We would like to take the opportunity to acknowledge the following individuals and groups:

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2 ACKNOWLEDGEMENTS We would like to take the opportunity to acknowledge the following individuals and groups: Dr Simon Hurding and Sean MacBride-Stewart who have been instrumental in the development of this National Therapeutics Indicators Report 2012, by identifying the areas for focus, collating evidence and analysing data a mighty effort! Simon and Sean would also like to acknowledge the following individuals and groups for supporting them in this development: Billy Malcolm, Findlay Hickey, Graeme Bryson, Jan Jones, Anne Gilchrist, Alpana Mair, Margaret Ryan, Stuart Keys, Alan Lawrie, Carole Morton, Louis Richie, Dilip Nathanwi and Jacqui Sneddon. A number of groups should also be acknowledged including the Scottish Prescribing Advisors Association (SPAA) Executive for assessing the proposed indicators, Scottish Antimicrobial Prescribing Group (SAPG), Information Services Division (ISD) and the Diabetes MCN. Finally, the data analysis and report building would not have been possible without Kenny McGowan, Ruth Edwards, the ISD PRISMS and Prescribing Teams. Thanks to all of the above for their time, patience and expertise. Cover image: foto76 / FreeDigitalPhotos.net 1

3 FOREWORD We are pleased to present the National Therapeutic Indicators Report for 2012 containing the baseline data from the last quarter of the fiscal year 2011/12. This version of the report replaces the previous one. NHSScotland has a very good track record in delivering high standards of care and the safe, effective and efficient use of medication is no exception. It is important to highlight that this is management information for Boards to use locally; to identify areas for improvement, to reduce unwarranted variation, waste and harm. The aim is to improve the quality of care while reducing inefficiencies. Detailed financial analysis is provided by a separate report. The National Therapeutic Indicators are designed to inform Board Prescribing Action Plans and consideration of the specific areas is recommended for the national focus approach. For 2012/13 the NTIs may also be used by boards for the Scottish Quality Prescribing Initiative (SQPI). We commend the information within this report to you, please use wisely and efficiently. Kind Regards BILL SCOTT CHIEF PHARMACEUTICAL OFFICER FRANK STRANG DEPUTY DIRECTOR, PRIMARY CARE 26 March

4 NATIONAL THERAPEUTIC INDICATORS (2012) These National Therapeutic Indicators have been developed as part of the Scottish Government Prescribing Efficiency & Productivity work-stream ( ). The aim is to continue to improve the quality of prescribing in Primary Care whilst optimising efficiencies. This report recognises the exceptional work already achieved in prescribing by the NHS Boards. The belief is that a national approach with shared focus on key areas will deliver the efficiencies required to maintain the excellent standard of health care in Scotland. Therapeutic or prescribing indicators have been used increasingly by the NHS Boards to inform quality and cost-effective prescribing over at least the last ten years. The pioneer work for this approach of medicines management was the Audit Scotland report: Supporting prescribing in general practice 1,2 in Many of these early indicators are still used today in one form or another. Therapeutic or prescribing indicators are a way of providing an evidence-based prescribing standard. The ideal indicator also promotes cost-effective prescribing and optimises efficiency. They allow prescribers, practices, CH(C)Ps and NHS Boards to compare current practice against an agreed standard of quality. Reflection on this can lead to change in prescribing behaviour and ultimately improve patient care. The Prescribing Information System for Scotland (PRISMS) provides all of the data used for therapeutic and prescribing indicators within Scotland. PRISMS is maintained by the Information Services Division (ISD) and is a means of accessing the data collected by Practitioner Services Division (PSD) when processing each prescription dispensed. The resulting payment verification data is then interpreted by PRISMS. Through time, considerable expertise has developed at interpreting these data for use as measures of prescribing quality. The National Therapeutic Indicators (2012) have been developed with detailed consultation with medicines management experts from all of the Scottish NHS Boards. Initial consensus agreement was decided at the National Prescribing Efficiency & Productivity meeting on the 27 th June Subsequent to this there has been ongoing consultation by review of NHS Board Prescribing Action Plans 2011/12 (particularly the Quality & Productivity Quality Outcomes Framework Prescribing actions) and consideration of recognised national and international prescribing indicators (e.g. NHS Better Care, Better Value Indicators 3 and QIPP Comparators 4 ). Consultation on development and fine tuning of the National Therapeutic Indicators is now focussed by discussion with the experts of the Scottish Prescribing Advisers Association executive. In addition, selection of the final Ten Indicators has involved review of the type of data generated in PRISMS. Over thirty potential therapeutic indicators were considered and the data generated analysed. Review of this further informed the suitability for use as National Therapeutic Indicators and influenced the final selection. The final list of ten National Therapeutic Indicators was presented as an advanced report to those in each NHS Board involved with developing the Prescribing Action Plans for 2012/13. This early release ensured clear awareness of the areas for national focus. This report provides the finalised list of ten National Therapeutic Indicators; comparison between the Scottish NHS Boards based on the most current data and the evidence and rationale behind each of the indicators. The Indicators are also presented as Corporate Reports within PRISMS enabling NHS Board medicine management teams to monitor progress throughout 2012/13. Nani gigantum humeris insidentes References: 1. Supporting prescribing in general practice a progress report June 2003 ISBN Supporting prescribing in general practice September 1999 ISBN NHS Better Care, Better Value Indicators NHS Institute for Innovation and Improvement

