Transfusion reactions (TR)
Transfusion reactions are undesirable or unexpected events which may be related to the administration of labile blood products. Article 63 para. 2 TPO requires these events and all the relevant and available information to be reported to Swissmedic.
For further information on transfusion reactions, please see the corresponding information sheet "Classification and investigation of transfusion reactions".
Serious incidents
Art. 63 TPO requires anyone who uses or dispenses medicinal products professionally, or is entitled to do so, to report to Swissmedic observations of serious or previously unknown facts which endanger drug safety. This also includes transfusion errors.
Equally, Art. 59 para. 3 TPA requires serious or previously unknown adverse effects and incidents, observations of other serious or previously unknown facts and quality defects that are of significance for drug safety to be reported. According to Art. 4 para. 1 let. a TPA, blood and blood products are also medicinal products. The explanatory report on the Therapeutic Products Ordinance published in September 2018 states the following: “Observations of serious facts are incorporated for the first time following the revision of Article 59 paragraph 3 TPA. This specifically addresses situations in which erroneous use of a medicinal product was avoided but which favour errors in use and could lead to substantial damage to health. […]. Where blood products are concerned, transfusion errors that are barely avoided must also be reported.” Here the Ordinance explicitly addresses near misses.
The reporting obligations for "Serious incidents" are explained in detail in the corresponding information sheet:
Incidents during manufacture that must be reported
In accordance with Art. 58 para. 1 TPA, Swissmedic and the other authorities responsible for enforcing the Therapeutic Products Act monitor the legitimate manufacture, distribution, dispensing and promotion of therapeutic products within the scope of their responsibilities. They perform periodic inspections to establish whether the conditions for licensing are still being met. Swissmedic’s responsibility for inspections relating to blood and blood products is set out in Art. 60 para. 2 let. b TPA.
The regional blood transfusion services (RBTS) report all donor reactions (grades 1-4) cumulatively to Swissmedic and to Swiss Transfusion SRC once a year. Serious (grades 3 and 4) donor reactions must also be reported individually to Swissmedic (on a separate form) within 15 days, as stipulated in Art. 62 TPO and Art. 63 para. 3 TPO.
For further information on donor reactions, please see the corresponding information sheet "Haemovigilance - Adverse reactions in blood donors".
Only high-quality, safe and effective therapeutic products may be placed on the market (Art. 1 Therapeutic Products Act, TPA). Blood and labile blood products are therapeutic products and, according to Article 4 paragraph 1 a TPA, are classified as medicinal products. Any person manufacturing, distributing, dispensing or using therapeutic products must notify Swissmedic of any quality defects which cast doubt on the established use, efficacy or safety of the medicinal product (see Art. 59 para. 2 and 3 TPA). In this context, and with respect to labile blood products, “serious defects in relation to the GMP rules that have occurred during the blood collection process or the manufacturing of labile blood products” and the corresponding (protective) measures which have been taken – among other things – are subject to mandatory reporting (Art. 61 para. 7 TPO and Art. 37 para. 1 let. e and para. 2 MPLO).
For further information on serious quality defects and serious defects during the manufacture of labile blood products, please see the corresponding information sheet "Reporting quality defects in labile blood products".
If it is found that the donor did not fulfil the criteria for donor suitability during the donation, the tests for communicable diseases were not performed correctly or the donor has been discovered to have a blood-borne disease, Art. 37 para. 1 MPLO requires holders of a licence to handle blood and labile blood products to take the necessary protective measures without delay.
Reports that describe protective measures usually concern infection markers identified in donors who test positive. They also include the documentation of any further investigations triggered by this finding with respect to earlier donations by the same person and/or other blood donors in some cases (known as the “look-back” procedure).
The responsible blood transfusion service reports the infection markers, the measures implemented and the data for the donated blood products to Swissmedic. The exposure risk must also be reported for certain infection markers. For repeat donors, the data from the last-but-one donation must also be provided, and it must be stated whether a look-back procedure was initiated.
However, quality defects and protective measures may also involve the users. Institutions (usually hospitals and doctors’ practices) which use blood and labile blood products in patients must inform manufacturers, on request, of the relevant information about the use of the labile blood product and about the conclusion of the look-back procedure. This is stipulated In Art. 37 para. 4 MPLO. On the other hand, quality defects in a product may not be identified until the product is used in a hospital. These defects must be reported to Swissmedic in accordance with Art. 63 para. 1 let. c TPO. Quality defects must be reported immediately to the blood transfusion service since, in certain cases (e.g. if bacterial contamination of the blood product is suspected), further products from the donor may have to be blocked or recalled without delay.
Look-backs are performed to investigate the transmission of infections in blood products. The procedure may focus on the donor (confirmed diagnosis of a blood-borne infection in a repeat donor) or the patient (confirmed diagnosis of a blood-borne infection in a recipient of blood products). The investigations are coordinated by the Look Back B-CH coordinating office and performed using algorithms specific to each infection. The underlying legal basis is Art. 35 para. 2 in conjunction with Art. 37 para. 1 let. c and d and para. 3 MPLO.
In a tracing procedure, Art. 37 para. 4 MPLO requires users to provide the manufacturer and Swissmedic on request with relevant information about the use of the labile blood product and about the conclusion of the look-back procedure.
