CPRD StudyPrimary Care PASS Study

Abstract 271: Impact analyses of EU pharmacovigilance interventions on public health burden

Abstract 271: Impact analyses of EU pharmacovigilance interventions on public health burden

S. Lane* 1, E. Lynn1, 2, J. Slattery3, S. Shakir1, 2
Affiliations: 1 Drug Safety Research Unit 2 University of Portsmouth 3 European Medicines Agency UK


Adverse drug reactions (ADRs) account for 5% hospital admissions and 197,000 deaths each year, amounting to a societal cost of €79billion.[1, 2] These ADRs have large impacts on public health in terms of morbidity and mortality. Since the implementation of the 2012 pharmacovigilance (PV) legislation, monitoring success of pharmacovigilance (PV) has become commonplace; however impact of PV regulatory interventions on public health remains mostly unquantified.[3] There is a current need for research identifying the best technique for measuring impact of these actions, and guidelines on reporting impact analyses.[3]


Interim analysis to identify predictive modelling techniques for estimation of public health impact of PV regulatory interventions.


Prescription products used in primary care whose marketing authorisations were withdrawn, revoked or suspended in France, Germany or the UK between 2012 and 2016 were previously identified.[4] The French, German and British Health Improvement Network (THIN) databases were used to estimate usage of the identified products for the year prior to PV action. Systematic searches of the PubMed/MEDLINE database, and European Medicines Agency and national competent authority websites and documents were conducted to identify quantitative studies for the product and ADR of interest. Study data were meta-analysed to produce an overall weighted odds ratio for each ADR relating to each product. Background risk was estimated using THIN data. Modelling of usage figures, odds ratios and background risk allowed the public health impact of the intervention to be estimated in terms of morbidity attributable to the withdrawn, revoked or suspended product.


18 products were considered for impact analysis; 9 were excluded as no quantitative studies were identified for the respective ADRs. This interim analysis on a subset of these products provides a prediction of the number of ADRs avoided as a result of the included products’ marketing authorisation withdrawal, revocation or suspension, and an estimation of the public health impact of these PV actions using changes in morbidity as an indicator.


This study identifies a method for predicting public health impact of PV interventions, based on drug utilisation data and expected changes in morbidity. This interim analysis tested the method on a subset of products. Further validation of the predictive modelling method will be undertaken before completion of the study.


  1. Mammi M, Citraro R, Torcasio G, Cusato G, Palleria C, di Paola ED. Pharmacovigilance in pharmaceutical companies: An overview. J Pharmacol Pharmacother. 2013;4(Suppl 1):S33-7.
  2. Mazzitello C, Esposito S, De Francesco AE, Capuano A, Russo E, De Sarro G. Pharmacovigilance in Italy: An overview. J Pharmacol Pharmacother. 2013;4(Suppl 1):S20-8.
  3. Goedecke T, Morales D, Pacurariu A, Kurz X. Measuring the impact of medicines regulatory interventions – systematic review and methodological considerations. Br J Clin Pharmacol. 2017.
  4. Lane S, Lynn E, Shakir S. Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012. BMJ Open. 2018;8(1).