Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 299-306 |
| Number of pages | 8 |
| Journal | Hematological Oncology |
| Volume | 36 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 2018 |
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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 journal › Article
}
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 -