C. L. Van Der Poel

The PROTON study: profiles of blood product transfusion recipients in the Netherlands

Backgroundu2002 Transfusion recipient data are needed for correct estimation of cost‐effectiveness in terms of recipient outcomes after transfusion. Also, such data are essential for monitoring blood use, estimation of future blood use and benchmarking.

Cost-effectiveness of additional hepatitis B virus nucleic acid testing of individual donations or minipools of six donations in the Netherlands

BACKGROUND: To further reduce the risk of hepatitis B virus (HBV) transmission by blood transfusion, nucleic acid testing (NAT) can be employed. The aim of this study is to estimate the incremental cost‐effectiveness ratio (ICER) in the Netherlands of employing a triplex NAT assay aimed at HBV nucleic acid detection in individual donations (ID‐NAT) or in minipools of 6 donations (MP‐6‐NAT), compared to a triplex NAT assay in minipools of 24 donations (MP‐24‐NAT).

Survival after transfusion in the Netherlands

Backgroundu2002 Cost‐effectiveness analyses of blood safety interventions require estimates of the life expectancy after blood product transfusion. These are best derived from survival after blood transfusion, per age group and blood component type.

Cost-effectiveness of leucocyte depletion of red-cell transfusions for patients undergoing cardiac surgery

1 Groningen University Institute for Drug Exploration/University of Groningen Institute of Pharmacy (GUIDE/GRIP), Groningen, the Netherlands 2 Department of Immunohematology and Blood Bank, Leiden University Medical Centre, Leiden, the Netherlands 3 Martini Hospital, Department of Clinical Pharmacy and Toxicology, Groningen, the Netherlands 4 Sanquin Blood Supply Foundation, Amsterdam, the Netherlands

Monitoring viral incidence rates: tools for the implementation of European Union regulations

Background and Objectivesu2002 European legislation requires manufacturers of plasma products to report epidemiological data on human immunodeficiency virus, hepatitis B virus and hepatitis C virus in donor populations. The incidence rates of such infections are directly related to the risk of infection transmission. We propose two statistical tests to evaluate these incidence rates.

Validation of the NucliSens Extractor in combination with the hepatitis C virus Cobas Amplicor 2.0 assay in four laboratories in the Netherlands utilizing nucleic acid amplification technology for blood screening

Since July 1 1999, four laboratories in the Netherlands have been routinely screening plasma minipools for the release of labile blood components utilizing hepatitis C virus nucleic acid amplification technology (HCV NAT). This report describes the performance evaluation of the HCV NAT method and the quality control results obtained during 6 months of routine screening.

On the fruitfulness of comparisons: ‘The safest is the best for both’

Dr Farrugia’s comment that there is compelling body of evidence indicating that remuneration of whole blood donations increases the risk of blood transfusion is agreed and welcomed. But he restricts the comments to ‘poorly regulated environments’. It is not completely clear what he means. The Chicago Tribune in 19 November 2008 has a news heading, ‘In weak economy, plasma centres pulsate with donors seeking dollars’, and reports that ‘donations remunerated with

Implementation of donor screening for infectious agents transmitted by blood by nucleic acid technology: update to 2003

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Transmission of Hepatitis C Virus by Anti-HCV-Negative Blood Transfusion

45 may hit 16 million this year, up from 10 million in 2005, industry group says’. The article continues, ‘College students and the down-and-out have long donated plasma for easy money – in plasma industry parlance, people do not sell plasma, they are compensated for the time it takes to donate – but in a trying economic climate the number of people extracting gas or grocery money from their veins is booming.’ [1] And on MSNBC it can be read that in Seattle ‘Short of cash some put a price on themselves’ [2]. Interestingly, it seems not so much the ‘poorly regulated environments’ as suggested by Farrugia, but rather ‘poor environments’. The mechanism of paid donations being focused on the underprivileged in certain microeconomies was described by James et al . in 2004 [3]. The significance of the Kalibatas article in this journal lies in the fact that the data compare remunerated and nonremunerated donors from the same area [4]. Remuneration and not geography was the determinant of viral risk, the latter of which was suggested by Offergeld et al . [5]. The statement that viral transmission by plasma products was not reported in the last 15 years is true for lipid-enveloped viruses. But is somewhat contradicted by the transmission of human parvovirus B19, fortunately not resulting in any significant disease in recipients. This example only indicates that safety is a relative entity, preferably assessed by quantitative analysis [6]. In that respect, Farrugia agrees that the incidence rates of viral infections in the donor populations remain very important, also for the safety of plasma products. In the European Union (EU), the same whole blood donations that yield red blood cells, platelets and plasma for transfusion, are also a main source of plasma for fractionation into medicinal products. It is therefore quite just that the EU applies the same safety criteria to the donation of plasma, be it for transfusion or be it for further fractionation into medicinal products [7]. No apples and oranges are compared here. A more fruitful discussion would be why plasma (apples) to be transfused fresh or plasma (apples) to be pooled and further processed (apple juice) would be allowed to have different safety requirements, given that the safest is the best for both. In addition, it could be questioned why data on the safety of donor populations, which are submitted to the EMEA [8], would be considered proprietary information, and not be transparent to the public, such as was done previously in the USA [9]. The suggestion by Farrugia about a catastrophic restriction in access to treatment for patients by any import restrictions is contentious indeed. Import restrictions were not suggested [10]. Apparently safety requirements are sometimes perceived as import restrictions. This is not unique to our field. Even while transmission of TSE by plasma products has never been reported, it would not be very wise to perceive the USA exclusion of plasma and blood components from Europe as an import restriction. Considering the access to treatment, one might sooner wonder about mechanisms on maximization of offsets, off-label use and shifting of supplies of scarce product to regions with the highest prices [11]. Rightfully the medical profession would advocate optimal use [12]. In Europe, Belgium and The Netherlands with a 100% non-remunerated donor base obtain around 20 l of plasma for fractionation per thousand population, sufficient for the need of their patients [13]. And Norway with about 10 l of plasma for fractionation per thousand population [13] has an agreement with the plasma industry on their self-sufficiency from their volunteer donors [14]. Could the same not be done elsewhere? In the light of endurable blood management in the future, nobody expects an overnight change. But rather a world-wide ‘phasing-in’ towards non-remunerated donations as ‘best practice’. An endurable blood supply goal that could be set within a predefined number of years to come. Finally, in the above discussion, the ethics of selling body parts by the underprivileged is not even fully addressed.