FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

N.S. Fracchiolla, S. Artuso, A. Cortelezzi, A.M. Pelizzari, P. Tozzi, M. Bonfichi, F. Bocchio, L. Gargantini, E. De Rosa, G.D. Vighi, L. Prestini, S. Sammassimo, N. Frungillo, M.C. Pasquini, A. Ragazzi, D. Boghi, A. Pastore, E. Lanzi, G. Gritti, G. Quaresmini & 11 others S. Voltolini, R. Gaiardoni, C. Corti, M.C. Vilardo, M.L. La Targia, G. Berini, M. Magagnoli, C. Bacci, D. Consonni, A.L. Rivolta, G. Muti

Research output: Contribution to journalArticle

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. Copyright © 2017 John Wiley & Sons, Ltd.
Original languageEnglish
Pages (from-to)299-306
Number of pages8
JournalHematological Oncology
Volume36
Issue number1
DOIs
Publication statusPublished - 2018

Fingerprint

Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Hematology
Italy
Delivery of Health Care
Nuclear Family
Non-Hodgkin's Lymphoma
Hospitalization
Logistic Models
Economics
Quality of Life
Morbidity

Keywords

  • adverse drug reactions
  • drug safety
  • medication safety
  • patient safety
  • pharmacovigilance
  • alemtuzumab
  • allopurinol
  • amphotericin B
  • bleomycin
  • cisplatin
  • cotrimoxazole
  • cyclophosphamide
  • dexamethasone
  • doxorubicin
  • drug
  • etoposide
  • fludarabine
  • hydroxyurea
  • imatinib
  • lenalidomide
  • methotrexate
  • methylprednisolone
  • nilotinib
  • pegfilgrastim
  • phenytoin
  • prednisone
  • procarbazine
  • retinoic acid
  • rituximab
  • thalidomide
  • unindexed drug
  • vinblastine
  • vincristine
  • vinorelbine tartrate
  • zoledronic acid
  • abdominal pain
  • acute leukemia
  • adult
  • adverse drug reaction
  • aged
  • algorithm
  • anemia
  • Article
  • asthenia
  • cancer patient
  • cerebrovascular accident
  • chronic leukemia
  • dermatitis
  • diarrhea
  • digestive system perforation
  • drug eruption
  • drug substitution
  • drug surveillance program
  • drug treatment failure
  • drug withdrawal
  • edema
  • erythema
  • evaluation research
  • faintness
  • febrile neutropenia
  • female
  • fever
  • gastrointestinal hemorrhage
  • gastrointestinal infection
  • hematologic disease
  • Hodgkin disease
  • hospitalization
  • human
  • hyperhidrosis
  • inflammation
  • infusion related reaction
  • intestine infarction
  • Italy
  • laboratory test
  • leukopenia
  • major clinical study
  • malaise
  • male
  • middle aged
  • motor dysfunction
  • multiple myeloma
  • myelodysplastic syndrome
  • nausea
  • neuropathy
  • neutropenia
  • nonhodgkin lymphoma
  • pain
  • pancytopenia
  • patient monitoring
  • priority journal
  • pruritus
  • respiratory tract infection
  • sepsis
  • septic shock
  • sex ratio
  • skin exfoliation
  • stomatitis
  • thorax pain
  • thrombocytopenia
  • tremor
  • urticaria
  • virus infection
  • vomiting
  • complication
  • psychology
  • quality of life
  • Aged
  • Drug-Related Side Effects and Adverse Reactions
  • Female
  • Hematologic Neoplasms
  • Humans
  • Male
  • Middle Aged
  • Pharmacovigilance
  • Quality of Life

Cite this

FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients. / Fracchiolla, N.S.; Artuso, S.; Cortelezzi, A.; Pelizzari, A.M.; Tozzi, P.; Bonfichi, M.; Bocchio, F.; Gargantini, L.; De Rosa, E.; Vighi, G.D.; Prestini, L.; Sammassimo, S.; Frungillo, N.; Pasquini, M.C.; Ragazzi, A.; Boghi, D.; Pastore, A.; Lanzi, E.; Gritti, G.; Quaresmini, G.; Voltolini, S.; Gaiardoni, R.; Corti, C.; Vilardo, M.C.; La Targia, M.L.; Berini, G.; Magagnoli, M.; Bacci, C.; Consonni, D.; Rivolta, A.L.; Muti, G.

