Evidence map›Paper›PMID 37349651›Full record

ArticlePharmaceutical research2023

Preventive Pharmacovigilance: timely and precise prevention of adverse events through person-level patient screening and dose-level product surveillance.

Yihua Bruce Yu, Katharine T Briggs, Marc B Taraban

Erratum issuedAbstract read
In one paragraph

Article in Pharmaceutical research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

3 authors.

Yihua Bruce YuBio and Nano-technology Center, University of Maryland School of Pharmacy, 20 North Penn Street, Baltimore, MD, 21201, USA. byu@rx.umaryland.edu.ORCID http://orcid.org/0000-0001-8043-6530
Katharine T BriggsBio and Nano-technology Center, University of Maryland School of Pharmacy, 20 North Penn Street, Baltimore, MD, 21201, USA.
Marc B TarabanBio and Nano-technology Center, University of Maryland School of Pharmacy, 20 North Penn Street, Baltimore, MD, 21201, USA.

Funding

National Institute for Innovation in Manufacturing Biopharmaceuticals ARP-25U.S. Food and Drug Administration 75F40119C10104
6 · The paper itself

Abstract

The goal of pharmacovigilance (PV) is to prevent adverse events (AEs) associated with drugs and vaccines. Current PV programs are of a reactive nature and rest entirely on data science, i.e., detecting and analyzing AE data from provider/patient reports, health records and even social media. The ensuing preventive actions are too late for people who have experienced AEs and often overly broad, as responses include entire product withdrawals, batch recalls, or contraindications of subpopulations. To prevent AEs in a timely and precise manner, it is necessary to go beyond data science and incorporate measurement science into PV efforts through person-level patient screening and dose-level product surveillance. Measurement-based PV may be called 'preventive pharmacovigilance', the goal of which is to identify susceptible individuals and defective doses to prevent AEs. A comprehensive PV program should contain both reactive and preventive components by integrating data science and measurement science.

Indexed as

PharmacovigilanceVaccinesHumansVaccinesdose-level product surveillancemeasurement scienceperson-level patient screeningpreventive pharmacovigilancevaccine safety

Identifiers

PMID37349651
PMCPMC10547648

What OpenQuestion holds

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LicenceCC BY
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.