Australia Committee

The Society of Hospital Pharmacists of Australia Committee of Specialty Practice in Clinical Pharmacy. SHPA Standards of Practice for Clinical Pharmacy. In Practice Standards and Definitions, Johnstone, J.M., Vienet, M.D., Eds. The Society of Hospital Pharmacists of Australia Melbourne, 1996. 

Estimates were made by Uhlig in the USA. Worner in Australia, and Vernon in the UK, in which the cost of protection and prevention were added to the cost of deterioration due to corrosion. These early estimates were made by individual scientists from cost information from new major industries scaled up to a national level, and were of the order of 1-1.5% of GNP. More detailed estimates were subsequently made by the Committee on Corrosion and Protection (the Hoar Committee) in the UK, and Payer etal. for the National Bureau of Standards in the USA. The later estimates were around 3.5-4% of GNP, the higher figure reflected factors not covered in the earlier surveys, which were, moreover, based on organisations which had probably already taken action to minimise their corrosion costs. Estimates have since been made for other European countries which tend to confirm the higher figure. 

Nomenclature Committee oflUBMB (NC-1UBMB) (those additional to JCBN) A. Bairoch (Switzerland), H. Berman (USA), H. Bielka (Germany), C.R. Cantor (USA), W. Saenger (Germany), N. Sharon (Israel), E. van Lenten (USA), E.C. Webb (Australia). 

The consumer movement, particularly the Consumers Health Fomm, also has considerable political influence. As a result of political pressure exerted by HIV/AIDS pressure groups and industry, the DRA was reviewed, new legislation introduced and new committees established to ensure that the regulatory authority responded more efficiently to public and political needs. Professional associations, especially the Pharmacy Guild of Australia, have traditionally played an active role in decisions related to pharmaceutical regulation. The Australian Pharmaceutical Advisory Council was established by the Australian Government to advise the Commonwealth Minister for Health on pharmaceutical policy. 

Membership of committees Australia is the only country in the group with a system for including pharmaceutical industry representatives on committees which have the power to consider applications. 

Australia Newsletter Inclusion in committees Seminar with industry Inclusion in committees Website Recommendations of expert committees made public Annual report... 

In Estonia, however, as many as 17% of the applications are withdrawn Ifom the process. Rejection rates are highest in Venezuela and Malaysia (30% and 29%, respectively). In both countries, withdrawal rates are small (0% and 3%, respectively). In Australia in particular, the number of applications withdrawn before a final decision has increased significantly in the past four years. This increase in withdrawals is probably a result of the way in which the registration system now operates, with a proposed decision to reject being made by the Delegate, prior to obtaining formal advice from the Australian Dmg Evaluation Committee. 

In those countries where reports are evaluated and recorded, specialized bodies have been set up to review ADR reports. Each country has a different set of operating procedures for this body. In Australia, Malaysia and Zimbabwe, a specialized committee is employed as part of the DRA to carry out the review task. The Adverse Dmg Reactions Advisory Committee in Australia, for example, has a system for following up and validating the reports, classifying the reported incidents as possible , probable or certain and then referring them to the appropriate patties for further action. 

In Australia, approval of clinical trials involves both the regulatory authority and an ethics committee. Under the Clinical Trial Exemption (CTX) scheme, a clinical trial proposal must first be evaluated by the TGA, and then approved by an ethics committee on-site. Under the Clinical Trial Notification (CTN) scheme, a trial is evaluated and approved by the local ethics committee, and then notified to the TGA. 

Australia Voluntary monitoring by companies, but anyone can lodge complaints to APMA Code of Conduct Committee Under Therapeutic Goods Act possible prosecution/fines (currently US 500-15 000) Under APMA fines, obligation to correct advertisement or withdraw it, or expulsion from APMA... 

Monitoring, violation and sanction spheres For post-marketing surveillance of product safety, ADR monitoring systems exist in all the countries, with the exception of Uganda. But it is difficult to evaluate the effectiveness of these systems in monitoring product safety. Only the Adverse Dmg Reactions Advisory Committee in Australia... 

Adverse Drug Reactions Advisory Committee (Australia)... 

National Energy Advisory Committee (Commonwealth of Australia), "Australia s Energy Resources An Assessment", Report No.2, (published by Dept, of National Development), December 1977. 

Phycotoxins accumulate in fish and shellfish because of the natural feeding habits of the respective organisms, rather than because of food handling or processing practices. The toxins causing the diseases discussed in this chapter are heat stable (Australia New Zealand Food Authority, 2001 Committee on Evaluation of the Safety of Fishery Products, 1991). Complete inactivation of saxitoxin (associated with PSP) requires at least ten minutes of exposure to 260°C dry heat. Brevetoxins (associated with NSP) were inactivated (i.e., to levels below the limit of assay detection using Japanese medaka [Oryzias latipes]) by exposure to 500°C heat for 10 to 15 minutes (Poli, 1988). Complete inactivation required 10 minutes exposure to 2760°C dry heat (Wannamacher, 2000). 

Harmonization of pharmacopeial standards as a practical matter began at the International Congresses of Pharmacy between 1865 and 1910 [2], but the first formal attempt can be traced to 1902. Both USP President Horatio C. Wood, M.D., and Frederick M. Power, Ph.D., an American chemist of the Wellcome Chemical Research Laboratories of London, were appointed by the U.S. Secretary of State as delegates to represent the United States government at the International Conference for the Unification of the Formulae for Heroic Medicines, a conference of 19 countries from Europe and North America [3]. The second conference occurred in 1918. The 3rd in 1925 was attended by 31 countries from all continents except Asia and Australia. They drafted a new International Convention, which came in force in 1929. It revised the 1902 agreements on 77 heroic medicines and introduced the concept of maximum dose. It also requested that the League of Nations create a permanent secretariat of pharmacopeias [4]. Andrew G. DuMez, Ph.D., represented the USP, and was officially appointed by the U.S. Public Health Service to represent the United States at this conference [4,5]. An expert committee of the League of Nations planned a third conference for 1938, but it was never convened because of World War II [2]. 

In April/May 2003 the TGA forced the recall of approximately 1600 complementary medicines at retail level throughout Australia, due to concerns about the quality of their manufacture. The recalled products were manufactured in Australia by Pan Pharmaceuticals, principally as a contract manufacturer for other companies. The resultant publicity impacted around the world and highlighted the importance of effective implementation of GMP standards for all therapeutic products. In view of the issues raised by this massive recall, and to restore community confidence, an Expert Committee on Complementary Medicines in the Health System was established to consider a wide range of matters relating to complementary medicines. Their report was published in September 2003 and is available from the TGA website. 

Pharmaceutical Benefits Advisory Committee rejections, and the lack of available appeal mechanisms, have been increasingly challenged in recent years. One route available is to pursue a legal challenge to the Federal Court of Australia for a review of the decision. Most recently, in March 2000, the Federal Court rejected a pharmaceutical company s application to overturn the recommendation of the PBAC not to list a product on the scheme. 

Furthermore, Australia has a strong framework in place to support the ethical conduct of clinical trials, provided by the NHMRC, its principal committees and HRECs. In June 2003, there were 226 registered HRECs in Australia - 125 hospital (public and private), 53 imiversity, 23 government and 25 associated with professional and other bodies. 

A principal committee of the NHMRC, the Australian Health Ethics Committee (AHEC), provides guidance and support for HRECs in Australia, and is responsible for developing and publishing the National Statement on the Ethical Conduct of Research Involving Humans 1999, which replaced the previous NHMRC Statement on Human Experimentation and Supplementary Notes 1992. ... 

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