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FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients
Author(s) -
Fracchiolla Nicola S.,
Artuso Silvia,
Cortelezzi Agostino,
Pelizzari Anna M.,
Tozzi Paola,
Bonfichi Maurizio,
Bocchio Federica,
Gargantini Livio,
De Rosa Elisa,
Vighi Giuseppe D.,
Prestini Lucia,
Sammassimo Simona,
Frungillo Niccolò,
Pasquini Maria C.,
Ragazzi Alessandra,
Boghi Daniele,
Pastore Alessia,
Lanzi Eraldo,
Gritti Giuseppe,
Quaresmini Giulia,
Voltolini Simone,
Gaiardoni Roberta,
Corti Consuelo,
Vilardo Maria C.,
La Targia Maria L.,
Berini Giacomo,
Magagnoli Massimo,
Bacci Claudia,
Consonni Dario,
Rivolta Alma L.,
Muti Giuliana
Publication year - 2018
Publication title -
hematological oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 44
eISSN - 1099-1069
pISSN - 0278-0232
DOI - 10.1002/hon.2451
Subject(s) - pharmacovigilance , medicine , drug reaction , adverse drug reaction , logistic regression , adverse effect , emergency medicine , pediatrics , drug , pharmacology
Adverse drug reactions (ADRs) reduce patients' quality of life, increase mortality and morbidity, and have a negative economic impact on healthcare systems. Nevertheless, the importance of ADR reporting is often underestimated. The project “FarmaREL” has been developed to monitor and evaluate ADRs in haematological patients and to increase pharmacovigilance culture among haematology specialists. In 13 haematology units, based in Lombardy, Italy, a dedicated specialist with the task of encouraging ADRs reporting and sensitizing healthcare professionals to pharmacovigilance has been assigned. The ADRs occurring in haematological patients were collected electronically and then analysed with multiple logistic regression. Between January 2009 and December 2011, 887 reports were collected. The number of ADRs was higher in older adults (528; 59%), in male (490; 55%), and in non‐Hodgkin lymphoma patients (343; 39%). Most reactions were severe (45% required or prolonged hospitalization), but in most cases, they were fully resolved at the time of reporting. According to Schumock and Thornton criteria, a percentage of ADRs as high as 7% was found to be preventable versus 2% according to reporter opinion. Patients' haematological diagnosis, not age or gender, resulted to be the variable that most influenced ADR, in particular severity and outcome. The employment of personnel specifically dedicated to pharmacovigilance is a successful strategy to improve the number and quality of ADR reports. “FarmaREL”, the first programme of active pharmacovigilance in oncohaematologic patients, significantly contributed to reach the WHO “Gold Standard” for pharmacovigilance in Lombardy, Italy.