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This is a two phase project. First a Modified Delphi consensus process of three rounds will be used to build a databases assessment tool. In the second phase the accessibility and usability of this National DU Databases Appraisal Tool will be tested using questionnaires.

Sales of medicines continue to grow world-wide driven in part by increasing expenditures on biological medicines leading to concerns with the long-term sustainability of European healthcare systems. The increasing use of biosimilars at lower costs can potentially address this. However, there can be concerns with their prescribing. There are also concerns with biosimilar insulin glargine including concerns with different devices despite increasing sales of long-acting insulin analogues worldwide. Consequently, a need to appraise the European biosimilar market incorporating measures to enhance their use including potential ways to increase the prescribing of biosimilars of insulin glargine at lower costs. Multiple approaches were used to undertake the study including measures to enhance biosimilar use and their impact across Europe. In addition, undertake cross national research on the utilization and expenditure of long-acting insulin analogues, which includes biosimilars, principally among Central and Eastern European countries. Multiple demand-side measures across countries have enhanced the use of biosimilars. There was variable use of biosimilar insulin glargine 100IU/ml driven by increasing use of patented 300IU/ml formulations and small price differences between the originator and biosimilars in practice. Overall, multiple demand-side initiatives can appreciably increase biosimilar use benefiting all groups. Additional measures are needed to enhance future prescribing of long-acting biosimilar insulin analogues.

Sales of medicines continue to grow world-wide driven in part by increasing expenditures on biological medicines leading to concerns with the long-term sustainability of European healthcare systems. The increasing use of biosimilars at lower costs can potentially address this. However, there can be concerns with their prescribing. There are also concerns with biosimilar insulin glargine including concerns with different devices despite increasing sales of longacting insulin analogues worldwide. Consequently, a need to appraise the European biosimilar market incorporating measures to enhance their use including potential ways to increase the prescribing of biosimilars of insulin glargine at lower costs. Multiple approaches were used to undertake the study including researching measures to enhance biosimilar use and their impact across Europe. In addition, undertake cross national research on the utilization and expenditure of long-acting insulin analogues, which includes biosimilars, principally among Central and Eastern European countries. Multiple demand-side measures across the countries have enhanced the use of biosimilars. There was variable use of biosimilar insulin glargine 100 IU/ml driven by increasing use of patented 300 IU/ml formulations and small price differences between the originator and biosimilars in practice. Overall, multiple demand-side initiatives can appreciably increase biosimilar use benefiting all groups. Additional measures are needed to enhance future prescribing of long-acting biosimilar insulin analogues., peer-reviewed

Objective: Global expenditure on medicines is increasing driven by a number of factors. These include the launch of new premium-priced medicines for complex diseases including oncology, rise in non-communicable diseases especially with ageing populations and changes in clinical practice. There are also concerns with the rise in antimicrobial resistance due to inappropriate prescribing of antimicrobials as well as concerns with polypharmacy. Both situations increase morbidity, mortality and costs. We are aware of ongoing activities across Scotland to improve the managed entry of new medicines, including new oncology medicines, improve the prescribing of antimicrobials as well as enhance the prescribing of low-cost multiple sourced medicines and biosimilars without compromising care. In addition, seeking to address concerns with polypharmacy. Consequently, we wanted to document these multiple measures and their outcomes to provide an overview to inform all key stakeholders in Scotland as well as the global community as resource pressures grow. Methods: A narrative review of the literature documenting examples of ongoing national and regional initiatives across Scotland to influence future prescribing and their impact where known across multiple disease areas. Significant findings: The co-ordinated approach to improve the prescribing of new medicines limited the prescribing of dabigatran when first launched with recent research providing guidance on the effectiveness and safety of different direct oral anticoagulants as more are launched. The patient reported outcome measures project and other ongoing research activities, including linking datasets, is progressing under the Cancer Medicines Outcomes Programme in Scotland to improve future care with typically differences in the effectiveness of new cancer medicines in routine care versus clinical trials. The Scottish Antimicrobial Prescribing Group is also active in Scotland instigating multiple measures to improve antimicrobial prescribing. This includes improving the dosing of gentamicin and vancomycin as well as reducing the prescribing of antibiotics for women with urinary tract infections. Multiple activities have also resulted in high International Non-proprietary Name (INN) prescribing in Scotland at between 91.4% to 100% across a range of medicines. In addition, increased the prescribing of low-cost multiple sourced medicines versus patented medicines in a class or related class, as well as biosimilars, leading to considerable savings without compromising care. There have also been initiatives to address concerns with the rising costs of combination inhalers for patients with respiratory diseases as well as areas of polypharmacy with varying success. Conclusion: Multiple and co-ordinated approaches have improved the quality and efficiency of prescribing in Scotland. Additional measures are still needed and we will continue to monitor the situation.

