In my daily practice, I have seen many people reporting ADR's without a causality assessment and even few were reported without clinically observing the patient. Is this appropriate? How do we overcome these obstacles for better results? Please help the reporters in overcoming such barriers with your suggestions.
Just a quick point of vocabulary: adverse events (AEs) are reported, and these AEs are then assessed to identify ADRs. Not all AEs are ADRs. The same goes for most published studies, whereby the authors lists all events and then assess their causality.
I think there's a difference in identifying hitherto unrecognized ADEs caused by a molecule, and identifying patients experiencing ongoing ADRs/ADEs as a consequence of therapy that they "tolerate" to maintain health. There's a lot of hidden suffering going on out there. We've developed a screening technology to "ADDRESS" this- see the ADverse Drug Reaction/Event Screening System at:
http://www.pharmacy.purdue.edu/ptrqol/
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