1. No category

Key therapeutic topics 2010/11 –
Medicines management options for local
implementation
July 2010
Foreword
Ensuring value for money from the primary care drugs bill has been normal business for the NHS for two
decades. Over that period we have seen significant improvements in the quality of prescribing, increasingly
robust arrangements for managing the introduction of new medicines into clinical care and, in recent years,
more controlled growth in the primary care drugs bill.
We know this is largely testimony to the work of clinicians, prescribing advisers and pharmacists working
locally in the NHS. It is no small achievement that analysis by Keele University has revealed savings of
£443million in 2009 (relative to a 2005 baseline), due to significant improvements in the cost-effectiveness of
prescribing across four categories of drugs examined in a 2007 National Audit Office report
Of course there are a large number of national organisations who support such local work. It is perhaps
invidious to mention just a few, but this work would not have been possible without: NHS Prescription
Services; the NHS Information Centre; the National Institute for Innovation and Improvement; the National
Prescribing Centre and many teams within the Department of Health itself – I could go on and on.
However, we now find ourselves in a new environment. The Government has pledged that health funding will
rise in real terms in each year of the Parliament. It is, however, estimated that efficiency improvements of
around £15-20bn will be required by 2013-14 because:
• demographic changes and rising expectations are likely to lead to increased demand for our services
• new drugs and technologies will drive up the cost of providing care
• our ambitions to improve quality will lead to increased costs in some areas.
The Department of Health’s approach to this challenge has focussed on identifying areas where it can
simultaneously improve the quality of care and release substantial efficiency savings, by working at scale and
pace across the NHS. This work is called ‘Quality, Innovation, Productivity and Prevention (QIPP)’. I lead the
QIPP ‘Medicines Use and Procurement’ national workstream, providing strategic direction to a number of
related strands of work. I know that with your help and support we can generate cash-releasing savings from
this area without adversely impacting patient care; in fact we can deliver quality benefits for many patients.
This document provides an initial list of therapeutic topics which offer real opportunities for maintaining or
improving quality and also, in most cases, improving value. Some of the topics here improve quality but have
little or no associated cost savings. Others, when considered alone locally, can deliver relatively small cost
savings, but when aggregated nationally and implemented with much less variation than currently, the
savings become very significant. None of the topics identified here are new to clinicians. Not all will be equally
applicable to all localities, and further data analysis is underway to confirm these topics as a priority and to
examine additional opportunities. We will keep you informed as this work progresses.
This is a significant list of potential options for local work and presents an important early opportunity, as part
of the wider QIPP agenda, that will require increasingly sophisticated approaches to medicines management.
I am sure that clinicians practicing in primary care, supported by prescribing advisers, will again be able to
rise to this new challenge. I also recognise that this area will become a key issue for the new GP
Commissioning Consortia, announced in the White Paper - Equity and excellence: Liberating the NHS. There
will need to be increasingly close working with consortia leads over the coming months.
Peter Rowe - Chief Executive, Ashton, Leigh & Wigan Primary Care Trust
and
QIPP National Workstream Lead ‘Medicines Use and Procurement’ - Department of Health
July 2010
1
Introduction
This brief report identifies some key therapeutic medicines management options for local implementation in
2010/11. It has been produced following a multidisciplinary scoping exercise, undertaken to identify a
validated list of options for maximising efficient use of NHS spending on primary care prescribing, whilst
maintaining quality, in the context of a challenging medium term financial position.
The project was developed by the National Prescribing Centre and informed by preparatory work undertaken
by Parkwood Associates UK Ltd. Potential areas of work and topics were originally identified from a wide
survey of appropriate outputs from both the National Institute for Health and Clinical Excellence and the
National Prescribing Centre.
Importantly, whilst the purpose of this piece of work was to identify topics that would increase the efficiency of
primary care prescribing, the evidence base for all the topics identified has been carefully examined to ensure
that safety and clinical effectiveness would be maintained, or in some cases even improved, if they were
incorporated into prescribing practice with less variation than at present.
Finally, the topics here should neither be considered final nor complete. Work continues to both confirm these
topics and to identify further areas where it is possible to maintain or improve quality whilst increasing value
for money.
Neal Maskrey
Director of Evidence-based Therapeutics
National Prescribing Centre
July 2010
2
Options for local implementation and the evidence context
1. Renin-angiotensin system drugs
Options for local implementation
Review and, where appropriate, revise prescribing to ensure it is in line with NICE guidance.
