A retrospective analysis of VIOXX in Australia: using clinical trial data and linked administrative health data to predict patient groups at risk of an adverse drug event.

Australian and New Zealand Journal of Public Health (Impact Factor: 1.64). 08/2010; 34(4):431-2. DOI: 10.1111/j.1753-6405.2009.00579.x
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    ABSTRACT: estimate — that 10.4% of patients attending general practice experience an ADE — almost 2 million people have an ADE annually. Moreover, their findings show that these ADEs are not trivial, with about 1 million being moderate or severe and 138 000 requiring hospitalisation, a finding consistent with previous estimates. 3 Many of these ADEs are preventable, although the exact proportion of preventable events can be debated. There have now been more than 30 Australian studies estimating the number of ADEs in different settings. 3 It is clear that counting is not enough — it is time for action, but what can be done? Every developed country is trying to cope with the problem of ADEs. Australia has many structures and initiatives in place to reduce the occurrence of ADEs, and preventing ADEs necessarily involves them all. 3 Regulatory agencies, the medicines industry, quality use of medicines organisations and information providers, safety and quality organisations, professional bodies, health profes- sionals and consumers can all assist. Prevention of ADEs cannot occur without better knowledge. It is noteworthy that the Therapeutic Goods Administration has adopted the European Medicines Agency guideline on pharmaco- vigilance planning. Increased pharmacovigilance, including obser- vational studies, will require a substantial increase in resources. In Canada, less than 10% of the budget for drug regulation is allocated to issues concerning marketed products, including safety. Yet, in 50% of new drugs, serious adverse drug reactions are detected after market approval. 4 We need systems that can deal with the reality that only limited numbers of highly selected patients are studied before a drug is marketed. Regulators may have to consider restricting prescribing of new medications if they have limited safety information, particularly when equally efficacious therapy is available. New systems for detecting early signals of potential adverse drug reactions in expanded populations could complement the current reporting system for adverse drug reactions. An example is the Drug Safety Research Unit in the United Kingdom, which captures information on the first 10 000 patients using a newly marketed drug. 5 We need to capitalise on and expand the importance and significance of consumer reporting.
    The Medical journal of Australia 07/2006; 184(12):646. · 2.85 Impact Factor
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    ABSTRACT: To assess trends in the first two years of prescribing of COX-2-selective non-steroidal anti-inflammatory drugs (C2SNs) by Australian general practitioners. Retrospective analysis of deidentified electronic patient records from GPs enrolled in the General Practice Research Network (GPRN). Overall prescription rates for C2SNs and NSAIDs were assessed for all GPRN participants (437 GPs) between 1 September 1999 and 30 September 2002. Also, three cohorts of patients, with at least 12 months of prescription data, who received their first prescription for celecoxib between August and October 2000 (Cohort 1, 2366 patients), celecoxib between February and April 2001 (Cohort 2, 640 patients), and rofecoxib between February and April 2001 (Cohort 3, 608 patients) were selected for further analysis. Age and sex of patients; reason for prescription; previously prescribed pain medications and concomitant use of medications that could predispose to an adverse renal or bleeding event. Prescriptions for C2SNs increased dramatically after they were listed on the Pharmaceutical Benefits Scheme (PBS). C2SN prescriptions for patients aged less than 65 years accounted for 52.6%, 59.5% and 50.7% of those in Cohorts 1, 2 and 3, respectively; large numbers of patients in the study cohort had reasons recorded for prescription that did not comply with PBS restrictions, and between 36.7% and 61.3% of patients in the three cohorts had not received a prescription for any pain medication in the year before being prescribed a C2SN. Between 4.7% and 7.9% were coprescribed drugs that could cause renal complications. Rapid, early adoption of C2SNs by Australian GPs has resulted in prescribing and drug use patterns that were not in accord with quality use of medicine (QUM) principles.
    The Medical journal of Australia 11/2003; 179(8):403-7. · 2.85 Impact Factor


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May 22, 2014