Richard Croker

Trends, geographical variation and factors associated with prescribing of gluten-free foods in English primary care: a cross-sectional study.

Objectives There is substantial disagreement about whether gluten-free foods should be prescribed on the National Health Service. We aim to describe time trends, variation and factors associated with prescribing gluten-free foods in England. Setting English primary care. Participants English general practices. Primary and secondary outcome measures We described long-term national trends in gluten-free prescribing, and practice and Clinical Commissioning Group (CCG) level monthly variation in the rate of gluten-free prescribing (per 1000 patients) over time. We used a mixed-effect Poisson regression model to determine factors associated with gluten-free prescribing rate. Results There were 1.3 million gluten-free prescriptions between July 2016 and June 2017, down from 1.8 million in 2012/2013, with a corresponding cost reduction from £25.4 million to £18.7 million. There was substantial variation in prescribing rates among practices (range 0 to 148 prescriptions per 1000 patients, IQR 7.3–31.8), driven in part by substantial variation at the CCG level, likely due to differences in prescribing policy. Practices in the most deprived quintile of deprivation score had a lower prescribing rate than those in the highest quintile (incidence rate ratio 0.89, 95% CI 0.87 to 0.91). This is potentially a reflection of the lower rate of diagnosed coeliac disease in more deprived populations. Conclusion Gluten-free prescribing is in a state of flux, with substantial clinically unwarranted variation between practices and CCGs.

The clinician impact and financial cost to the NHS of litigation over pregabalin: an economic impact analysis

Objectives Following litigation over pregabalin’s second-use medical patent for neuropathic pain NHS England were required by the court to instruct GPs to prescribe the branded form (Lyrica) for pain. Pfizer’s patent was found invalid in 2015; a ruling subject to ongoing appeals. If the Supreme Court appeal in February 2018 is unsuccessful, the NHS can reclaim excess prescribing costs. We set out to describe the variation in prescribing of pregabalin as branded Lyrica, geographically and over time; to determine how clinicians responded to the NHS England instruction to GPs; and to model excess costs to the NHS attributable to the legal judgments. Setting English primary care Participants English general practices Primary and secondary outcome measures Variation in prescribing of branded Lyrica across the country before and after the NHS England instruction, by practice and by Clinical Commissioning Group (CCG); excess prescribing costs. Results The proportion of pregabalin prescribed as Lyrica increased, from 0.3% over six months before the NHS England instruction (September 2014-February 2015) to 25.7% afterwards (April - September 2015). Although 70% of pregabalin is estimated to be for neuropathic pain, only 11.6% of practices prescribed Lyrica at this level; the median proportion prescribed as Lyrica was 8.8% (IQR 1.1-41.9%). If pregabalin had come entirely off patent in September 2015, and Pfizer had not appealed, we estimate the NHS would have spent £502m less on pregabalin to July 2017. Conclusion NHS England instructions to GPs regarding branded prescription of pregabalin were widely ignored, and have created much debate around clinical independence in prescribing. Protecting revenue from “skinny labels” will pose a challenge. If Pfizer’s final appeal on the patent is unsuccessful the NHS can seek reimbursement of excess pregabalin prescribing costs, potentially £502m.

Is use of homeopathy associated with poor prescribing in English primary care? A cross-sectional study