Evidence context
Hypertension, diabetes mellitus, chronic kidney disease, chronic heart failure and post-myocardial infarction
are the main indications for this class of drugs and all of these are covered by NICE guidance. The
therapeutics is therefore complex with multiple indications and the need to decide in individual patients
whether they should take an ACE inhibitor or an angiotensin-2 receptor antagonist (A2RA), and whether there
are advantages of an ACE inhibitor plus an A2RA. This evidence has been summarised here:
http://www.npci.org.uk/nsm/nsm/renin/workshops/workshop_60minute_elearn_event1.php and
here:http://www.npci.org.uk/nsm/nsm/renin/library/library_merec_publication1.php
In summary, there is no recommendation in any NICE guidance to use A2RAs as first line therapy, ACE
inhibitors have a larger evidence base than A2RAs and in some conditions better evidence of efficacy. In
addition, dual therapy has only a limited place – for example, in a small minority of patients with heart failure.
There has been progress on this topic in only a minority of localities, despite it being one of the BCBV national
indicators. However, progress in those localities demonstrates that improvement is possible. Reviews of the
evidence demonstrate that there are likely to be safety and effectiveness benefits as well as cost savings from
reviewing and, where appropriate, revising prescribing of ACE inhibitors and A2RAs.
2. Statins
Options for local implementation
Review and, where appropriate, revise prescribing of high cost statins to ensure it is in line with NICE
guidance.
The use of low acquisition cost statins is promoted through the Better Care, Better Value (BCBV) indicators.
The National Audit Office have highlighted that there are still substantial savings to be made by some NHS
organisations through use of low cost statins. PCOs in the North West of England, and Yorkshire and the
Humber have the greatest potential to make savings.
Evidence context
NICE recommends that treatment for the primary and secondary prevention of cardiovascular disease should
normally be initiated with simvastatin 40mg daily (unless there are potential drug interactions or simvastatin
40mg is contraindicated). In secondary prevention patients without acute coronary syndrome (ACS),
prescribers should consider increasing the dose of simvastatin to 80mg in patients whose total cholesterol is
greater than 4mmol/L and also whose LDL-cholesterol is greater than 2mmol/L: if either figure is below that
level, then increasing the dose is not recommended. It is important to note that these are not targets patients
are expected to achieve. Any decision to offer higher intensity statin should take into account the patient’s
informed preference, co morbidities, multiple drug therapy, and the benefits and risks of treatment. (High
intensity statins still account for 40% of overall statin spends). For patients with ACS NICE state that
simvastatin 80mg or atorvastatin 80mg are cost effective. See
http://www.npci.org.uk/therapeutics/cardio/cdlipids/workshops/workshop_60minute_elearn_event1.php
Atorvastatin patent expiry is anticipated to be 2011; but the generic price of atorvastatin and the pace at which
the generic price will fall remains uncertain. Based on previous experience with the introduction of generic
statins, atorvastatin at significantly reduced cost may not be available until 2012 at the earliest.
July 2010
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The May 2010 edition of Drug Safety Update from the MHRA includes an article advising healthcare
professionals that the product information for simvastatin has been updated to highlight the increased risk of
myopathy associated with the 80mg daily dose. MeReC Stop Press 1423 discusses the place in therapy of
simvastatin 80mg daily in the context of the MHRA advice, NICE guidance and the current evidence base,
including the risks of other statins at high doses.
A MeReC Bulletin on lipid-modifying treatment is also available. It:
•
•
•
addresses the similarities and differences between NICE guidance for people with and without type 2
diabetes
provides clarification on NICE’s recommendations regarding thresholds for intensifying treatment
discusses the evidence base for high-intensity statins, for rosuvastatin and for ezetimibe▼, the
reliability of single cholesterol measurements, and the side effects of statins.
NICE guidance on management of familial hyperlipidaemia (FH) includes using the maximum licensed or
tolerated dose of statins, plus ezetimibe if necessary, to try to achieve at least a 50% reduction in LDLcholesterol from baseline. However, if a patient cannot tolerate or does not wish to take such intensive
treatment, cohort studies show that the prognosis for patients with FH improved substantially when standard
doses of ‘less intensive’ statins were introduced, to the point when their rate of CV events was reduced to the
general population. There is no good outcome data to show that a more intensive regimen is better than a
standard one. See MeReC Rapid Review 357
3 . Newer hypoglycaemics
Options for local implementation
In type 2 diabetes mellitus consider the risks and benefits of both tight glycaemic control and newer
hypoglycaemic agents carefully. Review and, where appropriate, revise prescribing to ensure that it is in line
with NICE guidance.
