Evidence map›Paper›PMID 34607871›Full record

ArticleBMJ open2021

Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study.

Megha Sharma, Ruchi Baghel, Sunil Thakur, Sandeep Adwal

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.3field-weighted citation impact, top 13% 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

19 citing papers in PubMed, 28 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

4 authors at 2 institutions in 2 countries.

Megha Sharma *Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden meghasharma27@rediffmail.com.ORCID 0000-0001-9165-9393
Ruchi Baghel *Department of Pharmacology, RD Gardi Medical College, Ujjain, India.
Sunil ThakurDepartment of Pharmacology, RD Gardi Medical College, Ujjain, India.
Sandeep AdwalDepartment of Pharmacology, Zydus Medical College and Hospital, Dahod, Gujarat, India.
Ruxmaniben Deepchand Gardi Medical College · INKarolinska Institutet · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo analyse and present the occurrence and severity of spontaneous adverse drug reaction (ADR) reports prospectively registered at an ADR monitoring centre (AMC) in Central India. SETTING AND DATA: The survey was conducted between 2013 and 2019 at an ADR Monitoring Centre in Central India. ADRs were recorded using the standard 'Suspected ADR Reporting form'. OUTCOME MEASURES: The causality of the ADRs were categorised using the WHO causality assessment scale to assess the relationship between a drug and the occurrence of an ADR.

resultsTotally 1980 spontaneous ADRs were reported involving 960 patients and 1316 drugs prescriptions. The occurrence of ADRs was common among male patients (64%) and patients of age between 19 and 65 years (81%). Antimicrobials caused 29% ADRs, followed by drugs of antiretroviral therapy (19%). Zidovudine caused most ADRs (88%) followed by ethambutol and ciprofloxacin. The ADRs of skin and subcutaneous tissue disorders (28%) were most common among all system organ classes followed by gastrointestinal systems (18%). Four per cent of all reported ADRs were severe. A peak of ADR reports was attained in 2016 with 224 reports, which decreased to 127 in 2019.

conclusionA high number of ADRs caused by antimicrobials is an alarming situation, which adds up to antimicrobial resistance. Judicious use of antimicrobials is yet again proven as need of the hour. Under-reporting of ADRs is evident in our study and is a major factor for the delay in the withdrawal of drugs responsible for causing ADRs. Interventions in terms of training and feedback are suggested to encourage and improve ADR reporting.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsAdultAgedCausalityHumansIndiaMaleMiddle AgedSurveys and QuestionnairesYoung Adultadverse eventsclinical pharmacologyhealth & safetypharmacologyrisk managementtoxicity

Identifiers

PMID34607871
PMCPMC8491296
OpenAlexW3203850459

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.