Florence van Hunsel1, Laura Peters2,3, Helga Gardarsdottir3, Agnes Kant2. 1. Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. f.vanhunsel@lareb.nl. 2. Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5237 MH, 's-Hertogenbosch, The Netherlands. 3. Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht, Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Abstract
INTRODUCTION: The impact of pharmacovigilance activities on public health remains under-investigated, and measuring the impact on health of pharmacovigilance activities for a specific safety signal is challenging. OBJECTIVE: To gain more insight into the methodological challenges and the data required, we assessed the impact of pharmacovigilance on public health for four identified product-specific safety signals using publicly available data in the Netherlands. The assessment was on the impact of the intertwined and complementary steps of the pharmacovigilance pathways. METHODS: The impact of pharmacovigilance on public health was assessed using the assessment support tool and 'open data' from the Netherlands for four different types of pharmacovigilance safety signals: (1) off-label use of cyproterone acetate/ethinyloestradiol (CPA/EE) and thrombotic risk after pharmacovigilance measures after 2014; (2) pergolide and the risk of cardiac valvulopathy after pharmacovigilance activities in 2003; (3) proton pump inhibitors and the risk of hypomagnesaemia after pharmacovigilance activities in 2011; (4) rosiglitazone withdrawal from the market because of cardiovascular effects in 2010. RESULTS: For the signals on CPA/EE and pergolide, a crude estimation of the impact could be made with varying degrees of assumptions based on the risk described in the literature and utilisation data. CONCLUSION: This article highlights the methodological challenges and the data required to assess the impact of product-specific safety signals. A structured assessment support tool can be used as a guide for the necessary data elements and steps needed for the measurement or estimation of impact of pharmacovigilance activities on public health, provided that the appropriate data are available.
INTRODUCTION: The impact of pharmacovigilance activities on public health remains under-investigated, and measuring the impact on health of pharmacovigilance activities for a specific safety signal is challenging. OBJECTIVE: To gain more insight into the methodological challenges and the data required, we assessed the impact of pharmacovigilance on public health for four identified product-specific safety signals using publicly available data in the Netherlands. The assessment was on the impact of the intertwined and complementary steps of the pharmacovigilance pathways. METHODS: The impact of pharmacovigilance on public health was assessed using the assessment support tool and 'open data' from the Netherlands for four different types of pharmacovigilance safety signals: (1) off-label use of cyproterone acetate/ethinyloestradiol (CPA/EE) and thrombotic risk after pharmacovigilance measures after 2014; (2) pergolide and the risk of cardiac valvulopathy after pharmacovigilance activities in 2003; (3) proton pump inhibitors and the risk of hypomagnesaemia after pharmacovigilance activities in 2011; (4) rosiglitazone withdrawal from the market because of cardiovascular effects in 2010. RESULTS: For the signals on CPA/EE and pergolide, a crude estimation of the impact could be made with varying degrees of assumptions based on the risk described in the literature and utilisation data. CONCLUSION: This article highlights the methodological challenges and the data required to assess the impact of product-specific safety signals. A structured assessment support tool can be used as a guide for the necessary data elements and steps needed for the measurement or estimation of impact of pharmacovigilance activities on public health, provided that the appropriate data are available.
Authors: Johannes Bitzer; Jean-Jacques Amy; Rob Beerthuizen; Martin Birkhäuser; Teresa Bombas; Mitchell Creinin; Philip D Darney; Lisa Ferreira Vicente; Kristina Gemzell-Danielsson; Bruno Imthurn; Jeffrey T Jensen; Andrew M Kaunitz; Ali Kubba; Medard M Lech; Diana Mansour; Gabriele Merki; Thomas Rabe; Katarina Sedlecki; David Serfaty; Jacques Seydoux; Lee P Shulman; Regine Sitruk-Ware; Sven O Skouby; Anne Szarewski; James Trussell; Carolyn Westhoff Journal: J Fam Plann Reprod Health Care Date: 2013-04-12
Authors: Aaron S Kesselheim; Eric G Campbell; Sebastian Schneeweiss; Paula Rausch; Brian M Lappin; Esther H Zhou; John D Seeger; John S Brownstein; Steven Woloshin; Lisa M Schwartz; Timothy Toomey; Gerald J Dal Pan; Jerry Avorn Journal: Drug Saf Date: 2015-06 Impact factor: 5.606
Authors: Bernardine H Stegeman; Marcos de Bastos; Frits R Rosendaal; A van Hylckama Vlieg; Frans M Helmerhorst; Theo Stijnen; Olaf M Dekkers Journal: BMJ Date: 2013-09-12