Perspectives

Roberto Satolli
Focus Farmacovigilanza 2015;91(12):1
The Italian Medicines Agency (AIFA) was founded in 2004 under the management of Nello Martini and grew enriching its regulatory mandate with complementary activities such as funding independent research and providing information/education for professionals. One of the biggest damage caused by the...
Michael Rawlins
Focus Farmacovigilanza 2015;90(9):1
Background NICE – the National Institute for Clinical Excellence – was established in 1999 by the UK’s Department of Health as an independent body free from political (or other) vested interests. Its remit was to provide advice (“guidance”) to enable health professionals, working in the...
Roberto Leone and Lara Magro
Focus Farmacovigilanza 2015;89(8):1
Earlier this year, at the presentation of the OsMed/AIFA report on drug consumption in Italy, health Minister Lorenzin expressed "grave concern at the increased consumption of opiates." Are Minister's concerns justified? Were we not the country with one of the lowest morphine consumption rates in...
Roberto Satolli
Focus Farmacovigilanza 2015;88(5):1
Last October, when I wrote an editorial for Focus Pharmacovigilance (Focus November-December 2014, page 1) about "Ebola exceptions" concerning the rules for assessing the safety and efficacy of drugs, I could never have imagined that within a few days I would find myself personally involved in the...
Giampaolo Velo, Mauro Venegoni, Pietro Dri
Focus Farmacovigilanza 2015;88(5):1
The bulletin “Focus Farmacovigilanza” has always been particularly sensitive to the conflict of interest issue, to the point of reporting to the reader even the possible conflicts concerning the sources used in the various articles. It’s worth reminding that “Focus Farmacovigilanza” is not a...
The bulletin “Focus Farmacovigilanza” has always been particularly sensitive to the conflict of interest issue, to the point of reporting to the reader even the possible conflicts concerning the sources used in the various articles. It’s worth reminding that “Focus Farmacovigilanza” is not a...
Fabio Firenzuoli
Focus Farmacovigilanza 2015;87(3):1
The term “herbal” often instinctively arouses an immediate sense of stiffened perplexity, caution, mistrust or complete opposition in pharmacologists as well as clinicians, not least of all because numerous active or non-active destabilising factors are present within in the same botanical species...
Monia Donati, Mauro Melis
Focus Farmacovigilanza 2015;86(1):1
"Can we rely on RE-LY?" was the title of an editorial in the New England Journal of Medicine1 in 2009, commenting on the RE-LY study2 which compared dabigatran (110 and 150 mg), the first member of the new class of oral anticoagulants, and warfarin in patients with non-valvular atrial fibrillation...
Roberto Satolli, Zadig
Focus Farmacovigilanza 2014;85(11):1
The tragedy of Ebola, in its now catastrophic development, besides wiping out so many human lives is already producing a cascade of effects at a global level whose extension and broad reach are impossible to foresee.Also drug safety evaluation (or, as it is always better to say, the benefit-damage...
Alasdair Breckenridge
Focus Farmacovigilanza 2014;84(5):1
When a medicine is marketed, much is known about its quality and pharmacology and in its efficacy in a carefully screened group of patients in clinical trials. These data, however, may provide an incomplete and even misleading account of the drug’s effectiveness in the community at large. Even less...

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