ReviewSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2016
Dilemmas of the causality assessment tools in the diagnosis of adverse drug reactions.
Review in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 1 of them a synthesis that pooled it.
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Who cites it
35 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature.BMC medicine · 2016Pooled it
- A Scoping Review of Case-Level Causality Assessment Tools Developed Between 2008 and 2023; Strengths, Weaknesses and Potential Future Improvements.Drug safety · 2026Article
- Reply : Primary suspect drugs of cataracts in pediatric patients: FDA adverse events reporting database analysis.Journal of cataract and refractive surgery · 2026Article
- Hospital physicians' reasoning and information needs in the diagnosis and prevention of drug-induced acute kidney injury: a qualitative study.BMC nephrology · 2026Article
- Trajectory-Ordered Objectives for Self-Supervised Representation Learning of Temporal Healthcare Data Using Transformers: Model Development and Evaluation Study.JMIR medical informatics · 2025Article
- Drug-Event Pairs as Indicators for the Detection of Adverse Drug Reactions during Hospitalization in Routinely Collected Electronic Data Sources.Clinical pharmacology and therapeutics · 2025Article
- Serious Adverse Events: A Replicability and Validation Study of Naranjo Causality Assessment Tool in a Canadian Clinical Setting.Journal of evaluation in clinical practice · 2025Article
- Qualitative Interviews with Stakeholders in Herbal Pharmacovigilance and Recommendations for Best Practices to be Applied Worldwide.Drug safety · 2025Article
- Article
- Adverse Drug Reactions Related with Antibiotic Medicines in Malawi: A Retrospective Analysis of Prevalence and Associated Factors.Drug, healthcare and patient safety · 2024Article
- Clinical Characteristics and Outcomes of Drug-Induced Acute Kidney Injury Cases.Kidney international reports · 2023Article
- Causality assessment of adverse drug reactions in neonates: a comparative study between Naranjo's algorithm and Du's tool.International journal of clinical pharmacy · 2023Observational
- Causality assessment of adverse drug reaction: A narrative review to find the most exhaustive and easy-to-use tool in post-authorization settings.Journal of applied biomedicine · 2023Review
- Detection of Adverse Drug Reactions in COVID-19 Hospitalized Patients in Saudi Arabia: A Retrospective Study by ADR Prompt Indicators.Healthcare (Basel, Switzerland) · 2023Article
- Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard.Drug safety · 2022Article
- Risk factors for and characteristics of community- and hospital-acquired drug-induced acute kidney injuries.Fundamental & clinical pharmacology · 2022Article
- Prioritisation of Adverse Drug Events Leading to Hospital Admission and Occurring during Hospitalisation: A RAND Survey.Journal of clinical medicine · 2022Article
- Recurrent pneumothorax in a patient with liposarcoma as either a complication of lung micrometastasis or a potential adverse event from antibiotic therapy: A case report.Oncology letters · 2022Article
- Scoping Review of Studies Evaluating Frailty and Its Association with Medication Harm.Drugs & aging · 2022Article
- Incidence and Temporal Trend of Antituberculosis Drug-Induced Liver Injury: A Systematic Review and Meta-Analysis.Journal of tropical medicine · 2022Article
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
importanceBasic essence of Pharmacovigilance is prevention of ADRs and its precise diagnosis is crucially a primary step, which still remains a challenge among clinicians.
objectiveThis study is undertaken with the objective to scrutinize and offer a notion of commonly used as well as recently developed methods of causality assessment tools for the diagnosis of adverse drug reactions and discuss their pros and cons. EVIDENCE REVIEW: Overall 49 studies were recognized for all assessment methods with five major decisive factors of causality evaluation, all the information regarding reasons allocating causality, the advantages and limitations of the appraisal methods were extracted and scrutinized.
findingsFrom epidemiological information a past prospect is designed and subsequent possibility merged this background information with a clue in the individual case to crop up with an approximation of causation. Expert judgment is typically based on the decisive factor on which algorithms are based, nevertheless in imprecise manner. The probabilistic methods use the similar principle; however connect probabilities to each measure. Such approaches are quite skeptical and liable to generate cloudy causation results. Causation is quite intricate to ascertain than correlation in Pharmacovigilance due to numerous inherent shortcomings in causality assessment tools. CONCLUSIONS AND RELEVANCE: We suggest that there is a need to develop a high quality assessment tool which can meticulously establish suitable diagnostic criteria for ADRs with universal acceptance to improvise the fundamental aspect of drug safety and evade the impending ADRs with the motive to convert Pharmacovigilance into a state of art.
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