The QIPP medicines use and procurement workstream aims to ensure that value for money is further enhanced while quality of care is maintained or improved by optimising the use of medicines. This bulletin is the second of three that focus on several of the key prescribing topics outlined in the current version of the NPC document, Key therapeutic topics – Medicines management options for local implementation.
These bulletins summarise the evidence-base for the therapeutic topics reviewed, and contrast this with the prescribing data available for these topics. They aim to provide a focus for prescribers and prescribing managers on the ‘implementation gaps’ there may be in some localities between this evidence-base and prescribing, highlighting potential areas for local action.
Two earlier bulletins have discussed how people make decisions and how decision-making might be done better (MeReC Bulletin 22:1), and how the adoption of evidence into practice can be supported (MeReC Bulletin 22:2).
Topics included in this bulletin are:
Topics included in the first bulletin in this series were NSAIDs; antibiotics; and inhaled corticosteroids in asthma. The third bulletin will cover hypoglycaemic agents; long-acting insulin analogues; and self-monitoring of blood glucose in type 2 diabetes.
Department of Health. Quality, Innovation, Productivity and Prevention (QIPP) webpage
The Banerjee report (November 2009) was an independent report commissioned by the Department of Health1. It supports the need to follow NICE/SCIE guidelines2 with regard to behavioural and psychological symptoms of dementia. It recognised the limited benefits that have been demonstrated in clinical trials for antipsychotics when used to treat behavioural and psychological symptoms of dementia (BPSD). The report concluded that:
Raising the quality of care for people with dementia and their carers is a major Government priority3,4.
In October 2011 the NHS Institute for Innovation and Improvement published an economic evaluation of alternatives to antipsychotic drugs for individuals living with dementia in England5. It estimated that using behavioural interventions to treat individuals with dementia, rather than antipsychotic drugs, would cost an extra £27.6 million per year. However, health care savings would be nearly £70.4 million due to reduced incidence of stroke, falls, and medication savings. When these health care savings are combined with quality of life improvements, the net benefit of behavioural interventions was estimated at nearly £54.9 million per year.
The NICE/SCIE clinical guideline on dementia2 advises that people with dementia who develop non-cognitive symptoms that cause them significant distress or who develop behaviour that challenges should be offered an assessment at an early opportunity to establish likely factors that may generate, aggravate or improve such behaviour. Individually tailored care plans that help carers and staff address the behaviour that challenges should be developed, recorded in the notes and reviewed regularly. The frequency of such review should be agreed by the carers and staff involved, and recorded6.
Is there a place for the prescribing of antipsychotics for people with BPSD?
Pharmacological interventions, including antipsychotics, have only a limited role in the management of non-cognitive symptoms of dementia4. The NICE dementia quality standard6 states ‘the goal for the proportion of people with dementia and mild-to-moderate non-cognitive symptoms who are prescribed antipsychotic medication should be 0%’.
Do prescribing data reflect the evidence?
Figure 1 compares the net ingredient cost (NIC) per 1000 patients of antipsychotics prescribed in the quarter to September 2011 in Primary Care Trusts (PCTs) in Northern England; Southern England is similar. It shows a three-fold variation among individual PCTs in this comparator. What cannot be seen from these data is the variation between practices within PCTs, which may also be considerable.
|Figure 1. Variation in spending on antipsychotics between Primary Care Trusts in Northern England (Quarter to September 2011)7
Figure 2 shows the trend in prescribing of antipsychotics in general practice in England from July 2006 to September 2011 (note the Banerjee report was published in November 2009). Total items for first generation antipsychotics have remained static, while those for second generation antipsychotics have steadily risen. It should be noted that prescribing data by indication is not available; these numbers reflect total antipsychotic prescribing for all indications.
Figure 2. Trends in prescribing of antipsychotic drugs (BNF 4.2.1) in general practice in England. (July 2006 to September 2011)7
The appropriateness of low dose antipsychotic prescribing for people with BPSD should be reviewed and, where appropriate, revised in accordance with NICE/SCIE guidance2 and the NICE Quality Standard on dementia6.
