Walker Irwin R, Sek Julia T, Almonte Theresa M, Carruthers Julie B, Chan Anthony K C, Pai Mohan K, Thibault Alain A, Heddle Nancy M
McMaster University Medical Center, 1200 Main St. West, Hamilton, Ontario, Canada, L8N 3Z5, USA.
Transfusion. 2003 May;43(5):556-62. doi: 10.1046/j.1537-2995.2003.00387.x.
In response to the transfusion- transmitted AIDS epidemic, Canadian authorities recommended the development of tracking systems and improved reporting of adverse events. This study describes the development of a verifiable and comprehensive regional tracking system for coagulation factor concentrates.
The Hamilton- Niagara Regional Hemophilia Program received distribution and utilization data from Canadian Blood Services, 26 regional hospitals, and 70 individuals with bleeding disorders on home-based therapy. Purpose-specific software, the Canadian Hemophilia Assessment and Resource Management System (CHARMS), was used to store, monitor, analyze, and validate data.
During a 1-year period (2001), all factor concentrates distributed in this region were accounted for. A higher proportion of FVIII and FIX concentrates (88 vs. 12%) was infused at home than in hospitals, and a higher proportion (63 vs. 28%) was used to prevent than to treat bleeds. During a period of shortage, a 5-percent reduction in utilization of both FVIII and FIX concentrates was documented. One recall was managed swiftly and efficiently. Two patients reported allergic skin reactions.
A verifiable tracking system has been developed that can provide ongoing data for both clinical and administrative purposes. Data collection from patients needs to be made more efficient and real-time recording is an important future objective. Such a system can be instituted locally for less than 1.5 percent of the cost of the factor concentrate used.
为应对输血传播的艾滋病疫情,加拿大当局建议开发追踪系统并改进不良事件报告。本研究描述了一种用于凝血因子浓缩物的可验证且全面的区域追踪系统的开发情况。
汉密尔顿 - 尼亚加拉地区血友病项目从加拿大血液服务机构、26家地区医院以及70名接受家庭治疗的出血性疾病患者那里获取了分发和使用数据。使用了专门用途的软件——加拿大血友病评估与资源管理系统(CHARMS)来存储、监测、分析和验证数据。
在2001年的1年期间,该地区分发的所有因子浓缩物都有记录。在家中输注的FVIII和FIX浓缩物比例(88%对12%)高于在医院,用于预防出血的比例(63%对28%)高于治疗出血。在供应短缺期间,记录到FVIII和FIX浓缩物的使用量均减少了5%。一次召回得到了迅速有效的处理。两名患者报告了过敏性皮肤反应。
已开发出一种可验证的追踪系统,可为临床和管理目的提供持续数据。患者数据收集需要提高效率,实时记录是未来的一个重要目标。这样一个系统在当地建立的成本不到所用因子浓缩物成本的1.5%。