Advancing the Science of Pharmacovigilance

Honig, P K

doi:10.1038/clpt.2013.60

Cited by 19 publications

(19 citation statements)

References 4 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The FDA adverse event reporting system (FAERS) is currently the main source for detecting post-market ADEs, but has recognized shortcomings [2, 5–8] such as under-reporting of adverse events (AEs), an issue that is not unique to FAERS [9]. The time required for a sufficient signal when using such sources can delay the release of ADE alerts [10, 11].…”

Section: Introductionmentioning

confidence: 99%

Analyzing Search Behavior of Healthcare Professionals for Drug Safety Surveillance

et al. 2014

View full text Add to dashboard Cite

Post-market drug safety surveillance is hugely important and is a significant challenge despite the existence of adverse event (AE) reporting systems. Here we describe a preliminary analysis of search logs from healthcare professionals as a source for detecting adverse drug events. We annotate search log query terms with biomedical terminologies for drugs and events, and then perform a statistical analysis to identify associations among drugs and events within search sessions. We evaluate our approach using two different types of reference standards consisting of known adverse drug events (ADEs) and negative controls. Our approach achieves a discrimination accuracy of 0.85 in terms of the area under the receiver operator curve (AUC) for the reference set of well-established ADEs and an AUC of 0.68 for the reference set of recently labeled ADEs. We also find that the majority of associations in the reference sets have support in the search log data. Despite these promising results additional research is required to better understand users' search behavior, biasing factors, and the overall utility of analyzing healthcare professional search logs for drug safety surveillance.

show abstract

Section: Introductionmentioning

confidence: 99%

Analyzing Search Behavior of Healthcare Professionals for Drug Safety Surveillance

et al. 2014

View full text Add to dashboard Cite

show abstract

“…In addition, the aspect of missing data limits the impact of our findings. Another aspect is that the way of ADR‐reporting, analysis and risk assessment varies between different national pharmacovigilance databases . Thus, our observations only represent the situation in Germany and cannot be generalized.…”

Section: Discussionmentioning

confidence: 99%

Abuse liability of flupirtine revisited: Implications of spontaneous reports of adverse drug reactions

Gahr¹,

Freudenmann²,

Connemann³

et al. 2013

The Journal of Clinical Pharmacology

View full text Add to dashboard Cite

Early studies suggested that the centrally acting non-opioid and non-steroidal analgesic flupirtine (FLP) has no potential for abuse. However, FLP's agonistic effects at the GABAA receptor might prime addictive behaviors, and literature provides some anecdotal reports on FLP abuse/dependence. To shed more light on this topic we acquired and evaluated data obtained from a national German pharmacovigilance database. We analyzed all reports of FLP abuse/dependence that were recorded in the database of the German Federal Institute for Drugs and Medical Devices (BfArM). A total of n = 48 reports of FLP abuse/dependence could be identified (mean age 45 years, 62.5% female). First reports were submitted to BfArM in 1991 with increasing numbers of annual reports from the year 2006 on. Mean daily FLP dosage was 805 mg (range 200-3,000 mg). Current or previous substance abuse/dependence was reported in 21% and 17%, respectively. Mean duration of FLP abuse/dependence until report to BfArM was 23 months (range 1-84 months). Withdrawal syndromes after discontinuation of FLP were reported in n = 9 (19%). Our findings strengthen the hypothesis that FLP features a potential to cause addictive behaviors. Female sex, age >40 years, and long-term FLP-treatment may be possible risk factors for the development of FLP abuse/dependence.

show abstract

“…Recently, statistical techniques have been incorporated into routine pharmacovigilance and applied to spontaneous reports[3, 4] and clinical trials[5] to identify signals of ADEs. Nonetheless, well recognized limitations[6, 7] inherent to the type and diversity of data sources employed in routine pharmacovigilance, along with increased public concern over the safe use of drugs, have stimulated several worldwide research and legislative initiatives[8, 9] with the objective of improving pharmacovigilance. It is widely accepted that progress in pharmacovigilance depends on a comprehensive approach that examines ADE-related information from a diverse set of potentially complementing data sources.…”

Section: Introductionmentioning

confidence: 99%

Text Mining for Adverse Drug Events: the Promise, Challenges, and State of the Art

et al. 2014

View full text Add to dashboard Cite

Text mining is the computational process of extracting meaningful information from large amounts of unstructured text. Text mining is emerging as a tool to leverage underutilized data sources that can improve pharmacovigilance, including the objective of adverse drug event detection and assessment. This article provides an overview of recent advances in pharmacovigilance driven by the application of text mining, and discusses several data sources—such as biomedical literature, clinical narratives, product labeling, social media, and Web search logs—that are amenable to text-mining for pharmacovigilance. Given the state of the art, it appears text mining can be applied to extract useful ADE-related information from multiple textual sources. Nonetheless, further research is required to address remaining technical challenges associated with the text mining methodologies, and to conclusively determine the relative contribution of each textual source to improving pharmacovigilance.

show abstract

Advancing the Science of Pharmacovigilance

Cited by 19 publications

References 4 publications

Analyzing Search Behavior of Healthcare Professionals for Drug Safety Surveillance

Analyzing Search Behavior of Healthcare Professionals for Drug Safety Surveillance

Abuse liability of flupirtine revisited: Implications of spontaneous reports of adverse drug reactions

Text Mining for Adverse Drug Events: the Promise, Challenges, and State of the Art

Contact Info

Product

Resources

About