Vol. 418 No. 2
91 Mr. Callely asked the Minister for Health if he has satisfied himself with the existing voluntary report scheme whereby medical personnel may report suspected adverse reactions their patients experienced after administration of drug therapy; and his views on whether such reporting should be mandatory on all medical personnel.
Ireland's level of reporting of "adverse drug reactions" (ADR) is in keeping with other countries and in particular with other EC member states who have voluntary reporting systems. The pharmaceutical industry also provide a backup for the ADR voluntary reporting system, as the industry have a legal obligation to submit ADR reports (as a condition of the product authorisation under which a medicinal product is placed on the market). Indeed, this country's contribution to the WHO drug monitoring programme has been praised by WHO for its consistent quality.
A mandatory system for reporting would be impossible to police. Furthermore, the quality of mandatory reports could not be guaranteed and therefore many would be unclassifiable and accordingly of no use in assessing a possible drug side-effect relationship. I would add that no country, currently, has a mandatory system of reporting for practitioners.
