Vol. 486 No. 2
6 Mr. G. Mitchell asked the Minister for Health and Children whether the Government intends to enact legislation to require that, prior to any blood product being administered to a patient, the patient be advised by the medical practitioner concerned of the nature of these products; and his views on the fact that many of those to whom Amerscan Pulmonate II was administered were not told in advance of the nature of this product. [2052/98]
7 Mr. Finucane asked the Minister for Health and Children whether the Government intends to enact legislation to require that, prior to any blood product being administered to a patient, the patient be advised by the medical practitioner concerned of the nature of these products; and his views on the fact that many of those to whom Amerscan Pulmonate II was administered were not told in advance of the nature of this product. [2053/98]
17 Mr. Bell asked the Minister for Health and Children if he will report on the use of Amerscan Pulmonate II; the numbers who received this treatment; and the information and counselling services which have been provided for them. [2204/98]
82 Mr. Boylan asked the Minister for Health and Children whether the Government intends to enact legislation to require that prior to any blood product being administered to a patient that that patient be advised by the medical practitioner concerned of the nature of these products; and his views on the fact that many of those to whom Amerscan Pulmonate II was administered were not told in advance the nature of this product. [2051/98]
I propose to take Questions Nos. 6, 7, 17 and 82 together.
The product Amerscan Pulmonate II is administered to persons undergoing lung scans by x-ray. It is an imaging agent, administered by injection, and finds its way to the lungs, where it enables doctors to produce an image of the lung structure so they can detect lung disorders. It is often used in the late stage of lung disease and disorder and assists both the investigating and treating physicians in arriving at the relevant diagnosis and in prescribing the appropriate treatment regime.
Following contact with the hospitals in which the product, which was the subject of recent publicity, was administered, the Department has established that a total of 460 persons received the product. The Department asked each of the nine hospitals involved to identify all persons to whom the product was administered, to make arrangements to inform each person and to provide appropriate counselling. A clinical information pack was sent to each hospital, and this consisted of scientific data in relation to the composition and operation of Amerscan Pulmonate II, on the clinical issues in relation to nvCJD and the possibility of its transmission through the product.
The Department asked each hospital to ensure that the physicians who treated the persons concerned would meet each person individually and brief him or her fully on the particular circumstances, using the background information in the clinical information pack. In addition the Department asked each hospital to arrange counselling appropriate to the needs and wishes of each of the persons who received the product and that the treating physician should liaise with the person's general practitioner, to facilitate any follow-up that might be required.
Blood, blood products and pharmaceutical products which contain blood derivatives are essential parts of health care. In the case of Amerscan Pulmonate II, the use of this product, which is not a blood product, but which contains a very small amount of a protein albumin isolated from blood plasma, is an essential prerequisite for determining the relevant treatment regime in individual patients suffering from lung disease and disorder.
The provision of information about a diagnostic test using Amerscan Pulmonate II would be part of the confidential doctor-patient relationship, under which a person undergoing any test or treatment, would be informed by the doctor of the benefits that would accrue to the patient, as well as any known risk arising from the intervention or treatment, the nature and magnitude of any risk and, in the doctor's view, the degree to which the benefit outweighs any risk.
I consider that currently there is adequate provision in the Medical Council's "Guide to Ethical Conduct and Behaviour and to Fitness to Practice" to ensure that patients are informed about medical interventions and I do not consider it necessary to propose to Government that further legislation is required.
Is the Minister aware that the majority of people to whom Amerscan Pulmonate II was administered were blissfully unaware that this product contained any blood derivative of any nature? Does he agree it is important that in the future if any product is found to contain such derivatives, the patient is informed?
The Patients' Charter provides that people should be informed. The product in question contains one twenty-thousandth of a drop of blood. One has to take cognisance of that. I am not aware of any complaint having been made by anybody about the fact that they were not informed of the exact nature of the product. There is a doctor-client relationship, and I would not be aware of a complaint unless it was made to a third party at the Irish Medical Council.
Does the Minister agree that in the context of this and any other product that might be administered in the future, it is desirable that medical practitioners inform patients of the nature of the product in so far as it does contain a blood derivative, no matter how small the blood derivative might be?
Except for emergency procedures that might preclude that, it would be advisable that medical practitioners recognise this is an issue that members of the community would like to be advised about prior to ingesting any such product.
