signal above the noise early detection of adverse drug reactions in the literature 4/10/2015 marie...

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

anne.slaney@tga.gov.au

www.tga.gov.au

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