Measuring the impact of pharmacovigilance interventions is challenging as treatment and disease outcomes often overlap, and there may be significant time lags until clinical effects are seen with many existing studies being ecological in nature. It can also be difficult to evaluate decisions relating to single products if use is low and potential clinical outcomes are rare or when multiple interventions occur simultaneously. Nearly 50 years after the creation of the first national programmes for pharmacovigilance 5 there are no established guidelines for measuring the impact of regulatory interventions on public health 6, 7, 8.
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