Using Data from the Canadian Post-marketing Spontaneous Pharmacovigilance System for Drug Safety Research: A Feasibility Study

Akinola, Samuel; Silveira, Carolina Galli da; Corbin, Sonia; Lavallée, Maude; Thibault, Magalie; Gonella, Jennifer Midiani; Gimenes, Fernanda Raphael Escobar; Leclerc, Jacinthe

doi:10.1007/s40290-020-00345-w

Cited by 3 publications

(4 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…[12][13][14] Nevertheless, the limitations of the data should be understood in interpreting the results obtained from the SRS, since the SRS is a passive reporting system that is liable to over-reporting, underreporting, missing data on patient characteristics, exclusion of healthy subjects, missing denominators, and the presence of confounding factors. 15,16) In this study, we applied the ROR as a signal to find unknown correlations between adverse events and drugs. Notably, the ROR is an indicator of increased risk of adverse events and does not represent the absolute risk of occurrence of adverse events.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Appendicitis Cases in the Japanese Adverse Drug Event Report (JADER) Database

Kyotani

Zhao

Nakahira

et al. 2023

Biological & Pharmaceutical Bulletin

View full text Add to dashboard Cite

Appendicitis is one of the most common abdominal surgical emergencies worldwide; however, its causes remain poorly understood. The Japanese Adverse Drug Event Report (JADER) database is a spontaneous reporting system (SRS) that can be utilized to analyze the safety signals of adverse events. In this study, we investigated the association between drug use and the onset of appendicitis using the JADER database. We first used the reporting odds ratio (ROR) as the signal and found signals for appendicitis, perforated appendicitis, and complicated appendicitis for 23, 9, and 1 drug, respectively. To investigate the level of hazard over time in drug-associated appendicitis, the Weibull shape parameter β was calculated using a Weibull plot, which revealed drug-dependent patterns for changes in the risk of appendicitis over time for the eight drugs. Furthermore, logistic regression analysis was performed to account for the influence of age, sex, and primary disease, and a significant association was detected between two drugs and appendicitis. Several types of drugs, such as antitumor, antirheumatic, and anti-inflammatory drugs, were included in our analyses; however, only clozapine, which is used for patients with schizophrenia, was commonly identified in these analyses. The resulting data suggest that certain drugs may be associated with appendicitis and may require adequate attention.

show abstract

Section: Discussionmentioning

confidence: 99%

Analysis of Appendicitis Cases in the Japanese Adverse Drug Event Report (JADER) Database

Kyotani

Zhao

Nakahira

et al. 2023

Biological & Pharmaceutical Bulletin

View full text Add to dashboard Cite

show abstract

“…In terms of transparency, our final dataset is available to the public. Our group has previously worked on validating the methodologies for using Canada Vigilance data in research, boosting confidence in the quality of the information [ 1 ]. Despite these strengths, some limitations were unavoidable.…”

Section: Discussionmentioning

confidence: 99%

“…At the point of data extraction (January 2020), data were available from 1 January 1965 to 31 October 2019. The method for using this source of data for applied pharmacovigilance studies has been previously published [ 1 ]. The Statistics Canada database provides the annual Canadian population since 1965, but only since 1971 specifically for female and male Canadians [ 40 ].…”

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Reporting Rates of Opioid-Related Adverse Events Since 1965 in Canada: A Descriptive Retrospective Study

Lavallée

Silveira

Akinola

et al. 2021

Drugs - Real World Outcomes

Self Cite

View full text Add to dashboard Cite

Background Patients with chronic or acute/postoperative pain frequently use opioids. However, opioids may cause considerable adverse reactions (ARs), such as respiratory depression, which could be lethal. Unfortunately, only 5% of drug-related ARs (including those to opioids) are reported to health authorities. Therefore, little is known regarding the occurrence of opioid-related ARs at the population level. Objective The aim of this study was to investigate how the rates of reported opioid-related ARs have changed in Canada since 1965. Methods Our retrospective study examined trends of reported opioid-related ARs occurring in hospitalized and outpatients. Data on opioid-related ARs and mortality between 1965 and 2019 were obtained from the Canada Vigilance and Statistics Canada databases. Descriptive and Joinpoint regression analyses were performed. Results Oxycodone and normethadone were the most and least involved opioid agents, respectively, among the 18,407 reported ARs. The highest rate of reported opioid ARs (3.8 per 100,000 person-years) was recorded in 2012, whereas the lowest was recorded in 1965 (0.1 per 100,000 person-years).

show abstract

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis

Viganò

Moride

Hachem

et al. 2023

Cannabis and Cannabinoid Research

View full text Add to dashboard Cite

Using Data from the Canadian Post-marketing Spontaneous Pharmacovigilance System for Drug Safety Research: A Feasibility Study

Cited by 3 publications

References 5 publications

Analysis of Appendicitis Cases in the Japanese Adverse Drug Event Report (JADER) Database

Analysis of Appendicitis Cases in the Japanese Adverse Drug Event Report (JADER) Database

Reporting Rates of Opioid-Related Adverse Events Since 1965 in Canada: A Descriptive Retrospective Study

The Quebec Cannabis Registry: Investigating the Safety and Effectiveness of Medical Cannabis

Contact Info

Product

Resources

About