title: Use of the dose, time, susceptibility (DoTS) classification scheme for adverse drug reactions in pharmacovigilance planning.
abstract: In the process of conceiving a pharmacovigilance plan, as proposed in the International Conference on Harmonisation E2E guideline, the challenge will be how to address possible safety issues with a set of appropriate pharmacovigilance methods. For successful planning, the various and sometimes complex dimensions of the adverse drug reaction in question have to be appropriately described. In order to accommodate these better, a 3-dimensional approach, based on dose, time and patient susceptibility, has recently been proposed (the DoTS model). This approach offers a way of presenting the various dimensions of the problem graphically. The aim of this article is to propose how an extended DoTS model, applied to three different scenarios, could give a better understanding of adverse drug reactions and assist in preparing a pharmacovigilance plan.
authors.affiliation: Research Unit of Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Odense, Denmark. tcallreus@health.sdu.dk
authors.forename: Torbjörn
authors.initials: T
authors.lastname: Callréus
mesh_terms: D004305:Dose-Response Relationship, Drug; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D008954:Models, Biological; D017891:Pharmacoepidemiology; D011358:Product Surveillance, Postmarketing