Changes in medication safety indicators in England throughout the covid-19 pandemic using OpenSAFELY: population based, retrospective cohort study of 57 million patients using federated analytics

Objective: To implement complex, PINCER (pharmacist led information technology intervention) prescribing indicators, on a national scale with general practice data to describe the impact of the covid-19 pandemic on safe prescribing.Design: Population based, retrospective cohort study using federated analytics.Setting: Electronic general practice health record data from 56.8 million NHS patients by use of the OpenSAFELY platform, with the approval of the National Health Service (NHS) England.Participants: NHS patients (aged 18-120 years) who were alive and registered at a general practice that used TPP or EMIS computer systems and were recorded as at risk of at least one potentially hazardous PINCER indicator.Main outcome measure: Between 1 September 2019 and 1 September 2021, monthly trends and between practice variation for compliance with 13 PINCER indicators, as calculated on the first of every month, were reported. Prescriptions that do not adhere to these indicators are potentially hazardous and can cause gastrointestinal bleeds; are cautioned against in specific conditions (specifically heart failure, asthma, and chronic renal failure); or require blood test monitoring. The percentage for each indicator is formed of a numerator of patients deemed to be at risk of a potentially hazardous prescribing event and the denominator is of patients for which assessment of the indicator is clinically meaningful. Higher indicator percentages represent potentially poorer performance on medication safety.Results: The PINCER indicators were successfully implemented across general practice data for 56.8 million patient records from 6367 practices in OpenSAFELY. Hazardous prescribing remained largely unchanged during the covid-19 pandemic, with no evidence of increases in indicators of harm as captured by the PINCER indicators. The percentage of patients at risk of potentially hazardous prescribing, as defined by each PINCER indicator, at mean quarter 1 (Q1) 2020 (representing before the pandemic) ranged from 1.11% (age ≥65 years and non-steroidal anti-inflammatory drugs) to 36.20% (amiodarone and no thyroid function test), while Q1 2021 (representing after the pandemic) percentages ranged from 0.75% (age ≥65 years and non-steroidal anti-inflammatory drugs) to 39.23% (amiodarone and no thyroid function test). Transient delays occurred in blood test monitoring for some medications, particularly angiotensin-converting enzyme inhibitors (where blood monitoring worsened from a mean of 5.16% in Q1 2020 to 12.14% in Q1 2021, and began to recover in June 2021). All indicators substantially recovered by September 2021. We identified 1 813 058 patients (3.1%) at risk of at least one potentially hazardous prescribing event.Conclusion: NHS data from general practices can be analysed at national scale to generate insights into service delivery. Potentially hazardous prescribing was largely unaffected by the covid-19 pandemic in primary care health records in England

The Oxford Royal College of General Practitioners clinical informatics digital hub: Protocol to develop extended COVID-19 surveillance and trial platforms

Background: Routinely recorded primary care data have been used for many years by sentinel networks for surveillance. More recently, real world data have been used for a wider range of research projects with the anticipation they could be used to support rapid, lower cost clinical trials. Much larger numbers of general practices are required to deliver effective surveillance and in-pandemic trials, given the partial national lockdown has resulted in falling community disease incidence. Objective: To describe the rapid design and development of the Oxford Royal College of General Practitioners Clinical Informatics Digital (ORCHID) Hub, and its first two platforms. The Surveillance Platform will provide extended primary care surveillance, while the Trials Platform will be a streamlined clinical trials platform integrated into routine primary care practice. Methods: We will apply the FAIR (Findable, Accessible, Interoperable and Reusable) metadata principles to a new, unique, integrated digital health hub, combining routinely collected electronic health date from UK general practice. The hub will be findable through membership of Health Data Research UK and European metadata repositories. Accessibility through an online application system will allow study-ready datasets to be accessed or custom datasets developed. Interoperability will be facilitated by fixed linkage to other key sources such as Hospital Episodes Statistics and the Office of National Statistics using pseudonymised data. All semantic descriptors (i.e. ontologies) and code used for analysis will be made shareable, to accelerate analyses. We will also make data available using common data models starting with the FDA Sentinel and OMOP approaches to facilitate international studies. The Surveillance Platform will provide access to data for health protection and promotion work as authorised through agreements between Oxford, the Royal College of General Practitioners and by Public Health England. All studies using the Trials Platform will have gone through appropriate ethical and other regulatory approval. Results: The hub will be a bottom-up, professionally led network ensuring benefits for member practices, our health service and the population served. Data will only be used for SQuIRE (surveillance, quality improvement, research and education) purposes. There has already been a positive response from practices and the number in the network has doubled since February to over 1,150. COVID-19 Surveillance has delivered a trebling of virology sites to 293 (target 300), helping collect the largest ever weekly total of surveillance swabs in the UK as well as over 3,000 SARS-CoV-2 serology samples. Practices are recruiting to the PRINCIPLE trial and follow-up of these participants will take place through ORCHID. These initial outputs demonstrate the feasibility of ORCHID to provide an extended national, digital health hub. Conclusions: ORCHID will deliver equitable and innovative use of big data, through a professionally-led national primary care network and the application of FAIR principles. The unique and secure data hub will host routinely collected general practice data linked to other key healthcare repositories. ORCHID will support rapid data extraction, analysis and dissemination with the aim of improving future research and development in general practice to positively impact upon patient care