The 2025 report by the Office of Inspector General (OIG), detailed under reference OEI-06-18-00401, evaluated whether hospitals effectively captured patient harm events among hospitalized Medicare patients, significantly impacting healthcare quality and safety insights. According to this analysis, hospitals failed to capture nearly half of such harm events in their incident reporting or other surveillance systems. Specifically, it was noted that 49 percent of harm events during a sample period in October 2018 were not documented, despite being identified through comprehensive medical record reviews. This gap in reporting was attributed to several factors, including narrow definitions of what constitutes harm, non-standard practice to report specific types of harm, difficulties in distinguishing harm from underlying disease, and events occurring post-discharge. Furthermore, the report highlighted that among the harm events hospitals did capture, only a small fraction were investigated, with even fewer prompting initiatives to enhance patient safety. Of the 94 incidents captured, investigations were conducted for only 17 cases, and merely 11 led to any form of safety improvement action. The findings underscore the need for unified definitions of patient harm and robust reporting mechanisms. Recommendations included collaboration between AHRQ and CMS to develop a comprehensive taxonomy of patient harm and urging surveyors to prioritize Medicare Quality Assurance and Performance Improvement requirements, ensuring hospital accountability in preventing patient harm. These recommendations aim to refine surveillance systems and foster a broader recognition of harm events, ultimately enhancing patient safety protocols within hospitals. [1]

A narrative overview published in the European Journal of Clinical Pharmacology in 2022 compiled a comprehensive examination of medication-related adverse events (MRAEs) in healthcare, highlighting the prevalence, risk factors, and methods of surveillance. The review, focusing on studies published post-2000, synthesized data from multiple electronic databases, including PubMed, MEDLINE, Web of Science, and Scopus. In its methodology, the review emphasized the heterogeneity in study results due to differing study settings, patient populations, and detection methods. The prevalence rates of MRAEs were found to be highly variable, with significant differences in detection rates attributable to the setting and methods used, patient demographics, and definitions employed in individual studies. ADEs are also likely underdetected; only an estimated 3%–10% are identified. Reported incidence and prevalence rates span a wide range. For example, the review noted that medication errors (MEs) ranged from 0.8 errors per patient day to 22.2% of all administered medicines. In contrast, adverse drug reactions (ADRs) ranged from 3.5 ADRs per 1000 emergency department visits to affecting 14.7% of patients. In specific hospitalized populations, reported ADE prevalence includes 24.7 events per 100 adult hospitalizations and 15.4% among surgical patients. Higher rates have been observed in certain services, including 58% in patients from geriatric, internal medicine, and gastroenterology/rheumatology services. In intensive care unit (ICU) patients, reported prevalence ranges widely from 3.3% to 72.5%. Psychiatric services report rates between 10.6% and 17.5%, and among hospitalized older adults, prevalence has been reported at 16.7%. The review identified elderly patients and those with compromised liver or kidney function as being particularly at risk of MRAEs. Polypharmacy and the use of high-risk medicines further exacerbated the risk. In terms of economic impact, MRAEs were reported to impose substantial costs on healthcare systems, with estimates ranging up to €207.56 billion annually in the USA alone. The narrative overview also underscored the importance of developing real-time detection methods to improve prevention and forecasting of MRAEs. By advancing surveillance and reporting methods, the review suggested that healthcare systems could better mitigate the incidence and repercussions of medication-related adverse events, ultimately improving patient safety and reducing healthcare costs. [2]

A 2024 research article compared medication errors identified through audit, direct observation, and reports in incident systems across two tertiary pediatric hospitals in Sydney, Australia. The comparison study evaluated prescribing errors from 7,785 patient records through medication chart audits and analyzed medication administration errors by observing 5,137 doses administered to 1,530 patients. The study aimed to assess differences in types and severities of medication errors detected and reported by staff. Despite identifying 11,302 prescribing errors at audit, only 36 errors had corresponding incident reports, resulting in a reporting rate of 3.2 per 1,000 errors. Of the 2,224 potentially serious prescribing errors, staff detected 26.1%, with a mere 1.1% reported in the incident system. Further analysis showcased significant discrepancies in error detection and reporting. Of 40 prescribing errors linked with actual patient harm, only seven were detected by staff, and four were reported. The article highlighted a stark under-reporting of medication administration errors, with none of the 2,883 observed errors being reported, not even the 144 associated with actual patient harm. This research underscores that incident reporting data does not accurately reflect medication errors and related harm in pediatric hospitals, suggesting the need for enhanced electronic monitoring systems to improve medication safety. The findings emphasize the critical requirement for developing interventions that enhance staff ability to detect and report errors proactively, aiming toward minimizing pediatric medication-related risks and improving patient safety outcomes. [3]

A 2021 retrospective clinical audit examined the associations of person-related, environment-related, and communication-related factors on medication errors in public and private hospitals. The audit was conducted over an 18-month period in two Australian health services, encompassing 16 hospitals. The study analyzed 11,540 reported medication errors through descriptive statistical analysis as well as univariate and multivariable regression analysis. Key variables included the healthcare professional responsible for the error, the presence of electronic systems for prescribing and dispensing, and various communication channels. Factors such as patient age, double-checking of medications, and patient involvement in error detection were also assessed. The analysis revealed that medication errors caused by doctors, pharmacists, or patients and families—compared to those caused by nurses or midwives—were significantly less likely to result in possible or probable harm. Electronic systems for prescribing and dispensing were associated with a reduction in harmful errors. Conversely, insufficient patient counseling, patient transitions across care settings, and interruptions increased the likelihood of harmful medication errors. Patients and families identified approximately 9.5% of the errors, highlighting the importance of their involvement in medication management. The findings suggest that interdisciplinary initiatives and improved communication strategies could significantly reduce the prevalence and severity of medication errors. [4]

A 2007 article examined the incidents reported in two US hospitals' incident reporting systems, involving approximately 16,575 randomly selected patients from an academic hospital and a community hospital. These hospitals retained traditional paper-based reporting systems typical of the era, despite the introduction of electronic reporting in 2002. The primary focus was to assess the frequency and nature of reported incidents, which included medication errors, falls, and operative incidents. Among these, medication incidents accounted for 29% of reports, falls for 14%, operative incidents for 15%, and miscellaneous incidents for 16%. Nurses contributed to 89% of reports, with physicians and other providers accounting for only 1.9% and 8.9% respectively. The findings highlighted that 9% of patients experienced at least one reported incident, and there was a rate of 17 incidents per 1000 patient-days recorded. The study identified critical gaps in reporting, particularly under-detection of physician-related incidents, such as prescribing errors and events during high-risk procedures. It noted that while most adverse events in the Harvard and Utah/Colorado studies occurred during hospitalizations and often involved physicians, the incident reporting system captured only a small fraction of such cases. Although 59% of incidents appeared preventable, there was an under-reporting of physician-related incidents. This lack of comprehensive reporting suggests a need to address structural and cultural barriers to improve physician participation in incident reporting, crucial for enhancing the overall effectiveness of hospital safety systems. [5]