Is Ebenezer Scrooge Running UK Pharmacovigilance?

(with acknowledgments to Charles Dickens)

As the name implies, pharmacovigilance is the observation and monitoring of possible harms from exposure to a variety of pharmaceuticals, biologics and devices: from drugs to vaccines and antibodies, devices and e-cigarettes.

The aim is to observe and detect abnormalities against a baseline of reactions, say fever, post-exposure to product X and then noticing a spike or a particular trend. Numbers matter with frequent reactions like fever, and clusters matter when you have unusual or complex reactions like neurological syndromes. Excess fever or, in our example, a cluster of syndromes alerts the surveillance-trained personnel that something may be going on. Indeed defective or counterfeit products can also be reported.

Having a yellow card-notified reaction is not proof of causality. But if enough of these numbers or trends are well over the average or are very unusual (think of narcolepsy after the 2009 influenza pandemic vaccines), a potential “signal” is generated requiring further i…