Dr Pam Brown (left), Dr Wendy Carr, and Paul Mitchell discuss the introduction of an osteoporosis web resource to help primary care with the implementation of the new QOF domain
The quality and outcomes framework (QOF) is a voluntary incentive scheme for GP practices in the UK that rewards high-quality care. Since the inception of the QOF in 2004, the National Osteoporosis Society and a small group of GPs have campaigned for osteoporosis and fracture prevention to be included within this framework. Following a pilot, we now welcome the inclusion of the osteoporosis domain and three of our proposed indicators in the QOF for 2012/13.1 As with other domains, there are some limitations; for example, it will only look at fractures sustained prospectively from 1 April 2012 and it will therefore not encourage treatment of individuals who have had fragility fractures before this date or cover those who are at high risk and have osteopenia.
- outlines the requirements of the QOF indicators for osteoporosis
- introduces a new online resource from the Royal College of General Practitioners (RCGP) and the National Osteoporosis Society (NOS), which aims to help practices maximise QOF points in the new domain and improve post-fracture care.2
Why include osteoporosis in the QOF?
Osteoporosis has been defined as: ‘... a systemic skeletal disorder, characterised by low bone mass and micro-architectural deterioration of bone tissue, with a consequent increase in bone fragility and susceptibility to fracture.’ 3 The condition is diagnosed by measuring bone mineral density (BMD) using a dual energy X-ray absorptiometry (DXA) scan—a T-score of ?-2.5 denotes osteoporosis.1
Osteoporosis is only important because of the fractures that it causes. Hip fractures result in a mortality rate of around 20% during the first year after they occur.4 Of equal concern is the pain, and loss of mobility and independence among those who have experienced a hip fracture—50% of people who were able to live independently prior to a hip fracture, will no longer be able to do so afterwards.5
Approximately 40% of people who have a hip fracture have had a previous fragility fracture and have therefore already demonstrated themselves to be at high risk of this life-changing event,6-8 yet only approximately 12% are receiving bone-sparing therapy on admission to hospital.9 This means there is a preventable burden of fracture that primary care can do something about, since drug treatments—usually with bone-sparing drugs that are easy to administer and monitor in primary care—have been demonstrated to reduce future fracture rates by 30%–50% with 3–5 years of treatment.10
More recently, we have been prompted to think of osteoporosis as a chronic disease of the skeleton, with fractures as the acute exacerbation.2 This aligns it with other chronic conditions such as cardiovascular disease, where we always identify and treat underlying risk factors when people experience the acute exacerbation of a myocardial infarction. Primary care teams are good at managing such chronic diseases, and are therefore well placed to manage osteoporosis and prevent future fractures, making this clinical area an ideal candidate for inclusion in QOF.
QOF indicators for osteoporosis
Three indicators—OST1, 2, and 3—have been included in the 2012/13 QOF and are related to reducing the incidence of fragility fractures (see Table 1). Each indicator is worth a maximum of 3 points and OST2 and OST3 have a payment threshold of 30–60%.1 Although 9 is a low number of points, the requirements are not onerous and it is hoped that inclusion of these indicators in the QOF will provide the impetus to encourage all practices across the UK to think about osteoporosis and their role in preventing future fractures.
Indicator OST1 involves setting up a register of all men and women over the age of 50 years who sustain a fragility fracture from 1 April 2012 onwards and who qualify for bone-sparing treatment.1 A fragility fracture is defined as a low-trauma fracture occurring as a result of a fall from standing height or less in someone over the age of 50 years, or a low-trauma vertebral or rib fracture that occurs during normal activities of daily living, such as lifting a shopping bag, turning over in bed, or coughing.11 If in doubt over whether it is a fragility fracture, it is useful to ask whether
a fracture would normally have been expected from that particular fall or activity.
