Perspectives

Drug Safety. Whose Responsibility?
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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Pharmacovigilance and communication failure
Ivor Ralph Edwards
Focus Farmacovigilanza 2014;83(7):1
In FOCUS March 2013, Antonio Addis discusses the inadequacies of information and communication in pharmacovigilance and also challenges us, ‘Do try and find someone asserting that information in pharmacovigilance is useless’. In FOCUS July 2013, Richard Smith talks about peoples’ perception of drug...
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Online medicines and recreational drugs: a real risk
Giovanni Serpelloni1 and Claudia Rimondo2
Focus Farmacovigilanza 2014;82(5):1
New psychoactive substances (NPS) and their commercialization on the Internet In the last years the United Nations and the European Union have often reported the appearance, on the illegal drug market, of new psychoactive substances (NPS), purely synthetic and characterized by particularly harmful...
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Direct oral anticoagulants:a new challenge for pharmacovigilance
Pier Mannuccio Mannucci
Focus Farmacovigilanza 2014;81(3):1
More than two thirds of people undergoing long-term anticoagulant therapy with the vitamin-K antagonists (VKAs) warfarin and acenocoumarol have non–valvular atrial fibrillation (AF). This cardiac arrhythmia affects as many as 8.8 million people in the European Union, 700.000 in Italy. Because AF...
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Adverse effects of antiepileptic drugs
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...
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Safety of atypical antipsychotics in paediatrics
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...
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Drug interactions with smoking
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...
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Citizens perceptions of drug safety
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...
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The results of the European Study of Acute Liver Transplant (SALT)
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....
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Haste can be detrimental for health
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...
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