Objectives Prescribing of homeopathy still occurs in a small minority of English general practices. We hypothesised that practices that prescribe any homeopathic preparations might differ in their prescribing of other drugs. Design Cross-sectional analysis. Setting English primary care. Participants English general practices. Main outcome measures We identified practices that made any homeopathy prescriptions over six months of data. We measured associations with four prescribing and two practice quality indicators using multivariable logistic regression. Results Only 8.5% of practices (644) prescribed homeopathy between December 2016 and May 2017. Practices in the worst-scoring quartile for a composite measure of prescribing quality (>51.4 mean percentile) were 2.1 times more likely to prescribe homeopathy than those in the best category (<40.3) (95% confidence interval: 1.6–2.8). Aggregate savings from the subset of these measures where a cost saving could be calculated were also strongly associated (highest vs. lowest quartile multivariable odds ratio: 2.9, confidence interval: 2.1–4.1). Of practices spending the most on medicines identified as ‘low value’ by NHS England, 12.8% prescribed homeopathy, compared to 3.9% for lowest spenders (multivariable odds ratio: 2.6, confidence interval: 1.9–3.6). Of practices in the worst category for aggregated price-per-unit cost savings, 12.7% prescribed homeopathy, compared to 3.5% in the best category (multivariable odds ratio: 2.7, confidence interval: 1.9–3.9). Practice quality outcomes framework scores and patient recommendation rates were not associated with prescribing homeopathy (odds ratio range: 0.9–1.2). Conclusions Even infrequent homeopathy prescribing is strongly associated with poor performance on a range of prescribing quality measures, but not with overall patient recommendation or quality outcomes framework score. The association is unlikely to be a direct causal relationship, but may reflect underlying practice features, such as the extent of respect for evidence-based practice, or poorer stewardship of the prescribing budget.

Trends and variation in prescribing of low-priority treatments identified by NHS England: a cross-sectional study and interactive data tool in English primary care:

Objectives NHS England recently announced a consultation seeking to discourage the use of treatments it considers to be low-value. We set out to produce an interactive data resource to show savings in each NHS general practice and to assess the current use of these treatments, their change in use over time, and the extent and reasons for variation in such prescribing. Design Cross-sectional analysis. Setting English primary care. Participants English general practices. Main outcome measures We determined the cost per 1000 patients for prescribing of each of 18 treatments identified by NHS England for each month from July 2012 to June 2017, and also aggregated over the most recent year to assess total cost and variation among practices. We used mixed effects linear regression to determine factors associated with cost of prescribing. Results Spend on low-value treatments was £153.5 m in the last year, across 5.8 m prescriptions (mean, £26 per prescription). Among individual treatments, liothyronine had the highest prescribing cost at £29.6 m, followed by trimipramine (£20.2 m). Over time, the overall total number of low-value prescriptions decreased, but the cost increased, although this varied greatly between treatments. Three treatment areas increased in cost and two increased in volume, all others reduced in cost and volume. Annual practice level spending varied widely (median, £2262 per thousand patients; interquartile range £1439 to £3298). Proportion of patients over 65 was strongly associated with low-value prescribing, as was Clinical Commissioning Group. Our interactive data tool was deployed to OpenPrescribing.net where monthly updated figures and graphs can be viewed. Conclusions Prescribing of low-value treatments is extensive but varies widely by treatment, geographic area and individual practice. Despite a fall in prescription numbers, the overall cost of prescribing for low-value items has risen. Prescribing behaviour is clustered by Clinical Commissioning Group, which may represent variation in the optimisation efficiency of medicines, or in some cases access inequality.

The clinician impact and financial cost to the NHS of litigation over pregabalin: a cohort study in English primary care

Objectives Following litigation over pregabalin’s second-use medical patent for neuropathic pain, National Health Service (NHS) England was required by the court to instruct general practitioners (GPs) to prescribe the branded form (Lyrica) for pain. Pfizer’s patent was found invalid in 2015, a ruling subject to ongoing appeals. If the Supreme Court appeal in February 2018, whose judgement is awaited, is unsuccessful, the NHS can seek to reclaim excess prescribing costs. We set out to describe the variation in prescribing of pregabalin as branded Lyrica, geographically and over time; to determine how clinicians responded to the NHS England instruction to GPs; and to model excess costs to the NHS attributable to the legal judgements. Setting English primary care. Participants English general practices. Primary and secondary outcome measures Variation in prescribing of branded Lyrica across the country before and after the NHS England instruction, by practice and by Clinical Commissioning Group; excess prescribing costs. Results The proportion of pregabalin prescribed as Lyrica increased from 0.3% over 6 months before the NHS England instruction (September 2014 to February 2015) to 25.7% afterwards (April to September 2015). Although 70% of pregabalin is estimated to be for pain, including neuropathic pain, only 11.6% of practices prescribed Lyrica at this level; the median proportion prescribed as Lyrica was 8.8% (IQR 1.1%–41.9%). If pregabalin had come entirely off patent in September 2015, and Pfizer had not appealed, we estimate the NHS would have spent £502 million less on pregabalin to July 2017. Conclusion NHS England instructions to GPs regarding branded prescription of pregabalin were widely ignored and have created much debate around clinical independence in prescribing. Protecting revenue from ‘skinny labels’ will pose a challenge. If Pfizer’s final appeal on the patent is unsuccessful, the NHS can seek reimbursement of excess pregabalin prescribing costs, potentially £502 million.