5 THE NATIONAL THERAPEUTIC INDICATORS 2012 (in order of BNF chapter): 1a. Proton Pump Inhibitors: DDDs per 1,000 patients per day b. Proton Pump Inhibitors: high strength PPIs as a % of all PPIs (DDDs) Statins: Simvastatin, atorvastatin & pravastatin as a percentage of all statins (DDD) Ezetimibe: Ezetimibe as a percentage of ezetimibe and all statins (DDDs) Dipyridamole MR: Dipyridamole DDD per 1,000 patients per day High Strength Inhaled Corticosteroids: High Strength Inhaled Corticosteroids as a percentage of all inhalers (items) Hypnotics: Hypnotics and anxiolytics DDD per patients per day a. Total Antibiotic Use: total items per 1,000 patients per day b. 4C Antibiotics: proportion of 4C antibiotics (fluoroquinolones,cephalosporins, co-amoxiclav and climamycin) items per 1,000 patients per day Quinine Use: DDDs per 1000 patients per day Antidiabetic drugs: established oral hypoglycaemics (metformin & sulphonylureas) as percentage of all antidiabetic drugs (DDDs) Antimicrobial Wound Products: Antimicrobial wound products as percentage of total wound products (items)

6 Proton Pump Inhibitors This National Therapeutic Indicator focuses on the use of high-dose, high-cost Proton Pump Inhibitors (PPI)*. The total volume of PPI prescribed and the proportion that is for high-dose products is measured. There is no evidence suggesting improved efficacy of high-dose, high-cost PPIs when compared to low-dose, low cost PPIs and increasing safety concerns about their chronic use, though the MHRA has not yet issued definitive safety advice on this matter. It is recognised that there are considerable drivers to prescribe PPIs and the difficulties of withdrawing treatment once commenced. The aim is to encourage use of PPIs at the lowest and most cost-effective dose and to minimise their inappropriate long-term prescription. PPIs inhibit gastric acid secretion by blocking the hydrogen-potassium adenosine triphosphatase enzyme system ( proton pump ) of the gastric parietal cell. They are used to treat: peptic ulcers (gastric and duodenal); Helicobacter pylori eradication; dyspepsia and gastro-oesophageal reflux disease. For patients at high risk of gastro-intestinal complications with a NSAID, a PPI should be considered for gastroprotection. 1 The commonest use in primary care is in the management of dyspepsia. Around 25-40% of adults in the general population have dyspepsia at any one time and it accounts for up to 5% of GP consultations. 2 The best empirical anti-secretory drug for treating uninvestigated dyspepsia remains unclear. (Note that uninvestigated dyspepsia would include all patients with peptic ulcers; dyspepsia and gastrooesophageal reflux.) However, a recent Cochrane review confirmed that proton pump inhibitors are the most effective anti-secretory drug for treating univestigated gastro-oesophageal reflux. 3 Despite the development of key guidelines, 4,5 the management of uninvestigated dyspepsia remains controversial. In the absence of red flag features, two management strategies are recommended: empirical PPI or Test and Treat for H pylori 5. SIGN 68 Dyspepsia 4 currently only recommends the latter approach. NICE CG17 5 recommends as-required low-dose PPI (omeprazole 20 mg capsule or lansoprazole 15 mg capsule) for univestigated dyspepsia. This should be reviewed at least annually. Where patients have uninvestigated reflux-like symptoms regular high-dose PPI (omeprazole 40 mg capsule or lansoprazole 30 mg capsule) may be required until symptoms are controlled. Then, asrequired low-dose PPI should be considered. Review of spending trend on PPIs in Scotland shows that, despite a decrease in overall cost, the proportion spent on high cost PPIs is increasing. This is of concern when high cost PPIs offer no advantages over low cost equivalents. 5 The preference for as-required low-dose PPI with regular review is further reinforced by concerns around serious side effects. Chronic use of PPIs is associated with: community acquired pneumonia 6 ; fragility fractures 7 and Clostridium difficile Infection (CDI). 8 Generic anticipation for esomeprazole and rabeprazole may mean that these medicines become cost-effective with time, and this is unlikely to occur for a number of years. Patients prescribed PPIs should be reviewed at least annually and where appropriate continued use stopped. When it is not possible to stop the PPI then as-required low-dose with the most costeffective agent should be prescribed. References: 1. Joint Formulary Committee. British National Formulary. Edition 62, September Zagari RM, et al. Investigating dyspepsia. BMJ 2008;337:a van Pinxteren B, et al. Cochrane Database of Systematic Reviews 2010, Issue 11. Art. No.: CD SIGN 68 Dyspepsia, March 2003 (Due for review in 2012) 5. NICE CG17 Dyspepsia, August Laheij RJF, et al. JAMA 2004;292(16): Kahlili H, et al. BMJ 2012;344:e Howell MD, et al. Arch Intern Med 2010;170(9): * High dose PPI: omeprazole 40mg; esomeprazole 40mg. 5

7 1a. Proton Pump Inhibitors: DDDs per 1,000 patients per day. This indicator measures the volume of proton pump inhibitor (PPI) prescribing. The quantity and strength of each drug preparation is used to calculate a standard measure of volume using the WHO defined daily dose (DDD). The sum of DDDs for all the medicines within the class is calculated. The total DDDs is then normalised to allow comparison between practices using their registered populations. A further level of normalisation is applied which calculates a standard time period. Lower use of Proton Pump Inhibitors is the desirable therapeutic aim. 250 Proton Pump Inhibitors: DDDs/1,000patients/day Report Period: Jan-12 to Mar-12 DDDs per 1000 patients per day NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE NHS WESTERN ISLES SCOTLAND Lower quartile Minimum Maximum Upper quartile Median Proton Pump Inhibitors: DDDs/1,000patients/day Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE NHS WESTERN ISLES SCOTLAND Approximately 1,500 prescriptions for generic esomeprazole have been added to PRISMS as DUMMY DRUG during the baseline period (Jan-Mar 2012). This missing prescribing has been manually accounted for and these figures adjusted accordingly. 6

