Establishing an Adverse Drug Reactions Database in Romania: Practical Value

Abstract

Objectives: The need to monitor, track, evaluate and proper manage adverse drug reactions (ADRs) in the hospital setting has become a fundamental component of the routine clinical practice and of the healthcare system. Computerized systems are used for such data entry, storage and further analysis with the final goal of avoiding ADRs. This paper describes a database designed for this purpose as part of a pharmacovigilance program in Romania. Methods and Setting: Stimulated spontaneous reporting is the method used for the detection of ADRs in two internal medicine departments. The ADRs collection is paper based. The information is further evaluated for various parameters and then the data is entered into the database. In the design of the database we took into consideration some basic requirements for such a database: comfortable user interface with easy access and handling, high level of security, data protection and desired statistics. Results: The database was designed in order to include a complete description of ADRs (e.g. causality, preventability, severity, outcome, type of ADR, risk factors, drug interactions). Auxiliary databases such as ICD-10, ATC codes and the MedDRA terminology are being used. The database has been in operation for a year, during which approximately 250 ADR case reports have been evaluated and entered. Conclusions: To improve and strengthen the ADRs reporting at a hospital level we developed and populated a computer-based system for standardized collection, evaluation and storage of ADRs that could be further adopted by other academic hospitals that want to keep track of preventable ADRs.