An integrated approach to monitoring the safety of medicines that includes both active surveillance and spontaneous reporting is essential to a well-functioning pharmaceutical sector. Active surveillance is particularly important to support the introduction of new essential medicines in low-and middle-income countries, where regulatory systems are often still developing and need support. In such 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.
What is PViMS?
The PharmacoVigilance Monitoring System (PViMS) is a web-based application used by clinicians, regulatory bodies, and implementing partners to monitor the safety of medicines. 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 was developed by the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, implemented by Management Sciences for Health (MSH).
- 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