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 Mr Sean MacBride-Stewart who have been instrumental in the development of this National Therapeutics Indicators Baseline Report Simon and Sean would also like to acknowledge the following individuals and groups for supporting them in this development: Findlay Hickey, Billy Malcolm, Graeme Bryson, Anne Gilchrist, Alpana Mair, Margaret Ryan, Stuart Keys, 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 Baseline Report for , containing the data from the fourth quarter of the fiscal year NHS Scotland has an excellent 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. We commend the information within this report to you, please use wisely and efficiently. Kind Regards BILL SCOTT CHIEF PHARMACEUTICAL OFFICER HARRY BURNS CHIEF MEDICAL OFFICER 11 September

4 NATIONAL THERAPEUTIC INDICATORS (2013) The National Therapeutic Indicators continue to be developed as part of the Scottish Government Prescribing Efficiency & Productivity work-stream ( ). The aim is 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. Audit Scotland s most recent report, Prescribing in general practice in Scotland 3 (2013), supports the on-going use of National Therapeutic Indicators. 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. 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 allows access to the data collected by Practitioner Services Division (PSD) when processing each prescription dispensed. The resulting payment verification data is then accessed via PRISMS. Through time, considerable expertise has developed at interpreting these data for use as measures of prescribing quality. The National Therapeutic Indicators (2013) have been developed with on-going, detailed consultation with medicines management experts from all of the Scottish NHS Boards. Refinement and development of the indicators for has occurred primarily through discussion with the Scottish Prescribing Advisers Association executive. Consideration of the Welsh National Prescribing Indicators ( ) 4 and the English Key Therapeutics Topics (2012) 5 has been important in confirming the value of national prescribing indicators. There was the intention that Prescribing Information System (PIS) data would be used for the 2013 National Prescribing Indicators. This data set allows the development of indicators using anonymous patient level data. The potential is for indicators of greater sophistication than currently possible. For example it would be possible to get comparative data on medicine combinations, or it would be possible to analyse the prescribing of specific strengths of medicines for certain age groups. However, it was felt that we don t yet have the required expertise to use this data in the robust way required for comparison at a National level. It is proposed to gain the required knowledge over the next twelve months. The final list of twelve National Therapeutic Indicators was presented as an advanced report to NHS Boards in order to inform Prescribing Action Plans for This early release ensured clear awareness of the areas for national focus. This report provides the finalised list of twelve 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 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 Prescribing in general practice in Scotland January 2013 ISBN All Wales Medicines Strategy Group. National Prescribing Indicators (January 2013) 5. NICE. Key therapeutic topics Medicines management options for local implementation(2013) 3

5 THE NATIONAL THERAPEUTIC INDICATORS 2013(in order of BNF chapter): Contents 1. Proton Pump Inhibitors: DDDs per 1,000 patients per day Statins: Simvastatin, atorvastatin & pravastatin as a percentage of all statins (DDDs) a. High Strength Corticosteroid Inhalers: High Strength Corticosteroid Inhalers (including Fostair ) as a percentage of all inhalers (items) b. High Strength Corticosteroid Inhalers: High Strength Corticosteroid Inhalers (excluding Fostair ) as a percentage of all inhalers (items) Hypnotics: Hypnotics and anxiolytics DDD per 1,000 patients per day Analgesics: Pregabalin and gabapentin cost (GIC) per 1,000 patients per day a. Antibiotics: Total antibiotic items per 1,000 patients per day b. 4C Antibiotics: Total fluoroquinolone antibiotics (items per 1,000 patients per 100 days) c. 4C Antibiotics: Total cephalosporin antibiotics (items per 1,000 patients per 100 days) d. 4C Antibiotics: Total co-amoxiclav antibiotic (items per 1,000 patients per 100 days) a. Antidiabetics: Established antidiabetic drugs (metformin & sulphonylureas) as percentage of all anti-diabetic drugs (DDDs) b. Long acting insulin analogues: Long-acting insulin analogues (detemir and glargine) as a % of all intermediate and long-acting insulins (excluding biphasic insulins) (DDDs) Antimicrobial Wound Products: Antimicrobial wound products as percentage of total wound products (items) Key for enclosed graphs: Median dark grey bar Interquartile range grey box Maximum and minimum whiskers, unless greater than 1.5 of interquartile range Outliers - ( ) values of greater than 1.5, but less than 3.0 of interquartile range 1 Extreme outliers ( ) values of greater than 3.0 of interquartile range Reference: 1. Tukey, JW (1977).Exploratory Data Analysis. Addison-Wesley. ISBN