It can be assumed that individuals aged 75 years and over are at high risk of future fractures if they have sustained one fragility fracture, and primary care teams can therefore choose to treat them without carrying out DXA scanning to specifically measure BMD. This patient group is very straightforward and can be included in the register immediately. Patients between the ages of 50 and 75 years need to be referred for DXA scanning and should be included in the register if they have osteoporosis, that is if they have a DXA scan that shows they have a T-score of ?-2.5. As with other QOF domains, accurate coding is vital to ensure that the practice is paid for the work they undertake, and this is discussed in more detail below.
Indicator OST2 involves ‘appropriate’ treatment of people aged 50–74 years with a fragility fracture from 1 April 2012 onwards, and confirmed osteoporosis on DXA scanning.1 ‘Appropriate’ first-line therapy for post-menopausal women with fragility fracture is alendronate, as recommended by NICE Technology Appraisal (TA) 161 (see below for advice on men).12 Patients need to be initiated on therapy as soon as possible; achievement will be measured on 31 March 2013 and effort will therefore need to be invested in maintaining patients on tolerated therapy. For some individuals this may necessitate annual intravenous therapy or twice-yearly subcutaneous therapy for those intolerant of oral therapy as discussed below.
Indicator OST3 involves the use of ‘appropriate’ bone-sparing therapy for people aged ?75 years who have had a fragility fracture from 1 April 2012 onwards.1 Again the choice of first-line therapy will reflect the recommendations of Technology Appraisal 161 initially, but co-morbidities in this group make the use of second-line agents, including denosumab as recommended by NICE in TA204, more likely.12,13
|Table 1: QOF indicators relating to osteoporosis1|
The practice can produce a register of patients:
1. Aged 50–74 years with a record of a fragility fracture after 1 April 2012 and a diagnosis of osteoporosis confirmed on DXA scan, and
2. Aged 75 years and over with a record of a fragility fracture after 1 April 2012
The percentage of patients aged between 50 and 74 years, with a fragility fracture, in whom osteoporosis is confirmed on DXA scan, who are currently treated with an appropriate bone-sparing agent
The percentage of patients aged 75 years and over with a fragility fracture, who are currently treated with an appropriate bone-sparing agent
|DXA=dual energy X-ray absorptiometry|
Osteoporosis Resources for Primary Care website
The Osteoporosis Resources for Primary Care website (see Figure 1) (www.osteoporosis-resources.org.uk) outlines further guidance on how to fulfil the QOF requirements for osteoporosis and this is discussed below.2 This resource will be updated regularly as new material becomes available, and reflects a UK perspective on management options. The seven sections of the site are listed in Box 1. Primary care teams should however make themselves aware of any local adaptations of NICE treatment algorithms, which may recommend different treatment thresholds for second- and third-line therapies, as well as regional guidance on the use of intravenous and subcutaneous drug therapy.
|Figure 1: Osteoporosis Resources for Primary Care2|
The most important consideration for implementing the new osteoporosis indicators is to ensure that all fragility fractures that occur to patients from 1 April 2012 are coded accurately. To facilitate identification of these patients with fragility fractures and to avoid having to search for each individual fracture type, the Osteoporosis Resources for Primary Care recommends that in addition to coding the specific fracture, the fragility fracture code, N331N, should also be used.2 The detailed business rules that cover which codes should be used for the QOF are now available and specify the use of codes N331N and N331M (fragility fracture due to unspecified osteoporosis) for inclusion in the register.14 Use of codes for intolerance of bisphosphonates or other treatment options will help explain therapy choices.2 These codes will be helpful for internal practice use and some will be used for confirming that the indicators for osteoporosis have been achieved.
It is vitally important for primary care to ensure that secondary causes of osteoporosis and other underlying conditions which cause fractures are identified before treatment is initiated.2 This is particularly important in:15
- men where around 50% of those with osteoporosis will have secondary causes16
- patients with vertebral fractures, where myeloma and other underlying conditions should be excluded
- patients with previous malignancy who may have bone metastases that have caused vertebral collapse.
It is important to check that calcium and estimated glomerular filtration rate (eGFR) are satisfactory before initiating therapy for fragility fractures. Additional investigations that may also be considered prior to treatment include:15
- full blood count and erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP)
- bone profile including calcium and phosphate and alkaline phosphatase
- myeloma screen—protein electrophoresis and urinary Bence Jones protein if ESR/CRP elevated
- level of tissue transglutaminase for coeliac disease if full blood count is abnormal
- thyroid profile
- levels of vitamin D or parathyroid hormone
- levels of luteinising hormone/follicle-stimulating hormone and testosterone in men.
Initiation of therapy
Although NICE Technology Appraisal 161 only made recommendations for medication use in post-menopausal women with osteoporosis,7 this advice can be extrapolated to cover men over the age of 50 years. The use of generic alendronate is recommended as first-line therapy by NICE.12 However, risedronate, another oral once-weekly bisphosphonate, is also available generically and its cost is falling rapidly,17 and some localities now permit this to be used as first-line therapy interchangeably with alendronate.
Bisphosphonates are absorbed poorly and may cause upper gastrointestinal side-effects, and it is therefore important that patients are given an explanation on exactly how to take them (i.e. first thing in the morning, on an empty stomach, with a full glass of tap water; patients should remain upright, and refrain from taking any other medication, food, or fluids for at least 30 minutes).2,18 This should ensure that the drug passes straight down the oesophagus and into the stomach where it can be absorbed, pass into the bloodstream to bone, and achieve its antiresorptive effect. The necessity to take bisphosphonates exactly as recommended mean that they may not be suitable for some patients, and that detailed explanation is necessary when prescribing them for care-home and nursing-home residents, (e.g. all patients on this therapy receive it at the same time at least 30 minutes before the drug round and breakfast).
Every practice will have patients for whom oral bisphosphonates are contraindicated, not tolerated, or where dosing instructions cannot be followed. In these patients, it is useful to consider other oral therapies, such as strontium ranelate and raloxifene. However, it must be remembered that raloxifene does not reduce the risk of hip fracture,19 and therefore is not an appropriate choice of therapy in older people at risk of or who have already experienced a hip fracture. In some parts of the UK, the NICE treatment thresholds for second-line therapy are slavishly enforced while in other areas, if patients qualify (i.e. they have osteoporosis with a T-score of ?-2.5, and they have had a fragility fracture) but are intolerant of therapy with alendronate and risedronate or these drugs are contraindicated, they can be treated with other drugs regardless of whether they meet the NICE thresholds on T-score and clinical risk factors or not.
Additional treatment options
Some patients will be intolerant of all oral therapies and require referral to secondary care for treatment with denosumab or zoledronate if these are not available in primary care. Likewise, those with an eGFR ?30 ml/min/1.73 m2 will only be suitable for denosumab.
Intravenous zoledronate, given as an annual 5 mg infusion over at least 15 minutes, 20 has not been the subject of a NICE technology appraisal and there is therefore more flexibility with its use. Patients need to be calcium and vitamin D replete prior to infusion, and to continue taking oral supplements between infusions. Some patients develop an acute-phase response with flu-like symptoms, which respond to paracetamol and last for a few days following infusion. This is most likely to occur following the first infusion of zoledronate. Further details of contraindications and interactions with intravenous zoledronate are outlined in the Summary of Product Characteristics and summarised in the British National Formulary (BNF).18,20
Quarterly intravenous ibandronate can be given by primary care in some areas, as it is given by bolus injection rather than intravenous infusion, but this is rarely used now.
