EDQM publishes Trends and Observations related to Blood and Blood Components

Recommendation

7/8 May 2024

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals - Live Online Training
Regulatory Requirements and Practical Implementation

On 7 August 2015, the EDQM published a report "Trends and observations on the collection, testing and use of blood and blood components in Europe 2001 - 2011". This report will be a chance to get information about trends in the collection, testing and use of blood and blood components in Europe.

Since 2001, the member states annually send their data to the Council of Europe. With these data two reports were published before (from 2001-2005 and 2001 -2008) and now the first decade was completed. For the future, the report should be updated every three years. Amongst the introduction and information about materials and methods, the report covers information about the following results in chapter 3:

3.2. Number of responses
3.3. Percentage first-time donors
3.4. Donors per 1000 inhabitants
3.5. Whole blood donations per 1000 inhabitants
3.6. Plasmapheresis (L) per 1000 inhabitants
3.7. Percentage autologous out of total whole blood
3.8. Red blood cell units per 1000 inhabitants
3.9. Percentage whole blood used out of total red blood cells
3.10. Platelet units per 1000 inhabitants
3.11. Percentage platelets by apheresis
3.12. Fresh frozen plasma use per 1000 inhabitants
3.13. Fresh frozen plasma red blood cell ratio
3.14. Litres plasma for fractionation per 1000 inhabitants
3.15. Percentage leucocyte-depleted red blood cell
3.16. Percentage irradiated red blood cell
3.17. HIV repeat donor incidence rate
3.18. HBV repeat donor incidence rate
3.19. HCV repeat donor incidence rate
3.20. HIV first-time donor prevalence
3.21. HBV first-time donor prevalence
3.22. HCV first-time donor prevalence
3.23. Screening for infectious agents
3.23.1. Serological testing
3.23.2. NAT testing
3.24. Quality assurance and labelling

Additionally, the EDQM provides information about the conclusion out of the data, the related future plans and possible limitations in chapter 4. In their summary, the EDQM stated:

"There were no overall trends found in the number of (first-time) donors and the use of red blood cells (RBC), indicating a stable blood supply overall. Only the number of whole blood (WB) donations per 1,000 inhabitants slightly increased. There were however some clear trends (both upwards and downwards) in individual MSs. As in the 2001-2008 trend report, there was no trend in the number of plasma units used per inhabitant, nor was there a trend in the ratio of plasma or RBC usage, in the amount of plasmapheresis plasma obtained per inhabitant, or in the amount of plasma obtained for fractionation per inhabitant. A consistent increase in platelet use, as found in the previous trend report, continued until 2011. Also, the proportion of leuco-depleted RBCs consistently increased over this period. In contrast, the previously found positive trends in the percentage of platelets obtained by apheresis did not continue when considering the whole 11-year time period."

For further information, read directly EDQM's 2001-2011 report "Trends and observations on the collection, testing and use of blood and blood components in Europe".