6 Proton Pump Inhibitors This National Therapeutic Indicator focuses on the overall prescribing of proton pump inhibitors (PPI). The total volume of PPI is measured. There is no current evidence suggesting improved efficacy of high-dose, high-cost PPIs when compared to low-dose, low cost PPIs. There are increasing safety concerns about their chronic use, though the MHRA has not yet issued definitive safety advice on this matter. The considerable drivers to prescribe PPIs and the difficulties of withdrawing treatment once commenced are recognised. 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. A PPI should be considered for gastroprotection for patients at high risk of gastro-intestinal complications with a NSAID. 1 The most common use of PPIs in primary care is in the management of dyspepsia. Around 25 to 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 15mg 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 30mg capsule) may be required until symptoms are controlled. Then, asrequired low-dose PPI should be considered. Review of the 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 8 and Clostridium difficile Infection (CDI). Manufacturing patency expiry in 2013 has resulted in more cost-effective versions of esomeprazole and rabeprazole, though their cost remains considerably higher than for first line agents. 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 agent should be used when clinically possible. References: 1. Joint Formulary Committee. British National Formulary. Edition 65, March Zagari RM, et al.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 overdue) 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): * 5

7 1. 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 desired outcome. 500 Proton Pump Inhibitors: DDDs/1,000patients/day Report Period: January 2013 to March A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE DDDs per 1000 patients per day WI SCOTLAND Proton Pump Inhibitors: Lower Upper DDDs/1,000patients/day Minimum Quartile Median Quartile 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

8 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. They reduce cardiovascular 1 disease events and total mortality irrespective of the initial cholesterol concentration. The Heart Protection Study remains the best evidence base for prescribing statins in primary care for secondary and primary prevention. 2 Simvastatin 40mg remains the first line statin. Due to patent expiry in 2012, atorvastatin has 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 (OR 0.86; 95% CI )when used in people at higher risk of cardiovascular disease. 3 Eighteen RCTs were included and patients had an age range of 28 to 97 years. Reductions in allcause mortality, major vascular events and revascularisations were found with no excess of adverse events amongst people without evidence of CVD treated with statins. The NNT of statin versus placebo, to prevent a CV event, is 55, and that to prevent one death is 96. The combination of increased physical activity and taking a statin results in a significantly reduced mortality rate, when compared to either intervention alone. 4 For secondary prevention there is irrefutable evidence that statins reduce all-cause mortality and prevent cardiovascular events. 5 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 80mg/day) compared to moderate (e.g. simvastatin 40mg/day) or low dosing (e.g. simvastatin 20mg/day). 6 This finding is further supported by the double blind randomised SEARCH trial. 7 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). 8 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 support the QOF audit standard target of total cholesterol <5mmol/L. the current NHS Scotland target for individuals at high cardiovascular risk is a TC level of <5mmol/L. This level is consistent with the Quality and 5 Outcomes Framework. Moderate dose simvastatin (simvastatin 40mg) remains the treatment of choice for most patients requiring statin therapy due to current clinical and cost-analysis evidence. With manufacturing licence patent expiry atorvastatin has become a cost-effective alternative. References: 1. Joint Formulary Committee. British National Formulary. Edition 65. March MRC/BHF Heart Protection Study. Lancet 2002;360: Taylor F, et al. Cochrane Database of Systematic Reviews 2013, Issue 1. Art. No.: CD Kokkinos PF, et al. Lancet 2013;381: 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 2008 (reissued March 2010) 7

