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Medicines optimisation

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What is covered

This interactive flowchart covers the decision-making processes to help optimise a person's medicines. The guidance is combined with recommendations from the medicines adherence guideline to demonstrate how this decision-making process supports patient compliance to a treatment regimen with an aim to managing long-term conditions, multi-morbidities and polypharmacy.
Medicines optimisation is defined as 'a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines'. In order to better guide this process, the recommendations cover the shared decision-making between healthcare professionals and the people for whom the medicines are being considered to understand the person's needs, preferences and values.
In these recommendations, the term 'medicines' covers all healthcare treatments, such as oral medicines, topical medicines, inhaled products, injections, wound care products, appliances and vaccines.

Updates

Updates to this interactive flowchart

27 April 2017 Osteoporosis (NICE quality standard 149) added.
29 March 2016 Medicines optimisation (NICE quality standard 120) added.

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Short Text

Everything NICE has said on shared decision-making and processes to optimise medicines and support adherence in an interactive flowchart

What is covered

This interactive flowchart covers the decision-making processes to help optimise a person's medicines. The guidance is combined with recommendations from the medicines adherence guideline to demonstrate how this decision-making process supports patient compliance to a treatment regimen with an aim to managing long-term conditions, multi-morbidities and polypharmacy.
Medicines optimisation is defined as 'a person-centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines'. In order to better guide this process, the recommendations cover the shared decision-making between healthcare professionals and the people for whom the medicines are being considered to understand the person's needs, preferences and values.
In these recommendations, the term 'medicines' covers all healthcare treatments, such as oral medicines, topical medicines, inhaled products, injections, wound care products, appliances and vaccines.

Updates

Updates to this interactive flowchart

27 April 2017 Osteoporosis (NICE quality standard 149) added.
29 March 2016 Medicines optimisation (NICE quality standard 120) added.

Sources

NICE guidance and other sources used to create this interactive flowchart.
Osteoporosis (2017) NICE quality standard 149
Medicines optimisation (2016) NICE quality standard 120

Quality standards

Osteoporosis

These quality statements are taken from the osteoporosis quality standard. The quality standard defines clinical best practice for managing osteoporosis and should be read in full.

Quality statements

Shared decision-making

This quality statement is taken from the medicines optimisation quality standard. The quality standard defines clinical best practice in medicines optimisation and should be read in full.

Quality statement

People are given the opportunity to be involved in making decisions about their medicines.

Rationale

Clinical outcomes and patient satisfaction are likely to be better when decisions about medicines are made jointly between the person taking the medicine and the prescriber (shared decision making). A person’s preferences and how they value treatment options and outcomes should be taken into account. People also need to have enough information to make informed choices. Patient decision aids can be used to support shared decision-making. Choices may include decisions not to take specific medicines.

Quality measures

Structure
a) Evidence that prescribers give people information about the potential benefits and harms of using medicines.
Data source: Local data collection.
b) Evidence that prescribers take into account people’s preferences and values about treatment options that includes the use of medicines.
Data source: Local data collection.
c) Evidence that prescribers offer people the opportunity to use available decision aids to make informed choices about the use of medicines that take account of the trade-off between potential benefits and harms.
Data source: Local data collection.
Outcome
a) Medicines adherence.
Data source: Local data collection.
b) Patient satisfaction with outcomes from the use of medicines.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as primary and secondary care and pharmacy services) ensure that people are given the opportunity to be involved in making decisions about their medicines in partnership with professionals who prescribe medicines.
Healthcare professionals (such as prescribers and community pharmacists) ensure that people are given the opportunity to be involved in making decisions about their medicines. For example, healthcare professionals can use patient decision aids to support shared decision-making and they should ensure that people who take medicines have information about the potential benefits and harms.
Commissioners (such as clinical commissioning groups and NHS England) ensure they commission services in which people are given the opportunity to be involved in making decisions about their medicines in partnership with professionals who prescribe medicines.

What the quality statement means for patients, service users and carers

People who are considering whether or not to take a medicine are given the opportunity to be involved in making the decision with their healthcare professional. The decision should be in line with the person’s preferences and what they consider is important, and should take into account information about the potential benefits and harms of the medicine.

