PViMS, or the PharmacoVigilance Monitoring System, is a web-based application used by clinicians, regulatory bodies, and implementing partners to monitor the safety of medicine to monitor the safety of medicines.
The application was developed by the US Agency for International Development-funded Systems for Improved Access to Pharmaceuticals and Services [SIAPS] program (2011-2018) and is implemented by the USAID-funded Medicines, Technologies, and Pharmaceutical Services [MTaPS] program (2018-2023), both led by Management Sciences for Health (MSH), a global health nonprofit. PViMS is maintained by MSH.
PViMS enables the implementation of active surveillance activities in low- and middle-income countries (LMICs) by addressing the entire data collection, data analysis and reporting process.
This allows decision makers to identify potential adverse events related to medicine use, and consequently implement decisions for improving patient safety.
When used for spontaneous reporting, PViMS provides a comprehensive pharmacovigilance solution for LMIC.
PViMS is 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
Features:
Strict documentation requirements: Each entry requires a number of fields to be completed, including clinical stage, concomitant medications, test results, co-morbid conditions, treatment regimen, initiation date, and adherence to improve clinical documentation at participating sentinel sites.
Standardized terminology: 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
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.
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
Customized reports and frequency tables: Can be generated by users
Customizable data fields and auditability:
• Can assign and restrict user access, enabling tracking of changes
• Monitoring the quantities of stock requested, ordered, received, and distributed
• Recommending quantities of stock to be ordered based on historical data
• Tracking batch/lot and expiry dates for all stock
• Tracking dispensing information for prescribers, dispensers, and patients
• Monitoring and controlling the movement of stock among institutions
PViMS is also available to be used by other DOH programs, such as malaria, HIV/AIDS, immunization, family planning, maternal and child health and nutrition, to ensure not only patient safety for medicines being used in these programs.
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