Reporting obligations

Duty to report adverse drug reactions in accordance with Section 16 of the Transfusion Act

All adverse events associated with the use of blood products are subject to a reporting obligation, which in the case of serious ADRs must also be reported to the competent higher federal authority(Paul Ehrlich Institute), which ensures central registration and evaluation as part of haemovigilance. In the case of transfusion-associated infectious diseases, a traceability procedure must also be carried out.

According to the Transfusion Act (PDF) §16 Transfusion Act, a distinction is made between three types of adverse reactions to the use of blood products:

Adverse event

All complications, even if a connection with the use of blood products is not immediately apparent. Immediate notification of the transfusion officer and the physician on duty at the Institute for Transfusion Medicine. They will decide on further measures.

Suspicion of an adverse reaction

Prompt connection of the side effect with the administration of the blood products. Probable cause of the side effects due to the administration of blood products. Notification of the transfusion officer and the physician on duty at the Institute of Transfusion Medicine. The pharmaceutical company is informed by the Institute of Transfusion Medicine.

Suspicion of a serious adverse reaction

The side effect is fatal or life-threatening, leads to incapacity to work or a disability, results in inpatient treatment or prolongs inpatient treatment. Informing the transfusion officer and the physician on duty at the Institute for Transfusion Medicine and the Paul Ehrlich Institute. The pharmaceutical company will be informed by the Institute of Transfusion Medicine.

Adverse reactions that can be attributed to a blood product are documented by the transfusing physician on the transfusion report and immediately sent to the Institute of Transfusion Medicine together with the request for clarification of the transfusion reaction using the transfusion reaction request card. In addition, an ADR report form "Adverse drug reaction" must be kept on the symptoms, diagnosis and therapy, filed in the patient file after completion of the documentation and sent to the transfusion officer, the person responsible for transfusion and the Institute of Transfusion Medicine. The documentation is a prerequisite for fulfilling the statutory information obligations. The records are kept for at least 30 years.

The documentation and the document distribution list are prerequisites for the fulfillment of the legal notification obligations and must therefore be strictly observed.

Notification to the Drug Commission of the German Medical Association is made by the responsible transfusion officer (Section 30 (7) of the Professional Code for German Physicians).