Improving Pharmacovigilance Beyond Spontaneous Reporting

Abajo, Francisco J. de

doi:10.2165/00124363-200519040-00002

Cited by 10 publications

(2 citation statements)

References 40 publications

(50 reference statements)

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“…Pharmacoepidemiological studies using large electronic health record databases make it possible to study the association of rare AE and provide timely answers to meet the short deadlines of the pharmacovigilance decision-making process. This not only simplifies the logistics and reduces the costs of pharmacoepidemiological research, but can also increase it validity [74]. However, these electronic databases contain observational data which has not been collected for research purposes.…”

Section: System Considerationsmentioning

confidence: 99%

Introduction of new vaccines for immunization in pregnancy – Programmatic, regulatory, safety and ethical considerations

Kochhar

Edwards

Álvarez

et al. 2019

Vaccine

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Immunizing pregnant women is a promising strategy to reduce infectious disease-related morbidity and mortality in pregnant women and their infants. Important pre-requisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient numbers of healthcare workers to deliver the vaccines; close integration of immunization programs with antenatal care and Maternal and Child Health services; adequate access to antenatal care by pregnant women in the country (especially in low and middle-income countries (LMIC)); and a high proportion of births occurring in health facilities (to ensure maternal and neonatal follow-up can be done). The framework needed to advance a vaccine program from product licensure to successful country-level implementation includes establishing and organizing evidence for anticipated vaccine program impact, developing supportive policies, and translating policies into local action. International and national coordination efforts, proactive planning from conception to implementation of the programs (including country-level policy making, planning, and implementation, regulatory guidance, pharmacovigilance) and country-specific and cultural factors must be taken into account during the vaccines introduction.

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Section: System Considerationsmentioning

confidence: 99%

Introduction of new vaccines for immunization in pregnancy – Programmatic, regulatory, safety and ethical considerations

Kochhar

Edwards

Álvarez

et al. 2019

Vaccine

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“…The traditional pharmacovigilance method of data acquisition from spontaneous reporting systems is often used to detect AEs [ 16 ]. However, this method is limited by under-reporting as it is known that fewer than 10% of AEs are reported [ 17 ].…”

Section: Introductionmentioning

confidence: 99%

Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study

Park¹,

Choi²,

Song³

et al. 2022

JMIR Public Health Surveill

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Background Tramadol is known to cause fewer adverse events (AEs) than other opioids. However, recent research has raised concerns about various safety issues. Objective We aimed to explore these new AEs related to tramadol using social media and conventional pharmacovigilance data. Methods This study used 2 data sets, 1 from patients’ drug reviews on WebMD (January 2007 to January 2021) and 1 from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS; January 2016 to December 2020). We analyzed 2062 and 29,350 patient reports from WebMD and FAERS, respectively. Patient posts on WebMD were manually assigned the preferred terms of the Medical Dictionary for Regulatory Activities. To analyze AEs from FAERS, a disproportionality analysis was performed with 3 measures: proportional reporting ratio, reporting odds ratio, and information component. Results From the 869 AEs reported, we identified 125 new signals related to tramadol use not listed on the drug label that satisﬁed all 3 signal detection criteria. In addition, 20 serious AEs were selected from new signals. Among new serious AEs, vascular disorders had the largest signal detection criteria value. Based on the disproportionality analysis and patients’ symptom descriptions, tramadol-induced pain might also be an unexpected AE. Conclusions This study detected several novel signals related to tramadol use, suggesting newly identified possible AEs. Additionally, this study indicates that unexpected AEs can be detected using social media analysis alongside traditional pharmacovigilance data.

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Upper gastrointestinal bleeding associated with NSAIDs, other drugs and interactions: a nested case–control study in a new general practice database

Abajo

Gil²,

Bryant³

et al. 2012

Eur J Clin Pharmacol

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Improving Pharmacovigilance Beyond Spontaneous Reporting

Cited by 10 publications

References 40 publications

Introduction of new vaccines for immunization in pregnancy – Programmatic, regulatory, safety and ethical considerations

Introduction of new vaccines for immunization in pregnancy – Programmatic, regulatory, safety and ethical considerations

Comparison of Online Patient Reviews and National Pharmacovigilance Data for Tramadol-Related Adverse Events: Comparative Observational Study

Upper gastrointestinal bleeding associated with NSAIDs, other drugs and interactions: a nested case–control study in a new general practice database

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