Evidence map›Paper›PMID 24347984›Full record

ArticleJournal of pharmacology & pharmacotherapeutics2013

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

Chiara Giofrè, Francesca Scicchitano, Caterina Palleria, Carmela Mazzitello, Miriam Ciriaco, Luca Gallelli, Laura Paletta, Giuseppina Marrazzo, Christian Leporini, Pasquale Ventrice and 13 more

Abstract read
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In one paragraph

Article in Journal of pharmacology & pharmacotherapeutics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Pharmacovigilance in Italy: An overview.Journal of pharmacology & pharmacotherapeutics · 2013
    Review
  3. Safety and efficacy of generic drugs with respect to brand formulation.Journal of pharmacology & pharmacotherapeutics · 2013
    Article
  4. Informatics applied to pharmacovigilance: Future perspectives.Journal of pharmacology & pharmacotherapeutics · 2013
    Article
  5. Article
  6. Article
  7. Article
  8. A case of figurate urticaria by etanercept.Journal of pharmacology & pharmacotherapeutics
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

23 authors.

Chiara GiofrèDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Francesca ScicchitanoDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Caterina PalleriaDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Carmela MazzitelloDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Miriam CiriacoDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Luca GallelliDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Laura PalettaDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Giuseppina MarrazzoDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Christian LeporiniDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Pasquale VentriceDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Claudia CarboneDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Francesca SaulloDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Pierandrea RendeDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Michele MennitiDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Laura MumoliDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Serafina ChimirriDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Marinella PatanèDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Stefania EspositoDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Felisa CilurzoDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Orietta StaltariDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Emilio RussoDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
Giovambattista De SarroDepartment of Science of Health, School of Medicine, University of Catanzaro, Italy and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.
UNIVIGIL CZ Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPharmacovigilance (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

methodsWe 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.

resultsA 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.

conclusionsCalabria 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.

Indexed as

Adverse drug reactionItalyketoprofenpharmacovigilancesafety

Identifiers

PMID24347984
PMCPMC3853671

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.