Mr Price asked the Minister for Health and Family Services, upon notice, on 5 November 1996:

(1) Is he able to say whether there is a requirement to report reactions to drugs; if so, to whom.

(2) How many reactions reported since 1991 have been attributed to out-of-date drugs.

(3) What were identified as being the most common causes of drug reactions since 1991.

Dr Wooldridge —The answer to the honourable member's questions are as follows:

(1) Yes, if the sponsor of a drug product supplied in Australia becomes aware of a serious, unexpected adverse reaction or event which is suspected as being associated with the use of the drug, the sponsor is required to report that in writing to the Therapeutic Goods Administration (TGA).

In addition, a voluntary scheme for reporting by health professionals of suspected adverse reactions to drugs has been in operation in Australia since the 1960's.

(2) Regular and detailed clinical analysis of incoming adverse drug reaction reports has only detected evidence of a causal role due to `out-of-date' (also known as `expired') drugs in exceptionally rare instances.

(3) The more frequently encountered adverse reactions in specific individuals result from allergy, exaggerated (pharmacological) effects or genetic predisposition.