9 2. Statins: Simvastatin, atorvastatin & pravastatin as a percentage of all statins (DDDs) 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 desired outcome. Percent Simvastatin, Atorvastatin & Pravastatin Simvastatin, atorvastatin & pravastatin as a percentage of total statins (DDDs) Report Period: January 2013 to March % 95% 90% 85% 80% 75% 70% 65% 60% A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE WI SCOTLAND Simvastatin, atorvastatin & pravastatin Lower Upper as a percentage of total statins (DDDs) Minimum Quartile Median Quartile Maximum NHS AYRSHIRE & ARRAN 79.30% 96.24% 97.61% 98.46% 99.67% NHS BORDERS 91.64% 96.74% 97.43% 98.51% 99.23% NHS DUMFRIES & GALLOWAY 89.86% 95.49% 97.10% 98.06% 99.35% NHS FIFE 84.00% 92.00% 94.15% 95.29% 97.92% NHS FORTH VALLEY 85.58% 95.43% 96.99% 98.08% 99.11% NHS GRAMPIAN 78.28% 92.09% 94.37% 96.56% % NHS GREATER GLASGOW & CLYDE 83.14% 97.19% 98.26% 99.09% % NHS HIGHLAND 73.31% 93.39% 96.41% 97.77% % NHS LANARKSHIRE 82.72% 92.88% 95.46% 97.38% % NHS LOTHIAN 88.05% 94.32% 96.13% 97.03% % NHS ORKNEY 81.62% 92.97% 97.83% 99.05% % NHS SHETLAND 71.30% 83.75% 91.81% 97.46% 98.88% NHS TAYSIDE 86.71% 93.30% 94.96% 96.40% 99.56% NHS WESTERN ISLES 61.95% 80.17% 93.04% 97.25% 98.12% SCOTLAND 94.43% 96.60% 98.18% 8

10 High Strength Inhaled Corticosteroids This National Therapeutic Indicator focuses on the safety concerns regarding the inappropriate use of high strength corticosteroid inhalers and the importance of ensuring that the patient s steroid load is kept to the minimum effective level, whilst effectively treating symptoms. It is recognised that there is considerable benefit to appropriate standard dose use of Inhaled Corticosteroids (ICS) and that some patients will require treatment with high dose ICS. The proportion of high strength corticosteroid inhalers prescribed compared with the total amount of inhalers prescribed for asthma or chronic obstructive pulmonary disease (COPD) is measured. 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). 1,2 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). 1,2 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 clinical safety 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. 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: the most concerning is adrenal suppression, but others include - growth failure, reduced bone density, cataracts and glaucoma, anxiety and depression, and diabetes mellitus. 1 Marked adrenal suppression can occur with doses greater than 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. Of particular concern is the use of high dose ICS 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. 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. 2 Two sets of data are presented. One includes Fostair as a high strength ICS, the other excludes Fostair as a high strength ICS. References: 1. Joint Formulary Committee. British National Formulary. Edition 65, March SIGN/BTS British guideline on the management of asthma, May 2008 (revised May 2011) 3. Thomas M et al. Br J Gen Pract 2006;56: MHRA/CSM. Current Problems in Pharmacovigilance2002;28:7-12 * Standard dose ICS: beclometasone& budesonide 200 to 800micrograms; fluticasone 100 to 400micrograms * High dose ICS: beclometasone &budesonide >800 micrograms; fluticasone >400micrograms * For CHILDREN halve the equivalent doses 1,2, 9

