The Swiss Haemovigilance reporting system – Fundamentals

Manufacturers

Art. 59 para. 1 TPA requires anyone who manufactures or distributes therapeutic products to put in place a reporting system in compliance with the requirements of Art. 65 TPO. In accordance with Art. 59 para. 1 and 2 TPA in conjunction with Art. 61 ff. TPO, Swissmedic must be notified of quality defects and other findings and evaluations which could influence the basis for assessment and of adverse effects and incidents which:

• are or could be due to the therapeutic product itself, its use or incorrect labelling or instructions for use;

• could endanger or impair the health of patients.

Under the haemovigilance system, donor reactions, quality defects, transfusion reactions and near misses must be reported to Swissmedic within the timelines stipulated in Art. 62 TPO.

Users

According to Art. 59 para. 3 TPA, any person who professionally dispenses therapeutic products or administers them to humans or who is entitled to do so as medical personnel must notify Swissmedic of any serious or previously unknown adverse effects and incidents, clusters of events, observations of other serious or previously unknown facts and quality defects that are of significance for drug safety within the timelines stipulated in Art. 63 para. 3 TPO. Under the haemovigilance system this applies to transfusion reactions, transfusions of incorrect blood products (IBPT), quality defects and near misses.

Procedure in practice

Swissmedic is in direct contact with the blood transfusion centres and users. The RPHv at each institution is always the direct contact for Swissmedic. Examples of the incidents reported to Swissmedic by the blood transfusion service (BTS) include transfusion reactions (including allo-immunisation), near misses, donor reactions and quality defects.

If quality defects are found after a blood product has been supplied to the user, the blood transfusion service also informs the user. If the product has already been transfused, a look-back procedure (tracing procedure) can be initiated.

Reports from users to the RPHv are usually submitted by the doctor responsible for the transfusion or the medical staff involved in the transfusion.

Reported transfusion reactions (including allo-immunisation), near misses and transfusion errors are first evaluated internally and the appropriate investigations carried out before the reports are passed on to Swissmedic and the blood transfusion service within the specified timelines. The blood transfusion service must be informed immediately about a post-transfusion infection in the recipient so that other products which may be affected can be blocked or recalled.

In addition to cooperation and regular contact with the blood transfusion services and users, Swissmedic also cooperates with national and international authorities and specialist organisations. For example, information about disease-causing pathogens relevant in transfusion medicine is exchanged with the Federal Office of Public Health (FOPH).

The regular exchange between the various international authorities and specialist organisations generates new findings which Swissmedic implements in cooperation with national specialist organisations with the aim of optimising the Swiss guidelines and improving safety in transfusion medicine.