Ten years of pharmacovigilance in Italy: the experience of Emilia-Romagna region in the monitoring of drug’s safety profile.

Background: Spontaneous reporting of suspected adverse drug reactions (ADR) is considered the eornerstone of pharrnacovigilance as it allows to assess the risklbenefit ratio of alI marketed drugs. Regional health service has arranged numerous initiatives aimed at promoting the culture of pharrnacovigilance and the participation of ali health care professiona!s. Aim: To describe the evolution of spontaneous reporting in the EmiliaRomagna Region (ERR) in the period 2001-2010 through qualitative (e.g. proper compìlation of the report form) and quantitative indicators (number of annua! reports for Local Health Authority, source of the report, etc). Metbod: Data of regìonal spontaneous reporting 2001-2010 were extracted from the National Network of Pharrnacovigilance of the Italian Drug Agency (AIFA). Drugs were classified according to the ATC classification (Anatomical Therapeutic Chemica! Classification System). For the analysis of adverse drug reactions the dictionary of terminology of Regulatory Agencies MedDRA was used. Results: The contributìon of the Region in the decade was approximately lO % of the national amount (9,633 out of 99,321), with 8 reports per 100 physicians and 230 per million inhabitants. The number of national and regional reports progressively decreased from 200 1 onwards and then retumed to grow in recent years. Strong differences between the individuai Local Health Authorities were identified. The reports concerned more females than males (FIM ratio 1.3: l) and age classes 0-2 and 60-80 years. Hospital doctors were the main source of reports, followed by generai physicians while it is still negligible the contribution by nurses and pharmacists. 2,556 reports (26.5 %) were c1assified as serious and 125 cases were lethal (4.9 % of serious ADRs and 1.3 % of ali regional reports). Iomeprol, amoxicillinlclavulanic acid, lenalidomide and ticlopidine were the most reported suspected drngs. Several serious cases involved vaccines. Discussion: ERR contributes most to the national pharmacovigilance system. Several initiatives launched in recent years allowed to involve in the spontaneous reporting system nurses and pharmacists who in the past underestimated the importance of monitoring the safety of drngs, but there is considerable room for improvement. Generai practitioners lost their major role in spontaneous reporting, probably due to the loss of patenes of drugs and also for the marketing of new drugs made for hospital use only. Conclusion: The pharmacovigilance system of ERR participates in the periodic signal analysis, therefore the quality of the data and the number of reports are essenti al for the emergence of these signals that allow to reevaluate the safety profile of marketed drugs in the primary interest of public health.