Ali Ferhina S, Schneider Eric W, Arepalli Sruthi, Borkar Durga, Deaner Jordan D, Jain Nieraj, London Nikolas J S, Suner Ivan J, Thomas Akshay S, Vajzovic Lejla, Vora Robin A, Witkin Andre J
New York Medical College, Valhalla, NY, USA.
Tennessee Retina, Nashville, TN, USA.
J Vitreoretin Dis. 2025 Jul 14:24741264251356296. doi: 10.1177/24741264251356296.
In 2024, the American Society of Retina Specialists (ASRS) Research and Safety in Therapeutics (ReST) Committee became aware of reports of coring of vial stoppers in relation to preparation of intravitreal injections. A literature review was performed to further understand and characterize this occurrence within the context of retina practice and the broader medical community. Relevant articles were identified through a systematic search of PubMed using predefined criteria. Coring can be observed when a needle punctures the rubber stopper of a medication vial, pushing a small piece or pieces of the stopper material into the container and introducing extrinsic particles into the drug product. Factors associated with coring include larger gauge needles, perpendicular needle entry, multiple-use vials, and thicker rubber stoppers. Rubber stopper thickness and composition also influence the likelihood of coring. To prevent patient safety issues from coring, filter needles are commonly used to draw up medications from vials because they are effective in mitigating particulate matter from entering syringes. No documented cases of clinical complications related to coring in ophthalmology have been identified. Coring represents an unreported phenomenon in the preparation of intraocular medications. Although there have been no safety implications in retina practice related to coring and intravitreal drug vials, these reports underscore the importance of careful medication preparation, inspection of vials, the use of appropriate needles, and adherence to best clinical practices.
2024年,美国视网膜专家协会(ASRS)治疗研究与安全(ReST)委员会获悉了与玻璃体内注射制剂相关的药瓶瓶塞穿孔的报告。进行了文献综述,以在视网膜治疗实践及更广泛的医学界背景下进一步了解并描述这一现象。通过使用预定义标准在PubMed上进行系统检索,确定了相关文章。当针头刺穿药瓶的橡胶瓶塞,将一小片或多片瓶塞材料推入容器并将外部颗粒引入药品时,就会观察到瓶塞穿孔现象。与瓶塞穿孔相关的因素包括较大规格的针头、垂直进针、多次使用的药瓶以及较厚的橡胶瓶塞。橡胶瓶塞的厚度和成分也会影响瓶塞穿孔的可能性。为防止因瓶塞穿孔引发患者安全问题,通常使用过滤针头从药瓶中抽取药物,因为它们能有效减少颗粒物进入注射器。在眼科领域,尚未发现有记录的与瓶塞穿孔相关的临床并发症病例。瓶塞穿孔是眼内药物制剂制备过程中一种未被报道的现象。尽管在视网膜治疗实践中,瓶塞穿孔和玻璃体内药物药瓶尚未产生安全隐患,但这些报告强调了谨慎制备药物、检查药瓶、使用合适的针头以及遵循最佳临床实践的重要性。