In: Hematological Oncology, Vol. 36, No. 1, 2018, p. 299-306.

Research output: Contribution to journalArticle

Fracchiolla, NS, Artuso, S, Cortelezzi, A, Pelizzari, AM, Tozzi, P, Bonfichi, M, Bocchio, F, Gargantini, L, De Rosa, E, Vighi, GD, Prestini, L, Sammassimo, S, Frungillo, N, Pasquini, MC, Ragazzi, A, Boghi, D, Pastore, A, Lanzi, E, Gritti, G, Quaresmini, G, Voltolini, S, Gaiardoni, R, Corti, C, Vilardo, MC, La Targia, ML, Berini, G, Magagnoli, M, Bacci, C, Consonni, D, Rivolta, AL & Muti, G 2018, 'FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients', Hematological Oncology, vol. 36, no. 1, pp. 299-306. https://doi.org/10.1002/hon.2451
Fracchiolla, N.S. ; Artuso, S. ; Cortelezzi, A. ; Pelizzari, A.M. ; Tozzi, P. ; Bonfichi, M. ; Bocchio, F. ; Gargantini, L. ; De Rosa, E. ; Vighi, G.D. ; Prestini, L. ; Sammassimo, S. ; Frungillo, N. ; Pasquini, M.C. ; Ragazzi, A. ; Boghi, D. ; Pastore, A. ; Lanzi, E. ; Gritti, G. ; Quaresmini, G. ; Voltolini, S. ; Gaiardoni, R. ; Corti, C. ; Vilardo, M.C. ; La Targia, M.L. ; Berini, G. ; Magagnoli, M. ; Bacci, C. ; Consonni, D. ; Rivolta, A.L. ; Muti, G. / FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients. In: Hematological Oncology. 2018 ; Vol. 36, No. 1. pp. 299-306.
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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. Copyright {\circledC} 2017 John Wiley & Sons, Ltd.",
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author = "N.S. Fracchiolla and S. Artuso and A. Cortelezzi and A.M. Pelizzari and P. Tozzi and M. Bonfichi and F. Bocchio and L. Gargantini and {De Rosa}, E. and G.D. Vighi and L. Prestini and S. Sammassimo and N. Frungillo and M.C. Pasquini and A. Ragazzi and D. Boghi and A. Pastore and E. Lanzi and G. Gritti and G. Quaresmini and S. Voltolini and R. Gaiardoni and C. Corti and M.C. Vilardo and {La Targia}, M.L. and G. Berini and M. Magagnoli and C. Bacci and D. Consonni and A.L. Rivolta and G. Muti",
note = "Cited By :1 Export Date: 5 February 2019 CODEN: HAOND Correspondence Address: Fracchiolla, N.S.; UOC Oncoematologia, Fondazione IRCCS Ca' Granda-Ospedale Maggiore PoliclinicoItaly; email: n.fracchiolla@policlinico.mi.it Chemicals/CAS: alemtuzumab, 216503-57-0; allopurinol, 315-30-0; amphotericin B, 1397-89-3, 30652-87-0; bleomycin, 11056-06-7, 9041-93-4; cisplatin, 15663-27-1, 26035-31-4, 96081-74-2; cotrimoxazole, 8064-90-2; cyclophosphamide, 50-18-0; dexamethasone, 50-02-2; doxorubicin, 23214-92-8, 25316-40-9; etoposide, 33419-42-0, 433304-61-1; fludarabine, 21679-14-1; hydroxyurea, 127-07-1; imatinib, 152459-95-5, 220127-57-1; lenalidomide, 191732-72-6; methotrexate, 15475-56-6, 59-05-2, 7413-34-5; methylprednisolone, 6923-42-8, 83-43-2; nilotinib, 641571-10-0; pegfilgrastim, 208265-92-3; phenytoin, 57-41-0, 630-93-3; prednisone, 53-03-2; procarbazine, 366-70-1, 671-16-9; retinoic acid, 302-79-4; rituximab, 174722-31-7; thalidomide, 50-35-1; vinblastine, 865-21-4; vincristine, 57-22-7; vinorelbine tartrate, 125317-39-7, 71486-22-1; zoledronic acid, 118072-93-8, 131654-46-1, 165800-06-6, 165800-07-7 References: Sultana, J., Cutroneo, P., Trifir{\`o}, G., Clinical and economic burden of adverse drug reactions (2013) J Pharmacol Pharmacother, 4, pp. S73-S77; Beijer, H.J.M., de Blaey, C.J., Hospitalisations caused by adverse drug reactions: a meta-analysis of observational studies (2002) Pharm World Sci, 24, pp. 46-54; Lazarou, J., Pomeranz, B.H., Corey, P.N., Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies (1998) JAMA, 279 (15), pp. 1200-1205; Liu, L., Li, Y., The unexpected side effects and safety of therapeutic monoclonal antibodies (2014) Drugs Today (Barc), 50 (1), pp. 33-50; Romano, A., Conticello, C., Cavalli, M., Salvage therapy of multiple myeloma: the new generation drugs (2014) Biomed Res Int, 2014, p. 456037; Schmitt, A., Soubeyran, P., New drugs for follicular lymphoma in older adults (2014) Anticancer Agents Med Chem, 14 (5), pp. 657-664; Keng, M.K., Wenzell, C.M., Sekeres, M.A., A drug's life: the pathway to drug approval (2013) Clin Adv Hematol