Written Answers. - Community Drugs Scheme.

Mary Harney


202 Miss Harney asked the Minister for Health the plans, if any, he has to add the drug Optimax to the list of drugs covered by the medical card in view of the fact that this drug is used to treat sufferers of manic depression and the prohibitive cost of it is resulting in patients not taking their prescribed medicine; and if he will make a statement on the matter. [16353/96]

Limerick East): Medicinal products are provided free of charge to persons covered by medical cards under the general medical services scheme. Products included in the scheme must conform to certain published criteria. A key criterion is that the product must be the subject of a current product authorisation. The granting and continuation in force of such an authorisation indicates that the Irish Medicines Board has been satisfied as to the quality, safety and efficacy of the product concerned.

Optimax, which contains L-tryptophan has been on the Irish market since 1971 as an antidepressant. However, in 1989, a serious life threatening condition — Eosinophilia-Myalgia Syndrome — was reported in association with the use of oral L-tryptohan containing products. Most of these reports came from the United States and Germany. Although there has been no reports of EMS in Ireland, the then National Drugs Advisory Board recommended that Optimax should remain available to those named patients already on the medication. In July 1993, the manufacturer concerned failed to renew the product authorisation which would be essential if the product were to continue to be marketed in the State.

Because of the unlicensed status of this drug, it is considered inappropriate to include Optimax for reimbursement under any of the community drug schemes. I understand, however, that it remains available on a "named patient" basis to those for whom the product is deemed essential.