2017
DOI: 10.1590/1980-5497201700030010
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Causalidade em farmacoepidemiologia e farmacovigilância: uma incursão teórica

Abstract: ABSTRACT:The article presents some considerations about causality in Pharmacoepidemiology and Pharmacovigilance. To begin, we provide a brief introduction about the importance of the issue, noting that the understanding of causal relationships is considered one of science's greatest achievements and has been, over time, a continuous and central concern of philosophers and epidemiologists. Next, we describe definitions and types of causes, demonstrating their influences on pharmacoepidemiological thought. After… Show more

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Cited by 9 publications
(6 citation statements)
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References 33 publications
(66 reference statements)
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“…In practice, few reactions are considered "defined" and this is due to the complexity of evaluating a causal relationship between a drug and an adverse reaction. This is because there are multiple approaches and different scenarios that can bring uncertainties regarding the causal link of the reaction, including the underlying disease itself (as a confounding factor), competing with the drug for the cause of the reaction 20 .…”
Section: Discussionmentioning
confidence: 99%
“…In practice, few reactions are considered "defined" and this is due to the complexity of evaluating a causal relationship between a drug and an adverse reaction. This is because there are multiple approaches and different scenarios that can bring uncertainties regarding the causal link of the reaction, including the underlying disease itself (as a confounding factor), competing with the drug for the cause of the reaction 20 .…”
Section: Discussionmentioning
confidence: 99%
“…In this model, the causal agent may be composed of a constellation of causes, sufficient of an adverse event. The model further explains that different causal components act in groups to produce an effect, necessarily implying that the component causes must act at the same time (15) .…”
Section: Discussionmentioning
confidence: 99%
“…(34) The limitations related to safety data resulting from clinical trials in the pre-marketing phase are well known. Studies report that around 50% of approved drugs can cause adverse reactions that were not detected before their registration (35).…”
Section: Patient Safetymentioning
confidence: 99%