Evidence map›Paper›PMID 30094557›Full record

ArticleInternational journal of clinical pharmacy2018

Pharmacovigilance workflow in Europe and Italy and pharmacovigilance terminology.

Paolo Baldo, Sara Francescon, Giulia Fornasier

Abstract read
In one paragraph

Article in International journal of clinical pharmacy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Medication Risk Management.Innovations in pharmacy · 2019
    Article
  12. Overview of this issue: pharmacovigilance, what is new?International journal of clinical pharmacy · 2018
    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

3 authors.

Paolo BaldoPharmacy Unit, CRO Aviano IRCCS, National Cancer Institute, Aviano, Italy. pbaldo@cro.it.ORCID http://orcid.org/0000-0002-5106-7120
Sara FrancesconPharmacy Unit, CRO Aviano IRCCS, National Cancer Institute, Aviano, Italy.
Giulia FornasierPharmacy Unit, CRO Aviano IRCCS, National Cancer Institute, Aviano, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The terminology used in pharmacovigilance can cause confusion, because there are similar terms that describe different phenomena (e.g. adverse reactions, adverse drug reactions, and side effects). Incorrect use of terminology can have negative effects on the reporting of adverse drug reactions and on the interpretation of these reports. To explain the most common terms used in pharmacovigilance, this article first describes the pharmacovigilance workflow process in the European Union and, as an example, in Italy. Then, the article reviews common pharmacovigilance terms.

Indexed as

Adverse Drug Reaction Reporting SystemsPharmacovigilanceTerminology as TopicWorkflowDrug-Related Side Effects and Adverse ReactionsEuropean UnionHumansItalyPatient SafetyRisk AssessmentRisk FactorsAdverse drug reactionAlertsDefinitionsPharmacovigilance systemSignalTerminology

Identifiers

PMID30094557
PMCPMC6132975

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.