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Survey on 'Safety for blood donors'

From 3 April 2018 to 30 September 2018, the Paul-Ehrlich-Institut (PEI) will be conducting a survey on the safety of donating blood. The aim of this survey is to obtain a representative view of physical reactions in connection with the blood collection.

The survey addresses all blood donors regardless of when or how often they have donated or will donate blood during the period of the survey. Donors will be able to participate in the survey several times and should communicate their experience even if the blood donation did not cause any physical reactions.

Click here for the survey (German only)


Publication of the results

The PEI will capture all survey data anonymously without assigning them to a person or individual questionnaires. The evaluation and publication of the results will be carried out exclusively on the basis of pooled data. The publication of the results is planned for 2019.

Background

Data on notifiable serious reactions in connection with blood donations pursuant to the Arzneimittelgesetz (AMG, German Medicines Act) are currently available to the PEI. The survey is designed to complete the overall picture on the number and type of reactions as well as their distribution to various different donor groups (such as age and gender), together with the collection of non-serious and therefore non-notifiable reactions.

Up to now, the focus of the evaluation of blood safety has been mainly on the manufacture of safe and high-quality blood products and the their safe use in the clinic. Research was comparatively more seldom devoted to the safety of the actual blood donation and the wellbeing of blood donors.

Blood donors provide an important voluntary service which is extremely important for society. In 2016, they donated blood almost 7 million times in Germany. Out of these donation, around 4 million where whole blood donations, 2.6 million were plasma donations, and 0.2 million platelet donations (see: Reports on blood suppley). For this reason, it is a major concern to render the donation procedure as safe as possible for blood donors.

Up to now, a comprehensive overview for the whole of Germany on donation related physical reactions has been missing, since only the reporting of serious reactions is compulsory based on the law. The PEI intends to fill this gap with its survey, and obtain an overall picture on the type and number of blood donation related physical reactions. The results from the survey can provide important information on the motivation for and improvement in the care for blood donors.

The competent division at the PEI for medicines safety is among other things responsible for blood safety or haemovigilance as it is also called. The scientific staff in Unit Pharmacovigilance 2 records and evaluates all legally obligatory reports on serious reactions in blood and plasma donors and recipients of blood products. This information, which is collected throughout Germany, is published annually in a haemovigilance report.

Funk MB et al (2017): Haemovigilance Report of the Paul-Ehrlich-Institut 2015: Assessment of the Reports of Serious Adverse Transfusion Reactions pursuant to Section 63i AMG (Arzneimittelgesetz, German Medicines Act) (Englisch) (pdf, 1,021 KB, File does not meet accessibility standards.)


Contact

pharmakovigilanz2@pei.de

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