Study identification

PURI

https://redirect.ema.europa.eu/resource/6890

EU PAS number

EUPAS5289

Study ID

6890

Official title and acronym

Effect of Pharmacist Involvement on Patient Reporting of Adverse Drug Reactions: A Multiregional Italian Study

DARWIN EU® study

No

Study countries

Italy

Study description

Background: 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.

Study status

Finalised
Research institutions and networks

Institutions

PhV Regional Centre of Basilicata Region, PhV Regional Centre of Calabria Region, PhV Regional Centre of Friuli Venezia Giulia Region, PhV Regional Centre of Lazio Region, Centre of Bari, Puglia Region, Centre of Barletta, Puglia Region

Contact details

Leone Roberto

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

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Data analysis start date

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Date of final study report

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Sources of funding
Other

More details on funding

Italian Medicines Agency
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable