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SIGNAL ABOVE THE NOISEEARLY DETECTION OF ADVERSE DRUG REACTIONS IN THE LITERATURE
19/04/23
Marie Anne SlaneyTherapeutic Goods Administration
The role of the TGA
• ensure timely access to therapeutic goods that are of high quality, and are safe and effective for their purpose
• ensure the risks associatedwith medicines & devices are minimised and manageable
How the TGA regulates
• relies on the scientific and medical expertise of its highly skilled workforce
• TGA evaluation is based on a risk-benefit analysis – no product is completely free of risk but the benefit should be greater than the possible side-effects
• Expert Advisory Committees – provide independent advice
About myself
•biomedical information retrieval specialist at TGA for 16 years
• lead a team of five professional librarians
•have significant role in systematic literature searching for TGA
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Background story
Many years ago.............
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Current trend
•Increasing speed and penetration of reporting to regulatory agencies
but
•still some reliance on publishing to capture anecdotal reporting
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Early signals: what are we looking for?
Association; not necessarily causality
Remember that symptoms:
•describe effect, not cause
•may be confounded in the individual patient
•may be loosely reported
•range in severity
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Two key search concepts
•Physiological system: •broad e.g cardiovascular, CNS•narrow e.g. ocular, renal
•Class of medicine: •e.g. Cox-2 inhibitors, Glitazones
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Three more to consider
•Pharmacokinetics
•Non-clinical results
•Language
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Formatted databases
•Allow slicing and dicing different ways to control searching
•Allow recording of complex search history
•Allow discrimination in results
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•(Insert picture of pond ripples)
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Questions?
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Contact details
Marie Anne Slaney
Therapeutic Goods Administration
www.tga.gov.au
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