Dr Martin Duerden discusses how the NICE quality statements on medicines optimisation can improve patient satisfaction and ensure safer prescribing
Read this article to learn more about:
- why the term 'medicines optimisation' has replaced 'medicines management' in recent years
- the increasing emphasis on working with patients on shared decision-making
- the potential for practice-based clinical pharmacists to support medicines optimisation.
It is becoming increasingly important in the NHS to help people get the most from their medicines, which prevent, treat, or manage many illnesses and conditions and are the most common intervention in healthcare. Many people do not take medicines in the way that is intended when they are prescribed, and, increasingly, it is becoming recognised that complex medication regimens can create a burden of treatment for individuals that is onerous and can detract from their quality of life.1 Numerous prescribed medicines are wasted either because they are not taken properly or are not taken at all.
In the last few years there has been a move away from the term 'medicines management', which implies how prescribing is arranged to benefit and improve efficiency in the NHS, and towards 'medicines optimisation', which encourages much greater patient involvement.
In March 2015 NICE Guideline (NG) 5, Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes, was published (see Box 1, below).2 NICE NG5 presents the definition of medicines optimisation as:2'A person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines. Medicines optimisation applies to people who may or may not take their medicines effectively. Shared decision‑making is an essential part of evidence-based medicine, seeking to use the best available evidence to guide decisions about the care of the individual patient, taking into account their needs, preferences and values.'
Box 1: NICE Pathways
The context of multimorbidity and polypharmacy
Medicines optimisation becomes crucial in relation to the big changes that are taking place in the way medicines are used with multimorbidity, and associated polypharmacy is becoming 'normal' in older people. Prescribing is the most common intervention in primary care. Overall, 1064.6 million prescription items were dispensed in 2014; on average, the equivalent per head of 19.6 prescription items, worth £163 over the year.3 The average number of items per head has increased steadily from 13.7 in 2004.3 The number of items and costs per head for older people are considerably greater.
The main cause of this growth in prescribing is multimorbidity in an ageing population. Research from Scotland shows that, in older people, multimorbidity is the norm rather than the exception; fewer than 30% of people did not have at least one condition by the time they reached the age of 60 years, and many people had two or three.4 Young and middle-aged people in the lowest socioeconomic stratum acquired multimorbidity 10–15 years earlier than those people from the most affluent areas.4 The number and proportion of the population aged over 65 years is growing. Projections from the Office for National Statistics suggest that the number of people aged 75 years and over is to rise by 89%, to 9.9 million, by mid-2039.5 The number of people aged 85 years and over is projected to more than double, to reach 3.6 million by mid-2039.5
Polypharmacy associated with these trends is increasing year-on-year. Studies from Scotland have looked at the rapid growth in prescribing over the past decade, with a threefold increase in those individuals receiving ten or more prescription items, and they have examined the relationship between age and multimorbidity.6,7 In one of these studies, approximately 17% of the adults assessed received four to nine medications, and approximately 5% received ten or more medications.7 Prescribing increased with age and was directly related to the number of morbidities: in those patients with six or more comorbidities, approximately 42% received ten or more medications.7 It is highly likely that these studies reflect the situation elsewhere in the UK.
Polypharmacy is a term that has been in use for many years, but which has not been clearly defined. From a practical point of view, and easy for identification purposes, a threshold number of drugs has often been used to describe polypharmacy, such as 'four or more' used to trigger medication review. A recent King's Fund report looked at the subject of polypharmacy and used a qualitative, rather than numerical, definition based on the potential to do good (appropriate polypharmacy) as well as harm (problematic polypharmacy) mainly through drug interactions and adverse drug interactions.8 This is the definition used by NICE in its guideline NG5.2
NICE Quality Standard 120
To augment NG5, NICE published its Quality Standard for Medicines optimisation (QS120) in March 2016 (see Box 1, above).9 This sets out high-priority areas for quality improvement alongside recommendations that also support measurement of this improvement. This is useful in that it describes how to implement quite a complex and far-reaching guideline, but to deliver this quality standard will require considerable time and resources. The six quality statements for QS120 are listed in Table 1 (see below).