Denosumab is a fully human monoclonal antibody against RANK ligand, which is involved in activation of osteoclast precursors. It is licensed in the UK and is administrated as twice-yearly subcutaneous injections. The use of denosumab has been reviewed by NICE and it is recommended for the secondary prevention of osteoporotic fragility fractures in post-menopausal women who are at increased risk of fractures (i.e. those with osteoporosis) and are unable to comply with the special instructions for administering alendronate and either risedronate or etidronate, or have an intolerance or a contraindication to those treatments. Denosumab can also be used for primary prevention at lower T-score thresholds.13
The Scottish Medicines Consortium has advised that denosumab is accepted for restricted use within NHS Scotland for the treatment of osteoporosis in post-menopausal women at increased risk of fractures who have a BMD T-score between <-2.5 and ?-4.0 and for whom bisphosphonates are unsuitable.21
It is important that people are calcium and vitamin D replete prior to therapy and high-dose calcium and vitamin D supplements should continue between injections.18 An additional benefit of denosumab over bisphosphonates is that it can be used in those individuals with poor renal function (e.g. eGFR >15 ml/min/1.73 m2).18
At present, initiation of denosumab is restricted to secondary care or specialist clinics in some parts of the UK. The All Wales Medicines Strategy Group has recommended that the first two doses should be given in secondary care, after which continuing treatment can be administered in primary care.22 Likewise in England restrictions on its use vary, with one or two injections usually given in secondary care before primary care is asked to take over.
Further information on drug therapies can be obtained from the Osteoporosis Resources for Primary Care website2 and the BNF.20
Controversies in treatment
NICE recommends that all patients receiving bone-sparing therapy who are not known to be calcium and vitamin D replete should receive supplements.12 Readily available supplements contain 1000–1200 mg calcium and 800 IU vitamin D. The publication of clinical studies and meta-analyses suggesting that such treatment may increase the risk of myocardial infarction in some patient groups and the widespread lay media coverage of the results mean that many individuals are now reluctant to adhere to such therapy.23 A fuller discussion of this controversy is available on the Osteoporosis Resources for Primary Care website.2
Several other controversies in the treatment of osteoporosis remain, such as how long therapy with bisphosphonates should continue and whether prolonged therapy is associated with an increased risk of atypical subtrochanteric femoral fractures. Pragmatic guidance on each issue is included in the RCGP and NOS online resource, and practices can therefore be sure that the guidance they offer to their patients reflects current expert thinking.2
Sustaining one fragility fracture is known to increase the risk of further fractures greatly, particularly in the elderly and those with osteoporosis on DXA scanning. Recent changes in the positioning of osteoporosis as a chronic disease with a fracture as the acute exacerbation should ensure that the underlying disease is always considered and managed in the future when people aged over 50 years have a fracture.
Several things have contributed to this being the right time for primary care teams to take action on osteoporosis and for its inclusion in the QOF: easy access to evidence-based fracture risk-assessment tools, direct access to DXA scanning, clear guidance on osteoporosis and fracture risk management, and the availability of effective therapies that can be used in the community. The evolving Osteoporosis Resources in Primary Care web resource will help teams to take action.
Our thanks go to the other members of the authoring group of the RCGP and NOS Osteoporosis Resources for Primary Care web resource for their contributions to this article. This web resource is a work in progress and we look forward to feedback from primary and secondary care colleagues to develop it further (please email Anne Thurston, National Osteoporosis Society: A.Thurston@nos.org.uk).
|Box 1: The 7 ‘I’s of the Osteoporosis Resources for Primary Care website2|
Osteoporosis Resources for Primary Care: www.osteoporosis-resources.org.uk
View the Guidelines summary of the NOGG guideline on Guideline for the diagnosis and management of osteoporosis in postmenopausal women and men from the age of 50 years in the UK at: egln.co.uk/link/3342
- British Medical Association. NHS Employers. Quality and outcomes framework 2012/13. London: BMA, NHS Employers, 2012. Available at: www.bma.org.uk/employmentandcontracts/independent_contractors/quality_outcomes_framework/qofchanges2012.jsp#.T4bMoe1LKyG
- Osteoporosis Resources for Primary Care website: www.osteoporosis-resources.org.uk (accessed 19 March 2012).
- Consensus development conference: prophylaxis and treatment of osteoporosis. Osteoporosis International 1991; 1 (2): 114–117.
- British Orthopaedic Association, British Geriatrics Society. The care of patients with fragility fracture. London: British Orthopaedic Association, 2007.
- Department of Health. National service framework for older people. London: DH, 2001.