8 Proton Pump Inhibitors: high strength PPIs as a % of all PPIs (DDDs) This therapeutic indicator supports 1a and provides a more focussed analysis of the use of high strength PPIs. It can be used as an indicator for high dose, high cost PPI use. The indicator measures the proportion of high strength PPIs (e.g. omeprazole 40 mg capsules) prescribed within the total prescribing of PPIs. The quantity and strength of each drug preparation is used to calculate a standard measure of volume using the WHO defined daily dose (DDD). The number of DDDs for high strength PPIs is divided by total DDDs of PPIs. Injections, infusions and specially manufactured preparations are excluded. Lower use of high strength Proton Pump Inhibitors is the desirable therapeutic aim. 15% High strength PPIs as a percentage of all PPIs (DDDs) Report Period: Jan-12 to Mar-12 Percent High Strength PPIs 10% 5% 0% NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE Lower quartile Minimum Maximum Upper quartile Median NHS WESTERN ISLES SCOTLAND DDDs of high strength PPIs as a % of all PPIs, excluding injections/infusions Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN 2.09% 4.96% 7.31% 10.47% 23.28% NHS BORDERS 0.00% 0.35% 1.73% 2.59% 6.39% NHS DUMFRIES & GALLOWAY 1.05% 2.11% 3.07% 4.81% 35.02% NHS FIFE 1.52% 4.05% 6.65% 9.60% 20.19% NHS FORTH VALLEY 1.05% 3.50% 5.99% 7.72% 15.77% NHS GRAMPIAN 0.00% 1.82% 2.89% 4.60% 11.63% NHS GREATER GLASGOW & CLYDE 0.00% 3.00% 4.61% 6.44% 17.83% NHS HIGHLAND 0.00% 1.56% 4.11% 7.40% 27.05% NHS LANARKSHIRE 0.00% 3.73% 6.08% 8.14% 30.51% NHS LOTHIAN 0.00% 2.46% 3.78% 6.29% 21.60% NHS ORKNEY 0.00% 0.00% 0.21% 4.13% 5.68% NHS SHETLAND 0.00% 1.24% 5.06% 6.34% 11.07% NHS TAYSIDE 0.00% 3.84% 5.26% 7.14% 25.33% NHS WESTERN ISLES 0.00% 0.12% 1.33% 2.42% 8.72% SCOTLAND 2.59% 4.61% 6.94% Approximately 1,500 prescriptions for generic esomeprazole have been added to PRISMS as DUMMY DRUG during the baseline period (Jan-Mar 2012). This missing prescribing has been manually accounted for and these figures adjusted accordingly. 7

9 Statins This National Therapeutic Indicator looks at the use of statins for lipid modification and the importance of using cost-effective products. The proportion of simvastatin, atorvastatin and pravastatin compared to total statins prescribed is measured. The statins competitively inhibit 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase, an enzyme involved in the synthesis of cholesterol, especially in the liver. Statins reduce cardiovascular disease events and lower total mortality irrespective of the initial cholesterol concentration. 1 The Heart Protection Study remains the best evidence base for prescribing statins in primary care for secondary and primary prevention. 2 Simvastatin 40 mg remains the first line statin. Due to patent expiry in 2012, atorvastatin is likely to become a cost-effective option for managing patients requiring primary and secondary prevention by lipid lowering. Pravastatin remains an option as a cost-effective statin, although it is not included in all local Formularies. For primary prevention a recent Cochrane review confirms that statins reduce all-cause mortality (Relative Risk 0.83; 95% CI ) when used in people at higher risk of cardiovascular disease. 3 Eleven of the 14 trials included were for patients with hypertension, diabetes, raised lipids and microalbuminuria. This review supports recommending satins to patients with a 20% or greater 10 year CV event risk. However, it is important to note that the NNT of statin versus placebo, to prevent mortality, is 167 over four years and this should form part of the informed discussion between the patient and clinician. For secondary prevention there is irrefutable evidence that statins reduce all-cause mortality and prevent cardiovascular events. 4 The evidence remains controversial over the use of intensive lipid lowering. A large recent metaanalysis of randomised controlled trials did not find a statistically significant reduction in all-cause or cardiovascular mortality with intensive statin dosing (e.g. atorvastatin 80 mg/day) compared to moderate (e.g. simvastatin 40 mg/day) or low dosing (e.g. simvastatin 20 mg/day). 5 This finding is further supported by the double blind randomised SEARCH trial. 6 There is an important subgroup of patients those with Acute Coronary Syndrome (STEMI, non- STEMI and unstable angina) where there is benefit to intensive versus moderate statin therapy. Allcause mortality is reduced and cardiovascular mortality is also reduced (NNT over one year 119). 7 Duration of intensive treatment should be discussed with each patient in terms of increased risk of adverse drug reaction and lack of evidence for efficacy beyond two years The development of statin-related myopathy appears to be dose related and occurs with all statins. For Primary Prevention there is no need to monitor cholesterol levels, though LFTs should be checked at three and 12 months. Subsequently check LFTs only if clinically indicated. For Secondary Prevention (and patients with diabetes) cholesterol level measurement remains a requirement of Quality Outcomes Framework (QOF). Both SIGN and NICE 8 support the QOF audit standard target of total cholesterol <5mmol/L. the current NHSScotland target for individuals at high cardiovascular risk is a TC level of <5mmol/L. This level is consistent with the Quality and Outcomes Framework. 4 For patients requiring statin therapy moderate dose simvastatin (simvastatin 40 mg) remains the treatment of choice for most patients due to current clinical and cost-analysis evidence. With manufacturing licence patent expiry atorvastatin is likely to become a cost-effective alternative. References: 1. Joint Formulary Committee. British National Formulary. Edition 62. September MRC/BHF Heart Protection Study. Lancet 2002;360: Taylor F, et al. Cochrane Database of Systematic Reviews 2011, Issue 1. Art. No.: CD SIGN 97 Risk estimation and the prevention of cardiovascular disease, February Mills EJ, et al. Eur Heart J 2011;32(11): Bowman L, et al. (SEARCH). Am Heart J 2007;154(5): NICE CG67 Lipid modification guideline, May

