Evidence map›Paper›PMID 35812140›Full record

ArticleSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2022

The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study.

Khalidah A Alenzi, Najah S Alanazi, Mohammed Almalki, Homoud Alomrani, Fahad O Alatawi

Open access · hybridAbstract read
In one paragraph

Article in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.1field-weighted citation impact, top 15% 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

10 citing papers in PubMed, 14 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

5 authors at 3 institutions in 1 country.

Khalidah A AlenziMinistry of Health, Regional Drug Information & Pharmacovigilance Center, Tabuk, Saudi Arabia.
Najah S AlanaziPharm D, University of Tabuk, Tabuk, Saudi Arabia.
Mohammed AlmalkiMinistry of Health, Umlog Hospital, Tabuk, Saudi Arabia.
Homoud AlomraniMinistry of Health, Haqel Hospital, Tabuk, Saudi Arabia.
Fahad O AlatawiMinistry of Health, King Fahad Specialist Hospital, Tabuk, Saudi Arabia.
Ministry of Health · SAKing Fahad Specialist Hospital · SAUniversity of Tabuk · SA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This study aimed to assess the type, severity, seriousness, reasons, and outcomes of adverse drug reactions (ADRs) in the reports submitted to the regional spontaneous ADR database. Methods: A retrospective observational study was conducted to analyze all the Tabuk Health Affairs hospitals in Saudi Arabia submitted to SFDA from January 2020 to December 2020. The database was structured according to the Saudi ADR form's fields. The Naranjo algorithm was used to assess the causes of the ADRs (sFDA, 2022). Results: For 1 year, 2,349 ADR reports, along with 242 suspected drugs for 4,114 reactions, were submitted to SFDA. We found more males than females had ADRs (56.1% vs. 43.8%, Conclusions: The spontaneous report database is an important and valuable source of aftermarket authorization safety information. In our study, most drugs used as antimicrobial, cardiovascular, and hematologic therapies were associated with a higher risk of developing severe and serious events. We recommend monitoring and using medications optimally to ensure patient safety.

Indexed as

ADR, Adverse drug reactionAdverse drug reactionsKSA, The Kingdom of Saudi ArabiaMOH, The Saudi Ministry of HealthNaranjo scalePharmacovigilanceRDIC, Regional Drug Information CenterSFDA, Saudi Food and Drug AuthorityWHO, The World Health Organization

Identifiers

PMID35812140
PMCPMC9257871
OpenAlexW4221005799

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.