Plasma collection in Indonesia - a challenge to implement fractionation

Abstract

In recent years, the national usage of Plasma Derived Medicinal Products (PDMPs), particularly albumin and immunoglobulin, has expanded due to a rise in disease prevalence, as well as enhanced patient management practices and broader assurance coverage. Now, Indonesia is a country that imports all of its PDMPs, resulting in high pricing and market reliance; nevertheless, barely a third of recovered plasma gets transfused to patients. The plasma that has not been used should be discarded, at a cost. The government intended to begin meeting the needs of the PDMP by implementing the plasma fractionation program. The decision was taken to use contract fractionation for three years, after which a national fractionation manufacturer was anticipated. The potential utility of recovered plasma and the prospective requirement for plasmapheresis collection have been assessed. The Minister of Health has enacted legislation concerning plasma fractionation, including the potential of establishing plasmapheresis centers to facilitate plasma collections. The Food and Drug Administration of Indonesia has also initiated a certification scheme for blood establishments (BEs), and only certified BEs can provide plasma for fractionation. After the epidemic, the government restarted the fractionation program by modifying existing laws to allow private manufacturers to participate. The difficulty was obtaining plasma from uncompensated donors, recruiting plasma donors, increasing the number of qualified biological examiners, of which only 19 out of 469 have been certified, and increasing technology and personnel capacities. Other significant obstacles were the harmonization or consolidation of existing biological entities (BEs) and the expense of paying for recovered and source plasma. The government and other parties involved had to make substantial efforts and collaborate to overcome these problems.