Plasma collection in Indonesia - a challenge to implement fractionation
- pdf |
- DOI: https://doi.org/10.15562/bmj.v12i2.4296 |
- Published: 2023-04-17
Open Access & Peer Reviewed Multidisciplinary
Journal of Medical Sciences
Journal of Medical Sciences
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.
References
- Hartmann J, Klein HG. Supply and demand for plasma-derived medicinal products - A critical reassessment amid the COVID-19 pandemic. Transfusion. 2020;60(11):2748-2752. Doi: 10.1111/trf.16078
- Grazzini G, Mannucci PM, Oleari F. Plasma-derived medicinal products: demand and clinical use. Blood Transfus. 2013;11(4):2-5. Doi: 10.2450/2013.002s
- Cheraghali AM, Abolghasemi H. Improving availability and affordability of plasma-derived medicines. Biologicals. 2010;38(1):81-86. Doi: 10.1016/j.biologicals.2009.10.004
- Strengers PF, Klein HG. Plasma is a strategic resource [published correction appears in Transfusion. Transfusion. 2016;56(12):3133-3137. Doi: 10.1111/trf.13913
- De Angelis V, Breda A. Plasma-derived medicinal products self-sufficiency from national plasma: to what extent?. Blood Transfus. 2013;11 (4):132-137. Doi: 10.2450/2013.019s
- Brand A, De Angelis V, Vuk T, et al. Review of indications for immunoglobulin (IG) use: Narrowing the gap between supply and demand. Transfus Clin Biol. 2021;28(1):96-122. Doi: 10.1016/j.tracli.2020.12.005
- Arcot PJ, Kumar K, Mukhopadhyay T, Subramanian A. Potential challenges faced by blood bank services during COVID-19 pandemic and their mitigative measures: The Indian scenario. Transfus Apher Sci. 2020;59(5):102877. Doi: 10.1016/j.transci.2020.102877
- Barjas‐Castro MdL, Baumgartner JE, Sales LNM, Santos RA, Pereira FB and Castro V. Blood supply strategies facing a reference blood centre in Brazil during the COVID‐19 pandemic. VOXS. 2020. Doi: 10.1111/voxs.12565
- Masser BM, Hyde MK, Ferguson E. Exploring predictors of Australian community members' blood donation intentions and blood donation–related behavior during the COVID‐19 pandemic. Transfusion. 2020; 1– 11. Doi: 10.1111/trf.16067
- Ferguson E, Hill A, Lam M. A typology of blood donor motivations. Transfusion. 2020; 60: 2010– 2020. doi: 10.1111/trf.15913
- Prevot J, Jolles S. Global immunoglobulin supply: steaming towards the iceberg?. Curr Opin Allergy Clin Immunol. 2020;20(6):557-564. Doi: 10.1097/ACI.0000000000000696
- De Angelis V, Breda A. Trends in Plasma Toll Fractionation for Self Sufficiency of Plasma-Derived Medicinal Products in Italy. Transfus Med Hemother. 2019;46(4):232-238. Doi: 10.1159/000496750
How to Cite
Triyono, T. T., & Bidayah, H. F. . (2023). Plasma collection in Indonesia - a challenge to implement fractionation. Bali Medical Journal, 12(2), 1238–1242. https://doi.org/10.15562/bmj.v12i2.4296
