Exploring the Role of Guidelines in Contributing to Medication Errors: A Descriptive Analysis of National Patient Safety Incident Data

Introduction Clinical guidelines can contribute to medication errors but there is no overall understanding of how and where these occur. Objectives We aimed to identify guideline-related medication errors reported via a national incident reporting system, and describe types of error, stages of medication use, guidelines, drugs, specialties and clinical locations most commonly associated with such errors. Methods Retrospective analysis of reports to the National Reporting and Learning System for England and Wales. A hierarchical task analysis (HTA) was developed, describing expected practice when using guidelines. A free-text search was conducted of medication incident reports (2016–2021) using search terms related to common guidelines. All identified reports linked to moderate-severe harm or death, and a random sample of 5100 no/low-harm reports were coded to describe deviations from the HTA. A random sample of 500 cases were independently double-coded. Results In total, 28,217 reports were identified, with 608 relating to moderate-severe harm or death. Fleiss’ kappa for interrater reliability was 0.46. Of the 5708 reports coded, 642 described an HTA step discrepancy (including four linked to a death), suggesting over 3200 discrepancies in the entire dataset of 28,217 reports. Discrepancies related to finding guidelines ( n = 300 reports), finding information within guidelines ( n = 166) and using information ( n = 176). Discrepancies were most frequently identified for guidelines produced by a local organisation ( n = 405), and most occurred during prescribing ( n = 277) or medication administration ( n = 241). Conclusion Difficulties finding and using information from clinical guidelines contribute to thousands of prescribing and medication administration incidents, some of which are associated with substantial patient harm.