11 3a. High Strength Corticosteroid Inhalers: High Strength Corticosteroid Inhalers (including Fostair ) 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. Fostair is included as a high strength corticosteroid. Lower use of High Strength Corticosteroid Inhalers is the desired outcome. High Strength Steroid inhalers (incl Fostair(R)) as a percentage of all Steroid inhalers (items) Percent High Strength Steroid Inhalers 90% 80% 70% 60% 50% 40% 30% 20% 10% Report Period: January 2013 to March % A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE WI SCOTLAND High Strength Steroid inhalers (incl Fostair ) as a percentage of all Steroid inhalers (items) Minimum Lower Quartile Median Upper Quartile Maximum NHS AYRSHIRE & ARRAN 8.38% 34.73% 40.98% 48.38% 60.83% NHS BORDERS 24.03% 39.13% 44.25% 53.35% 61.80% NHS DUMFRIES & GALLOWAY 14.20% 26.46% 32.42% 38.05% 64.32% NHS FIFE 15.91% 38.41% 44.03% 48.46% 60.99% NHS FORTH VALLEY 13.90% 42.92% 51.99% 56.22% 72.06% NHS GRAMPIAN 20.37% 38.49% 43.11% 49.29% 78.95% NHS GREATER GLASGOW & CLYDE 13.62% 31.22% 38.94% 44.54% 70.04% NHS HIGHLAND 0.00% 31.91% 42.84% 49.45% 82.00% NHS LANARKSHIRE 13.21% 32.70% 38.09% 48.79% 69.53% NHS LOTHIAN 23.97% 41.66% 48.24% 54.07% 78.57% NHS ORKNEY 10.27% 34.03% 37.34% 49.06% 68.09% NHS SHETLAND 9.13% 21.25% 22.57% 32.44% 44.29% NHS TAYSIDE 27.20% 38.37% 45.56% 49.20% 62.43% NHS WESTERN ISLES 2.86% 28.20% 36.20% 50.87% 75.76% SCOTLAND 34.71% 42.05% 49.18% 10

12 3b. High Strength Corticosteroid Inhalers: High Strength Corticosteroid Inhalers (excluding Fostair ) 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. Fostair is excluded as a high strength corticosteroid. Lower use of High Strength Corticosteroid Inhalers is the desired outcome. High Strength Steroid inhalers (not Fostair(R)) as a percentage of all Steroid inhalers (items) Percent High Strength Steroid Inhalers 90% 80% 70% 60% 50% 40% 30% 20% 10% Report Period: January 2013 to March % A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE WI SCOTLAND High Strength Steroid inhalers (not Fostair ) as a percentage of all Steroid inhalers (items) Minimum Lower Quartile Median Upper Quartile Maximum NHS AYRSHIRE & ARRAN 8.38% 33.12% 39.22% 46.65% 60.00% NHS BORDERS 17.09% 35.93% 38.57% 43.05% 59.94% NHS DUMFRIES & GALLOWAY 12.78% 19.69% 26.87% 32.00% 62.56% NHS FIFE 15.37% 36.19% 41.41% 46.54% 59.69% NHS FORTH VALLEY 12.90% 42.92% 50.44% 55.59% 72.06% NHS GRAMPIAN 20.00% 36.16% 41.23% 47.65% 62.59% NHS GREATER GLASGOW & CLYDE 13.31% 29.38% 37.19% 42.42% 68.44% NHS HIGHLAND 0.00% 30.76% 42.49% 49.45% 80.00% NHS LANARKSHIRE 6.60% 28.62% 35.32% 44.34% 67.46% NHS LOTHIAN 19.83% 36.92% 43.29% 50.49% 71.43% NHS ORKNEY 10.27% 34.03% 37.34% 49.06% 68.09% NHS SHETLAND 9.13% 21.23% 22.17% 32.44% 44.29% NHS TAYSIDE 24.27% 35.70% 41.69% 46.43% 60.69% NHS WESTERN ISLES 2.86% 27.08% 35.03% 50.32% 75.76% SCOTLAND 31.84% 39.57% 47.06% 11