Source guidance

Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes (2015) NICE guideline NG5, recommendations 1.6.1, 1.6.2, 1.6.4 and 1.6.6

Definitions of terms used in this quality statement

Involved in making decisions
Patients should have the opportunity to make informed decisions about their medicines, in partnership with their healthcare professionals. Healthcare professionals should take account of a person’s values and preferences by discussing what is important to them about treating or managing their condition(s) and their medicines. They should ask open questions to understand the person’s ideas, concerns and expectations. This process can he helped by using patient decision aids. The person’s values and preferences about treatment options may be different from those of the healthcare professional, and making assumptions about these should be avoided.
[Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes (2015) NICE guideline NG5, recommendation 1.6.2 and full guideline]

Equality and diversity considerations

People who are offered or prescribed medicines may have different values and preferences to those of their healthcare professional, and these values and preferences may affect their choices about medicines. Healthcare professionals should be sensitive and supportive to ensure that everyone can express their preferences about the use of medicines and take part in shared decision-making. Healthcare professionals should take into account that some people may need additional support in communicating their preferences or in understanding the information given to them. This might be, for example, because English is not their first language or they have communication or sensory difficulties.

Medicines reconciliation in acute settings

This quality statement is taken from the medicines optimisation quality standard. The quality standard defines clinical best practice in medicines optimisation and should be read in full.

Quality statement

People who are inpatients in an acute setting have a reconciled list of their medicines within 24 hours of admission.

Rationale

Medicines-related patient safety incidents are more likely when medicines reconciliation happens more than 24 hours after a person is admitted to an acute setting. Undertaking medicines reconciliation within 24 hours of admission to an acute setting (or sooner if clinically necessary) enables early action to be taken when discrepancies between lists of medicines are identified.

Quality measures

Structure
Evidence of local arrangements to ensure that people who are inpatients in an acute setting have a reconciled list of their medicines within 24 hours of admission.
Data source: Local data collection and Medicines optimisation dashboard.
Process
Proportion of people who are inpatients in an acute setting who have a reconciled list of their medicines within 24 hours of admission.
Numerator – the number in the denominator who have a reconciled list of their medicines within 24 hours of admission.
Denominator – the number of people who are inpatients in an acute setting.
Data source: Local data collection.
Outcome
a) Harm attributable to errors in medication following acute inpatient admission.
Data source: Local data collection.
b) Patient satisfaction with outcomes from the use of medicines.
Data source: Local data collection.
c) Number of patient complaints relating to medication issues.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as secondary care and mental health providers) ensure that systems are in place for people who are inpatients in an acute setting, to have a reconciled list of their medicines within 24 hours of admission.
Healthcare professionals (such as doctors, nurses, pharmacists and pharmacist technicians) ensure that they reconcile a list of medicines for people who are inpatients in an acute setting within 24 hours of admission (or sooner if clinically necessary).
Commissioners (such as clinical commissioning groups and NHS England) ensure that they commission acute services that reconcile a list of medicines for people who are inpatients in an acute setting within 24 hours of admission.

What the quality statement means for patients, service users and carers

People who go into hospital as inpatients have an up-to-date list of their medicines in their hospital record within 24 hours. They may be involved in this process if they wish to be. This ensures that any mistakes with their medicines are quickly noticed and sorted out.

Source guidance

Definitions of terms used in this quality statement

Acute care settings
Acute care settings include secondary care, tertiary care and mental health services.
[Expert opinion]
Reconciled list
Medicines reconciliation is the process of identifying an accurate list of a person’s current medicines and comparing it with the current list in use. The information can be obtained from a variety of sources such as: medication brought to hospital by the patient, GP surgery patient records, repeat prescription slips, hospital case notes, community pharmacy patient medication records and care home medicines administration record. The list should include name, dosage, frequency and route of administration. Any discrepancies should be identified and any changes documented. The result is a complete list of medicines, accurately communicated to all health and social care professionals involved in the person’s care, in which any issues with the medicines, such as wrong dosage or omission, have been addressed.
Within 24 hours of admission
Medicines reconciliation for people who are inpatients in an acute setting should occur within 24 hours of admission, regardless of the time of admission or the day of the week.
[Expert opinion]

Equality and diversity considerations

Healthcare professionals should recognise that people’s ability to understand the issue of medicines reconciliation may differ, and take this into account in discussions with the person. Some people may need additional support to understand the issue, for example, if English is not their first language or if they have communication or sensory difficulties.

Medicines reconciliation in primary care

This quality statement is taken from the medicines optimisation quality standard. The quality standard defines clinical best practice in medicines optimisation and should be read in full.

