ArticleDrug safety2017
Identification of Substandard Medicines via Disproportionality Analysis of Individual Case Safety Reports.
Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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Who cites it
18 citing papers in PubMed.
- VigiBase: Resource Profile Update with a Summary of Global Patterns and Trends in Adverse Event Reports for Medicines and Vaccines.Drug safety · 2026Review
- A Comprehensive Disproportionality Analysis of Drug-Related Head Injury Reports Using the FAERS Database.Brain and behavior · 2026Article
- Seizures Risk Related to Atypical Antipsychotics: A Disproportionality Analysis Based on the FDA Adverse Event Reporting System (FAERS).Alpha psychiatry · 2026Article
- From class effects to specificity FAERS evidence and network mapping of adverse events in NSCLC targeted therapy.International journal of surgery (London, England) · 2026Article
- Post-marketing safety of tarlatamab in small cell lung cancer based on FAERS and WHO-VigiAccess with SHAP-based interpretable machine learning analysis of immune-related adverse events.Frontiers in pharmacology · 2026Article
- Drug-induced intestinal obstruction: insights from the FDA Adverse Event Reporting System.Therapeutic advances in drug safety · 2026Article
- Pharmacovigilance analysis of iodinated contrast media related respiratory adverse effects based on the FDA adverse event reporting system.Frontiers in pharmacology · 2026Article
- Real-world data and Mendelian randomization analysis in assessing adverse reactions of rilonacept.International journal of clinical pharmacy · 2025Article
- A comparative analysis of drug-induced kidney injury adverse reactions between cyclosporine and tacrolimus based on the FAERS database.BMC immunology · 2025Article
- A real-world pharmacovigilance study of FDA Adverse Event Reporting System (FAERS) events for Definity.PloS one · 2025Article
- Pharmacovigilance and Appropriate Drug Use.Healthcare (Basel, Switzerland) · 2024Article
- Adverse drug events associated with linezolid administration: a real-world pharmacovigilance study from 2004 to 2023 using the FAERS database.Frontiers in pharmacology · 2024Article
- Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety.Patient preference and adherence · 2024Review
- A pharmacovigilance study of etoposide in the FDA adverse event reporting system (FAERS) database, what does the real world say?Frontiers in pharmacology · 2023Article
- Article
- [Establishment of a rapid identification of adverse drug reaction program in R language implementation based on monitoring data].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2020Article
- Drug-Induced Anaphylaxis in a Vietnamese Pharmacovigilance Database: Trends and Specific Signals from a Disproportionality Analysis.Drug safety · 2019Article
- Toxicities with Immune Checkpoint Inhibitors: Emerging Priorities From Disproportionality Analysis of the FDA Adverse Event Reporting System.Targeted oncology · 2019Observational
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe distribution and use of substandard medicines (SSMs) is a public health concern worldwide. The detection of SSMs is currently limited to expensive large-scale assay techniques such as high-performance liquid chromatography (HPLC). Since 2013, the Pharmacovigilance Department at Novartis Pharma AG has been analyzing drug-associated adverse events related to 'product quality issues' with the aim of detecting defective medicines using spontaneous reporting. The method of identifying SSMs with spontaneous reporting was pioneered by the Monitoring Medicines project in 2011.
methodsThis retrospective review was based on data from the World Health Organization (WHO) Global individual case safety report (ICSR) database VigiBase
resultsThe analysis of ICSRs based on the specified selection criteria and threshold yielded 2506 hits including medicinal products with an excess of reports of product quality defects relative to other medicines in the database. Further investigations and a pilot study in five authorized medicinal products (proprietary and generic) licensed by a single marketing authorization holder, containing valsartan, methylphenidate, rivastigmine, clozapine, or carbamazepine, were performed. This resulted in an output of 23 potential SSMs. The literature search identified two communications issued to health professionals concerning a substandard rivastigmine patch, which validated our initial findings. Furthermore, we identified excess reporting of product quality issues with an ethinyl estradiol/norgestrel combination and with salbutamol. These were categorized as confirmed clusters of substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medical products by the UMC in 2014.
conclusionThis study illustrates the value of data mining of spontaneous adverse event reports and the applicability of disproportionality analysis to identify potential SSMs.
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Registered trials
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