asked the Minister for Health if he will make a statement regarding the way in which HIG 2 mercuric iodine soap is being sold in pharmacies without a prescription, taking into account the fact that it has been clearly established that it can be a health hazard; and the way in which the soap is available since it does not have a licence for sale from the National Drugs Advisory Board.
Written Answers. - Mercuric Iodine Soap.
22.
Mercuric iodine soap has been available in this country for the best part of this century. It was manufactured and marketed under the name of "HgI 2 Germicidal Soap". It was moderately efficient as an antiseptic and cheap but now has largely been replaced by other more efficient agents.
Following consultation with the Poisons Council (which, inter alia, advises me on regulations for the control of medicines under section 65 of the Health Act, 1947) mercuric iodine preparations were included as one of the medical preparations which I have subjected to prescription only control in the Medical Preparations (Control of Sale) Regulations, 1987. These regulations came into force on 1 July 1987. This means that mercuric iodine soap can only be obtained from a pharmacist on foot of a doctor's prescription.
My Department has not received any complaint in regard to any specific pharmacy selling the product without a doctor's prescription. A general complaint was received in November 1987 that the product was "on sale in several pharmacies". I asked the complainant for specific details to enable my Department to follow up the complaint but the information requested was not received. The Deputy can be assured however, that I would be concerned if the product were being sold without a doctor's prescription as required under the regulations and if he sends me details of any specific case, I will have the matter followed up.
I am aware that mercuric iodine soap does not have a product authorisation. Under the Medical Preparations (Licensing Advertisement and Sale) Regulations, 1984, a review procedure for products which are already on the market when the regulations were made, was set up. This review is structured in such a way that those products with greatest therapeutic benefit would be reviewed first and an appropriate timetable was incorporated in the regulations for that purpose. In accordance with this timetable, mercuric iodine soap will not require a Product Authorisation until 1 September 1988.
This review of established drugs is being carried out by the National Drugs Advisory Board, which examines the safety, quality and efficacy of each product being reviewed. The board also routinely, monitors the safety of medicinal products under its adverse reactions reporting system. The board to date has not received any adverse reaction report on mercuric iodine soap under this reporting system.