Evidence map›Paper›PMID 39160354›Full record

SynthesisDrug safety2024

A Comparison of Active Pharmacovigilance Strategies Used to Monitor Adverse Events to Antiviral Agents: A Systematic Review.

Renato Ferreira-da-Silva, Joana Reis-Pardal, Manuela Pinto, Matilde Monteiro-Soares, Bernardo Sousa-Pinto, Manuela Morato, Jorge Junqueira Polónia, Inês Ribeiro-Vaz

Abstract readSystematic ReviewComparative Study
In one paragraph

Synthesis in Drug safety, 2024. 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. Review
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

8 authors.

Renato Ferreira-da-SilvaPorto Pharmacovigilance Centre, Faculty of Medicine of the University of Porto, Porto, Portugal. renato.ivos@gmail.com.ORCID http://orcid.org/0000-0001-6517-6021
Joana Reis-PardalCenter for Health Technology and Services Research, Associate Laboratory RISE-Health Research Network (CINTESIS@RISE), Porto, Portugal.ORCID http://orcid.org/0000-0002-0314-8233
Manuela PintoSão João University Hospital Centre, Porto, Portugal.ORCID http://orcid.org/0009-0008-8759-1486
Matilde Monteiro-SoaresCenter for Health Technology and Services Research, Associate Laboratory RISE-Health Research Network (CINTESIS@RISE), Porto, Portugal.ORCID http://orcid.org/0000-0002-4586-2910
Bernardo Sousa-PintoCenter for Health Technology and Services Research, Associate Laboratory RISE-Health Research Network (CINTESIS@RISE), Porto, Portugal.ORCID http://orcid.org/0000-0002-1277-3401
Manuela MoratoLaboratory of Pharmacology, Department of Drug Sciences, Faculty of Pharmacy of the University of Porto, Porto, Portugal.ORCID http://orcid.org/0000-0002-9509-0613
Jorge Junqueira PolóniaPorto Pharmacovigilance Centre, Faculty of Medicine of the University of Porto, Porto, Portugal.ORCID http://orcid.org/0000-0002-0133-7217
Inês Ribeiro-VazPorto Pharmacovigilance Centre, Faculty of Medicine of the University of Porto, Porto, Portugal.ORCID http://orcid.org/0000-0002-3442-8158

Funding

Fundação para a Ciência e a Tecnologia 2020.10231.BD
6 · The paper itself

Abstract

introductionThe safety of antiviral agents in real-world clinical settings is crucial, as pre-marketing studies often do not capture all adverse events (AE). Active pharmacovigilance strategies are essential for detecting and characterising these AE comprehensively.

objectiveThe aim of this study was to identify and characterise active pharmacovigilance strategies used in real-world clinical settings for patients under systemic antiviral agents, focusing on the frequency of AE and the clinical data sources used.

methodsWe conducted a systematic review by searching three electronic bibliographic databases targeting observational prospective active pharmacovigilance studies, phase IV clinical trials for post-marketing safety surveillance, and interventional studies assessing active pharmacovigilance strategies, focusing on individuals exposed to systemic antiviral agents.

resultsWe included 36 primary studies, predominantly using Drug Event Monitoring (DEM), with a minority employing sentinel sites and registries. Human immunodeficiency virus (HIV) was the most common condition, with the majority using DEM. Within the DEM, there was a wide range of incidences of patients experiencing at least one AE, and most of these studies used one or two data sources. Sentinel site studies were less common, with two on hepatitis C virus (HCV) and one on HIV, each relying on one or two data sources. The single study using a registry focusing on HIV therapy reported using just one data source. Patient interviews were the most common data source, followed by medical records and laboratory tests. The quality of the studies was considered 'good' in 18/36, 'fair' in 1/36, and 'poor' in 17/36 studies.

conclusionDEM was the predominant pharmacovigilance strategy, employing multiple data sources, and appears to increase the likelihood of detecting higher AE incidence. Establishing such a framework would facilitate a more detailed and consistent approach across different studies and settings.

Indexed as

Adverse Drug Reaction Reporting SystemsAntiviral AgentsPharmacovigilanceDrug MonitoringDrug-Related Side Effects and Adverse ReactionsHumansProduct Surveillance, PostmarketingAntiviral Agents

Identifiers

PMID39160354
PMCPMC11554745

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.