Full version of the report (pdf, 2 MB) : http://www.rssp.salute.gov.it/rssp2011/documenti/RSSP_2011.pdf (Drugs, generics: page: 97 and following. Chap. 6)
Summary (pdf, 357 KB) : http://www.rssp.salute.gov.it/rssp2011/documenti/Sintesi_della_relazione.pdf
Healthcare: Report, in 2011 573 reports of drug quality defects
December 11, 2012 – 12:04
(ASCA) - Rome, Dec. 11 - During 2011, Aifa (the Italian Medicines Agency) received 573 reports of quality defects in medicines on the market (60 more than in 2010). 38 samplings were ordered and 3 rapid alerts issued, while 73 batch withdrawal orders were issued, 23 use bans, 3 seizure orders, 5 sales ban decisions.
As part of the annual drug control program (PCA) for the year 2011, 141 samplings were arranged.
For monitoring the safety of vaccines and blood products, AIFA completed 1,808 batch release procedures in 2011, of which 402 were treated with an urgent procedure. This is what emerges from the 2011 report on the state of health of the country, presented by the Ministry of Health.
During 2011, 23,742 reports of suspected adverse reactions to drugs were recorded in the National Pharmacovigilance Network (RNF), with an increase of 8% compared to 2010. In 2011, through the funds allocated by the State for the Regions, 146 regional and multi-regional projects were evaluated and approved, considered capable of increasing knowledge on specific categories of medicines and their safety profile. There are 192 medicines included in the intensive monitoring list. Italy is considered one of the countries of reference in the fight against pharmaceutical counterfeiting.
In 2011, important objectives were achieved in this area: development of an adequate and consistent regulatory framework with respect to the current scenario; strengthening of existing intersectoral collaborations; extension of controls to "borderline" product types such as food supplements, intensification of training activities aimed at sector operators and information activities aimed at the general public.
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