[Aggregated statistics from Swedish health registries has been used for evaluating compliance with a contraindication].

Abstract

The daily regulatory work with pharmacovigilance includes requirements of risk minimisation measures (RMM). However, when it comes to evaluating the efficacy of RMM, methodological issues have been raised regarding commonly used surveys, and the updated Guideline on good pharmacovigilance practices, Module XVI Addendum II, proposes using mixed methods when RMM outcome is evaluated.    The Swedish Medical Products Agency has used aggregated national register data to evaluate compliance to the contraindication for cyproterone in patients with previous or current meningioma. Among 13 036 patients diagnosed with meningioma during the period 2005-2022, 21 to 63 individuals had filled a prescription of cyproterone ever after diagnosis. This is regarded as a resource-efficient method to assess compliance to contraindications, although anonymous aggregated statistics entail an uncertainty of measurement because the data must not be granular enough to be attributed to single individuals.