- Gallagher J, Melton L, Riggs B, Bergstrath E. Epidemiology of fractures of the proximal femur in Rochester, Minnesota. Clin Orthop Relat Res 1980; 150: 163–171.
- Port L, Center J, Briffa N et al. Osteoporotic fracture: missed opportunity for intervention. Osteoporos Int 2003; 14 (9): 780–784.
- McLellan A, Reid D, Forbes K et al. Effectiveness of strategies for the secondary prevention of osteoporotic fractures in Scotland. CEPS: 99/03. NHS Quality Improvement Scotland, 2004. Available at: www.healthcareimprovementscotland.org/previous_resources/audit_report/osteoporotic_fractures_audit.aspx
- British Orthpaedic Association, Healthcare Quality Improvement Partnership, British Geriatrics Society, Information Centre. The national hip fracture database national report 2011. NHFD, 2011 Available at: www.parliament.uk/deposits/depositedpapers/2012/DEP2012-0261.pdf
- Cranney A, Guyatt G, Griffith L. IX: summary of meta-analyses of therapies for postmenopausal osteoporosis. Endocr Rev 2002; 23 (4): 570–578,
- Scottish Intercollegiate Guidelines Network. Management of osteoporosis. SIGN 71. Edinburgh: SIGN, 2004. Available at: www.sign.ac.uk/pdf/sign71.pdf
- National Institute for Health and Care Excellence. Alendronate, etidronate, risedronate, raloxifene, strontium ranelate and teriparatide for the secondary prevention of osteoporotic fragility fractures in postmenopausal women. Technology Appraisal 161. London: NICE, 2008. Available at: www.nice.org.uk/nicemedia/live/11748/42447/42447.pdf
- National Institute for Health and Care Excellence. Denosumab for the prevention of osteoporotic fractures in postmenopausal women. Technology Appraisal 204. London: NICE, 2010. Available at: www.nice.org.uk/nicemedia/live/13251/51293/51293.pdf
- Department of Health. New GMS contract QOF implementation dataset and business rules—osteoporosis: secondary prevention of fragility fractures. DH, 2011. Available at: www.pcc.nhs.uk/uploads/QOF/business%20rules%20v22.0/osteoporosis_-_secondary_prevention_of_fragility_fractures_ruleset_v22_0.pdf
- Compston J, Rosen C. Fast facts: osteoporosis. London: Health Press Limited, 2009.
- Evans S, Davie M. Vertebral fractures and bone mineral density in idiopathic, secondary and corticosteroid associated osteoporosis in men. Ann Rheum Diss 2000; 59: 269–275. Available at: ard.bmj.com/content/59/4/269.full.pdf+html
- Monthly Index of Medical Specialities website. Risedronate. Available at: mims.co.uk/Drugs/endocrine/osteoporosis-other-bone-disorders/risedronate/ (accessed 4 April 2012).
- electronic Medicines Compendium website. www.medicines.org.uk/EMC/default.aspx (accessed 4 April 2012).
- Ettinger B, Black D, Mitlak B. Reduction of vertebral fracture risk in postmenopausal women with osteoporosis treated with raloxifene. JAMA 1999; 282: 637–645. Available at: jama.ama-assn.org/content/282/7/637.full.pdf+html
- British National Formulary website. www.bnf.org/bnf/index.htm (accessed 4 April 2012).
- Scottish Medicines Consortium. Denosumab, 60 mg solution for injection in a pre-filled syringe. SMC No. (651/10). Glasgow: SMC, 2010. Available at: www.scottishmedicines.org.uk/files/advice/denosumab_Prolia_FINAL_November_2010_for_website.pdf
- All Wales Medicines Strategy Group. Proposal for the prescribing in Wales of denosumab for the prevention of osteoporotic fractures in postmenopausal women. 2011. Available at: www.wales.nhs.uk/sites3/Documents/371/denosumab%20recommendations%20%26%20guidance%20doc%20for%20AWMSG%20website.pdf
- Bolland M, Avenell A, Baron J et al. Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ 2010; 341: c3691.G