{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T01:14:00Z","timestamp":1780449240482,"version":"3.54.1"},"reference-count":35,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T00:00:00Z","timestamp":1775520000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Med."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 63,817 medication error reports related to biologics and biosimilars were identified. The majority occurred during the prescribing phase (76\u201379%) and were classified as non-harmful (Category B, \u224870%). Pharmacists were the leading reporters (87%), underlining their central role in patient safety. Adults (&amp;gt;18\u202fyears) represented the most affected demographic group (\u224870%). Insulin and anticoagulants (enoxaparin and heparin) together accounted for the highest proportion of errors, highlighting these agents as key targets for safety interventions.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fmed.2026.1795867","type":"journal-article","created":{"date-parts":[[2026,4,7]],"date-time":"2026-04-07T05:35:15Z","timestamp":1775540115000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Biologics and biosimilars medication errors in Saudi Arabia: a nationwide retrospective observational real-world study"],"prefix":"10.3389","volume":"13","author":[{"given":"Nouf T.","family":"Alshammri","sequence":"first","affiliation":[{"name":"Therapeutic Affairs Deputyship, Ministry of Health","place":["Riyadh, Saudi Arabia"]},{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University","place":["Riyadh, Saudi Arabia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wafa S.","family":"Alluwaymi","sequence":"additional","affiliation":[{"name":"Therapeutic Affairs Deputyship, Ministry of Health","place":["Riyadh, Saudi Arabia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ghadah A.","family":"Assiri","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, College of Pharmacy, King Saud University","place":["Riyadh, Saudi Arabia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thamir M.","family":"Alshammari","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, College of Pharmacy, Jazan University","place":["Jazan, Saudi Arabia"]},{"name":"Pharmacy Practice Research Unit, College of Pharmacy, Jazan University","place":["Jazan, Saudi Arabia"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,4,7]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"323","DOI":"10.1159\/000346296","article-title":"Clinical errors and medical negligence","volume":"22","author":"Oyebode","year":"2013","journal-title":"Med Princ Pract"},{"key":"ref2","year":"2023"},{"key":"ref3","year":"2024"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"96","DOI":"10.1136\/bmjqs-2019-010206","article-title":"Economic analysis of the prevalence and clinical and economic burden of medication error in England","volume":"30","author":"Elliott","year":"2021","journal-title":"BMJ Qual Saf"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1097\/PTS.0000000000000839","article-title":"Current situation of medication errors in Saudi Arabia: a nationwide observational study","author":"Alshammari","year":"2022","journal-title":"J Patient Saf"},{"key":"ref6","year":"2024"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"1013","DOI":"10.1007\/S40264-018-0684-9","article-title":"Safety of biologics, including Biosimilars: perspectives on current status and future direction","volume":"41","author":"Ingrasciotta","year":"2018","journal-title":"Drug Saf"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"100008","DOI":"10.1016\/j.rcsop.2021.100008","article-title":"Biosimilar medicines uptake: the role of the clinical pharmacist","volume":"1","author":"Okoro","year":"2021","journal-title":"Exploratory Res Clin Soc Pharm"},{"key":"ref9","year":"2022"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"188","DOI":"10.18773\/austprescr.2016.084","article-title":"Safety considerations of biosimilars","volume":"39","author":"McKinnon","year":"2016","journal-title":"Aust Prescr"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"226","DOI":"10.1007\/s40138-013-0023-5","article-title":"Biosimilars: an emerging category of biologic drugs for emergency medicine practitioners","volume":"1","author":"Sylvester","year":"2013","journal-title":"Curr Emerg Hosp Med Rep"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"56","DOI":"10.18520\/cs\/v120\/i1\/56-65","article-title":"Requirements for biosimilar authorisation: a legal and comparative perspective. 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