Avoiding patient harm through the application of prescribing safety indicators in English general practices: the PRoTeCT research programme evaluating OptimiseRx and PINCER

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Background Hazardous prescribing is an important and expensive preventable cause of patient harm, which can be identified using electronic healthcare records. In our Programme Grant we investigated the large-scale roll-out of a type of clinical decision support called OptimiseRx ® (First Databank, Hearst Health, Exeter, United Kingdom) (which had not been independently evaluated previously) and two large-scale roll-outs of pharmacist-led IT-based intervention (an intervention that had been shown to reduce hazardous prescribing in a cluster randomised trial). Objectives To estimate harm and economic impact of specific hazardous prescribing events. To investigate whether a clinical decision support intervention (OptimiseRx) was associated with reduction in hazardous prescribing. To investigate whether a pharmacist-led IT-based intervention was associated with reduction in hazardous prescribing. To undertake economic and process evaluations of both interventions. Design and methods The harm and economic impact of hazardous prescribing events were investigated using data from published sources to generate estimates of patient outcomes and cost associated with 11 prescribing safety indicators. An incomplete (not randomised) stepped-wedge design study with control groups was used to investigate the effectiveness of OptimiseRx (409 general practices). Incremental cost-effectiveness ratios were generated for OptimiseRx compared with standard care (cost per hazardous prescribing event prevented), subgroup analysis: cost per quality-adjusted life-year. Incomplete stepped-wedge design studies [East Midlands study (343 and 115 general practices); whole of England study (725 and 179 general practices)] investigated the effectiveness of pharmacist-led IT-based intervention. Incremental cost-effectiveness ratios were generated for pharmacist-led IT-based intervention compared with standard care (cost per hazardous prescribing event prevented, cost per quality-adjusted life-year). Data from interviews, focus groups, a survey and stakeholder events were analysed qualitatively to identify factors influencing the sustained implementation and operation of OptimiseRx or pharmacist-led IT-based intervention. Setting and participants The interventions took place in general practices in England. The process evaluation involved clinicians, patients and other stakeholders in England. Interventions Clinical decision support intervention (OptimiseRx). Pharmacist-led IT-based intervention. Main outcome measures Changes in hazardous prescribing rates. Cost per quality-adjusted life-year. Data sources Clinical Practice Research Datalink. ResearchOne. General practice clinical records. Process evaluation with clinicians, patients and other stakeholders. Results All the hazardous prescribing events studied were associated with loss of quality-adjusted life-years. The costliest for the National Health Service were prescriptions of antipsychotics to patients with dementia (£1168 per patient) and anticoagulants in combination with nonsteroidal anti-inflammatory drugs (£1020 per patient). Of 409 practices included in the clinical decision support study, 227 (56%) were intervention practices. Deployment of OptimiseRx was associated with a 10% reduction in exposure to hazardous prescribing after 2 years (odds ratio 0.90, 95% confidence interval 0.88 to 0.92). OptimiseRx costs £14–48 per hazardous prescribing event prevented, depending on time point and patient volume. Based on two indicators only, OptimiseRx costs £236 per quality-adjusted life-year gained at 6 months and becomes dominant (quality-adjusted life-year increasing; cost saving) at 24 months. Of 343 general practices included in the East Midlands pharmacist-led IT-based intervention evaluation, we completed further data extraction for 115 (33.5%) of these. Pharmacist-led IT-based intervention was associated with a decrease in hazardous prescribing of 18% (adjusted odds ratio 0.82, 95% confidence interval 0.78 to 0.86) at 6 months, and 22% (adjusted odds ratio 0.78, 95% confidence interval 0.73 to 0.84) at 24 months post intervention. Pharmacist-led IT-based intervention generates approximately 0.15 quality-adjusted life-years per practice extra compared with no intervention. Expected savings do not fully offset delivery costs, so pharmacist-led IT-based intervention costs just over £1000 per practice. Pharmacist-led IT-based intervention was estimated to be £7449. With 12- and 24-month intervention effects, health gains rise to over 0.2 quality-adjusted life-years and net expenditure falls to < £800 per practice; around £3500 per quality-adjusted life-year gained. Of 725 practices that implemented pharmacist-led IT-based intervention nationally, we had usable data for only 179 because of the COVID-19 pandemic. For these practices, pharmacist-led IT-based intervention was associated with a reduction in hazardous prescribing of 11% (adjusted odds ratio 0.89, 95% confidence interval 0.86 to 0.92) at 6 months post intervention. The process evaluation studies demonstrated the importance of collaboration and system-level support for the clinical decision support and pharmacist-led IT-based interventions. Limitations The main limitation was that we could not robustly evaluate the impact of OptimiseRx on serious harm outcomes and the analysis was limited for pharmacist-led IT-based intervention because of the COVID-19 pandemic. Future work Further research is needed to determine whether interventions that reduce hazardous prescribin

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