Ali Syed Mahib, Iqbal Arooba, Hamid Zymal, Rauf Sameer Abdul, Haque Md Ariful
Department of Internal Medicine, Karachi Institute of Medical Sciences, Pakistan.
Department of Internal Medicine, Dow University of Health Sciences, Karachi, Pakistan.
J Public Health Res. 2025 Jul 29;14(3):22799036251361620. doi: 10.1177/22799036251361620. eCollection 2025 Jul.
Off-label drug use, which involves prescribing medications beyond approved indications or dosages, is common in countries like Pakistan where regulatory oversight is limited. Avastin (Bevacizumab), originally approved for cancer treatment, is widely used off-label in ophthalmology to treat conditions such as diabetic retinopathy due to its anti-VEGF effects and lower cost compared to approved alternatives like Ranibizumab. However, its intravitreal use requires strict sterility and compounding standards. In 2023, an outbreak of vision loss occurred in Punjab, Pakistan, affecting 66 patients following intravitreal Avastin injections. Investigations linked the incident to contamination caused by improper repackaging and handling outside sterile conditions, revealing significant gaps in regulatory enforcement and clinical safety protocols. This outbreak highlights the urgent need for clear national guidelines, strict compounding practices, and informed consent to ensure patient safety. Although Avastin remains valuable for ophthalmic use, its safe administration depends on rigorous quality control. Lessons from this incident should guide efforts to improve drug safety and prevent future adverse events.
超说明书用药,即开具超出批准适应症或剂量的药物处方,在巴基斯坦等监管监督有限的国家很常见。阿瓦斯汀(贝伐单抗)最初被批准用于癌症治疗,由于其抗血管内皮生长因子(VEGF)的作用以及与雷珠单抗等批准的替代药物相比成本较低,因此在眼科被广泛用于治疗糖尿病性视网膜病变等病症。然而,其玻璃体内注射使用需要严格的无菌和配制标准。2023年,巴基斯坦旁遮普邦发生了一起视力丧失事件,66名患者在接受玻璃体内注射阿瓦斯汀后受到影响。调查将该事件与无菌条件外不当重新包装和处理导致的污染联系起来,揭示了监管执法和临床安全协议方面的重大漏洞。此次事件凸显了制定明确的国家指南、严格的配制规范以及知情同意以确保患者安全的迫切需求。尽管阿瓦斯汀在眼科使用中仍然具有价值,但其安全给药取决于严格的质量控制。此次事件的教训应指导提高药物安全性和预防未来不良事件的努力。