Perspectives

Accelerated approval of anticancer drugs: a safe choice?
All oncologists know how anxiously cancer patients look forward to the availability in clinical practice of drugs that have yielded positive results in the registration trials. And every year, returning from the annual meeting of the ASCO (American Society of Clinical Oncology), every specialist...
[more]
Bevacizumab for Off-label Ophthalmic Use
The recent ruling (21 November 2018) of the European Court of Justice puts an end to the dispute over the off-label use of bevacizumab for age-related macular degeneration. Below is a short summary which reconstructs the facts regarding the use of two monoclonal antibodies against vascular...
[more]
The Safety of Medicines in the 21st Century – some thoughts
Sadly, although there are plans to continue the Erice meetings to consider other globally important aspects of pharmacology, therapeutics and drug safety, "A New Erice Report Considering the Safety of Medicines in the 21st Century"1was published just after the death of Professor Giampaolo Velo. He...
[more]
The role of "big data" in pharmacovigilance
In the last 10 years, the term "big data" has become a keyword in many different contexts. Despite being a widespread term, though, it is not always clear what it refers to. The most appropriate definition is the one that breaks it down to the so-called "4 Vs": Volume, Variety, Velocity and...
[more]
The demise of Giampaolo Velo
Dear readers, It is with profound emotion that we remember Professor Giampaolo Velo, editor-in-chief of Focus Farmacovigilanza, whom died on the 17th of August, this year, after a long illness. Born in Padua in 1943, he graduated cum laude in Medicine from the University of Bologna, aged 24. After...
[more]
Vigifarmaco: reporting adverse drug reactions online
Ugo Moretti
Focus Farmacovigilanza 2017;96(3):1
At the end of February 2017, the Italian Agency of Medicines, AIFA, announced on its website (http://www.agenziafarmaco.gov.it/) the launch of a new modality for reporting suspect adverse reactions to drugs and vaccines. Healthcare professionals and citizens in Italy can now report directly from...
[more]
Diseases: non-vaccination adverse reactions
Michele Gangemi1, Ugo Moretti2 and Giampaolo Velo3
Focus Farmacovigilanza 2016;95(11):1
Focus Farmacovigilanza has already covered the phenomenon of vaccination drop and its possible solutions.1 This article aims at discussing the consequences for public health caused by the choice of not-vaccinating. After all, adverse-reaction reports do not regard the health of a single person only...
[more]
Medicines and Monza: hazards of the fast track
John Dowden
Focus Farmacovigilanza 2016;94(9):1
Autodromo Nazionale Monza is a famous fast track. It has also been the place of many injuries and deaths. Just like motor racing, drug development can be dangerous ̶ go too fast and there may be disaster. In drug regulation a fast track approval process aims to accelerate the availability of...
[more]
Pharmacovigilance: science or bureaucracy?
Ivor Ralph Edwards1 and Giampaolo Velo2
Focus Farmacovigilanza 2016;93(3):7
What are we talking about? To get started it is worth looking at the ways in which “bureaucracy” is used. According to Google definitions bureaucracy has 4 meanings: System of government in which most of the important decisions are taken by state officials rather than by elected representatives...
[more]
Pharmacovigilance Risk Assessment Committee: An Update
Hervé Le Louët*(MD, PhD), Jean Michel Dogné (PD, PhD)**
Focus Farmacovigilanza 2016;92(1):1
1) Background.In European Union (EU), the Burden of Adverse Drug Reactions (ADRs) is a major concern of public health with 5% of all hospital admissions due ADRs and 5% of all hospital patients suffering an ADR. Today ADRs are the 5th most common cause of hospital death with 197 000 deaths per year...
[more]

Pagine

80.211.154.110