Oncol, 11 (10), pp. 646-655; Bennett, C.L., Tigue, C.C., Angelotta, C., McKoy, J.M., Edwards, B.J., Adverse effects of drugs used to treat hematologic malignancies: surveillance efforts from the research on adverse drug events and reports project (2007) Semin Thromb Hemost, 33 (4), pp. 365-372; Johnson, P., Glennie, M., The mechanisms of action of rituximab in the elimination of tumor cells (2003) Semin Oncol, 30, pp. 3-8; Mazzitello, C., Esposito, S., De Francesco, A.E., Capuano, A., Russo, E., De Sarro, G., Pharmacovigilance in Italy: an overview (2013) J Pharmacol Pharmacother, 4, pp. S20-S28; Baldo, P., De Paoli, P., Pharmacovigilance in oncology: evaluation of current practice and future perspectives (2014) J Eval Clin Pract, 20 (5), pp. 559-569; (2017) The safety of medicines in public health programmes: pharmacovigilance an essential tool. Pag. 22. Essential medicines and health products: pharmacovigilance, , http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/, Accessed April 23; Pitts, P.J., Louet, H.L., Moride, Y., Conti, R.M., 21st century pharmacovigilance: efforts, roles, and responsibilities (2016) Lancet Oncol, 17 (11), pp. e486-e492; Naranjo, C.A., Busto, U., Sellers, E.M., A method for estimating the probability of adverse drug reactions (1981) Clin Pharmacol Ther, 30, pp. 239-245; Schumock, G.T., Thornton, J.P., Focusing on the preventability of adverse drug reactions (1992) Hosp Pharm, 27, p. 538; Hoign{\'e}, R., Jaeger, M.D., Wymann, R., Time pattern of allergic reactions to drugs (1990) Agents Actions Suppl, 29, pp. 39-58; Hosmer, D.W., Lemeshow, S., (1989) Applied Logistic Regression, , New York, Wiley; Lombardia, R., (2017) Centro Regionale per la Farmacovigilanza. Dati sulla segnalazione spontanea in Lombardia nel 2009, , http://www.agendadigitale.regione.lombardia.it/shared/ccurl/740/536/rel2009.pdf, Accessed on April 23; Dang, A., Bhandare, P.N., The profile of voluntary reported adverse drug reactions at a tertiary care hospital: a fifteen month prospective study (2012) J Clin Diagn Res, 6 (9), pp. 1504-1509; Arulmani, R., Rajendran, S.D., Suresh, B., Adverse drug reaction monitoring in a secondary care hospital in south India (2007) Br J Clin Pharmacol, 65 (2), pp. 210-216; Jose, J., Rao, P.G., Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital (2006) Pharmacol Res, 54, pp. 226-233; Subbanna, P.K.T., Chandy, S.J., The role of active surveillance in improving the hospital adverse drug event reporting (2006) Indian J Pharmacol, 38 (5), pp. 363-364; Sharma, H., Aqil, M., Imam, F., Alam, M.S., Kapur, P., Pillai, K.K., A pharmacovigilance study in the department of medicine of a university teaching hospital (2007) Pharmacy Practice, 5 (1), pp. 46-49; Turner, J.P., Shakib, S., Singhal, N., Hogan-Doran, J., Prowse, R., Johns, S., Prevalence and factors associated with polypharmacy in older people with cancer (2014) Support Care Cancer, 22 (7), pp. 1727-1734; Obreli Neto, P.R., Nobili, A., de Lyra, D.P., Jr., Incidence and predictors of adverse drug reactions caused by drug-drug interactions in elderly outpatients: a prospective cohort study (2012) J Pharm Pharmaceut Sci, 15 (2), pp. 332-343; Wilson, R.M., Runciman, W.B., Gibberd, R.W., Harrison, B.T., Newby, L., Hamilton, J.D., Quality in Australian health care study (1995) Med J Aust, 163, pp. 458-471; Baniasadi, S., Fahimi, F., Shalviri, G., Developing an adverse drug reaction reporting system at a teaching hospital (2008) Basic Clin Pharmacol Toxicol, 102 (4), pp. 408-411; Lau, P.M., Stewart, K., Dooley, M., The ten most common adverse drug reactions (ADRs) in oncology patients: do they matter to you? (2004) Support Care Cancer, 12, pp. 626-633; Knight, C., Hind, D., Brewer, N., Abbott, V., Rituximab (MabThera) for aggressive non-Hodgkin's lymphoma: systematic review and economic evaluation (2004) Health Technol Assess, 8 (37), pp. 1-82",
year = "2018",
doi = "10.1002/hon.2451",
language = "English",
volume = "36",
pages = "299--306",
journal = "Hematological Oncology",
issn = "0278-0232",
publisher = "wiley",
number = "1",

}

TY - JOUR

T1 - FarmaREL: An Italian pharmacovigilance project to monitor and evaluate adverse drug reactions in haematologic patients

AU - Fracchiolla, N.S.

AU - Artuso, S.

AU - Cortelezzi, A.

AU - Pelizzari, A.M.

AU - Tozzi, P.

AU - Bonfichi, M.

AU - Bocchio, F.

AU - Gargantini, L.

AU - De Rosa, E.

AU - Vighi, G.D.

AU - Prestini, L.

AU - Sammassimo, S.

AU - Frungillo, N.

AU - Pasquini, M.C.

AU - Ragazzi, A.

AU - Boghi, D.

AU - Pastore, A.

AU - Lanzi, E.

AU - Gritti, G.

AU - Quaresmini, G.

AU - Voltolini, S.

AU - Gaiardoni, R.

AU - Corti, C.

AU - Vilardo, M.C.

AU - La Targia, M.L.

AU - Berini, G.

AU - Magagnoli, M.

AU - Bacci, C.

AU - Consonni, D.

AU - Rivolta, A.L.

AU - Muti, G.

N1 - Cited By :1 Export Date: 5 February 2019 CODEN: HAOND Correspondence Address: Fracchiolla, N.S.; UOC Oncoematologia, Fondazione IRCCS Ca' Granda-Ospedale Maggiore PoliclinicoItaly; email: n.fracchiolla@policlinico.mi.it Chemicals/CAS: alemtuzumab, 216503-57-0; allopurinol, 315-30-0; amphotericin B, 1397-89-3, 30652-87-0; bleomycin, 11056-06-7, 9041-93-4; cisplatin, 15663-27-1, 26035-31-4, 96081-74-2; cotrimoxazole, 8064-90-2; cyclophosphamide, 50-18-0; dexamethasone, 50-02-2; doxorubicin, 23214-92-8, 25316-40-9; etoposide, 33419-42-0, 433304-61-1; fludarabine, 21679-14-1; hydroxyurea, 127-07-1; imatinib, 152459-95-5, 220127-57-1; lenalidomide, 191732-72-6; methotrexate, 15475-56-6, 59-05-2, 7413-34-5; methylprednisolone, 6923-42-8, 83-43-2; nilotinib, 641571-10-0; pegfilgrastim, 208265-92-3; phenytoin, 57-41-0, 630-93-3; prednisone, 53-03-2; procarbazine, 366-70-1, 671-16-9; retinoic acid, 302-79-4; rituximab, 174722-31-7; thalidomide, 50-35-1; vinblastine, 865-21-4; vincristine, 57-22-7; vinorelbine tartrate, 125317-39-7, 71486-22-1; zoledronic acid, 118072-93-8, 131654-46-1, 165800-06-6, 165800-07-7 References: Sultana, J., Cutroneo, P., Trifirò, G., Clinical and economic burden of adverse drug reactions (2013) J Pharmacol Pharmacother, 4, pp. S73-S77; Beijer, H.J.M., de Blaey, C.J., Hospitalisations caused by adverse drug reactions: a meta-analysis of observational studies (2002) Pharm World Sci, 24, pp. 46-54; Lazarou, J., Pomeranz, B.H., Corey, P.N., Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies (1998) JAMA, 279 (15), pp. 1200-1205; Liu, L., Li, Y., The unexpected side effects and safety of therapeutic monoclonal antibodies (2014) Drugs Today (Barc), 50 (1), pp. 33-50; Romano, A., Conticello, C., Cavalli, M., Salvage therapy of multiple myeloma: the new generation drugs (2014) Biomed Res Int, 2014, p. 456037; Schmitt, A., Soubeyran, P., New drugs for follicular lymphoma in older adults (2014) Anticancer Agents Med Chem, 14 (5), pp. 657-664; Keng, M.K., Wenzell, C.M., Sekeres, M.A., A drug's life: the pathway to drug approval (2013) Clin Adv Hematol Oncol, 11 (10), pp. 646-655; Bennett, C.L., Tigue, C.C., Angelotta, C., McKoy, J.M., Edwards, B.J., Adverse effects of drugs used to treat hematologic malignancies: surveillance efforts from the research on adverse drug events and reports project (2007) Semin Thromb Hemost, 33 (4), pp. 365-372; Johnson, P., Glennie, M., The mechanisms of action of rituximab in the elimination of tumor cells (2003) Semin Oncol, 30, pp. 3-8; Mazzitello, C., Esposito, S., De Francesco, A.E., Capuano, A., Russo, E., De Sarro, G., Pharmacovigilance