Workshop on the Italian Pharmacovigilance System in the International Context: Critical Issues and Perspectives
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The field of pharmacovigilance has evolved significantly since the turn of the millennium, from spontaneous reporting to complex pharmacoepidemiologic studies, to the implementation of new methodologies for proactive pharmacovigilance and risk minimisation measures and, more recently, the attempts to use big data for post-marketing drug safety assessment . Pharmacovigilance in Italy is no exception to such progress; the quality and quantity of spontaneous reporting have improved significantly, the number of centres of excellence dedicated to pharmacoepidemiology and pharmacovigilance has increased notably, partnerships and collaborations with Regional Pharmacovigilance Centres are being consolidated and the presence of pharmacovigilance experts at the Italian Drug Agency has increased [2, 3]. The availability of funding for pharmacovigilance, partly dedicated to the running of regional pharmacovigilance centres and partly dedicated to funding regional and...
The authors would like to thank all the other attendees of the workshop: Elena Arzenton, Gian Nicola Castiglione, Paola Cutroneo, Alessandra Del Porto, Armando Gennazzani, Carmen Ferrajolo, Olivia Leoni, Lorella Lombardozzi, Nadia Mores, Francesca Menniti-Ippolito, Pietro Minuz, Concetta Rafaniello, Carmela Santuccio, Giovanna Scroccaro, Liberata Sportiello, and Francesco Trotta. The authors would like to acknowledge the contribution of Cosimo Zaccaria to the writing of the paper. The authors would also like to acknowledge with gratitude the great contribution of Prof. Gianpaolo Velo, who passed away in 2017, to pharmacovigilance in Italy.
Writing and revision of the manuscript: Janet Sultana, Ugo Moretti, Antonio Addis, Pia Caduff, Annalisa Capuano, Agnes Kant, Joan-Ramon Laporte, Marie Lindquist, June Raine, Daniele Sartori, Gianluca Trifirò, Marco Tuccori, Mauro Venegoni, Eugene van Puijenbroek and Roberto Leone.
Compliance with Ethical Standards
The authors were not funded for their contribution to the present paper.
Conflict of interest
Janet Sultana, Ugo Moretti, Antonio Addis, Pia Caduff, Annalisa Capuano, Agnes Kant, Joan-Ramon Laporte, Marie Lindquist, June Raine, Daniele Sartori, Gianluca Trifirò, Marco Tuccori, Mauro Venegoni, Eugene van Puijenbroek and Roberto Leone have no conflicts of interest related to the present manuscript to declare. The present study was not funded, nor were the authors financially or otherwise compensated for their contribution to the present report.
- 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.Google Scholar
- 3.Spontaneous reporting keeps growing in Italy. Focus Farmacovigilanza 2013;76(5):2. https://www.pharmaco-vigilance.eu/content/spontaneous-reporting-keeps-growing-italy.
- 4.van Eekeren R, Rolfes L, Koster AS, Magro L, Parthasarathi G, Al Ramimmy H, Schutte T, Tanaka D, van Puijenbroek E, Härmark L. What future healthcare professionals need to know about pharmacovigilance: introduction of the WHO PV core curriculum for university teaching with focus on clinical aspects. Drug Saf. 2018;41(11):1003–11.CrossRefGoogle Scholar
- 7.de Vries ST, van der Sar MJM, Cupelli A, Baldelli I, Coleman AM, Montero D, Šipić I, Andrić A, Wennberg A, Ahlqvist-Rastad J, Denig P, Mol PGM, SCOPE Work Package 6. Communication on safety of medicines in Europe: current practices and general practitioners’ awareness and preferences. Drug Saf. 2017;40(8):729–42.CrossRefGoogle Scholar
- 8.de Vries ST, van der Sar MJM, Coleman AM, Escudero Y, Rodríguez Pascual A, Maciá Martínez MÁ, Cupelli A, Baldelli I, Šipić I, Andrić A, Michan L, Denig P, Mol PGM, SCOPE Work Package 6. Safety communication tools and healthcare professionals’ awareness of specific drug safety issues in Europe: a survey study. Drug Saf. 2018;41(7):713–24.CrossRefGoogle Scholar
- 11.Sultana J, Fontana A, Giorgianni F, Pasqua A, Cricelli C, Spina E, Gambassi G, Ivanovic J, Ferrajolo C, Molokhia M, Ballard C, Sharp S, Sturkenboom M, Trifirò G. The effect of safety warnings on antipsychotic drug prescribing in elderly persons with dementia in the United Kingdom and Italy: a population-based study. CNS Drugs. 2016;30(11):1097–109.CrossRefGoogle Scholar
- 12.Strengthening Pharmaceutical Systems (SPS) Program. 2009. Indicator-based pharmacovigilance assessment tool: manual for conducting assessments in developing countries. Submitted to the U.S. Agency for International Development by the SPS Program. Arlington: Management Sciences for Health.Google Scholar