Evidence context
The incidence of diabetes is increasing and the Quality and Outcomes Framework (QOF) allocates points for
achieving tight glycaemic control. However, control of blood pressure, smoking and cholesterol, and the use
of statins confer much greater advantages in terms of reducing mortality and morbidity.
A meta-analysis of prospective randomised controlled trials suggests a small absolute benefit of intensive
glucose control in people with type 2 diabetes in reducing coronary heart disease (but not stroke or death).
However, the benefit is not as great as that achieved by blood pressure control or lipid lowering. See MeReC
Rapid Review 351
Recent MHRA safety advice highlights the safety concerns regarding the glitazones. This states that
rosiglitazone and pioglitazone▼ should not be used in people with heart failure or history of heart failure.
Rosiglitazone should be used in patients with previous or current ischaemic heart disease only after a careful
evaluation of the individual patient’s risk.
A further recent study confirms that therapy including rosiglitazone substantially increases the risk of heart
failure as well as increasing the risk of fractures, and overall provides additional support for a strategy of
reviewing patients taking rosiglitazone and considering their hypoglycaemic medication in the light of recently
updated NICE guidance and MHRA advice. See MeReC Rapid Review 360
Recently updated NICE guidance states that glitazones (and now also sitagliptin▼or vildagliptin▼) can be
considered for dual therapy with either metformin or a sulphonylurea when either of these latter drugs is
contraindicated, not tolerated or (in the case of sulphonylureas) there is a significant risk of hypoglycaemia.
Long term efficacy and outcomes data are not available at this stage for the gliptins.
July 2010
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Long term studies are also required to determine the effects of exenatide▼ on disease-related morbidity and
mortality. Exenatide is an additional treatment option for certain patients not achieving adequate glycaemic
control on oral medication, however its need for parenteral administration may be regarded as a disadvantage
by patients. The potentially dose-limiting nausea and vomiting may also be unacceptable to patients.
NICE recommends considering adding exenatide as third-line therapy when control of blood glucose remains
or becomes inadequate (HbA1c ≥ 7.5%, or other higher level agreed with the individual) and either the person
has a BMI >35 kg/m2 (in people of European descent, with appropriate adjustment for other ethnic groups)
and specific psychological or medical problems associated with high body weight, or their BMI is < 35.0
kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit
other significant obesity-related comorbidities. NICE recommends that exenatide is continued only if the
person has had a reduction of at least 1.0 percentage point in HbA1c and a weight loss of at least 3% of initial
body weight at 6 months. See MeReC Stop Press 355
People with Type 2 diabetes mellitus are a heterogeneous group. Treatment must be tailored to each
individual patient's clinical needs with safety paramount. It is generally agreed and supported by NICE
guidance that metformin should be used as first line unless contraindicated. Smoking cessation, exercise,
losing weight, controlling blood pressure, lowering cholesterol and treatment of microalbuminuria are very
important to reduce cardiovascular and/or microvascular risk. Evidence of a beneficial effect on morbidity and
mortality from newer hypoglycaemics is not available.
4. Proton pump inhibitors (PPIs)
Options for local implementation
Review and, where appropriate, revise prescribing of PPIs to ensure it is in line with NICE guidance and, if a
PPI is required, that a low cost PPI is used unless it is ineffective or not tolerated.
When co-prescription of a PPI with clopidogrel is necessary, lansoprazole is preferred to omeprazole.
Evidence context
There is no evidence that any one PPI is more effective than the other when compared at equivalent doses.
NICE recommendations for the use of PPIs in the management of dyspepsia are that the least expensive PPI
is used. The BCBV indicator focuses on the percentage of low cost PPIs omeprazole and lansoprazole. See
http://www.npci.org.uk/nsm/nsm/ppis/workshops/workshop_60minute_elearn_event1.php
NICE guidance on dyspepsia recommends offering patients requiring long-term management of dyspepsia
symptoms an annual review of their condition, encouraging them to try stepping down or stopping treatment.
