The Historical Changes in the List of Plasma Fractionation Products Placed on the WHO Model List of Essential Medicines

Abstract

The purpose of this study was to summarize the historical changes in the list of plasma fractionation products (PFP) placed on the Model List of Essential Medicines (EML) issued by the World Health Organization (WHO). PFP such as albumin, blood coagulation factors, and immunoglobulins are derived from blood collected from thousands of people. PFP have been listed since theˆrst edition of the EML (1977). However, the PFP listed on the EML have changed dramatically because EML's selection process has changed from experience-based to evidence-based. For example, albumin, which had been listed since the 2nd edition (1979), was deleted in the 11th edition (2000) because of the uncertainty of its e‹cacy. Human immunoglobulin normal, which had been deleted from the 13th edition (2003), was relisted in the 15th edition (2007). Moreover, the WHO has issued several resolutions and guidelines regarding PFP production, quality, and safety in order to promote the establishment of blood programmes in every nation. The focus of WHO's EML selection process has changed over 30 years. In the 20th century, WHO mainly focused on PFP e‹cacy, quality, and safety problems. However, currently the focus is on the problem of PFP accessibility, especially in developing countries. Therefore, it would be important to know how to capitalize on established knowledge and production technology to increase the accessibility of PFP worldwide.

Current trends in the laboratory diagnosis of schistosomiasis infection

“…An estimated 600 to 700 million people worldwide are at risk from the disease because they live in countries where the organism is common [54][55] This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. need of treatment to prevent the disease [56]. Thus, the negative impacts caused by untreated infections demoralize both social and economic development on school performance among infected children in endemic areas [57].…”

Produção e controle de qualidade de medicamentos hemoderivados : uma visão mundial da regulação sanitária

“…De acordo a legislação brasileira vigente, apenas o plasma excedente das doações voluntárias dos hemocentros brasileiros poderão ser destinados à indústria farmacêutica para a elaboração dos medicamentos derivados do sangue (BRASIL, 2001a(BRASIL, , 2013a. Do momento da obtenção do plasma para a indústria produtora dos medicamentos hemoderivados, este passa por inúmeros processos e etapas que vão da seleção do doador até a preparação para a indústria -Figura 3 - (BRASIL, 2001b;ADATI, 2006;BRASIL, 2014;SAKAGAMI;TSUTANI, 2014).…”