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

Abstract

Objective: To describe the evolution of adverse drug reactions (ADRs) spontaneously reporting in the Emilia-Romagna region (ERR) in the period 2001 – 2010 through qualitative and quantitative indicators following local educational and editorial initiatives.

Methods: Data of regional spontaneous reporting from 1 January 2001 to 31 December 2010 were obtained from the Pharmacovigilance National Network of the Italian Medicines Agency. Drugs were classified according to the Anatomical Therapeutic Chemical classification. ADRs were coded using the Medical Dictionary for Regulatory Activities Terminology.

Results: The overall contribution of the ERR was 9.7% of the total national number of reports (9631 out of 99,319) with a rate of 8 reports per 100 physicians and 230 per million inhabitants. Reports concerned more females and more patients aged 0 – 2 and 60 – 80 years. Differences between the individual local health authorities were identified in rate of ADR reporting. Hospital doctors were the main source of reports followed by general physicians. Out of 2555 serious reports, 124 cases were lethal (4.9% of serious ADRs and 1.3% of all regional reports).

Conclusion: The results represent a useful trend analysis of the post-marketing surveillance and suggest that, although the pharmacovigilance system has succeeded in reaching a stable and lasting flow of information in ERR, there is considerable place for improvement.

Keywords::

• adverse drug reaction
• drug safety
• pharmacovigilance
• spontaneous reporting

Acknowledgments

We are very grateful to the Drug Policy Service, Emilia–Romagna Region Health Authority, Bologna, Italy, and to all health personnel and patients/citizens contributing to the regional system of pharmacovigilance.