When offering treatment with an oral NSAID/COX-2 inhibitor for the management and care of adults with
osteoarthritis, NICE guidance recommends these should be co-prescribed with a PPI, choosing the one with
the lowest acquisition cost.
Use of lower cost PPIs is addressed by a BCBV indicator. There remain significant opportunities for
improvement in a number of PCTs.
5. Non-steroidal anti-inflammatory drugs (NSAIDs)
Options for local implementation
Review the appropriateness of NSAID prescribing widely and on a routine basis. Older patients are at higher
risk of both gastro-intestinal and cardiovascular morbidity and mortality. Co-prescribing NSAIDs with
angiotension converting enzyme inhibitors (ACE inhibitors) may pose particular risks to renal function; this
combination should be especially carefully considered and if continued regularly monitored.
July 2010
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If initiating an NSAID is obligatory, prescribe ibuprofen (1200mg per day or less) as first line and naproxen
(1000mg per day) as second line NSAIDs.
Review patients currently prescribed NSAIDs. If continued use is necessary, consider changing to ibuprofen
(1200mg per day or less) or naproxen (1000mg per day).
Review and, where appropriate, revise prescribing of etoricoxib to ensure it is in line with MHRA and NICE
guidance.
Co-prescribe a proton pump inhibitor with NSAIDs in accordance with NICE guidance.
Evidence context
There are long standing and well recognised safety concerns with all NSAIDs regarding gastrointestinal and
renal adverse effects, and increased thromboembolic risks with many NSAIDs, including coxibs and some
traditional NSAIDs. In October 2006, a review of the CV safety of selective and non-selective NSAIDs by the
Commission on Human Medicines (CHM), identified that traditional NSAIDs, including diclofenac, may be
associated with a small increased risk of thrombotic events. This risk does not appear to be shared by
ibuprofen at 1200mg per day or less, or naproxen 1000mg per day.. See
http://www.npci.org.uk/therapeutics/pain/musculo/workshops/workshop_60minute_elearn_event1.php and
http://guidance.nice.org.uk/CG59/Guidance/pdf/English. There are significant and widening differences
between localities in the proportion of NSAIDs which are ibuprofen and naproxen, and diclofenac still
accounts for approximately 37% of all NSAID prescriptions in primary care in England.
Other safety concerns have also been highlighted with etoricoxib specifically. The EMEA’s Committee for
Medicinal Products for Human Use (CHMP) assessed the long-term benefits and risks of etoricoxib in patients
with rheumatoid arthritis or ankylosing spondylitis and concluded that the benefits outweighed the risks in
these conditions, when used at a dose of 90mg daily. Patients’ whose blood pressure is persistently above
140/90 mmHg and not adequately controlled should not take etoricoxib. Blood pressure should be monitored
for two weeks after treatment is initiated and regularly thereafter. See MeRec Stop Press 162. However,
etoricoxib accounts for approximately 37,000 prescription items a month in primary care in England, even
though the NICE osteoarthritis guidance advises against its use, see
http://www.npci.org.uk/therapeutics/pain/musculo/resources/dfc_musculo_pain.pdf
6. Low dose antipsychotics in people with dementia
Options for local implementation
Review, and where appropriate revise, prescribing of low dose antipsychotics in people with dementia.
Evidence context
The harms and limited benefits of using antipsychotic drugs, both first (typical) and second (atypical)
generation, for the treatment of people with dementia who exhibit challenging behaviours is well recognised.
They have been the subject of several previous reviews and MHRA warnings. In November 2009, the
Bannerjee report found significant harm for limited benefits, and that antipsychotics are too often used as a
first-line response to behavioural difficulty in dementia rather than as a considered second-line treatment
when other non-pharmacological approaches have failed. Data suggest that 20% of patients with dementia
are taking low dose antipsychotics. See MeReC Stop Press 847.
Prescribers should continue to follow the NICE-SCIE guideline on dementia. This advises avoiding the use of
any antipsychotics (first and second generation) for non-cognitive symptoms or challenging behaviour of
dementia unless the patient is severely distressed or there is an immediate risk of harm to them or others.
Any use of antipsychotics should include a full discussion with the patient and/or carers about the possible
benefits and risks of treatment.
July 2010
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7. Long acting insulin analogues
Options for local implementation
Review, and where appropriate revise, prescribing of long acting insulin analogues to ensure that it is in line
with NICE guidance.
