S Lane, E Lynn, J Slattery, S Shakir.
Since implementation of the 2012 pharmacovigilance (PV) legislation in the EU, monitoring the success of PV has become commonplace; however impact of PV regulatory interventions on public health remains mostly unquantified.(3) There is a need for research to identify the best technique for measuring impact of these actions, and guidelines on reporting impact analyses.(3) The overall aim of this study is to quantify the impact of EU marketing authorisation withdrawal, revocation or suspension (“PV regulatory interventions”) in terms of morbidity changes.
Interim analysis to assess the feasibility of 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Prescription products used in primary care whose marketing authorisations were withdrawn, revoked or suspended in France, Germany and the UK between 2012 and 2016 were previously identified.(4) Annual product utilisation figures for the year prior to PV action were estimated using IMS France, IMS Germany and the British Health Improvement Network (THIN) electronic health record databases. Systematic searches of PubMed/MEDLINE, and European Medicines Agency and national competent authority websites and documents were conducted to identify quantitative studies for the product and adverse drug reaction (ADR) of interest, allowing risks to be calculated. The public health impact of the intervention was estimated in terms of morbidity reduction due to product withdrawal, revocation or suspension by modelling of usage figures and risk of each ADR. Work continues to obtain background risk data to establish the actual reduction in morbidity attributable to removal of the product from market in this territory.
18 products were considered for impact analysis; 9 were excluded as no quantitative studies were identified for the respective ADRs. This interim analysis focused on ketoconazole, metoclopramide and domperidone, and provided a prediction of the number of ADRs avoided per year as a result of marketing authorisation withdrawal, revocation or suspension, and an estimation of the public health impact of each PV action using changes in morbidity as an indicator.
This interim analysis tested a method for predicting public health impact of PV interventions on a subset of products based on drug utilisation data and expected changes in morbidity. Results suggest the method could be useful in determining public health impact of future PV actions. The predictive modelling method will be further evaluated prior to completion of this study.
- 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.
- 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.
- 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.
- 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).