TGAL'S testing program for herbal medicines

Dried Stephania tetrandra root

In the interests of public safety the TGA Laboratories regularly test herbal medicines. A recent survey of nine of the eleven products containing the herb Stephania tetrandra listed on the Australian Register of Therapeutic Goods revealed the presence of aristolochic acid in analysis of four of the products. A consumer level recall of the affected batches has been carried out. The presence of aristolochic acid is evidence that the Stephania has been contaminated or substituted with an Aristolochia species (possibly Aristolochia fangchi). Confusion between Stephania and Aristolochia can arise from superficial similarities in the appearance of the dried root materials and from similarities in their Chinese names and characters. Several countries have banned the use of both herbs because of serious adverse reactions linked to the presence of Aristolochia fangchi.

Dried Aristolochia fangchi root

A survey is in progress of medicines listed as containing the herb Scutellaria lateriflora. To date TGAL has found that the majority of the products and raw herbal materials tested did not contain this herb. TGAL is working with the Nutritional Foods Association of Australia (NFAA) to identify the alternative herbs used and this process is complicated by the presence of mixtures of herbs in the products. The herbals testing unit (Chemistry Section), has developed methods to detect Scutellaria lateriflora, that will assist manufacturers of herbal medicines to test for the correct identity of bulk native herb and herbal extract deliveries. This work will be published in the near future and will result in a general correction to the established literature on S. lateriflora.

Scutellaria lateriflora plant

Batches of Chinese herbal liniments were recalled recently when found by TGAL to contain chemical additives instead of the natural oils represented on the label.

Layer Chromatogram of herbal extracts

Manufacturers of herbal medicines should note that it is their responsibility to ensure that the correct species of herb has been used in the product. Medicines which do not contain the herb as labelled and listed on the ARTG may be subject to recall action. In view of the errors found in some of the published literature and the recent failures of herbal medicines reported by TGA, manufacturers are well advised to take stock of their acceptance criteria and validate their methods of analysis, preferably using a specimen of the herb authenticated by a reputable herbarium. The methods of analysis also should be able to distinguish the particular species of herb used.

Top of page

Media release: New committee to advise on complementary medicines

THE HON. TRISH WORTH

Parliamentary Secretary to the Minister for Health and Family Services Member for Adelaide

29 October 1997

New Committee to Advise on Complementary Medicines

The Parliamentary Secretary for Health and Family Services, the Hon Trish Worth MP today announced the establishment of the Complementary Medicines Evaluation Committee.

"The establishment of this Committee recognises the increasingly important role which complementary medicines are playing in the health care choices of the Australian community," Ms Worth said.

"It is important that the community have confidence in the safety of the products they are using.

"The Committee will provide the Therapeutic Goods Administration (TGA) and myself with expert scientific and technical advice on the safety of complementary medicines," she said.

There are approximately 15,000 complementary medicinal products already approved for supply in Australia and new products are constantly being developed.

"This is a growing industry and we want the Australian community to have access to complementary medicinal products where there are no safety concerns.

"The Government believes that the level of regulation should be appropriate to the assessed risk to public health and safety. The Committee will have an important role to play in helping us achieve this.

"The Committee members have a wide range of expertise and experience which reflects the diversity of products classified as complementary medicines. Members will provide practical advice which recognises the philosophies of complementary products while ensuring that the required standards of safety, quality and efficacy are met.

"The membership includes experts in nutrition, complementary and traditional medicine, orthodox medicine, toxicology and chemistry as well as people with experience in consumer issues and the regulation of foods and drugs," Ms Worth said.

The Committee will be chaired by Professor David Roberts who is Foundation Professor of Nutrition and Dietetics at the University of Newcastle. The names of the other members will be announced shortly.

The Committee is expected to hold its first meeting before the end of the year.

Top of page

TGA's Parliamentary Secretary

Introducing Trish Worth

By now, you will be familiar with the former nurse and midwife - Trish Worth - now the Parliamentary Secretary to the Minister for Health and Family Services.

Trish Worth, Parliamentary Secretary for TGA

Ms Worth, the Member for Adelaide, joins two doctors - Health and Family Services Minister Dr Michael Wooldridge, and health spokesman in the Senate, Senator John Herron - to make up the Government's health team.

Patricia Mary Worth was born on 21 April 1946 in Riverton, South Australia. Ms Worth was educated at Riverton High School and Cabra College, and completed her education at Calvary Hospital in Adelaide, where she became a registered nurse and midwife.

In 1967, at the age of 21, she became the Nurse of the Year and State Gold Medallist.

After moving up through various senior nursing positions covering the full range of hospital care, Ms Worth took up the private sector role of Patient Services Manager, Pathology, in 1989 - a position she held for the next four years.

It was at that stage that her career took an interesting turn. In 1993 she won the seat of Adelaide, and in the elections of 1996 retained the seat.

In 1996, Ms Worth became the first female Government Whip in the House of Representatives - a position in which she remained until being appointed to her present position as Parliamentary Secretary.

She believes her background has placed her in a good position to see the broader health picture and also to understand the issues from the perspectives of both providers and consumers.

"My nursing background and the position of Patient Services Manager in a large private pathology company has provided me with a clear understanding of the issues affecting the broader health arena - from the needs of GPs and their patients in rural and remote areas to the highly specialised requirements of the services provided in the city," Ms Worth said.

Ms Worth has also served on a range of parliamentary committees, and was Chair of the Health, Family Services and Veterans' Affairs Committee for 14 months - a position from which she resigned to make time for her new responsibilities as Parliamentary Secretary. This work, she says, has provided her with exposure to different policy areas - and that will be valuable in her new role.

As Parliamentary Secretary to the Minister for Health and Family Services, she has specific responsibility for a range of areas, including: the Therapeutic Goods Administration (TGA); the Australia New Zealand Food Authority (ANZA); Hearing Services Program; the Pharmaceutical Benefits Scheme (PBS); and Health Services Australia.

Of her future ambitions, Ms Worth will say only "my aim is to see that the best possible decisions are made in an area that greatly affects the life of every Australian."