Last updated on: 25/06/2014
Name of organisation
1) Department/Research groupUnit of adverse drug reactions monitoring
2) Organisation/affiliationUniversity hospital of Pisa
Short Name in the inventoryUADRM
Administrative Contact
Title Dr
Last name Tuccori
First name Marco
Address line 1via Roma 55
Address line 2
Address line 3
CityPisa
Postcode56126
CountryItaly
Phone number (incl. country code)39-050-2218761
Alternative phone number
Fax number (incl. country code)
Scientific Contact
Title Dr
Last name Tuccori
First name Marco
Address line 1via Roma 55
Address line 2
Address line 3
CityPisa
Postcode56126
CountryItaly
Phone number (incl. country code)39-050-2218761
Alternative phone number
Fax number (incl. country code)
2. Description
The Unit of Adverse Drug reactions Monitoring of the University Hospital of Pisa is a key-element of the Tuscan Regional Centre of Pharmacovigilance. The main activities are represented by:
a) Periodic analysis of Italian spontaneous ADR reporting database (in collaboration with Agenzia AIFA and the other Italian Regional Centres of Pharmacovigilance)
b) Coordinating or participating centre to project of intensive monitoring of adverse drug reactions for specific drugs or in specific groups of patients. At January 2014, example of projects are:
MEREAFaPS: intensive monitoring of adverse drug reactions in Emergency Department (national project coordinated by the Lombardy Region); ASTRAGALUS: registry of patients exposed to treatments with biotechnological drugs for rheumatologic indications (4 rheumatology centres in Tuscany); ANCESTRAL: study on ADRs and drug-drug interactions in elderly patients in primary and secondary care
c) Drug safety studies by retrospective analysis of Hospital
3. Category
University based
Hospital based
4. Available resources
In houseVia Contacts/Network
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Disorders of the central nervous system
Gastrointestinal tract
Geriatrics
Immunological products and vaccines
Malignant disease
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
signal detection analysis
7. Experience in collecting data directly from individual patients/respondents
Number of Studies
Less than 5
Number of patients/respondents involved in the study(ies)
Between 1500 and 14999
8. Access to data collection resources
Capacity to conduct face-to-face interviews
Yes
In a clinic
Yes
In the community
Yes
Electronic data capture systems
No
Interactive voice response systems
No
Call centre
No
9. Experience in secondary research and meta-analysis
Yes
10. Work with existing data resources in the past 3 years
None
11. Registries established by centre
Drug Registrybiotechnological drugs used in rheumatology
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
None
14. Interest in research opportunities which are funded
By pharmaceutical companies
By charities
By government
By research councils
By EU funding schemes
15. Interest in contract research only if free to publish results
Yes
16. Selected publications of the last 5 calendar years
ReferenceLink to web-publication
Pugi A, Bonaiuti R, Maggini V, Moschini M, Tuccori M, Leone R, Rossi M, Motola D, Piccinni C, Ferrazin F, Sottosanti L, Mugelli A, Vannacci A, Lapi F. "Safety profile of antiviral medications: a pharmacovigilance study using the Italian spontaneous-reporting database." Am J Health Syst Pharm. 2013 Jun 15;70(12):1039-46. doi: 10.2146/ajhp120665.http://www.ncbi.nlm.nih.gov/pubmed/23719881
Colucci R, Gambaccini D, Ghisu N, Rossi G, Costa F, Tuccori M, De Bortoli N, Fornai M, Antonioli L, Ricchiuti A, Mumolo MG, Marchi S, Blandizzi C, Bellini M. "Influence of the serotonin transporter 5HTTLPR polymorphism on symptom severity in irritable bowel syndrome." PLoS One. 2013;8(2):e54831. doi: 10.1371/journal.pone.0054831. Epub 2013 Feb 5.http://www.ncbi.nlm.nih.gov/pubmed/23393559
Tuccori M, Lapi F, Testi A, Ruggiero E, Moretti U, Vannacci A, Bonaiuti R, Antonioli L, Fornai M, Giustarini G, Scollo C, Corona T, Ferrazin F, Sottosanti L, Blandizzi C. "Drug-induced taste and smell alterations: a case/non-case evaluation of an italian database of spontaneous adverse drug reaction reporting." Drug Saf. 2011 Oct 1;34(10):849-59. doi: 10.2165/11593120-000000000-00000.http://www.ncbi.nlm.nih.gov/pubmed/21879779
Cristiani C, Tuccori M, Pepe P, Sarteschi A, Maddalo F, Simonini G, Michi P, Consigli V, Fornai M, Antonioli L, Blandizzi C. "Safety of MF-59 adjuvanted vaccine for pandemic influenza: results of the vaccination campaign in an Italian health district." Vaccine. 2011 Apr 18;29(18):3443-8. doi: 10.1016/j.vaccine.2011.02.068. Epub 2011 Mar 9.http://www.ncbi.nlm.nih.gov/pubmed/21396903
Tuccori M, Focosi D, Blandizzi C, Pelosini M, Montagnani S, Maggi F, Pistello M, Antonioli L, Fornai M, Pepe P, Rossi G, Petrini M. "Inclusion of rituximab in treatment protocols for non-Hodgkin's lymphomas and risk for progressive multifocal leukoencephalopathy." Oncologist. 2010;15(11):1214-9. doi: 10.1634/theoncologist.2010-0098. Epub 2010 Nov 1.
http://www.ncbi.nlm.nih.gov/pubmed/21041380