Evidence context
NICE guidance on the management of type 1 diabetes states that adults with type 1 diabetes should have
access to the types of insulin they find allow them optimal well-being. They also recommend that children and
young people with type 1 diabetes are offered the most appropriate insulin preparations according to their
individual needs. However, NICE cautioned against switching patients with control problems onto the newer
more expensive insulins without proper assessment of underlying causes. Such causes of poor control might
include problems with the patient’s injection technique or inadequate knowledge and poor self-management
skills.
The recent NICE guidance on newer agents for blood glucose control in type 2 diabetes recommends that,
when insulin therapy is necessary, human NPH insulin is the preferred option. Insulin analogues can be
considered for those who fall into specific categories e.g. those who require assistance from a carer or
healthcare professional to administer their insulin injections, or those with problematic hypoglycaemia. A
health economic analysis in the NICE guidance found the cost effectiveness of long acting insulin analogues
was not favourable. The incremental cost per QALY (compared with conventional insulin) was greater than
£100,000 in all scenarios, and in some cases in excess of £400,000. See MeReC Rapid Review 826.
Nevertheless, prescribing has increased enormously over the past few years so that the newer insulin
analogues now account for more than a third of all insulin items and costs, with some localities having a
majority of insulins as analogues.
A Canadian Heath Technology Assessment has also concluded that the newer, insulin analogues offer little
clinical advantage over older, conventional insulins in terms of glycaemic control or reduced hypoglycaemia
for the management of patients with type 1, type 2 or gestational diabetes. These results are consistent with
recommendations made by NICE. See MeReC Stop Press 318.
In summary, NICE recommends that long acting insulin analogues have a specific but limited place in
therapy. They are substantially more expensive than conventional insulins, but their use has increased
enormously over the past few years. Any decision to start an insulin analogue needs to be balanced carefully
against the lack of long-term safety data and increased prescribing costs. In addition, people with glycaemic
control problems should be properly assessed for underlying causes before these newer, more expensive
insulins are considered. This includes education and checking understanding around how to manage their
disease and treatment.
8. Self-monitoring of blood glucose (SMBG) in type 2 diabetes mellitus
Options for local implementation
Review and, where appropriate, revise local use of SMBG in type 2 diabetes mellitus to ensure that it is in line
with NICE guidance.
Evidence context
NICE have produced guidance on the place of self-monitoring of blood glucose (SMBG) in people with type 2
diabetes mellitus. http://www.npci.org.uk/blog/?p=355 They recommend it should be used only if it is going
to be an integral part of the patients’ self-management education, and the continued benefit of self-monitoring
should be assessed in a structured way each year. It should be offered to patients on insulin and
sulphonylureas as they are at risk of hypoglycaemia.
For detailed guidance see "Self-monitoring of blood glucose in non-insulin-treated Type 2 diabetes"
published by NHS Diabetes http://www.diabetes.nhs.uk/news.php?o=171 .
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9. Clopidogrel
Options for local implementation
Review, and where appropriate revise, prescribing of clopidogrel to ensure it is in line with NICE guidance.
Evidence context
NICE guidance on the use of antiplatelet drugs and the clinical evidence is summarised here
http://www.npci.org.uk/therapeutics/cardio/antiplatelets/room_antiplatelets.php
NICE guidance recommends that clopidogrel monotherapy should be considered as an alternative treatment
to aspirin for patients who require an antiplatelet drug but who are intolerant of low dose aspirin (proven
hypersensitivity to aspirin or a history of severe dyspepsia induced by low-dose aspirin). In guidance on the
care of people who have had a myocardial infarction, NICE recommends that in patients with a history of
dyspepsia, treatment with a proton pump inhibitor (PPI) and low-dose aspirin should be considered in line with
NICE guidance on dyspepsia. After appropriate treatment, patients with a history of aspirin-induced ulcer
bleeding whose ulcers have healed and who are negative for Helicobacter pylori should be considered for
treatment with a full-dose PPI and low-dose aspirin.
NICE recommends use of clopidogrel in combination with aspirin in the following circumstances:
•
for 12 months after the most recent acute episode of non-ST-segment-elevation acute coronary
syndrome (clinical guideline 94)
•
for at least 4 weeks in patients treated with a combination of aspirin and clopidogrel during the first 24
hours after an ST-segment-elevation MI (clinical guideline 48)
•
following implantation of a coronary artery stent. Such drugs should be used in accordance with the
device-specific instructions for use (technology appraisal 71).
