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Pharmacovigilance Monitoring System (PViMS)

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.

Monitoring & Evaluation, Quality Assurance

  • Sub-categories HIV/AIDS, Malaria, Noncommunicable diseases (NCD), Reproductive health, TB
  • Commodities
  • Latest update 12/2015
  • Version 1
  • Developed by SIAPS
  • When to use 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.
  • Languages English
  • Level of use Central, District, Facility, Regional
  • Form Web-based interface • Centralized deployment for Intranet/Extranet/Internet environment • Microsoft .NET 4.0 Entity Framework • Service-oriented architecture (SOA) • HL7 compatibility • E2B compatibility • Smart-device compatibility • Custo
  • Amount of training / TA required Prior to data collection, site personnel are provided with detailed information on the active surveillance activity to enhance the accuracy of information entered into the tool and facilitate easy operation. PViMS will be implemented as an enterprise-level, web-based application that will require Internet connectivity for efficient use. A centrally deployed and managed web-based application allows for real-time data collection and processing and supports effective and timely decision making. It also enables consistent and quality data propagation of changes downstream to all facilities and entities involved. This is extremely important because the enhanced application will allow customization of datasets used in the active pharmacovigilance data gathering process. Because PViMS will need to work in LMICs where Internet connectivity may be limited, the application provides functionality in an offline mode.
  • Inputs & outputs Improves overall clinical documentation Completion of required fields, including clinical stage, concomitant medications, test results, co-morbid conditions, and treatment regimen, initiation date, and adherence to improve clinical documentation at participating sentinel sites 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 MedDRA, the National Cancer Institute Common Terminology Criteria for Adverse Events, WHO, and Naranjo; eventually users can develop a local dictionary using standard terms Provides for detailed description of adverse event (AE) outcome and generating signals Description of AEs, severity and seriousness, laboratory values, AE outcome, and AE management; can be used to generate signals of increased incidence to inform action or be further evaluated Computes basic active surveillance metrics Generates key metrics for cohort event monitoring, including incidence rates for exposed and non-exposed patient groups and adjusted/unadjusted risk ratios per AE/medication Reports and frequency tables Generates customized reports and frequency tables
  • Cost Free
  • Advantages Interoperable with third-party clinical systems and statistical tools 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 in previously validated statistical tools. PViMS has the ability to export case safety data in E2B interface, and is health level -7 (HL7) compliant. Customizable data fields and auditability Can assign and restrict user access; ability to track who and when changes are made
  • Limitations PViMS will be implemented as an enterprise-level, web-based application that will require Internet connectivity for efficient use.
  • Availability www.pvims@msh.org
  • Remarks
  • Contact pvims@msh.org
  • Submission date 2016-01-11 02:00:00