Quality statement

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.

Rationale

Medicines-related patient safety incidents are more likely when medicines reconciliation happens more than a week after discharge from a care setting such as a hospital or care home. Undertaking medicines reconciliation in primary care within 1 week of the GP practice receiving the information, and before a prescription or new supply of medicines is issued, allows early action to be taken when discrepancies between lists of medicines are identified. For example, it can prevent people from being prescribed medicines that were stopped while they were in hospital.

Quality measures

Structure
a) Evidence of local arrangements to ensure that 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.
Data source: Local data collection.
b) Evidence of local arrangements to ensure that people discharged from a care setting are not issued a prescription or new supply of medicines until they have a reconciled list of their medicines in their GP record.
Data source: Local data collection.
Process
a) 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.
Numerator – the number in the denominator who have a reconciled list of their medicines within 1 week of the GP practice receiving the information.
Denominator – the number of people on medicines who are discharged from a care setting.
Data source: Local data collection.
b) 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.
Numerator – Number in the denominator where there was a reconciled list of medicines in the patient’s GP record.
Denominator – Number of new prescriptions within 1 month of discharge from a care setting.
Data source: Local data collection.
Outcome
a) Harm attributable to errors in medication following discharge from a care setting.
Data source: Local data collection.
b) Patient satisfaction with outcomes from the use of medicines.
Data source: Local data collection.
c) Number of patient complaints relating to medication issues following discharge from a care setting.
Data source: Local data collection.

What the quality statement means for service providers, health and social care practitioners, and commissioners

Service providers (such as GP practices, secondary care and mental health providers) ensure that systems are in place for people discharged from a care setting to 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. Care providers should ensure comprehensive and accurate information on medicines is supplied to general practices in a timely manner on discharge. GP practices should have systems in place to act on the information received within 1 week.
Health and social care practitioners (such as GPs, secondary care consultants and residential care practitioners) ensure that 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. Health and social care practitioners should send comprehensive and accurate information on medicines to general practices in a timely manner on discharge. GPs should undertake medicines reconciliation within 1 week, and should not issue new prescriptions or supplies of medicines before medicines reconciliation is complete. General practices may also liaise with community pharmacies about any medicines discharge information the pharmacies receive.
Commissioners (such as clinical commissioning groups and NHS England) commission services that ensure that 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.

What the quality statement means for patients, service users and carers

People who take medicines who are discharged from a care setting such as a hospital or residential care have an up-to-date list of any medicines they are taking in their GP record within 1 week of the GP practice receiving the information. The person may be involved in making the list if they wish to be. The GP practice should not give new prescriptions or a new supply of medicines until the person’s list of medicines has been made and checked.

Source guidance

Definitions of terms used in this quality statement

Care settings
Care settings from which people are discharged include hospitals, mental health settings and social care residential settings. These care settings should provide lists of medicines to general practices for medicines reconciliation in primary care.
[Expert opinion]
Reconciled list
Medicines reconciliation is the process of identifying an accurate list of a person’s current medicines and comparing it with the current list in use. The information can be obtained from a variety of sources such as: medication brought to hospital by the patient, GP surgery patient records, repeat prescription slips, hospital case notes, community pharmacy patient medication records and care home medicines administration record. The list should include name, dosage, frequency and route of administration. Any discrepancies should be identified and any changes documented. The result is a complete list of medicines, accurately communicated to all health and social care professionals involved in the person’s care, in which any issues with the medicines, such as wrong dosage or omission, have been addressed.

Equality and diversity considerations

Primary healthcare professionals should recognise that people’s ability to understand the issue of medicines reconciliation may differ, and take this into account if the person wishes to be involved in the medicines reconciliation process. Health and social care practitioners should consider that people may need additional support to understand the issue, for example, if English is not their first language or if they have communication or sensory difficulties.

Structured medication review

This quality statement is taken from the medicines optimisation quality standard. The quality standard defines clinical best practice in medicines optimisation and should be read in full.

Quality statement

Local healthcare providers identify people taking medicines who would benefit from a structured medication review.

Rationale

A structured medication review, with the clear purpose of optimising the use of medicines for some people (such as those who have long-term conditions or who take multiple medicines), can identify medicines that could be stopped or need a dosage change, or new medicines that are needed. Structured medication review can lead to a reduction in adverse events. To offer a structured medication review to people who would benefit, local healthcare providers must first have systems in place to identify those people.

