Impact of Medicines Withdrawals and Revocations on Morbidity in France,
Germany, and the United Kingdom
Abstract
Purpose: Removing medicines from market may benefit public
health by preventing adverse drug reactions (ADRs), which should be
quantified. This study’s aim was to identify a model to quantify the
impact of medicines’ marketing authorisation (MA) withdrawal and
revocation in terms of morbidity and mortality. Methods: MA
withdrawals and revocations for safety reasons in France, Germany,
and/or the United Kingdom (UK) between July 2012 and December 2016 were
identified for prescription medicines. Annual exposure was estimated for
each medicine, using IQVIA Medical Research Data (IMRD)-France,
IMRD-Germany, and IMRD-UK primary care electronic health record
databases. European Medicines Agency records provided reasons for
regulatory action for each medicine. Absolute risks of ADRs in patients
exposed to each medicine were estimated by systematic review of
quantitative research. Public health impact, expressed as annual number
of ADRs avoided, was estimated by modelling exposure and ADR risk.
Results: Four MA withdrawals and two revocations met study
inclusion criteria. Each product’s usage decreased following MA
withdrawal or revocation. Absolute risk for ADRs was 0.1-41.25%. To
estimate impact of each withdrawal or revocation, its average annual
exposure within each IMRD population was multiplied by the absolute risk
to give the crude number of ADRs prevented annually due to regulatory
action. Conclusions: This model quantifies the public health
impact of MA withdrawal and revocation in terms of serious morbidity,
resulting from eliminated or reduced usage of medicines. This method can
be applied to products in other settings to quantify the impact of other
pharmacovigilance actions.