Evidence map›Paper›PMID 34100398›Full record

ReviewIndian journal of pharmacology

Adverse event reporting tools and regulatory measures in India through outcome of Pharmacovigilance Programme of India.

Jai Prakash, Raghav Sachdeva, Tarani Prakash Shrivastava, C V Jayachandran, Aseem Sahu

Abstract readReview
In one paragraph

Review in Indian journal of pharmacology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing 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

11 citing papers in PubMed.

  1. Article
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  4. Review
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  8. Review
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  11. 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

5 authors.

Jai PrakashNational Coordination Centre, Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India.
Raghav SachdevaSchool of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India.
Tarani Prakash ShrivastavaNational Coordination Centre, Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India.
C V JayachandranNational Coordination Centre, Pharmacovigilance Programme of India, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India.
Aseem SahuCentral Drugs Standard Control Organization, North Zone, Ghaziabad, Uttar Pradesh, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The primary care medical practitioners as well as common public must be made aware of the importance and benefits of reporting adverse drug reactions (ADRs). The reporting of ADRs through periodic safety update reports is a regulatory requirement in many countries including India, however, the importance of ADR reporting through spontaneous reporting system cannot be ignored. After the initiation of Programme for International Drug Monitoring, WHO-Uppsala Monitoring Centre (UMC), Sweden, succeeded in establishing a worldwide pharmacovigilance (PV) network in >150 countries. As a full member of this program, India also has developed a robust PV system through Pharmacovigilance Programme of India (PvPI) involving its various ADR Monitoring Centers and after due quality check of Individual Case Safety Reports (ICSRs), submits this information to UMC through a web-based tool VigiFlow

Indexed as

Adverse Drug Reaction Reporting SystemsDrug and Narcotic ControlPharmacovigilanceHumansIndiaPublic HealthWorld Health OrganizationAdverse drug reactionsadverse eventadverse event reporting toolspharmacovigilancePharmacovigilance Programme of India

Identifiers

PMID34100398
PMCPMC8265409

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.