Cheraghali A M, Aboofazeli R
Iranian Blood Transfusion Organization Research Center and Chemical Injury Research Center, University of Baqiyatallah Medical Sciences, Tehran, Iran.
Transfus Med. 2009 Dec;19(6):363-8. doi: 10.1111/j.1365-3148.2009.00961.x. Epub 2009 Sep 23.
In Iran all transfusion services are concentrated under authority of one public and centralized transfusion organization which has created the opportunity of using plasma produced in its blood centers for fractionation. In 2008 voluntary and non remunerated Iranian donors donated 1.8 million units of blood. This indicates a 25/1000 donation index. After responding to the needs for fresh plasma and cryoprecipitate each year about 150000 L of recovered plasma are reserved for fractionation. In an attempt to improve both blood safety profile and availability and affordability of plasma derived medicines, Iran's national transfusion service has entered into a contract fractionation agreement for surplus of plasma produced from donated blood by voluntary non remunerated donors. In order to ensure safety of product produced, Iran has chosen to collaborate with international fractionators based in highly regulated countries. The main objective of this study was to evaluate the impact of contract plasma fractionation on the affordability of the plasma derived medicines in Iran. During 2006-2008, Iran's contract fractionation project was able to produce 46%, 18% and 6% of IVIG, Albumin and FVIII consumed in Iran's market, respectively. In contrary to IVIG and Albumin, due to fairly high consumption of FVIII in Iran, the role of fractionation project in meeting the needs to FVIII was not substantial. However, Iran's experience has shown that contract plasma fractionation, through direct and indirect effects on price of plasma derived medicines, could substantially improve availability and affordability of such products in national health care system.
在伊朗,所有输血服务都集中在一个公共的中央输血组织的管理之下,这为利用其血液中心生产的血浆进行分馏创造了机会。2008年,伊朗的自愿无偿献血者捐献了180万单位血液。这表明献血指数为千分之二十五。在满足每年对新鲜血浆和冷沉淀的需求之后,约15万升回收血浆被留存用于分馏。为了提高血液安全水平以及血浆衍生药物的可及性和可负担性,伊朗国家输血服务机构就自愿无偿献血者所献血液产生的剩余血浆签订了一份分馏合同协议。为确保所生产产品的安全性,伊朗选择与位于监管严格国家的国际分馏商合作。本研究的主要目的是评估合同血浆分馏对伊朗血浆衍生药物可负担性的影响。在2006 - 2008年期间,伊朗的合同分馏项目分别能够生产出伊朗市场上所消费的静脉注射免疫球蛋白(IVIG)、白蛋白和凝血因子VIII(FVIII)的46%、18%和6%。与IVIG和白蛋白不同的是,由于伊朗对FVIII的消费量相当高,分馏项目在满足FVIII需求方面的作用并不显著。然而,伊朗的经验表明,合同血浆分馏通过对血浆衍生药物价格的直接和间接影响,能够大幅提高此类产品在国家医疗保健系统中的可及性和可负担性。