Written Answers. - Generic Drug Prescription.

Ivor Callely


49 Mr. Callely asked the Minister for Health if his attention has been drawn to the concern by patients and their GPs when patients' medication is switched from branded products to generic drugs; if his attention has been further drawn to the recent studies in the UK, in particular where a pilot study of 470 epileptic patients showed increased side effects following a switch to generics; and if he will make a statement on the matter. [897/94]

Richard Bruton


221 Mr. R. Bruton asked the Minister for Health if his attention has been drawn to the findings in the United Kingdom where epileptic patients have experienced problems when switching between branded and generic drugs; and the protocol, if any, he has set out for the use of generic drugs which could ensure that the various concerns in relation to generics are systematically addressed. [253/94]

I propose to take Questions Nos. 49 and 221 together.

Generic medicines licensed for sale in Ireland are required to undergo the same rigorous safety controls as proprietary medicines. A manufacturer of a generic medicine is required to demonstrate that the absorption of the medicine into the human body is similar, within stated limits to that of the branded product.
I am advised that the permitted variation in absorption is of no clinical significance for the vast majority of medicines. In a small number, it can give rise to problems, if a patient is switched from one brand of the medicine to another brand or to a generic version. These drugs are those in which the dose which is effective is close to the dose which is toxic and include drugs for the treatment of epilepsy.
I should point out that all qualified doctors are trained to be aware of such problems, and the regulation of their use, as with all medicinal drugs, rests with the prescribing doctor.
The National Therapeutics Advisory Committee, which advises me on all aspects of drug prescribing, has recommended that doctors should prescribe by generic name. The committee has accepted that for patients already maintained on medication falling within the category which I have referred to, a transfer from a particular product to a generic may neither be desirable nor possible. The recommendations of the committee are being widely circulated to hospitals and health board general practice units.