/pdf/English
  8. Horne R, Cooper V, Gellaitry G et al. Patients perceptions of highly active retroviral therapy in relation to treatment uptake and adherence: the utility of the necessity-concerns framework. J Acquir Immune Defic Syndr 2007; 45 (3): 334–341.
  9. British Medical Association, NHS Employers. Quality and outcomes framework guidance for GMS contract 2009/10. Delivering investment in general practice. London: BMA, NHS Employers, 2009. Available at: www.bma.org.uk/employmentandcontracts/independent_contractors/quality_outcomes_framework/qof0309.jsp?page=1G