TGA Information Office gets automated!

From Friday July 4 all calls to our Information Office (1800 020 653) have been directed to an automated calling system. While the former arrangements have served us well, it has become increasingly apparent over recent months that the breadth of information being sought made it difficult for a single officer to respond in a meaningful and timely way. The new arrangements include an initial filter process to assist callers to identify the area of the TGA best able to respond to their enquiry.

Our thanks go to Sam Wong who, for the past several years, has provided a valuable and valued service to the TGAas Information Officer. Sam's knowledge and skills have not been lost to the TGA - he will transfer to the Chemicals and Non-prescription Drugs Branch.

In addition to streamlining our Information Office processes, we are also investigating new ways of providing up to date information to both industry and consumers, including an enhancement of our Internet World Wide Web Site and installation of automatic fax back facilities. Further details will be provided in future editions of the TGA News.

All of the changes we are making are intended to provide a better service and we welcome any feedback you are able to give us.

Budget changes

In the 1997-98 budget, the Government moved to increase cost recovery from industry for the regulation of therapeutic goods to 100 per cent over the next two years. The level of cost recovery through industry contributions will rise from its present level of 58% to 75% in 1997-98 and to 100% from 1998-99.

This has required an increase of approximately 12.5% in TGA's fees and charges across the board. TGA has been able to keep the increase to a minimum because of its ongoing efficiencies and increased turnover. The new fees and charges are included in this edition of TGA News.

In announcing these changes, Senator Chris Ellison said that at the same time, a range of initiatives would be implemented to improve the regulation of medicinal products in Australia. These measures were outlined in the Government's response to recommendations arising from the TGA Review.

"Industry and consumers will benefit from a more streamlined and efficient approach to the entire regulatory system," Senator Ellison said.

Canberra phone numbers changing from 18 August 1997

Over a three year period, from mid 1994, Australian telephone numbers have been increasing from six or seven digits to eight digits.

Canberra telephone numbers will change on 18 August 1997 when those in the (06) area convert to an eight digit local number with a two digit area code.

The changes to Canberra numbers will be uniform and simple. A '6' will be added to our existing local numbers and, simultaneously, our area code (06) will change to (02).

A revised list of TGA phone numbers has been included in the TGA News for your convenience.

Enforcement news

Recent prosecutions

Recent prosecutions by the Surveillance Unit have resulted in the convictions of:

• a Gold Coast man in relation to the importation of the drug "fantasy" (sodium oxybate - a general anaesthetic), six kilos of which was seized; and
• a Brisbane man in relation to the importation of a range of prescription and non-prescription drug products that included both prohibited imports and protected species products, six tons of which was seized.

Herbal ecstasy

Part of a shipment of Herbal Ecstasy tablets
(not containing ephedrine) illegally imported into Sydney

"Herbal Ecstasy" is a generic term used to describe a tablet, manufactured from plant material and presented as a "natural high". These drugs are usually sourced from the United States and often contain ephedrine. Although generally marketed as a safe alternative to "Ecstasy" (the amphetamine MDMA), these tablets have been implicated in a number of adverse reactions, including death, in the United States.

Recent investigations by the Surveillance Unit have resulted in the seizure of thousands of illegally imported Herbal Ecstasy tablets in Sydney, Brisbane and Melbourne.

Counterfeit drugs

A counterfeit medicine is one which is defined by the World Health Organization (WHO) as being "one which is deliberately and fraudulently mislabelled with respect to identity and/or source".

Such a product may contain the correct ingredients, wrong ingredients or be without active ingredients. The WHO have reported that in cases where the counterfeit product contains wrong, inadequate or toxic ingredients, it can be responsible for lack of effectiveness, serious damage to health or even death.

Pharmaceutical markets are international and as a consequence, the manufacture and smuggling of counterfeit medicines is also an international trade. Counterfeit products are often of poor quality and if not recognised as such, can cause great commercial harm to industry generally and to the genuine product they purport to be.

This trade is of vital interest to the Surveillance Unit due to the grave risk these goods may pose to public health and the potential damage they can cause to the integrity of the industry.

Inside premises in Auckland where labels and packaging was removed from prescription drug products sourced from Sydney, to which counterfeit labels and packaging was applied prior to distribution in New Zealand

Both the WHO and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) recommend that the industry share information in relation to counterfeiting with drug regulatory agencies.

These organisations also recommend that industry continue to develop anti-counterfeiting measures, including the use of both overt and covert devices that are made known to reliable enforcement agencies, to facilitate identification of counterfeit product.

The Surveillance Unit has detected instances of drug counterfeiting and strongly encourages the Australian industry to adopt these recommendations and to make these measures known to the Unit.

Part of a quantity of prescription and nonprescription drug products from which labels were removed in Melbourne, prior to the attachment of counterfeit labels that concealed the presence of ingredients banned from consumption in Singapore, to where the drugs were destined for export