13 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-regarded 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 confounders 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 their 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 88% of cases are secondary and treatment of the underlying cause should be sought: depression and/or anxiety (50%); physical illness affecting sleep (43%); restless leg syndrome (22%); sleep apnoea (excessive day time sleepiness) (9%); delayed sleep phase syndrome (2%). 3 For primary insomnia, 30% of cases improve with sleep hygiene. Bed-time restriction has also been shown to be a beneficial treatment. 2 Hypnotics are not particularly effective for treating insomnia and have a high potential to cause harm. 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). 4 There is clear evidence demonstrating the link between benzodiazepine use and an increased risk of developing dementia. 5 This is a powerful argument to dissuade the use of these drugs by older adults. A Norwegian study found that taking a hypnotic increased the risk of having a road traffic accident (RTA) four-fold. 6 This finding has been confirmed by a more recent French study. 7 Data from the USA show that there is an association between hip fracture rate and taking a benzodiazepine. 8 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. Z drugs offer no therapeutic advantages. There are no significant differences in perceptions of efficacy or side-effects when patients use and experiences of Z drugs are compared with benzodiazepines. 9 Reported prescribing practices were often at variance with the licence for shortterm 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 65, March Falloon K, et al. BMJ2011;342:d Arroll, et al.bjgp2012;62:e99-e103(5) 4. Glass J, et al.bmj 2005; 331: Billioti de Gage S, et al. BMJ2012;345:e Gustavsen I et al. Sleep Med2008; 9: Orriols L, et al.clinical Pharmacology and Therapeutics. 2011; 89(4): Wagner AK et al.arch Intem Med 2004; 164: Siriwardena AN et al. BJGP 2008; 58:

14 4. Hypnotics: Hypnotics and anxiolytics DDD per 1,000 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 desired outcome. 300 Hypnotics and anxiolytics: DDDs/1,000patients/day Report Period: January 2013 to March A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE DDDs per 1000 patients per day WI SCOTLAND Hypnotics and anxiolytics: Lower Upper DDDs/1,000patients/day Minimum Quartile Median Quartile 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 Analgesics This National Therapeutic Indicator looks at the use of antiepileptics in the treatment of neuropathic pain. The aim is to promote the use of the most cost-effective product choice for gabapentin and pregabalin. The total spend on gabapentin and pregabalin is measured. It has been estimated that up to 8% of the European population is affected by neuropathic pain, the two most common causes of which are peripheral diabetic neuropathy and post-herpetic neuralgia. The other common group of patients are those with chronic low back pain where there is a combination of inflammatory and neuropathic pain. 1 Gabapentin and pregabalin are antiepileptics with a licence in the UK for the treatment of neuropathic pain. The Scottish Medicines Consortium has advised (April 2009) that pregabalin is accepted for restricted use within NHS Scotland for the treatment of peripheral neuropathic pain only. Its use is acceptable only when first and second line treatments are unsuccessful. Treatment should be discontinued if sufficient benefit is not achieved after 8 weeks of the maximum tolerated dose. The SIGN 116 (March 2010) guideline on The Management of Diabetes recommends that the initial treatment of Diabetic Peripheral Neuropathy is dependent on individual patient choice, dosing regimens, cost and side-effect profile. Options include antidepressants (tricyclic s, duloxetine and venlafaxine), anticonvulsants (pregabalin and gabapentin) and opiate analgesics in combination with gabapentin. 2 The NICE CG96 (2010) Guideline on Neuropathic Pain controversially recommended the use of pregabalin ahead of gabapentin. NICE are currently reviewing the economic modelling behind this recommendation as the cost of pregabalin is so much greater than that of gabapentin, which is now available as a non-proprietary product. 3 A key recommendation of the guideline is the importance of dose titration and provision of written guidance where possible. It is also important to counsel patients that the aim of treatment is to reduce the severity of pain, and that they should not expect complete resolution. Subsequent to both the SIGN and NICE guidelines has been a Cochrane systematic review confirming the efficacy of gabapentin. 4 At a dose of at least 900 mg gabapentin provides substantial pain relief in about a third of people who take it for neuropathic pain (NNT 7). Adverse events are frequent, but mostly tolerable. More patients on a daily dose of 1200 mg, or greater, withdrew due to side effects (NNH 32). A systematic review of pregabalin use to treat neuropathic pain demonstrated that a minority of patients will have substantial benefit, and more will have moderate benefit (NNT 6) 5. Many will have no or trivial benefit, or discontinue due to adverse events. In the subgroup of patients with painful diabetic neuropathy, more on a daily dose of 600 mg withdrew treatment due to side effects (NNH 9). Pregabalin has a flat pricing structure and so prescribing multiples of lower strength capsules increases costs by 1.15 per additional capsule. Gabapentin mid-range strengths (100mg, 300mg and 400mg) are the most cost-effective. For example, at the time of this report switching 1X800mg to 2X400mg reduces the cost by 15p per dose. References: 1. DTB : doi: /dtb SIGN 116 The Management of Diabetes, March 2010 ISBN NICE CG 96 Neuropathic pain: the pharmacological management of neuropathic pain in adults in non-specialist settings, March Moore RA et al.cochrane Database Syst Rev 2011; 3: CD DOI: / CD pub2 5. Moore RA et al. Cochrane Database Syst Rev 2009; 3: CD DOI: / CD pub2 14

