Evidence map›Paper›PMID 33623659›Full record

ArticleTherapeutic advances in drug safety2021

Pharmacovigilance and the digital world in Italy: presentation of the results of a national survey.

Lisa Stagi, Ilenia Bocchi, Salvatore Bianco, Grazia Sirizzotti, Daniela Bernardini, Valentina Calderazzo, Giacomo Pirisino, Ilaria Grisoni, Silvia Romano

Abstract read
In one paragraph

Article in Therapeutic advances in drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

9 authors.

Lisa StagiRoche, Monza, Lombardia, Italy.
Ilenia BocchiBayer S.p.A, Viale Certosa 130, Milano, 20156, Italy.ORCID https://orcid.org/0000-0001-5762-2466
Salvatore BiancoAKROS BioScience S.r.l., Pomezia, Rome, Italy.
Grazia SirizzottiDrug Safety, Biogen Italia, Milano, Lombardia, Italy.
Daniela BernardiniNovartis Farma Italia, Origgio, Lombardia, Italy.
Valentina CalderazzoBoehringer Ingelheim Italia, Milano, Lombardia, Italy.
Giacomo PirisinoAstellas Pharma Italy, Carugate, Lombardia, Italy.
Ilaria GrisoniEEA QPPV, Jazz Pharmaceuticals.
Silvia RomanoSanofi S.p.A., Milano, Lombardia, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe digital world has undergone an essential metamorphosis in recent years, making the easy sharing of information possible, including those related to pharmacovigilance and the safety aspects of pharmaceutical and other healthcare products. These new interactive ways pose both opportunities and challenges to healthcare/pharmaceutical companies. The Pharmacovigilance Working Group "Ernesto Montagna" of the Italian Society of Pharmaceutical Medicine (SIMeF) decided to carry out a survey to gain a better understanding of the role of pharmacovigilance in digital activities.

methodsThe Pharmacovigilance Working Group "Ernesto Montagna" sent a questionnaire

resultsNinety-three members of the Group "Ernesto Montagna" completed the questionnaire. The results show that, in the panorama of Italian healthcare/pharmaceutical companies, digital activities are ongoing, but there are still areas of uncertainty: on when a pharmacovigilance team should be involved, on the governance tools and on the guidance to be used to ensure effective governance of digital projects.

conclusionIn a scenario which is evolving very quickly, a critical factor is the availability of specific and updated regulations. Scientific societies, such as SIMeF and Farmindustria, the Italian national Pharma-Companies Association, could give a valuable contribution to the development of appropriate guidance together with the competent authorities. PLAIN LANGUAGE SUMMARY:

Indexed as

adverse eventsartificial intelligencedigital activitiespharmacovigilancesocial media

Identifiers

PMID33623659
PMCPMC7878998

What OpenQuestion holds

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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.