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Fifty years of independent expert advice on prescription medicines
Selected achievements of the first three decades
At its second committee meeting, ADEC recommended that a Registry of Adverse Reactions to Drugs be established so that there was a central place for reports of adverse reactions to be stored. Fifty years later, this internal card index system has become a publicly searchable database on the TGA website: the Database of Adverse Event Notifications.
ADEC also prepared a form for reporting adverse reactions and a covering letter from the chairman, Dr Edgar Thomson. This form, with the covering letter, was sent to all doctors in Australia on five occasions, as well as to State Health Departments, medical colleges and hospitals. Now the 'blue card' is still available, but online and telephone reporting is also possible.
Doctors were advised that long-acting sulfonamides should not be given to children for 'trivial reasons' because there had been 82 cases of serious reactions (Stevens-Johnson syndrome) in Australia and overseas.
In the first three years, 112 ADEC resolutions were forwarded to the Minister. These resolutions were about new medicines proposed to be marketed and actual or potential safety issues with those already available in Australia.
By December 1966, in response to 760 adverse reaction reports:
- 4 medicines were banned for safety reasons
- 21 warning letters were published by ADEC in the Medical Journal of Australia to warn Australian doctors about particular safety issues
- 17 warning letters about safety issues were sent to doctors by pharmaceutical companies after communication with ADEC
- 30 amendments to advertisements were made
- 3 medicines were voluntarily withdrawn by the manufacturer.
Sir Arthur William (Bill) Morrow DSO, MB, BS, MRCP, FRACP, FRCP, FACP, second chair, 1967-1975
Dr Stanley Goulston AM, MB, BS, MD, M Phil, FRCP, FRACP, third chair, 1976-1982
Sir William and Dr Goulston worked together to establish Australia's first specialist gastroenterology unit at the Royal Prince Alfred Hospital, which is now named the AW Morrow Gastroenterology and Liver Centre.
Today, we understand that guidelines are a necessary part of regulating medicines, enabling pharmaceutical companies and the regulator to have a common understanding of the experiments and clinical studies required to investigate quality, safety and efficacy.
In the sixties and seventies there were no internationally accepted guidelines.
ADEC stepped in and set up subcommittees to develop relevant guidelines. This occurred for:
- parenteral nutrition, that is, a sterile food substitute that is administered through an intravenous drip
- radiopharmaceuticals: radioactive medicines used as imaging agents.
In the seventies Australians affected by cancer were getting frustrated. They didn't have access to experimental treatments available in the US, and some of them were very promising.
ADEC sent a delegation to the US National Cancer Institute, and negotiated for Australian oncologists to be able to use particular experimental anti-cancer medicines, with the condition that the same protocol would be used in Australia as in the US.
In 1982, there was an application for a new medicine for arthritis (benoxaprofen), but some people participating in the clinical trials had unpleasant skin reactions to light (photosensitivity reactions).
When the Department investigated further, it was discovered that similar reactions were also occurring in the UK, where it had been marketed for a couple of years. In fact, a small number of the UK reactions were serious and potentially fatal.
ADEC considered the medicine unsuitable for Australians.
Although suggestions were made that using sunscreen would make the medicine acceptably safe, ADEC held its ground. The medicine was never available in Australia - and it was withdrawn worldwide at the end of 1982 because of the photosensitivity reactions and apparent liver toxicity.