Thereafter, standard treatment including low-dose aspirin should be given, unless there are other indications
to continue dual antiplatelet therapy. However, audits indicate that many patients are continued on clopidogrel
and aspirin combination beyond the period recommended in NICE guidance.
Generic prescribing of clopidogrel should be maximised.
10. Ezetimibe
Options for local implementation
Review and, where appropriate, revise prescribing to ensure it is in line with NICE guidance
Evidence context
There is no good evidence that ezetimibe, either alone or added to a statin, reduces the risk of cardiovascular
events or mortality compared to a statin alone. NICE recommends that people with primary
hypercholesterolaemia should be considered for ezetimibe monotherapy treatment when they are intolerant to
statins or statins are contraindicated. NICE also recommends that ezetimibe should be considered in people
with primary hypercholesterolaemia in addition to a statin of lowest acquisition cost when LDL cholesterol is
not controlled after titration of the statin dose and if consideration is being given to changing the statin. The
NICE implementation costing statement estimated that this guidance would result in an additional 1400
people receiving ezetimibe monotherapy at an additional annual cost of £260k and that potential increased
use of ezetimibe in combination with a statin would be unlikely to have a significant resource impact on the
NHS. Since NICE guidance was published in November 2007 annual spend on ezetimibe has increased from
£48m to £68m. This suggests potential over-implementation of NICE recommendations.
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NICE guidance on management of familial hyperlipidaemia (FH) includes using the maximum licensed or
tolerated dose of statins, plus ezetimibe if necessary, to try to achieve at least a 50% reduction in LDLcholesterol from baseline. However, if a patient cannot tolerate or does not wish to take such intensive
treatment, cohort studies show that the prognosis for patients with FH improved substantially when standard
doses of ‘less intensive’ statins were introduced, to the point when their rate of CV events was reduced to the
general population. There are no data to show a more intensive regimen is better than a standard one. See
MeReC Rapid Review 357. NICE’s implementation report indicates that a large majority of patients with FH
are receiving a high intensity statin plus ezetimibe.
11. Antibiotic prescribing – especially quinolones and cephlasporins
Options for local implementation
Review and, where appropriate, revise current prescribing practice and use implementation techniques to
ensure prescribing is in line with Health Protection Agency (HPA) guidance.
Benchmark and review the total volume of antibiotic prescribing against local and national data.
Benchmark and review the use of quinolones and cephalosporin prescribing against local and national data.
Evidence context
Antibiotic resistance poses a significant threat to public health and new infectious diseases and pathogens
are continually being identified. Emerging resistance against antimicrobials which are currently used and the
upsurge in a number of types of infections, some of which had previously been well-controlled, are two factors
that contribute to this threat.
Of particular concern is methicillin-resistant Staphylococcus aureus (MRSA) which remains a serious threat,
especially to hospital inpatients. Addressing healthcare-associated Clostridium difficile infection also remains
a key issue on which NHS organisations have been mandated to implement national guidance that includes
restriction of broad spectrum antibiotics, and in particular third-generation cephlasporins. Broad spectrum
antibiotics such as quinolones and cephlasporins need to be reserved to treat resistant disease and should
generally be used only when standard and less expensive antibiotics are ineffective. In primary care in
England usage of these antibiotics accounts for a substantial proportion of all antibiotic daily doses:
ciprofloxacin 4% and cephlasporins 9%. See
http://www.hpa.org.uk/web/HPAwebFile/HPAweb_C/1232006607827
The increase in the prescribing of quinolones (e.g. ciprofloxacin) in general practice is a particular cause for
concern. They are recommended first-line by the HPA only in limited situations (e.g. acute pyelonephritis or
acute prostatitis). Resistance to quinolones is increasing at a considerable rate e.g. quinolone resistant
Neisseria gonorrhoeae, (QRNG)- in which resistance is usually high-level and affects all the quinolones. See
http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1195733778434?p=1174555864747
12. Hypnotics
Options for local implementation
Review and, where appropriate, revise prescribing of hypnotics to ensure that it is in line with national
guidance.
Evidence context
Risks associated with long term use of hypnotic drugs have been well recognised for many years.
