I assume the Deputy is referring to the recent newspaper article concerning ten reports of adverse transfusion events in Irish hospitals. The data referred to is contained in an annual report which was published recently under the Serious Hazards of Transfusion scheme, also known as the SHOT scheme, which is a UK based system established in September 1996 to report on adverse events associated with the transfusion of blood and blood components. Adverse events include both expected and unexpected reactions by recipients to blood components, as well as failures in best transfusion practice at hospital level.
Ten such incidents in Irish hospitals were reported in the period September 1996 to October 1997. Five patients who required transfusion received blood components which were not intended for them. Four patients reacted to the use of filters which were necessary as the patients required filtered blood components. One patient had a delayed reaction to a whole blood transfusion which was not unexpected. None of the incidents involved patients having unexpected reactions to blood products, nor did they involve procedures and processes at the Blood Transfusion Service Board, nor did they involve suspected bacterial contamination or viral transmission.
The Deputy refers to the implementation of the Finlay recommendation in relation to reporting abnormal reactions. There is a well established reporting arrangement by hospitals to the BTSB of any suspected bacterial contamination or viral transmission associated with blood components made available by the BTSB. Such reports would be available to the Irish Medicines Board as part of its routine inspections of the BTSB. No reports were received by the BTSB during 1997.
The reporting to the IMB of adverse reactions to medicinal blood products is already in place. Under section 4 of the Irish Medicines Board Act, 1995, one of the principal functions of the IMB is to establish and administer a service for obtaining and assessing reports on any adverse effects of medicinal products in use in the State. Medicinal products are defined under EU Council directives and include blood products, such as clotting factor concentrates, and immunoglobulins, such as anti-D and albumin. Human blood components such as red cells, platelets or plasma are not currently defined as medicinal products. The statutory reporting system in place for medicinal products is provided for under the Medical Preparations (Licensing and Sale) Regulations, 1996, which require the holders of medicinal product authorisations, usually pharmaceutical companies, to:
keep a record of reports of adverse effects associated with the use of the product to which the authorisation relates. The record shall be available for inspection by a person authorised by the Board who may take copies thereof. The authorisation holder shall furnish to the Board a copy of any such report of which he has a record or of which he is aware.
The first annual report of the IMB relating to its inspections of the BTSB, which was submitted to me on 8 April, notes that the IMB received three reports of suspected adverse reactions associated with the use of blood-derived medicinal products. In each of the cases notified, the symptoms described — fever, headache and allergy-like symptoms — are known to occur and were resolved with symptomatic treatment.
My Department, in consultation with the IMB and the BTSB, is developing a number of proposals which will improve the reporting of adverse reactions and transfusion practice generally. A statutory reporting procedure for the reporting of abnormal reactions to blood components will be established which will strengthen the existing reporting system. The details of the scheme are being discussed with the IMB whose regulatory authority would require extension to include blood components.
As well as extending the regulatory role of the IMB in relation to haemovigilance, I consider it important that a national haemovigilance office be established. The main function of this office would be to receive, analyse and report on adverse reaction data provided by hospitals and generally support the improvement of haemovigilance and transfusion practice nationally. Resources for the establishment of this office, which will be located initially within the BTSB, have been made available by my Department. The delineation of the respective roles of the proposed haemovigilance office and the IMB is currently being discussed.
The success of a haemovigilance programme will rely to a large extent on the active involvement of hospitals and the timely and accurate return of data on adverse reactions. In a number of hospitals specific responsibility in this area has been assigned to transfusion surveillance officers. It will be necessary to increase the number of hospitals currently employing such officers and my Department is currently examining how best to achieve this objective.
