Nostrapharmus explores how life science organisations are going to have to navigate the perfect storm to shape the future of patient safety
The origin of our current pharmacovigilance systems can be traced back to the teratogenic effects of thalidomide, first reported as a series of three cases in The Lancet in 1961. Recognition of thalidomide's association with a variety of birth defects and, in particular, limb defects known as phocomelia, led to the drug's withdrawal from the market. Up until this time, the only way of reporting adverse drug reactions was through publication in medical literature. The lessons of thalidomide, 50 years ago, led to the creation of systems to detect, assess, and report suspected adverse reactions.
Early systems for drug safety reporting relied upon a medically qualified person, suspecting a causal association between the event and the medication to report a suspected adverse reaction. Today's PV systems are still built upon adverse event reporting, with over 50% of the resources in a typical drug safety organisation being dedicated to this activity alone. When the requirements to report summaries of the same data in aggregate form are considered, then close to 80% of resources are consumed in performing routine and reactive safety processes.
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