Serious adverse events (SAE) occurring during the production of blood components as well as serious adverse reactions (SAR) in recipients of blood and blood components or in donors are systematically collected by means of a haemovigilance system. The resulting data provide the basis for adequate measures to further improve the safety of blood-derived medicinal products, haemotherapy as well as blood donors.
Haemovigilance – Definition
In Directive 2002/98/EC, article 3, of the European Parliament, haemovigilance is defined as a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors.
Haemovigilance Notification System in Germany
The German Medicines Act (AMG), Article 63i, governs the reporting obligation of the manufacturer or blood establishment, which have to report all suspected SAR and SAE to the competent authority without delay. The reporting obligation of the responsible physician is laid down in the German Transfusion Act (TFG), according to which all suspected cases of SAR due to a blood component or plasma protein concentrate have to be reported to the competent authority.
The PEI provides standardised forms on its homepage for this type of reporting or reports can be submitted via an online submission platform
Physician in Charge and Transfusion Officer
In the case of a suspected adverse reaction (serious or non-serious) due to a blood component or (recombinant) plasma protein concentrate, the manufacturer or blood establishment shall be notified according to the German Transfusion Act (TFG). In addition, if the suspected adverse reaction is serious, the competent federal authority must be notified within 15 days.
Marketing Authorisation Holder / Manufacturer (e.g., Blood Establishment)
The manufacturer shall provide additional information in order to complement an initial report and may be necessary to evaluate a transfusion reaction. Moreover, the manufacturer is obligated to report serious adverse events that occur during the preparation and production of blood components to the competent federal authority.
Details on the definition of serious adverse events can be found at Guidelines / Recommendations.
Objective of the Reporting Pursuant to AMG and TFG
The assessment of reports received by the competent federal authority aims to further improve the safety and quality standards of blood-derived medicinal products and prevent the occurrence or recurrence of untoward effects or possible harm. A summery and analysis of the obtained data is published in regular intervals by the PEI in form of the haemovigilance reports.