Introduction: The growing prevalence of non-communicable diseases, combined with greater recognition of the effectiveness of lipid lowering agents (LLAs), has fueled their increasing use in recent years. Similarly, increasing recognition of mental health and, arguably, societal expectations and pressures has driven appreciable growth in antidepressant prescribing in recent years. Concurrent with this, growing resource pressures enhanced by the continual launch of new premium priced medicines necessitates reforms and initiatives within finite budgets. Scotland has introduced multiple measures in recent years to improve both the quality and efficiency of prescribing. There is a need to document these initiatives and outcomes to provide future direction. Method: Assessment of the utilization (items dispensed) and expenditure of key LLAs (mainly statins) and SSRIs between 2001 and 2017 in Scotland alongside initiatives. Results: Multiple interventions have increased international non-proprietary name (INN) prescribing (99% for statins and up to 99.9% for SSRIs). They have also increased preferential prescribing of generic versus patented statins with low costs for generics, reduced inappropriate prescribing of ezetimibe due to effectiveness concerns, and increased the prescribing of higher dose statins (71% in 2015). These measures have resulted in a 50% reduction in LLA expenditure between 2001 and 2015 despite a 412% increase in utilization. Initiatives to reduce the prescribing of escitalopram as lack of evidence demonstrating cost-benefits over generic citalopram, along with high INN prescribing, achieved a 73.7% reduction in SSRI expenditure between 2001 and 2017 despite a 2.34-fold increase in utilisation. Concerns with paroxetine, and more recently citalopram and escitalopram following safety warnings, resulted in a considerable reduction in their use alongside a significant increase in sertraline. Conclusion: Generic availability coupled with multiple measures has resulted in appreciable shifts in statin and SSRI prescribing behavior and reduced ezetimibe prescribing, resulting in improvements in both the quality and efficiency of prescribing to provide future direction.

Background: Based on recent clinical trial evidence, updated treatment guidelines in the UK recommend high-intensity statin therapy (atorvastatin 80mg) for secondary prevention of cardiovascular disease. However, with this high statin dose, there are concerns about a potential increase in the incidence of statin-related side effects, which might affect patients’ adherence and, in turn, clinical outcomes. Hence, this study aimed to evaluate the effect of statin intensity on adherence and persistence to therapy. Objectives: To evaluate adherence, discontinuation, and persistence to high-intensity statin in comparison to moderate and low-intensity in Scotland. Methods: Retrospective cohort study using linked health records. The study population included patients (≥ 18 years) initiated on statins between January 2010 and December 2015. Statin treatment was stratified into high, moderate, and low-intensity based on the current National Institute for Health and Care Excellence classifications. Treatment discontinuation and persistence were evaluated using the refill-gap and anniversary methods, respectively; adherence was assessed by calculating the proportion of days covered (PDC). Results: A total of 73,716 patients (mean age 62 years [SD 12.6]) initiated statins during the study period: high-intensity n=7,163 (9.7%), moderate-intensity n=65,125 (88.3%), and low-intensity n=1,428 (1.9%). High-intensity therapy was more common among males (10.7%) than females (8.6%), and most common (17.1%) in the youngest age group (18 – 24 years). The majority of patients initiating high-intensity treatment received either atorvastatin 20mg (43.1%) or 40mg (32.3%), while 22.8% received atorvastatin 80mg. Crude discontinuation rates (50.9% high-intensity versus 75.5% low-intensity) and 1-year persistence (74.7% high-intensity versus 53.1% low-intensity) differed significantly between intensity levels; crude adherence (PDC ≥ 80%) was highest among high-intensity patients with 63.7%, compared to 51.6% and 40.5% in moderate and low-intensity, respectively. Conclusion: Increasing the intensity of statin therapy does not seem to negatively impact adherence and persistence to treatment, although findings could be due to confounders (e.g. primary versus secondary prevention) and/or the low proportion of patients using the recommended high dose statin. Further analysis is ongoing to adjust for confounders, and to evaluate clinical outcomes associated with high-intensity statin therapy.

Objectives High-risk prescribing in primary care is common and causes considerable harm, with for example, ~6% of emergency hospital admissions caused by adverse drug effects. Our aim is to rigorously develop and evaluate complex interventions to improve primary care prescribing safety using routine clinical and administrative data. Approach Co-design of interventions by joint academic and clinical teams with implementation embedded in NHS Scotland information and contractual systems. Routine data from general practice electronic medical records (EMRs) or from the NHS Scotland prescribing payment system are used to both underpin the interventions and allow evaluation. Two cluster-randomised trials in 295 general practices have been completed (EFIPPS and DQIP), and two trials in 298 practices are in progress (EPIPP and POEMS), involving ~55% of Scottish general practices in total. The completed EFIPPS trial was a three-arm cluster randomised trial of a routine data feedback intervention +/- a theory-informed behaviour intervention involving 262 (~95%) of practices in three health boards. The completed DQIP trial was a stepped-wedge cluster randomised trial in 33 (50%) practices in one Health Board, the intervention comprising a web-based informatics tool to identify patients needing review from practice EMRs and to facilitate and structure review, an educational outreach visit, and financial incentives to review patients. EPIPP is evaluating a more complex feedback intervention, where both arms receive an active intervention on a different topic, involving all 242 practices in one Health Board. POEMS is evaluating an ‘enhanced medication summary’ to support contractually required-polypharmacy reviews in older people taking 10 or more regular medications, involving all 56 practices in one Health Board. Results The simpler EFIPPS intervention reduced high-risk prescribing by 12% by 15 months after feedback started. We are currently examining what happened in the year after feedback ceased. The more intensive DQIP intervention reduced high-risk prescribing by 37% at 12 months. This effect was sustained in the 12 months after the financial incentives ceased because the intervention reduced new high-risk prescribing. The DQIP intervention also led to large reductions in related emergency hospital admissions with gastrointestinal bleeding, acute kidney injury and heart failure. Conclusion We have shown that informatics-based interventions using routine data and co-designed with clinicians and managers are effective in improving primary care prescribing safety. The presentation will describe our approach to intervention development and implementation, show examples of the interventions, and present outcomes and process evaluation data from the two completed trials.