16 5. Analgesics: Pregabalin and gabapentin cost (GIC) per 1,000 patients per day This indicator measures the gross ingredient cost (GIC) of gabapentin and pregabalin. The total cost (GIC) is then normalised to allow comparison between practices using the practice s registered population. A further level of normalisation is then applied, which calculates the standard time period. Lower overall cost of gabapentin and pregabalin is the desired outcome. 50 Pregabalin and Gabapentin (Cost/1,000patients/day) Report Period: January 2013 to March A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE Cost per 1000 patients per day WI SCOTLAND Pregabalin and Gabapentin Lower Upper (Cost/1,000patients/day) Minimum Quartile Median Quartile 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

17 Antibiotics This indicator is proposed and supported by the Scottish Antimicrobial Prescribing Group (SAPG). 1 Reductions 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 and 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 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 throughout all sectors of healthcare. 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 restriction in the use of broad-spectrum antibiotics. NHS Boards are required by Audit Scotland to report on what they are doing to reduce antibiotic use in Primary Care. This approach is further supported by the introduction of a level 3 HEAT target to reduce total antibiotic use. 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 Respiratory Tract Infections, 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):

18 6a. Antibiotics: Total antibiotic 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 desired outcome. 14 Antibiotics: Items/1,000patients/day Report Period: January 2013 to March A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE Items per 1000 patients per day WI SCOTLAND Lower Upper Antibiotics: Items/1,000patients/day Minimum Quartile Median Quartile 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 6b. 4C Antibiotics: Total fluoroquinolone antibiotics (items per 1,000 patients per 100 days) This indicator measures the frequency of prescribing of fluoroquinolone 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 fluoroquinolones is the desired outcome. 30 Fluoroquinolone Antibiotics: Items/1,000patients/100days Report Period: January 2013 to March A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE Items per 1000 patients per 100 days WI SCOTLAND Fluoroquinolone Antibiotics: Lower Upper Items/1,000patients/100days Minimum Quartile Median Quartile 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

20 6c. 4C Antibiotics: Total cephalosporin antibiotics (items per 1,000 patients per 100 days) This indicator measures the frequency of prescribing of cephalosporin 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 cephalosporin antibiotics is the desired outcome. 35 Cephalosporin Antibiotics: Items/1,000patients/100days Report Period: January 2013 to March A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE Items per 1000 patients per 100 days WI SCOTLAND Cephalosporin Antibiotics: Lower Upper Items/1,000patients/100days Minimum Quartile Median Quartile 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 6d. 4C Antibiotics: Total co-amoxiclav antibiotic (items per 1,000 patients per 100 days) This indicator measures the frequency of prescribing of the antibiotic co-amoxiclav. 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 antibiotic co-amoxiclav is the desired outcome. 45 Co-amoxiclav: Items/1,000patients/100days Report Period: January 2013 to March A&A BORDERS D&G FIFE FV GRAMPIAN GGC HIGHLAND LANARKSHIRE LOTHIAN ORKNEY SHETLAND TAYSIDE Items per 1000 patients per 100 days WI SCOTLAND Co-amoxiclav: Lower Upper Items/1,000patients/100days Minimum Quartile Median Quartile 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