10 2. Statins: Simvastatin, atorvastatin & pravastatin as a percentage of all statins (DDD) This indicator measures the proportion of established HMG CoA reductase inhibitors (simvastatin, atorvastatin, pravastatin) prescribed within the total prescribing of HMG CoA reductase inhibitors, commonly known as statins. The quantity and strength of each drug preparation is used to calculate a standard measure of volume using the WHO defined daily dose (DDD). The number of DDDs for the established statins is divided by total DDDs of statins. Higher proportional use of simvastatin 40mg is the desirable therapeutic aim Percent Simvastatin, Atorvastatin & Pravastatin 100% 95% 90% 85% 80% 75% 70% NHS AYRSHIRE & ARRAN Simvastatin, atorvastatin & pravastatin as a percentage of total statins (DDDs) Report Period: Jan-12 to Mar-12 NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHI RE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE NHS WESTERN ISLES Lower quartile Minimum Maximum Upper quartile Median SCOTLAND Simvastatin, atorvastatin & pravastatin as a percentage of total statins (DDDs) Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN 77.84% 96.20% 97.43% 98.40% 99.63% NHS BORDERS 91.83% 97.09% 98.35% 99.02% 99.58% NHS DUMFRIES & GALLOWAY 83.31% 94.06% 95.90% 97.71% 99.20% NHS FIFE 45.69% 76.17% 81.07% 86.18% 93.33% NHS FORTH VALLEY 75.40% 95.38% 97.10% 98.15% 99.57% NHS GRAMPIAN 47.93% 92.10% 94.69% 96.51% % NHS GREATER GLASGOW & CLYDE 80.72% 97.25% 98.37% 99.11% % NHS HIGHLAND 62.82% 93.20% 96.75% 97.87% % NHS LANARKSHIRE 0.00% 87.80% 93.24% 96.27% 99.68% NHS LOTHIAN 82.03% 94.30% 96.00% 97.39% % NHS ORKNEY 82.85% 93.11% 98.69% % % NHS SHETLAND 68.48% 79.98% 84.26% 94.22% 98.57% NHS TAYSIDE 85.01% 94.19% 95.62% 97.03% 99.14% NHS WESTERN ISLES 61.29% 81.32% 93.23% 97.62% 98.78% SCOTLAND 93.28% 96.63% 98.22% 9

11 Ezetimibe This National Therapeutic Indicator focuses on the use of ezetimibe for patients requiring lipid modification and the lack of clinical evidence to support this practice. The proportion of ezetimibe compared to the total use of ezetimibe and statins is measured. Ezetimibe, a cholesterol-absorption inhibitor, reduces levels of low-density lipoprotein when added to statin treatment. 1 Despite this unique pharmacological effect all ezetimibe clinical trials have demonstrated that it has no positive effect on Patient Orientated Outcomes. The ENHANCE trial was published in 2008 and looked at the effect on carotid artery intimal thickness of adding ezetimibe to simvastatin. 2 Participants with familial hypercholesterolaemia were randomised to simvastatin 80 mg or simvastatin 80 mg plus ezetimibe 10 mg. There was no statistically significant difference in intimal thickness between the two groups after 24 months. In spite of this both SIGN97 and NICE CG67 still recommends considering the use of ezetimibe in this group of patients. 3,4 Also published in 2008 the SEAS trial looked at whether a combination of ezetimibe (10mg) and simvastatin (40mg) prevented major cardiovascular events in patients with mild to moderate aortic stenosis when compared to placebo. 5 The results showed no difference between the two groups in terms of incidence of major cardiovascular events (primary end-point) ([CI] 0.83 to 1.12; p=0.59) or progression of aortic stenosis (secondary end-point) ([CI] 0.84 to 1.18; p=0.97). The SHARP trial was published in In this five year trial patients with Chronic Kidney Disease (CKD) and no evidence of coronary heart disease were randomised to placebo or simvastatin 20mg plus ezetimibe 10mg. 6 Within the treatment arm there was a reduction in major cardiovascular event compared with placebo ([CI] 0.74 to 0.94; p=0.0021). It is impossible to separate out the effect of the simvastatin from this result. The IMPROVE-IT trial is due to be published in June This phase 3 trial looks at the effect of simvastatin 40mg plus ezetimibe 10mg compared with simvastatin 40mg in patients with stabilised acute coronary syndrome. Clinical benefit will be identified by a composite reduction in major cardiovascular event and mortality. Despite lowering Low Density Lipoprotein, particularly in combinations with a low dose statin, ezetimibe remains a poor choice for lipid modification based on current best clinical evidence. In recognition of this some NHS Boards have removed ezetimibe from their formularies. Patients currently prescribed ezetimibe should be reviewed and this lack of evidence discussed with a view to stopping the drug. References: 1. Joint Formulary Committee. British National Formulary. Edition 62. September Kastelein JJP, et al (ENHANCE investigators). Simvastatin with or without ezetimibe in familial Hypercholesterolaemia. N Engl J Med 2008;358(14): SIGN 97 Risk estimation and the prevention of cardiovascular disease, February NICE CG67 Lipid Modification Guideline, May Rossebo AB, et al. (SEAS investigators). Intensive lipid lowering with Simvastatin and Ezetimibe in Aortic Stenosis. N Engl J Med 2008; 359(13): Baigent C, et al (SHARP investigators). The effects of lowering LDL cholesterol with simvastatin plus ezetimibe in patients with chronic kidney disease (Study of Heart and Renal Protection): a randomised placebo-controlled trial. Lancet2011;377(9784):

