Evolution of adverse drug reactions reporting systems: paper based to software based

Madhushika, M T; Weerarathna, Thilak Priyantha; Liyanage, Plgc; Jayasinghe, S

doi:10.1007/s00228-022-03358-3

Cited by 3 publications

(4 citation statements)

References 25 publications

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“…Lack of qualitative databases, weak technology, insufficient human resources and insufficient support from governments are just a few examples 46 . While current algorithms are not sufficient for complete automation, they can still be applied to improve efficiency, value and consistency if included into a system with human intelligence in control 47,48 …”

Section: Discussionmentioning

confidence: 99%

“…46 While current algorithms are not sufficient for complete automation, they can still be applied to improve efficiency, value and consistency if included into a system with human intelligence in control. 47,48 The value of mass media, social media and the Internet, as sources of case reports, has been debated and intensely investigated.…”

Section: Data Collectionmentioning

confidence: 99%

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The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

Mueller

Lewis

Alexe

2022

Brit J Clinical Pharma

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Aims Moore's law predicts the doubling of complexity of integrated circuits every 2 years; Kryder's corollary assumes a doubling of data storage every 13 months. With the increasing volume of legislation, pharmacovigilance systems today are inherently complex, and the emphasis has shifted from reactive (responding to emerging risks) to planned, active, risk‐proportionate approaches operating throughout the life cycle of medicines. Methods Exploration of the drivers for increasing complexity of pharmacovigilance systems, focusing on regulatory environment, data management and evaluation. Results Evaluation of postmarketing data plays an increasingly important role in pharmacovigilance. There is great interest on the part of all stakeholders in optimizing the use of these data. Innovative approaches, including pharmacogenetics and passive measures (sensors), will lead to increased complexity and volumes of data and inevitably to an increase in the volume of case reports. There is a multiplicity of regulations and guidelines on how to manage these data, with an inherent lack of harmonization. Conclusion We summarize the current characterization of safety data types, sources and the classification of these data. Using this benchmark, we discuss the future requirements of an effective pharmacovigilance ecosystem, keeping the principle of parsimony in mind. In this complex, continuously and rapidly changing environment, there is a need for a return to simplicity and pragmatism. The application of Occam's razor could help to support the rapid provision of new, affordable medicines with a positive benefit to risk profile.

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Section: Discussionmentioning

confidence: 99%

Section: Data Collectionmentioning

confidence: 99%

The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

Mueller

Lewis

Alexe

2022

Brit J Clinical Pharma

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“…As often happens in pharmacovigilance, this represents a signal that needs further studies producing in‐depth information, as close to the truth as possible, on the association between IL‐23 inhibitors and oncological adverse reactions. Development and acquisition of newer technologies to promote adverse reactions monitoring and reporting is a necessity for a more effective pharmacovigilance system 5 . However, the shortcomings of spontaneous reporting are not a good reason not to accept the results of a method that until now served to discover important links between drugs and potential damage to health.…”

mentioning

confidence: 99%

“…Development and acquisition of newer technologies to promote adverse reactions monitoring and reporting is a necessity for a more effective pharmacovigilance system. 5 However, the shortcomings of spontaneous reporting are not a good reason not to accept the results of a method that until now served to discover important links between drugs and potential damage to health. So, even if results may be not pleasant, our duty is not to hide them behind comforting statements such as “in general, IL‐23 inhibitors are safe drugs typically well tolerated by patients.” Especially if in support of this statement, the commentary of Lovell and Feldman cites scientific articles published years ago that certainly do not discuss the use of IL‐23 inhibitors in the treatment of psoriasis.…”

mentioning

confidence: 99%

Response to “Evaluating Adverse Events in Databases”

Calapai,

Mannucci,

Cardia

et al. 2023

Pharmacology Res & Perspec

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Safety assessment of sulfasalazine: a pharmacovigilance study based on FAERS database

Ye,

Ding,

et al. 2024

Front. Pharmacol.

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BackgroundSulfasalazine is a widely used anti-inflammatory medication for treating autoimmune disorders such as ulcerative colitis (UC), Crohn’s disease, and rheumatoid arthritis. However, its safety profile has not been systematically evaluated in real-world settings. By analyzing the FDA Adverse Event Reporting System (FAERS) database, we identified risk signals associated with adverse reactions to sulfasalazine, offering valuable insights for clinical decision-making and risk management.MethodsReports of adverse events (AEs) associated with sulfasalazine, covering the period from Q1 2004 to Q4 2023, were extracted from the FAERS database. Detailed case information was aggregated to assess demographic characteristics. The associations between sulfasalazine and adverse events were evaluated using the Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayes Geometric Mean (EBGM).ResultsWe extracted 7,156 adverse event reports from the FAERS database where sulfasalazine was identified as the “Primary Suspect (PS)” drug. Using disproportionality analysis, we identified 101 preferred terms (PT) related to sulfasalazine across 24 organ systems. Notable adverse reactions consistent with the drug’s labeling were observed, including Stevens-Johnson syndrome, agranulocytosis, eosinophilic pneumonia, and crystalluria. Additionally, novel positive signals not previously documented in the drug label were identified, including acute febrile neutrophilic dermatosis, aseptic meningitis, glomerulonephritis, and hepatosplenic T-cell lymphoma.ConclusionMost of the adverse reaction findings in this study are consistent with previous clinical research, and we have also identified new potential AEs associated with sulfasalazine. These findings provide valuable insights for the safety monitoring and clinical application of sulfasalazine.

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Evolution of adverse drug reactions reporting systems: paper based to software based

Cited by 3 publications

References 25 publications

The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

The evolution of pharmacovigilance ecosystems: Does Moore's law invite the use of Occam's razor?

Response to “Evaluating Adverse Events in Databases”

Safety assessment of sulfasalazine: a pharmacovigilance study based on FAERS database

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