22 Antidiabetic Drugs This National Therapeutic Indicator has been developed with support from the national Diabetes Managed Clinical Network. The rational for its use is that metformin remains the only hypoglycaemic agent for which we have clear positive patient orientated outcomes. 1 In addition the importance of lipid lowering and blood pressure control over blood glucose control for type two diabetics is highlighted. The proportion of metformin and sulphonylureas compared to the total antidiabetic drugs is measured. Antidiabetic drugs should be used to augment the effect of diet and exercise, not replace it. 2 Metformin is a biguanide that decreases gluconeogenesis and increases peripheral utilisation of glucose. It only works in the presence of endogenous insulin and so requires residual functioning pancreatic islet cells. Sulphonylureas augment insulin secretion and so also require residual pancreatic islet cell functioning. They uncommonly cause hypoglycaemia, which if occurs should be considered for treatment in hospital. Pioglitazone is a thiazolidinedione that reduces peripheral insulin resistance. It should not be used in patients with heart failure. The DPP4 (dipeptidylpeptidase-4) inhibitors, ( gliptins ), increase insulin secretion and lower glucagon secretion. The GLP-1 (glucagon-like-peptide-1) agonists increase insulin secretion, suppress glucagon secretion and slow gastric emptying. The QOF HbA 1c target has increased to 59mmol/L (7.5%). The Cardiff UK GPRD Study was a retrospective cohort study that showed a HbA 1c of 59mmol/L (7.5%) was the lowest risk for all cause mortality. 4 Increase above or decrease below this level is associated with an increased risk of all cause mortality. A recent meta-analysis looked at the effects of intensive glucose lowering on all-cause mortality, cardiovascular death and micro-vascular complications. 5 Intensive treatment had no significant effect on allcause mortality or cardiovascular death, although risk of non-fatal myocardial infarction was reduced (NNT = 117) as was the risk of developing microalbuminuria (NNT = 32). However, the risk of severe hypoglycaemia was doubled (NNH = 15). The result of this meta-analysis should also be put in the context of the relationship between reductions in cholesterol, blood pressure and HbA 1c with improvements in coronary heart disease and cardiovascular outcomes 6. It has been calculated that the absolute reduction in cardiovascular events prevented by the different interventions per 1,000 patients per one year of treatment are: Lowering HbA 1c by 1% = 3 events prevented Lowering LDL by 1 mmol/l = 8 events prevented Lowering BP by 10/5mmHg = 12 events prevented 7 the emphasis in type 2 diabetes should remain on tight control of lipids and blood pressure with reasonable but not exaggerated attempts to control glycaemia. 8 The management of type 2 diabetes should emphasise diet and increased activity. Lipid lowering and BP control should be managed optimally when such treatment is required. Metformin should be the first line agent followed by sulphonylureas. Pioglitazone, DPP4 inhibitors and GLP1 agonists should be considered as third line agents with unique merits and weaknesses, and in the context of the risks of intensive HbA 1c lowering. Reference: 1. Holman RR, et al. N Engl J Med 2008;359: Joint Formulary Committee. British National Formulary. Edition 65. March Balkau B, et al. Lancet 2010;375(9713): Boussageon R, et al.bmj2011;343:d Yudkin JS, et al. Daibetologia 2010;53: Preiss D, et al. BMJ 2011;343:d Opie LH. Lancet 2011;378(9713):103 21