in Italy: an overview (2013) J Pharmacol Pharmacother, 4, pp. S20-S28; Baldo, P., De Paoli, P., Pharmacovigilance in oncology: evaluation of current practice and future perspectives (2014) J Eval Clin Pract, 20 (5), pp. 559-569; (2017) The safety of medicines in public health programmes: pharmacovigilance an essential tool. Pag. 22. Essential medicines and health products: pharmacovigilance, , http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/, Accessed April 23; Pitts, P.J., Louet, H.L., Moride, Y., Conti, R.M., 21st century pharmacovigilance: efforts, roles, and responsibilities (2016) Lancet Oncol, 17 (11), pp. e486-e492; Naranjo, C.A., Busto, U., Sellers, E.M., A method for estimating the probability of adverse drug reactions (1981) Clin Pharmacol Ther, 30, pp. 239-245; Schumock, G.T., Thornton, J.P., Focusing on the preventability of adverse drug reactions (1992) Hosp Pharm, 27, p. 538; Hoigné, R., Jaeger, M.D., Wymann, R., Time pattern of allergic reactions to drugs (1990) Agents Actions Suppl, 29, pp. 39-58; Hosmer, D.W., Lemeshow, S., (1989) Applied Logistic Regression, , New York, Wiley; Lombardia, R., (2017) Centro Regionale per la Farmacovigilanza. Dati sulla segnalazione spontanea in Lombardia nel 2009, , http://www.agendadigitale.regione.lombardia.it/shared/ccurl/740/536/rel2009.pdf, Accessed on April 23; Dang, A., Bhandare, P.N., The profile of voluntary reported adverse drug reactions at a tertiary care hospital: a fifteen month prospective study (2012) J Clin Diagn Res, 6 (9), pp. 1504-1509; Arulmani, R., Rajendran, S.D., Suresh, B., Adverse drug reaction monitoring in a secondary care hospital in south India (2007) Br J Clin Pharmacol, 65 (2), pp. 210-216; Jose, J., Rao, P.G., Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital (2006) Pharmacol Res, 54, pp. 226-233; Subbanna, P.K.T., Chandy, S.J., The role of active surveillance in improving the hospital adverse drug event reporting (2006) Indian J Pharmacol, 38 (5), pp. 363-364; Sharma, H., Aqil, M., Imam, F., Alam, M.S., Kapur, P., Pillai, K.K., A pharmacovigilance study in the department of medicine of a university teaching hospital (2007) Pharmacy Practice, 5 (1), pp. 46-49; Turner, J.P., Shakib, S., Singhal, N., Hogan-Doran, J., Prowse, R., Johns, S., Prevalence and factors associated with polypharmacy in older people with cancer (2014) Support Care Cancer, 22 (7), pp. 1727-1734; Obreli Neto, P.R., Nobili, A., de Lyra, D.P., Jr., Incidence and predictors of adverse drug reactions caused by drug-drug interactions in elderly outpatients: a prospective cohort study (2012) J Pharm Pharmaceut Sci, 15 (2), pp. 332-343; Wilson, R.M., Runciman, W.B., Gibberd, R.W., Harrison, B.T., Newby, L., Hamilton, J.D., Quality in Australian health care study (1995) Med J Aust, 163, pp. 458-471; Baniasadi, S., Fahimi, F., Shalviri, G., Developing an adverse drug reaction reporting system at a teaching hospital (2008) Basic Clin Pharmacol Toxicol, 102 (4), pp. 408-411; Lau, P.M., Stewart, K., Dooley, M., The ten most common adverse drug reactions (ADRs) in oncology patients: do they matter to you? (2004) Support Care Cancer, 12, pp. 626-633; Knight, C., Hind, D., Brewer, N., Abbott, V., Rituximab (MabThera) for aggressive non-Hodgkin's lymphoma: systematic review and economic evaluation (2004) Health Technol Assess, 8 (37), pp. 1-82

