Evidence map›Paper›PMID 23826016›Full record

ArticleJournal of research in medical sciences : the official journal of Isfahan University of Medical Sciences2012

Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.

Francesca Scicchitano, Chiara Giofrè, Caterina Palleria, Carmela Mazzitello, Miriam Ciriaco, Luca Gallelli, Laura Paletta, Giuseppina Marrazzo, Salvatore De Fazio, Michele Menniti and 9 more

Abstract read
In one paragraph

Article in Journal of research in medical sciences : the official journal of Isfahan University of Medical Sciences, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
–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

14 citing papers in PubMed.

  1. Review
  2. Article
  3. Article
  4. Skin rash during treatment with generic itraconazole.Journal of pharmacology & pharmacotherapeutics · 2014
    Article
  5. Safety and efficacy of generic drugs with respect to brand formulation.Journal of pharmacology & pharmacotherapeutics · 2013
    Article
  6. Informatics applied to pharmacovigilance: Future perspectives.Journal of pharmacology & pharmacotherapeutics · 2013
    Article
  7. Article
  8. Article
  9. Article
  10. Article
  11. Pharmacovigilance in Italy: An overview.Journal of pharmacology & pharmacotherapeutics · 2013
    Review
  12. Vertigo/dizziness as a Drugs' adverse reaction.Journal of pharmacology & pharmacotherapeutics · 2013
    Article
  13. Article
  14. 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

19 authors.

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.
Chiara Giofrè
Caterina Palleria
Carmela Mazzitello
Miriam Ciriaco
Luca Gallelli
Laura Paletta
Giuseppina Marrazzo
Salvatore De Fazio
Michele Menniti
Rubens Curia
Concetta Arena
Serafina Chimirri
Marinella Patanè
Stefania Esposito
Felisa Cilurzo
Orietta Staltari
Emilio Russo
Giovambattista De Sarro

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. MATERIALS AND

methodsWe analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field.

resultsRegarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested).

conclusionsDespite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.

Indexed as

Adverse drug reaction reporting systemsadverse effectscalabriadrug toxicityitalypharmacovigilance

Identifiers

PMID23826016
PMCPMC3697214

What OpenQuestion holds

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LicenceCC BY-NC-SA
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Registered trials

None linked

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.