New mechanism to identify cost savings in English NHS prescribing: minimising ‘price per unit’, a cross-sectional study

Background Minimising prescription costs while maintaining quality is a core element of delivering high-value healthcare. There are various strategies to achieve savings, but almost no research to date on determining the most effective approach. We describe a new method of identifying potential savings due to large national variations in drug cost, including variation in generic drug cost, and compare these with potential savings from an established method (generic prescribing). Methods We used English National Health Service (NHS) Digital prescribing data, from October 2015 to September 2016. Potential cost savings were calculated by determining the price per unit (eg, pill, millilitre) for each drug and dose within each general practice. This was compared against the same cost for the practice at the lowest cost decile to determine achievable savings. We compared these price-per-unit savings to the savings possible from generic switching and determined the chemicals with the highest savings nationally. A senior pharmacist manually assessed whether a random sample of savings were practically achievable. Results We identified a theoretical maximum of £410 million of savings over 12 months. £273 million of these savings were for individual prescribing changes worth over £50 per practice per month (mean annual saving £33 433 per practice); this compares favourably with generic switching, where only £35 million of achievable savings were identified. The biggest savings nationally were on glucose blood testing reagents (£12 million), fluticasone propionate (£9 million) and venlafaxine (£8 million). Approximately half of all savings were deemed practically achievable. Discussion We have developed a new method to identify and enable large potential cost savings within NHS community prescribing. Given the current pressures on the NHS, it is vital that these potential savings are realised. Our tool enabling doctors to achieve these savings is now launched in pilot form at OpenPrescribing.net. However, savings could potentially be achieved more simply through national policy change.

Why did some practices not implement new antibiotic prescribing guidelines on urinary tract infection? A cohort study and survey in NHS England primary care

Objectives To describe prescribing trends and geographic variation for trimethoprim and nitrofurantoin; to describe variation in implementing guideline change; and to compare actions taken to reduce trimethoprim use in high- and low-using Clinical Commissioning Groups (CCGs). Design A retrospective cohort study and interrupted time series analysis in English NHS primary care prescribing data; complemented by information obtained through Freedom of Information Act requests to CCGs. The main outcome measures were: variation in practice and CCG prescribing ratios geographically and over time, including an interrupted time-series; and responses to Freedom of Information requests. Results The amount of trimethoprim prescribed, as a proportion of nitrofurantoin and trimethoprim combined, remained stable and high until 2014, then fell gradually to below 50% in 2017; this reduction was more rapid following the introduction of the Quality Premium. There was substantial variation in the speed of change between CCGs. As of April 2017, for the 10 worst CCGs (with the highest trimethoprim ratios): 9 still had trimethoprim as first line treatment for uncomplicated UTI (one CCG had no formulary); none had active work plans to facilitate change in prescribing behaviour away from trimethoprim; and none had implemented an incentive scheme for change in prescribing behaviour. For the 10 best CCGs: 2 still had trimethoprim as first line treatment (all CCGs had a formulary); 5 (out of 7 who answered this question) had active work plans to facilitate change in prescribing behaviour away from trimethoprim; and 5 (out of 10 responding) had implemented an incentive scheme for change in prescribing behaviour. 9 of the best 10 CCGs reported at least one of: formulary change, work plan, or incentive scheme. None of the worst 10 CCGs did so. Conclusions Many CCGs failed to implement an important change in antibiotic prescribing guidance; and report strong evidence suggesting that CCGs with minimal prescribing change did little to implement the new guidance. We strongly recommend a national programme of training and accreditation for medicines optimisation pharmacists; and remedial action for CCGs that fail to implement guidance; with all materials and data shared publicly for both such activities.

