Evidence map›Paper›PMID 29515280›Full record

ArticleIndian journal of pharmacology

Pediatric pharmacovigilance in an institute of national importance: Journey has just begun.

Pramod Kumar Sharma, Arup Kumar Misra, Neeraj Gupta, Daisy Khera, Ajay Gupta, Pushpinder Khera

Abstract read
In one paragraph

Article 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
2.0field-weighted citation impact, top 12% of its field
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

3 citing papers in PubMed, 11 citations in OpenAlex.

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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

6 authors at 1 institution in 1 country.

Pramod Kumar SharmaDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Arup Kumar MisraDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Neeraj GuptaDepartment of Pediatrics, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Daisy KheraDepartment of Pediatrics, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Ajay GuptaDepartment of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Pushpinder KheraDepartment of Radio-Diagnosis, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
All India Institute of Medical Sciences Jodhpur · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study is to determine the nature and severity of adverse drug reactions (ADRs) in pediatric patients. MATERIALS AND

methodsIn this retrospective cohort study, we extracted the data from all the available pediatric ADR forms submitted to ADR monitoring center (AMC) from May 2014 to December 2016. The data including nature, frequency, causality (World Health Organization [WHO] causality scale), and the severity (Hartwig and Siegel scale for severity) of ADR were extracted. We also assessed the preventability of the event on modified Schumock and Thornton scale of ADR preventability.

resultsThere were a total of 20 pediatric ADRs reported during this period. Nearly two-thirds of the ADRs occurred in patients who were receiving multiple drugs (polytherapy). Antimicrobial agents were the most commonly implicated drugs. The most common ADRs were skin rash (maculopapular, erythematous, and urticaria, itching, etc.). The severity and preventability scales indicated that most reactions (18/20) were moderate in nature and all were preventable. Four reactions were "certainly" and ten ADRs were "probably" related to the suspected drug as determined by the WHO causality assessment.

conclusionFrequency of ADR increased with number of medications patient was receiving. Health-care providers (HCPs) involved in the care of children must be aware of this fact and should use additional drugs when absolutely necessary. They should be involved in pharmacovigilance program by exchanging and updating each other through sharing constructive information, communication, and education concerning the appropriate use of drugs in children. Pediatric pharmacovigilance is the need of the hour and should be given utmost importance for monitoring the safety of drugs in children. Motivating HCPs for voluntary reporting of ADRs for preventing the morbidity and mortality in this vulnerable population could be of immense importance.

Indexed as

Adverse Drug Reaction Reporting SystemsPharmacovigilanceAdolescentChildChild, PreschoolCohort StudiesDrug-Related Side Effects and Adverse ReactionsFemaleHumansIndiaInfantMaleRetrospective StudiesSeverity of Illness IndexAdverse drug reactionsantibioticspolytherapypreventabilityseverity

Identifiers

PMID29515280
PMCPMC5830850
OpenAlexW2800694055

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.