The Eighth World Congress on Clinical Pharmacology and Therapeutics (CPT; www.cpt2004.com) was held in Brisbane, the State capital of Queensland, Australia, from August 1-6, 2004. A feature of this CPT was the inclusion of a parallel stream throughout the meeting titled 'Medicines and Society.' This provided a unique opportunity for sessions on a variety of topics with an emphasis on societal implications ranging from Access to Medicines through Quality Use of Medicines to Pharmacoeconomics. This stream included the sessions on pharmacovigilance and pharmacoepidemiology topics. All these sessions were well attended.

A number of office bearers and members of ISPE took part, all having survived the long plane journeys, jet lag and local hospitality.

A workshop on the first day opened with presentations based loosely around the topic of data-mining. Anne Kiuru gave an update on signal detection activities at the WHO Collaborating Centre, Uppsala, Sweden and Manfred Hauben (Pfizer, New York) provided a critical overview on the various current options for data-mining of national and company ADR databases. Petra Thuermann (Helios Hospital, Wuppertal,Germany) addressed the topic of systems and methods to detect ADRs in hospitals. Petra explained how German Drug Law now recognises pharmacovigilance centers — there is a considerable investment in a number of regions to provide good data on medicine-attributable admissions to hospitals.

Chris Kelman of the Australian Department of Health and Ageing told of his work in data-mining medical records of the State of Queensland that have been linked to the national medicines subsidy database. He foreshadowed the real prospect that the national medicines and private medical services subsidy databases, which cover twenty million Australians, may soon be linked through a unique trusted third party mechanism to one and hopefully in time all eight state and territory public hospital medical record sets.

The second half of the workshop involved three presentations of personal predictions of the future of pharmacovigilance. Susana Perez (Pfizer, Spain; President, ISPE) emphasized the evolving discussions about Pharmacovigilance Planning and Risk Management. She also reminded everyone of coming ISPE meetings in Bordeaux and Barcelona. Tom MacDonald (Scotland; Past President ISPE) argued that 'Safety and Tolerability are the Modern Efficacy!' His theme was that we must move from being reactive to signals to producing "proactive" evidence of safety. Some salutary messages were then provided by Kenneth Hartigan-go (Philippines). He reminded the audience that what happens in the developed world does not necessarily happen in the developing world. The main concerns are not about Type A and B reactions but about the unwanted effects of medicines with no active ingredient, medicines with dubious indications and medicines inappropriately sold over the counter.

Elsewhere in the CPT program, Petra Thuermann gave a masterful overview of pharmacovigilance in a tutorial series designed for those attendees coming to grips with the basics of various topics in clinical pharmacology.

A Symposium on Pharmacovigilance included further presentations related to their Workshop themes from Susana Perez and Manfred Hauben. Arnold Chan (Harvard) described the use of large databases to assess medication safety and Yola Moride (Montreal) presented on the limitations of these databases including issues of data quality and epidemiological issues such as sources of confounding. John McEwen (TGA) closed the session with some retrospective and prospective views of pharmacovigilance in the Western Pacific and Asia-Pacific Rim countries.

In a session entitled "Must we always randomize?", Tom MacDonald advocated randomization of patients within large medical record databases, and Nicholas Moore (Chair, Scientific Program Committee, ICPE 2004, Bordeaux) proposed increased use of large trials with simple endpoints. He illustrated his thoughts with a discussion of methodological aspects of a hypothetical trial of 'spa therapy' for 'heavy legs.' Alex MacMahon (Scotland) surveyed possible options for the conduct of studies of drug safety, and Dianne O'Connell (Australia) provided clear evidence that individual trial quality has an important bearing on the outcome of systematic reviews and meta-analyses.

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