Evidence map›Paper›PMID 42157209›Full record

ArticleBMC medical education2026

Quality of adverse drug reaction reports submitted to the national pharmacovigilance center of Nepal: a pre- and post-training evaluation.

Sushil Nepal, Shyam Shah, Narayan Prasad Dhakal, Umanga Tripathee, Santusta Adhikari, Sunil Shrestha, Birna Trap, Tamara Hafner, Andy Stergachis

Abstract read
In one paragraph

Article in BMC medical education, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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0cells of the map it votes in
1citing 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

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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

1 citing paper in PubMed.

  1. 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.

Sushil NepalUSAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, Management Sciences for Health, Kathmandu, Nepal. snepalepi@gmail.com.ORCID http://orcid.org/0000-0003-4047-342X
Shyam ShahUSAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, Management Sciences for Health, Kathmandu, Nepal.ORCID http://orcid.org/0000-0003-1072-1824
Narayan Prasad DhakalDepartment of Drug Administration, Ministry of Health and Population, Kathmandu, Nepal.
Umanga TripatheeDepartment of Drug Administration, Ministry of Health and Population, Kathmandu, Nepal.
Santusta AdhikariUSAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, Management Sciences for Health, Kathmandu, Nepal.ORCID http://orcid.org/0009-0009-4424-0165
Sunil ShresthaDepartment of Research and Academics, Kathmandu Cancer Center, Tathali, Nala Road, Bhaktapur, Nepal.ORCID http://orcid.org/0000-0002-9174-7120
Birna TrapUSAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, Management Sciences for Health, Kathmandu, Nepal.ORCID http://orcid.org/0000-0001-9432-9699
Tamara HafnerUSAID Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program, Management Sciences for Health, Arlington, USA.ORCID http://orcid.org/0000-0002-4710-0979
Andy StergachisSchool of Pharmacy and School of Public Health, University of Washington, Seattle, USA.ORCID http://orcid.org/0000-0003-0057-6627

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPharmacovigilance (PV) plays a critical role in monitoring and evaluating adverse drug reactions (ADRs) to ensure the safety of marketed medical products. This study aimed to assess the quality of ADR reports submitted to the national PV center of Nepal by comparing pre- and post-training periods, and to identify factors associated with ADR reporting quality.

methodsA retrospective analysis of ADR reports submitted to the national PV center was conducted over a three year period. Reports from January 2020 to November 2022 were classified as the pre-training phase while reports from December 2022 to April 2023 consitituted the post-training phase. In December 2022, the research team developed and implemented a capacity building plan that included a two-day training program for regional PV center contact persons, consisting of pharmacists and other health care professionals (HCPs) responsible for submitting ADR reorts through the VigiFlow system. The quality of ADR reports was assessed using the validated Adverse Drug Report Quality Algorithm (AQUA-12) tool. Statistical analysis was performed using Microsoft Excel and R.

resultsA total of 86 reports were evaluated, 57 from the pre-training phase and 29 from the post-training phase. Overall, 35% (n = 30) of the reports were classified as high quality according to the AQUA-12 criteria. Prior to the training, only 16% (n = 9) met the high quality level whereas this proportion increased to 72% (n = 21) following the training. This improvement in ADR reporting quality was statistically significant (p = 0.000; p < 0.05).

conclusionThe training significantly improved the quality of ADR reports, underscoring the value of continuous quality improvement within PV systems. Targeted programs for health care professionals, particularly pharmacists and regulatory authority personnel, are essential to strengthen ADR reporting quality and enhancing patient safety.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsHealth PersonnelPharmacovigilanceHumansNepalRetrospective StudiesAdverse drug reactionsNepalPharmacovigilanceQuality

Identifiers

PMID42157209
PMCPMC13361585

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Registered trials

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