Abstract
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.
| Original language | English |
|---|---|
| Pages (from-to) | 299-306 |
| Number of pages | 8 |
| Journal | Hematological Oncology |
| Volume | 36 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - Feb 2018 |
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- Journal Article
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FarmaREL : An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients. / 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.
In: Hematological Oncology, Vol. 36, No. 1, 02.2018, p. 299-306.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - FarmaREL
T2 - An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients
AU - Fracchiolla, Nicola S
AU - Artuso, Silvia
AU - Cortelezzi, Agostino
AU - Pelizzari, Anna M
AU - Tozzi, Paola
AU - Bonfichi, Maurizio
AU - Bocchio, Federica
AU - Gargantini, Livio
AU - De Rosa, Elisa
AU - Vighi, Giuseppe D
AU - Prestini, Lucia
AU - Sammassimo, Simona
AU - Frungillo, Niccolò
AU - Pasquini, Maria C
AU - Ragazzi, Alessandra
AU - Boghi, Daniele
AU - Pastore, Alessia
AU - Lanzi, Eraldo
AU - Gritti, Giuseppe
AU - Quaresmini, Giulia
AU - Voltolini, Simone
AU - Gaiardoni, Roberta
AU - Corti, Consuelo
AU - Vilardo, Maria C
AU - La Targia, Maria L
AU - Berini, Giacomo
AU - Magagnoli, Massimo
AU - Bacci, Claudia
AU - Consonni, Dario
AU - Rivolta, Alma L
AU - Muti, Giuliana
N1 - Copyright © 2017 John Wiley & Sons, Ltd.
PY - 2018/2
Y1 - 2018/2
N2 - 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.
AB - 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.
KW - Journal Article
U2 - 10.1002/hon.2451
DO - 10.1002/hon.2451
M3 - Article
C2 - 28771763
VL - 36
SP - 299
EP - 306
JO - Hematological Oncology
JF - Hematological Oncology
SN - 0278-0232
IS - 1
ER -