Page 2119 - Week 07 - Tuesday, 28 May 1991
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Yes, these drugs are being prescribed in Canberra. The indications for which these drugs may be marketed are those which have been approved by the Australian Drug Evaluation Committee. Before a drug is registered, the product information document for that drug must be approved by the Commonwealths Therapeutic Goods Administration. These documents are widely distributed in annual compendia, and are consulted frequently by doctors.
If new risks are recognised after a drug is registered, amendment of the product information document will be required. For example, the approved product information document for a well known UNSAID lists gastrointestinal haemorrhage and ulcer as possible adverse effects of the drug, and includes a warning that the drug should be used with extreme caution in patients with a history of gastrointestinal haemorrhage or ulcer. In addition, it advises the exercise of particular caution in elderly patients who are generally more prone to side effects, and recommends that the lowest effective dosage be used in these patients.
It is the professional duty and responsibility of medical practitioners to balance the risks against the expected benefits of any proposed treatment, particularly in the elderly; to advise their patients on possible adverse reactions to drugs they prescribe; to exercise extreme care in selecting drugs and dosages to treat old people; and to monitor carefully long-term therapy. To assist medical practitioners in the discharge of these responsibilities, the Commonwealth has in place several mechanisms to encourage reporting of suspected adverse reactions to all drugs and regularly publishes the Australian Adverse Drug Reactions Bulletin which recently reported details of side effects of a particular UNSAID.
The Commonwealth Governments on-going commitment to informing medical practitioners of the clinical applications and side effects of products available for prescribing is highlighted by its quarterly publication of the Australian Prescriber. This independent review has on a number of occasions reported on NASAs, both as a group and as individual drugs. The Bulletin and the Australian Prescriber are distributed free of charge to all medical practitioners.
The National Health and Medical Research Council recently reviewed individual NASAs and the restrictions on their sale in the ACT are those of Council. Similar controls exist in each State and Territory in Australia.
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