Inconsistencies between clinical assay and usual practice at drug surveillance

Authors

  • Ana Julia García Milian Escuela Nacional de Salud Pública
  • Liuba Alonso Carbonell
  • Odalis Rodríguez-Ganen

Keywords:

Drug surveillance, side effect, clinical essay, phamaco-epidemiology

Abstract

Introduction. Drug surveillance is necessary to prevent drug risks in human beings and avoiding not expected side effect-associated economic costs.
Objective: To conduct a drug surveillance-related revision of terms, to identify inconsistencies between the clinical assay and daily practice of this activity.
Method: This is a documentary research. A content analysis of documents and standards for the implementation of drug surveillance and research. Its elaboration process included a bibliographical, documentary review on this subject.
Outcomes: Review of the terms used in pharmacy-vigilance for the classification of drugs side effect subject to clinical research and usual practice.
Conclusions: Terms used in drug surveillance in clinical trial differ from those used in usual clinical practice resulting in confusion in interpreting side effect. Standardization of concepts, algorithms and classification axes applicable to pre and post-marketing researches are imposed. This exigency increases when considering that assistances and research are overlapped in a same professional (physician/clinical research).

Downloads

Download data is not yet available.

Downloads

Published

2016-02-08

How to Cite

1.
García Milian AJ, Alonso Carbonell L, Rodríguez-Ganen O. Inconsistencies between clinical assay and usual practice at drug surveillance. INFODIR [Internet]. 2016 Feb. 8 [cited 2025 Sep. 17];(23):13-24. Available from: https://revinfodir.sld.cu/index.php/infodir/article/view/179

Issue

No. 23 (2016): INFODIR

Section

Original Articles

License

Those authors who have published with this journal, accept the following terms:

a.         The authors will keep their copyright and guarantee the magazine the right of first publication of their work, which will be simultaneously subject to the Creative Commons Attribution License that allows third parties to share the work as long as the author and first publication of this magazine are indicated.

b.         The authors may adopt other non-exclusive license agreements for the distribution of the published version of the work (e.g., deposit it in an institutional telematic archive or publish it in a monographic volume) as long as the initial publication in this journal is indicated.

c.         Authors are allowed and recommended to disseminate their work through the Internet (e.g.: in institutional telematic archives or in their web page) before and during the submission process, which may produce interesting exchanges and increase the number of citations of the published work. (See The effect of open access).