12 3. Ezetimibe: Ezetimibe as a percentage of ezetimibe and all statins (DDDs) This indicator measures the proportion of ezetimibe prescribed within the total prescribing of ezetimibe and statins (HMG CoA reductase inhibitors). The quantity and strength of each drug preparation is used to calculate a standard measure of volume using the WHO defined daily dose (DDD). The number of DDDs for ezetimibe is divided by total DDDs of ezetimibe and all statins. Low use of ezetimibe is the desirable therapeutic aim 6% Ezetimibe as a percentage of ezetimibe and all statins (DDDs) Report Period: Jan-12 to Mar-12 5% Percent Ezetimibe 4% 3% 2% 1% 0% NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE Lower quartile Minimum Maximum Upper quartile Median NHS WESTERN ISLES SCOTLAND Ezetimibe as a percentage of ezetimibe and all statins (DDDs) Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN 0.00% 0.35% 0.86% 1.87% 4.88% NHS BORDERS 0.59% 2.03% 2.52% 3.95% 5.72% NHS DUMFRIES & GALLOWAY 0.19% 1.28% 1.77% 2.40% 3.72% NHS FIFE 0.20% 1.43% 2.23% 3.42% 8.38% NHS FORTH VALLEY 0.00% 0.98% 1.73% 2.39% 5.85% NHS GRAMPIAN 0.00% 1.35% 2.10% 2.85% 7.93% NHS GREATER GLASGOW & CLYDE 0.00% 0.38% 0.77% 1.42% 5.56% NHS HIGHLAND 0.00% 0.00% 0.36% 0.95% 8.01% NHS LANARKSHIRE 0.00% 0.11% 0.45% 1.07% 2.93% NHS LOTHIAN 0.00% 0.95% 1.37% 2.26% 8.16% NHS ORKNEY 0.00% 0.00% 1.15% 2.68% 8.39% NHS SHETLAND 0.00% 0.72% 1.40% 3.30% 7.18% NHS TAYSIDE 0.00% 1.20% 1.71% 2.58% 5.35% NHS WESTERN ISLES 0.00% 0.00% 0.23% 0.74% 7.34% SCOTLAND 0.45% 1.12% 2.07% 11

13 Dipyridamole MR This National Therapeutic Indicator focuses on the change in recommendation by NICE for antiplatelet therapy after ischaemic stroke and transient ischaemic attack (TIA). 1 The guidance is a Multiple Technology Appraisal and so applies in Scotland. The anti-platelet treatment of choice is now generic clopidogrel and not modified-release dipyridamole (dipyridamole MR) plus aspirin. The volume prescribed of dipyridamole MR is measured. This is considered a surrogate marker for the recommended change to use of generic clopidogrel for secondary prevention. Total dipyridamole MR use is expected to fall. Dipyridamole MR has both antiplatelet and vasodilating properties and is thought to inhibit the uptake of adenosine into blood and vascular cells. Its vasodilator activity means that it should be used with caution in people with severe coronary artery disease. 2 Clopidogrel is an irreversible adenosine diphosphate receptor antagonist with antiplatelet properties. 2 The PRoFESS trial made head-to-head comparison of clopidogrel and dipyridamole MR plus aspirin for secondary prevention after an ischaemic stroke. The trial reported no statistically difference in the primary outcome of recurrent stroke, (HR 1.01; 95% CI 0.92 to 1.11). 3 With the availability of generic clopidogrel this now becomes the preferred cost-effective treatment for secondary prevention after an ischaemic stroke. 1 SIGN CG108 4 for antiplatelet therapy after ischaemic stroke and TIA currently recommends: Lowdose aspirin (75 mg daily) and dipyridamole (200 mg modified release twice daily) should be prescribed after ischaemic stroke or TIA for secondary prevention of vascular events OR Clopidogrel (75 mg daily) monotherapy should be considered as an alternative to combination aspirin and dipyridamole after ischaemic stroke or TIA for secondary prevention of vascular events. It should be noted that this advice predates the manufacturing licence patent expiry for clopidogrel. NICE TA210 1 guidance can be summarised: Clopidogrel is recommended first-line for: Ischaemic stroke secondary prevention Peripheral arterial disease Multivascular disease Dipyridamole MR & aspirin is recommended as an option for: TIA secondary prevention It is anticipated that this therapeutic indicator will have a short life span. Once NHS Boards have adopted the new guidance, and this is implemented, the potential for further therapeutic shift will be limited. It is recognised that some NHS Boards have already initiated this change in practice. References: 1. NICE technology appraisal guidance 210, December Joint Formulary Committee. British National Formulary. Edition 62. September Sacco RL, et al; the PRoFESS Study Group. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008;359: SIGN 108 Management of patients with stroke or TIA: assessment, investigation, immediate management and secondary prevention., December

