Perspectives | Farmacovigilanza

Communication and information on drug safety

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 –...

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Monitoring the safety of medicines used off-label

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...

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Discrepancies between observational studies and randomized controlled trials

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...

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Pharmacovigilance and prescribing decisions

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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Pharmacogenomics and adverse drug reactions: a promise postponed?

Michael D Rawlins

Focus Farmacovigilanza 2012;68(1):1

It has long been the goal of clinical pharmacologists to be able to provide the right patient, with the right drug, and at the right dose. To date this aspiration has only, to a modest extent, been achieved. Physicians select antimicrobial agents on the basis of the sensitivity of particular micro-...

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The power of observation

Marie Lindquist

Focus Farmacovigilanza 2011;64(5):1

“You see, but you do not observe. The disctinction is clear.” Sherlock Holmes complaining to Dr Watson in A scandal in Bohemia.”Ready, next!” Old Mrs A enters. She is slightly demented, does not sleep very well, and has a failing heart, but insists on living on her own. Her medical conditions have...

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Medication errors

Jeffrey K Aronson MA DPhil MBChB FRCP FBPharmacolS FFPM (Hon)

Focus Farmacovigilanza 2008;53(9):1

A medication error is defined as “a failure in the treatment process that leads to, or has the potential to lead to, harm to the patient” [1]. The “treatment process” starts after the decision is made to adopt treatment for symptoms or their causes, or to investigate or prevent disease or...

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Pharmacovigilance considerations for therapeutic biologic protein products

Gerald J. Dal Pan

Focus Farmacovigilanza 2009;58(12):1

The opinions expressed herein are those of the author, and not necessarily of the US Food and drug Administration In medicine, the term “biologic” refers to a wide range of medicinal products. These can include blood, blood components, vaccines, allergenics, recombinant therapeutic proteins,...

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JM Ritter

Focus Farmacovigilanza 2010;62(12):1

Introduction Drug regulation acquired high prominence in Europe as a result of the thalidomide catastrophe. In the 1950s barbiturates were commonly used as hypnotics, and because of their narrow margin of safety due to respiratory and cardiovascular depression were predictably highly lethal when...

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