PY - 2018

Y1 - 2018

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. Copyright © 2017 John Wiley & Sons, Ltd.

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. Copyright © 2017 John Wiley & Sons, Ltd.

KW - adverse drug reactions

KW - drug safety

KW - medication safety

KW - patient safety

KW - pharmacovigilance

KW - alemtuzumab

KW - allopurinol

KW - amphotericin B

KW - bleomycin

KW - cisplatin

KW - cotrimoxazole

KW - cyclophosphamide

KW - dexamethasone

KW - doxorubicin

KW - drug

KW - etoposide

KW - fludarabine

KW - hydroxyurea

KW - imatinib

KW - lenalidomide

KW - methotrexate

KW - methylprednisolone

KW - nilotinib

KW - pegfilgrastim

KW - phenytoin

KW - prednisone

KW - procarbazine

KW - retinoic acid

KW - rituximab

KW - thalidomide

KW - unindexed drug

KW - vinblastine

KW - vincristine

KW - vinorelbine tartrate

KW - zoledronic acid

KW - abdominal pain

KW - acute leukemia

KW - adult

KW - adverse drug reaction

KW - aged

KW - algorithm

KW - anemia

KW - Article

KW - asthenia

KW - cancer patient

KW - cerebrovascular accident

KW - chronic leukemia

KW - dermatitis

KW - diarrhea

KW - digestive system perforation

KW - drug eruption

KW - drug substitution

KW - drug surveillance program

KW - drug treatment failure

KW - drug withdrawal

KW - edema

KW - erythema

KW - evaluation research

KW - faintness

KW - febrile neutropenia

KW - female

KW - fever

KW - gastrointestinal hemorrhage

KW - gastrointestinal infection

KW - hematologic disease

KW - Hodgkin disease

KW - hospitalization

KW - human

KW - hyperhidrosis

KW - inflammation

KW - infusion related reaction

KW - intestine infarction

KW - Italy

KW - laboratory test

KW - leukopenia

KW - major clinical study

KW - malaise

KW - male

KW - middle aged

KW - motor dysfunction

KW - multiple myeloma

KW - myelodysplastic syndrome

KW - nausea

KW - neuropathy

KW - neutropenia

KW - nonhodgkin lymphoma

KW - pain

KW - pancytopenia

KW - patient monitoring

KW - priority journal

KW - pruritus

KW - respiratory tract infection

KW - sepsis

KW - septic shock

KW - sex ratio

KW - skin exfoliation

KW - stomatitis

KW - thorax pain

KW - thrombocytopenia

KW - tremor

KW - urticaria

KW - virus infection

KW - vomiting

KW - complication

KW - psychology

KW - quality of life

KW - Aged

KW - Drug-Related Side Effects and Adverse Reactions

KW - Female

KW - Hematologic Neoplasms

KW - Humans

KW - Male

KW - Middle Aged

KW - Pharmacovigilance

KW - Quality of Life

U2 - 10.1002/hon.2451

DO - 10.1002/hon.2451

M3 - Article

VL - 36

SP - 299

EP - 306

JO - Hematological Oncology

JF - Hematological Oncology

SN - 0278-0232

IS - 1

ER -