14 4. Dipyridamole MR: Dipyridamole DDD per 1,000 patients per day This indicator measures the volume of modified-release dipyridamole (dipyridamole MR) 200 mg capsule prescribing as a surrogate marker for change in the anti-platelet treatment recommendation after ischaemic stroke and TIA. The quantity and strength of the drug preparation is used to calculate a standard measure of volume using the WHO defined daily dose (DDD). The total DDDs are then normalised to allow comparison between practices using the practice s registered population. A further level of normalisation is applied which calculates a standard time period. Lower use of dipyridamole MR is the desirable therapeutic aim Dipyridamole MR: DDDs/1,000patients/day Report Period: Jan-12 to Mar DDDs per 1000 patients per day NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE Lower quartile Minimum Maximum Upper quartile Median NHS WESTERN ISLES SCOTLAND Dipyridamole MR: DDDs/1,000patients/day Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE NHS WESTERN ISLES SCOTLAND

15 High Strength Inhaled Corticosteroids This National Therapeutic Indicator focuses on the safety concerns regarding the inappropriate use of High Strength Inhaled Corticosteroids and the importance of ensuring that the patient s steroid load is kept to the minimum effective level. It is recognised that there is considerable benefit to appropriate standard dose use of Inhaled Corticosteroids (ICS). The proportion of High dose ICS prescribed compared with the total amount of inhalers prescribed for asthma or chronic obstructive pulmonary disease (COPD) is measured.the only licenced ICS combination products for COPD are: Symbicort 200/6 & 400/6 Turbohaler and Seratide 500/50 Acuhaler. They should be considered for patients with an FEV 1 less than 50% predicted 1. Standard dose ICS * (200 to 800 micrograms/day in adults; 200 to 400 micrograms/day in children 12 years) is used regularly for prophylaxis of asthma when patients require a short-acting beta 2 agonist more than twice a week, or if symptoms disturb sleep more than once a week, of if the patient has suffered exacerbations in the last two years requiring systemic corticosteroids or nebulised bronchodilator, (Step 2 BTS). 2,3 High dose ICS * (>800 to 2000 micrograms/day in adults; >400 to 800 micrograms/day in children 5 to12 years) can be prescribed for patients who respond only partially to standard doses with a longacting beta 2 agonist or another long-acting bronchodilator, (Step 4 BTS). 2,3 High doses should be continued only if there is clear benefit over the lower dose. The use of High dose ICS has increased in Scotland. This trend has both resource implications and presents the possibility that patients are being treated at inappropriately high doses with the subsequent increased risk of serious side effects. In addition it is not clear as to whether aggressive management of asthma is improving the quality of care. A recent review of the Quality and Outcomes Framework (QOF) demonstrates that asthma management is the only one of two areas where reduced emergency admission is not associated with high QOF score. 4 It is recommended that all patients treated with High dose ICS carry a steroid card. There are recognised potentially serious systemic side effects from ICS (growth failure; reduced bone density; cataracts and glaucoma; anxiety and depression and diabetes mellitus) and the most concerning is adrenal suppression. 2 Marked adrenal suppression can occur with doses of ICS above 1,500 micrograms beclometasone per day (750 micrograms fluticasone per day) in adults or 800 micrograms beclometasone per day (375 micrograms fluticasone per day) in children. A UK observational study found that high-dose ICS prescribing occurred in 5.6% of the under 5s and 10% of the 5 to 11 year olds. 3 In addition very high-dose ICS (>800 micrograms beclometasone or equivalent) were prescribed to 3.9% of the under 5s and 4.9% of the 5 to 11 year olds. Current advice for children on ICS can be summarised. 2,3,6 Regular growth monitoring (unreliable indicator of adrenal suppression) High-dose ICS should be used only under the care of specialist paediatrician Adrenal insufficiency should be considered in any child with shock and/or reduced consciousness who is maintained on ICS Patients should be maintained at the lowest possible dose of ICS. This is a dynamic process requiring stepping down therapy. Reductions in dose of ICS should be considered every three months, reducing the dose by 25 to 50% every time. 3 References: 1. NICE Clinical Guideline June Joint Formulary Committee. British National Formulary. Edition 62. September SIGN/BTS British guideline on the management of asthma. May 2008, revised May A Dixon et al. NIHR Service Delivery and Organisation programme; Thomas M et al. Br J Gen Pract 2006;56: MHRA/CSM. Current Problems in Pharmacovigilance 2002;28:7-12 * Standard dose ICS: beclometasone & budesonide 200 to 800 micrograms; fluticasone 100 to 400 micrograms * High dose ICS: beclometasone & budesonide >800 micrograms; fluticasone >400 micrograms 14

