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Advanced Search Results For "reporting"

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 "reporting"
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The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions.

Publication Type: Academic Journal

Source(s): Drug safety [Drug Saf] 2022 Jan; Vol. 45 (1), pp. 83-95. Date of Electronic Publication: 2021 Dec 08.

Abstract: Introduction and Objective: European Union legislation has mandated the submission of European Economic Area non-serious reports to the EudraVigilance database since November 2017. As spontaneous reports of suspected adverse reactions to medicines repr...

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Antibacterial-associated acute kidney injury among older adults: A post-marketing surveillance study using the FDA adverse events reporting system.

Publication Type: Academic Journal

Source(s): Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2022 Nov; Vol. 31 (11), pp. 1190-1198. Date of Electronic Publication: 2022 Jun 23.

Abstract: Purpose: Antibacterials induce a differential risk of acute kidney injury (AKI) in older adults. This study investigated the reporting risk of AKI associated with antibacterials using the individual case safety reports (ICSRs) submitted to the Food and...

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Changing paradigms in detecting rare adverse drug reactions: from disproportionality analysis, old and new, to machine learning.

Publication Type: Editorial & Opinion

Source(s): Expert opinion on drug safety [Expert Opin Drug Saf] 2022 Oct; Vol. 21 (10), pp. 1235-1238. Date of Electronic Publication: 2022 Oct 04.

Abstract: PLAIN LANGUAGE SUMMARYYour physician, pharmacist, nurse, or even you can voluntarily report suspected adverse events associated with drugs. The FDA Adverse Reporting System (FAERS) and the WHO Vigibase are large databases that store individual reports ...

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Health behaviors are largely not predictive of adverse events following influenza vaccination.

Publication Type: Academic Journal

Source(s): Expert review of vaccines [Expert Rev Vaccines] 2022 Dec; Vol. 21 (12), pp. 1895-1904. Date of Electronic Publication: 2022 Nov 09.

Abstract: Background: Identifying health behaviors associated with adverse events following immunization (AEFI) could identify intervention targets for AEFI prevention.Methods: University employees receiving an influenza vaccination (n = 1301) completed a series...

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Comparison of the MOdified NARanjo Causality Scale (MONARCSi) for Individual Case Safety Reports vs. a Reference Standard.

Publication Type: Academic Journal

Source(s): Drug safety [Drug Saf] 2022 Dec; Vol. 45 (12), pp. 1529-1538. Date of Electronic Publication: 2022 Oct 23.

Abstract: Introduction: In 2018, we published the MONARCSi algorithmic decision support tool showing high inter-rater agreement, moderate sensitivity, and high specificity compared with drug-event pairs (DEPs) previously reviewed using current, industry-establis...

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Development of a multivariate prediction model to identify individual case safety reports which require clinical review.

Publication Type: Academic Journal

Source(s): Pharmacoepidemiology and drug safety [Pharmacoepidemiol Drug Saf] 2022 Dec; Vol. 31 (12), pp. 1300-1307. Date of Electronic Publication: 2022 Oct 21.

Abstract: Background: The number of Individual Case Safety Reports (ICSRs) in pharmacovigilance databases are rapidly increasing world-wide. The majority of ICSRs at the Netherlands Pharmacovigilance Centre Lareb is reviewed manually to identify potential signal...

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Adverse drug reaction reporting via mobile applications: A narrative review.

Publication Type: Academic Journal

Source(s): International journal of medical informatics [Int J Med Inform] 2022 Dec; Vol. 168, pp. 104895. Date of Electronic Publication: 2022 Oct 13.

Abstract: Introduction: Pharmacovigilance importance has increased in the last few decades and it has led to rise in awareness of adverse drug reaction reporting by both patients and health care professionals. Despite this, research shows reporting practice of h...

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Comment on: "A Disproportionality Analysis of Drug-Drug Interactions of Tizanidine and CYP1A2 Inhibitors from the FDA Adverse Event Reporting System (FAERS)".

Publication Type: Editorial & Opinion

Source(s): Drug safety [Drug Saf] 2022 Dec; Vol. 45 (12), pp. 1551-1552. Date of Electronic Publication: 2022 Oct 12.

Authors:
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Barriers to healthcare workers reporting adverse events following immunization in Zhejiang province, China.

Publication Type: Academic Journal

Source(s): Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2022 Nov 30; Vol. 18 (5), pp. 2083865. Date of Electronic Publication: 2022 Jul 12.

Authors:

Abstract: Objectives: A cross-sectional survey was conducted among healthcare workers (HCWs) to assess their knowledge, attitude, and reporting behavior in adverse event following immunization (AEFI) surveillance as well as to identify barriers.Methods: A simple...

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