Pharmacovigilance and drug safety in Calabria (Italy): 2012 adverse events analysis

Abstract

Introduction:Pharmacovigilance (PV) is designed to monitor drugs continuously after their commercialization, assessing and improving their safety profile. The main objective is to increase the spontaneous reporting of adverse drug reactions (ADRs), in order to have a wide variety of information. The Italian Drug Agency (Agenzia Italiana del Farmaco [AIFA]) is financing several projects to increase reporting. In Calabria, a PV information center has been created in 2010.Materials and Methods:We obtained data using the database of the National Health Information System AIFA relatively to Italy and Calabria in the year 2012. Descriptive statistics were performed to analyze the ADRs.Results:A total number of 461 ADRs have been reported in the year 2012 with an increase of 234% compared with 2011 (138 reports). Hospital doctors are the main source of this reporting (51.62%). Sorafenib (Nexavar®), the combination of amoxicillin/clavulanic acid and ketoprofen represent the drugs most frequently reported causing adverse reactions. Adverse events in female patients (61.83%) were more frequently reported, whereas the age groups “41-65” (39.07%) and “over 65” (27.9%) were the most affected.Conclusions:Calabria has had a positive increase in the number of ADRs reported, although it has not yet reached the gold standard set by World Health Organization (about 600 reports), the data have shown that PV culture is making inroads in this region and that PV projects stimulating and increasing PV knowledge are needed.

A case of figurate urticaria by etanercept

“…Post-marketing surveillance represents the cornerstone of pharmacovigilance especially for those adverse event, which are rare, to obtain additional information potentially useful to better understand the safety profile of the drugs in a real life contest. [ 19 20 21 22 23 24 25 26 27 28 ]…”

Informatics applied to pharmacovigilance: Future perspectives

“…The regional centers of active pharmacovigilance seems to play an important role in supporting the signaling as confirmed by the difference between the regions where the pharmacovigilance center is supported and funded than in regions without funded activities. [1,2] The use of electronic support will be the future, as it has happened in many fields and it will help to provide better health care professional prescribing patterns and therapies to enhance patient's safety.…”

“…There are many causes for under-reporting by physicians or pharmacists, the lack of time; the amount of information that the form requires. [1] More often, crucial information is not available (i.e., patient does not remember the concomitant medications or the exact brand for generic drugs) and it results in incomplete or invalid reports. Perhaps, it would be enough to simplify the form pattern to increase the number of reports.…”

“…Based on the experience at the Calabria's Pharmacovigilance Center, [1,2] we suggest that the form should be exclusively compiled online and immediately storable. Then, it should be automatically sent to the pharmacovigilance manager.…”

“…Spontaneous ADRs reporting represents a precious resource for control and information about the drug's safety, since it allows the detection of potential warning signals related to the use of all drugs available in a country. [1,2] Pharmacovigilance involves the entire community physicians, healthcare professionals, pharmacists; reporting can be made not only by healthcare personnel but also by the patients. [3,4]…”