Last updated on: 13/02/2012
Name of organisation
1) Department/Research groupDepartment of Pharmacology
2) Organisation/affiliationUniversity of Bologna
Short Name in the inventoryUNIBO
Administrative Contact
Title Dr
Last name Poluzzi
First name Elisabetta
Address line 1via Irnerio, 48
Address line 2
Address line 3
CityBologna
Postcode40126
CountryItaly
Phone number (incl. country code)39-051-2091809
Alternative phone number
Fax number (incl. country code)39-051-248862
Scientific Contact
Title Professor
Last name De Ponti
First name Fabrizio
Address line 1via Irnerio, 48
Address line 2
Address line 3
CityBologna
Postcode40126
CountryItaly
Phone number (incl. country code)39-051-2091805
Alternative phone number
Fax number (incl. country code)39-051-248862
Alternative Scientific Contact
Title Dr
Last name Poluzzi
First name Elisabetta
Address line 1via Irnerio, 48
Address line 2
Address line 3
CityBologna
Postcode40126
CountryItaly
Phone number (incl. country code)39-051-2091809
Alternative phone number
Fax number (incl. country code)39-051-248862
2. Description
Safety evaluation and regulatory aspects of drugs with QT liability: (1) critical review of the published literature to rank drugs of specific classes; (2) drug utilisation studies to indirectly quantify population exposure to drugs with QT liability; (3) signal detection of Torsades de Pointes gathered through investigation of spontaneous reporting databases (FP7 project: ARITMO).
Safety issues currently under investigation by analysing international spontaneous reporting databases: drug-induced TdP, drug-induced PML and glitazones; collaborative projects with the Italian Medicines Agency (i.e., antipsychotics, hepatotoxicity, biphosphonates).
Drug utilisation: active involvement in EuroDURG and SIG-DUR-ISPE initiatives (e.g. CNC project and European ATC browser); study of patterns of drug use and appropriateness in Italy (i.e., cardiovascular drugs, osteoporosis, antipsychotics, multiple sclerosis, NSAIDs) by using drug prescription databases, questionnaires, registries.
3. Category
University 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
Cardiovascular diseases
Disorders of the central nervous system
Endocrine disorders
Gastrointestinal tract
Immunosuppression
Liver disease
Musculoskeletal and joint diseases
Osteoporosis
Psychiatry
6. Design of drug safety/risk-benefit studies published in the past 5 years
Drug Utilisation
Spontaneous report database analyses
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)
Less than 150
Between 1500 and 14999
8. Access to data collection resources
Capacity to conduct face-to-face interviews
No
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
Name of data resourceNo. of studies
Emilia Romagna health care databases3
FDA_AERS6
WHO_vigibase1
11. Registries established by centre
Drug RegistryImmunomodulating drugs in multiple sclerosis
Disease RegistryMental Health Information System - LHA Bologna
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Other networks:
Network nameNationalInternationalLink to webpage
14. Interest in research opportunities which are funded
By government
By research councils
By EU funding schemes
15. Interest in contract research only if free to publish results
No
16. Selected publications of the last 5 calendar years
ReferenceLink to web-publication
Raschi E, Piccinni C, Poluzzi E, Marchesini G, De Ponti F. The association of
pancreatitis with antidiabetic drug use: gaining insight through the FDA
pharmacovigilance database. Acta Diabetol. 2011 Oct 19. [Epub ahead of print]
PubMed PMID: 22008948.http://www.ncbi.nlm.nih.gov/pubmed/22008948
Poluzzi E, Piccinni C, Carta P, Puccini A, Lanzoni M, Motola D, Vaccheri A, De
Ponti F, Montanaro N. Cardiovascular events in statin recipients: impact of
adherence to treatment in a 3-year record linkage study. Eur J Clin Pharmacol.
2011 Apr;67(4):407-14.http://www.ncbi.nlm.nih.gov/pubmed/21152908
Poluzzi E, Raschi E, Motola D, Moretti U, De Ponti F. Antimicrobials and the
risk of torsades de pointes: the contribution from data mining of the US FDA
Adverse Event Reporting System. Drug Saf. 2010 Apr 1;33(4):303-14.http://www.ncbi.nlm.nih.gov/pubmed/20297862
Piccinni C, Sacripanti C, Poluzzi E, Motola D, Magro L, Moretti U, Conforti A,
Montanaro N. Stronger association of drug-induced progressive multifocal
leukoencephalopathy (PML) with biological immunomodulating agents. Eur J Clin
Pharmacol. 2010 Feb;66(2):199-206.http://www.ncbi.nlm.nih.gov/pubmed/19838692
Raschi E, Poluzzi E, Zuliani C, Muller A, Goossens H, De Ponti F. Exposure to
antibacterial agents with QT liability in 14 European countries: trends over an
8-year period. Br J Clin Pharmacol. 2009 Jan;67(1):88-98.http://www.ncbi.nlm.nih.gov/pubmed/19076158