Quality measures

Structure
a) Evidence that local healthcare providers have arrangements to identify people taking medicines who would benefit from a structured medication review.
Data source: Local data collection.
b) Evidence that local healthcare providers have arrangements to offer structured medication reviews to people who are likely to benefit.
Data source: Local data collection.
Process
a) Proportion of people taking medicines for long-term conditions who are identified as potentially benefiting from a structured medication review.
Numerator – the number in the denominator who are identified as potentially benefiting from a structured medication review.
Denominator – the number of people taking medicines for long-term conditions.
b) Proportion of people taking multiple medicines who are identified as potentially benefiting from a structured medication review.
Numerator – the number in the denominator who are identified as potentially benefiting from a structured medication review.
Denominator – the number of people taking multiple medicines.
Data source: Local data collection.
c) The proportion of people identified as potentially benefiting from a structured medication review who have a structured medication review.
Numerator – the number in the denominator who have a structured medication review.
Denominator – the number of people identified as potentially benefiting from a structured medication review.
Data source: Local data collection.
Outcome
a) People with long term conditions gain optimum outcomes from use of medicines.
Data source: Local data collection.
b) People using multiple medicines gain optimum outcomes from use of medicines.
Data source: Local data collection.
c) Patient satisfaction with outcomes from the use of medicines.
Data source: Local data collection.

What the quality statement means for service providers, healthcare professionals and commissioners

Service providers (such as GP practices, acute and mental health services) ensure that systems are in place to identify people taking medicines who would benefit from a structured medication review. Such patients may include people taking medicines for long-term conditions and people taking multiple medicines.
Healthcare professionals (such as GPs and pharmacists) ensure that they identify people taking medicines who would benefit from a structured medication review. Such patients may include people taking medicines for long-term conditions and people taking multiple medicines. Healthcare professionals should carry out the review with patients who agree to attend when the need and purpose of the structured medication review is clear. The healthcare professional should take into account the person’s views, whether the person has had or has any risk factors for developing adverse drug reactions and any monitoring that is needed.
Commissioners (such as clinical commissioning groups and NHS England) ensure that they commission services that identify people taking medicines who would benefit from a structured medication review. Where the need and purpose is clear, structured medication reviews should be carried out with patients who agree to attend.

What the quality statement means for patients, service users and carers

People who may benefit from a structured medication review of their medicines are invited to talk about this with their healthcare professional. They might be asked because they are taking several medicines or are taking medicines for long term conditions. The review can help to identify any medicines that are no longer needed or any that need the dosage changed. The healthcare professional should listen to the person’s views and take these into account. They should also think about whether the person has had or has any risk factors for developing adverse drug reactions and whether any monitoring is needed.

Source guidance

Definitions of terms used in this quality statement

Structured medication review
A structured medication review is a critical examination of a person’s medicines with the objective of reaching an agreement with the person about treatment, optimising the impact of medicines, minimising the number of medication-related problems and reducing waste.

Equality and diversity considerations

Healthcare professionals should recognise that people’s ability to understand the importance of medication reviews may differ, and ensure that people are supported to understand the purpose and benefits of a structured medication review. Healthcare professionals should take into account that people may need additional support to understand the issue, for example, if English is not their first language or if they have communication or sensory difficulties.

Assessment of fragility fracture risk

This quality statement is taken from the osteoporosis quality standard. The quality standard defines clinical best practice for managing osteoporosis and should be read in full.

Quality statement

Adults who have had a fragility fracture or use systemic glucocorticoids or have a history of falls have an assessment of their fracture risk.

Rationale

Risk assessment of adults who may be at increased risk of a fragility fracture enables healthcare professionals to estimate their fracture risk. This can be used to consider options for prevention and treatment, which will reduce the risk of future fractures.

