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 remaining two components of the PINCER intervention, which ensure that improved outcomes are achieved for patients, are: 1. Pharmacists, specifically trained to deliver the intervention, providing an educational outreach intervention where they meet with GPs and other practice staff to: a. Discuss the search results and highlight the importance of the hazardous prescribing identified using brief educational materials b. Agree an action plan for reviewing patients identified as high risk and improving prescribing and medication monitoring systems using root cause analysis (RCA) to minimise future risk 2. Pharmacists (and pharmacy technicians) working with, and supporting, general practice staff to implement the agreed action plan.
Findings from the PINCER trial, published in the Lancet [2], demonstrated that PINCER is an effective and cost-effective method for reducing a range of clinically important and commonly made medication errors in primary care. For example, at 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed an oral non-steroidal anti-inflammatory drug (NSAID) if they had a history of peptic ulcer without gastroprotection (Odds ratio (OR): 0·58; 95% Confidence Interval (CI): 0·38-0·89), thereby reducing their risk of hospital admission with gastrointestinal (GI) bleeding.
It is important to appreciate that the PINCER indicators capture rates of potentially hazardous prescribing: in some scenarios there may be a legitimate reason for a GP not to comply with the prescribing behaviour suggested by the indicator (e.g., in the case of the Asthma & beta-blocker indicator, it may be necessary to prescribe a beta-blocker to a patient with substantial cardiovascular disease and/or allergies to other cardiovascular disease medication despite having a recorded diagnosis of asthma). In this context, full compliance is not expected for all indicators but any movement towards compliance is considered positive.
PRIMIS is able to provide a full and tailored service which includes access to a PINCER Specification and GP system searches for the PINCER indicators; IT support for the implementation of those searches within existing software solutions; a comparative analysis service that permits practices to benchmark themselves against local averages, or against themselves at an earlier point in time; and training and educational materials to enable primary care pharmacists to implement the PINCER intervention in GP practices in England. More information is available on the PINCER website.
Definitions of the PINCER hazardous prescribing indicators are provided in the table below. 3. PRIMIS Team. PINCER National Rollout: Progress Report to NHS England and the AHSN Network. University of Nottingham; 2020 Jul. Available: https://www.nottingham.ac.uk/primis/documents/pincer/pincer-progress-report-july-2020. pdf   The percentage of patients identified as at risk of potentially blood test monitoring as measured by each indicator is reported for the period September 2019 to September 2021 (inclusive). The median percentage is displayed as a thick blue line and deciles are indicated by dashed blue lines. The month of national lockdown in England as a response to the onset of COVID-19 (March 2020) is highlighted with an orange dashed vertical line. The monitoring window, as measured from the onset of COVID-19, for each indicator is shown by a green dashed vertical line.