Following the Banerjee report,1 the NHS Information Centre is performing a three stage audit of the level of antipsychotic prescribing within GP practices in England8. The Alzheimer’s Society has also published guidance for the treatment and care of behavioural and psychological symptoms of dementia9 and a best practice guide for health and social care professionals10 to complement NICE guidance.
NICE has issued several pieces of guidance relating to lipid modification in adults. These include the use of ezetimibe in TA1321, which is referred to in the clinical guidelines on lipid management2 and type 2 diabetes3 and incorporated into the clinical guideline on familial hypercholesterolaemia (FH)4. A brief overview of the salient points is given below.
The patient’s informed preferences should be taken into account, including the benefits and risks of initiating proposed treatment, or when considering a higher intensity statin2,5.
Simvastatin 40 mg is the statin and dose of first choice for most people for primary or secondary prevention2. There is no NHS lipid target for primary prevention patients, and higher intensity statins should not be used routinely2. There is also no NHS lipid target for most secondary prevention patients2.
Where available evidence has shown additional or alternative action may be beneficial, NICE has given further specific advice on lipid management in certain circumstances or conditions. NICE has also published important guidance on involving patients in decisions about prescribed medicines and supporting adherence5.
Consider using a high intensity statin to reduce LDL by more than 50%4. Ezetimibe may be co-administered with initial statin therapy when total cholesterol or LDL ‘is not appropriately controlled’; either after dose titration of initial statin therapy or because dose titration is limited by intolerance to the statin therapy and consideration is being given to changing from initial statin therapy to an alternative statin1.
Simvastatin 40 mg is the drug of first choice when offering to initiate treatment. If the patient’s total cholesterol is greater than 4 mmol/L and also their LDL is greater than 2 mmol/L then consider an increase to simvastatin 80 mg or a drug of similar efficacy and acquisition cost. If either level is less than this, no increase in dose is recommended.
Simvastatin 40 mg is the drug of first choice when offering to initiate treatment3. An increase to simvastatin 80 mg or a drug of similar efficacy and cost is advised if the patient’s total cholesterol is greater than 4 mmol/L and also their LDL is greater than 2 mmol/L. If either level is less than this, no increase in dose is recommended3.
A QIPP comparator has been published for lipid modifying drugs8. It indicates simvastatin and pravastatin prescription items as a percentage of all statins, including formulations containing ezetimibe. Figure 3 shows there is wide variation in prescribing among individual PCTs for this comparator. What cannot be seen from these data is the variation between practices within PCTs, which may also be considerable.
Figure 3. QIPP comparator: Simvastatin and pravastatin as a percentage of all statins, including combination of simvastatin/ezetimibe and ezetimibe (Quarter to September 2011)8
Number of prescription items for simvastatin and pravastatin as a percentage of the total number of prescription items for all statins, including combination of simvastatin/ezetimibe and ezetimibe. Values to the right indicate a higher percentage of simvastatin and pravastatin prescribing. Lowest value 61%. Highest value 85%.
Figure 4 shows the comparative annual costs of various statin and ezetimibe formulations. It demonstrates a 30- fold difference in price across the range of formulations shown.
Figure 4. Comparative annual costs of common statin and ezetimibe formulations (prices based on Drug Tariff February 2012)9
Prescribing of ezetimibe and high-cost statins should be reviewed and, where appropriate, revised to ensure it is in line with NICE guidance.
Simvastatin and pravastatin both have considerably lower acquisition costs than other lipid modifying drugs of similar lipid-lowering effect9. It should be noted that while the patent on atorvastatin will expire on May 2012, the initial generic price and the pace at which this may fall remain unclear. Also, use of ezetimibe has increased to over 500,000 items per quarter10; practitioners need to be mindful that their prescribing is in keeping with NICE guidance11.