|1||People are given the opportunity to be involved in making decisions about their medicines.|
|2||People who are prescribed medicines are given an explanation on how to identify and report medicines-related patient safety incidents.|
|3||Local health and social care providers monitor medicines-related patient safety incidents to inform their learning in the use of medicines.|
|4||People who are inpatients in an acute setting have a reconciled list of their medicines within 24 hours of admission.|
|5||People discharged from a care setting have a reconciled list of their medicines in their GP record within 1 week of the GP practice receiving the information, and before a prescription or new supply of medicines is issued.|
|6||Local healthcare providers identify people taking medicines who would benefit from a structured medication review.|
|NICE (2016) QS120. Medicines optimisation.
Reproduced with permission
Shared decision-making—statement 1
Statement 1 is based on the premise that clinical outcomes and patient satisfaction are likely to be better when decisions about medicines are made jointly between the patient and the prescriber. A person's preferences, and how they value treatment options and outcomes, need to be taken into account. It is much more likely that medicines will be taken as intended if there is patient 'ownership' of these decisions and an informed choice has been made. In this statement there is a tacit recognition that compromise between the prescriber's perspective and the patient's viewpoint will be needed; choices may include decisions not to take specific medicines. Increasingly, patient decision aids (PDAs) are used to help reach these kinds of decision; for example, NICE has developed PDAs to help agree targets for glycaemic control in type 2 diabetes, which balance potential benefits (reduction in cardiovascular events) against potential harms (side-effects and risks of hypoglycaemia).10
To implement NICE QS120, prescribers, both in primary and secondary care, will need to collect evidence that people are being given information about the potential benefits and harms of using medicines, and demonstrate that they have taken into account people's preferences and values with regard to treatment options. Prescribers will need to demonstrate that people have been offered the opportunity to use PDAs to make informed choices about the use of medicines. It is not immediately clear how this validation work will be carried out, and it will be a major challenge for general practice, which is faced with many conflicting demands and time constraints. A starting point could be the coding of these activities on GP computer systems. This could be subject to audit. General practitioners will also need systems to collect information on adherence and patient satisfaction with outcomes from the use of medicines. This could also be quite onerous and will involve patient satisfaction surveys at a time when many people are already experiencing feedback overload.
Patient identification and reporting of medicines-related patient safety incidents—statement 2
The quality standard states that encouraging and empowering patients to report incidents can make reporting and learning from medicines-related patient safety incidents more effective. NICE advises taking the opportunity to tell people about how to identify and report medicines-related patient safety incidents when a prescription is written or dispensed, or at medication review. This should increase the number of incidents reported, and can aid learning.
Statement 2 means that prescribers in both primary and secondary care will need to collect evidence of the systems in use to ensure patients have an explanation of how to identify medicines-related patient safety incidents and how to report them; for example, patients could be given advice on the Yellow Card reporting system.11 Again this may be quite a challenge for general practices, which will need to collate information on things like the proportion of new prescriptions for which patients are given this advice. Practices should already have a system for reporting significant incidents and should be collating information on harm attributable to medication error.
Learning from medicines-related patient safety incidents—statement 3
Monitoring medicines-related patient safety incidents can help to identify trends and causes of harms or 'near misses'. Learning from these, reviewing clinical case notes, and sharing the outcome of this work, can lead to effective action and avoid similar incidents and ensure better outcomes for patients. NICE advises that this process might include setting up computer alerts and delivering continuing professional development. NICE suggests that practitioners provide evidence of investigations and of local arrangements to ensure use of national patient safety reporting systems (for example, through the National Reporting and Learning System).12 Evidence should be provided of shared-learning from these incidents and findings of investigations.
For many in general practice the collection of this type of information, with audit, already happens. Disseminating findings and ensuring that everyone in the team learns from these incidents is possibly less well established; for example, sharing findings across clinical commissioning groups may need facilitating and further development.
