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Drug surveillance system for type B adverse effects: a vision

Since type B adverse drug reactions tend to be rare and serious, they tend to be treated by tertiary-care specialists; and since they are commonly iatrogenic, the specialists should be concerned to document carefully not only the case per se but also the drug use history, leading to practice data of good research quality. The specialist should also be concerned to submit the data record to a central facility that would supply the probabilities, evidence-based, that a recent drug use by a patient caused the adverse event. Continual and systematic accumulation of these data records at the central facility--using the same logistic and organizational framework for each of different type B events--provides for both the numerator and denominator series for etiologic research. Since the targeted events are quite rare, the catchment population of the "registry" would have to be very large, international in scope, especially if the system is to provide for rapid resolution of crises arising from novel suspicions of type B effects with respect to newly marketed drugs.

Identiferoai:union.ndltd.org:LACETR/oai:collectionscanada.gc.ca:QMM.22865
Date January 1995
CreatorsNguyen, Vu Xuan, 1957-
ContributorsOs, Miettinen (advisor)
PublisherMcGill University
Source SetsLibrary and Archives Canada ETDs Repository / Centre d'archives des thèses électroniques de Bibliothèque et Archives Canada
LanguageEnglish
Detected LanguageEnglish
TypeElectronic Thesis or Dissertation
Formatapplication/pdf
CoverageMaster of Science (Department of Epidemiology and Biostatistics.)
RightsAll items in eScholarship@McGill are protected by copyright with all rights reserved unless otherwise indicated.
Relationalephsysno: 001467511, proquestno: MM08036, Theses scanned by UMI/ProQuest.

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