Quality measures

Structure
Evidence of local arrangements to ensure that adults who have had a fragility fracture, use systemic glucocorticoids or have a history of falls, have an assessment of their fracture risk.
Data source: Local data collection, for example, service specifications.
Process
a) Proportion of adults who have had a fragility fracture who have an assessment of their fracture risk.
Numerator – the number in the denominator who have an assessment of their fracture risk.
Denominator – the number of adults who have had a fragility fracture.
Data source: Local data collection, for example, local audit of patient records. The Quality and Outcomes Framework captures data on patients aged 50 to 74 with a record of a fragility fracture and a diagnosis of osteoporosis confirmed on dual-energy X-ray absorptiometry (DXA) scan, and aged 75 or over with a record of a fragility fracture and a diagnosis of osteoporosis.
b) Proportion of adults who use systemic glucocorticoids who have an assessment of their fracture risk.
Numerator – the number in the denominator who have an assessment of their fracture risk.
Denominator – the number of adults who use systemic glucocorticoids.
Data source: Local data collection, for example, local audit of patient records.
c) Proportion of adults aged 50 and over who have a history of falls who have an assessment of their fracture risk.
Numerator – the number in the denominator who have an assessment of their fracture risk.
Denominator – the number of adults aged 50 and over who have a history of falls.
Data source: Local data collection, for example, local audit of patient records.
Outcome
Incidence of fragility fractures.
Data source: Local data collection, for example, local audit of patient records.

What the quality statement means for different audiences

Service providers (general practices, secondary care services and fracture liaison services) ensure that systems are in place for adults who have had a fragility fracture, use systemic glucocorticoids or have a history of falls, to have an assessment of their fracture risk.
Healthcare professionals (GPs, specialists, specialist nurses and fracture liaison practitioners) assess fracture risk, or confirm that assessment has taken place, in adults who have had a fragility fracture, use systemic glucocorticoids or have a history of falls, to estimate their risk of fracture and determine their treatment options.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which adults who have had a fragility fracture, use systemic glucocorticoids or have a history of falls, have their fracture risk assessed.
Adults who have had a fragility fracture or falls in the past, or who are taking steroid treatment have their risk of fracture assessed. Fragility fractures happen in people with fragile bones that break easily, usually older people with osteoporosis. There are treatments available to help prevent fractures in people who are at increased risk. An assessment can help to decide if treatment will reduce the chance of having a fracture.

Source guidance

Osteoporosis: assessing the risk of fragility fracture (2012) NICE guideline CG146, recommendations 1.1 and 1.2

Definitions of terms used in this quality statement

Fragility fracture
Fragility fractures are fractures that result from mechanical forces that would not ordinarily result in fracture, known as low-level (or 'low energy') trauma. The World Health Organization has quantified this as forces equivalent to a fall from a standing height or less. Fragility fractures occur most commonly in the spine (vertebrae), hip (proximal femur) and wrist (distal radius). They may also occur in the arm (humerus), pelvis, ribs and other bones.
[NICE’s guideline on osteoporosis: assessing the risk of fragility fracture, introduction]
Use of systemic glucocorticoids
Adults currently using systemic glucocorticoids, or who have been using systemic glucocorticoids for more than 3 months, at a dose of prednisolone of 5 mg daily or more (or equivalent doses of other glucocorticoids).
[Expert opinion and The University of Sheffield’s FRAX fracture risk assessment tool]
History of falls
One or more falls in the last 12 months. A fall is defined as an unintentional or unexpected loss of balance resulting in coming to rest on the floor, the ground, or an object below knee level. Adults aged 50 and over should have a fracture risk assessment if they have a history of falls.
[NICE’s clinical knowledge summary on falls – risk assessment and NICE’s guideline on osteoporosis: assessing the risk of fragility fracture, recommendations 1.1 and 1.2]
Assessment of fracture risk
An assessment of fracture risk should include estimating absolute fracture risk (for example, the predicted risk of major osteoporotic or hip fracture over 10 years, expressed as a percentage). Either FRAX (without a bone mineral density [BMD] value if a DXA scan has not previously been undertaken) or QFracture should be used within their allowed age ranges. Above the upper age limits defined by the tools, consider people to be at high risk. Measure BMD to assess fracture risk in people aged under 40 years.
[Adapted from NICE’s guideline on osteoporosis: assessing the risk of fragility fracture, recommendations 1.3, 1.4 and 1.9]

Starting drug treatment

This quality statement is taken from the osteoporosis quality standard. The quality standard defines clinical best practice for managing osteoporosis and should be read in full.

Quality statement

Adults at high risk of fragility fracture are offered drug treatment to reduce fracture risk.

Rationale

Fragility fractures can cause substantial pain and severe disability, often leading to a reduced quality of life and sometimes to decreased life expectancy. Taking drug treatment to improve bone density reduces the chance of future fractures and related problems.