Medicines reconciliation in acute settings—statement 4
Medication reconciliation is the process of identifying an accurate list of a person's current medicines and comparing it with the list held in their medical record. Any discrepancies can be recognised and any changes documented, thereby resulting in a complete list of medicines, which can be accurately communicated. This is essential as a patient moves between healthcare settings. The term 'medicines' also includes over-the-counter or complementary medicines, which are sometimes overlooked. Unfortunately, when patients are admitted to hospital, mistakes can be made and the reconciliation process fails; for example, a medicine may be omitted, or the patient may inadvertently be put back on a medicine that has previously been stopped. The quality standard advises that adverse incidents are more likely when medicines reconciliation happens more than 24 hours after a person is admitted to an acute setting. It therefore recommends undertaking medicines reconciliation within 24 hours of admission (or sooner if clinically necessary), which will enable early action when discrepancies are identified. For implementation of this quality statement, evidence is required that this has occurred, with information on reduction of errors in medication. Information should be collected on patient satisfaction. The aim is to achieve a reduction in the number of complaints relating to medication issues.
This will be a challenge for hospitals and emphasises the role of hospital clinical pharmacists in overseeing this process and supporting medicines use by patients. It is regrettable that direct electronic transfer of GP prescription information to hospitals, and vice versa, is so poorly developed in the UK.
Medicines reconciliation in primary care—statement 5
The provision of medicines information on transfers back to community settings can be as problematic as that on admission to hospital. This also applies to transfer from residential care back to the patient's home. The quality standard advises undertaking medicines reconciliation within 1 week of the GP practice receiving the information, and before a prescription or new supply of medicines is issued, allowing early action to be taken when discrepancies between lists of medicines are identified. This can also prevent people being prescribed medicines that were stopped while they were in hospital. The quality standard advises collecting evidence that this reconciliation has occurred, alongside information on patient satisfaction and any complaints.
Again, this will require collecting data and audit, which could be complicated and time-consuming in the busy life of general practice. There does seem to be a useful role for practice-based pharmacists to support the process of medicines reconciliation, collecting evidence that this has occurred, and enabling the audit process.
Structured medication review—statement 6
Many medicines are prescribed over a long period of time and the key to medicines optimisation is to undertake medication review at regular intervals (at least annually). NICE QS120 reinforces the necessity for structured medication review to optimise the use of medicines for people with long-term conditions, or for those who take multiple medicines. The medication review will help to identify when medicines should be stopped, or increased or reduced in dosage, and any new medicines that are needed. Structured medication review can lead to a reduction in adverse events and also ensure that timely monitoring occurs. One example of a framework for structured medication review is provided in Box 2 (see below).
Box 2: Tasks of the medication review13
- the medication prescribed is (still) appropriate for the patient's needs
- the medication is effective for the patient
- the medication is a cost-effective choice (is there an alternative?)
- any required monitoring has been done or arrangements are in place.
- drug interactions
- over-the-counter and complementary medicines
- lifestyle and non-medicinal interventions
- unmet need
- stopping medication—'deprescribing'.
- information pertinent to any decisions made
- read code for the level of medication review conducted
- proposed follow up.
Reproduced, with modification, from NHS Cumbria Clinical Commissioning Group. Clinical medication review: a practice guide. NHS Cumbria CCG, 2013.
The first step is to have systems in place to determine who needs review, with appropriate recall systems. It will then be necessary to ensure that structured medication reviews take place and to collect evidence of how the process has made changes that might potentially improve outcome. Many practices may consider using or directly employing practice-based clinical pharmacists to support this type of work, and recently NHS England has made money available to encourage this.14 The quality standard proposes that evidence is collected of patient satisfaction with medication reviews.
Many practices already have robust systems in place for regular medication review, but recent evidence does suggest a wide variation between practices in the prevalence of validated safety indicators in prescribing, and in particular delays in monitoring of drugs where blood tests are indicated.15 This suggests there is still a lot of work to be done.
Some useful practical tips to support medicines optimisation and delivery of NICE QS120 are provided in Box 3 (see below). Much of this can be achieved by careful reflection when prescribing and ensuring that systems are in place in general practice to enable a safe prescribing environment (including for repeat prescriptions).
