A proposal for pharmacovigilance data restructuring at the teaching hospital

Abstract

Introduction: The increasing volume of pharmacovigilance data froom reports of Adverse Drug Reaction (ADR) indicates the need for a database (DB) to manage its electronic records. Objective: Thus, the objective of the present study is to prepare a prototype computing environment that will permit data recording, storage and recovery aimed at generating information and creating an effective database within the Pharmacovigilance Unit of the Professor Edgard Santos Teaching Hospital in Salvador, Bahia, Brazil. Methods: This descriptive study managed by pharmacists and development systems professionals whose object of study was based on preexisting electronic spread sheets used to store data on adverse drug reactions since 2000. The work consisted of three principal steps: the normalization of the data, relationships between the data collected, and database modeling with implementation of the information system. Results: This restructuring allows a database to be consolidated quickly and consistently, with reliable data duly completed and analyzed. Conclusion: Thus, the HUPES Pharmacovigilance Information System (SIFAVI) was modeled, which integrates into a web application na easy mechanism for storing and recovering the data stored in the database. This also permits the data on adverse drug reactions to be categorized and crosschecked, enabling more precise inferences to be made, thus rendering this practice simpler for users and improving the culture of notifying and validating adverse drug reactions.