Evidence map›Paper›PMID 30101375›Full record

ArticleInternational journal of clinical pharmacy2018

Pharmacovigilance in a rare disease: example of the VIGIAPATH program in pulmonary arterial hypertension.

Marie-Camille Chaumais, Caroline O'Connell, Laurent Savale, Christophe Guignabert, Frédéric Perros, Xavier Jaïs, Olivier Sitbon, Marc Humbert, David Montani

Abstract read
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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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 26% of its field
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, 7 citations in OpenAlex.

  1. Review
  2. 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

9 authors at 2 institutions in 2 countries.

Marie-Camille ChaumaisFaculté de Pharmacie, Univ. Paris-Sud, Université Paris-Saclay, Chatenay Malabry, France. marie-camille.chaumais@u-psud.fr.ORCID http://orcid.org/0000-0002-1217-8442
Caroline O'ConnellINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.ORCID http://orcid.org/0000-0001-6776-5110
Laurent SavaleINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.ORCID http://orcid.org/0000-0002-9089-7311
Christophe GuignabertINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.ORCID http://orcid.org/0000-0002-8545-4452
Frédéric PerrosINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.ORCID http://orcid.org/0000-0001-7730-2427
Xavier JaïsINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.
Olivier SitbonINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.ORCID http://orcid.org/0000-0002-1942-1951
Marc HumbertINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.ORCID http://orcid.org/0000-0003-0703-2892
David MontaniINSERM UMR_S 999, Hôpital Marie Lannelongue, Le Plessis Robinson, France.ORCID http://orcid.org/0000-0002-9358-6922
Université Paris-Sud · FRInserm · FR

Funding

Agence Nationale de Sécurité du Médicament et des Produits de Santé AAP-2013-028
6 · The paper itself

Abstract

Spontaneous reporting is the primary method used in pharmacovigilance (PV) to detect drug safety signal. Specific criteria used in pharmacovigilance to prove accountability of a drug are rarely present in rare disease. The low number of alerts also makes it challenging. The aim of this commentary is to raise awareness among pharmacists on issues and opportunities for pharmacovigilance in rare diseases, taking pulmonary arterial hypertension (PAH) as example, from which a subset of cases are drug-induced. It is demonstrated how a dedicated program named VIGIAPATH created to reinforce pharmacovigilance of drug-induced pulmonary arterial hypertension at a national level, led to increase self-reporting and confirm safety signals. Thanks to a specific program such as VIGIAPATH, pharmacists can play an important role in communication with clinicians, patients and regulatory agencies, facilitating the detection of potential safety signals at an early stage in rare disease.

Indexed as

Adverse Drug Reaction Reporting SystemsPharmacovigilanceAntibiotics, AntineoplasticAttitude of Health PersonnelDiagnosis, DifferentialHealth Knowledge, Attitudes, PracticeHumansHypertension, PulmonaryInterdisciplinary CommunicationMitomycinPatient SafetyPharmacistsPredictive Value of TestsProfessional RoleProgram EvaluationProtein Kinase InhibitorsAntibiotics, AntineoplasticMitomycinProtein Kinase InhibitorsAdverse drug reactionPharmacovigilancePulmonary arterial hypertensionRare diseases

Identifiers

PMID30101375
OpenAlexW2885795590

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.