Although time is required to develop and evaluate these systems, they will ensure better outcomes for patients, and more patients who are satisfied.
However, some of the recommendations from NICE QS120 are quite demanding and time consuming at a time when general practice is struggling with resources and manpower. Changing the general practice workforce may help to remedy these problems and the enhanced role of practice-based clinical pharmacists will allow additional time for engagement with patients and shared decisions on medicines. Clinical commissioning groups in England (and Health Boards in Wales) need to consider how best to support and facilitate this type of work, and how to break down the barriers at the interface with hospitals to ensure better medicines reconciliation.
Box 3: Practical tips for medicines optimisation8
- Never assume your patient is taking what you think they are taking
- Regular medication review is essential. Brown bag reviews (ask the patient to bring all the medicines they are taking to the clinic) or reviews in the patient's home can be illuminating
- Keep medication regimens as simple as possible—ideally with once or twice daily dosages. The number of pills or 'pill burden' should be kept to the minimum necessary to provide effective treatment
- Patient values, choices, and preferences should always be considered when prescribing. Consider the use of Patient Decision Aids to enhance informed choice
- Provide clear written instructions and a dosing schedule
- Ensure that the directions on each prescription item identify the problem it is intended to treat
- Be aware of the known pitfalls with specific drugs and recognised drug interactions. You should carefully consider and avoid hazardous prescribing wherever possible
- It is important to put systems in place to ensure consistent and appropriate biochemical monitoring takes place for high-risk medicines, e.g. lithium, disease-modifying drugs for rheumatoid arthritis, warfarin
- Consider the use of compliance aids such as monitored dosage boxes or 'pill organisers' to improve medicine-taking, but be aware that they can also have disadvantages
- Discuss complex repeat medication regimens with clinical pharmacy colleagues (both in the community and hospital setting). They can advise on safety, check for hazardous interactions, guide on formulations appropriate to the patient's needs, and help in checking patient understanding
- Try to ensure that quantities of medication are synchronised so that patients can order their repeat items at the same time and thus avoid potential missed doses and waste
- Avoid use of the term 'as directed' instead of specific dosage instructions on prescriptions
- Always ask your patient if they are using home remedies, such as herbal products or 'over-the-counter' products. Also, could the patient be using somebody else's treatment?
- Try to substitute rather than add to medication regimens
- Think of introducing drugs as a trial: do not forget to stop treatment that is unnecessary or ineffective—always consider 'deprescribing'.
Adapted from: Duerden M, Avery A, Payne R. (2013). Polypharmacy and medicines optimisation: making it safe and sound. The King's Fund, 2013.
Reproduced with permission
NICE quality measures
- Statement 1: (no process statement in NICE QS120)
- Statement 2: Proportion of new prescriptions of medicines for which patients are given an explanation on how to identify and report medicines-related patient safety incidents
- Statement 3: Proportion of reported medicines-related patient safety incidents that are investigated
- Statement 4: Proportion of people who are inpatients in an acute setting who have a reconciled list of their medicines within 24 hours of admission
- Statement 5:
- The proportion of people on medicines discharged from a care setting who have a reconciled list of their medicines within 1 week of the GP practice receiving the information
- Proportion of new prescriptions within 1 month of discharge from a care setting where there was a reconciled list of medicines in the patient's GP record
- Statement 6:
- Proportion of people taking medicines for long-term conditions who are identified as potentially benefiting from a structured medication review
- Proportion of people taking multiple medicines who are identified as potentially benefiting from a structured medication review
- The proportion of people identified as potentially benefiting from a structured medication review who have a structured medication review.
NICE (2016) QS120. Medicines optimisation.
Reproduced with permission
- The number of prescription items issued per head of population in England has increased by almost 50% in the past decade
- Multimorbidity (two or more long-term conditions) is increasing and is now more common than one condition or none in people over the age of 60 years in the UK
- The number of medicines prescribed to a person increases considerably in the context of multimorbidity
- Patients find complex medication regimens a burden and often do not take medicines as intended by the prescriber
- Medicines optimisation is a process that encourages patient-centred decisions on medicines-taking and may involve compromises that reflect patient choice rather than decisions driven by the views of clinicians
- There is an increasing role for shared decision-making and the use of patient decision aids (and a requirement to show that these have been considered)
- Patients should be informed about medication safety and should be regarded as an integral part of reporting of medication safety incidents
- Learning from reports and investigations of medication safety incidents should be used to inform education and continuing professional development
- Medicines reconciliation processes need to be improved and made more timely when patients move between healthcare settings
- Structured medication reviews are an important part of medicines optimisation and there is evidence that the processes need to be strengthened in many practices.
GP commissioning messages
written by Dr David Jenner, GP, Cullompton, Devon
- CCGs can:
- use answers from the National GP Patient Survey as an indication of how well doctors and nurses involve patients in decisions about their care and explain tests and treatments (these are available and reported for each practice)
- encourage medicines reconciliation at discharge by commissioning targeted MUR services from either community-based or practiced-based pharmacists
- look to involve the practice pharmacist for every 30,000 population as promised in the General practice forward view to help meet the aspirations of NICE QS120
- SEAs reported by practices can indicate problems with particular medicines (e.g. bleeds on vitamin K antagonists), which can then form priorities for medicines optimisation interventions
MUR=medicines use review; SEAs=significant event audits
- Mair F. Thinking about the burden of treatment. BMJ 2014; 349: g6680.
- NICE. Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes. NICE Guideline 5. NICE, 2015. Available at: www.nice.org.uk/ng5
- Health and Social Care Information Centre. Prescriptions dispensed in the community: England 2004–14. HSCIC, 2015. Available at: www.hscic.gov.uk/prescribing (accessed 8 May 2016).
- Barnett K, Mercer S, Norbury M et al. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study. Lancet 2012; 380: 37–43.
- Office for National Statistics. National population projections: 2014-based statistical bulletin. ONS, 2015. Available at: ons.gov.uk/ons/rel/npp/national-population-projections/2014-based-projections/stb-npp-2014-based-projections.html (accessed 8 May 2016).
- Guthrie B, Makubate B, HernandezSantiago V, Dreischulte T. The rising tide of polypharmacy and drug–drug interactions: population database analysis 1995–2010. BMC Medicine 2015; 13: 74.
- Payne R, Avery A, Duerden M et al. Prevalence of polypharmacy in a Scottish primary care population. Eur J Clin Pharmacol 2014; 70 (5): 575–581.
- Duerden M, Avery A, Payne R. Polypharmacy and medicines optimisation: making it safe and sound. The King's Fund, 2013. Available at: www.kingsfund.org.uk/publications/polypharmacy-and-medicines-optimisation (accessed 8 May 2016).
- NICE. Medicines optimisation. Quality Standard 120. NICE, 2016. Available at: www.nice.org.uk/qs120
- NICE. Type 2 diabetes in adults: controlling your blood glucose by taking a second medicine—what are your options? Patient decision aid NG28. Available at: www.nice.org.uk/guidance/ng28/resources/patient-decision-aid-1687717
- Medicines and Healthcare products Regulatory Agency. Yellow card scheme. Available at: yellowcard.mhra.gov.uk/ (accessed 8 May 2016).
- NHS England. National reporting and learning system. Available at: www.nrls.npsa.nhs.uk/report-a-patient-safety-incident/about-reporting-patient-safety-incidents (accessed 8 May 2016).
- NHS Cumbria Clinical Commissioning Group. Clinical medication review: a practice guide. NHS Cumbria CCG, 2013. Available at: medicines.necsu.nhs.uk/cumbria-practice-resources/
- NHS England. Clinical pharmacists in general practice pilot. www.england.nhs.uk/commissioning/primary-care-comm/gp-action-plan/cp-gp-pilot/ (accessed 8 May 2016).
- Stocks S, Kontopantelis E, Akbarov A et al. Examining variations in prescribing safety in UK general practice: cross sectional study using the Clinical Practice Research Datalink. BMJ 2015; 351: h5501. G