Report: Growth in Medical Device Adverse Events Outpaces Industry Growth Share

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In 2011, the number of reports entered in the National Pharmacovigilance Network was 21,473, equivalent to a reporting rate of 356 reports per million inhabitants.
The value of 300 reports per million inhabitants, defined by the World Health Organization (WHO) as the gold standard for an efficient pharmacovigilance system capable of promptly generating alarm signals, has therefore been reached and exceeded.

30% of the reports entered in 2011 concerned serious adverse reactions, 69% non-serious reactions. Only 1% of the reports did not report the severity.
Also in 2011, hospital doctors represent the main source of reports (55%) with an increase of + 11% compared to 2010. Pharmacists follow with 12% of reports compared to the total and the whistleblowers or health workers of the districts and vaccination centers for which a significant increase is observed.

In 2011, reports coming directly from patients dropped drastically (-85%), coinciding with the conclusion of specific projects, demonstrating that pharmacovigilance is an activity that requires continuous stimulation to keep the results achieved constant.
In 2011, 84% of the medicines indicated as suspicious in the reports concerned drugs in general and 16% vaccines.

Excluding vaccines from the analysis, it is observed that the highest number of reports in the total database is related to drugs belonging to the ATC class of antimicrobials for systemic use (J 21%), followed by antineoplastic drugs (L 14%) and cardiovascular drugs (C 14%), those of the central nervous system (N 12%) and those of the musculoskeletal system (M 11%).

Comparing the data of 2011 with those of 2010, it can be observed that in percentage values ​​the greatest increases were recorded for drugs belonging to the ATC class of antineoplastics (L + 20%), antimicrobials for systemic use (excluding vaccines) (J +16 %) and dermatologists (D + 14%).

The greatest decreases are for drugs of the genitourinary system and sex hormones (G-23%) and for systemic hormonal preparations (H-16%).
The most reported reactions in the total database are skin reactions (22%), followed by those relating to general conditions and gastrointestinal ones.
Although the national value of the reporting rate is significantly higher than that of the WHO Gold Standard, at the regional level it has been achieved and exceeded by only 4 Regions: Lombardy (934), Tuscany (788), Basilicata (388) and Molise (341).

Another 5 Regions have a reporting rate that exceeds 250 reports: these are Campania (285), the Autonomous Province of Trento (271), Lazio (270), Emilia Romagna (266) and Veneto (262). The remaining regions are still far below the WHO Gold Standard. Lombardy and Tuscany have a much higher number of reports than the other regions: in 2011 over half of the Italian reports come from these two Regions.