Quality measures

Structure
Evidence of local arrangements to ensure that adults at high risk of fragility fracture are offered drug treatment to reduce fracture risk.
Data source: Local data collection, for example, local protocols.
Process
Proportion of adults at high risk of fragility fracture receiving drug treatment to reduce fracture risk.
Numerator – the number in the denominator who receive drug treatment to reduce fracture risk.
Denominator – the number of adults at high risk of fragility fracture.
Data source: Local data collection, for example, local audit of patient records. The Quality and Outcomes Framework captures data on patients aged 50 to 74 with a record of a fragility fracture and a diagnosis of osteoporosis confirmed on dual-energy X-ray absorptiometry (DXA) scan, and aged 75 or over with a record of a fragility fracture and a diagnosis of osteoporosis, who are currently treated with an appropriate bone-sparing agent.
Outcomes
a) Incidence of fragility fractures.
Data source: Local data collection, for example, local audit of patient records.
b) Hospital admission rates for fragility fractures.
Data source: Local data collection, for example, Hospital episode statistics from NHS Digital.

What the quality statement means for different audiences

Service providers (general practices and secondary care services) ensure that systems are in place for adults at high risk of fragility fracture to be offered drug treatment to reduce fracture risk.
Healthcare professionals (GPs, specialists and specialist nurses) are aware of when to prescribe drug treatments to reduce fracture risk, and offer them to adults at high risk of fragility fracture.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which adults at high risk of fragility fracture are offered drug treatment to reduce fracture risk.
Adults with a high chance of fragility fracture are offered medicine to help strengthen their bones and prevent fractures.

Source guidance

Definitions of terms used in this quality statement

At high risk of fragility fracture
Women with a prior fragility fracture (particularly hip or vertebral fracture) and men and women with a 10-year probability of a major osteoporotic fracture derived from FRAX, above the upper assessment threshold, should be considered for treatment (see table 1). Men and women with a 10-year probability between the upper and lower assessment threshold should be referred for bone mineral density measurement and their fracture probability reassessed. If their 10-year fracture probability is above the intervention threshold after reassessment (see table 1), treatment should be offered.
Table 1. Lower and upper assessment thresholds and intervention thresholds for major osteoporotic fracture probability based on fracture probabilities derived from FRAX (BMI set to 25 kg/m2)
10-year probability of a major osteoporotic fracture (%)
Age (years)
Lower assessment threshold
Upper assessment threshold
Intervention threshold
40
2.6
7.1
5.9
45
2.7
7.2
6.0
50
3.4
8.6
7.2
55
4.5
11
9.4
60
5.9
14
12
65
8.4
19
16
≥70
11
24
20
Reproduced with permission from McCloskey et al. (2015) FRAX-based assessment and intervention thresholds – an exploration of thresholds in women aged 50 years and older in the UK. Osteoporosis International 26 (8), 2091–9
[Adapted from National Osteoporosis Guideline Group’s Clinical guideline for the prevention and treatment of osteoporosis, section 11, recommendation 7]
Drug treatment to reduce fracture risk
Drugs that can be prescribed to prevent fragility fractures include bisphosphonates (alendronate, ibandronate, risedronate and zoledronic acid) and non-bisphosphonates (raloxifene, denosumab, teriparatide, calcitriol and hormone replacement therapy).
[Adapted from National Osteoporosis Guideline Group’s Clinical guideline for the prevention and treatment of osteoporosis, section 6]
Full details of the licensed indications for these drugs can be found in the summary of product characteristics. At the time of publication (April 2017), not all bisphosphonate and non-bisphosphonate drugs have UK marketing authorisation for preventing osteoporosis. The prescriber should follow relevant professional guidance, taking full responsibility for the decision to prescribe an unlicensed medicine. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.

Equality and diversity considerations

Guidance on treatment to prevent fragility fractures has been focused on treating post-menopausal women, because of their increased risk. Clinicians should ensure that other populations who might benefit from recommended treatments are also considered.  

Adverse effects and adherence to treatment

This quality statement is taken from the osteoporosis quality standard. The quality standard defines clinical best practice for managing osteoporosis and should be read in full.

Quality statement

Adults prescribed drug treatment to reduce fracture risk are asked about adverse effects and adherence to treatment at each medication review.

Rationale

People prescribed drugs to prevent fragility fractures sometimes stop taking them because of adverse effects. Adherence to treatment, including taking their medicine by the recommended method, is needed to ensure that fracture risk is reduced effectively. Checking how well a person is managing their treatment at each medication review means that any problems can be discussed and their treatment adjusted if needed, which will improve adherence and quality of life.

