Status: Finalised First registered on: 27/11/2013
Last updated on: 26/06/2014
1. Study identification
EU PAS Register NumberEUPAS5289
Official titleEffect of Pharmacist Involvement on Patient Reporting of Adverse Drug Reactions: A Multiregional Italian Study
Study title acronym
Study typeActive surveillance
Brief description of the studyBackground: Patients may increase spontaneuos reporting system and contribute to the detection of signals. Community pharmacies could have an important role in this context as a service for promoting patient reporting of ADRs. A pilot study was conducted in 2010 in the Veneto Region of Italy to increase the patient reporting through the role of the pharmacist. This project had so good results we decided to extend it to a mullti- regional level. Objectives: to assess the potential impact of an intevention to promote patient reporting in community pharmacies and to compare the characteristics of patients and general practitioners reports of adverse drug reactions (ADRs). Methods: Eight regional centres (Basilicata, Calabria, Campania, Friuli-Venezia Giulia,Lazio, Puglia Bari, Puglia Barletta, Veneto) have been involved in the study. Each pharmacist was asked to select, during the study period, about 240 customers who had received at least one drug and then to offer the spontaneuos reporting form to those who had experienced a suspected ADRs. Patients were asked to complete the ADR report form and either give it back to the pharmacist o send it by fax or email or else to fill in the form online. Preliminary results: in a 3-month period (from October 2013 to March 2014) the study involved 615 pharmacists working in 388 community pharmacies. 115,055 patients (58% female) were interviewed by the pharmacists and 12,185 (10,6%) referred a suspected ADR. The project has collected a total of about 4,000 citizen’s ADR reporting form , corresponding to about 30% of all patients interviewed who had experienced suspected ADRs. After a quality control about 60% of these reports were entered into the Italian Pharmacovigilance Database. A comparison with the reports sent by the general practitioners in the same region and in the same period is in progress. Further results will be published as soon as available.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPharmacol UNIVR
Department/Research groupPharmacology Unit - Veneto Pharmacovigilance Centre
Organisation/affiliationUniversity Hospital Verona
Website/Homepagewww.sfm.univr.it
Details of (Primary) lead investigator
Title Professor
Last name Roberto
First name Leone
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?8

Pharmacol UNIVR
CRF_Campania
PhV Regional Centre of Basilicata Region, Potenza, Basilicata, Italy
PhV Regional Centre of Calabria Region, Catanzaro, Calabria, Italy
PhV Regional Centre of Friuli Venezia Giulia Region, Trieste, Friuli Venezia Giulia, Italy
PhV Regional Centre of Lazio Region, Roma, Lazio, Italy
Centre of Bari, Puglia Region, Bari, Puglia, Italy
Centre of Barletta, Puglia Region, Barletta, Puglia, Italy
Countries in which this study is being conducted
National study

Italy
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/201201/01/2012
Start date of data collection01/10/201201/10/2012
Start date of data analysis01/09/201301/09/2013
Date of interim report, if expected
Date of final study report31/01/201431/01/2014
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councilsItalian Medicines Agency100
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Roberto
First name Leone
Address line 1Pharmacology Unit
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly
Phone number (incl. country code)390458124244 
Alternative phone number390458027612 
Fax number (incl. country code)390458124876 
Email address roberto.leone@univr.it
Public Enquiries
Title Professor 
Last name Roberto 
First name Leone 
Address line 1Pharmacology Unit 
Address line 2Policlinico GB Rossi 
Address line 3P.le L.A. Scuro 10 
CityVerona 
Postcode37134 
CountryItaly 
Phone number (incl. country code)390458124244 
Alternative phone number390458027612 
Fax number (incl. country code)390458124876 
Email address roberto.leone@univr.it 
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