Dáil Éireann debate -
Thursday, 24 Oct 1991

Vol. 411 No. 6

Written Answers. - Drug Labelling Guidelines.

Richard Bruton

Question:

58 Mr. R. Bruton asked the Minister for Health whether his Department plan to introduce labelling guidelines to govern medical preparations containing drugs whose dosage must be controlled in the interests of safety but which are available over the counter in view of the claim that deaths from paracetamol poisoning may be due to misleading labelling; and if he will make a statement on the matter.

Minister for Health (Dr. O'Hanlon)

Regulations governing the labelling of medicinal products are laid down in the Medical Preparations (Advertisement and Sale) Regulations, 1958. These regulations set out in detail the information that must be contained on the labelling and packaging of medicines. In addition to these statutory requirements, further specific requirements may be stipulated in the terms of the product authorisation granted for any individual product.

There are also proposals for an EC Council Directive in relation to the labelling of medicinal products. Consideration of these proposals is at an advanced stage and when adopted the provisions will be fully incorporated into our own statutory regulations.

I am satisfied that the present combination of statutory requirements, together with the specific requirements of product authorisations, are together sufficiently adequate to ensure that ample information is contained in the labelling or packaging, which, when correctly followed, will ensure the safe handling of such medicines.

The controls on medicines, including labelling requirements, are matters that are kept under continuous review both within my Department and by the National Drugs Advisory Board, which have a particular responsibility to advise me on these matters. Following the recent reports relating to paracetamol poisoning I asked that the NDAB should review current labelling requirements of medicines containing paracetamol. The board however, are of the view that present labelling requirements are adequate but would emphasise the need for people to read instructions carefully and to follow the directions given.

I would stress the importance of the need to treat all medicines with the greatest of care and respect. Medicines should only be taken in accordance with the advice of one's doctor or, in the case of self-medication, be taken strictly in accordance with the instructions provided. I would also draw attention to the possible dangers that may arise as a result of mixing medicines. Expert advice on the proper use of any medicine is readily available from one's pharmacist or doctor and where there are any doubts whatsoever such advice should be sought.