Evidence map›Paper›PMID 30284215›Full record

Observational studyDrug safety2019

Surveillance of Drug Safety During Pregnancy: Insight in Current International Activities, Future Intentions and Need for Support of National Pharmacovigilance Centres.

Agnes Kant, Loes de Vries, Leàn Rolfes

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing 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

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

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Article
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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.

Agnes KantNetherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's Hertogenbosch, The Netherlands.ORCID http://orcid.org/0000-0001-9046-1609
Loes de VriesNetherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's Hertogenbosch, The Netherlands.
Leàn RolfesNetherlands Pharmacovigilance Centre Lareb, WHO Collaborating Centre for Pharmacovigilance in Education and Patient Reporting, Goudsbloemvallei 7, 5237 MH, 's Hertogenbosch, The Netherlands. L.rolfes@lareb.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSurveillance of drug safety during pregnancy is a special interest of pharmacovigilance (PV). The role that national PV centres take in this field is, however, unclear.

aimThe aim of this study was to provide insight into current activities, future intentions and need for support of national PV centres in the field of drug safety during pregnancy.

methodA web-based questionnaire was used to ask PV centres about their current activities concerning the surveillance of drug safety during pregnancy, their intentions to implement or improve activities and need for support. For these three main topics, questions were posed about spontaneous adverse drug reaction (ADR) reporting, additional activities to obtain information, signal detection and informing healthcare professionals and the public.

resultsThe questionnaire was sent to PV centres of 172 countries. Response was 40%. In general, the PV centres received limited numbers of reports of ADRs in the (unborn) child, related to drug exposure during pregnancy. Signal detection in pregnancy cases is carried out by 8 out of 58 PV centres (13.5%). Most PV centres mention they have intentions to implement or improve activities, mainly for spontaneous reporting (69.4%) and methods for signal detection (67.2%). Support was needed for all topics of the questionnaire.

conclusionCurrent activities of national PV centres concerning drug safety during pregnancy are limited. The majority of PV centres are, however, willing to improve or implement activities. Programmes should be set up in order to support and stimulate PV centres with these activities. The aim of all these activities is to increase knowledge about the safety of drugs during pregnancy.

Indexed as

InternationalityPharmacovigilanceAdverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsFemaleForecastingHumansPregnancyPregnancy ComplicationsRetrospective StudiesSurveys and Questionnaires

Identifiers

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.