16 5. High Strength Inhaled Corticosteroids: High Strength Inhaled Corticosteroids as a percentage of all inhalers (items) This indicator measures the proportion of high strength steroid inhalers (including combinations) within the total prescribing of inhalers for asthma or COPD. The number of dispensed prescriptions (items) is used to measure the frequency of prescribing. The number of items of high strength steroid inhalers is divided by total inhaler items. The calculation of DDDs in this group of preparations is problematic. Lower use of High Strength Inhaled Corticosteroids is the desirable therapeutic aim 40% High Strength Steroid inhalers as a percentage of all inhalers (items) Report Period: Jan-12 to Mar-12 Percent High Strength Steroid Inhalers 35% 30% 25% 20% 15% 10% 5% 0% NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE Lower quartile Minimum Maximum Upper quartile Median NHS WESTERN ISLES SCOTLAND High Strength Steroid inhalers as a percentage of all inhalers (items) Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN 7.00% 11.68% 14.24% 16.89% 24.99% NHS BORDERS 8.66% 16.30% 17.09% 19.68% 25.22% NHS DUMFRIES & GALLOWAY 3.71% 6.84% 9.60% 12.40% 26.31% NHS FIFE 5.58% 13.56% 16.17% 18.86% 23.71% NHS FORTH VALLEY 6.44% 16.62% 19.60% 21.86% 31.03% NHS GRAMPIAN 6.92% 14.29% 17.63% 19.91% 36.22% NHS GREATER GLASGOW & CLYDE 4.78% 11.52% 14.23% 16.74% 23.54% NHS HIGHLAND 0.00% 12.12% 16.70% 20.20% 48.94% NHS LANARKSHIRE 0.00% 11.28% 13.68% 17.71% 26.83% NHS LOTHIAN 9.91% 15.06% 17.61% 19.88% 29.63% NHS ORKNEY 4.81% 10.27% 15.87% 19.91% 25.00% NHS SHETLAND 3.44% 6.13% 11.86% 14.27% 15.34% NHS TAYSIDE 7.98% 13.90% 15.71% 18.07% 24.79% NHS WESTERN ISLES 1.80% 10.33% 13.42% 18.75% 24.10% SCOTLAND 12.34% 15.58% 18.58% 15

17 Hypnotics This National Therapeutic Indicator focuses on the use of benzodiazepines and Z drugs (nonbenzodiazepine hypnotics). Hypnotics and anxiolytics are a well established subject for a therapeutic indicator and low use is a well recognised marker for quality in prescribing. Total volume of hypnotic and anxiolytic prescribed is measured for the indicator. It is recognised that differing drug-maintenance and drug-withdrawal policies between NHS Health Boards can act as a confounder to using this measure for comparative data. Hypnotic use in all ages is clearly linked with tolerance, dependence, rebound insomnia and abuse. In the elderly population hypnotic use is also associated with falls, cognitive impairment and fatigue. 1 Before a hypnotic is prescribed the cause of the insomnia should be established. It is important to realise that some patients have unrealistic sleep expectations and others underestimate alcohol consumption, which may be the cause of the insomnia. Reassurance that this is a common problem is important as 30% of the population have insomnia at any one time. 2 70% of cases are secondary and treatment of the underlying cause should be sought: Depression and/or anxiety Physical illness affecting sleep Sleep apnoea (excessive day time sleepiness) Delayed sleep phase syndrome For primary insomnia, 30% of cases improve with sleep hygiene. Bed-time restriction has also been shown to be a beneficial treatment. 2 For 13 people taking a hypnotic for one week: 12 people s sleep would either improve or not irrespective of whether they had taken a hypnotic or a placebo and one person would experience sleep improvement (NNT13); two patients would experience an adverse event (NNH 6). 3 A Norwegian study found that taking a hypnotic increased the risk of having a road traffic accident (RTA) four-fold. 4 This finding has been confirmed by a more recent French study. 5 Data from the USA show that there is an association between hip fracture rate and taking a benzodiazepine. 6 Short half-life benzodiazepines were no safer than long half-life benzodiazepines. The risk of hip fracture is highest in the first two weeks after starting a benzodiazepine. When patient s use and experiences of Z drugs is compared with benzodiazepines. There are no significant differences in perceptions of efficacy or side-effects. 7 Reported prescribing practices were often at variance with the licence for short-term use. Hypnotics should not be prescribed indiscriminately and routine prescribing is undesirable. They should be reserved for short courses in the acutely distressed. Tolerance to their effects develops within 3 to 14 days of continuous use. Withdrawal after long term use can cause rebound insomnia and withdrawal syndrome. References: 1. Joint Formulary Committee. British National Formulary. Edition 62. September Falloon K, et al. The assessment and management of insomnia in primary care. BMJ 2011;342:d Glass J, et al. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits BMJ 2005;331: Gustavsen I et al. Road traffic accident risk related to prescriptions of the hypnotics zopiclone, zolpidem, flunitrazepam and nitrazepam. Sleep Med 2008; 9: Orriols L, et al. Benzodiazepine-like hypnotics and the associated risk of road traffic accidents. Clinical Pharmacology and Therapeutics. 2011;89(4): Wagner AK et al. Benzodiazepine Use and Hip Fractures in the Elderly. Arch Intem Med 2004; 164: Siriwardena AN et al. Magic bullets for insomnia? Patient s use and experiences of newer (Z drugs) versus older (benzodiazepine) hypnotics for sleep problems in primary care. BJGP 2008; 58:

18 6. Hypnotics: Hypnotics and anxiolytics DDD per patients per day This indicator measures the volume of hypnotic and anxiolytic prescribing. These are preparations within subsections and of the BNF. Injections, infusions and rectal preparations are excluded from the data. The quantity and strength of each drug preparation is used to calculate a standard measure of volume using the WHO defined daily dose (DDD). The sum of DDDs for all medicines within the class is then calculated. The total DDDs are then normalised to allow comparison between practices using the practice s registered population. A further level of normalisation is applied which calculates a standard time period. Lower use of hypnotics and anxiolytics is the desirable therapeutic aim Hypnotics and anxiolytics: DDDs/1,000patients/day Report Period: Jan-12 to Mar DDDs per 1000 patients per day NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE Lower quartile Minimum Maximum Upper quartile Median NHS WESTERN ISLES SCOTLAND Hypnotics and anxiolytics: DDDs/1,000patients/day Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE NHS WESTERN ISLES SCOTLAND

