Launch of a new web based pharmacovigilance system called PViMS
The US Agency for International Development (USAID)-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program, implemented by Management Sciences for Health, has launched a new, web-based pharmacovigilance management system called PViMS. PViMS enables health programs in low- and middle-income countries to follow recent World Health Organization (WHO) recommendations for implementing active drug safety monitoring and management (aDSM) when introducing new tuberculosis (TB) drugs and novel regimens.
Officially launched on July 6, 2016, PViMS helps to monitor serious adverse events for every drug resistant (DR)-TB patient and all DR-TB medicines, including new medicines such as bedaquiline and delamanid, in Georgia. Georgia is the first country to adopt this groundbreaking system to support serious adverse event monitoring for over 250 cases already enrolled on treatment with new TB medicines.
PViMS meets all WHO recommendations for an aDSM system and provides countries that are introducing bedaquiline with an easy-to-use electronic solution to the challenge of drug safety monitoring. The main features of PViMS include:
- Improved clinical documentation
- Standardized reporting terminology
- Causality assessment process
- Reports, frequency tables, and signal detection
- Customizable components
Developed to address an unmet need for national TB programs, PViMS can be used for all medicines across all health programs. Nino Lomtadze, Head of the National Center for Tuberculosis and Lung Disease Surveillance and Strategic Planning Department, observed “It is noteworthy that the established pharmacovigilance system can also be actively used in monitoring of other diseases. The electronic system allows us to assign the patients to different cohorts. Thus, the system could be also useful for Hepatitis C, HIV/AIDS, and other programs in Georgia.”
Because it strengthens health systems, PViMS is an important tool that can help national TB programs and pharmacovigilance professionals better manage risks associated with anti-TB medicines and ensure improved health outcomes for patients. Visit the SIAPS website http://newtbdruginfo.org/ to learn about the technical assistance SIAPS has provided to countries that are introducing bedaquiline.
SIAPS gratefully acknowledges the invaluable support of Nino Lomtadze; Eka Kokhreidze; Mari Buziashvili; and Dr. Zaza Avaliani, Director of the TB Center, all of whom contributed to the successful launch of PViMS in Georgia.
For more on this story, visit: http://siapsprogram.org/2016/07/25/siaps-launches-innovative-digital-health-tool-in-georgia-to-monitor-adverse-drug-reactions/
For more information on PViMS, visit http://siapsprogram.org/tools-and-guidance/pvims/