Providing advice on appropriate routines to encourage good sleep (i.e. sleep hygiene) is fundamental to the overall management strategy for insomnia1,2.
Benzodiazepines can provide limited relief from insomnia in the short term, but there is little evidence to support their efficacy during longer-term use. In 1988 the Committee on Safety of Medicines (CSM) raised concerns about adverse events including the risk of dependence and advised:3
‘Z-drugs’ (zaleplon, zolpidem, zopiclone) are non-benzodiazepine hypnotics but they act on the benzodiazepine receptor4 there is a lack of compelling evidence to distinguish between the ‘Z-drugs’ or the shorter-acting benzodiazepine hypnotics1. Hypnotics are not licenced for long-term use4; treatment should be limited to four weeks with zopiclone and zolpidem, or two weeks for zaleplon1.
The NICE technology appraisal for the use of ‘Z-drugs’ in insomnia states:1
A large meta-analysis of randomised controlled trials found out of every 13 people over the age of 60 taking a hypnotic for at least five consecutive nights, on average:5
When comparing ‘Z-drugs’ with benzodiazepines, the authors found no differences in outcomes between the two groups.
In a large observational study of Norwegian drivers aged 18 to 69 years, people prescribed zopiclone or zolpidem in the previous seven days had double the risk of road traffic accidents, compared with people not prescribed hypnotics6.
Another large observational study found an increased incidence of hip fracture associated with benzodiazepine use, after adjusting for confounders (e.g. age, gender, nursing home occupancy)7.
A questionnaire study of patients in the UK who had been prescribed a hypnotic in the last six months gives some insight into what is happening in clinical practice. The high rate of repeat prescriptions and daily use points towards a high prevalence of dependence:8
The volume of prescribing of benzodiazepine and ‘Z-drugs’ in general practice in England has remained steady, and is not decreasing9. This is despite CSM advice3 and NICE guidance1 that recommends hypnotics should be used only in the management of severe insomnia interfering with normal daily life, for short periods of time.
There is a QIPP prescribing comparator for hypnotics10, which indicates the total volume of hypnotics that are being prescribed, expressed as average daily quantities (ADQ) per STAR-PU. Figure 5 shows a four-fold variation among individual PCTs in this comparator. What cannot be seen from these data is the variation between practices within PCTs, which may also be considerable.
Figure 5. QIPP comparator: Hypnotics: ADQ/STAR(09) PUQuarter to September 2011)10
Number of ADQs per STAR-PU for all hypnotics (BNF 4.1.1). Values to the left indicate lower prescribing volumes of hypnotics. Lowest value 0.55. Highest value 2.23.
Figure 6 compares the number of hypnotics prescribed in the quarter to September 2011 in general practice. It shows that over 100,000 items per quarter were issued for 50–56 tablets of ‘Z-drugs’, indicating that MHRA advice3 and NICE guidance1 to limit the prescribing of these drugs to two to four weeks is not being followed in many cases.
Figure 6. Prescribing of hypnotics in general practice in England (Quarter to September 2011)9
Prescribing of hypnotics should be reviewed and, where appropriate, revised to ensure it is in line with national guidance.
The risks associated with long-term use of hypnotic drugs have been well recognised for many years3, and the provision of advice on appropriate routines to encourage good sleep (i.e. sleep hygiene) is fundamental to the overall management strategy for insomnia1,2. Treatment of insomnia with a hypnotic should only be considered if insomnia is severe, disabling or subjecting the patient to extreme distress, and long-term chronic use is not recommended.3,4
The National Prescribing Centre (NPC) is responsible for helping the NHS to optimise its use of medicines. NPC is part of the National Institute for Health and Clinical Excellence (NICE), an independent organisation providing national guidance on promoting good health and preventing and treating ill health.
© National Institute for Health and Clinical Excellence, 2012. All rights reserved. This material may be freely reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the express written permission of NICE.
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