Perspectives

Emilio Perucca
Focus Farmacovigilanza 2014;80(1):1
Over half million people in Italy are affected by epilepsy and require antiepileptic drugs to achieve or maintain seizure control. An even higher number of people are prescribed the same drugs for other indications, some of which are officially approved (i.e. bipolar disorder, migraine, neuropathic...
Domenico Italiano and Edoardo Spina
Focus Farmacovigilanza 2013;79(11):1
In the last ten years, atypical antipsychotics progressively substituted first generation drugs thanks to a more favourable tolerability profile, particularly for the minor frequency of neurological extrapyramidal effects.1 Atypical antipsychotics have been widely used for few years also in...
Cristiano Chiamulera1 and Giampaolo Velo1,2
Focus Farmacovigilanza 2013;78(9):1
Tobacco smoke: what are smokers inhaling?In the last few years, a new health and hygiene awareness has matured, leading to healthier nutrition and life-styles. Consumers of any social and cultural level are nowadays able to read the ingredients of the product they are about to purchase and can...
Richard Smith
Focus Farmacovigilanza 2013;77(7):1
Hospitals are unsafe places, but citizens perceive them as safe. Citizens, at least in Britain, are also unaware of the variations in performance among hospitals. I was at a meeting on quality in health care where the head of a patient organisation described his ideas of quality. He didn’t mention...
Sinem Ezgi Gulmez, Nicholas Moore
Focus Farmacovigilanza 2013;76(5):1
Many adverse reactions have been discovered by spontaneous reporting, and this has led to important public health issues and drugs being removed from the market, in some cases issues are not so clear-cut as they may seem: in this respect the case of nimesulide hepatotoxicity is quite interesting....
Silvio Garattini
Focus Farmacovigilanza 2013;74(1):1
Every medical intervention, even a very positive one, has unfortunately very often a negative offset. In other words, every benefit is counterbalanced by a risk. It is then very difficult for those who have to decide the commercialization of a new drug (EMA in Europe and FDA in the US) to...
Antonio Addis
Focus Farmacovigilanza 2013;75(3):1
Do try and find someone asserting that information in pharmacovigilance is useless. I am sure you will not be very successful. Nevertheless, there are no clear indications on how and when these instruments for information and communication should be used. Even though the new European Regulation –...
Gerald J. Dal Pan, MD, MHS
Focus Farmacovigilanza 2009;55(3):1
The views expressed are those of the author, and not necessarily those of the US Food and Drug Administration. The label of a medicine contains important information on the conditions of use for that medicine. These conditions of use typically include the indication, the dosage, the frequency of...
Francesco Trotta
Focus Farmacovigilanza 2012;73(11):1
Observational Studies (OSs) and Randomized Controlled Trials (RCTs) are the main types of studies used to evaluate treatments. In the last ones, patients are assigned to active or control group by chance - through randomization - in order to reduce errors or bias and to remark only the differences...
Gerald J. Dal Pan
Focus Farmacovigilanza 2012;72(9):1
One of the important roles of a drug regulatory agency is to provide timely and accurate information on the safety and efficacy of medicines. While pre-approval clinical trials characterize the common adverse reactions associated with a new medicine and some of the less common serious adverse...

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