Biologics and biosimilars medication errors in Saudi Arabia: a nationwide retrospective observational real-world study

Background: In Saudi Arabia, the Ministry of Health reported 71, 332 errors from 2018 to 2019. Biologics and biosimilars are safe treatment options for various medical conditions; however, safety concerns remain. Immunogenicity and unique brand names can cause adverse reactions, and the ability to predict immune responses is limited. This study aims to determine the number and characteristics of medication errors associated with biological and biosimilar medications in Saudi Arabia from 2020 to 2023. Methods: A retrospective observational real-world study was conducted to analyze the number of biologic and biosimilar medication errors reported to the MOH, Saudi Arabia, from 2020 to 2023 using an electronic database as a data source. Categorical data were summarized as frequency and percentage. All analyses were performed using Microsoft Excel. Results: A total of 63,817 medication error reports related to biologics and biosimilars were identified. The majority occurred during the prescribing phase (76-79%) and were classified as non-harmful (Category B, ≈70%). Pharmacists were the leading reporters (87%), underlining their central role in patient safety. Adults (>18 years) represented the most affected demographic group (≈70%). Insulin and anticoagulants (enoxaparin and heparin) together accounted for the highest proportion of errors, highlighting these agents as key targets for safety interventions. Conclusion: This study offers a comprehensive national evaluation of medication errors associated with biologic and biosimilar products reported to the Saudi Ministry of Health between 2020 and 2023. High-alert medications, particularly insulin and anticoagulants, consistently ranked among the top error-related agents, highlighting the need for targeted interventions.