Quality measures

Structure
Evidence of local arrangements to ensure that adults prescribed drug treatment to reduce fracture risk are asked about adverse effects and adherence to treatment at each medication review.
Data source: Local data collection, for example, service specifications.
Process
Proportion of medication reviews for adults prescribed drug treatment to reduce fracture risk that include a record of adverse effects and adherence to treatment.
Numerator – the number in the denominator that include a record of adverse effects and adherence to treatment.
Denominator – the number of medication reviews for adults prescribed drug treatment to reduce fracture risk.
Data source: Local data collection, for example, local audit of patient records.
Outcomes
a) Adults adhering to drug treatment to reduce fracture risk.
Data source: Local data collection, for example, local audit of patient records.
b) Incidence of fragility fracture.
Data source: Local data collection, for example, local audit of patient records.

What the quality statement means for different audiences

Service providers (general practices, secondary care services and pharmacies) ensure that systems are in place for adults prescribed drug treatment to reduce fracture risk to be asked if they have had any adverse effects and about adherence to treatment at each medication review.
Healthcare professionals (GPs, specialists, specialist nurses and pharmacists) carry out medication reviews with adults prescribed drug treatments to reduce fracture risk. At the reviews, they ask if the person has had any adverse effects and if they are taking their medicine by the recommended method and as prescribed. If any problems are raised, these should be discussed and treatment adjusted if needed, which may involve input from a specialist.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which adults prescribed drug treatment to reduce fracture risk are asked if they have had any adverse effects and about adherence to treatment at each medication review.
Adults taking medicine to help prevent fractures have regular medicine reviews with their doctor to check if they are having any side effects, such as heartburn or reflux, and that they are taking the medicine correctly. The review gives the chance for any problems to be discussed and treatment can be adjusted if needed to help with side effects.

Source guidance

Definitions of terms used in this quality statement

Drug treatment to reduce fracture risk
Drugs that can be prescribed to prevent fragility fractures include bisphosphonates (alendronate, ibandronate, risedronate and zoledronic acid) and non-bisphosphonates (raloxifene, denosumab, teriparatide, calcitriol and hormone replacement therapy).
[Adapted from National Osteoporosis Guideline Group’s Clinical guideline for the prevention and treatment of osteoporosis, section 6]
Full details of the licensed indications for these drugs can be found in the summary of product characteristics. At the time of publication (April 2017), not all bisphosphonate and non-bisphosphonate drugs have UK marketing authorisation for preventing osteoporosis. The prescriber should follow relevant professional guidance, taking full responsibility for the decision to prescribe an unlicensed medicine. Informed consent should be obtained and documented. See the General Medical Council's Prescribing guidance: prescribing unlicensed medicines for further information.
Medication review
The review should include:
  • asking about adverse effects, including upper gastrointestinal adverse effects (such as dyspepsia or reflux), symptoms of atypical fracture (including new onset hip, groin, or thigh pain), and dental problems
  • asking about adherence to treatment, including following the recommended method of taking the treatment
  • discussing alternative treatment options if adverse effects are unacceptable or the person has difficulty adhering to treatment.
[Expert opinion and NICE’s clinical knowledge summary on osteoporosis – prevention of fragility fractures]

Long-term follow-up

This quality statement is taken from the osteoporosis quality standard. The quality standard defines clinical best practice for managing osteoporosis and should be read in full.

Quality statement

Adults having long-term bisphosphonate therapy have a review of the need for continuing treatment.

Rationale

The optimal duration of bisphosphonate therapy is unclear and there are possible adverse effects of long-term treatment. A medication review for people having long-term bisphosphonate therapy gives the opportunity to consider whether continuing treatment is the best option, or if treatment should be changed or stopped. The response to treatment may also be evaluated to help determine whether to continue treatment.