Measuring the Impact of an Open Online Prescribing Data Analysis Service on Clinical Practice: a Cohort Study in NHS England Data (Preprint)

Background OpenPrescribing is a freely accessible service that enables any user to view and analyze the National Health Service (NHS) primary care prescribing data at the level of individual practices. This tool is intended to improve the quality, safety, and cost-effectiveness of prescribing. Objective We aimed to measure the impact of OpenPrescribing being viewed on subsequent prescribing. Methods Having preregistered our protocol and code, we measured three different metrics of prescribing quality (mean percentile across 34 existing OpenPrescribing quality measures, available “price-per-unit” savings, and total “low-priority prescribing” spend) to see whether they changed after the viewing of Clinical Commissioning Group (CCG) and practice pages. We also measured whether practices whose data were viewed on OpenPrescribing differed in prescribing, prior to viewing, compared with those who were not. We used fixed-effects and between-effects linear panel regression to isolate change over time and differences between practices, respectively. We adjusted for the month of prescribing in the fixed-effects model to remove underlying trends in outcome measures. Results We found a reduction in available price-per-unit savings for both practices and CCGs after their pages were viewed. The saving was greater at practice level (−£40.42 per thousand patients per month; 95% CI −54.04 to −26.81) than at CCG level (−£14.70 per thousand patients per month; 95% CI −25.56 to −3.84). We estimate a total saving since launch of £243 thosand at practice level and £1.47 million at CCG level between the feature launch and end of follow-up (August to November 2017) among practices viewed. If the observed savings from practices viewed were extrapolated to all practices, this would generate £26.8 million in annual savings for the NHS, approximately 20% of the total possible savings from this method. The other two measures were not different after CCGs or practices were viewed. Practices that were viewed had worse prescribing quality scores overall prior to viewing. Conclusions We found a positive impact from the use of OpenPrescribing, specifically for the class of savings opportunities that can only be identified by using this tool. Furthermore, we show that it is possible to conduct a robust analysis of the impact of such a Web-based service on clinical practice.

7 Producing data-driven tools

Objectives EBM DataLab is a team that aims to produce tools from data, rather than just academic publications. We have a multidisciplinary approach that combines the skills of software engineers, clinicians and academics. In this workshop we will give an overview covering how to make effective interactive services driven by data, through: Providing an overview of the software and services which can be used to create your own data–driven tools. Demonstrating examples from the work of the EBM DataLab. Providing an opportunity for attendees to discuss their own ideas or experiences related to data–driven tools. Method In this session you will learn the very basics about a range of useful software and services including Python, pandas and iPython notebooks, GitHub, Google Analytics, Google Sheets, Google Forms, API’s (for Scopus, PubMed, and Web of Science), SQL databases such as BigQuery and Postgres, and graphical tools such as Tableau and d3. We will demonstrate the creative use of these tools with worked examples from our recent output including the Retractobot, various trials trackers, OpenPrescribing long term trends, the Drug Tariff explorer, and more. Results Attendees should leave this workshop with a better grasp of how to identify user needs, select the appropriate software or services for the job, design tools to be deliverable and impactful, manage the development cycle from prototyping to launch, and carry out the basic process of user testing. Conclusions Simple yet engaging presentation of data that allows people to act on it can be a critical step in disseminating evidence and improving quality of care. Live updating dynamic tools can keep information at the cutting-edge and provide a platform that provides real and enduring value to users. There are great resources available that can allow researchers to quickly and efficiently turn their findings into public-facing tools. We hope this workshop will empower attendees to begin presenting and sharing their data in new and effective ways in order to promote positive change in their respective fields.

Pregabalin: what the patent litigation means for doctors and drug companies

Darren Smyth, Richard Croker, and Ben Goldacre explain the arguments over the patent case and explore the wider implications for the NHS and drug development