19 Antibiotics This indicator is proposed and supported by the Scottish Antimicrobial Prescribing Group (SAPG). 1 Reduction in overall use of antibiotics is a key part of improving antimicrobial stewardship. The aim is to reduce antimicrobial resistance and reduce health-care associated infections in a safe manner that does not put patients at risk. Total volume of antibiotics is measured for the first antibiotic National Therapeutic Indicator. There is evidence that antibiotic use in primary care drives bacterial antibiotic resistance for the individual and for the population. 2,3 Higher levels of antibiotic resistance are associated with high use of antibiotics. 4 The solution is not just to use fewer antibiotics: Our mission is not to prescribe as few antibiotics as possible, but to identify that small group of patients who really need antibiotic treatment and to explain, reassure and educate the large group of patients who don t. 5 There are many clinical areas where antibiotic use clearly benefits an individual patient and the associated risks are outweighed. For example, Upper urinary tract infections (pyelonephritis), cellulitis, community acquired pneumonia, are all infections that should not be targeted for a reduction in antibiotic use as the risk to the individual of not treating is too great. However 70% of antibiotics in primary care are used to treat self-limiting respiratory tract infections (acute sore throat, acute otitis media, acute rhinosinusitis and acute cough/bronchitis). The evidence shows that the benefit of using antibiotics to treat these conditions in most patients is so marginal that it is outweighed by the risks to the individual and to society. 6 The Scottish Antimicrobial Prescribing Group has produced a toolkit to aid the process of using fewer antibiotics to manage the self-limiting respiratory tract infections. 1 The Health Protection Agency (HPA) template has been formally adopted for use in Scotland and gives clear guidance on the subgroups of patients that may benefit from the use of antibiotics. 7 This evidence will have been considered by all NHS Board Antimicrobial Management Teams (AMTs) when writing local antibiotic guidelines. The second antimicrobial National Therapeutic Indicator focuses on restricting the use of broad spectrum antibiotics. Use of the broad spectrum 4C antibiotics (fluoroquinolones, particularly ciprofloxacin, cephalosporins co-amoxiclav and climamycin) is a well recognised risk for Clostridium difficile infection (CDI), 8 MRSA and resistant UTIs in secondary care. 9 Evidence of the link between 4C antibiotics and CDI in primary care is emerging. The effect of restricting these agents in secondary care has been so profound that it makes sense to apply these same principles of antimicrobial stewardship through out the health service. As the number of CDI cases in secondary care reduces the proportion attributable to primary care is on the increase. The antibiotic National Therapeutic Indicators encompass the key aims of antibiotic stewardship by promoting the reduction in overall use of antibiotics and restricting the use of broad-spectrum antibiotics. Implementation of change in antibiotic prescribing behaviour should include consideration of national guidance from SAPG and local direction from Boards Antimicrobial Management Teams. References: 1. The SAPG, Scottish Medicines Consortium, Delta House, 50 West Nile Street, Glasgow, G1 2NP 2. Costelloe C et al. Br Med J 2010; 340:c Priest P et al. Br Med J 2001;323: European Antimicrobial Resistance Surveillance system (EARSS). Interactive database 5. Verheij TJM, Br J Gen Pract. 2009; 59(567): NICE CG69 July HPA Management of infection guidance for primary care for consultation & local adaptation March Pepin J et al. Clinical Infectious Diseases 2005; 41(9): Davey P et al. Emerging Infectious Diseases 2006; 12(2):

20 7a. Total Antibiotic Use: total items per 1,000 patients per day This indicator measures the frequency of prescribing of antibiotics. The number of dispensed prescriptions (items) is used to measure the frequency of prescribing. The total items are then normalised to allow comparison between practices using the practice s registered population. A further level of normalisation is applied which calculates a standard time period. Lower total antibiotic use is the preferred therapeutic outcome 4.00 Antibiotics: Items/1,000patients/day Report Period: Jan-12 to Mar-12 Items per 1000 patients per day NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE Lower quartile Minimum Maximum Upper quartile Median NHS WESTERN ISLES SCOTLAND Antibiotics: Items/1,000patients/day Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE NHS WESTERN ISLES SCOTLAND

21 7b. 4C Antibiotics: proportion of 4C antibiotics (fluoroquinolones, cephalosporins, co-amoxiclav and climamycin) items per 1,000 patients per day This indicator measures the frequency of prescribing of 4C antibiotics. The number of dispensed prescriptions (items) is used to measure the frequency of prescribing. The total items are then normalised to allow comparison between practices using the practice s registered population. A further level of normalisation is applied which calculates a standard time period. Lower use of the 4C Antibiotics is the desirable therapeutic outcome C Antibiotics: Items/1,000patients/day Report Period: Jan-12 to Mar Items per 1000 patients per day NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE Lower quartile Minimum Maximum Upper quartile Median NHS WESTERN ISLES SCOTLAND 4C Antibiotics: Items/1,000patients/day Minimum Lower Median Upper Maximum NHS AYRSHIRE & ARRAN NHS BORDERS NHS DUMFRIES & GALLOWAY NHS FIFE NHS FORTH VALLEY NHS GRAMPIAN NHS GREATER GLASGOW & CLYDE NHS HIGHLAND NHS LANARKSHIRE NHS LOTHIAN NHS ORKNEY NHS SHETLAND NHS TAYSIDE NHS WESTERN ISLES SCOTLAND