ArticleSaudi medical journal2015
Completeness of adverse drug reactions reports of the Saudi adverse event reporting system.
Article in Saudi medical journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Antibiotics-Related Adverse Drug Reaction in a Tertiary Hospital in Saudi Arabia: A Cohort, Retrospective Study.Cureus · 2023Article
- Detection of Adverse Drug Reactions in COVID-19 Hospitalized Patients in Saudi Arabia: A Retrospective Study by ADR Prompt Indicators.Healthcare (Basel, Switzerland) · 2023Article
- The completeness of adverse drug reaction reports in South Africa: An analysis in VigiBase®.African journal of primary health care & family medicine · 2023Article
- The evaluation of adverse drug reactions in Saudi Arabia: A retrospective observational study.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2022Article
- The comparative assessment of awareness, perspective, and basic practice skills about the Saudi pharmacovigilance system among students of different health-care professionals of a Saudi Female University.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2020Article
- National Cross-Sectional Study of Community-Based Adverse Drug Reactions in Saudi Arabia.Drugs - real world outcomes · 2020Article
- Severe cutaneous adverse drug reactions manifesting as Stevens-Johnson syndrome and toxic epidermal necrolysis reported to the national pharmacovigilance center in Nigeria: a database review from 2004 to 2017.Therapeutic advances in drug safety · 2020Article
- Patterns of adverse drug reaction signals in NAFDAC pharmacovigilance activities from January to June 2015: safety of drug use in Nigeria.Pharmacology research & perspectives · 2018Article
- Current status, and future prospects of pharmaco-epidemiology and post-marketing surveillance in Saudi Arabia: A review of literature.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2018Review
- Adverse reactions to fluoroquinolones in the Nigerian population: an audit of reports submitted to the National Pharmacovigilance Centre from 2004 to 2016.Pharmacology research & perspectives · 2017Article
- A qualitative exploration of the major challenges facing pharmacovigilance in Saudi Arabia.Saudi medical journal · 2015Article
- Retrospective Assessment of the Reporting of Adverse Drug Reactions in a Malaysian Clinical Training Center: A Short Communication.Journal of pharmacy & bioallied sciencesArticle
- Adverse drug reactions reporting by undergraduate medical students in a tertiary care teaching hospital of India: Content and quality analysis in comparison to physician reporting.Perspectives in clinical researchArticle
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications.
methodsA cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS. The completeness was assessed by reviewing the components of the adverse drug reactions (ADRs) form, and how many fields were completed. Descriptive statistics are reported.
resultThere were 14,783 reports during the study period. Eighty percent of these reports were spontaneous reports. Information related to the drug (99%) and adverse events (98%) of the reports were completed. While the patient's demographic data were completed only in 38% of all reports, the least completed item in the ADRs form was the reporter information (15%). The most reported drug class was tumor necrosis factor inhibitors (7%), whereas events involving the respiratory organ system were the most frequently reported (4.5%).
conclusionAlthough the SAERS is considered new, it has a high number of reports. More efforts are needed to improve the completeness of the SAERS to be a good source to assess the signals between events and suspected drugs, especially when there is a high number of reports.
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