Nevertheless, overall prescribing of hypnotics is not decreasing. As long ago as 1988, the Committee on
Safety of Medicines advised that benzodiazepine hypnotics should be used only if insomnia is severe,
disabling or causing the patient extreme distress. The lowest dose that controls symptoms should be used, for
July 2010
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a maximum of 4 weeks and intermittently if possible. NICE guidance also recommends that when, after due
consideration of the use of nonpharmacological measures, hypnotic drug therapy is considered appropriate
for the management of severe insomnia interfering with normal daily life, hypnotics should be prescribed for
short periods of time only, in strict accordance with their licensed indications. NICE also confirms that there is
no compelling evidence of a clinically useful difference between zaleplon, zolpidem and zopiclone (the so
called ‘Z drugs’) and benzodiazepine hypnotics from the point of view of their effectiveness, adverse effects,
or potential for dependence or abuse. There is no evidence to suggest that if patients do not respond to one
of these hypnotic drugs, they are likely to respond to another. Despite these national safety warnings and
guidance, overall prescribing of hypnotics is not decreasing.
Novel approaches to step-down clinics can achieve significant successes. See
http://www.npci.org.uk/medicines_management/medicines/medicinesintro/resources/personalising_medicines
_management_web.pdf
13. Orlistat
Options for local implementation
Review and, where appropriate, revise prescribing to ensure it is in line with the Summary of Product
Characteristics (SPC) and NICE guidance.
Evidence context
NICE guidance on obesity recommends that multicomponent interventions are the treatment of choice.
Weight management programmes should include behaviour change strategies and the decision to start drug
treatment, and the choice of drug, should be made after discussing with the patient the potential benefits and
limitations. The SPC for orlistat states that it should be discontinued at 12 weeks if patients have been unable
to lose 5% of their body weight as measured at the start of treatment.
There has been a recent increase in the use of orlistat, perhaps reflecting an increase in focus on obesity
management and the impact of NICE guidance. Health professionals and commissioners of health care
should ensure a balanced approach with the focus on effective prevention and management or obesity on
sustained lifestyle changes as well as pharmacological interventions. See
http://www.npci.org.uk/therapeutics/therap/obes/resources/obesity_dfc.pdf
14. High dose inhaled corticosteroids
Options for local implementation
Review the use of inhaled corticosteroids (ICS) routinely in patients with asthma and COPD.
Step down the dose and use of ICS whenever possible.
Evidence context
Prescribing of high dose (both single component and combination) ICS inhalers is increasing in both items
and costs. To minimise side-effects from corticosteroids, people should be maintained on the lowest possible
dose. In the management of asthma, the BTS/SIGN British guideline recommends that reductions in ICS dose
should be considered every 3 months, decreasing the dose by 25-50% each time. Data suggest that this is
realistic and possible without compromising patient-care. The guideline states that this is not routinely
implemented leaving some patients over-treated. See
http://www.npci.org.uk/therapeutics/resp/asthma/data_commentary/data_focussed_commentary_asthma.php
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The newly updated NICE guideline for the management of COPD recommends that an ICS (with a long acting
beta agonist, LABA) is an option in the following groups of people with stable COPD:
•
•
•
Those who remain breathless or have exacerbations despite using short-acting bronchodilators as
required, if FEV1 < 50% predicted
Those with an FEV1 ≥ 50% who remain breathless or have exacerbations despite maintenance
therapy with a LABA,
Those with stable COPD who remain breathless or have exacerbations despite maintenance therapy
with long-acting muscarinic antagonist (LAMA) irrespective of their FEV1
The NICE guideline and MHRA guidance highlight an increased risk of pneumonia with ICS treatment in
COPD and recommends ICS should not be used alone in COPD.
Fostair® is the least costly LABA / ICS combination inhaler. Wider use offers potential cost savings at current
prices. However, there may be practical limitations to wider use given current first choices for earlier
management steps in current guidelines for asthma and COPD. See MeReC Rapid Review 1474
15. Alendronate
Options for local implementation
Promote the use of generic alendronate as first line bisphosphonate for osteoporosis.
Evidence context
Alendronate is recommended by NICE as the first choice bisphosphonate for the primary and secondary
prevention of osteoporotic fragility fractures in postmenopausal women. When the decision has been made to
initiate treatment with alendronate in accordance with NICE guidance, the preparation prescribed should be
chosen on the basis of the lowest acquisition cost available.
National Prescribing Centre
July 2010.
July 2010
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