OpenRIMS-PVM - User Manual Chapter 1

1        Introduction

The Challenge

Active surveillance for monitoring the safety and effectiveness of medical products is increasingly recognized as an approach that complements passive (or spontaneous) reporting, which is the most common method used by countries’ pharmacovigilance systems. Active surveillance is particularly important to support the introduction of new medicines in low- and middle- income countries whose regulatory systems are developing and need support. In resource-limited settings, active surveillance can help determine the real-life frequency, risk factors, and impact of clinically significant adverse drug events on treatment outcomes in the population. However, many of these countries lack the resources and capacity to implement active surveillance activities. One major resource constraint is the lack of a data collection and analysis tool to support active safety surveillance.

The Solution

The Pharmacovigilance Monitoring System (PViMS) is a web-based application used by clinicians, regulatory bodies, and implementing partners to monitor the safety and effectiveness of medicines.

The application can improve overall clinical documentation. It is designed to ensure completion of required fields, including clinical stage, concomitant medications, test results, co-morbid conditions, and treatment regimen initiation date to improve clinical documentation at participating sites. It provides for the use of common terms, checklists, and adoption of standard terminologies. Users enter the common terms or choose from pre-coded causality assessment lists and scales such as the Medical Dictionary for Regulatory Activities (MedDRA), the National Cancer Institute Common Terminology Criteria for Adverse Events, WHO, and Naranjo; or users can develop a local dictionary using standard terms.

PViMS provides for detailed description of adverse event (AE) outcomes and for generating safety signals. Description of AEs, severity and seriousness, laboratory values, AE outcomes, and AE management can be used to generate signals of increased incidence to inform for action or further evaluation.

It is interoperable with third-party clinical systems and statistical tools. PViMS can import and export data from third-party electronic medical record or dispensing tools in XML, CSV, and Excel. Analyses can be cross-checked by analyzing data with previously validated statistical tools. Additionally, PViMS has the ability to export case safety data in E2B interface, and is health level-7 (HL7) compliant.

For information about the MedDRA dictionary contact your system administrator.

1.1        Using the Manual

This document discusses functional requirements for the electronic pharmacovigilance system (PViMS) framework.

1.2        Purpose of the Document

A user manual defines the software program’s functionalities. The document aims to ensure that any reader or user gains complete system knowledge of the product. The document should also function as a reference guide and training manual for new system users.

This User Manual will outline the system functionality that is currently included in the PViMS application framework and will be updated throughout the various incremental development iterations and any system upgrades.

1.3        Audience

The intended audiences for this document are identified as follows:

●     All project stakeholders

●     System super users

●     General system users

●    New system users