Quality measures

Structure
a) Evidence of local arrangements to ensure that adults taking zoledronic acid for 3 years have a review of the need for continuing treatment.
Data source: Local data collection, for example, local protocols.
b) Evidence of local arrangements to ensure that adults taking alendronate, ibandronate or risedronate for 5 years have a review of the need for continuing treatment.
Data source: Local data collection, for example, local protocols.
Process
a) Proportion of adults taking zoledronic acid for 3 years who have a review of the need for continuing treatment.
Numerator – the number in the denominator who have a review of the need for continuing treatment.
Denominator – the number of adults taking zoledronic acid for 3 years.
Data source: Local data collection, for example, local audit of patient records.
b) Proportion of adults taking alendronate, ibandronate or risedronate for 5 years who have a review of the need for continuing treatment.
Numerator – the number in the denominator who have a review of the need for continuing treatment.
Denominator – the number of adults taking alendronate, ibandronate or risedronate for 5 years.
Data source: Local data collection, for example, local audit of patient records.
Outcomes
a) Patient satisfaction with long-term bisphosphonate therapy.
Data source: Local data collection, for example, patient surveys.
b) Health-related quality of life for adults having long-term bisphosphonate therapy.
Data source: Local data collection, for example, patient surveys.

What the quality statement means for different audiences

Service providers (general practices, secondary care services and pharmacies) ensure that systems are in place for adults having long-term bisphosphonate therapy to have a review of the need for continuing treatment.
Healthcare professionals (GPs, specialists, specialist nurses and pharmacists) offer adults having long-term bisphosphonate therapy a medication review to discuss the risks and benefits of continuing treatment and assess their response to treatment, if needed.
Commissioners (clinical commissioning groups and NHS England) ensure that they commission services in which adults having long-term bisphosphonate therapy have a review of the need for continuing treatment.
Adults taking a type of medicine called a bisphosphonate over a long time to help prevent fractures have a review to discuss the risks and benefits of continuing with the treatment. They might also have a scan to check whether their bone strength has improved to help decide whether to continue treatment.

Source guidance

Definitions of terms used in this quality statement

Long-term bisphosphonate therapy
Adults who have been taking zoledronic acid for 3 years or alendronate, ibandronate or risedronate for 5 years should have a review of the need for continuing treatment.
[National Osteoporosis Guideline Group’s Clinical guideline for the prevention and treatment of osteoporosis, section 7, recommendation 6]
Review of the need for continuing treatment
Continuation of treatment is recommended for people with any of the following risk factors:
  • age over 75 years
  • previous hip or vertebral fracture
  • one or more low trauma fractures during treatment (after poor adherence to treatment, for example less than 80% of treatment has been taken, and causes of secondary osteoporosis have been excluded)
  • current treatment with oral glucocorticoids of 7.5 mg or more prednisolone/day or equivalent.
For people without risk factors, arrange a dual-energy X-ray absorptiometry (DXA) scan and consider:
  • Continuing treatment if the T-score is less than -2.5, and reassessing fracture risk and bone mineral density (BMD) every 3 to 5 years.
  • Stopping treatment if the T-score is greater than -2.5, and reassessing their fracture risk and BMD after 2 years.
[Adapted from NICE’s clinical knowledge summary on osteoporosis – prevention of fragility fractures and National Osteoporosis Guideline Group’s Clinical guideline for the prevention and treatment of osteoporosis, section 7, recommendation 4]

Effective interventions library

Effective interventions library

Successful effective interventions library details

Implementation

Information for the public

NICE has written information for the public on each of the following topics.

Pathway information

Person-centred care

People have the right to be involved in discussions and make informed decisions about their care, as described in your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.

Your responsibility

Guidelines

The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.
Local commissioners and providers of healthcare have a responsibility to enable the guideline to be applied when individual professionals and people using services wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with complying with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Technology appraisals

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, health professionals are expected to take these recommendations fully into account, alongside the individual needs, preferences and values of their patients. The application of the recommendations in this interactive flowchart is at the discretion of health professionals and their individual patients and do not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Commissioners and/or providers have a responsibility to provide the funding required to enable the recommendations to be applied when individual health professionals and their patients wish to use it, in accordance with the NHS Constitution. They should do so in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Medical technologies guidance, diagnostics guidance and interventional procedures guidance

The recommendations in this interactive flowchart represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take these recommendations fully into account. However, the interactive flowchart does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
Commissioners and/or providers have a responsibility to implement the recommendations, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this interactive flowchart should be interpreted in a way that would be inconsistent with compliance with those duties.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.

Supporting information

Glossary

screening tool to alert to right treatment
screening tool of older persons' potentially inappropriate prescriptions
Patient information leaflets contain information for patients on how medicines should be used. It is a legal requirement that this information is included on the label or within the packaging of a medicine.

Paths in this pathway

Pathway created: March 2015 Last updated: May 2017

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